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Item 1. Business

2026-03-12 compared with 2025-03-18 · 561 added, 527 removed, 662 unchanged (62% of the section changed)

ITEM 1 – BUSINESS

We are a biopharmaceutical company focused on

advancing innovative immuno-oncology technologies addressing difficult to treat cancers.

Our proprietary DNase technology is designed to

improve outcomes of existing treatments, including immunotherapies, by targeting NETs, which are involved in cancer growth, metastasis

and progression, and contribute to immunotherapy, chemotherapy and radiotherapy resistance.

The DNase technology is designed to target NETs,

which are weblike structures composed of extracellular chromatin coated with histones and other proteins.

NETs are expelled by activated

neutrophils in response to microbial or pro-inflammatory challenges.

However, excessive production or reduced clearance of NETs can lead

to aggravated inflammatory, hypercoagulability and autoimmune pathologies, as well as creation of pro-tumorigenic niches in the case of

cancer growth and metastasis.

We are focused on advancing the development of

our DNase technology toward a first-in-human, multicenter, dose escalation and dose-expansion study of IV rhDNase I in subjects with locally

We are a biopharmaceutical company focused on advancing

innovative immuno-oncology technologies addressing difficult to treat cancers.

Our proprietary DNase technology is designed to improve

outcomes of existing treatments, including immunotherapies, by targeting neutrophil extracellular traps (“NETs”), which are

involved in cancer growth, metastasis and progression, and contribute to immunotherapy, chemotherapy and radiotherapy resistance.

The DNase technology is designed to target NETs, which

are weblike structures composed of extracellular chromatin coated with histones and other proteins.

NETs are expelled by activated neutrophils

in response to microbial or pro-inflammatory challenges.

However, excessive production or reduced clearance of NETs can lead to aggravated

inflammatory, hypercoagulability and autoimmune pathologies, as well as creation of pro-tumorigenic niches in the case of cancer growth

and metastasis.

We are focused on advancing the development of our

DNase technology toward a first-in-human, multicenter, dose escalation and dose-expansion study of IV rhDNase I in subjects with locally

advanced or metastatic solid tumors.

Our systemic DNase program is initially targeting multi-billion-dollar indications including pancreatic

ductal adenocarcinoma (“PDAC”), colorectal carcinoma (“CRC”) and other gastrointestinal cancers.

These are all

cancer indications with significant unmet need, and with opportunities for substantial improvement of the currently available therapeutic

PDAC has a low rate of early diagnosis, a high mortality rate and a poor five-year survival prognosis.

Symptoms are usually non-specific

and as a result, PDAC is often not diagnosed until it reaches an advanced stage.

Once the disease has metastasized, or spread to other

organs, it becomes especially difficult to treat.

There were about approximately 511,000 new cases of pancreatic cancer globally in 2022

and according to the American Cancer Society, in 2025, an estimated 67,000 people in the U.S.

will be diagnosed with pancreatic cancer,

with approximately 52,000 deaths projected from the disease;

this translates to a high mortality rate, as the five-year relative survival

rate for pancreatic cancer remains around 13%, which constitutes the highest mortality rate among solid tumor malignancies;

diagnosed with metastatic disease, the overall five-year survival rate is only 2%.

Recent developments that have improved the survival

in many cancer types have not been effective for pancreatic cancer patients, highlighting the urgent need for the development of newer,

more effective therapeutic options.

For those few patients that present with earlier stage PDAC, surgical resection followed by chemotherapy

is possible, but for the majority of PDAC patients that present at diagnosis with advanced disease, chemotherapy is the only option, and

has only very limited benefit.

Second-line patients that were diagnosed already with metastatic disease have even fewer therapeutic options.

The only approved regimen for second-line patients is Onivyde®, a liposomal irinotecan in combination with 5FU and LV.

For these Stage

IV at diagnosis patients reaching second-line therapy, median overall survival is only 4.7 months (Macarulla et al, Pancreas 2020 ).

CRC is the second most common cause of cancer

death in the U.S.

cancer, including pancreatic ductal adenocarcinoma (“PDAC”), colorectal carcinoma (“CRC”) and other gastrointestinal

These are all cancer indications with significant unmet need, and with opportunities for substantial improvement of the currently

available therapeutic options.

PDAC has a low rate of early diagnosis, a high mortality

rate and a poor five-year survival prognosis.

Symptoms are usually non-specific and as a result, PDAC is often not diagnosed until it

reaches an advanced stage.

Once the disease has metastasized, or spread to other organs, it becomes especially difficult to treat.

there are over 500,000 new pancreatic cancers annually and according to the American Cancer Society, in 2025, an estimated 67,000 people

will be diagnosed with pancreatic cancer, with approximately 52,000 deaths projected from the disease;

this translates to

a high mortality rate, as the five-year relative survival rate for pancreatic cancer remains around 13%, which constitutes the highest

mortality rate among solid tumor malignancies;

among those diagnosed with metastatic disease, the overall five-year survival rate is only

Recent developments that have improved the survival in many cancer types have not been effective for pancreatic cancer patients, highlighting

the urgent need for the development of newer, more effective therapeutic options.

For those few patients that present with earlier stage

PDAC, surgical resection followed by chemotherapy is possible, but for the majority of PDAC patients that present at diagnosis with advanced

disease, chemotherapy is the only option, and has only very limited benefit.

Second-line patients that were diagnosed already with metastatic

disease have even fewer therapeutic options.

The only approved regimen for second-line patients is Onivyde®, a liposomal irinotecan

in combination with 5FU and LV.

For these Stage IV at diagnosis patients reaching second-line therapy, median overall survival is only

4.7 months (Macarulla et al, Pancreas 2020).

CRC is the second most common cause of cancer death

after lung cancer.

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to the World Health Organization GLOBOCAN database.

In the U.S., CRC is the second most common cause of cancer death after lung cancer.

According to the American Cancer Society, in 2025, an estimated 154,000 people in the US will be diagnosed with colorectal cancer, with

approximately 52,900 deaths expected from the disease;

this translates to around 107,000 new colon cancer cases and 47,000 new rectal

cancer cases.

CRC is in decline in older patients (>65 years) but that is offset by a steady increase in CRC diagnoses and deaths in

individuals younger than 55 years of age.

Despite continued overall declines, CRC is rapidly shifting to diagnosis at a younger age, at

a more advanced stage, and in the left colon/rectum.

If CRC is diagnosed at a localized stage, the 5-year survival rate is 91%.

if the cancer has spread to surrounding tissues or organs and/or the regional lymph nodes, the 5-year relative survival rate is 72%.

are numerous treatment options for earlier stage CRC patients, but as they progress to advanced and metastatic disease (“mCRC”),

those options become limited.

Approximately 22% of CRC cases have metastasis at presentation, and 19% will develop metastasis after primary

tumor removal.

Unfortunately, if CRC has spread to distant parts of the body, the 5-year relative survival rate is 13%.

According to the American Cancer Society, in 2025, an estimated 154,000 people in

the US will be diagnosed with colorectal cancer, with approximately 53,000 deaths expected from the disease;

this translates to around

107,000 new colon cancer cases and 47,000 new rectal cancer cases.

CRC is in decline in older patients (>65 years) but that is offset

by a steady increase in CRC diagnoses and deaths in individuals younger than 55 years of age.

Despite continued overall declines, CRC

is rapidly shifting to diagnosis at a younger age, at a more advanced stage, and in the left colon/rectum.

If CRC is diagnosed at a localized

stage, the 5-year survival rate is 91%.

However, if the cancer has spread to surrounding tissues or organs and/or the regional lymph nodes,

the 5-year relative survival rate is 72%.

There are numerous treatment options for earlier stage CRC patients, but as they progress to

advanced and metastatic disease (“mCRC”), those options become limited.

Approximately 22% of CRC cases have metastasis at

presentation, and 19% will develop metastasis after primary tumor removal.

Unfortunately, if CRC has spread to distant parts of the body,

the 5-year relative survival rate is 13%.

All major guidelines recommend patients with mCRC

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development of newer, more effective therapeutic options.

A substantial amount of scientific literature

has implicated NETs in the context of cancer pathogenesis and resistance to cancer therapies (including chemo, radio, and immunotherapies

A substantial amount of scientific literature has

implicated NETs in the context of cancer pathogenesis and resistance to cancer therapies (including chemo, radio, and immunotherapies

such as checkpoint inhibitors and cell therapies).

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adjunctive therapy for pancreatic carcinoma and locally advanced or metastatic solid tumors, including CRC.

Adoptive transfer of Chimeric Antigen Receptor

(“CAR”) T cells has emerged as one of the most promising advances in cancer immunotherapy.

CAR T cell therapy, while highly

effective against blood cancers, faces significant challenges when applied to solid tumors due to the complex tumor microenvironment which

hinders CAR T cell infiltration, persistence, and efficacy, making it difficult for them to reach and attack cancer cells within the solid

this includes barriers like dense connective tissue, abnormal blood vessels, and immunosuppressive cells that can exhaust

the CAR T cells, limiting their anti-tumor activity.

To successfully treat solid tumors, CAR T cells must be able to infiltrate, persist,

and maintain anti-tumor function in a hostile tumor microenvironment that is itself immunosuppressive and conducive to tumor cell survival

and metastasis.

Published evidence suggests that in addition to immunosuppressive factors, mechanical barriers formed by NETs can impede

T-cell penetration and occlude T-cell contact with tumor cells.

Recent approaches to CAR T design include “armored” CAR-T

cells, so named because they can express additional factors to resist immunosuppression or degrade physical components of the tumor’s

extracellular matrix, including NETs.

We intend to conduct pre-clinical research with the goal of demonstrating that armoring CAR T cells

to secrete DNase can support depth and durability of response against solid tumor indications.

Engineered CAR T cells, designed to recognize

cancer-associated antigens, are capable of sustained and selective killing of tumor cells, with substantial reduction of tumor burden.

The conduct of several CAR T in vivo models has been a primary focus of our Scripps collaboration.

Our collaboration with Belgian Volition SARL Limited

(“Volition”) is an early exploratory program to evaluate the potential combination of Volition’s Nu.Q® technology

and Xenetic’s DNase-Armored CAR T platform to develop proprietary adoptive cell therapies potentially targeting multiple types of

solid cancers for which current CAR T cell therapies have shown limited or no effect.

Under the terms of the collaboration agreement,

Volition will fund a research program and the two parties will share proceeds from commercialization or licensing of any products arising

from the collaboration.

Epigenetically modified nucleosomes are present on tumor cell surfaces and within the tumor microenvironment of

multiple types of solid cancers, and thus these nucleosomes may represent generalizable tumor antigens that are not limited to a single

Volition’s Nu.Q® technology can specifically recognize and target epigenetically modified nucleosomes, while our

DNase-Armored CAR T platform is designed to enhance the function of CAR T cells within solid tumor microenvironments.

Additionally, we have partnered with biotechnology

and pharmaceutical companies to develop our proprietary drug delivery platform, PolyXen, and receive royalty payments under an exclusive

license arrangement in the field of blood coagulation disorders.

PolyXen is an enabling platform technology for protein and peptide drug

It uses the biological polymer polysialic acid (“PSA”) to prolong the drug's half-life and potentially improve the

stability of therapeutic peptides and proteins.

Both the site of attachment and the length of the PSA chain can influence the properties

of the therapeutic by changing the apparent hydrodynamic radius of the molecule, which in turn, can enhance a number of the biological

characteristics of the therapeutic.

Adoptive transfer of Chimeric Antigen Receptor (“CAR”)

T cells has emerged as one of the most promising advances in cancer immunotherapy.

CAR T cell therapy, while highly effective against

blood cancers, faces significant challenges when applied to solid tumors due to the complex tumor microenvironment which hinders CAR T

cell infiltration, persistence, and efficacy, making it difficult for them to reach and attack cancer cells within the solid tumor mass;

this includes barriers like dense connective tissue, abnormal blood vessels, and immunosuppressive cells that can exhaust the CAR T cells,

limiting their anti-tumor activity.

To successfully treat solid tumors, CAR T cells must be able to infiltrate, persist, and maintain

anti-tumor function in a hostile tumor microenvironment that is itself immunosuppressive and conducive to tumor cell survival and metastasis.

Published evidence suggests that in addition to immunosuppressive factors, mechanical barriers formed by NETs can impede T-cell penetration

and occlude T-cell contact with tumor cells.

Recent approaches to CAR T design include “armored” CAR-T cells, so named because

they can express additional factors to resist immunosuppression or degrade physical components of the tumor’s extracellular matrix,

including NETs.

We intend to conduct pre-clinical research with the goal of demonstrating that armoring CAR T cells to secrete DNase can

support depth and durability of response against solid tumor indications.

Engineered CAR T cells, designed to recognize cancer-associated

antigens, are capable of sustained and selective killing of tumor cells, with substantial reduction of tumor burden.

The conduct of several

CAR T in vivo models has been a primary focus of our Scripps collaboration.

We have partnered with biotechnology and pharmaceutical

companies to develop our proprietary drug delivery platform, PolyXen, and receive royalty payments under an exclusive license arrangement

in the field of blood coagulation disorders.

PolyXen is an enabling platform technology for protein and peptide drug delivery.

the biological polymer polysialic acid (“PSA”) to prolong the drug's half-life and potentially improve the stability of therapeutic

peptides and proteins.

Both the site of attachment and the length of the PSA chain can influence the properties of the therapeutic by

changing the apparent hydrodynamic radius of the molecule, which in turn, can enhance a number of the biological characteristics of the

It can also be used for small molecule drugs.

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efforts in 2025 was on the licensing and advancement of our DNase technology.

We were incorporated under the laws of the State

of Nevada in August 2011.

We were incorporated under the laws of the State of

Nevada in August 2011.

We, directly or indirectly, through our wholly-owned subsidiaries, Hesperix S.A.

(“Hesperix”) and

Xenetic Biosciences (U.K.) Limited (“Xenetic U.K.”), and the wholly-owned subsidiaries of Xenetic UK, Lipoxen Technologies

Limited (“Lipoxen”), Xenetic Bioscience, Incorporated and SymbioTec, GmbH (“SymbioTec”), own various U.S.

trademark registrations and applications, along with unregistered trademarks and service marks, including but not limited to XCART, OncoHist,

PolyXen, ErepoXen and ImuXen.

(“Hesperix”) and Xenetic

Biosciences (U.K.) Limited (“Xenetic U.K.”), and the wholly-owned subsidiaries of Xenetic UK, Lipoxen Technologies Limited

(“Lipoxen”), Xenetic Bioscience, Incorporated and SymbioTec, GmbH (“SymbioTec”), own various U.S.

federal trademark

registrations and applications, along with unregistered trademarks and service marks, including but not limited to XCART, OncoHist, PolyXen,

ErepoXen and ImuXen.

Our primary focus is aimed at advancing the systemic

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DNase for other uses and indications.

We intend to pursue orphan drug designations and

accelerated approval pathways for relevant oncology indications as appropriate in both the U.S.

If our orphan oncology drug

candidates are granted orphan drug designation, then we may benefit from certain key advantages of orphan status including certain market

exclusivities.

We intend to advance development of our DNase

technology primarily through the use of contract manufacturing, contract research organizations (“CROs”) and academic institutions

in order to efficiently manage our resources.

Continuous pipeline growth and advancement of out-licensed drug candidates is dependent,

in part, on our ability to raise sufficient capital and to advance our existing co-development collaborations and strategic arrangements

We intend to pursue orphan and orpha drug designations

and accelerated approval pathways for relevant oncology indications as appropriate in both the U.S.

If our orphan oncology

drug candidates are granted orphan drug designation, then we may benefit from certain key advantages of orphan status including certain

market exclusivities.

We intend to advance development of our DNase technology

primarily through the use of contract manufacturing, contract research organizations (“CROs”) and academic institutions in

order to efficiently manage our resources.

Continuous pipeline growth and advancement of out-licensed drug candidates is dependent, in

part, on our ability to raise sufficient capital and to advance our existing co-development collaborations and strategic arrangements

as well as enter into new such arrangements.

Business Developments

University of Virginia (“UVA”)

On December 21, 2023, we entered into a Research

Funding and Material Transfer Agreement with UVA (the “UVA Agreement”) to advance the development of our systemic DNase program.

Under the terms of the UVA Agreement, i n addition to

advancing our existing intellectual property, we have an option to acquire an exclusive license to any new intellectual property arising

from the DNase research program.

Allan Tsung, MD, a member of the Company’s Scientific Advisory Board and Chair of the Department

of Surgery at the UVA School of Medicine, oversees the research conducted under the UVA Agreement.

In November 2024, we entered into an amendment to extend the term of the UVA Agreement through December 2025.

UVA will build on the preclinical

and translational data produced to date and continue to investigate combinations of DNase I with immunotherapies in models of primary

and metastatic colorectal cancer.

Scripps Research Institute (“Scripps

On March 17, 2023, we entered into a Research

Funding and Option Agreement (the “Agreement”) with Scripps Research, pursuant to which we agreed to provide Scripps Research

an aggregate of up to $0.9 million to fund research relating to advancing the pre-clinical development of our DNase

Under the Agreement, we have the option to acquire a worldwide exclusive license to Scripps Research’s rights in the

Technology or Patent Rights (as defined in the Agreement), as well as a non-exclusive, royalty-free, non-transferrable license to make

and use TSRI Technology (as defined in the Agreement) solely for our internal research purposes during the performance of the research

program contemplated by the Agreement.

During the second quarter of 2024, the Company amended the Agreement to extend the term to October

31, 2024 with no additional funding required.

On November 1, 2024, we entered into a Second

Amendment to the Agreement with Scripps Research (the “Second Amendment”) extending the term of the Agreement for an additional

twelve (12) month period and to provide Scripps Research additional funding in an aggregate amount of up to approximately $400,000 to

fund continuing research.

Strategic Review Process

While we believe our DNase platform technology holds

promise, given we are in early stage development, we have initiated a formal strategic review process with the assistance of outside financial

and legal advisors.

We are considering a wide range of alternatives to maximize shareholder value, including, but not limited to, the

sale of all or part of the Company or its assets or a business combination, including a “reverse merger”, share exchange or

similarly structured transaction.

An independent committee of the Board has engaged in preliminary discussions with third parties regarding

potential transactions.

Any such completed transaction could have a significant impact on the Company’s stockholders, including

if the transaction would result in the current investors of the counterparty holding a substantial majority of the Company’s outstanding

common stock following consummation of the potential transaction.

Given the preliminary stage of such discussions, at this time there

is no way to quantify the potential impact of a transaction, if any.

There is no deadline or definitive timetable set for the completion

of the strategic alternatives process, and there can be no assurance any proposal will be made or accepted, any agreement will be executed,

or any transaction will be consummated in connection with this review.

In addition, if we do enter into definitive agreements with respect

to a potential transaction, we expect that consummation of the potential transaction would be subject to a number of conditions, including

approval by our stockholders and Nasdaq, and other customary conditions, which would be out of our control and may never be satisfied.

We remain committed to advancing our DNase technology and do not intend to make further announcements regarding the review process unless

and until the Board approves a specific transaction or otherwise determines that further disclosure is appropriate.

PeriNess Ltd (“PeriNess”)

During the fourth quarter of 2024, we entered into

a clinical trial services agreement with PeriNess, a privately held Israeli company, to advance our development program for our systemic

DNase I oncology program in combination with chemotherapy and immunotherapy platforms for the treatment of pancreatic carcinoma, colorectal

cancer and other locally advanced or metastatic solid tumors toward institutional, investigator led exploratory studies in Israel.

this agreement, PeriNess has announced the dosing of patients in an exploratory study of systemic DNase I in combination with Folfirinox

for the first line treatment of unresectable, locally advanced or metastatic pancreatic cancer at Bnei Zion Medical Center.

PeriNess announced that it had entered into a clinical study agreement with the Tel-Aviv Sourasky Medical Center in Israel to support

an exploratory study of DNase I in combination with anti-CD 19 CAR T cells in patients with large B cell lymphoma.

Scripps Research Institute (“Scripps Research”)

On March 17, 2023, we entered into a Research Funding

and Option Agreement (the “Scripps Agreement”) with Scripps Research, pursuant to which we agreed to provide Scripps Research

an aggregate of up to $0.9 million to fund research relating to advancing the pre-clinical development of our DNase technology.

the Scripps Agreement, we have the option to acquire a worldwide exclusive license to Scripps Research’s rights in the Technology

or Patent Rights (as defined in the Scripps Agreement), as well as a non-exclusive, royalty-free, non-transferrable license to make and

use TSRI Technology (as defined in the Scripps Agreement) solely for our internal research purposes during the performance of the research

program contemplated by the Scripps Agreement.

During the second quarter of 2024, the Company amended the Scripps Agreement to extend

the term to October 31, 2024 with no additional funding required.

On November 1, 2024, we entered into a Second Amendment

to the Scripps Agreement with Scripps Research (the “Second Amendment”) extending the term of the Scripps Agreement for an

additional twelve (12) month period and to provide Scripps Research additional funding in an aggregate amount of up to approximately $400,000

to fund continuing research.

The research funding is payable by us to Scripps Research on a monthly basis in accordance with a negotiated

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approximately $65,000 over a 5-month period.

All other terms of the Original Agreement remain unchanged.

All other terms of the Scripps Agreement remain unchanged.

Effective May 1, 2025, we entered into a Third Amendment

to the Scripps Agreement with Scripps Research (the “Third Amendment”), pursuant to which we expanded the services to be performed

under the Scripps Agreement and provided Scripps Research additional funding in an aggregate amount of up to approximately $0.4 million

to fund continuing research.

The research funding is payable by us to Scripps Research on a monthly basis in accordance with a negotiated

budget, which provides for an initial payment of approximately $70,000 on the date of the Third Amendment and subsequent monthly payments

of approximately $70,000 over a 5-month period.

All other terms of the Scripps Agreement remain unchanged.

Effective November 1, 2025, we entered into a Fourth

Amendment to the Scripps Agreement with Scripps Research (the “Fourth Amendment”), pursuant to which we extended and expanded

the services to be performed under the Scripps Agreement and provided Scripps Research with additional funding in an aggregate amount

of up to approximately $0.3 million.

The research funding is payable by us to Scripps Research on a monthly basis in accordance with a

negotiated budget, which provides for an initial payment of approximately $85,000 on the effective date of the Fourth Amendment and subsequent

monthly payments of approximately $85,000 over a 3-month period.

All other terms of the Scripps Agreement remain unchanged.

Effective March 1, 2026, we entered into a Fifth

Amendment to the Scripps Agreement with Scripps Research (the “Fifth Amendment”), pursuant to which we extended and expanded

the services to be performed under the Scripps Agreement and agreed to provide Scripps Research additional funding in an aggregate amount

of up to approximately $0.5 million.

The research funding is payable by us to Scripps Research on a monthly basis in accordance with a

negotiated budget, which provides for an initial payment of approximately $80,000 on the effective date of the Fifth Amendment and subsequent

monthly payments of approximately $80,000 over a 5-month period.

All other terms of the Scripps Agreement remain unchanged.

University of Virginia (“UVA”)

On December 21, 2023, we entered into a Research Funding

and Material Transfer Agreement with UVA (the “UVA Agreement”) to advance the development of our systemic DNase program.

the terms of the UVA Agreement, i n addition to advancing our existing intellectual property,

we have an option to acquire an exclusive license to any new intellectual property arising from the DNase research program.

MD, a member of the Company’s Scientific Advisory Board and Chair of the Department of Surgery at the UVA School of Medicine,

oversees the research conducted under the UVA Agreement.

In November 2024, we entered into an amendment

to extend the term of the UVA Agreement through December 2025.

UVA produced preclinical and translational data under the UVA Agreement

and has investigated combinations of DNase I with immunotherapies in models of primary and metastatic colorectal cancer.

The Company is

currently in discussions with UVA concerning completion of current activities and expansion of the scope of work under the UVA Agreement.

Our Technology and Drug Candidates

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of our internal development efforts was on the advancement of our DNase technology.

We have not been actively pursuing development

efforts for XCART or PolyXen or any of our other technologies.

The DNase technology is designed to target NETs,

which are weblike structures composed of extracellular chromatin coated with histones and other proteins.

NETs are expelled by activated

neutrophils, in response to microbial or pro-inflammatory challenges.

However, excessive production or reduced clearance of NETs can lead

to aggravated inflammatory and autoimmune pathologies, as well as creation of pro-tumorigenic niches in the case of cancer growth and

We have not been actively pursuing development efforts

for XCART or PolyXen or any of our other technologies.

The DNase technology is designed to target NETs, which

are weblike structures composed of extracellular chromatin coated with histones and other proteins.

NETs are expelled by activated neutrophils,

in response to microbial or pro-inflammatory challenges.

However, excessive production or reduced clearance of NETs can lead to aggravated

inflammatory and autoimmune pathologies, as well as creation of pro-tumorigenic niches in the case of cancer growth and metastasis.

Program Highlights:

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Systemic DNase program initially targeting multi-billion-dollar indications including pancreatic carcinoma and other locally advanced or metastatic solid tumors including CRC;

Ongoing collaboration with UVA to advance the development of our systemic DNase program;

DNase-armored CAR T program in early pre-clinical development;

Collaboration with UVA to advance the development of our systemic DNase program;

Pre-clinical development related to DNase-armored CAR T program has been completed;

Advancing mechanism-of-action and translational studies related to DNase-armored CAR T program;

Ongoing collaboration with Scripps Research to conduct several CAR T in vivo models and enhance the function of CAR T cells within solid tumor microenvironments;

Exploratory studies in pancreatic cancer and large B cell lymphoma being conducted in Israel medical centers;

Research, Outside Services and Collaborations

Through partner efforts, we are developing our

pipeline of next-generation bio-therapeutics and novel oncology drugs based on our DNase proprietary technology.

In order to do this while

efficiently managing our overhead, we rely on the services of contract manufacturers, CROs and our strategic collaborations.

do not have in-house research facilities to pursue these initiatives.

Through partner efforts, we are developing our pipeline

of next-generation bio-therapeutics and novel oncology drugs based on our DNase proprietary technology.

In order to do this while efficiently

managing our overhead, we rely on the services of contract manufacturers, CROs and our strategic collaborations.

We currently do not have

in-house research facilities to pursue these initiatives.

Accordingly, continuous pipeline growth and advancement of our technologies

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treatments across multiple modalities;

PJSC Pharmsynthez (“Pharmsynthez”), including its wholly-owned subsidiary SynBio LLC (“SynBio”), a beneficial owner of approximately 3.4% of our common stock;

Scripps Research, one of the world’s largest, private non-profit research organizations;

The University of Virginia, a non-profit, educational, research and healthcare institution;

PeriNess, a privately held Israeli company focused on the use of DNase I in male infertility.

Accordingly, in addition to pursuing our development

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However, other than royalty payments under a sublicense with Takeda Pharmaceutical Co.

with its wholly-owned subsidiaries, “Takeda”) and potential royalty payments under our collaboration agreement with Pharmsynthez,

we do not anticipate any milestone or royalty payments in the near term, if at all.

For further detail, please read the section titled

“Significant Collaborations and Strategic Arrangements” below.

with its wholly-owned subsidiaries, “Takeda”) and potential royalty payments under our collaboration agreement with PJSC Pharmsynthez

(“Pharmsynthez”), we do not anticipate any milestone or royalty payments in the near term, if at all.

For further detail,

please read the section titled “Significant Collaborations and Strategic Arrangements” below.

Our Drug Candidate Pipeline

Our product pipeline contains drug candidates

under development internally and with our biotechnology and pharmaceutical collaborators.

The following table summarizes key information

regarding our current drug candidates:

Our product pipeline contains drug candidates under

development internally and with our biotechnology and pharmaceutical collaborators.

The following table summarizes key information regarding

our current drug candidates:

ErepoXen, or polysialylated erythropoietin (“PSA-EPO”),

uses our PolyXen platform technology for the treatment of anemia in chronic kidney disease (“CKD”) patients.

It is designed

to reduce the dosing frequency by extending the circulating half-life of the therapeutic in the body.

We are not pursuing clinical development

of ErepoXen but continue to entertain out-license opportunities for the drug candidate in our licensed territories.

uses our legacy PolyXen platform technology for the treatment of anemia in chronic kidney disease (“CKD”) patients.

designed to reduce the dosing frequency by extending the circulating half-life of the therapeutic in the body.

We are not pursuing clinical

development of ErepoXen but continue to entertain out-license opportunities for the drug candidate in our licensed territories.

We have collaboration agreements with Pharmsynthez

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our PolyXen technology.

Pharmsynthez filed a registration dossier to obtain approval in Russia and received a response letter indicating

certain deficiencies in the dossier.

Pharmsynthez developed a gap mitigation strategy and is currently determining next steps.

Serum Institute conducted Phase I and Phase II

clinical trials of ErepoXen in ninety-five human subjects.

These safety trials, which had no significant drug-related adverse events,

provided us with the data to commence a Phase II, repeat dosing, International Conference on Harmonisation of Technical Requirements for

Pharmaceuticals for Human Use compliant clinical trial for ErepoXen in Australia, New Zealand and South Africa for CKD patients not on

We completed three cohorts of this study and then terminated the study.

In addition, Serum Institute finished Phase I/II

clinical trials in India of ErepoXen for in-center-dialysis patients.

Serum Institute is not actively pursuing this program but may seek

to leverage Pharmsynthez’ trial data and potential Russian marketing authorization to request a waiver for a Phase III clinical

trial in India, subject to local regulatory authority approval.

Pharmsynthez filed a registration dossier to obtain approval in Russia and informed us that it had received a

response letter indicating certain deficiencies in the dossier.

Pharmsynthez further informed the Company that they developed a gap mitigation

strategy and are awaiting further feedback from regulatory authorities.

Serum Institute informed the Company that it finished

Phase I/II clinical trials in India of ErepoXen for in-center-dialysis patients.

Serum Institute further informed the Company that it

is not actively pursuing this program but may seek to leverage Pharmsynthez’ trial data and potential Russian marketing authorization

to request a waiver for a Phase III clinical trial in India, subject to local regulatory authority approval.

Pipeline Expansion Opportunities

Operating under licenses from us within their

home markets, our collaborators can potentially generate preclinical and clinical data related to our technologies across a wide spectrum

of therapeutic areas.

Operating under licenses from us within their home

markets, our collaborators can potentially generate preclinical and clinical data related to our technologies across a wide spectrum of

therapeutic areas.

Under these agreements, we retain all rights for major markets and co-own the clinical data.

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Significant Collaborations and Strategic Arrangements

Significant collaborations with UVA and Scripps Research are described

above under the “Business Developments” section of this Item 1 to Part I of the Form 10-K.

In October 2017, the Company granted to Takeda

the right to grant a non-exclusive sublicense to certain patents related to the Company’s PolyXen technology that were previously

exclusively licensed to Takeda in connection with products related to the treatment of blood and bleeding disorders.

Royalty payments

of approximately $2.5 million were recorded as revenue for each year by the Company during the years ended December 31, 2024 and 2023

and are based on single digit royalties on net sales of certain covered products.

Belgian Volition SARL Limited (“Volition”)

Collaboration

On August 2, 2022, we announced a research and

development collaboration with Volition to develop NETs-targeted adoptive cell therapies for the treatment of cancer.

The collaboration

is an early exploratory program to evaluate the potential combination of Volition’s Nu.Q ® Technology Test and our

DNase-Armored CAR T platform to develop proprietary adoptive cell therapies potentially targeting multiple types of solid cancers.

the terms of the collaboration agreement, Volition will fund a research program and the two parties will share proceeds from commercialization

or licensing of any products arising from the collaboration.

Significant collaborations with Scripps Research, PeriNess and UVA are

described above under the “Business Developments” section of this Item 1 to Part I of the Form 10-K.

In October 2017, the Company granted to Takeda the

right to grant a non-exclusive sublicense to certain patents related to our PolyXen technology that were previously exclusively licensed

to Takeda in connection with products related to the treatment of blood and bleeding disorders.

Royalty payments of approximately $3.0

million and $2.5 million were recorded as revenue by us during the years ended December 31, 2025 and 2024 and are based on single digit

royalties on net sales of certain covered products.

Catalent Pharma Solutions LLC (“Catalent”)

On June 30, 2022, we entered into a Statement

of Work (the “SOW”) with Catalent to outline the general scope of work, timeline, and pricing pursuant to which Catalent will

provide certain services to the Company to perform current Good Manufacturing Principles (“cGMP”) manufacturing of the Company’s

On June 30, 2022, we entered into a Statement of Work

(the “SOW”) with Catalent to outline the general scope of work, timeline, and pricing pursuant to which Catalent will provide

certain services to the Company to perform current Good Manufacturing Practices (“cGMP”) manufacturing of the Company’s

recombinant protein, Human DNase I.

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of Pharmsynthez.

Our collaborative partners continued to engage in research and development activities with no resultant commercial products

through December 31, 2024.

No amounts were recognized as revenue related to the Serum Institute, Pharmsynthez or SynBio agreements during

each of the years ended December 31, 2024 and 2023.

Our collaborative partners continued to engage in research and development activities with our legacy technologies as

discussed above with no resultant commercial products through December 31, 2025.

No amounts were recognized as revenue related to the

Serum Institute, Pharmsynthez or SynBio agreements during each of the years ended December 31, 2025 and 2024.

Our Intellectual Property

We strive to protect and enhance the proprietary

technology, inventions and improvements that are commercially important to our business, including seeking, maintaining and defending

patent rights, whether developed internally or licensed from our collaborators or other third parties.

Our policy is to seek to protect

our proprietary position by, among other methods, filing patent applications in the U.S.

We strive to protect and enhance the proprietary technology,

inventions and improvements that are commercially important to our business, including seeking, maintaining and defending patent rights,

whether developed internally or licensed from our collaborators or other third parties.

Our policy is to seek to protect our proprietary

position by, among other methods, filing patent applications in the U.S.

and in jurisdictions outside of the U.S.

our proprietary technology, inventions, improvements and product candidates that are important to the development and implementation of

our business.

We also rely on trade secrets and know-how relating to our proprietary technology and product candidates, continuing innovation

and in-licensing opportunities to develop, strengthen and maintain our proprietary position in the field of oncology.

We also plan to

rely on data exclusivity, market exclusivity and patent term and supplemental patent certificate extensions when available.

Our commercial

success will depend in part on our ability to obtain and maintain patent and other proprietary protection for our technology, inventions

and improvements;

to preserve the confidentiality of our trade secrets;

to obtain and maintain licenses to use intellectual property owned

by third parties;

covering our proprietary

technology, inventions, improvements and product candidates that are important to the development and implementation of our business.

We also rely on trade secrets and know-how relating to our proprietary technology and product candidates, continuing innovation and in-licensing

opportunities to develop, strengthen and maintain our proprietary position in the field of oncology.

We also plan to rely on data exclusivity,

market exclusivity and patent term and supplemental patent certificate extensions when available.

Our commercial success will depend in

part on our ability to obtain and maintain patent and other proprietary protection for our technology, inventions and improvements;

preserve the confidentiality of our trade secrets;

to obtain and maintain licenses to use intellectual property owned by third parties;

to defend and enforce our proprietary rights, including any patents that we may own in the future;

and to operate without

infringing on the valid and enforceable patents and other proprietary rights of third parties.

and to operate without infringing on

the valid and enforceable patents and other proprietary rights of third parties.

Our drug candidates are in various stages of development,

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in certain other developed countries.

Our first issued patents began to expire in 2021 with the remaining PolyXen technology expiring

As these PolyXen related patents approach their expiration, we have not renewed these patents for the last years of their life.

Our XCART and XDNASE patent families include patent applications that were recently filed, with those most recently filed having an expiration

date of 2042.

Our first issued patents expired in 2021 with the remaining PolyXen technology expiring over the

next few years as we are not renewing patents and pending patent applications related to our legacy PolyXen technology going forward.

Our DNase patent families include patent applications that were recently filed, with those most recently filed having an expiration date

Our patent strategy is to file patent applications

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These jurisdictions generally include for our key patent portfolios, but are not limited to, the

U.S., U.K., Australia, Japan, Canada, South Korea, China, India, Russia and certain other countries in the European Union (“E.U.”),

U.S., U.K., Australia, Japan, Canada, South Korea, Israel, China, India, Russia and certain other countries in the European Union (“E.U.”),

though we do not necessarily file a patent application in each of these jurisdictions for every patent family.

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This number includes patents and patent applications that we have acquired or filed covering various aspects of our

XDNASE and XCART platform technology, including all rights throughout the world in and to patents and patent applications related to “Articles

And Methods Directed To Personalized Therapy Of Cancer,” and our PolyXen platform technology covering polysialylation and advanced

polymer conjugate technologies, respectively, as well as our other product candidates.

More specifically, our patents and patent applications

cover cancer treatments, method of use, drug conjugates, formulations, along with methods of administering polymer conjugates.

We have also received patent protection for our

XDNASE technology, which covers the use of DNase for the treatment of cancer and amelioration of the side effects associated with a cancer

DNase and XCART platform technology, including all rights throughout the world in and to patents and patent applications related to “Articles

And Methods Directed To Personalized Therapy Of Cancer.” as well as our other product candidates.

More specifically, our patents

and patent applications cover cancer treatments, method of use, drug conjugates, formulations, along with methods of administering polymer

We have also received patent protection for our DNase

technology, which covers the use of DNase for the treatment of cancer and amelioration of the side effects associated with a cancer treatment.

The DNase can be administered alone or in combination with a cancer therapeutic.

This portfolio and that of the XCART portfolio

also provide coverage for the use of certain types of CAR-T cells, with or without the addition of a DNase to treat a cancer.

The portfolio

further covers the use of CAR-T cells with or without DNase that are administered with an immune checkpoint inhibitor or modulator to

treat a cancer.

This portfolio provides coverage for the use of certain

types of CAR-T cells, with or without the addition of a DNase to treat a cancer.

The portfolio further covers the use of CAR-T cells with

or without DNase that are administered with an immune checkpoint inhibitor or modulator to treat a cancer.

Issued patents can provide protection for varying

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the validity and enforceability of the patent.

In certain situations, where we work with drugs

covered by one or more patents, our ability to develop and commercialize our technologies may be affected by limitations of our access

to these proprietary drugs.

Even if we believe we are free to work with a proprietary drug, we cannot guarantee that we will not be accused

of, or be determined to be, infringing on a third party’s rights and be prohibited from working with the drug or found liable for

Any such restriction on access or liability for damages would have a material adverse effect on our business, results of operations

and financial condition.

In certain situations, where we work with drugs covered

by one or more patents, our ability to develop and commercialize our technologies may be affected by limitations of our access to these

proprietary drugs.

Even if we believe we are free to work with a proprietary drug, we cannot guarantee that we will not be accused of,

or be determined to be, infringing on a third party’s rights and be prohibited from working with the drug or found liable for damages.

Any such restriction on access or liability for damages would have a material adverse effect on our business, results of operations and

financial condition.

The patent positions of pharmaceutical and biotechnology

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Further, we understand that if any of our pending patent applications do not issue,

or are deemed invalid following issuance, we may lose valuable IP protection.

or are deemed invalid following issuance, we may lose valuable intellectual property ( IP) protection.

and foreign patent rights and other proprietary

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Further, we may not be able to obtain IP licenses related to the development of our drug candidates on a commercially reasonable basis,

It is our policy to require our employees and

consultants, outside scientific collaborators, sponsored researchers and other advisors who receive confidential information from us to

execute confidentiality agreements upon the commencement of employment or consulting relationships with us.

These agreements provide that

all confidential information developed or made known to the individual during the course of the individual’s relationship with us

is to be kept confidential and not disclosed to third parties except in specific circumstances.

The agreements provide that all inventions

conceived by an employee shall be our property.

There can be no assurance, however, that these agreements will provide meaningful protection

or adequate remedies for our trade secrets in the event of unauthorized use or disclosure of such information.

It is our policy to require our employees and consultants,

outside scientific collaborators, sponsored researchers and other advisors who receive confidential information from us to execute confidentiality

agreements upon the commencement of employment or consulting relationships with us.

These agreements provide that all confidential information

developed or made known to the individual during the course of the individual’s relationship with us is to be kept confidential

and not disclosed to third parties except in specific circumstances.

The agreements provide that all inventions conceived by an employee

shall be our property.

There can be no assurance, however, that these agreements will provide meaningful protection or adequate remedies

for our trade secrets in the event of unauthorized use or disclosure of such information.

Manufacturing and Supply

We do not have the capability to manufacture our

own materials necessary to support our drug candidate development programs nor do we intend to acquire such capability as part of our

present business strategy.

We currently have the SOW in place with Catalent to produce clinical materials for use in the development of

drug candidates involving our DNase technology.

We do not have the capability to manufacture our own

materials necessary to support our drug candidate development programs nor do we intend to acquire such capability as part of our present

business strategy.

We currently have the SOW in place with Catalent to produce clinical materials for use in the development of drug candidates

involving our DNase technology.

Government Regulation

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Drug Development Process

In the U.S., the FDA regulates drugs under the

Federal Food, Drug, and Cosmetic Act (“FDCA”), and in the case of biologics, also under the Public Health Service Act (“PHSA”)

and the FDCA, and their 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.

to comply with the applicable U.S.

requirements at any time during the product development process, approval process or after approval

may subject an applicant to administrative actions or judicial sanctions.

These actions or sanctions could include the FDA’s refusal

to approve pending applications, withdrawal of an approval, required additional studies, license revocation, a clinical hold, warning

letters or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions,

fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.

Any agency or judicial enforcement

action could have a material adverse effect on us.

In the U.S., the FDA regulates drugs under the Federal

Food, Drug, and Cosmetic Act (“FDCA”), and in the case of biologics, also under the Public Health Service Act and the FDCA,

and their 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 U.S.

requirements at any time during the product development process, approval process or after approval may subject

an applicant to administrative actions or judicial sanctions.

These actions or sanctions could include the FDA’s refusal to approve

pending applications, withdrawal of an approval, required additional studies, license revocation, a clinical hold, warning letters or

untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals

of government contracts, restitution, disgorgement or civil or criminal penalties.

Any agency or judicial enforcement action could have

a material adverse effect on us.

Prior to marketing a drug or biologic in the U.S.

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completion of preclinical laboratory tests, animal studies and formulation studies in accordance with Good Laboratory Practices (“GLP”) regulations and other applicable regulations;

submission to the FDA of an IND, which must become effective before human clinical trials may begin;

submission to the FDA of an Investigational New Drug (“IND”), which must become effective before human clinical trials may begin;

performance of adequate and well-controlled human clinical trials in accordance with Good Clinical Practice (“GCP”) regulations to establish the safety and efficacy of the proposed drug for its intended use;

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FDA review and approval of the NDA or BLA.

The drug or biologic manufacturer may also be

subject to post-approval regulatory requirements.

Once a pharmaceutical candidate is identified for development, it enters the preclinical

testing stage.

The drug or biologic manufacturer may also be subject

to post-approval regulatory requirements.

Once a pharmaceutical candidate is identified for development, it enters the preclinical testing

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

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.

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the hold has been lifted.

All clinical trials must be conducted under the

supervision of one or more qualified investigators in accordance with GCP regulations.

They must be conducted under protocols detailing

the objectives of the trial, dosing procedures, subject selection and exclusion criteria and the safety and effectiveness criteria to

be evaluated.

Each protocol must be submitted to the FDA as part of the IND, and timely safety reports must be submitted to the FDA if

any serious and unexpected adverse events occur.

An institutional review board (“IRB”) at each institution participating in

the clinical trial (or in some cases an independent IRB) must review and approve each protocol before a clinical trial commences at that

As part of its review, the IRB must also approve the information regarding the trial and the consent form that must be provided

to each trial subject or his or her legal representative, monitor the study until completion and otherwise comply with IRB regulations.

All clinical trials must be conducted under the supervision

of one or more qualified investigators in accordance with GCP regulations.

They must be conducted under protocols detailing the objectives

of the trial, dosing procedures, subject selection and exclusion criteria and the safety and effectiveness criteria to be evaluated.

protocol must be submitted to the FDA as part of the IND, and timely safety reports must be submitted to the FDA if any serious and unexpected

adverse events occur.

An institutional review board (“IRB”) at each institution participating in the clinical trial (or in

some cases an independent IRB) must review and approve each protocol before a clinical trial commences at that institution.

its review, the IRB must also approve the information regarding the trial and the consent form that must be provided to each trial subject

or his or her legal representative, monitor the study until completion and otherwise comply with IRB regulations.

Human clinical trials are typically conducted in three sequential phases

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These clinical trials are intended to establish the overall risk-benefit ratio of the drug candidate and provide, if appropriate, an adequate basis for product labeling.

Post-approval trials, sometimes referred to as

Phase IV studies, may be conducted after initial marketing approval.

Post-approval trials, sometimes referred to as Phase

IV studies, may be conducted after initial marketing approval.

These trials are used to gain additional experience from the treatment

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as a condition of approval of an NDA or BLA.

The FDA or the sponsor may suspend a clinical

trial at any time on various grounds, including a finding that the research subjects 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.

some clinical trials are overseen by an independent group of qualified experts organized by the sponsor, known as a data safety monitoring

board or committee.

Depending on its charter, this group may determine whether a trial may move forward at designated check points based

on access to certain data from the trial.

Concurrent with clinical trials, sponsors 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 FDA or the sponsor may suspend a clinical trial

at any time on various grounds, including a finding that the research subjects are being exposed to an unacceptable health risk.

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.

In addition, some clinical

trials are overseen by an independent group of qualified experts organized by the sponsor, known as a data safety monitoring board or

Depending on its charter, this group may determine whether a trial may move forward at designated check points based on access

to certain data from the trial.

Concurrent with clinical trials, sponsors 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

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Market Approval Process

The results of product development, preclinical

and other non-clinical 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 will be submitted to the FDA as part of an NDA or BLA requesting

The results of product development, preclinical and

other non-clinical 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 will be submitted to the FDA as part of an NDA or BLA requesting

approval to market the product.

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to review before the FDA accepts it for filing.

Once the submission is accepted for filing, the

FDA begins an in-depth substantive review.

Once the submission is accepted for filing, the FDA

begins an in-depth substantive review.

The FDA may refer the NDA or BLA to an advisory committee for review, evaluation and recommendation

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an NDA or BLA, the FDA will inspect the facility or facilities where the product is manufactured.

After the FDA evaluates an NDA or BLA, it will

issue an approval letter or a Complete Response Letter.

An approval letter authorizes commercial marketing of the drug with prescribing

information for specific indications.

A Complete Response Letter indicates that the review cycle of the application is complete and the

application will not be approved in its present form.

A Complete Response Letter usually describes the specific deficiencies in the NDA

or BLA identified by the FDA and may require additional clinical data, such as an additional pivotal Phase III trial or other significant

and time-consuming requirements related to clinical trials, nonclinical studies or manufacturing.

If a Complete Response Letter is issued,

the sponsor must resubmit the NDA or BLA, addressing all of the deficiencies identified in the letter, or withdraw the application.

if such data and information are submitted, the FDA may decide that the NDA or BLA does not satisfy the criteria for approval.

If a product receives regulatory approval, the

approval may be significantly limited to specific diseases and dosages or the indications for use may otherwise be limited, which could

restrict the commercial value of the product.

In addition, the FDA may require a sponsor to conduct Phase IV testing, which involves clinical

trials designed to further assess a drug’s safety and effectiveness after NDA or BLA approval, and may require testing and surveillance

After the FDA evaluates an NDA or BLA, it will issue

an approval letter or a Complete Response Letter.

An approval letter authorizes commercial marketing of the drug with prescribing information

for specific indications.

A Complete Response Letter indicates that the review cycle of the application is complete and the application

will not be approved in its present form.

A Complete Response Letter usually describes the specific deficiencies in the NDA or BLA identified

by the FDA and may require additional clinical data, such as an additional pivotal Phase III trial or other significant and time-consuming

requirements related to clinical trials, nonclinical studies or manufacturing.

If a Complete Response Letter is issued, the sponsor must

resubmit the NDA or BLA, addressing all of the deficiencies identified in the letter, or withdraw the application.

Even if such data and

information are submitted, the FDA may decide that the NDA or BLA does not satisfy the criteria for approval.

If a product receives regulatory approval, the approval

may be significantly limited to specific diseases and dosages or the indications for use may otherwise be limited, which could restrict

the commercial value of the product.

In addition, the FDA may require a sponsor to conduct Phase IV testing, which involves clinical trials

designed to further assess a drug’s safety and effectiveness after NDA or BLA approval, and may require testing and surveillance

programs to monitor the safety of approved products which have been commercialized.

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Pediatric Information

Under the Pediatric Research Equity Act of 2007

(“PREA”), NDAs or BLAs or supplements to NDAs or BLAs must contain data to assess the safety and effectiveness of the drug

for the claimed indication(s) in all relevant pediatric sub-populations and to support dosing and administration for each pediatric sub-population

for which the drug is safe and effective.

Under the Pediatric Research Equity Act of 2007 (“PREA”),

NDAs or BLAs or supplements to NDAs or BLAs must contain data to assess the safety and effectiveness of the drug for the claimed indication(s)

in all relevant pediatric sub-populations and to support dosing and administration for each pediatric sub-population 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 drug designation has been granted.

Pharmaceuticals for Children Act (“BPCA”) provides sponsors of NDAs with an additional six-month period of market exclusivity

for all unexpired patent or non-patent exclusivity on all forms of the drug containing the active moiety if the sponsor submits results

of pediatric studies specifically requested by the FDA under BPCA within required timeframes.

The Biologics Price Competition and Innovation

Act provides sponsors of BLAs an additional six-month extension for all unexpired non-patent market exclusivity on all forms of the biologic

containing the active moiety pursuant to the BPCA if the conditions under the BPCA are met.

Unless otherwise required by regulation,

PREA does not apply to any drug for an indication for which orphan drug designation has been granted.

The Best Pharmaceuticals for Children

Act (“BPCA”) provides sponsors of NDAs with an additional six-month period of market exclusivity for all unexpired patent

or non-patent exclusivity on all forms of the drug containing the active moiety if the sponsor submits results of pediatric studies specifically

requested by the FDA under BPCA within required timeframes.

The Biologics Price Competition and Innovation Act provides sponsors of BLAs

an additional six-month extension for all unexpired non-patent market exclusivity on all forms of the biologic containing the active moiety

pursuant to the BPCA if the conditions under the BPCA are met.

The Food and Drug Administration Safety and Innovation

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and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the

Any product submitted to the FDA for marketing,

including under a Fast Track program, may be eligible for other types of FDA programs intended to expedite development and review, such

as priority review and accelerated approval.

Fast Track designation, priority review and accelerated approval do not change the standards

for approval but may expedite the development or approval process.

Any product is eligible for priority review if it has the potential

to provide safe and effective therapy where no satisfactory alternative therapy exists or a significant improvement in the treatment,

diagnosis or prevention of a disease compared to marketed products.

The FDA will attempt to direct additional resources to the evaluation

of an application for a new drug or biological product designated for priority review in an effort to facilitate the review.

Additionally,

a product may be eligible for accelerated approval.

Drug or biological 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, which means that they may be approved on the basis of adequate and well-controlled clinical trials establishing that the product

has an effect on a surrogate endpoint that is reasonably likely to predict a 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 or biological

product receiving accelerated approval perform adequate and well-controlled post-marketing clinical trials.

In addition, the FDA currently

requires as a condition for accelerated approval pre-approval of promotional materials, which could adversely impact the timing of the

commercial launch of the product.

If the FDA concludes that a drug shown to be effective can be safely used only if distribution or use

is restricted, it will require such post-marketing restrictions as it deems necessary to assure safe use of the drug, such as (i) distribution

restricted to certain facilities or physicians with special training or experience or (ii) distribution conditioned on the performance

of specified medical procedures.

FDASIA established a new category of drugs and

biologics referred to as “breakthrough therapies” that may be eligible to receive Breakthrough Therapy Designation.

may seek FDA designation of a drug or biologic candidate as a “breakthrough therapy” if the product is intended, alone or

in combination with one or more other products, to treat a serious or life-threatening disease or condition and preliminary clinical evidence

indicates that the product may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints,

such as substantial treatment effects observed early in clinical development.

Any product submitted to the FDA for marketing, including

under a Fast Track program, may be eligible for other types of FDA programs intended to expedite development and review, such as priority

review and accelerated approval.

Fast Track designation, priority review and accelerated approval do not change the standards for approval

but may expedite the development or approval process.

Any product is eligible for priority review if it has the potential to provide safe

and effective therapy where no satisfactory alternative therapy exists or a significant improvement in the treatment, diagnosis or prevention

of a disease compared to marketed products.

The FDA will attempt to direct additional resources to the evaluation of an application for

a new drug or biological product designated for priority review in an effort to facilitate the review.

Additionally, a product may be

eligible for accelerated approval.

Drug or biological 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, which means that

they may be approved on the basis of adequate and well-controlled clinical trials establishing that the product has an effect on a surrogate

endpoint that is reasonably likely to predict a 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 or biological product receiving accelerated

approval perform adequate and well-controlled post-marketing clinical trials.

In addition, the FDA currently requires as a condition for

accelerated approval pre-approval of promotional materials, which could adversely impact the timing of the commercial launch of the product.

If the FDA concludes that a drug shown to be effective can be safely used only if distribution or use is restricted, it will require such

post-marketing restrictions as it deems necessary to assure safe use of the drug, such as (i) distribution restricted to certain facilities

or physicians with special training or experience or (ii) distribution conditioned on the performance of specified medical procedures.

FDASIA established a new category of drugs and biologics

referred to as “breakthrough therapies” that may be eligible to receive Breakthrough Therapy Designation.

A sponsor may seek

FDA designation of a drug or biologic candidate as a “breakthrough therapy” if the product is intended, alone or in combination

with one or more other products, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates

that the product may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such

as substantial treatment effects observed early in clinical development.

The designation includes all of the Fast Track program features,

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Patent Term Restoration and Marketing Exclusivity

The Biologics Price Competition and Innovation

Act, or BPCIA, amended the Public Health Service Act to authorize the FDA to approve similar versions of innovative biologics, commonly

known as biosimilars.

A competitor seeking approval of a biosimilar must file an application to establish its molecule as highly similar

to an approved innovator biologic, among other requirements.

The Biologics Price Competition and Innovation Act,

or BPCIA, amended the Public Health Service Act to authorize the FDA to approve similar versions of innovative biologics, commonly known

as biosimilars.

A competitor seeking approval of a biosimilar must file an application to establish its molecule as highly similar to

an approved innovator biologic, among other requirements.

The BPCIA, however, bars the FDA from approving biosimilar applications based

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on the expected length of the clinical trials and other factors involved in the filing of the relevant NDA or BLA.

Marketing exclusivity provisions under the FDCA

can also delay the submission or the approval of certain marketing applications.

Marketing exclusivity provisions under the FDCA can

also delay the submission or the approval of certain marketing applications.

The FDCA provides a five-year period of non-patent marketing

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Foreign Regulation

In addition to regulations in the U.S., we will

be subject to a variety of regulations in other jurisdictions governing, among other things, clinical trials and any commercial sales

and distribution of our drug candidates.

Whether or not we obtain FDA approval for our

drug candidates, we must obtain the requisite approvals from regulatory authorities in foreign countries prior to the commencement of

clinical trials or marketing of the drug candidates in those countries.

In addition to regulations in the U.S., we will be

subject to a variety of regulations in other jurisdictions governing, among other things, clinical trials and any commercial sales and

distribution of our drug candidates.

Whether or not we obtain FDA approval for our drug

candidates, we must obtain the requisite approvals from regulatory authorities in foreign countries prior to the commencement of clinical

trials or marketing of the drug candidates in those countries.

Certain countries outside of the U.S.

have a similar process that

requires the submission of a clinical trial application (“CTA”) much like the IND prior to the commencement of human clinical

In the European Union, for example, a CTA must be submitted to each country’s national health authority and an independent

ethics committee, much like the FDA and the IRB, respectively.

Once the CTA is approved in accordance with a country’s requirements,

clinical study development may proceed.

have a similar process that requires

the submission of a clinical trial application (“CTA”) much like the IND prior to the commencement of human clinical trials.

In the European Union, for example, a CTA must be submitted to each country’s national health authority and an independent ethics

committee, much like the FDA and the IRB, respectively.

Once the CTA is approved in accordance with a country’s requirements, clinical

study development may proceed.

The requirements and process governing the conduct

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No extension to any supplementary protection certificate can be granted on the basis of pediatric studies for orphan indications.

The criteria for designating an “orphan

medicinal product” in the European Union are similar in principle to those in the U.S.

Under Article 3 of Regulation (EC) 141/2000,

a medicinal product may be designated as orphan if (1) it is intended for the diagnosis, prevention or treatment of a life-threatening

or chronically debilitating condition;

(2) either (a) such condition affects no more than five in 10,000 persons in the European Union

when the application is made, or (b) the product, without the benefits derived from orphan status, would not generate sufficient return

in the European Union to justify investment;

and (3) there exists no satisfactory method of diagnosis, prevention or treatment of such

condition authorized for marketing in the European Union, or if such a method exists, the product will be of significant benefit to those

affected by the condition, as defined in Regulation (EC) 847/2000.

Orphan medicinal products are eligible for financial incentives such

as reduction of fees or fee waivers and are, upon grant of a marketing authorization, entitled to ten years of market exclusivity for

the approved therapeutic indication.

The application for orphan drug designation must be submitted before the application for marketing

authorization.

The applicant will receive a fee reduction for the marketing authorization application if the orphan drug designation has

been granted, but not if the designation is still pending at the time the marketing authorization is submitted.

Orphan drug designation

does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.

The 10-year market exclusivity may be reduced

to six years if, at the end of the fifth year, it is established that the product no longer meets the criteria for orphan designation,

for example, if the product is sufficiently profitable not to justify maintenance of market exclusivity.

In addition, marketing authorization

may be granted to a similar product for the same indication at any time if:

The criteria for designating an “orphan medicinal

product” in the European Union are similar in principle to those in the U.S.

Under Article 3 of Regulation (EC) 141/2000, a medicinal

product may be designated as orphan if (1) it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically

debilitating condition;

(2) either (a) such condition affects no more than five in 10,000 persons in the European Union when the application

is made, or (b) the product, without the benefits derived from orphan status, would not generate sufficient return in the European Union

to justify investment;

and (3) there exists no satisfactory method of diagnosis, prevention or treatment of such condition authorized

for marketing in the European Union, or if such a method exists, the product will be of significant benefit to those affected by the condition,

as defined in Regulation (EC) 847/2000.

Orphan medicinal products are eligible for financial incentives such as reduction of fees or fee

waivers and are, upon grant of a marketing authorization, entitled to ten years of market exclusivity for the approved therapeutic indication.

The application for orphan drug designation must be submitted before the application for marketing authorization.

The applicant will receive

a fee reduction for the marketing authorization application if the orphan drug designation has been granted, but not if the designation

is still pending at the time the marketing authorization is submitted.

Orphan drug designation does not convey any advantage in, or shorten

the duration of, the regulatory review and approval process.

The 10-year market exclusivity may be reduced to six

years if, at the end of the fifth year, it is established that the product no longer meets the criteria for orphan designation, for example,

if the product is sufficiently profitable not to justify maintenance of market exclusivity.

In addition, marketing authorization may be

granted to a similar product for the same indication at any time if:

the second applicant can establish that its product, although similar, is safer, more effective or otherwise clinically superior;

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subject to federal and state consumer protection and unfair competition laws.

The distribution of pharmaceutical products is

subject to additional requirements and regulations, including extensive record-keeping, licensing, storage and security requirements intended

The distribution of pharmaceutical products is subject

to additional requirements and regulations, including extensive record-keeping, licensing, storage and security requirements intended

to prevent the unauthorized sale of pharmaceutical products.

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Changes in regulations, statutes or the interpretation

of existing regulations, including those resulting from the new Trump Administration or the Executive Branch’s actions, could impact

of existing regulations, including those resulting from the Trump Administration or the Executive Branch’s actions, could impact

our business in the future by requiring, for example:

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Reimbursement

In both domestic and foreign markets, sales and

reimbursement of any approved products will depend, in part, on the extent to which the costs of such products will be covered by third-party

payors, such as government health programs, commercial insurance and managed healthcare organizations.

In both domestic and foreign markets, sales and reimbursement

of any approved products will depend, in part, on the extent to which the costs of such products will be covered by third-party payors,

such as government health programs, commercial insurance and managed healthcare organizations.

These third-party payors are increasingly

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Then, on December 29,

2021, CMS issued a final rule that formally rescinded the most-favored nation rule.

There is also pending litigation to stay the changes

to the Medicare Part D drug rebate program and the Anti-Kickback Statute.

On January 30, 2021, the District Court for the District of

Columbia granted the parties’ stipulated request to delay the effective date of the Part D rebate rule to January 1, 2023.

7, 2022, Congress passed the Inflation Reduction Act of 2022 which delayed the implementation of the changes to the Medicare Part D drug

rebate program and the U.S.

2021, the Centers for Medicare and Medicaid Services (“CMS”) issued a final rule that formally rescinded the most-favored

There is also pending litigation to stay the changes to the Medicare Part D drug rebate program and the Anti-Kickback Statute.

On January 30, 2021, the District Court for the District of Columbia granted the parties’ stipulated request to delay the effective

date of the Part D rebate rule to January 1, 2023.

On August 7, 2022, Congress passed the Inflation Reduction Act of 2022 which delayed

the implementation of the changes to the Medicare Part D drug rebate program and the U.S.

Federal Anti-Kickback Statute until January

As a result of the 2024 presidential election, it is unclear

whether the new Trump Administration will renew, resume, or enact any similar efforts or proposals that may impact drug pricing and/or

drug reimbursement in the U.S.

It is unclear whether the Trump Administration will renew, resume, or enact any similar efforts or proposals that may impact drug

pricing and/or drug reimbursement in the U.S.

Additionally, the Inflation Reduction Act of 2022

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More broadly, in 2024, the U.S.

Supreme Court

in Loper Bright Enterprises v.

Raimondo , overturned the long-standing “Chevron” doctrine, which had accorded deference

to an agency's interpretation of ambiguous laws since 1984.

Following the Loper decision, the healthcare space may face increased

judicial scrutiny of agency regulations, as courts are no longer required to defer to federal agencies' interpretations of ambiguous statutes.

Although the full impact of this reversal remains to be seen, this change could lead to significant alterations in how healthcare laws

and regulations are applied and enforced.

Supreme Court in Loper

Bright Enterprises v.

Raimondo , overturned the long-standing “Chevron” doctrine, which had accorded deference to an agency's

interpretation of ambiguous laws since 1984.

Following the Loper decision, the healthcare space may face increased judicial scrutiny

of agency regulations, as courts are no longer required to defer to federal agencies' interpretations of ambiguous statutes.

the full impact of this reversal remains to be seen, this change could lead to significant alterations in how healthcare laws and regulations

are applied and enforced.

At the state level, legislatures have increasingly

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which could make the introduction of competing products and technologies much easier.

Regardless of the future of the Affordable Care

Act provisions, the Congress will continue to debate a range of policies that could impact the prices pharmaceutical companies charge

for products or how much they are reimbursed.

Moreover, whether and to what extent the new Trump Administration will take actions, whether

through new legislation, changes in regulations, or Executive Orders, that may impact pricing and/or reimbursement for pharmaceutical

products remains to be seen.

Affordable Care Act provisions and other federal

healthcare programs may be adversely affected by broader political or budgetary events, including disputes over healthcare funding and

coverage mechanisms under the Affordable Care Act, such as delays in appropriations or temporary lapses in government funding.

2025, disagreements in Congress regarding healthcare funding priorities, including funding related to Affordable Care Act coverage provisions,

contributed to a federal government shutdown until mid-November 2025.

Government shutdowns or similar disruptions could impair the operations

of federal agencies responsible for administering healthcare programs, delay regulatory or payment processes, and create additional uncertainty

regarding the administration, coverage, or reimbursement of pharmaceutical products.

Regardless of the future of the Affordable Care Act

provisions, Congress will continue to debate a range of policies that could impact the prices pharmaceutical companies charge for products

or how much they are reimbursed.

Moreover, whether and to what extent the Trump Administration will take further actions, whether through

new legislation, changes in regulations, or Executive Orders, that may impact pricing and/or reimbursement for pharmaceutical products

remains to be seen.

Environmental Regulation

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process at any stage of the process.

Although we believe that our safety procedures

for using, handling, storing and disposing of our drug candidate materials comply with the environmental standards required by state and

federal laws and regulations, we cannot completely eliminate the risk of accidental contamination or injury from these materials.

not carry a specific insurance policy to mitigate this risk to us or to the environment.

At December 31, 2024, we employed two full-time

We are not a party to any collective bargaining agreement with our employees, nor are any of our employees a member of any

labor unions.

Although we believe that our safety procedures for

using, handling, storing and disposing of our drug candidate materials comply with the environmental standards required by state and federal

laws and regulations, we cannot completely eliminate the risk of accidental contamination or injury from these materials.

We do not carry

a specific insurance policy to mitigate this risk to us or to the environment.

At December 31, 2025, we employed two full-time employees.

We are not a party to any collective bargaining agreement with our employees, nor are any of our employees a member of any labor unions.

To complement our own professional staff, we utilize

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These individuals include scientific advisors as well as independent consultants.

The biotechnology and pharmaceutical industries

are characterized by rapidly advancing technologies, intense competition, and a strong emphasis on proprietary products.

The biotechnology and pharmaceutical industries are

characterized by rapidly advancing technologies, intense competition, and a strong emphasis on proprietary products.

While we believe

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will compete with existing therapies and new therapies that may become available in the future.

Many of our competitors may have significantly

greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials,

obtaining regulatory approvals, and marketing approved products than we do.

Mergers and acquisitions in the pharmaceutical, biotechnology,

and diagnostic industries may result in even more resources being concentrated among a smaller number of our competitors.

These competitors

also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and

patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.

or early stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and

established companies.

Many of our competitors may have significantly greater

financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining

regulatory approvals, and marketing approved products than we do.

Mergers and acquisitions in the pharmaceutical, biotechnology, and diagnostic

industries may result in even more resources being concentrated among a smaller number of our competitors.

These competitors also compete

with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration

for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.

Smaller or early stage companies

may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

The key competitive factors affecting the success

of all our product candidates, if approved, are likely to be their efficacy, safety, side effects, convenience, price, the level of generic

competition, and the availability of reimbursement from government and other third-party payors.

Our commercial opportunity could be reduced or

eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects,

are more convenient, or are less expensive than any products that we may develop.

Our competitors also may obtain FDA or other regulatory

approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong

market position before we are able to enter the market.

In addition, our ability to compete may be affected in many cases by insurers

or other third-party payors seeking to encourage the use of generic products.

There are many generic products currently on the market

for the indications that we are pursuing, and additional products are expected to become available on a generic basis over the coming

If our therapeutic product candidates are approved, we expect that they will be priced at a significant premium over competitive

generic products.

of any of our product candidates, if approved, are likely to be their efficacy, safety, side effects, convenience, price, the level of

generic competition, and the availability of reimbursement from government and other third-party payors.

Our commercial opportunity could be reduced or eliminated

if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more

convenient, or are less expensive than any products that we may develop.

Our competitors also may obtain FDA or other regulatory approval

for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market

position before we are able to enter the market.

In addition, our ability to compete may be affected in many cases by insurers or other

third-party payors seeking to encourage the use of generic products.

There are many generic products currently on the market for the indications

that we are pursuing, and additional products are expected to become available on a generic basis over the coming years.

If our therapeutic

product candidates are approved, we expect that they will be priced at a significant premium over competitive generic products.

The most common methods of treating patients with

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In the first line setting, Gemcitabine in combination with Abraxane ® or FOLFIRINOX regimen are the current standard of

care, although NALIRIFOX, which substitutes liposomal irinotecan (Onivyde) for irinotecan, recently received FDA approval for first-line

treatment of metastatic pancreatic adenocarcinoma.

Oncologists have limited options of existing therapies for second-line metastatic patients.

The only FDA-approved second-line treatment is Onivyde ® in combination with Fluorouracil (5FU) and leucovorin (LV) for

gemcitabine-treated patients.

In addition to chemotherapy, Merck’s KEYTRUDA ® was approved for MSI-H cancers (approximately

1% of all cases) and Lynparza ® was approved for maintenance of BRCA (or “BReast CAncer gene”) mutated pancreatic

cancer (approximately 7% of all cases).

In the last years there have been a number of

care, although NALIRIFOX, which substitutes liposomal irinotecan (Onivyde) for irinotecan, is poised to become the standard of care in

first-line treatment of metastatic pancreatic adenocarcinoma.

Oncologists have limited options of existing therapies for second-line metastatic

The only FDA-approved second-line treatment is Onivyde ® in combination with Fluorouracil (5FU) and leucovorin

(LV) for gemcitabine-treated patients.

In addition to chemotherapy, Merck’s KEYTRUDA ® was approved for MSI-H cancers

(approximately 1% of all cases) and Lynparza ® was approved for maintenance of BRCA (or “BReast CAncer gene”)

mutated pancreatic cancer (approximately 7% of all cases).

In the last few years there have been a number of

late-stage clinical failures of compounds for advanced PDAC.

Most of these failed trials have been based on a single promising endpoint.

There are very few compounds in advanced stages of development in PDAC.

With respect to other solid tumors, there are

a large number of companies developing treatments intended to be used in combination with approved immunotherapies, including immune checkpoint

There are still a number of compounds in advanced stages of development in PDAC.

With respect to other solid tumors, there are a large

number of companies developing treatments intended to be used in combination with approved immunotherapies, including immune checkpoint

inhibitors, to treat a variety of solid tumor indications.

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mutation typically receive an encorafenib-cetuximab regimen.

For those 5% of patients with MSI-H/dMMR mCRC,

immune checkpoint inhibitors are now the preferred first line therapy.

However, 50% of those will fail and the therapeutic options then

become very limited.

For those 15% of patients with MSI-H/MMRd mCRC, immune

checkpoint inhibitors are now the preferred first line therapy.

However, 50% of those will fail and the therapeutic options then become

very limited.

Immunotherapy is so far largely considered ineffective in MSS/MMRp mCRC.

We will compete with novel combinations

of ICIs with conventional cancer drugs or immunotherapeutics that have started to expose vulnerabilities in MSS/MMRp mCRC.

These include

dual immune checkpoint inhibition of both the PD-1/L1 axis and CTLA-4.

Other combinations being explored include immunotherapies combined

with anti-EGFR antibodies, small molecule VEGFR inhibitors, small molecule inhibitors against other targets (for example, KRAS), and novel

We will compete with novel combinations of ICIs

with conventional cancer drugs or immunotherapeutics that have started to expose vulnerabilities in MSS/MMRp mCRC.

These include dual

immune checkpoint inhibition of both the PD-1/L1 axis and CTLA-4.

Other combinations being explored include immunotherapies combined with

anti-EGFR antibodies, small molecule VEGFR inhibitors, small molecule inhibitors against other targets (for example, KRAS), and novel

ICIs targeting lymphocyte activation gene 3 (LAG3).

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PSA for Drug Delivery

Current competing platforms include PEGylation,

Fc-fusion, albumin-fusion, HESylation, PASylation, and CTP-fusion, among others as well as those of academic institutions and other smaller

pharmaceutical companies engaged in drug development.

In addition to competing with universities and other research institutions in the

development of drug products, therapies, technologies and processes, we may compete with other companies in acquiring rights to products

or technologies from universities.

Current competing platforms include PEGylation, Fc-fusion,

albumin-fusion, HESylation, PASylation, and CTP-fusion, among others as well as those of academic institutions and other smaller pharmaceutical

companies engaged in drug development.

In addition to competing with universities and other research institutions in the development of

drug products, therapies, technologies and processes, we may compete with other companies in acquiring rights to products or technologies

from universities.

Available Information

Our website address is www.xeneticbio.com.

information on, or that can be accessed through, our website is not part of this Annual Report on Form 10-K.

Our Annual Reports on Form

10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K and amendments to those reports are available, free of charge, on

or through our website as soon as practicable after we electronically file such forms, or furnish them to, the SEC.

The SEC maintains

an internet site that contains reports, proxy and information statements and other information regarding our filings at www.sec.gov.

In addition to disclosing current information

pursuant to Section 13 or 15(d) of the Exchange Act and for reports of information required to be disclosed by Regulation FD through our

SEC filings, we also intend to disclose such current information through our investor relations website, press releases, public conference

calls and webcasts.

The information

on, or that can be accessed through, our website is not part of this Annual Report on Form 10-K.

Our Annual Reports on Form 10-K, Quarterly

Reports on Form 10-Q and Current Reports on Form 8-K and amendments to those reports are available, free of charge, on or through our

website as soon as practicable after we electronically file such forms, or furnish them to, the SEC.

The SEC maintains an internet site

that contains reports, proxy and information statements and other information regarding our filings at www.sec.gov.

In addition to disclosing current information pursuant

to Section 13 or 15(d) of the Exchange Act and for reports of information required to be disclosed by Regulation FD through our SEC filings,

we also intend to disclose such current information through our investor relations website, press releases, public conference calls and

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business