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Item 1A. Risk Factors

2024-03-29 compared with 2023-03-27 · 421 added, 379 removed, 1050 unchanged (43% of the section changed)

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for the foreseeable future.

We are a clinical-stage biopharmaceutical company focused on developing

a novel class of TSTx in oncology and inflammation.

Investment in biopharmaceutical product development is highly speculative because

it entails substantial upfront capital expenditures and significant risk that a product candidate will fail to prove effective, gain regulatory

approval or become commercially viable.

We do not have any products approved by regulatory authorities and have not generated any revenues

from collaboration or licensing agreements or product sales to date, and have incurred significant research, development and other expenses

related to our ongoing operations and expect to continue to incur such expenses.

As a result, we have not been profitable and have incurred

significant operating losses since our inception.

For the years ended December 31, 2022 and 2021, we reported net losses of $8,229,713

and $24,383,879, respectively.

As of December 31, 2022, we had an accumulated deficit of $37,985,247.

are a clinical-stage biopharmaceutical company focused on developing a novel class of TSTx in oncology and inflammation.

Investment in

biopharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and significant

risk that a product candidate will fail to prove effective, gain regulatory approval or become commercially viable.

We do not have any

products approved by regulatory authorities and have not generated any revenues from collaboration or licensing agreements or product

sales to date, and have incurred significant research, development and other expenses related to our ongoing operations and expect to

continue to incur such expenses.

As a result, we have not been profitable and have incurred significant operating losses since our inception.

For the years ended December 31, 2023 and 2022, we reported net losses of $15,595,522 and $8,229,713, respectively.

As of December

31, 2023, we had an accumulated deficit of $53,411,295.

do not expect to generate revenues for many years, if at all.

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pre-clinical and clinical trials of our product candidates;

or acquire the rights to, and pursue development of, other products, product candidates or technologies;

or acquire the rights to, and pursue development of, other products, product candidates or

technologies;

additional clinical, manufacturing, quality control, quality assurance and scientific personnel;

marketing approval for any product candidates that successfully complete clinical trials;

sales, marketing and distribution capabilities, if we receive, or expect to receive, marketing approval for any product candidates;

sales, marketing and distribution capabilities, if we receive, or expect to receive, marketing

approval for any product candidates;

expand and protect our intellectual property portfolio;

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will need to raise significant additional capital to complete development and obtain regulatory approval for our product candidates.

Although we believe that our existing cash balance of $13,436,714 as of December 31, 2022, and funds available to be raised pursuant to the Sales Agreement, will be sufficient to meet our cash, operational and liquidity requirements for at

least 12 months from March 27, 2023, our operating plan may change as a result of many factors currently unknown to us, and we may

need additional funds sooner than planned.

Although we believe that our existing cash and cash equivalents balance of $17,509,791 as of December 31, 2023, plus the net proceeds

of $15.5 million from our February 2024 offering of common stock, will be sufficient to meet our cash, operational and

liquidity requirements for at least 12 months from the date of this report, our operating plan may change as a result of many

factors currently unknown to us, and we may need additional funds sooner than planned.

expect to expend substantial resources for the foreseeable future to continue the clinical development and manufacturing of our product

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and achieve profitability also depends on a number of additional factors, including our ability to:

● successfully

complete development activities, including the necessary clinical trials;

and submit either BLAs or NDAs to the FDA and obtain U.S.

regulatory approval for indications for which there is a commercial market;

regulatory approval for indications

for which there is a commercial market;

and submit applications to foreign regulatory authorities;

regulatory approval in territories with viable market sizes;

coverage and adequate reimbursement from third parties, including government and private payors;

coverage and adequate reimbursement from third parties, including government and private

commercially viable prices for our products, if any;

and maintain supply and manufacturing relationships with reliable third parties, legally globally compliant manufacturing of bulk

drug substances and drug products to maintain that supply;

and maintain supply and manufacturing relationships with reliable third parties, legally

globally compliant manufacturing of bulk drug substances and drug products to maintain that

distribution processes for our product candidates;

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ability to use net operating losses to offset future taxable income may be subject to limitations.

As of December 31, 2022, we had federal net operating loss (“NOLs”)

carryforwards of approximately $5,800,000.

Our NOLs generated in tax years ending on or prior to December 31, 2017 are only permitted

to be carried forward for 20 years under applicable U.S.

tax laws, and will begin to expire, if not utilized, beginning in 2027.

NOL carryforwards could expire unused and be unavailable to offset future income tax liabilities.

Under the Tax Act, federal NOLs incurred

in tax years ending after December 31, 2017 may be carried forward indefinitely, but the deductibility of such federal NOLs is limited.

It is uncertain if and to what extent various states will conform to the Tax Act, or whether any further regulatory changes may be adopted

in the future that could minimize its applicability.

In addition, under Section 382 of the Internal Revenue Code of 1986, as amended,

and certain corresponding provisions of state law, if a corporation undergoes an “ownership change,” which is generally defined

as a greater than 50% change, by value, in the ownership of its equity over a three-year period, the corporation’s ability to use

its pre-change NOL carryforwards and other pre-change tax attributes to offset its post-change income may be limited.

of December 31, 2023 we had federal net operating loss (“NOLs”) carryforwards of approximately $11,800,000.

Our NOLs generated

in tax years ending on or prior to December 31, 2017 are only permitted to be carried forward for 20 years under applicable U.S.

laws, and will begin to expire, if not utilized, beginning in 2034.

These NOL carryforwards could expire unused and be unavailable to

offset future income tax liabilities.

Under the Tax Act, federal NOLs incurred in tax years ending after December 31, 2017 may be carried

forward indefinitely, but the deductibility of such federal NOLs is limited.

It is uncertain if and to what extent various states will

conform to the Tax Act, or whether any further regulatory changes may be adopted in the future that could minimize its applicability.

In addition, under Section 382 of the Internal Revenue Code of 1986, as amended, and certain corresponding provisions of state law, if

a corporation undergoes an “ownership change,” which is generally defined as a greater than 50% change, by value, in the

ownership of its equity over a three-year period, the corporation’s ability to use its pre-change NOL carryforwards and other pre-change

tax attributes to offset its post-change income may be limited.

Relating to the Development and Regulatory Approval of Our Product Candidates

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the following:

● successfully

completing formulation and process development activities;

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marketing approval from applicable regulatory authorities;

● establishing

commercial manufacturing capabilities;

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including, but not limited to:

● discussions

with the FDA or other regulatory agencies regarding the scope or design of our clinical trials;

limited number of, and competition for, suitable sites to conduct our clinical trials, many of which may already be engaged in other

clinical trial programs, including some that may be for the same indication as our product candidates;

delay or failure to obtain approval or agreement to commence a clinical trial in any of the countries where enrollment is planned;

limited number of, and competition for, suitable sites to conduct our clinical trials, many

of which may already be engaged in other clinical trial programs, including some that may

be for the same indication as our product candidates;

delay or failure to obtain approval or agreement to commence a clinical trial in any of the

countries where enrollment is planned;

to obtain sufficient funds required for a clinical trial;

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or failure to manufacture sufficient supplies of product candidates for our clinical trials;

or failure to reach agreement on acceptable clinical trial agreement terms or clinical trial protocols with prospective sites or

clinical research organizations (“CROs”), the terms of which can be subject to extensive negotiation and may vary significantly

among different sites or CROs;

or failure to reach agreement on acceptable clinical trial agreement terms or clinical trial

protocols with prospective sites or clinical research organizations (“CROs”),

the terms of which can be subject to extensive negotiation and may vary significantly among

different sites or CROs;

or failure to obtain IRB approval to conduct a clinical trial at a prospective site;

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of patients to complete the clinical trial;

inability to enroll a sufficient number of patients in studies to ensure adequate statistical power to detect statistically significant

treatment effects;

safety issues, including severe or unexpected drug-related adverse effects experienced by patients, including possible deaths;

inability to enroll a sufficient number of patients in studies to ensure adequate statistical

power to detect statistically significant treatment effects;

safety issues, including severe or unexpected drug-related adverse effects experienced by

patients, including possible deaths;

of efficacy during clinical trials;

● termination

of our clinical trials by one or more clinical trial sites;

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to monitor patients adequately during or after treatment;

study sites failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at

all, deviating from the protocol or dropping out of a study;

to address any non-compliance with regulatory requirements or safety concerns that arise during the course of a clinical trial;

need to repeat or terminate clinical trials as a result of inconclusive or negative results or unforeseen complications in testing;

clinical trials may be suspended or terminated upon a breach or pursuant to the terms of any agreement with, or for any other reason

by, current or future strategic partners that have responsibility for the clinical development of any of our product candidates.

study sites failing to comply with regulatory requirements or meet their contractual obligations

to us in a timely manner, or at all, deviating from the protocol or dropping out of a study;

to address any non-compliance with regulatory requirements or safety concerns that arise

during the course of a clinical trial;

need to repeat or terminate clinical trials as a result of inconclusive or negative results

or unforeseen complications in testing;

clinical trials may be suspended or terminated upon a breach or pursuant to the terms of

any agreement with, or for any other reason by, current or future strategic partners that

have responsibility for the clinical development of any of our product candidates.

in regulatory requirements, policies and guidelines may also occur and we may need to significantly amend clinical trial protocols to

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factors may affect our ability to identify, enroll and maintain qualified patients, including the following:

criteria of our ongoing and planned clinical trials with specific characteristics appropriate for inclusion in our clinical trials;

● eligibility

criteria of our ongoing and planned clinical trials with specific characteristics appropriate

for inclusion in our clinical trials;

of the clinical trial;

and nature of the patient population;

perceptions as to risks and benefits of the product candidate under study and the participation in a clinical trial generally in

relation to other available therapies, including any new drugs that may be approved for the indications we are investigating;

perceptions as to risks and benefits of the product candidate under study and the participation

in a clinical trial generally in relation to other available therapies, including any new

drugs that may be approved for the indications we are investigating;

availability and efficacy of competing therapies and clinical trials;

of other trials underway in the same patient population;

● willingness

of physicians to participate in our planned clinical trials;

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authorities may require us to take our approved product off the market;

authorities may require the addition of labeling statements, specific warnings, and/or a contraindication or field alerts to physicians

and pharmacies;

may be required to change the way the product is administered, conduct additional clinical trials or change the labeling of the product;

authorities may require the addition of labeling statements, specific warnings, and/or a

contraindication or field alerts to physicians and pharmacies;

may be required to change the way the product is administered, conduct additional clinical

trials or change the labeling of the product;

may be subject to limitations on how we may promote the product;

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incur significant additional expenses.

do not own or operate any manufacturing facilities.

We rely on and intend to continue to rely on CMOs to formulate and manufacture our

pre-clinical and clinical materials.

Our reliance on a CMO exposes us to a number of risks, any of which could delay or prevent the completion

of our pre-clinical studies or clinical trials, or the regulatory approval or commercialization of our product candidates, result in

higher costs, or deprive us of potential product revenues.

Although in January

2024, the Company entered into a long-term operating lease agreement for manufacturing space located in California, as of March

2024, we do not own or operate any operating manufacturing

We rely on and intend to continue to rely on CMOs to formulate and manufacture our pre-clinical and clinical materials.

Our reliance on a CMO exposes us to a number of risks, any of which could delay or prevent the completion of our pre-clinical

studies or clinical trials, or the regulatory approval or commercialization of our product candidates, result in higher costs, or

deprive us of potential product revenues.

Some of these risks include:

CMO failing to develop an acceptable formulation to support later-stage clinical trials for, or the commercialization of, our product

CMO failing to manufacture our product candidate according to our specifications, the FDA’s cGMP requirements, or otherwise

manufacturing material that we, the FDA or other regulatory agencies may deem to be unsuitable in our clinical trials;

CMO being unable to increase the scale of, increase the capacity for, or reformulate the form of our product candidates.

We may experience

a shortage in supply, or the cost to manufacture our products may increase to the point where it may adversely affect the cost of

our product candidates.

We cannot assure you that our CMO will be able to manufacture our product candidates at a suitable scale,

or we will be able to find alternative manufacturers acceptable to us that can do so;

CMO placing a priority on the manufacture of their own products, or other customers’ products;

CMO failing to develop an acceptable formulation to support later-stage clinical trials for,

or the commercialization of, our product candidates;

CMO failing to manufacture our product candidate according to our specifications, the FDA’s

cGMP requirements, or otherwise manufacturing material that we, the FDA or other regulatory

agencies may deem to be unsuitable in our clinical trials;

CMO being unable to increase the scale of, increase the capacity for, or reformulate the

form of our product candidates.

We may experience a shortage in supply, or the cost to manufacture

our products may increase to the point where it may adversely affect the cost of our product

We cannot assure you that our CMO will be able to manufacture our product candidates

at a suitable scale, or we will be able to find alternative manufacturers acceptable to us

that can do so;

CMO placing a priority on the manufacture of their own products, or other customers’

CMO failing to perform as agreed upon or not remain in business;

CMO’s plants being closed as a result of regulatory sanctions, natural disasters, health epidemics or otherwise.

CMO’s plants being closed as a result of regulatory sanctions, natural disasters, health

epidemics or otherwise.

Manufacturers

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The degree of market acceptance of our product candidates will depend on a number of factors, including:

● limitations

or warnings contained in the approved labeling for a product candidate;

in the standard of care for the targeted indications for any of our product candidates;

● limitations

in the approved clinical indications for our product candidates;

● demonstrated

clinical safety and efficacy compared to other products;

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marketing and distribution support;

● availability

of coverage and reimbursement amounts from managed care plans and other third-party payors;

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cost-effectiveness of our product candidates;

of alternative products at similar or lower cost, including generic and over-the-counter products;

extent to which the product candidate is approved for inclusion on formularies of hospitals and managed care organizations;

the product is designated under physician treatment guidelines as a first-line therapy or as a second- or third-line therapy for

particular diseases;

● availability

of alternative products at similar or lower cost, including generic and over-the-counter

extent to which the product candidate is approved for inclusion on formularies of hospitals

and managed care organizations;

the product is designated under physician treatment guidelines as a first-line therapy or

as a second- or third-line therapy for particular diseases;

the product can be used effectively with other therapies to achieve higher response rates;

publicity about our product candidates or favorable publicity about competitive products;

● convenience

and ease of administration of our products;

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manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:

● restrictions

on the marketing or manufacturing of the product;

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warning letters or holds on clinical trials;

by the FDA, European Medicines Agency (“EMA”) or another competent regulatory authority to approve pending applications

or supplements to approved applications filed by us, or suspension or revocation of product license approvals;

by the FDA, European Medicines Agency (“EMA”) or another competent regulatory

authority to approve pending applications or supplements to approved applications filed by

us, or suspension or revocation of product license approvals;

seizure or detention, or refusal to permit the import or export of products;

● injunctions

or the imposition of civil or criminal penalties.

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of clinical trial participants;

● termination

of clinical trial sites or entire trial programs;

regulatory scrutiny;

● significant

litigation costs;

● substantial

monetary awards to or costly settlement with patients or other claimants;

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laws to which we will be subject and which could impact our business activities include the following.

and state healthcare program anti-kickback laws (including the federal Anti-Kickback Statute and Civil Monetary Penalties Law) prohibit

among other things, persons from soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral

of an individual, for an item or service or the purchasing or ordering of a good or service, for which payment may be made under

federal healthcare programs such as the Medicare and Medicaid programs.

Such anti-kickback laws can be implicated by, among other

activities, marketing arrangements with ordering providers, discount or rebate programs or other inducements to purchase our products.

Violation of these laws can result in criminal prosecution and imposition of criminal penalties and fines, as well civil monetary

penalties and multiple damage judgments, and exclusion from participation in federal healthcare programs;

and state healthcare program anti-kickback laws (including the federal Anti-Kickback Statute

and Civil Monetary Penalties Law) prohibit among other things, persons from soliciting, receiving

or providing remuneration, directly or indirectly, to induce either the referral of an individual,

for an item or service or the purchasing or ordering of a good or service, for which payment

may be made under federal healthcare programs such as the Medicare and Medicaid programs.

Such anti-kickback laws can be implicated by, among other activities, marketing arrangements

with ordering providers, discount or rebate programs or other inducements to purchase our

Violation of these laws can result in criminal prosecution and imposition of criminal

penalties and fines, as well civil monetary penalties and multiple damage judgments, and

exclusion from participation in federal healthcare programs;

Omnibus Budget Reconciliation Act of 1993 (42 U.S.C.

§ 1395nn) prohibit referrals by ordering

by a physician of “designated health services” which include pharmaceuticals and drugs that are payable, in whole or

in part, by Medicare or Medicaid, to an entity in which the physician or the physician’s immediate family member has an investment

interest or other financial relationship, subject to several exceptions.

Financial relationships that are implicated by the Stark

Law can include arrangements ranging from marketing arrangements and consulting agreements to medical director agreements with physicians

who order our products.

§ 1395nn) prohibit referrals by

ordering by a physician of “designated health services” which include pharmaceuticals

and drugs that are payable, in whole or in part, by Medicare or Medicaid, to an entity in

which the physician or the physician’s immediate family member has an investment interest

or other financial relationship, subject to several exceptions.

Financial relationships that

are implicated by the Stark Law can include arrangements ranging from marketing arrangements

and consulting agreements to medical director agreements with physicians who order our products.

The Stark Law also prohibits billing for services rendered pursuant to a prohibited referral.

Several states

have enacted laws similar to the Stark Law.

These state laws may cover all (not just Medicare and Medicaid) patients.

If we violate

the Stark Law, our financial results and operations could be adversely affected.

Several states have enacted laws similar to the Stark Law.

These state laws may cover all

(not just Medicare and Medicaid) patients.

If we violate the Stark Law, our financial results

and operations could be adversely affected.

Penalties for violations include denial of payment

for the services, significant civil monetary penalties, and exclusion from the Medicare and Medicaid programs;

false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented,

claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent, and which may apply to entities

like us which provide coding and billing information to customers;

which imposes certain requirements relating to the privacy, security and transmission of protected health information which includes

individually identifiable health information, demographic data, medical histories and test results;

Federal Food, Drug and Cosmetic Act which among other things, strictly regulates drug manufacturing and product marketing, prohibits

manufacturers from marketing drug products for off-label use and regulates the distribution of drug samples;

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

is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually

to the CMS, information related to payments and other transfers of value 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, and ownership and investment interests held by physicians and their immediate family members and applicable group

purchasing organizations;

law equivalents of each of the above federal laws, such as, Stark Law, anti-kickback and false claims laws which may apply to items

or services reimbursed by any third-party payer, including commercial insurers, state laws that require pharmaceutical companies

to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated

by the federal government, state laws that require drug manufacturers to report information related to payments and other transfers

of value to physicians and other healthcare providers, marketing expenditures, or drug pricing, state and local laws that require

the registration of pharmaceutical sales representatives, and state laws governing the privacy and security of health information

in certain circumstances, many of which differ from each other in significant ways and often are not preempted by federal laws, thus

complicating compliance efforts.

for the services, significant civil monetary penalties, and exclusion from the Medicare and

Medicaid programs;

false claims laws which prohibit, among other things, individuals or entities from knowingly

presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other

third-party payers that are false or fraudulent, and which may apply to entities like us

which provide coding and billing information to customers;

which imposes certain requirements relating to the privacy, security and transmission of

protected health information which includes individually identifiable health information,

demographic data, medical histories and test results;

Federal Food, Drug and Cosmetic Act which among other things, strictly regulates drug manufacturing

and product marketing, prohibits manufacturers from marketing drug products for off-label

use and regulates the distribution of drug samples;

Physician Payments Sunshine Act which requires manufacturers of drugs, devices, biologics,

and medical supplies for which payment is available under Medicare, Medicaid or the Children’s

Health Insurance Program (with certain exceptions) to report annually to the CMS, information

related to payments and other transfers of value 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, and ownership

and investment interests held by physicians and their immediate family members and applicable

group purchasing organizations;

law equivalents of each of the above federal laws, such as, Stark Law, anti-kickback and

false claims laws which may apply to items or services reimbursed by any third-party payer,

including commercial insurers, state laws that require pharmaceutical companies to comply

with the pharmaceutical industry’s voluntary compliance guidelines and the relevant

compliance guidance promulgated by the federal government, state laws that require drug manufacturers

to report information related to payments and other transfers of value to physicians and

other healthcare providers, marketing expenditures, or drug pricing, state and local laws

that require the registration of pharmaceutical sales representatives, and state laws governing

the privacy and security of health information in certain circumstances, many of which differ

from each other in significant ways and often are not preempted by federal laws, thus complicating

compliance efforts.

our operations are found to be in violation of any of the laws described above or any governmental regulations that apply to us, we may

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products will face significant competition, and if they are unable to compete successfully, our business will suffer.

compete in an industry that is characterized by:

(i) rapid technological

change, (ii) evolving industry standards, (iii) emerging competition, (iv) new product introductions and (v) an emphasis on proprietary

and novel products and product candidates.

Our competitors, some of which include larger pharmaceutical companies, biotechnology companies,

and academic institutions, have and may develop products and technologies that will compete with our products and technologies.

Specifically,

we face competition from companies developing therapies for both oncology and inflammation some of which include Kymera Therapeutics Inc.,

Morphic Holding Inc., and RAPT Therapeutics Inc.

In addition, we face competition from companies developing therapies for IBD (including

UC and CD) some of which include Arena Pharmaceuticals Inc., Landos Biopharma Inc., and Seres Therapeutics Inc.

Moreover, companies with

approved therapies and that are developing therapies for soft tissue sarcoma include, but are not limited to, BioAtla Inc., Epizyme Inc.,

Nanobiotix SA, C4 Therapeutics, Inc., Adaptimmune Therapeutics plc, Eisai, Novartis, and Janssen/Johnson & Johnson, and a company

developing multi-kinase inhibitors is Mirati Therapeutics, Inc.

We also face competition from companies developing CAR-Ts targeting multiple

myeloma, some of which include Janssen/Johnson & Johnson, Bristol Myers Squibb, and Arcellx, Inc.

and companies developing therapies

for AL amyloidosis some of which include Prothena Corp, Caelum Biosciences (Now Alexion/AstraZeneca), and Janssen/Johnson & Johnson.

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 new product candidates.

We compete in an industry that

is characterized by:

(i) rapid technological change, (ii) evolving industry standards, (iii) emerging competition, (iv) new product introductions

and (v) an emphasis on proprietary and novel products and product candidates.

Our competitors, some of which include larger pharmaceutical

companies, biotechnology companies, and academic institutions, have and may develop products and technologies that will compete with our

products and technologies.

Specifically, we face competition from companies developing therapies for AL amyloidosis which include Prothena

Corp, Caelum Biosciences (Now Alexion/AstraZeneca), and Janssen/Johnson & Johnson.

In addition, we face competition from companies

developing cell therapies for autoimmune indications, some of which include Kyverna Therapeutics, Inc.;

Cabaletta Bio, Inc.;

Fate Therapeutics

and Arcellx, Inc.

Moreover, companies with approved therapies for blood disorders include, but are not limited to, Novartis AG,

Bristol Myers Squibb Co, and Janssen/Johnson & Johnson.

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 new product

believe that a significant number of products are currently under development, and may become commercially available in the future, for

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effect on our business.

outbreak of COVID-19, or a similar pandemic, epidemic or outbreak of an infectious disease in the United States or elsewhere, could have

a material adverse impact on our business, financial condition and results of operations, including the execution of our pre-clinical

studies and clinical trials and the use and sufficiency of our existing cash.

outbreak of COVID-19 evolved into a global pandemic and 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 various variants, and the actions to contain the virus or treat its impact,

among others.

spread of an infectious disease, such as COVID-19, may also result in the inability of our suppliers to deliver supplies to us on a timely

We currently utilize third parties to, among other things, manufacture components of our product candidates and, in the future,

intend to utilize third parties to conduct our pre-clinical studies and clinical trials.

If either we or 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 a health

epidemic such as COVID-19, which, among other things, resulted in quarantines and restrictions on travel, our supply chain may be disrupted,

limiting our ability to manufacture our product candidates for our pre-clinical studies and clinical trials.

and deaths related to a health epidemic may also disrupt the United States’ healthcare and healthcare regulatory systems as well

as other healthcare systems which could divert healthcare resources away from, or materially delay review and/or approval of our product

candidates by the FDA and other regulatory agencies.

Furthermore, a health epidemic may also slow potential enrollment of current and

planned clinical trials, reduce the number of eligible patients for our current and planned clinical trials, create difficulties in recruiting

clinical site investigators and staff, divert healthcare resources away from the conduct of clinical trials, delay receiving approval

from local authorities to initiate our current and planned clinical trials, delay necessary interactions with local regulators, ethics

committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees,

interrupt key clinical trial activities (like site monitoring) and create difficulties in data collection and analysis, among other things.

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 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.

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 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 pre-clinical studies and clinical trials, healthcare systems or the

global economy as a whole.

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

geopolitical and macroeconomic developments could adversely affect our business, financial condition or results of operations.

business could be adversely affected by conditions in the U.S.

and global economies, the United States and global financial markets and

adverse geopolitical and macroeconomic developments, including rising inflation rates, the continuing impact of the COVID-19 pandemic,

the Ukrainian/Russian and Israeli/Palestinian conflicts and related sanctions, bank failures, and economic uncertainties related to these

example, inflation rates, particularly in the United States, have increased recently to levels not seen in years, and increased inflation

may result in increases in our operating costs (including our labor costs), reduced liquidity and limits on our ability to access credit

or otherwise raise capital on acceptable terms, if at all.

In response to rising inflation, the U.S.

Federal Reserve has raised, and

may again raise, interest rates, which, coupled with reduced government spending and volatility in financial markets, may have the effect

of further increasing economic uncertainty and heightening these risks.

the COVID-19 pandemic has abated, many of the consequences of the COVID-19 pandemic continue to cause disruption and increased costs

for businesses.

In the case of clinical stage biopharmaceutical companies, we believe there continue to be, among other things, supply

chain disruptions that are causing delays in the delivery of drug candidates and comparator products and healthcare staffing shortages

that are causing delays in the establishment of test sites and the conduct of clinical trials.

Additionally,

financial markets around the world experienced volatility following the invasion of Ukraine by Russia in February 2022 and the eruption

of the Israeli/Palestinian conflict in October 2023, including as a result of economic sanctions and export controls against Russia and

countermeasures taken by Russia.

The full economic and social impact of these sanctions and countermeasures, in addition to the ongoing

military conflicts in Ukraine and Gaza, which could conceivably expand, remains uncertain;

however, both the conflicts and related sanctions

have resulted and could continue to result in disruptions to trade, commerce, pricing stability, credit availability, and/or supply chain

continuity, in both Europe and globally, and has introduced significant uncertainty into global markets.

While we do not currently operate

in Russia, Ukraine or the Middle East, as the adverse effects of these conflicts continue to develop our business and results of operations

may be adversely affected.

international operations we undertake may subject us to risks inherent with operations outside of the United States.

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maintain an effective management team and work force could adversely affect our ability to operate, grow and manage our business.

employees, consultants, commercial partners and vendors may engage in misconduct or other improper activities,

including non-compliance with regulatory standards and requirements.

are exposed to the risk of employee fraud or other illegal activity by our employees, consultants, commercial

partners and vendors.

Misconduct by these parties could include intentional, reckless and/or negligent conduct that fails to comply with

FDA or other regulations, provide true, complete and accurate information to the FDA and other similar foreign regulatory bodies, comply

with manufacturing standards we may establish, comply with healthcare fraud and abuse laws and regulations, report financial information

or data accurately or disclose unauthorized activities to us.

If we obtain approval of any of our product candidates from the FDA or

any other foreign regulatory agency and begin commercializing those products in the United States or elsewhere, our potential exposure

under these laws will increase significantly, and our costs associated with compliance with these laws are likely to increase.

In particular,

sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent

fraud, kickbacks, self-dealing and other abusive practices.

These laws and regulations may restrict or prohibit a wide range of pricing,

discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements.

Employee misconduct

could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions

and serious harm to our reputation.

Additionally, we are subject to the risk that a person could allege such fraud or other misconduct,

even if none occurred.

It is not always possible to identify and deter employee misconduct, and the precautions we take to detect and

prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental

investigations or other actions or lawsuits stemming from a failure to comply with such laws or regulations.

If any such actions are

instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a material

and adverse effect on our business, financial condition, results of operations and prospects, including the imposition of significant

civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, the curtailment or restructuring of our operations,

loss of eligibility to obtain approvals from the FDA or other regulatory agencies, exclusion from participation in government contracting,

healthcare reimbursement or other government programs, including Medicare and Medicaid, integrity oversight and reporting obligations,

or reputational harm.

Because Immix Biopharma

and certain of its affiliates control a significant number of securities of Nexcella, it may have effective control over actions requiring

Nexcella stockholder approval.

As of March 20, 2023, Immix Biopharma and certain of its affiliates (Ilya Rachman, our Chief

Executive Officer and Chairman and Gabriel Morris, our Chief Financial Officer and director) collectively own 5,044,988 shares of Nexcella’s

common stock, or 98.50% of Nexcella’s outstanding common stock, 1,000,000 shares of Nexcella’s Class A common stock, or 100%

of Nexcella’s outstanding Class A common stock and 250,000 shares of Nexcella’s Class A preferred stock, or 100% of Nexcella’s

outstanding Class A preferred stock.

Therefore, Immix Biopharma would have the ability to control the outcome of matters submitted to

Nexcella’s stockholders for approval.

employees, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including non-compliance

with regulatory standards and requirements.

are exposed to the risk of employee fraud or other illegal activity by our employees, consultants, commercial partners and vendors.

by these parties could include intentional, reckless and/or negligent conduct that fails to comply with FDA or other regulations, provide

true, complete and accurate information to the FDA and other similar foreign regulatory bodies, comply with manufacturing standards we

may establish, comply with healthcare fraud and abuse laws and regulations, report financial information or data accurately or disclose

unauthorized activities to us.

If we obtain approval of any of our product candidates from the FDA or any other foreign regulatory agency

and begin commercializing those products in the United States or elsewhere, our potential exposure under these laws will increase significantly,

and our costs associated with compliance with these laws are likely to increase.

In particular, sales, marketing and business arrangements

in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, self-dealing and other

abusive practices.

These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion,

sales commission, customer incentive programs and other business arrangements.

Employee misconduct could also involve the improper use

of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation.

Additionally, we are subject to the risk that a person could allege such fraud or other misconduct, even if none occurred.

always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent this activity may not be

effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or

lawsuits stemming from a failure to comply with such laws or regulations.

If any such actions are instituted against us, and we are not

successful in defending ourselves or asserting our rights, those actions could have a material and adverse effect on our business, financial

condition, results of operations and prospects, including the imposition of significant civil, criminal and administrative penalties,

damages, fines, disgorgement, imprisonment, the curtailment or restructuring of our operations, loss of eligibility to obtain approvals

from the FDA or other regulatory agencies, exclusion from participation in government contracting, healthcare reimbursement or other

government programs, including Medicare and Medicaid, integrity oversight and reporting obligations, or reputational harm.

Relating to our Intellectual Property

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protect our rights or permit us to gain or keep our competitive advantage.

may be able to make compounds that are similar to our product candidates, but that are not covered by the claims of our patents;

may be able to make compounds that are similar to our product candidates, but that are not

covered by the claims of our patents;

might not have been the first to make the inventions covered by our pending patent applications;

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pending patent applications may not result in issued patents;

claims of our issued patents or patent applications when issued may not cover our products or product candidates;

patents that we may obtain from licensing or otherwise may not provide us with any competitive advantages;

granted patents that we rely upon may be held invalid or unenforceable as a result of legal challenges by third parties;

claims of our issued patents or patent applications when issued may not cover our products

or product candidates;

patents that we may obtain from licensing or otherwise may not provide us with any competitive

granted patents that we rely upon may be held invalid or unenforceable as a result of legal

challenges by third parties;

patents of others may have an adverse effect on our business.

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scope of rights granted under the license agreement and other interpretation-related issues;

extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing

extent to which our technology and processes infringe on intellectual property of the licensor

that is not subject to the licensing agreement;

diligence obligations under the license agreement and what activities satisfy those obligations;

a third-party expresses interest in an area under a license that we are not pursuing, under the terms of certain of our license agreements,

we may be required to sublicense rights in that area to a third party, and that sublicense could harm our business;

ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us.

a third-party expresses interest in an area under a license that we are not pursuing, under

the terms of certain of our license agreements, we may be required to sublicense rights in

that area to a third party, and that sublicense could harm our business;

ownership of inventions and know-how resulting from the joint creation or use of intellectual

property by our licensors and us.

disputes over intellectual property that we have licensed prevent or impair our ability to maintain our future licensing arrangements

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are typically not published until 18 months after the priority date;

● publications

in the scientific literature often lag behind actual discoveries.

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protection could adversely affect our business.

may be subject to claims that our employees or consultants have wrongfully used or disclosed alleged

trade secrets.

As is common in the biotechnology

and pharmaceutical industries, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies,

including our competitors or potential competitors.

Although we try to ensure that our employees or consultants do not use the proprietary

information or know-how of others in their work for us, we may be subject to claims that we or our employees or consultants have inadvertently

or otherwise used or disclosed trade secrets or other proprietary information of their former employers.

Litigation may be necessary to

defend against these claims.

If we fail in defending any such claims, in addition to paying monetary damages, we could lose valuable intellectual

property rights or personnel, which could adversely impact our business.

Even if we are successful in defending against these claims,

litigation could result in substantial costs and be a distraction to management.

may be subject to claims that our employees or consultants have wrongfully used or disclosed alleged trade secrets.

is common in the biotechnology and pharmaceutical industries, we employ individuals who were previously employed at other biotechnology

or pharmaceutical companies, including our competitors or potential competitors.

Although we try to ensure that our employees or consultants

do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or our employees

or consultants have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers.

Litigation may be necessary to defend against these claims.

If we fail in defending any such claims, in addition to paying monetary damages,

we could lose valuable intellectual property rights or personnel, which could adversely impact our business.

Even if we are successful

in defending against these claims, litigation could result in substantial costs and be a distraction to management.

intellectual property may not be sufficient to protect our product candidates from competition, which may negatively affect our business.

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monetary damages related to the legal expenses of the third party;

additional competition that may have a significant adverse effect on our product pricing, market share, business operations, financial

condition, and the commercial viability of our products;

additional competition that may have a significant adverse effect on our product pricing,

market share, business operations, financial condition, and the commercial viability of our

● restructuring

our Company or delaying or terminating select business opportunities, including, but not limited to, research and development, clinical

trial, and commercialization activities, due to a potential deterioration of our financial condition or market competitiveness.

our Company or delaying or terminating select business opportunities, including, but not

limited to, research and development, clinical trial, and commercialization activities, due

to a potential deterioration of our financial condition or market competitiveness.

third party may also challenge the validity, enforceability or scope of the intellectual property rights that we own or in the future

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business and results of operations could suffer.

In August 2016, we formed a wholly-owned

Australian subsidiary, Immix Biopharma Australia Pty Ltd to conduct various pre-clinical and clinical activities for our product and development

candidates in Australia.

We may not be able to efficiently or successfully monitor, develop and commercialize our lead products in Australia,

including conducting clinical trials.

Furthermore, we have no assurance that the results of any clinical trials that we conduct for our

product candidates in Australia will be accepted by the FDA or foreign regulatory authorities for development and commercialization approvals.

August 2016, we formed a wholly-owned Australian subsidiary, Immix Biopharma Australia Pty Ltd to conduct various pre-clinical and clinical

activities for our product and development candidates in Australia.

We may not be able to efficiently or successfully monitor, develop

and commercialize our lead products in Australia, including conducting clinical trials.

Furthermore, we have no assurance that the results

of any clinical trials that we conduct for our product candidates in Australia will be accepted by the FDA or foreign regulatory authorities

for development and commercialization approvals.

addition, current Australian tax regulations provide for a refundable research and development tax credit equal to 43.5% of qualified

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be adversely affected.

Breakthrough Therapy Designation, Fast

Track Designation or RPDD by the FDA, and equivalents granted by other regulatory authorities, even if granted for any of our

product candidates developed for therapeutic indications, may not lead to a faster development, regulatory review or approval

process, and it does not increase the likelihood that any of our product candidates will receive marketing approval in any

jurisdiction.

We may seek a Breakthrough Therapy Designation for some of our product

A breakthrough therapy is defined as a therapy that is intended, alone or in combination with one or more other therapies,

to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the therapy may demonstrate

substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects

observed early in clinical development.

For therapies that have been designated as breakthrough therapies, interaction and communication

between the FDA and the sponsor of the trial can help to identify the most efficient path for clinical development while minimizing the

number of patients placed in ineffective control regimens.

Therapies designated as breakthrough therapies by the FDA may also be eligible

for priority review and accelerated approval.

Designation as a breakthrough therapy is within the discretion of the FDA.

even if we believe one of our product candidates meets the criteria for designation as a breakthrough therapy, the FDA may disagree and

instead determine not to make such designation.

In any event, the receipt of a Breakthrough Therapy Designation for a product candidate

may not result in a faster development process, review or approval compared to therapies considered for approval under conventional FDA

procedures and does not assure ultimate approval by the FDA.

In addition, even if one or more of our product candidates qualify as breakthrough

therapies, the FDA may later decide that such product candidates no longer meet the conditions for qualification or decide that the time

period for FDA review or approval will not be shortened.

We may seek Fast Track Designation for some of our product candidates

for therapeutic indications.

If a therapy is intended for the treatment of a serious or life-threatening condition and the therapy demonstrates

the potential to address unmet medical needs for this condition, the therapy sponsor may apply for Fast Track Designation.

Therapy Designation, Fast Track Designation or RPDD by the FDA, and equivalents granted by indications, may not lead to a faster development,

regulatory review or approval process, and it does not increase the likelihood that any of our product candidates will receive marketing

approval in any jurisdiction.

may seek a Breakthrough Therapy Designation for some of our product candidates.

A breakthrough therapy is defined as a therapy that is

intended, alone or in combination with one or more other therapies, to treat a serious or life-threatening disease or condition, and

preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more

clinically significant endpoints, such as substantial treatment effects observed early in clinical development.

For therapies that have

been designated as breakthrough therapies, interaction and communication between the FDA and the sponsor of the trial can help to identify

the most efficient path for clinical development while minimizing the number of patients placed in ineffective control regimens.

designated as breakthrough therapies by the FDA may also be eligible for priority review and accelerated approval.

Designation as a breakthrough

therapy is within the discretion of the FDA.

Accordingly, even if we believe one of our product candidates meets the criteria for designation

as a breakthrough therapy, the FDA may disagree and instead determine not to make such designation.

In any event, the receipt of a Breakthrough

Therapy Designation for a product candidate may not result in a faster development process, review or approval compared to therapies

considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA.

In addition, even if one

or more of our product candidates qualify as breakthrough therapies, the FDA may later decide that such product candidates no longer

meet the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.

may seek Fast Track Designation for some of our product candidates for therapeutic indications.

If a therapy is intended for the treatment

of a serious or life-threatening condition and the therapy demonstrates the potential to address unmet medical needs for this condition,

the therapy sponsor may apply for Fast Track Designation.

Filling an unmet medical need is defined as providing a therapy where none

exists or providing a therapy which may be potentially better than available therapy.

broad discretion whether or not to grant this designation, so even if we believe a particular product candidate is eligible for this designation,

we cannot assure you that the FDA would decide to grant it.

Even if we do receive Fast Track Designation, we may not experience a faster

development process, review or approval 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 program.

Fast Track Designation alone does not guarantee

qualification for the FDA’s priority review procedures.

We may seek a RPDD for some of

our product candidates.

However, even if we believe a particular product candidate is eligible for this designation, we cannot guarantee

that FDA would agree.

The FDA may award priority review vouchers to sponsors of products that meet the definition of a “rare

pediatric disease.” A “rare pediatric disease” is a (a) serious or life-threatening disease in which the

serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years, including age groups often called

The FDA has broad discretion whether or not to

grant this designation, so even if we believe a particular product candidate is eligible for this designation, we cannot assure you that

the FDA would decide to grant it.

Even if we do receive Fast Track Designation, we may not experience a faster development process, review

or approval 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 program.

Fast Track Designation alone does not guarantee qualification for

the FDA’s priority review procedures.

may seek a RPDD for some of our product candidates.

However, even if we believe a particular product candidate is eligible for this designation,

we cannot guarantee that FDA would agree.

The FDA may award priority review vouchers to sponsors of products that meet the definition

of a “rare pediatric disease.” A “rare pediatric disease” is a (a) serious or life-threatening disease in which

the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years, including age groups often called

neonates, infants, children, and adolescents;

and (b) rare disease or conditions within the meaning of the Orphan Drug Act.

However, this designation is at the discretion of the FDA and, even if we do receive a Rare Pediatric Disease Designation, we may

not experience a faster development process, review or approval compared to conventional FDA procedures and are still not guaranteed final

approval of our product candidate by the FDA.

this designation is at the discretion of the FDA and, even if we do receive a Rare Pediatric Disease Designation, we may not experience

a faster development process, review or approval compared to conventional FDA procedures and are still not guaranteed final approval

of our product candidate by the FDA.

Additionally, the benefits of a RPDD may not be available for future product candidates.

After September 30, 2024, the FDA may only award a voucher for an approved rare pediatric disease product application if the sponsor has

a RPDD for the drug that was granted by September 30, 2024.

After September 30, 2026, the FDA may not award any additional rare pediatric

disease priority review vouchers.

After September

30, 2024, the FDA may only award a voucher for an approved rare pediatric disease product application if the sponsor has a RPDD for the

drug that was granted by September 30, 2024.

After September 30, 2026, the FDA may not award any additional rare pediatric disease priority

review vouchers.

Related to Owning our Common Stock

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and limitations in trading volumes of our shares of common stock;

ability to obtain financing to conduct and complete research and development activities including, but not limited to, our clinical

trials, and other business activities;

delays in the expected recognition of revenue due to lengthy and sometimes unpredictable sales timelines;

timing and success of introductions of new products by us or our competitors or any other change in the competitive dynamics of our

industry, including consolidation among competitors, customers or strategic partners;

ability to obtain financing to conduct and complete research and development activities including,

but not limited to, our clinical trials, and other business activities;

delays in the expected recognition of revenue due to lengthy and sometimes unpredictable

sales timelines;

timing and success of introductions of new products by us or our competitors or any other

change in the competitive dynamics of our industry, including consolidation among competitors,

customers or strategic partners;

outages or security breaches;

ability to attract new customers;

ability to secure resources and the necessary personnel to conduct clinical trials on our desired schedule;

ability to secure resources and the necessary personnel to conduct clinical trials on our

desired schedule;

● commencement,

enrollment or results of our clinical trials for our product candidates or any future clinical trials we may conduct;

enrollment or results of our clinical trials for our product candidates or any future clinical

trials we may conduct;

in the development status of our product candidates;

delays or adverse developments or perceived adverse developments with respect to the FDA or other regulatory agencies’ review

of our planned pre-clinical and clinical trials;

delay in our submission for studies or product approvals or adverse regulatory decisions, including failure to receive regulatory

approval for our product candidates;

delays or adverse developments or perceived adverse developments with respect to the FDA

or other regulatory agencies’ review of our planned pre-clinical and clinical trials;

delay in our submission for studies or product approvals or adverse regulatory decisions,

including failure to receive regulatory approval for our product candidates;

● unanticipated

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inability to enter into new markets or develop new products;

● reputational

● competition

from existing technologies and products or new technologies and products that may emerge;

● announcements

of acquisitions, partnerships, collaborations, joint ventures, new products, capital commitments, or other events by us or our competitors;

in general economic, political and market conditions in or any of the regions in which we conduct our business;

of acquisitions, partnerships, collaborations, joint ventures, new products, capital commitments,

or other events by us or our competitors;

in general economic, political and market conditions in or any of the regions in which we

conduct our business;

in industry conditions or perceptions;

in valuations of similar companies or groups of companies;

research reports, recommendation and changes in recommendations, price targets, and withdrawals of coverage;

research reports, recommendation and changes in recommendations, price targets, and withdrawals

and additions of key personnel;

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requiring stockholder approval.

of March 17, 2023, our directors, executive officers and principal stockholders, and their respective affiliates, beneficially own approximately

64.73% of our outstanding shares of common stock.

As a result, these stockholders, acting together, would 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, would 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

of March 25, 2024, our directors, executive officers and principal stockholders, and their respective affiliates, beneficially

own approximately 39% of our outstanding shares of common stock.

As a result, these stockholders, acting together, would 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, would 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;

a merger, consolidation, takeover or other business combination involving us;

a potential acquirer from making a tender offer or otherwise attempting to obtain control of us.

● discouraging

a potential acquirer from making a tender offer or otherwise attempting to obtain control

do not intend to pay cash dividends on our shares of common stock so any returns will be limited to the value of our shares.

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declaring or paying any cash dividends for the foreseeable future.

Furthermore, any future debt agreements may also preclude us from paying

or place restrictions on our ability to pay dividends.

Any future determination as to the declaration and payment of dividends will be

at the discretion of our board of directors and will depend on factors the board of directors deems relevant, including among others,

our results of operations, financial condition and cash requirements, business prospects, and the terms of any of our financing arrangements.

Furthermore, any future debt agreements may also preclude us from

paying or place restrictions on our ability to pay dividends.

Any future determination as to the declaration and payment of dividends

will be at the discretion of our board of directors and will depend on factors the board of directors deems relevant, including among

others, our results of operations, financial condition and cash requirements, business prospects, and the terms of any of our financing

arrangements.

Therefore, any return to stockholders may be limited to the increase, if any, of our share price.

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as applicable, among other things:

the board of directors with the ability to alter our Amended and Restated Bylaws without stockholder approval;

the board of directors with the ability to alter our Amended and Restated Bylaws without

stockholder approval;

limitations on the removal of directors;

advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon

at stockholder meetings;

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

advance notice requirements for nominations for election to the board of directors or for

proposing matters that can be acted upon at stockholder meetings;

that vacancies on the board of directors may be filled by a majority of directors in office,

although less than a quorum.

Certificate of Incorporation provides that the Court of Chancery of the State of Delaware will be the sole and exclusive forum for substantially

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disputes with the us or our directors, officers or employees.

Certificate of Incorporation provides that unless we consent in writing to the selection of an alternative forum, the State of Delaware

is the sole and exclusive forum for:

(i) any derivative action or proceeding brought on behalf of us, (ii) any action asserting a claim

of breach of a fiduciary duty owed by any director, officer or other employee of our Company to us or our stockholders, (iii) any action

asserting a claim against us, our directors, officers or employees arising pursuant to any provision of the Delaware General Corporation

Law (the “DGCL”) or our Amended and Restated Certificate of Incorporation or our Amended and Restated Bylaws, or (iv) any

action asserting a claim against us, our directors, officers, employees or agents governed by the internal affairs doctrine, except for,

as to each of (i) through (iv) above, any claim as to which the Court of Chancery determines that there is an indispensable party not

subject to the jurisdiction of the Court of Chancery (and the indispensable party does not consent to the personal jurisdiction of the

Court of Chancery within ten days following such determination), which is vested in the exclusive jurisdiction of a court or forum other

than the Court of Chancery, or for which the Court of Chancery does not have subject matter jurisdiction.

This exclusive forum provision

would not apply to suits brought to enforce any liability or duty created by the Securities Act or the Exchange Act or any other claim

for which the federal courts have exclusive jurisdiction.

To the extent that any such claims may be based upon federal law claims, Section

27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the

Exchange Act or the rules and regulations thereunder.

Amended and Restated Certificate of Incorporation provides that unless we consent in writing to the selection of an alternative forum,

the State of Delaware is the sole and exclusive forum for:

(i) any derivative action or proceeding brought on behalf of us, (ii) any

action asserting a claim of breach of a fiduciary duty owed by any director, officer or other employee of our Company to us or our stockholders,

(iii) any action asserting a claim against us, our directors, officers or employees arising pursuant to any provision of the Delaware

General Corporation Law (the “DGCL”) or our Amended and Restated Certificate of Incorporation or our Amended and Restated

Bylaws, or (iv) any action asserting a claim against us, our directors, officers, employees or agents governed by the internal affairs

doctrine, except for, as to each of (i) through (iv) above, any claim as to which the Court of Chancery determines that there is an indispensable

party not subject to the jurisdiction of the Court of Chancery (and the indispensable party does not consent to the personal jurisdiction

of the Court of Chancery within ten days following such determination), which is vested in the exclusive jurisdiction of a court or forum

other than the Court of Chancery, or for which the Court of Chancery does not have subject matter jurisdiction.

This exclusive forum

provision would not apply to suits brought to enforce any liability or duty created by the Securities Act or the Exchange Act or any

other claim for which the federal courts have exclusive jurisdiction.

To the extent that any such claims may be based upon federal law

claims, Section 27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability

created by the Exchange Act or the rules and regulations thereunder.

22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability

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costs associated with resolving such action in other jurisdictions, which could harm our business, results of operations, and financial

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

common stock.

If our internal controls are not effective, we may not be able to accurately report our financial results or prevent fraud.

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

price of our common stock.

If our internal controls are not effective, we may not be able to accurately report our financial results

or prevent fraud.

internal control over financial reporting is necessary for us to provide reliable financial reports in a timely manner.

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

We have implemented additional

review procedures including addition of accounting consultants to remediate such weakness.

While we believe that our remediation efforts

will resolve the identified material weakness, there is no assurance that such efforts will be sufficient or that additional actions will

not be necessary, 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.

have implemented additional review procedures including addition of accounting consultants to remediate such weakness.

While we believe

that our remediation efforts will resolve the identified material weakness, there is no assurance that such efforts will be sufficient

or that additional actions will not be necessary, 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.

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

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cause our share price to fall.

In addition, the perception that sales of our common stock could occur, could cause our stock price to fall.

In addition, the perception that sales of our common stock could occur, could cause our stock price to

expect that significant additional capital will be needed to continue our planned operations, including increased marketing, hiring new

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stockholders.

Furthermore, sales of a substantial number of our shares of common stock in the public markets or the perception

that such sales could occur, could depress the market price of our common stock and impair our ability to raise capital through the sale

of additional equity securities.

The number of shares of our common stock available

for future issuance or sale could adversely affect the per share trading price of our common stock.

We cannot predict whether future

issuances or sales of our common stock or the availability of shares for resale in the open market will decrease the per share trading

price of our common stock.

The issuance of a substantial number of shares of our common stock in the public market or the perception that

such issuances might occur could adversely affect the per share trading price of our common stock.

Furthermore, sales of a substantial number of our shares of common stock in the public markets or the perception that such

sales could occur, could depress the market price of our common stock and impair our ability to raise capital through the sale of additional

equity securities.

number of shares of our common stock available for future issuance or sale could adversely affect the per share trading price of our

common stock.

cannot predict whether future issuances or sales of our common stock or the availability of shares for resale in the open market will

decrease the per share trading price of our common stock.

The issuance of a substantial number of shares of our common stock in the public

market or the perception that such issuances might occur could adversely affect the per share trading price of our common stock.

are an “emerging growth company” and will be able to avail ourselves of reduced disclosure requirements applicable to emerging

45 unchanged sentences

otherwise we may fall out of compliance and risk becoming subject to litigation or being delisted, among other potential problems.

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