What changed in this filing

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Item 1A. Risk Factors

2024-04-15 compared with 2023-03-31 · 140 added, 81 removed, 1802 unchanged (11% of the section changed)

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to alter the cost of our Phase III clinical trial by adjusting the enrollment rate, the number of patients, and/or the number of immunological

While our budget for such Phase III trial may be flexible, our ability to reduce or modify costs may be adversely effected by,

While our budget for such Phase III trial may be flexible, our ability to reduce or modify costs may be adversely affected by,

among other things, unexpected or higher costs associated with the trial, time required to complete the trial and other factors that

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candidate may be denied for the same reasons that caused the delay.

from our clinical trials that we announce or publish from time to time may change as more patient data become available either through

long-term patient follow-up and/or as such data is audited and verified, which could result in material changes to clinical and safety

profiles for our products.

time to time, we may disclose data from our preclinical studies and clinical trials.

Such 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 or as patients from our clinical trials continue other treatments for their disease.

In addition, the clinical

trials evaluating our products and product candidates generally require that we continue to monitor and evaluate safety and efficacy

in patients over an extended period of time following treatment which may result in the safety or efficacy profile to change over time.

Changes in the efficacy and safety profile of our product or product candidates over time could significantly harm our business prospects

including resulting in volatility in the price of our common stock.

Additionally,

from time to time, we may publicly disclose preliminary or top-line data from our preclinical studies and clinical trials, which 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.

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

As a result, the top-line or preliminary 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.

Top-line 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, top-line data should be viewed with caution until the final data are available.

others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses

or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability

or commercialization of the particular product candidate or product and our Company in general.

In addition, the information we choose

to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others

may not agree with what we determine is material or otherwise appropriate information to include in our disclosure.

If others, including

regulatory authorities, disagree with the conclusions reached with respect to such information and assessments, our ability to obtain

approval for, and commercialize, our product candidates may be harmed, which could harm our business, operating results, prospects or

financial condition.

the clinical trials using GP2, improper intradermal injections or poor HLA binding by GP2 may potentially jeopardize the outcome of the

is administered intradermally to patients with and without the HLA-A*02 allele.

The effectiveness of GP2 is dependent upon attracting

sufficient antigen presenting cells in the patient’s intradermal space and the association of GP2 with the HLA type of a patient

to adequately train T cells to kill cancer cells, which may or may not be possible or consistent across all HLA types.

It is possible

that nurses may not successfully inject GP2 in the intradermal space or that certain HLA types may form weak or no association with GP2,

potentially leading to weak or no immune response to GP2 and thus no benefit to patients with some or any HLA type.

associated with out-licensing GP2 or future product candidates in foreign countries could materially adversely affect the commercialization

of our products.

may not be able to market products abroad if we cannot complete out-licensing transactions of GP2 or future product candidates by signing

licensing agreements with regional companies in countries where we plan to commercialize our products but where we do not have any operations.

Risks associated with out-licensing transactions of our products in foreign countries include:

to obtain regulatory approval or intellectual property rights in any country which could lead to the termination of a licensing

transaction in that country;

inability to obtain the issuance of patent claims or regulatory status in a foreign country that provide periods of market

exclusivity or data exclusivity prior to the entry of generic or biosimilar forms of our products;

difficulty of pursuing legal remedies to disputes or to secure monetary damages in foreign countries;

inability to repatriate income from a licensing transaction in a foreign country to the U.S.

or to other foreign countries where

cash is needed;

potential to not realize or to delay development or commercialization milestone payments due to unanticipated outcomes that prevent

or delay the milestone.

associated with operating in foreign countries could materially adversely affect our product development.

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before we can recover the expenses of development and commercialization.

business may be adversely affected by the ongoing coronavirus pandemic.

outbreak of the novel coronavirus (COVID-19) has evolved into a global pandemic.

The coronavirus has spread to many regions of the world.

The extent to which the coronavirus 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 the coronavirus and the actions to contain the

coronavirus or treat its impact, among others.

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

For instance, our clinical

trials may be affected by the pandemic.

Site initiation, participant recruitment and enrollment, participant dosing, distribution of

clinical trial materials, clinical trial monitoring and data analysis may be paused or delayed due to changes in hospital or university

policies, federal, state or local regulations, prioritization of hospital resources toward pandemic efforts, or other reasons related

to the pandemic.

If the coronavirus continues to spread, some participants and clinical investigators may not be able to comply with

clinical trial protocols.

For example, quarantines or other travel limitations (whether voluntary or required) may impede participant

movement, affect sponsor access to clinical trial sites, or interrupt healthcare services, and we may be unable to conduct our clinical

Further, if the spread of the coronavirus pandemic continues and our operations are adversely impacted, we risk a delay, default

and/or nonperformance under existing agreements which may increase our costs.

These cost increases may not be fully recoverable or adequately

covered by insurance.

and deaths related to the pandemic may disrupt the healthcare and healthcare regulatory systems in the U.S..

Such disruptions could divert

healthcare resources away from, or materially delay FDA review and/or approval with respect to, our clinical trials.

It is unknown how

long these disruptions could continue, were they to occur.

Any elongation or de-prioritization of our clinical trials or delay in regulatory

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

currently utilize third parties to, among other things, manufacture raw materials.

If any third-party parties in the supply chain for

materials used in the production of our product candidates are adversely impacted by restrictions resulting from the coronavirus outbreak,

our supply chain may be disrupted, limiting our ability to manufacture our product candidates for our clinical trials and research and

development operations.

a result of the shelter-in-place order and 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 which may result in our core activities

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

spread of the coronavirus, 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 is likely to result in further,

significant 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 spread of the coronavirus could materially

and adversely affect our business and the value of our common stock.

ultimate impact of the current 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, and we will continue to monitor the

situation closely.

COVID-19 coronavirus could adversely impact our business in the U.S.

and in other countries, including several key activities, including

clinical trial activities, manufacturing of drugs and clinical supplies, exportation of drug and supplies, and management of international

payments and cash flow that are critical to our success.

global outbreak of COVID-19 continues to rapidly evolve, including the emergence of new strains that could have the potential to be as

harmful as or more harmful than the original strains in 2020.

As a result, businesses may close, staffing may be reduced, including clinical

staffs, and limits may be placed on travel.

The extent to which COVID-19 may impact our business will depend on future developments,

which are highly uncertain and cannot be predicted with confidence, such as the ultimate impact of the disease on specific geographies,

the duration of the outbreak, travel restrictions and social distancing in the United States and other countries, business closures or

business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease.

spread of COVID-19 throughout the world has also created global economic uncertainty, which may cause partners, suppliers and potential

customers to closely monitor their costs and reduce their spending budget.

Any of the foregoing could materially adversely affect our

research and development activities, clinical trials, supply chain, financial condition and cash flows.

the COVID-19 outbreak continues to spread and evolve, we may need to limit operations or implement other limitations on our activities.

There is a risk that countries or regions outside the United States may be less effective at vaccinations and containing COVID-19, in

which case the risks described herein could be elevated significantly.

collection is governed by restrictive regulations governing the use, processing, and cross-border transfer of personal information.

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will need to grow the size of our organization in the future, and we may experience difficulties in managing this growth.

of March 15, 2023, we had 3 full-time employees and 3 part-time employees.

We will need to grow the size of our organization in

order to support our continued development and potential commercialization of our product candidate.

As our development and

commercialization plans and strategies continue to develop, our need for additional managerial, operational, manufacturing, sales,

marketing, financial and other resources may increase.

Our management, personnel and systems currently in place may not be adequate

to support this future growth.

Future growth would impose significant added responsibilities on members of management,

of April 10, 2024, we had 3 full-time employees and 4 part-time employees.

We will need to grow the size of our organization in order

to support our continued development and potential commercialization of our product candidate.

As our development and commercialization

plans and strategies continue to develop, our need for additional managerial, operational, manufacturing, sales, marketing, financial

and other resources may increase.

Our management, personnel and systems currently in place may not be adequate to support this future

Future growth would impose significant added responsibilities on members of management, including:

our clinical trials effectively;

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obtain necessary capital in order to properly capitalize and continue our operations.

are periodically involved in various litigation and/or regulatory proceedings that, if adversely decided or settled, could materially

and adversely affect our business, financial condition, and results of operations.

are periodically party to or the subject of litigation, investigations, regulatory proceedings or other disputes.

In general, claims

made by or against us in disputes and other legal or regulatory proceedings can be expensive and time consuming to bring or defend against,

requiring us to expend significant resources and divert the efforts and attention of our management and other personnel from our business

While we intend to pursue any claims made by us, or vigorously defend against any claims brought against us, we cannot predict

the outcomes of such claims.

Any failure to prevail in any claims made by us or any adverse determination against us in these legal and/or

regulatory proceedings, or even the allegations contained in such proceedings, regardless of whether they are ultimately found to be

without merit, may also result in settlements, injunctions, fines, penalties, or damages that could have a material adverse effect on

our business, financial condition and results of operations.

may hold cash and cash equivalents at various foreign subsidiaries and in countries outside of the US that may not be readily available

to meet cash requirements.

a majority of our cash and cash equivalents is held by our U.S.

parent company, however, our foreign subsidiary may in the future hold

parent company or our foreign subsidiary may hold cash balances outside the United States which may not be readily available,

or may not be available without an additional tax burden, to meet our domestic or foreign cash requirements.

tax laws may allow

for reductions to the potential tax burden on repatriation of foreign cash;

however, such actions would require us to record additional

income tax expense and remit additional taxes, which could have a material adverse effect on our results of operations, cash flows and

financial condition.

In addition, foreign exchange rates may fluctuate leading to unexpected losses and inefficient utilization of cash

in countries outside of the U.S.

may be adversely affected by the effects of inflation and a potential recession.

has the potential to adversely affect our liquidity, business, financial condition, and results of operations by increasing our overall

cost structure.

The existence of inflation in the economy has resulted in, and may continue to result in, higher interest rates and capital

costs, shipping costs, supply shortages, increased costs of labor, weakening exchange rates, and other similar effects.

As a result of

inflation, we have experienced and may continue to experience, cost increases.

In addition, poor economic and market conditions, including

a potential recession, may negatively impact market sentiment, which would adversely affect our results of operations.

If we are unable

to take effective measures in a timely manner to mitigate the impact of the inflation as well as a potential recession, our business,

financial condition, and results of operations could be adversely affected.

Related to Owning our Common Stock

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requiring stockholder approval.

of March 15, 2023, our directors, executive officers and principal stockholders, and their respective affiliates, beneficially own

approximately 52% of our outstanding shares of common stock.

As a result, these stockholders, acting together, have the ability to

control the outcome of matters submitted to our stockholders for approval, including the election of directors and any merger,

consolidation or sale of all or substantially all of our assets.

In addition, these stockholders, acting together, have the ability

to control the management and affairs of our company.

Accordingly, this concentration of ownership might harm the market price of

our common stock by:

of April 10, 2024, our directors, executive officers and principal stockholders, and their respective affiliates, beneficially own approximately

52% of our outstanding shares of common stock.

As a result, these stockholders, acting together, have the ability to control the outcome

of matters submitted to our stockholders for approval, including the election of directors and any merger, consolidation or sale of all

or substantially all of our assets.

In addition, these stockholders, acting together, have the ability to control the management and

affairs of our company.

Accordingly, this concentration of ownership might harm the market price of our common stock by:

deferring or preventing a change in corporate control;

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controls and procedures.

We are required to furnish a report by management on, among other things, the effectiveness of internal

control over financial reporting.

This assessment will include disclosure of any material weaknesses identified by management in our

internal control over financial reporting.

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

over financial reporting that results in more than a reasonable possibility that a material misstatement of annual or interim

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

Section 404 of the Sarbanes-Oxley Act also generally

requires an attestation from an issuer’s independent registered public accounting firm on the effectiveness of its internal

We are required to furnish a report by management on, among other things, the effectiveness of internal control

over financial reporting.

This assessment will include disclosure of any material weaknesses identified by management in our internal

control over financial reporting.

However, for as long as we remain an emerging growth company under the JOBS Act, we may take

advantage of the exemption permitting us not to comply with the independent registered public accounting firm attestation

A material weakness is a deficiency, or combination of deficiencies, in internal control over financial

reporting that results in more than a reasonable possibility that a material misstatement of annual or interim financial statements will

not be prevented or detected on a timely basis.

Section 404 of the Sarbanes-Oxley Act also generally requires an attestation from an

issuer’s independent registered public accounting firm on the effectiveness of its internal control over financial reporting.

for as long as we remain an emerging growth company under the JOBS Act, we may take advantage of the exemption permitting us not to comply

with the independent registered public accounting firm attestation requirement.

compliance with Section 404 of the Sarbanes-Oxley Act may require that we incur substantial accounting expense and expend significant

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effective control systems required of public companies, could also restrict our future access to the capital markets.

UNRESOLVED STAFF COMMENTS

sublease a facility to support our clinical trial operations and research and development.

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