What changed in this filing

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Item 1A. Risk Factors

2023-03-16 compared with 2022-04-01 · 294 added, 316 removed, 1789 unchanged (25% of the section changed)

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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 candidates,

HSB-1216, HSB-888 and HSB-510.

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.

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

plan on submitting an IND to the FDA for HSB-1216 in 2023;

however, no assurance can be provided that our IND will be accepted by the

FDA in 2023, if at all.

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.

are leveraging our TridentAI platform in an attempt to identify synthetic lethal sensitivities associated with degree of cell plasticity

using biomarkers that can be translated for patient selection and stratification for the development of oncology drugs.

While we believe

that applying our TridentAI platform is a precision oncology approach that identifies the mechanism of action, potential combination

drug usage and potentially responsive patient population, our approach is both innovative and in the early stages of development and

therefore, the cost and time needed to develop such platform difficult to predict, and our efforts may not result in the successful discovery

and development of biomarkers.

We may also be incorrect about the effects of the biomarkers on our drug candidates on the diseases of

our defined patient populations, which may limit the utility of our approach or the perception of the utility of our approach.

our estimates of our defined patient populations available for study and treatment may be lower than expected, which could adversely

affect our ability to conduct clinical trials and may also adversely affect the size of any market for medicines we may successfully

commercialize.

Our approach may not result in time savings, higher success rates or reduced costs as we expect it to, and if not, we

may not attract collaborators or develop new drugs as quickly or cost effectively as expected and therefore we may not be able to commercialize

our approach as originally expected.

TridentAI platform may fail to help us discover and develop appropriate biomarkers for our potential drug candidates which would limit

our commercialization prospects and cause our losses to continue.

biomarker discovery or drug development that we are conducting using our TridentAI platform may not be successful in identifying biomarkers

that have commercial value for our products or therapeutic utility.

Our TridentAI platform may initially show promise in identifying

potential biomarkers for our drug candidates, yet fail to stratify patients for clinical development or commercialization for a number

of reasons, including, but not limited to:

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.

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

biomarker discovery or drug development that we are conducting may not be successful in identifying biomarkers that have commercial value

for our products or therapeutic utility.

Platforms may initially show promise in identifying potential biomarkers for our drug candidates,

yet fail to stratify patients for clinical development or commercialization for a number of reasons, including, but not limited to:

programs to identify new biomarkers will require substantial technical, financial and human resources, and we may be unsuccessful

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impact our stock price;

identified through our TridentAI platform may not demonstrate correlation to efficacy, safety or tolerability;

data available for our TridentAI platform that seeks to correlate genomic or biomarker signatures with certain cancers may be influenced

by the race of the patient which may limit the efficacy of our drug candidates;

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

may limit the efficacy of our drug candidates;

regulatory pathway for the biomarkers may be too complex, expensive or otherwise difficult to navigate successfully;

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2021 we reported a net loss of $8.5 million and $2.2 million, respectively.

As of December 31, 2021, we had an accumulated deficit

of $6.9 million.

As of December 31, 2022, we had an accumulated deficit of

$15.4 million.

We have funded our operations primarily with proceeds from the sale of our equity and debt securities.

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

are currently advancing our product candidates, HSB-1216 and HSB-888, through pre-clinical stage development.

Developing 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.

of December 31, 2021, we had cash of $4,356 and we received net proceeds of approximately $13.0 million, after deducting underwriting

discounts and commissions and offering expenses borne by us in connection with our initial public offering in January 2022;

we will require additional capital to obtain regulatory approval for, and to commercialize, our product candidates.

Raising funds may

present challenges including, but not limited to, as a result of the novel Coronavirus (“COVID-19”).

Even if we believe we

have sufficient funds for our current or future operating plans, we may seek additional capital if market conditions are favorable or

if we have specific strategic considerations.

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.

of December 31, 2022, we had cash of $6.5 million;

however, we will require additional capital to obtain regulatory approval for, and

to commercialize, our product candidates.

Raising funds may present challenges.

Even if we believe we have sufficient funds for our current

or future operating plans, we may seek additional capital if market conditions are favorable or if we have specific strategic considerations.

additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to

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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.

Related to the Discovery and Development of Our Product Candidates

are substantially dependent on the success of our product candidates, HSB-1216 and HSB-888, which are currently in pre-clinical trials.

If we are unable to complete development of, obtain approval for and commercialize HSB-1216 or HSB-888 for one or more indications in

a timely manner, our business may be harmed.

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.

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

commercialize HSB-1216 and HSB-888, our product candidates which are in the pre-clinical stages of development.

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 and HSB-888

as well as other product candidates, which may never occur.

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.

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

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In either case, our development costs would increase.

still need to receive FDA clearance of our IND for HSB-1216 and HSB-888 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.

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.

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.

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

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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 or HSB-888.

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

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

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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 or HSB-888 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, 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.

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

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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 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 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,

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The extent to which COVID-19 impacts

our business and operating results will depend on future developments that are highly 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

a result of the continuing spread of COVID-19, our business operations could be delayed or interrupted.

For example, to date, as a result

of COVID-19 we have experienced delays from our manufacturers with respect to the shipping of our materials as well as delays in completion

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, our research and development may be affected

as a result of delays in study monitoring and data analysis.

Furthermore, if COVID-19 continues to spread, some participants and clinical

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;

For example, any quarantines or other travel limitations (whether

voluntary or required) may impede participant movement, affect sponsor access to study sites, or interrupt healthcare services, and we

may be unable to conduct our research activities, including our clinical trials.

continuing infections and deaths related to the pandemic may disrupt the United States’ healthcare and healthcare regulatory systems.

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

It is unknown how long these disruptions could continue, were they to occur.

Any elongation or de-prioritization of clinical trials or

delay in regulatory review resulting from such disruptions could materially affect the development and study of our product candidates.

the event of a shelter-in-place order or other mandated local travel restrictions, our employees conducting research and development

or manufacturing activities may not be able to access their laboratory or manufacturing space, and our core activities may be significantly

limited or curtailed, possibly for an extended period of time.

spread of COVID-19, which has caused a broad impact globally, including restrictions on travel and quarantine policies put into place

by businesses and governments, may have a material economic effect on our business.

While the potential economic impact brought by and

the duration of 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 the continued spread of COVID-19 could materially and adversely affect our business

and the value of our common stock.

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.

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global economy as a whole.

However, these effects could have a material impact on our operations, and we will continue to monitor the

situation closely.

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

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

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 and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.

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, 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.

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.

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, 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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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.

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.

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

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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We and our CROs are required to comply with current

GCP, which are regulations and guidelines enforced by the FDA, the Competent Authorities of the Member States of the European

Economic Area and comparable foreign regulatory authorities for all of our drugs in clinical development.

GCP, which are regulations and guidelines enforced by the FDA, the Competent Authorities of the Member States of the European Economic

Area and comparable foreign regulatory authorities for all of our drugs in clinical development.

authorities enforce these current GCP through periodic inspections of trial sponsors, principal investigators and trial sites.

If we or any of our CROs fail to comply with applicable GCP, the clinical data generated in our clinical trials may be deemed

unreliable and the FDA, the EMA or comparable foreign regulatory authorities may require us to perform additional clinical trials before

approving our marketing applications.

We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority

will determine that any of our clinical trials comply with GCP regulations.

In addition, our clinical trials must be conducted with products

produced under cGMP.

Our failure to comply with these regulations may require us to repeat clinical trials, which would delay

the regulatory approval process.

or any of our CROs fail to comply with applicable GCP, the clinical data generated in our clinical trials may be deemed unreliable and

the FDA, the EMA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our

marketing applications.

We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine

that any of our clinical trials comply with GCP regulations.

In addition, our clinical trials must be conducted with products produced

Our failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval

any of our relationships with these third-party CROs terminate, we may not be able to enter into arrangements with alternative CROs or

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work stoppages, do not meet expected deadlines, terminate their agreements with us or need to be replaced, or if the quality or accuracy

of the clinical data they obtain is compromised due to their failure to adhere to our clinical trial protocols or to GCP, or for

any other reason, we may need to enter into new arrangements with alternative third parties.

of the clinical data they obtain is compromised due to their failure to adhere to our clinical trial protocols or to GCP, or for any

other reason, we may need to enter into new arrangements with alternative third parties.

Switching or adding additional CROs involves

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manufacturers may not be able to comply with cGMP or similar regulatory requirements outside of the United States.

or the failure of our third-party manufacturers and suppliers, to comply with applicable regulations could result in sanctions being

imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license

revocation, seizures or recalls of drug candidates or products, operating restrictions and criminal prosecutions, any of which could

significantly and adversely affect supplies of our products.

In addition, our third-party manufacturers and suppliers are subject to

numerous environmental, health and safety laws and regulations, including those governing the handling, use, storage, treatment and disposal

of waste products, and failure to comply with such laws and regulations could result in significant costs associated with civil or criminal

fines and penalties for such third parties.

Based on the severity of regulatory actions that may be brought against these third parties

in the future, our clinical or commercial supply of drug and packaging and other services could be interrupted or limited, which could

harm our business.

Our failure, or the

failure of our third-party manufacturers and suppliers, to comply with applicable regulations could result in sanctions being imposed

on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation,

seizures or recalls of drug candidates or products, operating restrictions and criminal prosecutions, any of which could significantly

and adversely affect supplies of our products.

In addition, our third-party manufacturers and suppliers are subject to numerous environmental,

health and safety laws and regulations, including those governing the handling, use, storage, treatment and disposal of waste products,

and failure to comply with such laws and regulations could result in significant costs associated with civil or criminal fines and penalties

for such third parties.

Based on the severity of regulatory actions that may be brought against these third parties in the future, our

clinical or commercial supply of drug and packaging and other services could be interrupted or limited, which could harm our business.

drug candidates and any products that we may develop may compete with other drug candidates and products for access to manufacturing

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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, and the

inability to obtain the active ingredient in HSB-1216 as required could harm our business.

currently source the active ingredient in HSB-1216 from one supplier and manufacturer.

Although we believe that we can obtain the active

ingredient in HSB-1216 from other suppliers, supply shortages for this particular raw material has and may in the future delay our clinical

If we are unable to procure the active ingredient in HSB-1216 as needed, our business may be harmed.

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.

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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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-888, HSB-510 and any future product candidates in a timely manner.

if we eventually complete clinical testing and receive approval for HSB-1216, HSB-888, HSB-510 and any future product candidates, the

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

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.

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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 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

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.

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.

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

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

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:

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,

on such drugs, manufacturers or manufacturing processes;

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

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:

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

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Additionally,

in December 2019,

a federal appeals court held that the individual mandate portion of the ACA was

unconstitutional and left open the question whether the remaining provisions of the ACA

would be valid without the individual mandate.

However, on appeal, the Supreme Court ruled

in June 2021 that the parties challenging the law lacked standing, leaving the ACA in place.

is unclear how any other potential litigation challenging the ACA and the healthcare reform measures of the Biden administration will

impact the ACA.

We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or

administrative or executive action, either in the United States or abroad.

We expect that additional state and federal health care reform

measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for health care

products and services.

in December 2019, a federal appeals court held that the individual mandate portion of the ACA was unconstitutional and left open the

question whether the remaining provisions of the ACA would be valid without the individual mandate.

However, on appeal, the Supreme Court

ruled in June 2021 that the parties challenging the law lacked standing, leaving the ACA in place.

It is unclear how any other potential

litigation challenging the ACA and the healthcare reform measures of the Biden administration will impact the ACA.

We cannot predict

the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action,

either in the United States or abroad.

We expect that additional state and federal health care reform measures will be adopted in the

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.

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For example, the Leahy-Smith Act allows

third-party submission of prior art to the United States 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.

The first-to-file provisions, however, only became effective on March 16, 2013.

Accordingly, it is not yet clear

what, if any, impact the Leahy-Smith Act will have on the operation of our business.

However, the Leahy-Smith Act and its implementation

could make it more difficult to obtain patent protection for our inventions and increase the uncertainties and costs surrounding the

prosecution of our or our collaboration partners’ patent applications and the enforcement or defense of our or our collaboration

partners’ issued patents, all of which could harm our business, results of operations, financial condition and prospects.

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.

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

Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened

the rights of patent owners in certain situations.

This combination of events has created uncertainty with respect to the validity and

enforceability of patents once obtained.

Supreme Court and Federal Circuit rulings have narrowed the scope of patent protection available in certain circumstances

and weakened the rights of patent owners in certain situations.

This combination of events has created uncertainty with respect to the

validity and enforceability of patents once obtained.

Depending on future actions by the U.S.

Congress, the federal courts, and the USPTO, the laws

and regulations governing patents could change in unpredictable ways that could have a material adverse effect on our patent rights and

our ability to protect, defend and enforce our patent rights in the future.

Congress, the federal courts, and the USPTO,

the laws and regulations governing patents could change in unpredictable ways that could have a material adverse effect on our patent

rights and our ability to protect, defend and enforce our patent rights in the future.

or our future licensors may become involved in lawsuits to protect or enforce our patent or other intellectual property rights, which

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extreme volatility and disruptions in the capital and credit markets.

A severe or prolonged economic downturn, including due to the impact

of the COVID-19 pandemic, could result in a variety of risks to our business, including a reduced ability to raise additional capital

when needed on acceptable terms, if at all.

A weak or declining economy or international trade disputes could also strain our suppliers,

some of which are located outside of the United States, possibly resulting in supply disruption.

Any of the foregoing could harm our

business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely

impact our business.

A severe or prolonged economic downturn could result in a variety

of risks to our business, including a reduced ability to raise additional capital when needed on acceptable terms, if at all.

or declining economy or international trade disputes could also strain our suppliers, some of which are located outside of the United

States, possibly resulting in supply disruption.

Any of the foregoing could harm our business and we cannot anticipate all of the ways

in which the current economic climate and financial market conditions could adversely impact our business.

increasing use of social media platforms presents new risks and challenges.

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International

data protection laws, including Regulation 2016/679, known as the General Data Protection Regulation (“GDPR”) may also apply

to health-related and other personal information obtained outside of the United States.

data protection laws, including, but not limited to, Regulation 2016/679, known as the General Data Protection Regulation (“GDPR”)

may also apply to health-related and other personal information obtained outside of the United States.

The GDPR went into effect on May

GDPR introduced new data protection requirements in the European Union, as well as potential fines for noncompliant companies of up to

the greater of €20 million or 4% of annual global revenue.

The regulation imposes numerous new requirements for the collection,

use and disclosure of personal information, including more stringent requirements relating to consent and the information that must be

shared with data subjects about how their personal information is used, the obligation to notify regulators and affected individuals

of personal data breaches, extensive new internal privacy governance obligations and obligations to honor expanded rights of individuals

in relation to their personal information (e.g., the right to access, correct and delete their data).

In addition, the GDPR includes

restrictions on cross-border data transfer.

The GDPR will increase our responsibility and liability in relation to personal data that

we process, and we may be required to put in place additional mechanisms to ensure compliance with the new EU data protection rules.

Further, the United Kingdom’s vote in favor of exiting the EU, often referred to as Brexit, has created uncertainty with regard

to data protection regulation in the United Kingdom.

In particular, it is unclear whether the United Kingdom will enact data protection

legislation equivalent to the GDPR and how data transfers to and from the United Kingdom will be regulated.

The GDPR introduced new data protection requirements in the European Union, as well as potential fines for noncompliant companies.

The regulation imposes numerous new requirements for the collection, use and disclosure of personal information, including more stringent

requirements relating to consent and the information that must be shared with data subjects about how their personal information is used,

the obligation to notify regulators and affected individuals of personal data breaches, extensive new internal privacy governance obligations

and obligations to honor expanded rights of individuals in relation to their personal information (e.g., the right to access, correct

and delete their data).

In addition, the GDPR includes restrictions on cross-border data transfer.

The GDPR will increase our responsibility

and liability in relation to personal data that we process, and we may be required to put in place additional mechanisms to ensure compliance

with the new EU data protection rules.

In addition, as a result of the United Kingdom’s vote in favor of exiting the EU, often

referred to as Brexit, the United Kingdom’s Data Protection Act of 2018, as amended, may apply to health-related and other personal

information obtained outside of the United States.

and international data protection laws and regulations could require us to take on more onerous obligations in our contracts,

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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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addition, the stock market in general, and the market for biopharmaceutical companies in particular, have experienced extreme price and

volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies, including as

a result of the COVID-19 pandemic.

Broad market and industry factors may negatively affect the market price of our common stock, regardless

of our actual operating performance.

In the past, securities class action litigation has often been instituted against companies following

periods of volatility in the market price of a company’s securities.

This type of litigation, if instituted, could result in substantial

costs and a diversion of management’s attention and resources.

volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies.

and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance.

past, securities class action litigation has often been instituted against companies following periods of volatility in the market price

of a company’s securities.

This type of litigation, if instituted, could result in substantial costs and a diversion of management’s

attention and resources.

are currently listed on The Nasdaq Capital Market.

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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 shareholders:

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

liquidity of our common stock;

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In connection

with the audit of our financial statements for the years ended December 31, 2020 and 2019, our independent registered

public accounting firm identified a material weakness.

A material weakness is a significant deficiency, or a combination of significant

deficiencies, in internal controls over financial reporting such that it is reasonably possible that a material misstatement of

the annual or interim 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 control(s) to review 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.

amounts of our outstanding shares may be sold into the market when lock-up or market standoff periods end.

If there are substantial sales

of shares of our common stock, the price of our common stock could decline.

of our outstanding shares of common stock held by our directors, executive officers and our stockholders are subject to contractual lock-up

restrictions on resale.

Specifically, in connection with our initial public offering, our executive

officers and directors agreed to a 365 day lock-up restriction from the date of our prospectus in connection with our initial

public offering and other stockholders agreed to a 180 day lock-up restriction from the

date of our prospectus in connection with our initial public offering.

If these stockholders sell, or indicate an intent to sell, substantial

amounts of our common stock in the public market after the expiration of the applicable lock-up period, the trading price of our common

stock could decline significantly.

with the audit of our financial statements for the years ended December 31, 2022 and 2021, our independent registered public accounting

firm identified a material weakness.

A material weakness is a significant deficiency, or a combination of significant deficiencies, in

internal controls over financial reporting such that it is reasonably possible that a material misstatement of the annual or interim

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.

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

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over inflation, energy costs, geopolitical issues, the U.S.

mortgage market and a declining real estate market, unstable global credit

markets and financial conditions, and volatile oil prices have led to periods of significant economic instability, diminished liquidity

and credit availability, declines in consumer confidence and discretionary spending, diminished expectations for the global economy and

expectations of slower global economic growth going forward, increased unemployment rates, and increased credit defaults in recent years.

Our general business strategy may be adversely affected by any such economic downturns, volatile business environments and continued

unstable or unpredictable economic and market conditions.

If these conditions continue to deteriorate or do not improve, it may make

any necessary debt or equity financing more difficult to complete, 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 share

price and could require us to delay or abandon development or commercialization plans.

mortgage market and the real estate market, unstable global credit markets

and financial conditions, and volatile oil prices have led to periods of significant economic instability, diminished liquidity and credit

availability, declines in consumer confidence and discretionary spending, diminished expectations for the global economy and expectations

of slower global economic growth going forward, increased unemployment rates, and increased credit defaults in recent years.

business strategy may be adversely affected by any such economic downturns, volatile business environments and continued unstable or

unpredictable economic and market conditions.

If these conditions continue to deteriorate or do not improve, it may make any necessary

debt or equity financing more difficult to complete, 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 share price and

could require us to delay or abandon development or commercialization plans.

sales and issuances of our securities could result in additional dilution of the percentage ownership of our stockholders and could cause

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be materially diluted by subsequent sales.

Such sales may also result in material dilution to our existing shareholders, and new investors

could gain rights superior to our existing shareholders.

Such sales may also result in material dilution to our existing stockholders, and new investors

could gain rights superior to our existing stockholders.

are an emerging growth company, and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies

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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