What changed in this filing

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Item 1A. Risk Factors

2024-02-23 compared with 2023-03-16 · 463 added, 433 removed, 1650 unchanged (35% of the section changed)

RISK FACTORS.

investment in our common stock involves a high degree of risk.

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Since our inception, we have spent the first three years developing

and refining our Quatramer technology, and since 2019, we have focused our efforts on advancing the development of our product candidate,

HSB-1216, and most recently HSB-3215 and HSB-1940.

Quatramer technology is new and unproven.

We have not yet commenced human clinical trials for any of our product candidates, nor have

we demonstrated an ability to initiate or successfully complete any large-scale or pivotal clinical trials, obtain marketing approvals,

manufacture a commercial-scale product or arrange for a third party to do so on our behalf, or conduct sales and marketing activities

necessary for successful product commercialization.

As a result, it may be more difficult for you to accurately predict our likelihood

of success and viability than it could be if we had a longer operating history.

intend to submit INDs to the FDA to gain approval to initiate clinical studies in the second half of 2023 for HSB-1216 and in 2025 for

both HSB-3215 and HSB-1940;

however, no assurance can be provided that our INDs will be accepted by the FDA based on our anticipated

timeline, if at all.

Our other programs are in pre-clinical discovery and research stages.

As a result, we expect that it will take several

years, if ever, before we have a commercialized product and generate revenue from product sales.

Even if we succeed in receiving marketing

approval for and commercializing one or more of our product candidates, we expect that we will continue to incur substantial research

and development and other expenses in order to discover, develop and market additional potential products.

and refining our technology, and since 2019, we have focused our efforts on advancing the development of our product candidate, HSB-1216,

which we recently deprioritized, as well as TH3215, TH0059 and TH1940 (formerly known as HSB-3215, HSB-0059 and HSB-1940, respectively).

In November 2023, we entered into the Avior Patent License Agreement for a clinical-stage asset, TH104, and TH103, a compound which we

intend to potentially file an IND for.

have not yet commenced human clinical trials for any of our product candidates, nor have we demonstrated an ability to initiate or successfully

complete any large-scale or pivotal clinical trials, obtain marketing approvals, manufacture a commercial-scale product or arrange for

a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization.

a result, it may be more difficult for you to accurately predict our likelihood of success and viability than it could be if we had a

longer operating history.

intend to commence Phase 1 clinical studies for TH104 in 2023 and Phase 2 clinical studies in 2024.

In addition, we intend to submit

INDs to the FDA for our early-stage pre-clinical programs to gain approval to initiate clinical studies in 2025 for both TH3215 and TH1940;

however, no assurance can be provided that our clinical Phase 1 or Phase 2 studies will be completed or that our INDs will be accepted

by the FDA based on our anticipated timeline, if at all.

Our early-stage programs are in pre-clinical discovery and research stages.

As a result, we expect that it will take several years, if ever, before we have a commercialized product and generate revenue from product

Even if we succeed in receiving marketing approval for and commercializing one or more of our product candidates, we expect that

we will continue to incur substantial research and development and other expenses in order to discover, develop and market additional

potential products.

appropriate biomarkers for our potential drug candidates could limit our commercialization prospects and cause our losses to continue.

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biomarkers may not demonstrate correlation to efficacy, safety or tolerability;

data that seeks to correlate genomic or biomarker signatures with certain cancers may be influenced by the race of the patient which

data that seeks to correlate genomic or biomarker signatures with certain diseases may be influenced by the race of the patient which

may limit the efficacy of our drug candidates;

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curtail, delay or discontinue our research or drug development programs or any future commercialization efforts.

are currently advancing our lead product candidates, HSB-1216, HSB-3215 and HSB-1940, through pre-clinical stage development.

cancer drugs is expensive and we expect our research and development expenses to increase substantially in connection with our ongoing

activities, particularly as we advance our product candidates in clinical studies.

intend to advance TH104, a clinical stage asset, as well as our early-stage candidates, TH3215, TH0059 and TH1940, through development.

Developing drugs is expensive and we expect our research and development expenses to increase substantially in connection with our ongoing

activities, particularly as we advance our product candidates through clinical studies.

of December 31, 2023, we had cash of $10.9 million;

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capitalize on our business opportunities, as desired, which could materially affect our business, financial condition and results of

Management has performed an analysis and concluded

that there exists a substantial doubt about our ability to continue as a going concern.

Separately, our independent registered public

accounting firm has also concluded there exists a substantial doubt about our ability to continue as a going concern, which may hinder

our ability to obtain future financing.

Our financial statements as of December 31, 2022 have been prepared under

the assumption that we will continue as a going concern for the next twelve months.

Management has performed an analysis and concluded

that there exists a substantial doubt about our ability to continue as a going concern.

Separately, our independent registered public

accounting firm included in its opinion for the year ended December 31, 2022 an explanatory paragraph referring to our recurring losses

from operations and expressing substantial doubt in our ability to continue as a going concern without additional capital becoming available.

Our ability to continue as a going concern is dependent upon our ability to obtain additional equity or debt financing, obtain government

grants, reduce expenditures and generate significant revenue.

Our financial statements as of December 31, 2022 did not include any adjustments

that might result from the outcome of this uncertainty.

The reaction of investors to the inclusion of a going concern statement by management

and our auditors, and our potential inability to continue as a going concern, in future years could materially adversely affect our share

price and our ability to raise new capital or enter into strategic alliances.

has performed an analysis and concluded that there exists a substantial doubt about our ability to continue as a going concern, which

may hinder our ability to obtain future financing on terms acceptable to us, if at all.

financial statements as of December 31, 2023 have been prepared under the assumption that we will continue as a going concern for the

next twelve months.

Management has performed an analysis and concluded that there exists a substantial doubt about our ability to continue

as a going concern.

Separately, our independent registered public accounting firm included in its opinion for the year ended December

31, 2023 an explanatory paragraph referring to our recurring losses from operations and expressing substantial doubt in our ability to

continue as a going concern without additional capital becoming available.

Our ability to continue as a going concern is dependent upon

our ability to obtain additional equity or debt financing, obtain government grants, reduce expenditures and generate significant revenue.

Our financial statements as of December 31, 2023 did not include any adjustments that might result from the outcome of this uncertainty.

The reaction of investors to the inclusion of a going concern statement in the accompanying financial statement, and our potential inability

to continue as a going concern, in future years could materially adversely affect our share price and our ability to raise new capital

or enter into strategic alliances.

Related to the Discovery and Development of Our Product Candidates

are substantially dependent on the success of our product candidates, HSB-1216, HSB-3215 and HSB-1940, which are currently in pre-clinical

If we are unable to complete development of, obtain approval for and commercialize HSB-1216, HSB-3215 and/or HSB-1940 for one

or more indications in a timely manner, our business may be harmed.

are substantially dependent on the success of our product candidates.

If we are unable to complete development of, obtain approval for

and commercialize our product candidates for one or more indications in a timely manner, our business may be harmed.

future success is dependent on our ability to timely and successfully complete clinical trials, obtain marketing approval for and successfully

commercialize HSB-1216, HSB-3215 and HSB-1940, our product candidates which are in the pre-clinical stages of development.

have no products approved for sale.

The success of our business, including our ability to finance our Company and generate any revenue

in the future, will primarily depend on the successful development, regulatory approval and commercialization of HSB-1216, HSB-3215 and

HSB-1940 as well as other product candidates, which may never occur.

commercialize our product candidates.

We currently have no products approved for sale.

The success of our business, including our ability

to finance our Company and generate any revenue in the future, will primarily depend on the successful development, regulatory approval

and commercialization of our product candidates, which may never occur.

the future, we may also become dependent on other product candidates that we may develop or acquire;

however, no product candidates based

on our Quatramer technology have been tested in humans and given our early stage of development, it may be many years, if at all, before

we may be able to demonstrate the safety and efficacy of our product candidates to warrant approval for commercialization.

on our technology have been tested in humans and given our early stage of development, it may be many years, if at all, before we may

be able to demonstrate the safety and efficacy of our product candidates to warrant approval for commercialization.

clinical and commercial success of our current and any future product candidates will depend on a number of factors, including the following:

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ability, and the ability of any third parties with whom we contract, to remain in good standing with regulatory agencies and develop,

validate and maintain commercially viable manufacturing processes that are compliant with cGMP;

validate and maintain commercially viable manufacturing processes that are compliant with current good manufacturing practice (“cGMP”);

ability to demonstrate to the satisfaction of the FDA and similar foreign regulatory authorities the safety, efficacy and acceptable

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to alternative and competing treatments;

willingness of physicians, operators of hospitals and clinics and patients to utilize or adopt our cancer therapeutics approach;

willingness of physicians, operators of hospitals and clinics and patients to utilize or adopt our therapeutic approaches;

demand for our current or future product candidates, if approved;

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the sale of our product candidates to continue our business or achieve profitability.

Quatramer approach is based on novel ideas and technologies that are unproven and may not result in marketable products, which exposes

us to unforeseen risks and makes it difficult for us to predict the time and cost of product development and potential for regulatory

are using our Quatramer technology to develop product candidates to treat cancer.

Our foundational science and product development approach

are based on our ability to target specified cells or tissues and converge a therapeutic payload at the site of disease to boost efficacy

while abating adverse effects on healthy tissue.

We believe that this approach may offer an improved therapeutic effect by driving an

intense, focused attack selectively upon a patient’s tumor.

However, this approach to treating cancer is novel and the clinical

research that results in a product candidate has had limited testing in humans.

We are currently in the process of validating different

tumor-specific therapeutic product candidates.

We may spend substantial funds attempting to develop these products with the Quatramer

approach and never succeed in developing a marketable therapeutic.

such, we cannot assure you that even if we are able to develop product candidates to treat cancer, such therapies would safely and effectively

treat cancers.

We may spend substantial funds attempting to develop this approach and never succeed in developing a marketable therapeutic.

We are unable to predict when or if our drug candidates will prove effective or safe in humans or if we will obtain marketing approval.

Before obtaining marketing approval from regulatory authorities for the sale of any drug candidate, we must complete pre-clinical development

and then conduct extensive clinical trials to demonstrate the safety and efficacy of our drug candidates in humans.

Clinical testing

is expensive, difficult to design and implement, can take many years to complete and is uncertain as to the outcome.

A failure of one

or more clinical trials can occur at any stage of testing.

The outcome of pre-clinical testing and early clinical trials may not be predictive

of the success of later clinical trials, and interim or preliminary results of a clinical trial do not necessarily predict final results.

In particular, the small number of patients in our early clinical trials may make the results of these trials less predictive of the

outcome of later clinical trials.

pipeline is based on novel ideas and technologies that are unproven and may not result in marketable products, which exposes us to unforeseen

risks and makes it difficult for us to predict the time and cost of product development and potential for regulatory approval.

are using our technology to develop product candidates to treat rare diseases, inflammatory disorders and cancer.

Our foundational science

and product development approach are based on our ability to deliver our drug candidates to target receptors and specified cells or tissues

at the site of disease to boost efficacy while abating adverse effects on healthy tissue.

We believe that this approach may offer an

improved therapeutic effect by delivering drug candidates to areas which may alleviate symptoms and/or treat diseased tissue.

this approach to treating these diseases is novel and the clinical research that results in a product candidate has had limited testing

For our early-stage, preclinical compounds, we are in the process of validating different tumor-specific therapeutic product

We may spend substantial funds attempting to develop these products with our approach and never succeed in developing a marketable

such, we cannot assure you that even if we are able to develop product candidates to treat the diseases we are targeting, such therapies

would safely and effectively treat such diseases.

We may spend substantial funds attempting to develop this approach and never succeed

in developing a marketable therapeutic.

We are unable to predict when or if our drug candidates will prove effective or safe in humans

or if we will obtain marketing approval.

Before obtaining marketing approval from regulatory authorities for the sale of any drug candidate,

we must complete pre-clinical development and then conduct extensive clinical trials to demonstrate the safety and efficacy of our drug

candidates in humans.

Clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain

as to the outcome.

A failure of one or more clinical trials can occur at any stage of testing.

The outcome of pre-clinical testing and

early clinical trials may not be predictive of the success of later clinical trials, and interim or preliminary results of a clinical

trial do not necessarily predict final results.

In particular, the small number of patients in our early clinical trials may make the

results of these trials less predictive of the outcome of later clinical trials.

may experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent our ability to obtain

marketing approval or commercialize our drug candidates, including:

or IRBs/ethics committees (“ECs”) may not authorize us or our investigators to commence a clinical trial or conduct a

clinical trial at a prospective trial site;

or institutional review boards (“IRBs”)/ethics committees (“ECs”) may not authorize us or our investigators

to commence a clinical trial or conduct a clinical trial at a prospective trial site;

may experience delays in reaching, or fail to reach, agreement on acceptable clinical trial contracts or clinical trial protocols

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In either case, our development costs would increase.

still need to receive FDA clearance of our IND for HSB-1216, HSB-3215 and HSB-1940 before we can begin clinical trials and would require

the same acceptance by the FDA prior to initiating any clinical trials in the United States for any of our other drug candidates.

FDA may require us to conduct additional pre-clinical studies for any drug candidate before it allows us to initiate clinical trials

under any IND, which may lead to additional delays and increase the costs of our pre-clinical development programs.

addition, we will need to initiate clinical trials for TH104.

In addition, we will need to receive FDA clearance of our IND for TH3215,

TH0059 and TH1940 before we can begin clinical trials and would require the same acceptance by the FDA prior to initiating any clinical

trials in the United States for any of our other drug candidates.

The FDA may require us to conduct additional pre-clinical studies for

any drug candidate before it allows us to initiate clinical trials under any IND, which may lead to additional delays and increase the

costs of our pre-clinical development programs.

delays in the commencement or completion of our ongoing, planned or future clinical trials could significantly affect our product development

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clinical investigators losing the licenses or permits necessary to perform our clinical trials, not performing our clinical trials

on our anticipated schedule or consistent with the clinical trial protocol GCP or other regulatory requirements;

on our anticipated schedule or consistent with the clinical trial protocol Good Clinical Practice (“GCP”) or other regulatory

requirements;

or our third-party contractors not performing data collection or analysis in a timely or accurate manner or improperly disclosing

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available, and are subject to audit and verification procedures that could result in material changes in the final data.

time to time, we may publicly disclose preliminary, interim or topline data from our clinical trials, such as the interim data from our

Phase 1 clinical trial of HSB-1216, HSB-3215 or HSB-1940.

These interim updates are based on a preliminary analysis of then-available

data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related

to the particular study or trial.

For example, we may report tumor responses in certain patients that are unconfirmed at the time and

which do not ultimately result in confirmed responses to treatment after follow-up evaluations.

We also make assumptions, estimations,

calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully

evaluate all data.

As a result, the topline results that we report may differ from future results of the same studies, or different conclusions

or considerations may qualify such results, once additional data have been received and fully evaluated.

Topline data also remain subject

to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously

time to time, we may publicly disclose preliminary, interim or topline data from our clinical trials, such as the interim data from clinical

trials related to TH104, or preclinical data for TH3215, TH0059 or TH1940.

These interim updates are based on a preliminary analysis

of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review

of the data related to the particular study or trial.

For example, we may report responses in certain patients that are unconfirmed at

the time and which do not ultimately result in confirmed responses to treatment after follow-up evaluations.

We also make assumptions,

estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully

and carefully evaluate all data.

As a result, the topline results that we report may differ from future results of the same studies,

or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated.

data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary

data we previously published.

As a result, topline data should be viewed with caution until the final data are available.

In addition, we may report interim

analyses of only certain endpoints rather than all endpoints.

Interim data from clinical trials that we may complete are subject to the

risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available.

we may report interim analyses of only certain endpoints rather than all endpoints.

Interim data from clinical trials that we may complete

are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient

data become available.

Adverse changes between interim data and final data could significantly harm our business and prospects.

Further, additional disclosure

of interim data by us or by our competitors in the future could result in volatility in the price of our common stock.

additional disclosure of interim data by us or by our competitors in the future could result in volatility in the price of our common

addition, the information we choose to publicly disclose regarding a particular study or clinical trial is typically selected from a

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the preliminary or topline data that we report differs from late, final or actual results, or if others, including regulatory authorities,

disagree with the conclusions reached, our ability to obtain approval for, and commercialize, HSB-1216, HSB-3215, or HSB-1940 or any

other product candidates may be harmed, which could harm our business, financial condition, results of operations and prospects.

disagree with the conclusions reached, our ability to obtain approval for and commercialize our product candidates may be harmed, which

could harm our business, financial condition, results of operations and prospects.

we experience delays or difficulties in enrolling patients in our ongoing or planned clinical trials, our receipt of necessary regulatory

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and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA.

Patient enrollment is a significant

factor in the timing of clinical trials.

Our ability to enroll eligible patients may be limited or may result in slower enrollment than

we anticipate.

Even once enrolled, we may

be unable to retain a sufficient number of patients to complete any of our trials.

Patient enrollment is a significant factor in the

timing of clinical trials.

Our ability to enroll eligible patients may be limited or may result in slower enrollment than we anticipate.

enrollment may be affected if our competitors have ongoing clinical trials for programs that are under development for the same indications

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of the disease under investigation;

design of the trial and the complexity for patients and clinical sites;

and efficacy of approved drugs for the disease under investigation;

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willingness to screen their patients for biomarkers to indicate which patients may be eligible for enrollment in our clinical trials;

ability to obtain and maintain patient consents;

referral practices of physicians;

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and availability of clinical trial sites for prospective patients;

risk that patients enrolled in clinical trials will drop out of the trials before completion or, because they may be late-stage cancer

risk that patients enrolled in clinical trials will drop out of the trials before completion or, because they may be late-stage disease

patients and will not survive the full terms of the clinical trials.

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one or more clinical trials altogether.

Enrollment delays in our clinical trials may result in increased development costs for our product

candidates and jeopardize our ability to obtain marketing approval for the sale of our product candidates.

Furthermore, even if we are

able to enroll a sufficient number of patients for our clinical trials, we may have difficulty maintaining participation in our clinical

trials through the treatment and any follow-up periods.

no regulatory authority has granted approval for a cancer therapeutic based on a Quatramer approach.

We may never receive approval to

market and commercialize any product candidate.

Even if we obtain regulatory approval, the approval may be for targets, disease indications,

lines of therapy or patient populations that are not as broad as we intended or desired or may require labeling that includes significant

use or distribution restrictions or safety warnings.

Any negative results we may report in clinical trials of our product candidates may make it difficult

or impossible to recruit and retain patients in other clinical trials of that same product candidate.

Enrollment delays in our clinical

trials may result in increased development costs for our product candidates and jeopardize our ability to obtain marketing approval for

the sale of our product candidates.

Furthermore, even if we are able to enroll a sufficient number of patients for our clinical trials,

we may have difficulty maintaining participation in our clinical trials through the treatment and any follow-up periods.

may never receive approval to market and commercialize any product candidate.

Even if we obtain regulatory approval, the approval may

be for targets, disease indications, lines of therapy or patient populations that are not as broad as we intended or desired or may require

labeling that includes significant use or distribution restrictions or safety warnings.

have not previously submitted an NDA to the FDA or similar regulatory approval filings to comparable foreign authorities, for any product

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to maintain regulatory approval.

If our candidates prove to be ineffective, unsafe or commercially unviable, our entire technology platform

and pipeline would have little, if any, value, which would have a material and adverse effect on our business, financial condition, results

of operations and prospects.

HSB-3215 and HSB-1940 are novel technologies, making it difficult to predict the time, cost and potential success of these product candidates.

If our candidates prove to be ineffective, unsafe or commercially unviable, our pipeline would have

little, if any, value, which would have a material and adverse effect on our business, financial condition, results of operations and

TH3215, TH0059 and TH1940 are novel product candidates, making it difficult to predict the time, cost and potential success of these

product candidates.

We have not yet been able to assess the safety and efficacy of any product candidates in humans.

Our success depends on our ability to

develop and commercialize product candidates using our novel Quatramer technology.

The novel nature of our technology makes it difficult

to accurately predict the developmental challenges we may face for product candidates as they proceed through research, pre-clinical

or greenhouse studies and clinical or field trials.

have been a limited number of clinical trials of products created with induced ferroptosis and reverse EMT, none of which has utilized

our Quatramer technology, and we believe no therapeutic product candidates created with induced ferroptosis and reverse EMT technology

have received marketing approval in the United States or Europe.

Because our therapeutic research programs are all in research or pre-clinical

stages, we have not yet been able to assess the safety or efficacy of any product candidates in humans.

our product candidates do not achieve projected development milestones or commercialization in the announced or expected timeframes,

the further development or commercialization of such product candidates may be delayed, and our business may be harmed.

Current or future

product candidates may not meet safety and efficacy requirements for continued development or ultimate approval in humans and may cause

significant adverse events or toxicities.

Our success depends

on our ability to develop and commercialize product candidates.

The novel nature of some of our technology makes it difficult to accurately

predict the developmental challenges we may face for product candidates as they proceed through research, pre-clinical or greenhouse

studies and clinical or field trials.

our pre-clinical research programs are all research or pre-clinical stages, we have not yet been able to assess the safety or efficacy

of any product candidates in humans.

If our product candidates do not achieve projected development milestones or commercialization in

the announced or expected timeframes, the further development or commercialization of such product candidates may be delayed, and our

business may be harmed.

Current or future product candidates may not meet safety and efficacy requirements for continued development

or ultimate approval in humans and may cause significant adverse events or toxicities.

side effects or other safety risks associated with our drug candidates could delay or preclude approval, cause us to suspend or discontinue

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or the FDA for a number of reasons.

Additionally, due to the high mortality rates of the cancers for which we are initially pursuing

development and the pretreated nature of many patients in our planned clinical trials of HSB-1216, a material percentage of patients

in these clinical trials may die during a trial, which could impact development of HSB-1216.

If we elect or are required to delay, suspend

or terminate any clinical trial, the commercial prospects of our drug candidates will be harmed and our ability to generate product revenues

from this drug candidate will be delayed or eliminated.

Serious adverse events observed in clinical trials could hinder or prevent market

acceptance of our drug candidates.

Any of these occurrences may harm our business, prospects, financial condition and results of operations

significantly.

If we elect or are required to delay, suspend or terminate any clinical trial, the commercial prospects

of our drug candidates will be harmed and our ability to generate product revenues from this drug candidate will be delayed or eliminated.

Serious adverse events observed in clinical trials could hinder or prevent market acceptance of our drug candidates.

Any of these occurrences

may harm our business, prospects, financial condition and results of operations significantly.

if our drug candidates are associated with undesirable side effects in clinical trials or have characteristics that are unexpected, we

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authorities may withdraw approval of the drug;

may be required to recall a product or change the way the drug is administered to patients;

may be required to recall a product, change the dosage of a product, or change the way the drug is administered to patients;

authorities may require additional warnings on the label, such as a “black box” warning or a contraindication, or issue

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associated with our products.

Furthermore, inadequate performance of these products may result in lower confidence in our Quatramer platform

Furthermore, inadequate performance of these products may result in lower confidence in our pipeline in

may not succeed in achieving significant commercial market acceptance for our current or future products due to a number of factors,

ability to demonstrate the clinical utility of our Quatramer platform and related products and their potential advantages over existing

drug products to academic institutions, biopharmaceutical companies and the medical community;

ability to demonstrate the clinical utility of our pipeline and related products and their potential advantages over existing drug

products to academic institutions, biopharmaceutical companies and the medical community;

ability, and that of our collaborators, to secure and maintain FDA and other regulatory clearance, authorization or approval for

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or ability to pay for our products and will likely heavily influence physicians’ decisions to recommend our products;

rate of adoption of our Quatramer platform and related products by academic institutions, clinicians, key opinion leaders, advocacy

groups and biopharmaceutical companies;

rate of adoption of our pipeline and related products by academic institutions, clinicians, key opinion leaders, advocacy groups

and biopharmaceutical companies;

impact of our investments in product innovation and commercial growth.

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We may not be successful

in addressing these or other factors that might affect the market acceptance of our products and Quatramer technology.

Failure to achieve

widespread market acceptance of our Quatramer platform and related products would materially harm our business, financial condition and

results of operations.

business may be adversely affected by the coronavirus pandemic.

outbreak of COVID-19 evolved into a global pandemic as COVID-19 spread to many regions of the world.

The extent to which COVID-19 impacts

our business and operating results may continue to depend on future developments that are uncertain and cannot be accurately predicted,

including new information that may emerge concerning COVID-19, including variants, and the actions to contain COVID-19 or treat its impact,

among others.

the event that COVID-19 continues to spread, our business operations could be delayed or interrupted.

For example, as a result of COVID-19,

we previously experienced delays from our manufacturers with respect to the shipping of our materials as well as delays in completion

of analytical testing as a result of the shelter-in-place order restrictions.

In addition, in the event that COVID-19 continues to spread,

our research and development may be affected as a result of delays in study monitoring and data analysis;

some participants and clinical

investigators may not be able to comply with clinical trial protocols;

any quarantines or other travel limitations (whether voluntary

or required) may impede participant movement, affect sponsor access to study sites, or interrupt healthcare services, resulting in our

inability to conduct our research activities, including our clinical trials;

and infections and deaths related to the pandemic may disrupt

the United States’ healthcare and healthcare regulatory systems which could divert healthcare resources away from, or materially

delay FDA review and/or approval of our product candidates.

spread of COVID-19, which caused a broad impact globally may have a material economic effect on our business.

While the potential economic

impact brought by the pandemic may be difficult to assess or predict, it has already caused, and may result in further, disruption of

global financial markets, which may reduce our ability to access capital either at all or on favorable terms.

In addition, a recession,

depression or other sustained adverse market event resulting from COVID-19 could materially and adversely affect our business and the

value of our common stock.

ultimate impact of the COVID-19 pandemic, or any other health epidemic, is highly uncertain and subject to change.

We do not yet know

the full extent of potential delays or impacts on our business, our clinical trials, our research programs, healthcare systems or the

global economy as a whole.

However, these effects could have a material impact on our operations.

in addressing these or other factors that might affect the market acceptance of our products.

Failure to achieve widespread market acceptance

of our pipeline and related products would materially harm our business, financial condition and results of operations.

such as COVID-19, may adversely impact our business, results of operations, financial condition, liquidity and cash flows and that of

COVID-19 pandemic and efforts to control its spread had an impact on our operations.

example, as a result of COVID-19, we previously experienced delays from our manufacturers with respect to the shipping of our materials

as well as delays in completion of analytical testing as a result of the shelter-in-place order restrictions.

Pandemics, such as COVID-19,

may have a material economic effect on our business because our research and development may be affected as a result of delays in study

monitoring and data analysis;

some participants and clinical investigators may not be able to comply with clinical trial protocols;

quarantines or other travel limitations (whether voluntary or required) may impede participant movement, affect sponsor access to study

sites, or interrupt healthcare services, resulting in our inability to conduct our research activities, including our clinical trials;

and infections and deaths related to a pandemic may disrupt the United States’ healthcare and healthcare regulatory systems which

could divert healthcare resources away from, or materially delay FDA review and/or approval of our product candidates.

While the potential

economic impact brought by such pandemics may be difficult to assess or predict, it has caused, and may result in further significant

disruption of global financial markets, which may reduce our ability to access capital either at all or on favorable terms.

a recession, depression or other sustained adverse market event resulting from a health pandemic could materially and adversely affect

our business and the value of our common stock.

may expend our limited resources to pursue a particular drug candidate or indication and fail to capitalize on drug candidates or indications

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may not be successful in our efforts to design additional potential drug candidates.

key element of our strategy is to apply our knowledge and our understanding of the structure, biology and activity of ferroptosis to

develop drug candidates.

The therapeutic design and development activities that we are conducting may not be successful in developing

drug candidates that are useful in treating cancer or other diseases.

therapeutic design and development activities that we are conducting may not be successful in developing drug candidates that are useful

in treating rare diseases, inflammatory conditions, cancer or other diseases.

Our research programs may initially show promise in identifying

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This may make it difficult for us to replace existing therapies with our products.

particular, there is intense competition in the field of oncology.

We have competitors both in the United States and internationally,

including major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies, emerging

and start-up companies, universities and other research institutions.

We also compete with these organizations to recruit management,

scientists and clinical development personnel, which could negatively affect our level of expertise and our ability to execute our business

We will also face competition in establishing clinical trial sites, enrolling subjects for clinical trials and in identifying and

in-licensing new product candidates.

particular, there is intense competition in the fields of rare diseases, inflammatory conditions and oncology.

We have competitors both

in the United States and internationally, including major multinational pharmaceutical companies, established biotechnology companies,

specialty pharmaceutical companies, emerging and start-up companies, universities and other research institutions.

We also compete with

these organizations to recruit management, scientists and clinical development personnel, which could negatively affect our level of

expertise and our ability to execute our business plan.

We will also face competition in establishing clinical trial sites, enrolling

subjects for clinical trials and in identifying and in-licensing new product candidates.

commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective,

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The term “remuneration” has been broadly interpreted to include anything of value.

false claims and false statement laws, including the federal civil False Claims Act and the CMPL, prohibits, among other things,

any person or entity from knowingly presenting, or causing to be presented, for payment to, or approval by, federal programs, including

Medicare and Medicaid, claims for items or services, including drugs, that are false or fraudulent.

false claims and false statement laws, including the federal civil False Claims Act and the Civil

Monetary Penalties Law (“ CMPL”), prohibits, among other things, any person or entity from knowingly presenting,

or causing to be presented, for payment to, or approval by, federal programs, including Medicare and Medicaid, claims for items or

services, including drugs, that are false or fraudulent.

Insurance Portability and Accountability Act of 1996 (“HIPAA”) created additional federal criminal statutes that prohibit

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transactions, as well as standards relating to the privacy and security of individually identifiable health information.

The Federal Food, Drug and Cosmetic Act, which governs the production,

sale, distribution, promotion and sampling of drugs, biologics and medical devices and prohibits, among other things, the adulteration

or misbranding of drugs, biologics and medical devices including marketing drug products for off-label use;

The federal Physician Payments Sunshine Act requires certain manufacturers

of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health

Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services information related

to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors),

certain other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals, as well as ownership

and investment interests held by physicians and their immediate family members and applicable group purchasing organizations.

many states have similar laws and regulations, such as anti-kickback and false claims laws that may be broader in scope and may

apply regardless of payor, in addition to items and services reimbursed under Medicaid and other state programs.

Additionally, we

may be subject to state laws that require pharmaceutical companies to comply with the federal government’s and/or

pharmaceutical industry’s voluntary compliance guidelines, state laws that require drug manufacturers to report information

related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and state

laws requiring the registration of sales representatives, as well as state and foreign laws governing the privacy and security of

health information, many of which differ from each other in significant ways and often are not preempted by HIPAA.

Federal Food, Drug and Cosmetic Act, which governs the production, sale, distribution, promotion and sampling of drugs, biologics

and medical devices and prohibits, among other things, the adulteration or misbranding of drugs, biologics and medical devices including

marketing drug products for off-label use;

federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for which

payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report

annually to the Centers for Medicare & Medicaid Services information related to payments or other transfers of value made to

physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors), certain other healthcare professionals

(such as physician assistants and nurse practitioners), and teaching hospitals, as well as ownership and investment interests held

by physicians and their immediate family members and applicable group purchasing organizations.

many states have similar laws and regulations, such as anti-kickback and false claims laws that may be broader in scope and may apply

regardless of payor, in addition to items and services reimbursed under Medicaid and other state programs.

Additionally, we may be subject

to state laws that require pharmaceutical companies to comply with the federal government’s and/or pharmaceutical industry’s

voluntary compliance guidelines, state laws that require drug manufacturers to report information related to payments and other transfers

of value to physicians and other healthcare providers or marketing expenditures and state laws requiring the registration of sales representatives,

as well as state and foreign laws governing the privacy and security of health information, many of which differ from each other in significant

ways and often are not preempted by HIPAA.

laws and regulations applicable to our business are complex, changing and often subject to varying interpretations.

As a result, we

may not be able to adhere to all applicable laws and regulations.

Any violation or alleged violation of any of these laws or

regulations by us could have a material adverse effect on our business, financial condition, cash flows and results of operations.

We may be a party to various lawsuits, demands, claims, qui tam suits, third-party complaints to the FDA, government

investigations and audits, of which any could result in, among other things, substantial financial penalties or awards against us,

reputational harm, termination of relationships or contracts related to our business, mandated refunds, substantial payments made by

us, required changes to our business practices, exclusion from future participation in Medicare and other healthcare programs and

possible criminal penalties.

As a result, we may

not be able to adhere to all applicable laws and regulations.

Any violation or alleged violation of any of these laws or regulations

by us could have a material adverse effect on our business, financial condition, cash flows and results of operations.

We may be a party

to various lawsuits, demands, claims, qui tam suits, third-party complaints to the FDA, government investigations and audits,

of which any could result in, among other things, substantial financial penalties or awards against us, reputational harm, termination

of relationships or contracts related to our business, mandated refunds, substantial payments made by us, required changes to our business

practices, exclusion from future participation in Medicare and other healthcare programs and possible criminal penalties.

we are found in violation of applicable laws or regulations, we could suffer severe consequences that would have a material adverse effect

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could adversely affect our business.

We also cannot predict the outcome of any current or future litigation that may affect interpretation

of, or deference to, agency regulations and guidance.

FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and if we are

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In particular, a drug may not be promoted for uses that are not approved by the FDA or such other regulatory

agencies as reflected in the drug’s approved labeling.

If we receive marketing approval for our drug candidates for our proposed

indications, physicians may nevertheless use our drugs for their patients in a manner that is inconsistent with the approved label.

if we are found to have promoted our drugs for any off-label uses, the federal government could levy civil, criminal and/or administrative

penalties, and seek fines against us.

The FDA or other regulatory authorities could also request that we enter into a consent decree

or a corporate integrity agreement, or seek a permanent injunction against us under which specified promotional conduct is monitored,

changed or curtailed.

If we cannot successfully manage the promotion of our drug candidates, we could become subject to significant liability,

which would materially adversely affect our business and financial condition.

agencies as reflected in the drug’s approved labeling, including a different dosage, delivery or patient population than is contained

in the label.

If we receive marketing approval for our drug candidates for our proposed indications, physicians may nevertheless use

our drugs for their patients in a manner that is inconsistent with the approved label.

However, if we are found to have promoted our

drugs for any off-label uses, the federal government could levy civil, criminal and/or administrative penalties, and seek fines against

The FDA or other regulatory authorities could also request that we enter into a consent decree or a corporate integrity agreement,

or seek a permanent injunction against us under which specified promotional conduct is monitored, changed or curtailed.

successfully manage the promotion of our drug candidates, we could become subject to significant liability, which would materially adversely

affect our business and financial condition.

may not be able to obtain or maintain Fast Track designation or accelerated approval for our drug candidates.

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medical need for this condition, a drug sponsor may apply for FDA Fast Track designation.

If we seek Fast Track designation for a drug

candidate, we may not receive it from the FDA.

However, even if we receive Fast Track designation, Fast Track designation does not ensure

that we will receive marketing approval or that approval will be granted within any particular time frame.

We may not experience a faster

development or regulatory review or approval process with Fast Track designation compared to conventional FDA procedures.

the FDA may withdraw Fast Track designation if it believes that the designation is no longer supported by data from our clinical development

Fast Track designation alone does not guarantee qualification for the FDA’s priority review procedures.

If there are therapies already available for

the condition, a fast track drug must show an advantage over the available therapy including superior efficacy, lessening or avoidance

of side effects, improving the diagnosis of a serious condition, decreasing a clinical significant toxicity of an available therapy or

ability to address an emerging or anticipated public health need.

If we seek Fast Track designation for a drug candidate, we may not

receive it from the FDA.

However, even if we receive Fast Track designation, Fast Track designation does not ensure that we will receive

marketing approval or that approval will be granted within any particular time frame.

We may not experience a faster development or regulatory

review or approval process with Fast Track designation compared to conventional FDA procedures.

In addition, the FDA may withdraw Fast

Track designation if it believes that the designation is no longer supported by data from our clinical development program.

designation alone does not guarantee qualification for the FDA’s priority review procedures.

may not be able to obtain or maintain orphan drug designation or exclusivity for our drug candidates.

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and making a drug product available in the United States for the type of disease or condition will be recovered from sales of the product.

entitles a party to financial incentives, such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee

Additionally, if a product that has orphan designation subsequently receives the first FDA approval for the disease or condition

for which it has such designation, the product is entitled to orphan drug exclusivity.

This means that the FDA may not approve any other

applications to market the same drug or biological product for the same indication for seven years, except in certain circumstances,

including proving clinical superiority (i.e., another product is safer, more effective or makes a major contribution to patient care)

to the product with orphan exclusivity.

Competitors, however, may receive approval of different products for the indication for which

the orphan product has exclusivity, or obtain approval for the same product but for a different indication than that for which the orphan

product has exclusivity.

In addition, exclusive marketing rights in the United States may be limited if we seek approval for an indication

broader than the orphan-designated indication or may be lost if the FDA later determines that the request for designation was materially

drug designation entitles a party to financial incentives, such as opportunities for grant funding towards clinical trial costs, tax

advantages and user-fee waivers.

Additionally, if a product that has orphan designation subsequently receives the first FDA approval

for the disease or condition for which it has such designation, the product is entitled to orphan drug exclusivity.

This means that the

FDA may not approve any other applications to market the same drug or biological product for the same indication for seven years, except

in certain circumstances, including proving clinical superiority (i.e., another product is safer, more effective or makes a major contribution

to patient care) to the product with orphan exclusivity.

Competitors, however, may receive approval of different products for the indication

for which the orphan product has exclusivity, or obtain approval for the same product but for a different indication than that for which

the orphan product has exclusivity.

In addition, exclusive marketing rights in the United States may be limited if we seek approval for

an indication broader than the orphan-designated indication or may be lost if the FDA later determines that the request for designation

was materially defective.

Breakthrough Therapy designation by the FDA for our drug candidates may not lead to a faster development or regulatory review or approval

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future profit margins and our ability to commercialize any products that obtain marketing approval on a timely and competitive basis.

currently depend on a sole source supplier and manufacturer for the active ingredient in HSB-1216, the “knob” for HSB-1940

and the HER2 for HSB-3215 and the inability to obtain the active ingredient in HSB-1216, HSB-3215 and/or HSB-1940 as required could harm

our business.

currently source the active ingredient in HSB-1216, the “knob” for HSB-1940 and the HER2 for HSB-3215 from sole suppliers/manufacturers.

Although we believe that we can obtain the active ingredient in HSB-1216, the “knob” for HSB-1940 and the HER2 for HSB-3215

from other suppliers, supply shortages for these particular raw material may delay our clinical trials.

If we are unable to procure the

active ingredient in HSB-1216, the “knob” for HSB-1940 and the HER2 for HSB-3215 as needed, our business may be harmed.

currently depend on a sole source supplier and manufacturer for the active ingredient in our product candidates and the inability to

obtain the active ingredient for our product candidates as required could harm our business.

currently source the active ingredient for TH1940, TH3215 and TH0059 from sole suppliers/manufacturers.

In addition, we anticipate that

we will also source the active ingredient in TH104 from a sole supplier/manufacturer.

Although we believe that we can obtain the active

ingredient for TH1940, TH3215, TH0059 and TH104 from other suppliers, supply shortages for these particular raw material may delay our

clinical trials.

If we are unable to procure the active ingredient for our product candidates as needed, our business may be harmed.

failure to find third party collaborators to assist or share in the costs of drug development could materially harm our business, financial

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condition and results of operations.

launched an invasion in Ukraine in February 2022, which may have a material adverse effect on our operations.

February 2022, Russia launched an invasion in Ukraine, and while it is difficult to estimate the impact of such invasion on the Company’s

business and financial position, such invasion could adversely impact the Company’s ability to, among other things, obtain raw

In addition, the conflict involving Russia and Ukraine may impact our contract research organizations, clinical data management

organizations, and clinical investigators’ ability to conduct certain of our trials in Eastern European countries, and may prevent

us from obtaining data in these countries.

This could negatively impact our clinical trials and/or analyses of clinical results, which

may increase our product development costs and materially harm our business.

Related to Commercialization of Our Drug Candidates

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characteristics that may preclude our obtaining marketing approval or prevent or limit commercial use.

New cancer drugs frequently are

New therapeutics frequently are

indicated only for patient populations that have not responded to an existing therapy or have relapsed.

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business is dependent on our ability to successfully complete pre-clinical and clinical development, obtain regulatory approval for,

and, if approved, successfully commercialize HSB-1216, HSB-3215 and HSB-1940, and any future product candidates in a timely manner.

if we eventually complete clinical testing and receive approval for HSB-1216, HSB-3215, and HSB-1940, and any future product candidates,

the FDA, may grant approval or other marketing authorization contingent on the performance of costly additional clinical trials, including

post-marketing clinical trials.

The FDA, also may approve or authorize for marketing a product candidate for a more limited indication

or patient population than we originally request, and the FDA may not approve or authorize the labeling that we believe is necessary

or desirable for the successful commercialization of a product candidate.

Any delay in obtaining, or inability to obtain, applicable

regulatory approval or other marketing authorization would delay or prevent commercialization of that product candidate and would materially

adversely impact our business and prospects.

and, if approved, successfully commercialize our product candidates in a timely manner.

if we eventually complete clinical testing and receive approval for our product candidates, the FDA, may grant approval or other marketing

authorization contingent on the performance of costly additional clinical trials, including post-marketing clinical trials.

also may approve or authorize for marketing a product candidate for a more limited indication or patient population than we originally

request, and the FDA may not approve or authorize the labeling that we believe is necessary or desirable for the successful commercialization

of a product candidate.

Any delay in obtaining, or inability to obtain, applicable regulatory approval or other marketing authorization

would delay or prevent commercialization of that product candidate and would materially adversely impact our business and prospects.

addition, the FDA may change their policies, issue additional regulations or revise existing regulations, or take other actions, which

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it is possible that one or more of our drug candidates may require a companion diagnostic to select the patients who will likely respond

to a cancer therapy involving one of our drug candidates as a condition of approval, it is too early in our drug candidates development

to identify which drug candidate, if any, would require a companion diagnostic.

According to FDA guidance, if the FDA determines that

a companion diagnostic device is essential to the safe and effective use of a novel therapeutic drug or indication, the FDA generally

will not approve the therapeutic drug or new therapeutic drug indication if the companion diagnostic is not also approved or cleared

for that indication.

Under the FDCA, companion diagnostics are regulated as medical devices, and the FDA has generally required companion

diagnostics intended to select the patients who will respond to cancer treatment to obtain Premarket Approval (“PMA”) for

the diagnostic.

The PMA process, including the gathering of clinical and pre-clinical data and the submission to and review by the FDA,

involves a rigorous premarket review during which the applicant must prepare and provide the FDA with reasonable assurance of the device’s

safety and effectiveness and information about the device and its components regarding, among other things, device design, manufacturing

and labeling.

A PMA is not guaranteed and may take considerable time, and the FDA may ultimately respond to a PMA submission with a “not

approvable” determination based on deficiencies in the application and require additional clinical trial or other data that may

be expensive and time-consuming to generate and that can substantially delay approval.

As a result, if we are required by the FDA to

obtain approval of a companion diagnostic for a therapeutic drug candidate, and we do not obtain or there are delays in obtaining FDA

approval of a diagnostic device, we may not be able to commercialize the drug candidate on a timely basis or at all and our ability to

generate revenue will be materially impaired.

to a therapy involving one of our drug candidates as a condition of approval, it is too early in our drug candidates development to identify

which drug candidate, if any, would require a companion diagnostic.

According to FDA guidance, if the FDA determines that a companion

diagnostic device is essential to the safe and effective use of a novel therapeutic drug or indication, the FDA generally will not approve

the therapeutic drug or new therapeutic drug indication if the companion diagnostic is not also approved or cleared for that indication.

Under the Federal Food, Drug and Cosmetic Act (“FDCA”), companion diagnostics are regulated as medical devices, and the FDA

has generally required companion diagnostics intended to select the patients who will respond to treatment to obtain Premarket Approval

(“PMA”) for the diagnostic.

The PMA process, including the gathering of clinical and pre-clinical data and the submission

to and review by the FDA, involves a rigorous premarket review during which the applicant must prepare and provide the FDA with reasonable

assurance of the device’s safety and effectiveness and information about the device and its components regarding, among other things,

device design, manufacturing and labeling.

A PMA is not guaranteed and may take considerable time, and the FDA may ultimately respond

to a PMA submission with a “not approvable” determination based on deficiencies in the application and require additional

clinical trial or other data that may be expensive and time-consuming to generate and that can substantially delay approval.

if we are required by the FDA to obtain approval of a companion diagnostic for a therapeutic drug candidate, and we do not obtain or

there are delays in obtaining FDA approval of a diagnostic device, we may not be able to commercialize the drug candidate on a timely

basis or at all and our ability to generate revenue will be materially impaired.

drug candidate for which we obtain marketing approval, along with the manufacturing processes, post-approval clinical data, labeling,

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of approval, including the requirement to implement a REMS.

New cancer drugs frequently are indicated only for patient populations that

have not responded to an existing therapy or have relapsed.

If any of our drug candidates receives marketing approval, the accompanying

label may limit the approved use of our drug in this way, which could limit sales of the drug.

New drugs frequently are indicated only for patient populations that have

not responded to an existing therapy or have relapsed.

If any of our drug candidates receives marketing approval, the accompanying label

may limit the approved use of our drug in this way, which could limit sales of the drug.

FDA may also impose requirements for costly post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy

of the drug, including the adoption and implementation of REMS.

The FDA and other agencies, including the DOJ, closely regulate and monitor

the post-approval marketing and promotion of drugs to ensure they are marketed and distributed only for the approved indications and

in accordance with the provisions of the approved labeling.

The FDA and DOJ impose stringent restrictions on manufacturers’ communications

regarding off-label use, and if we do not market our drugs for their approved indications, we may be subject to enforcement action for

off-label marketing.

Violations of the FDCA and other statutes, including the False Claims Act, relating to the promotion and advertising

of prescription drugs may lead to investigations and enforcement actions alleging violations of federal and state healthcare fraud and

abuse laws, as well as state consumer protection laws.

In addition, later discovery of previously unknown adverse events or other problems

with our drugs, manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may have various consequences,

The FDA and other agencies, including the Department of Justice (“DOJ”),

closely regulate and monitor the post-approval marketing and promotion of drugs to ensure they are marketed and distributed only for

the approved indications and in accordance with the provisions of the approved labeling.

The FDA and DOJ impose stringent restrictions

on manufacturers’ communications regarding off-label use, and if we do not market our drugs for their approved indications, we

may be subject to enforcement action for off-label marketing.

Violations of the FDCA and other statutes, including the False Claims Act,

relating to the promotion and advertising of prescription drugs may lead to investigations and enforcement actions alleging violations

of federal and state healthcare fraud and abuse laws, as well as state consumer protection laws.

In addition, later discovery of previously

unknown adverse events or other problems with our drugs, manufacturers or manufacturing processes, or failure to comply with regulatory

requirements, may have various consequences, including:

on such drugs, manufacturers or manufacturing processes;

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involving patients using our drugs.

Reform in the United States.

reform initiatives in the United States may impact our business and results of operations.

the United States, there have been, and continue to be, a number of legislative and regulatory changes and proposed changes to the healthcare

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In particular, there have been and continue

to be a number of initiatives at the federal and state levels that seek to reduce healthcare costs.

On the federal level, the ACA was

enacted in March 2010, and included measures to significantly change the way healthcare is financed by both governmental and private

Among the provisions of the ACA that have been of greatest importance to the pharmaceutical and biotechnology industry are

the following:

to be a number of initiatives at the federal and state levels that seek to reduce healthcare and prescription drug costs.

On the federal

level, the Affordable Care Act (“ ACA”) was enacted in March 2010, and included

measures to significantly change the way healthcare is financed by both governmental and private insurers.

Among the provisions of the

ACA that have been of greatest importance to the pharmaceutical and biotechnology industry are the following:

annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned

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of a year that is commonly referred to as the “individual mandate.”

of the volatility surrounding the implementation and enforcement of the ACA since its passage, and at this time, the full effect that

the ACA would have on a pharmaceutical manufacturer remains unclear.

This uncertainty is heightened by President Biden’s January

28, 2021 Executive Order on Strengthening Medicaid and the Affordable Care Act which indicates that the Biden Administration may significantly

modify the ACA and further reform the ACA and other federal programs in manner that may impact our operations.

The Biden Administration

has indicated that a goal of its administration is to expand and support Medicaid and the ACA and to make high-quality healthcare accessible

and affordable.

The potential increase in patients covered by government funded insurance may impact our pricing.

Further, it is possible

that the Biden Administration may further increase scrutiny of drug pricing.

of the volatility surrounding the implementation and enforcement of the ACA since its passage, the full effect that the ACA would have

on a pharmaceutical manufacturer remains unclear.

This uncertainty is heightened by President Biden’s January 28, 2021 Executive

Order on Strengthening Medicaid and the ACA which indicates that the Biden Administration may significantly modify the ACA and further

reform the ACA and other federal programs in manner that may impact our operations.

The Biden Administration has indicated that a goal

of its administration is to expand and support Medicaid and the ACA and to make high-quality healthcare accessible and affordable.

potential increase in patients covered by government funded insurance may impact our pricing.

Further, it is possible that the Biden

Administration may further increase scrutiny of drug pricing.

Additionally,

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future, any of which could limit the amounts that federal and state governments will pay for health care products and services.

prescription drug pricing has been a recent focus of federal policymaking.

The Trump Administration issued a series of executive orders

and rules related to prescription drug pricing, including executive orders in July and September 2020 focused on reducing drug prices

and rules in November 2020 establishing a ‘Most Favored Nation’ rule tying Medicare Part B drug pricing to prices in other

countries, as well as a rule effectively banning rebates from Medicare Part D.

The Biden Administration has indicated that lowering prescription

drug prices is a priority for the Biden Administration as well.

prescription drug pricing and transparency has been a recent focus of federal policymaking.

The Inflation Reduction Act, signed into

law in August 2022, contained multiple provisions aimed at lowering the cost of prescription drugs.

The law allows Medicare to negotiate

the price of certain high-cost drugs with pharmaceutical manufacturers and puts a limit on out-of-pocked costs for Medicare Part D members.

Pharmaceutical manufacturers will also have to pay rebates to Medicare if the prices of their drugs under Medicare increase fast than

the rate of inflation.

The Biden Administration also issued an executive order in October 2022 aimed at evaluating new health care payment

and delivery models that would lower costs for prescription drugs and promote access to emerging therapies.

there is uncertainty surrounding the applicability of the biosimilars provisions under the ACA.

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For example, the Leahy-Smith Act allows

third-party submission of prior art to the USPTO during patent prosecution and additional procedures to attack the validity of a patent

by USPTO administered post-grant proceedings, including post-grant review, inter parties review, and derivation proceedings.

the Leahy-Smith Act has transformed the U.S.

patent system from a “first-to-invent” system to a “first-to-file”

system in which, assuming that other requirements for patentability are met, the first inventor to file a patent application will be

entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention.

third-party submission of prior art to the U.S.

Patent and Trademark Office (“ USPTO”)

during patent prosecution and additional procedures to attack the validity of a patent by USPTO administered post-grant proceedings,

including post-grant review, inter parties review, and derivation proceedings.

In addition, the Leahy-Smith Act has transformed the U.S.

patent system from a “first-to-invent” system to a “first-to-file” system in which, assuming that other requirements

for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless

of whether a third party was the first to invent the claimed invention.

addition, the patent positions of companies in the development and commercialization of biologics and pharmaceuticals are particularly

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we are found to infringe, misappropriate or otherwise violate a third party’s intellectual property rights, we could be required

to obtain a license from such third party to continue developing, manufacturing and marketing our technology and drug candidates.

we may not be able to obtain any required license on commercially reasonable terms or at all.

Even if we were able to obtain a license,

it could be non-exclusive;

thereby giving our competitors and other third parties access to the same technologies licensed to us and

could require us to make substantial licensing and royalty payments.

We could be forced, including by court order, to cease developing,

manufacturing and commercializing the infringing technology or drug.

In addition, we could be found liable for significant monetary damages,

including treble damages and attorneys’ fees, if we are found to have willfully infringed a patent or other intellectual property

right and could be forced to indemnify our collaborators or others.

A finding of infringement could prevent us from commercializing our

drug candidates or force us to cease some of our business operations, which could materially harm our business.

In addition, we may be

forced to redesign our drug candidates, seek new regulatory approvals and indemnify third parties pursuant to contractual agreements.

Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar material adverse

effect on our business, financial condition, results of operations, and prospects.

to obtain a license from such third party to continue developing, manufacturing and marketing our drug candidates.

However, we may not

be able to obtain any required license on commercially reasonable terms or at all.

Even if we were able to obtain a license, it could

be non-exclusive;

thereby giving our competitors and other third parties access to the same technologies licensed to us and could require

us to make substantial licensing and royalty payments.

We could be forced, including by court order, to cease developing, manufacturing

and commercializing the infringing technology or drug.

In addition, we could be found liable for significant monetary damages, including

treble damages and attorneys’ fees, if we are found to have willfully infringed a patent or other intellectual property right and

could be forced to indemnify our collaborators or others.

A finding of infringement could prevent us from commercializing our drug candidates

or force us to cease some of our business operations, which could materially harm our business.

In addition, we may be forced to redesign

our drug candidates, seek new regulatory approvals and indemnify third parties pursuant to contractual agreements.

Claims that we have

misappropriated the confidential information or trade secrets of third parties could have a similar material adverse effect on our business,

financial condition, results of operations, and prospects.

property litigation or other legal proceedings relating to intellectual property could cause us to spend substantial resources and distract

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may encounter difficulties in managing our growth, which could adversely affect our operations.

of March 10, 2023, we had 1 full-time employee and 1 part-time employee.

of February 20, 2024, we had 2 full-time employee and 1 part-time employee.

As our clinical development and commercialization plans and

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which could result in financial, legal, business or reputational harm.

disruptions of information technology systems or breaches of data security could adversely affect our business.

business is increasingly dependent on critical, complex, and interdependent information technology systems, including Internet-based

systems, to support business processes as well as internal and external communications.

These systems are also critical to enable remote

working arrangements, which have been growing in importance.

The size and complexity of our computer systems make us potentially vulnerable

to IT system breakdowns, internal and external malicious intrusion, and computer viruses and ransomware, which may impact product production

and key business processes.

We also have outsourced significant elements of our information technology infrastructure and operations

to third parties, which may allow them to access our confidential information and may also make our systems vulnerable to service interruptions

or to security breaches from inadvertent or intentional actions by such third parties or others.

addition, our systems are potentially vulnerable to data security breaches - whether by employees or others - which may expose sensitive

data to unauthorized persons.

Data security breaches could lead to the loss of trade secrets or other intellectual property, result in

demands for ransom or other forms of blackmail, or lead to the public exposure of personal information (including sensitive personal

information) of our employees, clinical trial patients, customers, and others.

Such attacks are of ever-increasing levels of sophistication

and are made by groups and individuals with a wide range of motives (including industrial espionage or extortion) and expertise, including

by organized criminal groups, “hacktivists,” nation states, and others.

As a company with an increasingly global presence,

our systems are subject to frequent attacks.

There is the potential that our systems may be directly or indirectly affected as nation-states

conduct global cyberwarfare, including in connection with the current Russia-Ukraine or Hamas-Israel armed conflict.

to the nature of some of these attacks, there is a risk that an attack may remain undetected for a period of time.

While we continue

to make investments to improve the protection of data and information technology, and to oversee and monitor the security measures of

our suppliers and/or service providers, there can be no assurance that our efforts will prevent service interruptions or security breaches.

In addition, we depend in part on third-party security measures over which we do not have full control to protect against data security

we or our suppliers and/or service providers fail to maintain or protect our information technology systems and data security effectively

and in compliance with U.S.

and foreign laws, or fail to anticipate, plan for, or manage significant disruptions to these systems, we

or our suppliers and/or service providers could have difficulty preventing, detecting, or controlling such disruptions or security breaches,

which could result in legal proceedings, liability under U.S.

and foreign laws that protect the privacy of personal information, disruptions

to our operations, government investigations, breach of contract claims, and damage to our reputation (in each case in the U.S.

or globally),

which could have a material adverse effect on our business, prospects, operating results, and financial condition.

current operations are concentrated in one location, and we or the third parties upon whom we depend may be adversely affected by earthquakes

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our business.

estimates of market opportunity and forecasts of market growth included in this Annual Report on Form 10-K may prove to be inaccurate,

and even if the markets in which we compete achieve the forecasted growth, our business may not grow at similar rates, or at all.

opportunity estimates and growth forecasts included in this Annual Report on Form 10-K are subject to significant uncertainty and are

based on assumptions and estimates which may not prove to be accurate.

The estimates and forecasts included in this Annual Report on

Form 10-K relating to size and expected growth of our target market may prove to be inaccurate.

Even if the markets in which we compete

meet the size estimates and growth forecasts included in this Annual Report on Form 10-K, our business may not grow at similar rates,

Our growth is subject to many factors, including our success in implementing our business strategy, which is subject to many

risks and uncertainties.

estimates of market opportunity and forecasts of market growth included in this prospectus may prove to be inaccurate, and even if the

markets in which we compete achieve the forecasted growth, our business may not grow at similar rates, or at all.

opportunity estimates and growth forecasts included in this prospectus are subject to significant uncertainty and are based on assumptions

and estimates which may not prove to be accurate.

The estimates and forecasts included in this prospectus relating to size and expected

growth of our target market may prove to be inaccurate.

Even if the markets in which we compete meet the size estimates and growth forecasts

included in this prospectus, our business may not grow at similar rates, or at all.

Our growth is subject to many factors, including

our success in implementing our business strategy, which is subject to many risks and uncertainties.

employees, independent contractors, consultants, commercial partners, collaborators and vendors may engage in misconduct or other improper

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In addition to the factors discussed in this “Risk Factors”

section and elsewhere in this Annual Report on Form 10-K, these factors include:

section and elsewhere in this prospectus, these factors include:

commencement, enrollment or results of clinical trials and pre-clinical studies of our drug candidates or those of our competitors;

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cash position;

failure to meet the estimates and projections of the investment community or that we may

otherwise provide to the public;

failure to meet the estimates and projections of the investment community or that we may otherwise provide to the public;

of research reports about us or our industry, or product candidates in particular, or positive or negative recommendations or withdrawal

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attention and resources.

are currently listed on The Nasdaq Capital Market.

If we are unable to maintain listing of our securities on Nasdaq or any stock exchange,

our stock price could be adversely affected and the liquidity of our stock and our ability to obtain financing could be impaired and

it may be more difficult for our stockholders to sell their securities.

our common stock is currently listed on The Nasdaq Capital Market, we may not be able to continue to meet the exchange’s minimum

listing requirements or those of any other national exchange.

If we are unable to maintain listing on Nasdaq or if a liquid market for

our common stock does not develop or is sustained, our common stock may remain thinly traded.

Listing Rules of Nasdaq require listing issuers to comply with certain standards in order to remain listed on its exchange.

reason, we should fail to maintain compliance with these listing standards and Nasdaq should delist our securities from trading on its

exchange and we are unable to obtain listing on another national securities exchange, a reduction in some or all of the following may

occur, each of which could have a material adverse effect on our stockholders:

we fail to comply with the continued listing requirements of The Nasdaq Capital Market, our common stock may be delisted and the price

of our common stock and our ability to access the capital markets could be negatively impacted.

we are unable to maintain our listing on Nasdaq and we are unable to obtain listing on another national securities exchange, a reduction

in some or all of the following may occur, each of which could have a material adverse effect on our stockholders:

liquidity of our common stock;

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therefore be limited to the appreciation of their stock.

principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters

subject to stockholder approval.

of March 10, 2023, our executive officers, directors and their affiliates will beneficially hold, in the aggregate, approximately 44.10%

of our outstanding voting stock.

These stockholders, acting together, would be able to significantly influence all matters requiring

stockholder approval.

For example, these stockholders would be able to significantly influence elections of directors, amendments of

our organizational documents, or approval of any merger, sale of assets, or other major corporate transaction.

This may prevent or discourage

unsolicited acquisition proposals or offers for our common stock that you may feel are in your best interest as one of our stockholders.

to maintain effective internal controls could cause our investors to lose confidence in us and adversely affect the market price of our

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financial statements will not be prevented or detected on a timely basis.

The material weakness that has been identified by our independent

registered public accounting firm relates to the design and implementation of appropriate segregation of duties to separate the roles of authorizing,

initiating, and recording transactions or reviewing transactions for the completeness and accuracy of contracts

with financial reporting implications.

In addition, the terms and conditions related to these contracts were not communicated to the

financial reporting function for analysis and reporting implications in a timely manner.

While we intend to take steps to remediate the

material weakness in our internal control over financial reporting by formalizing certain accounting policies and internal control documentation

and adding staff members with requisite experience to oversee the review of contracts, we may not be successful in remediating such weaknesses

in a timely manner, if at all, which may undermine our ability to provide accurate, timely and reliable reports on our financial and

operating results.

Furthermore, if we remediate our current material weakness but identify new material weaknesses in our internal control

over financial reporting in the future, investors may lose confidence in the accuracy and completeness of our financial reports and the

market price of our common stock may be negatively affected.

As a result of such failures, we could also become subject to investigations

by Nasdaq, the SEC, or other regulatory authorities, and become subject to litigation from investors and stockholders, which could harm

our reputation, financial condition or divert financial and management resources from our business.

The material weaknesses that have been identified by our independent

registered public accounting firm relate to (i) the design and implementation of appropriate segregation of duties to separate the roles

of authorizing, initiating, and recording transactions or reviewing transactions for the completeness and accuracy of contracts with

financial reporting implications and (ii) us lacking sufficient appropriate accounting and reporting knowledge to effectively perform

review controls surrounding technical accounting matters.

While we have initiated a procedure to remediate the material weakness by reviewing

the material contracts on a quarterly basis with the accounting department and supporting staff and intend to use third party experts

to review the accounting treatment for significant transactions and provide management with guidance on the treatment of the transactions,

we may not be successful in remediating such weaknesses in a timely manner, if at all, which may undermine our ability to provide accurate,

timely and reliable reports on our financial and operating results.

Furthermore, if we remediate our current material weakness but identify

new material weaknesses in our internal control over financial reporting in the future, investors may lose confidence in the accuracy

and completeness of our financial reports and the market price of our common stock may be negatively affected.

As a result of such failures,

we could also become subject to investigations by Nasdaq, the SEC, or other regulatory authorities, and become subject to litigation

from investors and stockholders, which could harm our reputation, financial condition or divert financial and management resources from

our business.

Certificate of Incorporation, as amended (“Certificate of Incorporation”) provides that the Court of Chancery of the State

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that vacancies on the board of directors may be filled by a majority of directors in office, although less than a quorum.

market and economic conditions and adverse developments with respect to financial institutions and associated liquidity risk may have

serious adverse consequences on our business, financial condition and stock price.

global credit and financial markets have recently experienced extreme volatility and disruptions, including severely diminished liquidity

and credit availability, declines in consumer confidence, declines in economic growth, inflationary pressure and interest rate changes,

increases in unemployment rates and uncertainty about economic stability.

The financial markets and the global economy may also be adversely

affected by the current or anticipated impact of military conflict, including the conflict between Russia and Ukraine, terrorism or other

geopolitical events.

Sanctions imposed by the United States and other countries in response to such conflicts, including the one in Ukraine,

may also adversely impact the financial markets and the global economy, and any economic countermeasures by the affected countries or

others could exacerbate market and economic instability.

More recently, the closures of Silicon Valley Bank and Signature Bank and their

placement into receivership with the Federal Deposit Insurance Corporation (“FDIC”) created bank-specific and broader financial

institution liquidity risk and concerns.

Although the Department of the Treasury, the Federal Reserve, and the FDIC jointly confirmed

that depositors at SVB and Signature Bank would continue to have access to their funds, even those in excess of the standard FDIC insurance

limits, under a systemic risk exception, future adverse developments with respect to specific financial institutions or the broader financial

services industry may lead to market-wide liquidity shortages, impair the ability of companies to access near-term working capital needs,

and create additional market and economic uncertainty.

There can be no assurance that future credit and financial market instability

and a deterioration in confidence in economic conditions will not occur.

Our general business strategy may be adversely affected by any

such economic downturn, liquidity shortages, volatile business environment or continued unpredictable and unstable market conditions.

If the equity and credit markets deteriorate, or if adverse developments are experienced by financial institutions, it may cause short-term

liquidity risk and also make any necessary debt or equity financing more difficult, more costly and more dilutive.

Failure to secure

any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial

performance and stock price and could require us to delay or abandon our business plans.

In addition, there is a risk that one or more

of our current clients, financial institutions or other third parties with whom we do business may be adversely affected by the foregoing

risks, which may have an adverse effect on our business.

and economic conditions may negatively impact our business, financial condition and share price.

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resources, which could harm our business.

UNRESOLVED STAFF COMMENTS

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 1A. Risk Factors