What changed in this filing

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Item 1A. Risk Factors

2024-03-08 compared with 2023-03-13 · 1133 added, 1007 removed, 1881 unchanged (53% of the section changed)

Risk Factors.

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

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commercializing drugs.

We are dependent on a short-term bridge

loan to finance our current operations.

are dependent on a short-term bridge loan to finance our current operations.

Our continued operations are dependent on us raising capital.

We currently do not have sufficient

working capital to fund our continued operations.

In November 2022, we entered into a short-term bridge loan arrangement with 3i, LP,

the sole holder of our Series A Preferred Stock, pursuant to which 3i, LP agreed to provide us with a loan for up to $1,000,000 in cash

subject to achievements of certain milestones.

In November 2022, $350,000 was advanced to us and the second advance of $650,000 was advanced

in December 2022.

In connection with the $1 million bridge loan, the Company also issued a secured promissory note to 3i, LP in the principal

amount of $1,666,640, which represents the payment of $1,666,640 due to 3i, LP in Alternative Conversion Floor Amounts, as defined in

the Certificate of Designations for the Series A Preferred Stock, that began to accrue on July 14, 2022.

The Company received no proceeds

from the issuance of the $1,666,640 promissory note.

In February 2023, pursuant to a private placement of our Series C Preferred Stock,

we issued 50,000 shares of our Series C Preferred Stock at a purchase price of $24.00 per share, for a subscription receivable in the

aggregate amount equal to the total purchase price of $1.2 million.

will need to raise additional capital after this offering to support our operations and execute on our business plan.

We may be required

to pursue sources of additional capital through various means, including debt or equity financings.

Any new securities that we may issue

in the future may be sold on terms more favorable for our new investors than the terms of this offering.

Newly issued securities may

include preferences, superior voting rights, and the issuance of warrants or other convertible securities that will have additional dilutive

We cannot assure that additional funds will be available when needed from any source or, if available, will be available on

terms that are acceptable to us.

Further, we may incur substantial costs in pursuing future capital and/or financing, including investment

banking fees, legal fees, accounting fees, printing and distribution expenses and other costs.

We may also be required to recognize non-cash

expenses in connection with certain securities we may issue, such as convertible notes and warrants, which will adversely impact our

financial condition and results of operations.

Our ability to obtain needed financing may be impaired by such factors as the weakness

of capital markets, and the fact that we have not been profitable, which could impact the availability and cost of future financings.

If the amount of capital we are able to raise from financing activities is not sufficient to satisfy our capital needs, we may have to

reduce our operations accordingly.

January 18, 2024, we entered into a Securities Purchase Agreement with 3i, pursuant to which we issued and sold 3i a senior convertible

promissory notes in an aggregate principal amount of $440,000 due on January 18, 2025 (the “First Note”, and together with

the Purchase Agreement, the “Transaction Documents”) for an aggregate purchase price of $400,000, representing an approximate

10% original issue discount (the “Transaction”).

We agreed to use the net proceeds from the sale of the Note for accounts

payable and working capital purposes.

Unless the Transaction Documents state otherwise, we may not prepay any portion of the principal

amount of the Note without the Purchaser’s prior written consent.

February 13, 2024 (the “Second Closing”), the Parties entered into a Limited Waiver Agreement (the “Waiver Agreement”)

and agreed that the Second Closing can be consummated prior to the 30th calendar day following January 18, 2024.

The Parties further

waive any rights or remedies that they may have under Section 2.3 of the Purchase Agreement, solely in connection with the Second Closing,

including any rights of termination, defaults, amendment, acceleration or cancellation that be triggered under the Purchase Agreement

solely as a result of accelerating the Second Closing.

As of the Second Closing, we issued and sold to the Purchaser a senior convertible

promissory note in an aggregate principal amount of $440,000 (the “Principal Amount”) due on February 13, 2025 (the “Second

Note,” and together with the First Note dated January 18, 2024, and Purchase Agreement, the “Second Transaction Documents”)

for an aggregate purchase price of $400,000, representing an approximately 10% original issue discount (the “Second Transaction”).

We agreed to use the net proceeds from the sale of the Second Note for accounts payable and working capital purposes.

Unless the Transaction

Documents state otherwise, we may not prepay any portion of the principal amount of the Second Note without the Purchaser’s prior

written consent.

will need to raise additional capital to support our operations and execute on our business plan.

We may be required to pursue sources

of additional capital through various means, including debt or equity financings.

Any new securities that we may issue in the future

may be sold on terms more favorable for our new investors than the terms of this offering.

Newly issued securities may include preferences,

superior voting rights, and the issuance of warrants or other convertible securities that will have additional dilutive effects.

assure that additional funds will be available when needed from any source or, if available, will be available on terms that are acceptable

Further, we may incur substantial costs in pursuing future capital and/or financing, including investment banking fees, legal

fees, accounting fees, printing and distribution expenses and other costs.

We may also be required to recognize non-cash expenses in

connection with certain securities we may issue, such as convertible notes and warrants, which will adversely impact our financial condition

and results of operations.

Our ability to obtain needed financing may be impaired by such factors as the weakness of capital markets,

and the fact that we have not been profitable, which could impact the availability and cost of future financings.

If the amount of capital

we are able to raise from financing activities is not sufficient to satisfy our capital needs, we may have to reduce our operations accordingly.

the event of default of the Secured Promissory Notes to 3i, LP, such default could adversely affect our business, financial condition,

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initiate clinical trials and to implement our business plan.

Since our inception of our

predecessor, Allarity Therapeutics A/S, we have incurred losses and have an accumulated deficit of $82.6 million as of December 31, 2022.

Our net losses were $16.1 million and $26.6 million for the years ended December 31, 2022 and 2021, respectively.

our inception of our predecessor, Allarity Therapeutics A/S, we have incurred losses and have an accumulated deficit of $94.5 million

as of December 31, 2023.

our cash deposits of $2.0 million were determined to be insufficient to fund our current operating plan and planned capital expenditures

for the next twelve months.

These conditions give rise to a substantial doubt over our ability to continue as a going concern.

to incur substantial operating losses for the foreseeable future and may never achieve profitability.

None of our current therapeutic

candidates have been approved for marketing in the United States, or in any other jurisdiction, and may never receive such approval.

could be several years, if ever, before we have a commercialized drug that generates significant revenues.

As a result, we are uncertain

when or if we will achieve profitability and, if so, whether we will be able to sustain profitability.

The net losses we incur may fluctuate

significantly from quarter to quarter and year to year.

We anticipate that our expenses will increase substantially as we:

continue the development of our therapeutic candidates, including,

but not limited to, the re-submission of an application for New Drug Approval (“NDA”) for dovitinib, our most advanced therapeutic

candidate, to the FDA and advancing our DRP®-guided Phase 2 clinical trial of stenoparib as a treatment for ovarian cancer and our

DRP®-guided Phase 2 clinical trial of IXEMPRA® as a treatment for metastatic breast cancer, being conducted at trial sites in

preclinical studies and clinical trials for any additional indications for our current therapeutic candidates and any future therapeutic

candidates that we may pursue;

to build our portfolio of therapeutic candidates through the acquisition or in-license of additional therapeutic candidates or technologies;

to develop, maintain, expand and protect our intellectual property portfolio;

to develop, maintain, and expand our proprietary DRP ® companion diagnostics platform;

regulatory approvals for our current and future therapeutic candidates that successfully complete clinical trials;

establish a sales, marketing, distribution and other commercial infrastructure to commercialize any therapeutic candidate for which

we may obtain marketing approval, or partner with third parties to affect the same;

additional clinical, regulatory, scientific and accounting personnel;

additional legal, accounting and other expenses in operating as a U.S.

Our net losses were $11.8 million and $16.1 million for the years ended December 31, 2023, and 2022, respectively.

As of December 31, 2023, our cash deposits of $166 thousand were determined to be insufficient to fund our current operating plan and

planned capital expenditures for the next twelve months.

These conditions give rise to a substantial doubt over our ability to continue

as a going concern.

We expect to incur substantial operating losses for the foreseeable future and may never achieve profitability.

of our current therapeutic candidates have been approved for marketing in the United States, or in any other jurisdiction, and may never

receive such approval.

It could be several years, if ever, before we have a commercialized drug that generates significant revenues.

As a result, we are uncertain when or if we will achieve profitability and, if so, whether we will be able to sustain profitability.

The net losses we incur may fluctuate significantly from quarter to quarter and year to year.

We anticipate that our expenses will increase

substantially as we:

continue the development

of our therapeutic candidates, including, but not limited to, advancing our DRP®-guided Phase 2 clinical trial of stenoparib

as a treatment for ovarian cancer and our DRP®-guided Phase 2 clinical trial of IXEMPRA® as a treatment for metastatic breast

cancer, being conducted at trial sites in Europe;

initiate preclinical studies

and clinical trials for any additional indications for our current therapeutic candidates and any future therapeutic candidates that

we may pursue;

continue to build our portfolio

of therapeutic candidates through the acquisition or in-license of additional therapeutic candidates or technologies;

continue to develop, maintain,

expand and protect our intellectual property portfolio;

continue to develop, maintain,

and expand our proprietary DRP ® companion diagnostics platform;

pursue regulatory approvals

for our current and future therapeutic candidates that successfully complete clinical trials;

ultimately establish a

sales, marketing, distribution and other commercial infrastructure to commercialize any therapeutic candidate for which we may obtain

marketing approval, or partner with third parties to affect the same;

hire additional clinical,

regulatory, scientific and accounting personnel;

incur additional legal,

accounting and other expenses in operating as a U.S.

listed public company.

To become and remain profitable, we must develop and eventually commercialize

one or more therapeutic candidates with significant market potential or license one or more of our therapeutic candidates to an industry

This will require us to be successful in a range of challenging activities, including completing clinical trials of our therapeutic

candidates, publishing our data and findings on our therapeutic candidates with peer reviewed publications, developing commercial scale

manufacturing processes, obtaining marketing approval, manufacturing, marketing and selling any current and future therapeutic candidates

for which we may obtain marketing approval, and satisfying any post-marketing requirements.

become and remain profitable, we must develop and eventually commercialize one or more therapeutic candidates with significant market

potential or license one or more of our therapeutic candidates to an industry partner.

This will require us to be successful in a range

of challenging activities, including completing clinical trials of our therapeutic candidates, publishing our data and findings on our

therapeutic candidates with peer reviewed publications, developing commercial scale manufacturing processes, obtaining marketing approval,

manufacturing, marketing and selling any current and future therapeutic candidates for which we may obtain marketing approval, and satisfying

any post-marketing requirements.

We submitted an NDA to the U.S.

therapeutic candidate Dovitinib in December 2021 and on February 15, 2022, we received RTF letters for both our dovitinib NDA and our

DRP®-Dovitinib companion diagnostic PMA.

The FDA determined that our NDA was not sufficiently complete to permit a substantive review

and therefore our NDA was not accepted for filing.

The primary grounds of rejection asserted by the FDA relates to our use of prior Phase

3 clinical trial data, generated by Novartis in a “superiority” endpoint study against sorafenib (Bayer), to support a “non-inferiority”

endpoint in connection with the DRP® Dovitinib companion diagnostic.

We anticipate that the FDA will require a prospective Phase 3

clinical trial as well as additional dosage studies before regulatory approval of Dovitinib as a monotherapy and its companion diagnostic

Dovitinib-DRP can be obtained.

While we have decided that the costs, risks and potential benefits of conducting these studies for dovitinib

as a monotherapy for mRCC are no longer the best path toward commercial success, we continue to evaluate other potential Phase 1b/2 clinical

trials for dovitinib combined with other approved drugs in the mRCC space and in other indications.

If we are successful in raising the

necessary funds, we anticipate commencing a stenoparib in combination with dovitinib Phase 1b/2 Clinical Trial for second-line or later

treatment of metastatic ovarian cancer and/or other solid tumors.

However, despite our efforts, we may never succeed in any or all these

activities and, even if we do, we may never generate sufficient revenue to achieve profitability.

Because of the numerous risks

and uncertainties associated with drug development, we are unable to accurately predict the timing or amount of expenses or when, or if,

we will obtain marketing approval to commercialize any of our therapeutic candidates.

If we are required by the FDA, or other regulatory

authorities such as the European Medicines Agency, or EMA, to perform studies and trials in addition to those currently expected, or if

there are any delays in the development, or in the completion of any planned or future preclinical studies or clinical trials of our current

or future therapeutic candidates, our expenses could increase, and profitability could be further delayed.

FDA on our therapeutic candidate Dovitinib in December 2021 and on February

15, 2022, we received RTF letters for both our dovitinib NDA and our DRP®-Dovitinib companion diagnostic PMA.

The FDA determined

that our NDA was not sufficiently complete to permit a substantive review and therefore our NDA was not accepted for filing.

grounds of rejection asserted by the FDA relates to our use of prior Phase 3 clinical trial data, generated by Novartis in a “superiority”

endpoint study against sorafenib (Bayer), to support a “non-inferiority” endpoint in connection with the DRP® Dovitinib

companion diagnostic.

We anticipate that the FDA will require a prospective Phase 3 clinical trial as well as additional dosage studies

before regulatory approval of Dovitinib as a monotherapy and its companion diagnostic Dovitinib-DRP can be obtained.

We have decided

that the costs, risks and potential benefits of conducting these studies for dovitinib as a monotherapy for mRCC are no longer the best

path toward commercial success.

of the numerous risks and uncertainties associated with drug development, we are unable to accurately predict the timing or amount of

expenses or when, or if, we will obtain marketing approval to commercialize any of our therapeutic candidates.

If we are required by

the FDA, or other regulatory authorities such as the European Medicines Agency, or EMA, to perform studies and trials in addition to

those currently expected, or if there are any delays in the development, or in the completion of any planned or future preclinical studies

or clinical trials of our current or future therapeutic candidates, our expenses could increase, and profitability could be further delayed.

decline in the value of our company also could cause you to lose all or part of your investment.

Our independent registered public accounting

firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial

statements included in this report.

Our audited financial statements at December 31, 2022, and for the year then ended, were prepared

assuming that we will continue as a going concern.

The report from our independent

registered public accounting firm for the year ended December 31, 2022, includes an explanatory paragraph stating that our recurring losses

from operations since inception and our accumulated deficit raise substantial doubt about our ability to continue as a going concern.

Such an opinion could materially limit our ability to raise additional funds through the issuance of new debt or equity securities or

There is no assurance that sufficient financing will be available when needed to allow us to continue as a going concern.

perception that we may not be able to continue as a going concern may also make it more difficult to operate our business due to concerns

about our ability to meet our contractual obligations.

Our ability to continue as a going concern is contingent upon, among other factors,

the sale of our common stock or obtaining alternate financing.

We cannot provide any assurance that we will be able to raise additional

independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern

in its report on our audited financial statements included in this report.

Our audited financial statements at December 31, 2023, and

for the year then ended, were prepared assuming that we will continue as a going concern.

report from our independent registered public accounting firm for the year ended December 31, 2023, includes an explanatory paragraph

stating that our recurring losses from operations since inception and our accumulated deficit raise substantial doubt about our ability

to continue as a going concern.

Such an opinion could materially limit our ability to raise additional funds through the issuance of

new debt or equity securities or otherwise.

There is no assurance that sufficient financing will be available when needed to allow us

to continue as a going concern.

The perception that we may not be able to continue as a going concern may also make it more difficult

to operate our business due to concerns about our ability to meet our contractual obligations.

Our ability to continue as a going concern

is contingent upon, among other factors, the sale of our common stock or obtaining alternate financing.

We cannot provide any assurance

that we will be able to raise additional capital.

will need substantial additional funding, and if we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate

our drug development programs or commercialization efforts.

We anticipate that our expenses

will increase substantially as we continue our efforts relating to the re-submission of an NDA to the U.S.

FDA for our therapeutic candidate

dovitinib and as we advance our DRP ® -guided Phase 2 clinical trial of stenoparib as a treatment for ovarian cancer, our

DRP ® -guided Phase 2 clinical trial of IXEMPRA ® as a treatment for metastatic breast cancer, being conducted

at trial sites in Europe, and advance development of our other therapeutic candidates;

seek to identify and develop additional therapeutic

acquire or in-license other therapeutic candidates or technologies;

seek regulatory and marketing approvals for our therapeutic

candidates that successfully complete clinical trials, if any;

establish sales, marketing, distribution and other commercial infrastructure

in the future to commercialize various drugs for which we may obtain marketing approval, if any;

require the manufacture of larger quantities

of therapeutic candidates for clinical development and, potentially, commercialization;

maintain, expand and protect our intellectual

property portfolio;

develop, maintain, and expand our proprietary DRP ® companion diagnostics platform;

hire and retain

additional personnel, such as clinical, quality control and scientific personnel;

add operational, financial and management information

systems and personnel, including personnel to support our drug development and help us comply with our obligations as a public company;

and add equipment and physical infrastructure to support our research and development programs.

to availability of funding, we intend to use such funds for our ongoing clinical development efforts for our three priority pipeline

projects, including commencing a stenoparib in combination with dovitinib Phase 1b/2 clinical trial for second-line or later treatment

of metastatic ovarian cancer and/or other solid tumors.

We will be required to expend significant funds in order to prepare and re-submit

an NDA with the U.S.

FDA for our therapeutic candidate dovitinib and to advance the development of stenoparib, IXEMPRA ® .

In addition, while we may seek one or more collaborators for future development of our current therapeutic candidates or any future therapeutic

anticipate that our expenses will increase as we advance our DRP ® -guided Phase 2 clinical trial of stenoparib as a treatment

for ovarian cancer.

We have already begun paring down resource expenditures on any program other than stenoparib so that all internal

resources can be devoted to accelerating stenoparib development in Ovarian Cancer.

Even with a single program on stenoparib, there will

be significant additional development costs.

These may include any or all of the following:

additional trials designed to seek regulatory

the expenses associated with regulatory and marketing approvals as well as sales, marketing, distribution and other commercial

infrastructure spend;

Commercial scale drug and Companion Diagnostic manufacture;

Maintenance of our intellectual property portfolio;

hiring and retaining additional personnel, such as clinical, quality control and scientific personnel;

adding operational, financial

and management information systems and personnel, including personnel to support our drug development and help us comply with our obligations

as a public company;

and adding equipment and physical infrastructure to support our research and development programs.

addition, while we may seek one or more collaborators for future development of our current therapeutic candidates or any future therapeutic

candidates that we may develop for one or more indications, we may not be able to enter into a partnership or out-license for any of

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will need to seek additional funding, which future funding requirements, both short-term and long-term, will depend on many factors,

the scope, progress, timing, costs and results of our DRP ® -guided

Phase 2 clinical trial of stenoparib as a treatment for ovarian cancer, our DRP ® -guided Phase 2 clinical trial of IXEMPRA ®

as a treatment for metastatic breast cancer, being conducted at trial sites in Europe, and our preclinical studies and clinical

trials of our other therapeutic candidates;

costs associated with maintaining, expanding and updating our proprietary DRP ® companion diagnostics platform;

costs, timing and outcome of seeking regulatory approvals;

costs of our licensing or commercialization activities for any of our therapeutic candidates that receive marketing approval to the

extent such costs are not the responsibility of any future collaborators, including the costs and timing of establishing drug sales,

marketing, distribution and manufacturing capabilities;

headcount growth and associated costs as we expand our research and development activities as well as potentially establish a commercial

infrastructure;

ability to enter into and the terms and timing of any collaborations, licensing agreements or other arrangements;

received from commercial sales, if any, of our current and future therapeutic candidates;

costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending

against intellectual property related claims;

number of future therapeutic candidates that we pursue and their development requirements;

in regulatory policies or laws that may affect our operations;

in physician acceptance or medical society recommendations that may affect commercial efforts;

costs of acquiring potential new therapeutic candidates or technology;

costs associated with maintaining and expanding our cybersecurity systems;

costs of operating as a public company.

We have identified material weaknesses in

our internal controls over financial reporting and as of December 31, 2022, our disclosure controls and procedures and internal control

over financial reporting were not effective.

If we are unable to remediate these material weaknesses, or if we identify additional material

weaknesses in the future or otherwise fail to maintain an effective system of internal controls, and disclosure controls and procedures,

we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect our business

and stock price.

In connection with the audits of our financial statements for the years

ended December 31, 2022 and 2021, we identified material weaknesses in our internal controls over financial reporting because we did not

have a formal process for period end financial closing and reporting, we historically had insufficient resources to conduct an effective

monitoring and oversight function independent from our operations and we lack accounting resources and personnel to properly account for

accounting transactions such as the issuance of warrants with a derivative liability component.

In particular, the material weaknesses

identified were:

lack of accounting resources required to fulfill US GAAP and SEC reporting requirements;

lack of comprehensive US GAAP accounting policies and financial reporting procedures and

lack of adequate procedures and controls to appropriately account for accounting transactions

including liability and the valuation allowance on the deferred tax asset relating to the

net operating losses;

lack of segregation of duties given the size of our finance and accounting team.

have implemented and are continuing to implement various measures to address the material weaknesses identified;

these measures include:

● as of June 30, 2022, upon separation with our former Chief Financial

Officer, our Director of Financial Reporting, a CPA (Illinois) in 2021 who is experienced with public company reporting and is conversant

in US GAAP and SEC accounting issues, was promoted to Interim Chief Financial Officer.

Effective January 1, 2023, our Interim Chief Financial

Officer was promoted to our full time Chief Financial Officer.

With this hire we are continuing to address our ongoing development of

our comprehensive US GAAP accounting policies, financial reporting procedures and internal controls over financial reporting;

consulting services to assist with the accounting treatment of complex financial instruments

an independent US GAAP consulting firm as well as an independent tax consulting firm.

significant deficiency is a control deficiency, or a combination of control deficiencies, that adversely affects our ability to initiate,

authorize, record, process, or report external financial data reliably in accordance with US GAAP such that there is more than a remote

likelihood that a misstatement of our annual or interim financial statements that is more than inconsequential will not be prevented

or detected by our employees.

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

in more than a remote likelihood that a material misstatement of our annual or interim financial statement will not be prevented or detected

by our employees on a timely basis.

In response, we have begun the process of evaluating our internal control over financial reporting.

We have also taken several remedial actions set forth above to address these material weaknesses.

it is possible that, had our independent registered public accounting firm conducted an audit of our internal control over financial

reporting such firm might have identified additional material weaknesses and deficiencies.

We are a public company in the United States

subject to the Sarbanes-Oxley Act of 2002.

Once we cease to be an “emerging growth company” as such term is defined in the

JOBS Act and a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K, our independent registered public

accounting firm must attest to and report on the effectiveness of our internal control over financial reporting.

Our management may continue

to conclude that our internal control over financial reporting is not effective.

Moreover, even if our management concludes that our

internal control over financial reporting is effective, our independent registered public accounting firm, after conducting its own independent

testing, may issue a report that is qualified if it is not satisfied with our internal controls or the level at which our controls are

documented, designed, operated or reviewed, or if it interprets the relevant requirements differently from us.

In addition, our reporting

obligations may place a significant strain on our management, operational and financial resources and systems for the foreseeable future.

We may be unable to timely complete our evaluation, testing and any required remediation.

documenting and testing our internal control procedures to satisfy the requirements of Section 404, we may identify other weaknesses

and deficiencies in our internal control over financial reporting.

In addition, if we fail to maintain the adequacy of our internal control

over financial reporting, as these standards are modified, supplemented, or amended from time to time, we may not be able to conclude

on an ongoing basis that we have effective internal control over financial reporting in accordance with Section 404.

If we fail to achieve

and maintain an effective internal control environment, we could experience material misstatements in our financial statements and fail

to meet our reporting obligations, which would likely cause investors to lose confidence in our reported financial information.

could in turn limit our access to capital markets, harm our results of operations, and lead to a decline in the trading price of our

common stock.

Additionally, ineffective internal control over financial reporting could expose us to increased risk of fraud or misuse

of corporate assets and subject us to potential delisting from the Nasdaq Stock market, regulatory investigations and civil or criminal

We may also be required to restate our financial statements for prior periods.

In addition, based on an evaluation of our disclosure controls and

procedures and internal control over financial reporting as of December 31, 2022, we have concluded that, as of such date, because (i)

of the material weaknesses identified in our internal controls over financial reporting;

and (ii) we were late in filing our reports on

Form 10-Q for the quarterly periods ended March 31, 2022 and June 30, 2022, our disclosure controls and procedures, and internal control

over financial reporting were not effective.

are committed to remediating our material weakness as promptly as possible.

Although we believe we are making process towards remediating

the material weaknesses there can be no assurance as to when this material weakness will be remediated or that additional material weaknesses

will not arise in the future.

If we are unable to maintain effective internal control over financial reporting, our ability to record,

process and report financial information timely and accurately could be adversely affected, which could subject us to litigation or investigations,

require management resources, increase our expenses, negatively affect our business and investor confidence in our financial statements

and adversely impact the price of our common stock.

the scope, progress, timing,

costs and results of our DRP ® -guided Phase 2 clinical trial of stenoparib as a treatment for ovarian cancer,;

the costs associated with

maintaining, expanding and updating our proprietary DRP ® companion diagnostics platform;

the costs, timing and outcome

of seeking regulatory approvals;

the costs of our licensing

or commercialization activities for any of our therapeutic candidates that receive marketing approval to the extent such costs are

not the responsibility of any future collaborators, including the costs and timing of establishing drug sales, marketing, distribution

and manufacturing capabilities;

our headcount growth and

associated costs as we expand our research and development activities as well as potentially establish a commercial infrastructure;

our ability to enter into

and the terms and timing of any collaborations, licensing agreements or other arrangements;

revenue received from commercial

sales, if any, of our current and future therapeutic candidates;

the costs of preparing,

filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending against intellectual

property related claims;

the number of future therapeutic

candidates that we pursue and their development requirements;

changes in regulatory policies

or laws that may affect our operations;

changes in physician acceptance

or medical society recommendations that may affect commercial efforts;

the costs of acquiring

potential new therapeutic candidates or technology;

the costs associated with

maintaining and expanding our cybersecurity systems;

the costs of operating

as a public company.

Controls Over Financial Reporting

Under the supervision

and with the participation of our management, including our principal executive officer and principal financial officer, as of the end

of the period covered by this report, we conducted an evaluation of the effectiveness of the design and operation of our disclosure controls

and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Act of 1934.

Our disclosure controls and procedures are

designed to provide reasonable assurance that the information required to be included in our SEC reports is recorded, processed, summarized

and reported within the time periods specified in SEC rules and forms, relating to the Company, including our consolidated subsidiaries,

and was made known to them by others within those entities, particularly during the period when this report was being prepared.

upon that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures

were effective as of December 31, 2023.

received a request for documents from the SEC in the investigation known as “In the Matter of Allarity Therapeutics, Inc.,”

63 unchanged sentences

Events that may prevent successful or timely completion of preclinical or clinical development include:

in conducting experiments or preclinical studies or unsatisfactory results from such experiments or studies;

in reaching a consensus with regulatory authorities on trial design;

in reaching agreement or failing to agree on acceptable terms with prospective CROs and clinical trial sites;

in opening sites and recruiting suitable patients to participate in our clinical trials;

in enrollment due to travel or quarantine policies, or other factors, related to COVID-19, other pandemics or other events outside

of a clinical hold by regulatory authorities as a result of a serious adverse event, concerns with a class of therapeutic candidates

or after an inspection of our clinical trial operations or trial sites;

in having patients complete participation in a trial or return for post-treatment follow-up;

of serious adverse events associated with the therapeutic candidate that are viewed to outweigh its potential benefits;

in regulatory requirements and guidance that require amending or submitting new clinical protocols.

For instance, committee and

staff shortages causing delays at processing the trials at the investigator sites resulting in delayed and slow patient enrollment, which

may delay, limit or prevent our employees and CROs from continuing research and development activities, impede the ability of patients

to enroll or continue in clinical trials, or impede testing, monitoring, data collection and analysis or other related activities, any

of which could delay our clinical trials and increase our development costs, and have a material adverse effect on our business, financial

condition and results of operations.

In addition, current inflation levels could lead to further increases in the costs for clinical supply

both in the U.S.

and Europe, which could lead to further increases in our development costs and materially affect our results of operations.

delays in conducting experiments

or preclinical studies or unsatisfactory results from such experiments or studies;

delays in reaching a consensus

with regulatory authorities on trial design;

delays in reaching agreement

or failing to agree on acceptable terms with prospective CROs and clinical trial sites;

delays in opening sites

and recruiting suitable patients to participate in our clinical trials;

delays in enrollment due

to travel or quarantine policies, or other factors, related to COVID-19, other pandemics or other events outside our control;

imposition of a clinical

hold by regulatory authorities as a result of a serious adverse event, concerns with a class of therapeutic candidates or after an

inspection of our clinical trial operations or trial sites;

delays in having patients

complete participation in a trial or return for post-treatment follow-up;

occurrence of serious adverse

events associated with the therapeutic candidate that are viewed to outweigh its potential benefits;

changes in regulatory requirements

and guidance that require amending or submitting new clinical protocols.

instance, committee and staff shortages causing delays at processing the trials at the investigator sites resulting in delayed and slow

patient enrollment, which may delay, limit or prevent our employees and CROs from continuing research and development activities, impede

the ability of patients to enroll or continue in clinical trials, or impede testing, monitoring, data collection and analysis or other

related activities, any of which could delay our clinical trials and increase our development costs, and have a material adverse effect

on our business, financial condition and results of operations.

In addition, current inflation levels could lead to further increases

in the costs for clinical supply both in the U.S.

and Europe, which could lead to further increases in our development costs and materially

affect our results of operations.

inability to timely and successfully complete preclinical and clinical development could result in additional costs to us or impair our

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therapeutic candidates, we may:

delayed in obtaining marketing approval, if at all;

approval for indications or patient populations that are not as broad as intended or desired;

approval with labeling that includes significant use or distribution restrictions or safety warnings;

subject to additional post-marketing testing requirements;

required to perform additional clinical trials to support approval or be subject to additional post-marketing testing requirements;

regulatory authorities withdraw, or suspend, their approval of the drug or impose restrictions on its distribution in the form of

a modified risk evaluation and mitigation strategy, or REMS;

subject to the addition of labeling statements, such as warnings or contraindications;

damage to our reputation.

be delayed in obtaining

marketing approval, if at all;

obtain approval for indications

or patient populations that are not as broad as intended or desired;

obtain approval with labeling

that includes significant use or distribution restrictions or safety warnings;

be subject to additional

post-marketing testing requirements;

be required to perform

additional clinical trials to support approval or be subject to additional post-marketing testing requirements;

have regulatory authorities

withdraw, or suspend, their approval of the drug or impose restrictions on its distribution in the form of a modified risk evaluation

and mitigation strategy, or REMS;

be subject to the addition

of labeling statements, such as warnings or contraindications;

experience damage to our

drug development costs will also increase if we experience delays in testing or obtaining marketing approvals.

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adversely affected.

We may experience difficulties

in patient enrollment in our clinical trials for a variety of reasons, including committee and staff shortages causing delays at processing

the trials at the investigator sites resulting in delayed and slow patient enrollment.

The timely completion of clinical trials in accordance

with their protocols depends, among other things, on our ability to enroll enough patients who remain in the study until its conclusion.

may experience difficulties in patient enrollment in our clinical trials for a variety of reasons, including committee and staff shortages

causing delays at processing the trials at the investigator sites resulting in delayed and slow patient enrollment.

The timely completion

of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll enough patients who remain

in the study until its conclusion.

The enrollment of patients depends on many factors, including:

patient eligibility criteria defined in the protocol;

size and health of the patient population required for analysis of the trial’s primary endpoints;

proximity of patients to study sites;

design of the trial;

ability to recruit clinical trial investigators with the appropriate competencies and experience;

and patients’ perceptions as to the potential advantages of the therapeutic candidate being studied in relation to other available

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

ability to obtain and maintain patient consents;

number of patients willing to consent to a recent biopsy;

risk that patients enrolled in clinical trials will drop out of the trials before completion.

the patient eligibility

criteria defined in the protocol;

the size and health of

the patient population required for analysis of the trial’s primary endpoints;

the proximity of patients

to study sites;

the design of the trial;

our ability to recruit

clinical trial investigators with the appropriate competencies and experience;

clinicians’ and patients’

perceptions as to the potential advantages of the therapeutic candidate being studied in relation to other available therapies, including

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

our ability to obtain and

maintain patient consents;

sufficient number of patients

willing to consent to a recent biopsy;

the risk that patients

enrolled in clinical trials will drop out of the trials before completion.

addition, our clinical trials will compete with other clinical trials for therapeutic candidates that are in the same therapeutic areas

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we fail to comply with our obligations in the agreements under which we have licensed the intellectual property rights from third parties

for our therapeutic candidates dovitinib and stenoparib or otherwise experience disruptions to our business relationships with our licensors,

we could lose rights to advance the development of dovitinib and stenoparib which would have a material adverse effect on our business.

have entered into intellectual property license agreements with third party licensors for our two most advanced therapeutic candidates,

dovitinib and stenoparib that are important to our business.

These license agreements impose various diligence, milestone payment, royalty

and other obligations on us.

If we fail to comply with any obligations under any of these agreements with our licensors, we may be subject

to termination of the license agreements in whole or in part;

increased financial obligations to our licensors or loss of exclusivity

in a particular field or territory, in which case our ability to develop or commercialize the therapeutic candidate covered by the license

agreement will be impaired.

for our therapeutic candidate stenoparib or otherwise experience disruptions to our business relationships with our licensors, we could

lose rights to advance the development of dovitinib and stenoparib which would have a material adverse effect on our business.

have entered into intellectual property license agreements with third party licensors for our primary therapeutic candidate, stenoparib

that are important to our business.

These license agreements impose various diligence, milestone payment, royalty and other obligations

If we fail to comply with any obligations under any of these agreements with our licensors, we may be subject to termination of

the license agreements in whole or in part;

increased financial obligations to our licensors or loss of exclusivity in a particular field

or territory, in which case our ability to develop or commercialize the therapeutic candidate covered by the license agreement will be

addition, disputes may arise regarding intellectual property rights subject to the license agreement, including:

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

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.

the scope of rights granted

under the license agreement and other interpretation-related issues;

the extent to which our

technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;

our diligence obligations

under the license agreement and what activities satisfy those obligations;

if 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;

the 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 dependent on our ability to advance the development of our therapeutic candidates.

If we are unable to submit an NDA to the FDA for

our therapeutic candidate dovitinib, or initiate or complete the clinical development of, obtain marketing approval for or successfully

commercialize our other therapeutic candidates, either alone or with a collaborator, or if we experience significant delays in doing

so, our business could be substantially harmed.

If we are unable to complete the clinical development

of, obtain marketing approval for or successfully commercialize our therapeutic candidate, either alone or with a collaborator, or if

we experience significant delays in doing so, our business could be substantially harmed.

we submitted an NDA to the FDA for our therapeutic candidate dovitinib in December 2021, we currently do not have any drugs that have

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We are investing a significant portion of our efforts and financial resources in the

advancement of dovitinib, stenoparib, IXEMPRA ® , and our other therapeutic candidates and in the development of our proprietary

DRP ® companion diagnostics platform.

Our prospects are substantially dependent on our ability, or those of any future

collaborator, to develop, obtain marketing approval for and successfully commercialize therapeutic candidates in one or more disease

success of dovitinib, stenoparib, IXEMPRA ® , and our other therapeutic candidates will depend on several

factors, including the following:

ability to successfully complete clinical trials to obtain regulatory approval for our therapeutics candidates without significant delay.

On February 15, 2022, we receive RTF letters for both our dovitinib NDA and our DRP®-Dovitinib companion diagnostic PMA.

determined that our NDA was not sufficiently complete to permit a substantive review and therefore or NDA was not accepted for filing.

The primary grounds of rejection asserted by the FDA relates to our use of prior Phase 3 clinical trial data, generated by Novartis in

a “superiority” endpoint study against sorafenib (Bayer), to support a “non-inferiority” endpoint in connection

with the DRP® Dovitinib companion diagnostic.

We anticipate that the FDA will require a prospective Phase 3 clinical trial as well

as additional dosage studies before regulatory approval of Dovitinib as a monotherapy and its companion diagnostic Dovitinib-DRP can

While we have decided that the costs, risks and potential benefits of conducting these studies for dovitinib as a monotherapy

for mRCC are no longer the best path toward commercial success, we continue to evaluate other potential Phase 1b/2 clinical trials for

dovitinib combined with other approved drugs in the mRCC space and in other indications.

If we are successful in raising the necessary

funds, we anticipate commencing a stenoparib in combination with dovitinib Phase 1b/2 Clinical Trial for second-line or later treatment

of metastatic ovarian cancer and/or other solid tumors.

The FDA has asserted that neither our NDA or PMA meets the regulatory requirements

to warrant a complete agency review.

The primary grounds of rejection asserted by the FDA relates to Allarity’s use of prior Phase

3 clinical trial data, generated by Novartis in a “superiority” endpoint study against sorafenib (Bayer), to support a “non-inferiority”

endpoint in connection with the DRP®-Dovitinib companion diagnostic.

While we are currently evaluating other potential Phase 1b/2

Clinical Trials for dovitinib combined with other approved drugs in the mRCC space, if we raise the necessary funds, we intend to commence

a stenoparib in combination with dovitinib Phase 1b/2 Clinical Trial for second-line or later treatment of metastatic ovarian cancer

and/or other solid tumors.

However, despite our efforts, we may never succeed in any or all these activities and, even if we do, we may

never generate sufficient revenue to achieve profitability;

advancing our DRP ® -guided Phase 2 clinical trial of

stenoparib as a treatment for ovarian cancer, and our DRP ® -guided Phase 2 clinical trial of IXEMPRA ®

as a treatment for metastatic breast cancer, being conducted at trial sites in Europe;

progress, timing, costs and results of clinical trials of our other therapeutic candidates and potential therapeutic candidates;

establishment

of a safety, tolerability and efficacy profile that is satisfactory to the FDA or any comparable foreign regulatory authority for

marketing approval;

and maintaining patent, trade secret protection and regulatory exclusivity, both in the United States and relevant global markets;

performance of our future collaborators, if any;

extent of any required post-marketing approval commitments to applicable regulatory authorities;

establishment

of supply arrangements with third-party raw materials suppliers and manufacturers;

establishment

of arrangements with third-party manufacturers to obtain finished drug product that is appropriately packaged for sale;

of our rights in our intellectual property portfolio;

launch of commercial sales following any marketing approval;

continued acceptable safety profile following any marketing approval;

acceptance by patients, the medical community and third-party payors;

ability to compete with other therapies.

advancement of dovitinib, stenoparib.

Our prospects are substantially dependent on our ability, or those of any future collaborator,

to develop, obtain marketing approval for and successfully commercialize therapeutic candidates in one or more disease indications.

success of stenoparib , and our other therapeutic candidates will depend on several factors, including the following:

our ability to successfully

complete clinical trials to obtain regulatory approval for our therapeutics candidates without significant delay.

On February 15,

2022, we receive RTF letters for both our dovitinib NDA and our DRP®-Dovitinib companion diagnostic PMA.

The FDA determined that

our NDA was not sufficiently complete to permit a substantive review and therefore or NDA was not accepted for filing.

grounds of rejection asserted by the FDA relates to our use of prior Phase 3 clinical trial data, generated by Novartis in a “superiority”

endpoint study against sorafenib (Bayer), to support a “non-inferiority” endpoint in connection with the DRP® Dovitinib

companion diagnostic.

We anticipate that the FDA will require a prospective Phase 3 clinical trial as well as additional dosage studies

before regulatory approval of Dovitinib as a monotherapy and its companion diagnostic Dovitinib-DRP can be obtained.

We have decided

that the costs, risks and potential benefits of conducting these studies for dovitinib as a monotherapy for mRCC are no longer the

best path toward commercial success.

advancing our DRP ® -guided

Phase 2 clinical trial of stenoparib as a treatment for ovarian cancer,

initiation, progress, timing,

costs and results of clinical trials of other potential therapeutic candidates;

establishment of a safety,

tolerability and efficacy profile that is satisfactory to the FDA or any comparable foreign regulatory authority for marketing approval;

obtaining and maintaining

patent, trade secret protection and regulatory exclusivity, both in the United States and relevant global markets;

the performance of our

future collaborators, if any;

the extent of any required

post-marketing approval commitments to applicable regulatory authorities;

establishment of supply

arrangements with third-party raw materials suppliers and manufacturers;

establishment of arrangements

with third-party manufacturers to obtain finished drug product that is appropriately packaged for sale;

protection of our rights

in our intellectual property portfolio;

successful launch of commercial

sales following any marketing approval;

a continued acceptable

safety profile following any marketing approval;

commercial acceptance by

patients, the medical community and third-party payors;

our ability to compete

with other therapies.

of these factors are beyond our control, including the results of clinical trials, the time required for the FDA or any comparable foreign

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therapeutic candidates could fail to receive regulatory clearance or marketing approval for many reasons, including the following:

FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials, including,

but not limited to, the use of genomic or biomarker signatures to identify patients that may respond to drug efficacy;

may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a therapeutic candidate

is safe and effective for its proposed indication;

may be unable to identify and recruit a sufficient number of patients with relevant genomic or biomarker signatures in order to conduct

clinical trials on our therapeutic candidates or the FDA or comparable foreign regulatory authorities may not approve a DRP ®

companion diagnostic that is required to select patients responsive to one of our therapeutic candidates;

results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory

authorities for approval;

FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical

data collected from clinical trials of our therapeutic candidates may not be sufficient to support the submission of an NDA, or other

submission or to obtain regulatory approval in the United States or elsewhere;

FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers

with which we contract for clinical and commercial supplies;

approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering

our clinical data insufficient for approval.

the FDA or comparable foreign

regulatory authorities may disagree with the design or implementation of our clinical trials, including, but not limited to, the

use of genomic or biomarker signatures to identify patients that may respond to drug efficacy;

we may be unable to demonstrate

to the satisfaction of the FDA or comparable foreign regulatory authorities that a therapeutic candidate is safe and effective for

its proposed indication;

we may be unable to identify

and recruit a sufficient number of patients with relevant genomic or biomarker signatures in order to conduct clinical trials on

our therapeutic candidates or the FDA or comparable foreign regulatory authorities may not approve a DRP ® companion

diagnostic that is required to select patients responsive to one of our therapeutic candidates;

the results of clinical

trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;

the FDA or comparable foreign

regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;

the data collected from

clinical trials of our therapeutic candidates may not be sufficient to support the submission of an NDA, or other submission or to

obtain regulatory approval in the United States or elsewhere;

the FDA or comparable foreign

regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract

for clinical and commercial supplies;

the approval policies or

regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data

insufficient for approval.

have not previously completed all clinical trials for any of our therapeutic candidates and we have relied on the clinical trial results

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These risks and uncertainties include, but are not limited to, the following:

remaining term of the initial patents filed with respect to a therapeutic candidate may be significantly less than the patent term

for a newly discovered therapeutic candidate;

out-licensees, alliance partners and collaborators may view a therapeutic candidate identified with our proprietary DRP ®

companion diagnostics platform with more skepticism because of its history of failed clinical trials, thereby requiring a higher

level of additional data and further explanations of mechanisms of action in order to overcome this skepticism and obtain commercially

reasonable terms for future development or collaboration;

personnel and institutional knowledge relating to a therapeutic candidate that we couple with a DRP ® companion diagnostic

may no longer be available for us;

current standard of care in the targeted therapeutic indication for the DRP ® companion diagnostic-selected patient

population may be different than the standard of care that existed during the candidate’s last clinical trial, which will require

more time and resources from us to reassess and redesign the regulatory development path for the DRP ® -coupled therapeutic

DRP ® -coupled therapeutic candidate may be perceived to be in an “older” therapeutic drug type or focus

area of oncology, thereby generating less enthusiasm and support compared to therapeutic focus areas of oncology that may be perceived

as more recent.

The remaining term of the

initial patents filed with respect to a therapeutic candidate may be significantly less than the patent term for a newly discovered

therapeutic candidate;

Potential out-licensees,

alliance partners and collaborators may view a therapeutic candidate identified with our proprietary DRP ® companion

diagnostics platform with more skepticism because of its history of failed clinical trials, thereby requiring a higher level of additional

data and further explanations of mechanisms of action in order to overcome this skepticism and obtain commercially reasonable terms

for future development or collaboration;

Key personnel and institutional

knowledge relating to a therapeutic candidate that we couple with a DRP ® companion diagnostic may no longer be available

The current standard of

care in the targeted therapeutic indication for the DRP ® companion diagnostic-selected patient population may be different

than the standard of care that existed during the candidate’s last clinical trial, which will require more time and resources

from us to reassess and redesign the regulatory development path for the DRP ® -coupled therapeutic candidate;

The DRP ® -coupled

therapeutic candidate may be perceived to be in an “older” therapeutic drug type or focus area of oncology, thereby generating

less enthusiasm and support compared to therapeutic focus areas of oncology that may be perceived as more recent.

rely on Smerud Medical Research International and Chosa ApS for the development of our LiPlaCis ® DRP ® companion

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in clinical testing could result in increased costs to us and delay our ability to generate revenue.

we intend to advance our ongoing DRP ® -guided Phase 2 clinical trial of stenoparib as a treatment for ovarian cancer, and

our ongoing DRP ® -guided Phase 2 clinical trial of IXEMPRA ® as a treatment for metastatic breast cancer,

being conducted at trial sites in Europe, we are planning for certain clinical trials relating to our other therapeutic candidates, or

for other indications of all of our therapeutic candidates, there can be no assurance that the FDA will accept our proposed trial designs.

We may experience delays in our clinical trials and we do not know whether planned clinical trials will begin on time, need to be redesigned,

enroll patients on time or be completed on schedule, if at all.

Clinical trials can be delayed for a variety of reasons, including delays

regulatory clearance to commence a trial or obtaining regulatory approval to utilize a DRP ® companion diagnostic in

a trial to select and treat patients;

agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites, the terms of which

can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

in our CRO’s schedules relating to testing patients involved in our clinical trials;

institutional review board, or IRB, approval at each site;

suitable patients to participate in a trial;

clinical sites with adequate infrastructure (including data collection) to conduct the trial;

sites deviating from trial protocol or dropping out of a trial;

patient safety concerns that arise during the course of a trial;

patients complete a trial or return for post-treatment follow-up;

a sufficient number of clinical trial sites;

manufacturing

sufficient quantities and quality of a therapeutic candidate for use in clinical trials.

we intend to advance our ongoing DRP ® -guided Phase 2 clinical trial of stenoparib as a treatment for ovarian cancer, being

conducted at trial sites in Europe, we are exploring certain clinical trials for other indications, there can be no assurance that the

FDA will accept our proposed trial designs.

We may experience delays in our clinical trials and we do not know whether planned clinical

trials will begin on time, need to be redesigned, enroll patients on time or be completed on schedule, if at all.

Clinical trials can

be delayed for a variety of reasons, including delays related to:

obtaining regulatory clearance

to commence a trial or obtaining regulatory approval to utilize a DRP ® companion diagnostic in a trial to select and

treat patients;

reaching agreement on acceptable

terms with prospective contract research organizations, or CROs, and clinical trial sites, the terms of which can be subject to extensive

negotiation and may vary significantly among different CROs and trial sites;

delays in our CRO’s

schedules relating to testing patients involved in our clinical trials;

obtaining institutional

review board, or IRB, approval at each site;

recruiting suitable patients

to participate in a trial;

identifying clinical sites

with adequate infrastructure (including data collection) to conduct the trial;

clinical sites deviating

from trial protocol or dropping out of a trial;

addressing patient safety

concerns that arise during the course of a trial;

having patients complete

a trial or return for post-treatment follow-up;

adding a sufficient number

of clinical trial sites;

manufacturing sufficient

quantities and quality of a therapeutic candidate for use in clinical trials.

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

receive marketing approval or commercialize our therapeutic candidates, including:

may receive feedback from regulatory authorities that requires us to modify the design of our clinical trials;

may not have the ability to test patients for our clinical trials that require a specific genomic or biomarker signature in order

to qualify for enrollment;

trials of our therapeutic candidates may produce negative or inconclusive results, and we may decide, or regulators may require us,

to conduct additional clinical trials or abandon drug development programs;

number of patients required for clinical trials of our therapeutic candidates may be larger than we anticipate, enrollment in these

clinical trials may be slower than we anticipate or participants may drop out of these clinical trials at a higher rate than we anticipate;

third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner,

cost of clinical trials of our therapeutic candidates may be greater than we anticipate;

supply or quality of our therapeutic candidates or other materials necessary to conduct clinical trials of our therapeutic candidates

may be insufficient or inadequate;

may revise the requirements for approving our therapeutic candidates, or such requirements may not be as we anticipate;

any future collaborators that conduct clinical trials may face any

of the above issues and may conduct clinical trials in ways they view as advantageous to themselves but that are suboptimal for us.

we may receive feedback

from regulatory authorities that requires us to modify the design of our clinical trials;

we may not have the ability

to test patients for our clinical trials that require a specific genomic or biomarker signature in order to qualify for enrollment;

clinical trials of our

therapeutic candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct

additional clinical trials or abandon drug development programs;

the number of patients

required for clinical trials of our therapeutic candidates may be larger than we anticipate, enrollment in these clinical trials

may be slower than we anticipate or participants may drop out of these clinical trials at a higher rate than we anticipate;

our third-party contractors

may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;

the cost of clinical trials

of our therapeutic candidates may be greater than we anticipate;

the supply or quality of

our therapeutic candidates or other materials necessary to conduct clinical trials of our therapeutic candidates may be insufficient

or inadequate;

regulators may revise the

requirements for approving our therapeutic candidates, or such requirements may not be as we anticipate;

any future collaborators

that conduct clinical trials may face any of the above issues and may conduct clinical trials in ways they view as advantageous to

themselves but that are suboptimal for us.

we are required to conduct additional clinical trials or other testing of our therapeutic candidates beyond those that we currently contemplate,

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or tests are not positive or are only modestly positive or if there are safety concerns, we may:

unplanned costs;

delayed in obtaining marketing approval for our therapeutic candidates or not obtain marketing approval at all;

marketing approval in some countries and not in others;

marketing approval for indications or patient populations that are not as broad as intended or desired;

marketing approval with labeling that includes significant use or distribution restrictions or safety warnings, including boxed warnings;

subject to additional post-marketing testing requirements;

the drug removed from the market after obtaining marketing approval.

incur unplanned costs;

be delayed in obtaining

marketing approval for our therapeutic candidates or not obtain marketing approval at all;

obtain marketing approval

in some countries and not in others;

obtain marketing approval

for indications or patient populations that are not as broad as intended or desired;

obtain marketing approval

with labeling that includes significant use or distribution restrictions or safety warnings, including boxed warnings;

be subject to additional

post-marketing testing requirements;

have the drug removed from

the market after obtaining marketing approval.

we intend to rely on CROs, cancer research centers and clinical trial sites to ensure the proper and timely conduct of our clinical trials

44 unchanged sentences

by such drugs, a number of potentially significant negative consequences could result, including:

authorities may withdraw approvals of such drugs;

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

restrictions may be imposed on the marketing or distribution of the particular drug or the manufacturing processes for the drug or

any component thereof;

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

may be required to implement Risk Evaluation and Mitigation Strategies, or REMS, or create a medication guide outlining the risks

of such side effects for distribution to patients;

could be sued and held liable for harm caused to patients;

drug may become less competitive;

reputation may suffer.

regulatory authorities

may withdraw approvals of such drugs;

we may be required to recall

a drug or change the way such a drug is administered to patients;

additional restrictions

may be imposed on the marketing or distribution of the particular drug or the manufacturing processes for the drug or any component

regulatory authorities

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

we may be required to implement

Risk Evaluation and Mitigation Strategies (REMS) or create a medication guide outlining the risks of such side effects for distribution

we could be sued and held

liable for harm caused to patients;

our drug may become less

our reputation may suffer.

of these events could prevent us from achieving or maintaining market acceptance of the particular therapeutic candidate or for particular

indications of a therapeutic candidate, if approved, and could significantly harm our business, results of operations and prospects.

We are leveraging our proprietary

DRP ® companion diagnostics platform in an attempt to create a pipeline of therapeutic candidates using biomarker identification

and patient stratification for the development of oncology drugs in a personalized medicine approach.

While we believe that applying our

proprietary DRP ® companion diagnostics platform to drugs that have failed, been abandoned or otherwise failed to meet clinical

endpoints and then developing a precision oncology approach that identifies the mechanism of action, potential combination drug usage

and potentially responsive patient population is a strategy, our approach has not been approved by the FDA or any equivalent foreign regulatory

While we have retrospectively validated our proprietary DRP ® companion diagnostics platform in 35 clinical trials

conducted by other companies, we have not yet received approval from the FDA or other regulatory agency to market a companion diagnostic.

Because our approach is both innovative and in the early stages of development, the cost and time needed to develop our therapeutic candidates

is difficult to predict, and our efforts may not result in the successful discovery and development of commercially viable medicines.

We may also be incorrect about the effects of our therapeutic candidates on the diseases of our defined patient populations, which may

limit the utility of our approach or the perception of the utility of our approach.

Furthermore, our estimates of our defined patient

populations available for study and treatment may be lower than expected, which could adversely affect our ability to conduct clinical

trials and may also adversely affect the size of any market for medicines we may successfully commercialize.

Our approach may not result

in time savings, higher success rates or reduced costs as we expect it to, and if not, we may not attract collaborators or develop new

drugs as quickly or cost effectively as expected and therefore we may not be able to commercialize our approach as originally expected.

platform in an attempt to create a pipeline of therapeutic candidates using biomarker identification and patient stratification for the

development of oncology drugs in a personalized medicine approach.

While we believe that applying our proprietary DRP ®

companion diagnostics platform to drugs that have failed, been abandoned or otherwise failed to meet clinical endpoints and then developing

a precision oncology approach that identifies the mechanism of action, potential combination drug usage and potentially responsive patient

population is a strategy, our approach has not been approved by the FDA or any equivalent foreign regulatory authority.

While we have

retrospectively validated our proprietary DRP ® companion diagnostics platform in 35 clinical trials conducted by other

companies, we have not yet received approval from the FDA or other regulatory agency to market a companion diagnostic.

Because our approach

is both innovative and in the early stages of development, the cost and time needed to develop our therapeutic candidates is difficult

to predict, and our efforts may not result in the successful discovery and development of commercially viable medicines.

be incorrect about the effects of our therapeutic candidates on the diseases of our defined patient populations, which may limit the

utility of our approach or the perception of the utility of our approach.

Furthermore, our estimates of our defined patient populations

available for study and treatment may be lower than expected, which could adversely affect our ability to conduct clinical trials and

may also adversely affect the size of any market for medicines we may successfully commercialize.

Our approach may not result in time

savings, higher success rates or reduced costs as we expect it to, and if not, we may not attract collaborators or develop new drugs

as quickly or cost effectively as expected and therefore we may not be able to commercialize our approach as originally expected.

proprietary DRP ® companion diagnostics platform may fail to help us select and treat likely responder patients for our

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commercialization for a number of reasons, including:

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

unsuccessful in our efforts to identify new therapeutic candidates.

If we are unable to identify suitable additional compounds for

preclinical and clinical development, our ability to develop therapeutic candidates and obtain product revenues in future periods

could be compromised, which could result in significant harm to our financial position and adversely impact our stock price;

identified through our proprietary DRP ® companion diagnostics platform may not demonstrate efficacy, safety or tolerability

at levels acceptable to regulatory authorities;

DRP ® companion diagnostics platform may fail to successfully identify likely responder patients and therefore not

yield greater therapeutic benefit than observed in un-selected patients.

therapeutic candidates may, on further study, be shown to have harmful side effects or other characteristics that indicate that they

are unlikely to receive marketing approval and achieve market acceptance;

may develop alternative therapies that render our potential therapeutic candidates non-competitive or less attractive;

potential therapeutic candidate may not be capable of being produced at an acceptable cost.

research programs to identify

new therapeutic candidates will require substantial technical, financial and human resources, and we may be unsuccessful in our efforts

to identify new therapeutic candidates.

If we are unable to identify suitable additional compounds for preclinical and clinical development,

our ability to develop therapeutic candidates and obtain product revenues in future periods could be compromised, which could result

in significant harm to our financial position and adversely impact our stock price;

compounds identified through

our proprietary DRP ® companion diagnostics platform may not demonstrate efficacy, safety or tolerability at levels

acceptable to regulatory authorities;

our DRP ® companion

diagnostics platform may fail to successfully identify likely responder patients and therefore not yield greater therapeutic benefit

than observed in un-selected patients.

potential therapeutic candidates

may, on further study, be shown to have harmful side effects or other characteristics that indicate that they are unlikely to receive

marketing approval and achieve market acceptance;

competitors may develop

alternative therapies that render our potential therapeutic candidates non-competitive or less attractive;

a potential therapeutic

candidate may not be capable of being produced at an acceptable cost.

failure by us to comply with existing regulations could harm our reputation and operating results.

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laws that may affect our ability to operate include:

federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting,

offering, receiving or paying any remuneration (including any kickback, bribe or certain rebates), directly or indirectly, overtly

or covertly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease, order or recommendation

of, any good, facility, item or service, for which payment may be made, in whole or in part, under U.S.

federal and state healthcare

programs such as Medicare and Medicaid.

A person or entity does not need to have actual knowledge of the statute or specific intent

to violate it in order to have committed a violation;

federal false claims, including the False Claims Act, which can be enforced through whistleblower actions, and civil monetary

penalties laws, which, among other things, impose criminal and civil penalties against individuals or entities for knowingly presenting,

or causing to be presented, to the U.S.

federal government, claims for payment or approval that are false or fraudulent, knowingly

making, using or causing to be made or used, a false record or statement material to a false or fraudulent claim, or from knowingly

making a false statement to avoid, decrease or conceal an obligation to pay money to the U.S.

federal Anti-Kickback

Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving or

paying any remuneration (including any kickback, bribe or certain rebates), directly or indirectly, overtly or covertly, in cash

or in kind, to induce or reward either the referral of an individual for, or the purchase, lease, order or recommendation of, any

good, facility, item or service, for which payment may be made, in whole or in part, under U.S.

federal and state healthcare programs

such as Medicare and Medicaid.

A person or entity does not need to have actual knowledge of the statute or specific intent to violate

it in order to have committed a violation;

federal false

claims, including the False Claims Act, which can be enforced through whistleblower actions, and civil monetary penalties laws, which,

among other things, impose criminal and civil penalties against individuals or entities for knowingly presenting, or causing to be

presented, to the U.S.

federal government, claims for payment or approval that are false or fraudulent, knowingly making, using or

causing to be made or used, a false record or statement material to a false or fraudulent claim, or from knowingly making a false

statement to avoid, decrease or conceal an obligation to pay money to the U.S.

federal government.

In addition, the

government may assert that a claim including items and services resulting from a violation of the U.S.

federal Anti-Kickback Statute

constitutes a false or fraudulent claim for purposes of the False Claims Act;

federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes criminal and civil liability for,

among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program,

or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement, in connection

with the delivery of, or payment for, healthcare benefits, items or services;

In addition, the government may

assert that a claim including items and services resulting from a violation of the U.S.

federal Anti-Kickback Statute constitutes

a false or fraudulent claim for purposes of the False Claims Act;

federal Health

Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes criminal and civil liability for, among other things,

knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and

willfully falsifying, concealing or covering up a material fact or making any materially false statement, in connection with the

delivery of, or payment for, healthcare benefits, items or services;

similar to the U.S.

federal Anti-Kickback Statute,

a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed

as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and its implementing regulations,

and as amended again by the Modifications to the HIPAA Privacy, Security, Enforcement and Breach Notification Rules Under HITECH

and the Genetic Information Nondiscrimination Act;

Other Modifications to the HIPAA Rules, commonly referred to as the Final HIPAA

Omnibus Rule, published in January 2013, which imposes certain obligations, including mandatory contractual terms, with respect to

safeguarding the privacy, security and transmission of individually identifiable health information without appropriate authorization

by covered entities subject to the Final HIPAA Omnibus Rule, i.e.

health plans, healthcare clearinghouses and certain healthcare

providers, as well as their business associates that perform certain services for or on their behalf involving the use or disclosure

of individually identifiable health information;

Federal Food, Drug and Cosmetic Act, which prohibits, among other things, the adulteration or misbranding of drugs, biologics

and medical devices;

federal legislation commonly referred to as Physician Payments Sunshine Act, enacted as part of the PPACA, and its implementing

regulations, which requires certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare,

Medicaid or the Children’s Health Insurance Program to report annually to the Centers for Medicare & Medicaid Services

(“CMS”) information related to certain payments and other transfers of value to physicians (defined to include doctors,

dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held

by the physicians described above and their immediate family members;

state laws and regulations, including:

state anti-kickback and false claims laws, which may apply to our business practices, including,

but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed

federal Anti-Kickback Statute, a person

or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

HIPAA, as amended by the

Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and its implementing regulations, and as amended

again by the Modifications to the HIPAA Privacy, Security, Enforcement and Breach Notification Rules Under HITECH and the Genetic

Information Nondiscrimination Act;

Other Modifications to the HIPAA Rules, commonly referred to as the Final HIPAA Omnibus Rule,

published in January 2013, which imposes certain obligations, including mandatory contractual terms, with respect to safeguarding

the privacy, security and transmission of individually identifiable health information without appropriate authorization by covered

entities subject to the Final HIPAA Omnibus Rule, i.e.

health plans, healthcare clearinghouses and certain healthcare providers,

as well as their business associates that perform certain services for or on their behalf involving the use or disclosure of individually

identifiable health information;

Federal Food,

Drug and Cosmetic Act, which prohibits, among other things, the adulteration or misbranding of drugs, biologics and medical devices;

federal legislation

commonly referred to as Physician Payments Sunshine Act, enacted as part of the PPACA, and its implementing regulations, which requires

certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid or the Children’s

Health Insurance Program to report annually to the Centers for Medicare & Medicaid Services (“CMS”) information related

to certain payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and

chiropractors) and teaching hospitals, as well as ownership and investment interests held by the physicians described above and their

immediate family members;

analogous state laws and

regulations, including:

state anti-kickback and false claims laws, which may apply to our business practices, including, but not

limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed

by any third-party payor, including private insurers;

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many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts;

and other foreign law equivalents of each of the laws, including reporting requirements detailing interactions with and payments

to healthcare providers.

European and other foreign

law equivalents of each of the laws, including reporting requirements detailing interactions with and payments to healthcare providers.

that our internal operations and future business arrangements with third parties comply with applicable healthcare laws and regulations

26 unchanged sentences

We expect we will supplement our clinical trial coverage with product liability coverage in connection

with the commercial launch of dovitinib or other therapeutic candidates we develop in the future;

however, we may be unable to obtain

such increased coverage on acceptable terms or at all.

If we are found liable in a clinical trial lawsuit or a product liability lawsuit

in the future, we will have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations

or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts.

with the commercial launch of other therapeutic candidates we develop in the future;

however, we may be unable to obtain such increased

coverage on acceptable terms or at all.

If we are found liable in a clinical trial lawsuit or a product liability lawsuit in the future,

we will have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not

covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts.

Related to the Approval and Commercialization of Our Therapeutic Candidates

39 unchanged sentences

price of our drugs relative to other products for the same or similar treatments;

perception by patients, physicians and other members of the health care community of the effectiveness and safety of our drugs for

their indicated applications and treatments, or the value of our DRP ® companion diagnostics in improving patient benefit;

ability to fund our sales and marketing efforts;

effectiveness of our sales and marketing efforts.

the perception by patients,

physicians and other members of the health care community of the effectiveness and safety of our drugs for their indicated applications

and treatments, or the value of our DRP ® companion diagnostics in improving patient benefit;

our ability to fund our

sales and marketing efforts;

the effectiveness of our

sales and marketing efforts.

our drugs do not gain market acceptance, we may not be able to fund future operations, including developing, testing and obtaining regulatory

168 unchanged sentences

or failure to comply with regulatory requirements, may have various consequences, including:

● restrictions

on such drugs, manufacturers or manufacturing processes;

and warnings on the labeling or marketing of a drug;

on drug distribution or use;

to conduct post-marketing studies or clinical trials;

letters or untitled letters;

of the drugs from the market;

to approve pending applications or supplements to approved applications that we submit;

restitution or disgorgement of profits or revenues;

or withdrawal of marketing approvals;

to relationships with any potential collaborators;

press coverage and damage to our reputation;

to permit the import or export of our drugs;

or the imposition of civil or criminal penalties;

involving patients using our drugs.

restrictions and warnings

on the labeling or marketing of a drug;

restrictions on drug distribution

requirements to conduct

post-marketing studies or clinical trials;

warning letters or untitled

withdrawal of the drugs

from the market;

refusal to approve pending

applications or supplements to approved applications that we submit;

recall of drugs;

fines, restitution or disgorgement

of profits or revenues;

suspension or withdrawal

of marketing approvals;

damage to relationships

with any potential collaborators;

unfavorable press coverage

and damage to our reputation;

refusal to permit the import

or export of our drugs;

drug seizure;

injunctions or the imposition

of civil or criminal penalties;

litigation involving patients

using our drugs.

operate in a highly competitive and rapidly changing industry .

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have no experience in marketing and selling drug products.

We have not yet entered into arrangements for the sale and marketing of dovitinib,

stenoparib, IXEMPRA ® or any other therapeutic candidate, although we are exploring several such arrangements.

pharmaceutical companies would employ groups of sales representatives and associated sales and marketing staff numbering in the hundreds

to thousands of individuals to call on this large number of physicians and hospitals.

We may seek to collaborate with a third-party to

market our drugs or may seek to market and sell our drugs by ourselves.

If we seek to collaborate with a third-party, we cannot be sure

that a collaborative agreement can be reached on terms acceptable to us.

If we seek to market and sell our drugs directly, we will need

to hire additional personnel skilled in marketing and sales.

We cannot be sure that we will be able to acquire, or establish third-party

relationships to provide, any or all these marketing and sales capabilities.

The establishment of a direct sales force or a contract

sales force or a combination direct and contract sales force to market our drugs will be expensive and time-consuming and could delay

any drug launch.

Further, we can give no assurances that we may be able to maintain a direct and/or contract sales force for any period

or that our sales efforts will be sufficient to generate or to grow our revenues or that our sales efforts will ever lead to profits.

if we obtain regulatory approvals to commercialize dovitinib, stenoparib, IXEMPRA ® or our other therapeutic candidates,

our therapeutic candidates may not be accepted by physicians or the medical community in general.

can be no assurance that dovitinib, stenoparib, IXEMPRA ® and our other therapeutic candidates or any other therapeutic

candidate successfully developed by us, independently or with partners, will be accepted by physicians, hospitals and other health care

Dovitinib, stenoparib, IXEMPRA ® and our other and any future therapeutic candidates we develop will compete

with several drugs manufactured and marketed by major pharmaceutical and biotech companies.

The degree of market acceptance of any drugs

we develop depends on several factors, including:

demonstration of the clinical efficacy and safety of dovitinib, stenoparib, IXEMPRA ® and our other therapeutic candidates;

of market approval and commercial launch of dovitinib, stenoparib, IXEMPRA ® and our other therapeutic candidates;

clinical indication(s) for which dovitinib, stenoparib, IXEMPRA ® and our other therapeutic candidates are approved;

label and package insert requirements;

and disadvantages of our therapeutic candidates compared to existing therapies, particularly in combination with our DRP ®

companion diagnostics;

interest in and growth of the market for anticancer tyrosine kinase inhibitory, PARP inhibitory, and microtubule inhibitory drugs;

of sales, marketing, and distribution support;

pricing in absolute terms and relative to alternative treatments;

changes in health care laws, regulations, and medical policies;

of reimbursement codes and coverage in select jurisdictions, and future changes to reimbursement policies of government and third-party

We have not yet entered into arrangements for the sale and marketing of stenoparib,

or any other therapeutic candidate, although we are exploring several such arrangements.

Typically, pharmaceutical companies would employ

groups of sales representatives and associated sales and marketing staff numbering in the hundreds to thousands of individuals to call

on this large number of physicians and hospitals.

We may seek to collaborate with a third-party to market our drugs or may seek to market

and sell our drugs by ourselves.

If we seek to collaborate with a third-party, we cannot be sure that a collaborative agreement can be

reached on terms acceptable to us.

If we seek to market and sell our drugs directly, we will need to hire additional personnel skilled

in marketing and sales.

We cannot be sure that we will be able to acquire, or establish third-party relationships to provide, any or

all these marketing and sales capabilities.

The establishment of a direct sales force or a contract sales force or a combination direct

and contract sales force to market our drugs will be expensive and time-consuming and could delay any drug launch.

Further, we can give

no assurances that we may be able to maintain a direct and/or contract sales force for any period or that our sales efforts will be sufficient

to generate or to grow our revenues or that our sales efforts will ever lead to profits.

if we obtain regulatory approvals to commercialize stenoparib, or our other future therapeutic candidates, our therapeutic candidates

may not be accepted by physicians or the medical community in general.

can be no assurance that stenoparib and other future therapeutic candidates or any other therapeutic candidate successfully developed

by us, independently or with partners, will be accepted by physicians, hospitals and other health care facilities.

Stenoparib and any

future therapeutic candidates we develop will compete with several drugs manufactured and marketed by major pharmaceutical and biotech

The degree of market acceptance of any drugs we develop depends on several factors, including:

demonstration of the clinical efficacy and safety of stenoparib and other future therapeutic

timing of market approval

and commercial launch of stenoparib and other future therapeutic candidates;

the clinical indication(s)

for which stenoparib and other future therapeutic candidates are approved;

drug label and package

insert requirements;

and disadvantages of our therapeutic candidates compared to existing therapies, particularly

in combination with our DRP ® companion diagnostics;

continued interest in and

growth of the market for anticancer tyrosine kinase inhibitory, PARP inhibitory, and microtubule inhibitory drugs;

strength of sales, marketing,

and distribution support;

drug pricing in absolute

terms and relative to alternative treatments;

future changes in health

care laws, regulations, and medical policies;

availability of reimbursement

codes and coverage in select jurisdictions, and future changes to reimbursement policies of government and third-party payors.

uncertainty exists as to the coverage and reimbursement status of any therapeutic candidate for which we obtain regulatory approval.

70 unchanged sentences

ability to profitably sell any product for which we obtain marketing approval.

The PPACA includes measures

that have significantly changed the way healthcare is financed by both governmental and private insurers.

There remain judicial, executive

and congressional challenges to certain aspects of the PPACA.

Since 2017, there have been executive orders and other directives designed

to delay the implementation of certain provisions of the PPACA or otherwise circumvent some of the requirements for health insurance mandated

by the PPACA.

In addition, while Congress has not passed comprehensive repeal legislation, it has enacted laws that modify certain provisions

of the PPACA such as removing penalties, effective January 1, 2019, for not complying with the PPACA’s individual mandate to

carry health insurance.

Additionally, the 2020 federal spending package permanently eliminated, effective January 1, 2020, the PPACA-mandated “Cadillac”

tax on high-cost employer-sponsored health coverage and medical device tax and, effective January 1, 2021, also eliminates the health

PPACA includes measures that have significantly changed the way healthcare is financed by both governmental and private insurers.

remain judicial, executive and congressional challenges to certain aspects of the PPACA.

Since 2017, there have been executive orders

and other directives designed to delay the implementation of certain provisions of the PPACA or otherwise circumvent some of the requirements

for health insurance mandated by the PPACA.

In addition, while Congress has not passed comprehensive repeal legislation, it has enacted

laws that modify certain provisions of the PPACA such as removing penalties, effective January 1, 2019, for not complying with the

PPACA’s individual mandate to carry health insurance.

Additionally, the 2020 federal spending package permanently eliminated, effective

January 1, 2020, the PPACA-mandated “Cadillac” tax on high-cost employer-sponsored health coverage and medical

device tax and, effective January 1, 2021, also eliminates the health insurer tax.

In 2018, a U.S.

District Court ruled that the PPACA is unconstitutional in its entirety because the “individual mandate”

was effectively repealed by Congress as part of the Tax Act.

District Court ruled that the

PPACA is unconstitutional in its entirety because the “individual mandate” was effectively repealed by Congress as part of

Additionally, in 2019, the U.S.

Court of Appeals for the 5 th Circuit

upheld the District Court ruling that the individual mandate was unconstitutional and remanded the case back to the District Court to

determine whether the remaining provisions of the PPACA are invalid as well.

Supreme Court heard oral argument on the case on

November 10, 2020, and issued its decision on June 17, 2021, holding that the state plaintiff’s in the case challenging the

constitutionality of minimum essential health care coverage provisions of the PPACA lacked standing to bring an action under Article III,

Section 2 of the U.S.

Court of Appeals for the 5 th Circuit upheld the District Court ruling that the

individual mandate was unconstitutional and remanded the case back to the District Court to determine whether the remaining provisions

of the PPACA are invalid as well.

Supreme Court heard oral argument on the case on November 10, 2020, and issued its decision

on June 17, 2021, holding that the state plaintiff’s in the case challenging the constitutionality of minimum essential health

care coverage provisions of the PPACA lacked standing to bring an action under Article III, Section 2 of the U.S.

Constitution.

On February 10, 2021, the Biden administration withdrew the federal government’s support for

overturning the PPACA.

10, 2021, the Biden administration withdrew the federal government’s support for overturning the PPACA.

Although the U.S.

Supreme Court had not yet ruled on the constitutionality of the PPACA, on January 28, 2021, President

Biden issued an executive order that initiated a special enrollment period for purposes of obtaining health insurance coverage through

the PPACA marketplace, which began on February 15, 2021, and remained open through August 15, 2021.

The executive order also instructed

certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among

others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary

barriers to obtaining access to health insurance coverage through Medicaid or the PPACA.

Notwithstanding the Supreme Court recent ruling

on standing to challenge the constitutionality of the PPACA, it is unclear how additional litigation and the healthcare reform measures

of the Biden administration will impact the PPACA and our business.

We continue to evaluate the effect that the PPACA and its possible

repeal and replacement has on our business.

Court had not yet ruled on the constitutionality of the PPACA, on January 28, 2021, President Biden issued an executive order that initiated

a special enrollment period for purposes of obtaining health insurance coverage through the PPACA marketplace, which began on February

15, 2021, and remained open through August 15, 2021.

The executive order also instructed certain governmental agencies to review and

reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration

projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health

insurance coverage through Medicaid or the PPACA.

Notwithstanding

the Supreme Court recent ruling on standing to challenge the constitutionality of the PPACA, it is unclear how additional litigation

and the healthcare reform measures of the Biden administration will impact the PPACA and our business.

We continue to evaluate the effect

that the PPACA and its possible repeal and replacement has on our business.

addition, other legislative changes have been proposed and adopted since the PPACA was enacted.

242 unchanged sentences

research, preclinical development, clinical trials and manufacturing;

and obtaining regulatory approvals;

commercializing any future therapeutic candidates.

seeking and obtaining regulatory

successfully commercializing

any future therapeutic candidates.

we are not able to establish further collaboration agreements, we may be required to undertake drug development and commercialization

14 unchanged sentences

Related to Our Business and Industry

have insufficient cash to continue our operations past December 2023, our continued operations are dependent on us raising capital and

these conditions give rise to substantial doubt over the Company’s ability to continue as a going concern

Company has incurred significant losses and has an accumulated deficit of $94.5 million as of December 31, 2023.

As of December

31, 2023, our cash deposits of $166 thousand is insufficient to fund our current operating plan and planned capital expenditures past

December 2023.

Further, we believe that our existing cash and cash equivalents as of March 7, 2024, and our anticipated expenditures

and commitments for the next twelve months, will not enable us to fund our operating expenses and capital expenditure requirements for

the twelve months from the date of this prospectus.

These conditions give rise to substantial doubt over the Company’s ability

to continue as a going concern.

We will need to raise additional capital after this offering to support our operations and execute our

business plan.

We will be required to pursue sources of additional capital through various means, including debt or equity financings.

Newly issued securities may include preferences, superior voting rights, and the issuance of warrants or other convertible securities

that will have additional dilutive effects.

We cannot assure that additional funds will be available when needed from any source or,

if available, will be available on terms that are acceptable to us and may cause existing shareholders both book value and ownership

Further, we may incur substantial costs in pursuing future capital and/or financing, including investment banking fees, legal

fees, accounting fees, printing and distribution expenses and other costs.

We may also be required to recognize non-cash expenses in

connection with certain securities we may issue, such as convertible notes and warrants, which will adversely impact our financial condition

and results of operations.

Our ability to obtain needed financing may be impaired by such factors as the weakness of capital markets,

and the fact that we have not been profitable, which could impact the availability and cost of future financings.

If the amount of capital

we are able to raise from financing activities is not sufficient to satisfy our capital needs, we may have to reduce our operations accordingly.

are delinquent in our payment to Eisai

consideration for extension of certain deadlines and payment obligations, the Company entered in several amendments to an Exclusive License

Agreement with Eisai.

On May 26, 2023, the Company and Eisai entered into a fourth amendment to the Exclusive License Agreement with

an effective date of May 16, 2023, under which the Company agreed to pay Eisai in periodic payments as follows:

(i) $100,000;

within 10 days of execution of the fourth amendment;

(iii) $100,000 upon completion of a capital raise (of which items (i) and (iii)

have been paid):

and (iv) $850,000 on or before March 1, 2024.

Under the Exclusive License Agreement, the Company will have until April

1, 2024, to complete enrollment in a further Phase 1b or Phase 2 Clinical Trial of the Product.

If the Company has not achieved successful

completion of a further Phase 1b or Phase 2 Clinical Trial of the Product prior to April 1, 2024, Eisai may terminate the Agreement in

its entirety, in its sole discretion on at least 120 days prior written notice.

In light of our financial condition and dependence on

financing for our operations, we may be unable to meet the payment requirements under the fourth amendment and we may lose our right

to use stenoparib, which will adversely affect our ability to conduct our clinical trials and to achieve our business objectives and

adversely affect our financial results.

dispute with our former Chief Executive Officer could be costly and adversely affect our business.

December 8, 2023, Mr.

Cullem was terminated as our Chief Executive Officer for cause under his employment agreement.

Cullem has indicated

that his termination should be without cause.

Any dispute with Mr.

Cullem could be costly and become a distraction to our management

and employees and adversely affect our business.

global market and economic conditions may have serious adverse consequences on our business, financial condition and stock price.

The global credit and financial

markets have from time-to-time experienced extreme volatility and disruptions, including severely diminished liquidity and credit availability,

declines in consumer confidence, declines in economic growth, increases in unemployment rates and uncertainty about economic stability.

The financial markets and the global economy may also be adversely affected by the current or anticipated impact of military conflict,

including the conflict between Russia and Ukraine, terrorism or other geopolitical events.

Sanctions imposed by the United States and

other countries in response to such conflicts, including the one in Ukraine, may also adversely impact the financial markets and the global

economy, and any economic countermeasures by the affected countries or others could exacerbate market and economic instability.

can be no assurance that further deterioration in credit and financial markets and confidence in economic conditions will not occur.

general business strategy may be adversely affected by any such economic downturn, volatile business environment or continued unpredictable

and unstable market conditions.

If the current equity and credit markets deteriorate, it may make any necessary debt or equity financing

more difficult, more costly and more dilutive.

Failure to secure any necessary financing in a timely manner and on favorable terms could

have a material adverse effect on our growth strategy, financial performance and stock price and could require us to delay or abandon

clinical development plans.

In addition, there is a risk that one or more of our current service providers, manufacturers and other partners

may not survive an economic downturn, which could directly affect our ability to attain our operating goals on schedule and on budget.

Our clinical development plans could be

adversely affected by the effects of health epidemics, including the ongoing COVID-19 pandemic, on clinical trials.

The effect of Covid-19 could

cause potential on going delay in clinical trials due to backup at ethical committee and staff shortage causing delay a s processing the

trials at the investigator site resulting in delay or slow patient enrollment which we have no control over.

In addition, our ongoing clinical trials in the U.S.

and Europe may

be affected by the COVID-19 pandemic.

In the future, clinical site initiation and patient enrollment may be delayed due to prioritization

of hospital resources toward the COVID-19 pandemic or concerns among patients about participating in clinical trials during

a pandemic and public health measures imposed by the respective national governments of countries in which the clinical sites are located.

Some patients may have difficulty following certain aspects of clinical trial protocols if quarantines impede patient movement or interrupt

healthcare services.

Similarly, our inability to successfully recruit and retain patients and principal investigators and site staff who,

as healthcare providers, may have heightened exposure to COVID-19 or experience additional restrictions by their institutions,

city or state governments could adversely impact our clinical trial operations.

global credit and financial markets have from time-to-time experienced extreme volatility and disruptions, including severely diminished

liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates and

uncertainty about economic stability.

The financial markets and the global economy may also be adversely affected by the current or anticipated

impact of military conflict, including the conflict between Russia and Ukraine, terrorism or other geopolitical events.

Sanctions imposed

by the United States and other countries in response to such conflicts, including the one in Ukraine, may also adversely impact the financial

markets and the global economy, and any economic countermeasures by the affected countries or others could exacerbate market and economic

There can be no assurance that further deterioration in credit and financial markets and confidence in economic conditions

will not occur.

Our general business strategy may be adversely affected by any such economic downturn, volatile business environment

or continued unpredictable and unstable market conditions.

If the current equity and credit markets deteriorate, it may make any necessary

debt or equity financing more difficult, more costly and more dilutive.

Failure to secure any necessary financing in a timely manner

and on favorable terms could have a material adverse effect on our growth strategy, financial performance and stock price and could require

us to delay or abandon clinical development plans.

In addition, there is a risk that one or more of our current service providers, manufacturers

and other partners may not survive an economic downturn, which could directly affect our ability to attain our operating goals on schedule

and on budget.

we fail to satisfy The Nasdaq Capital Market continued listing requirements and do not regain compliance, our Common Stock will be delisted.

we fail to meet any other Nasdaq listing requirements and do not regain compliance, we may be subject to delisting by Nasdaq.

event our Common Stock is no longer listed for trading on Nasdaq, our trading volume and share price may decrease and you may have a

difficult time selling your shares of Common Stock.

In addition, we may experience difficulties in raising capital which could materially

adversely affect our operations and financial results.

Further, delisting from Nasdaq markets could also have other negative effects,

including potential loss of confidence by partners, lenders, suppliers, and employees.

Finally, delisting could make it harder for you

and the Company to sell the securities and hard for us to raise capital.

will need to increase the size of our organization and the scope of our outside vendor relationships, and we may experience difficulties

in managing growth.

of March 1, 2023, we employed a total of 9 full-time employees.

Our current internal departments include research and development, finance,

and administration.

We intend to expand our management team to include an operation ramp up of additional scientific development and

technical staff required to achieve our business objectives.

We will need to expand our managerial, operational, technical, and scientific,

financial, and other resources in order to manage our operations and clinical trials, establish independent manufacturing, continue our

research and development activities, and commercialize our therapeutic candidates.

Our management and scientific personnel, systems,

and facilities currently in place may not be adequate to support our future growth.

of March 1, 2024, we employed a total of 5 full-time employees and 1 part-time employee.

Our current internal departments include research

and development, finance, and administration.

We intend to expand our management team to include an operation ramp up of additional scientific

development and technical staff required to achieve our business objectives.

We will need to expand our managerial, operational, technical,

and scientific, financial, and other resources in order to manage our operations and clinical trials, establish independent manufacturing,

continue our research and development activities, and commercialize our therapeutic candidates.

Our management and scientific personnel,

systems, and facilities currently in place may not be adequate to support our future growth.

need to effectively manage our operations, growth and various projects requires that we:

our ongoing and future clinical trials effectively;

our internal development efforts effectively while carrying out our contractual obligations to licensors, contractors and other third

to improve our operational, financial and management controls and reporting systems and procedures;

and retain sufficient numbers of talented employees.

manage our internal development

efforts effectively while carrying out our contractual obligations to licensors, contractors and other third parties;

continue to improve our

operational, financial and management controls and reporting systems and procedures;

attract and retain sufficient

numbers of talented employees.

may utilize the services of vendors and research partners or collaborators to perform tasks including preclinical studies and clinical

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business depends largely upon the continued services of our founder and Chief Scientific Officer, Dr.

Steen Knudsen, Ph.D., and James

Cullem, our i Chief Executive Officer, Chief Business Officer and Director.

We do not maintain “key person” insurance

Knudsen and Cullem or any of our other key employees.

We also rely on employees in the areas of research and development,

regulatory compliance and approvals, and general and administrative functions.

From time to time, there may be additional changes in

our executive management and employees resulting from the hiring or departure of executives or other key employees which could disrupt

our business.

The replacement of one or more of our executive officers or other key employees would likely involve significant time and

costs and may significantly delay or prevent the achievement of our business objectives.

Steen Knudsen, Ph.D., and Thomas

Jensen, our Interim Chief Executive Officer.

We do not maintain “key person” insurance for Messrs.

Knudsen and Jensen or

any of our other key employees.

We also rely on employees in the areas of research and development, regulatory compliance and approvals,

and general and administrative functions.

From time to time, there may be additional changes in our executive management and employees

resulting from the hiring or departure of executives or other key employees which could disrupt our business.

The replacement of one

or more of our executive officers or other key employees would likely involve significant time and costs and may significantly delay

or prevent the achievement of our business objectives.

continue to execute our growth strategy, we also must attract and retain highly skilled personnel.

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internationally involves several risks, including but not limited to:

conflicting and changing laws and regulations such as privacy regulations, tax laws, export and import restrictions, employment laws,

regulatory requirements and other governmental approvals, permits and licenses;

by us to obtain and maintain regulatory approvals for the use of our products in various countries;

or qualification of foreign clinical trial data by the competent authorities of other countries;

or interruptions of clinical trial due to backup at ethical committees and staff shortages causing delays in processing the trials

at investigator sites resulting in delayed and slow patient enrollment.

potentially relevant third-party patent and other intellectual property rights;

and difficulties in obtaining, maintaining, protecting and enforcing our intellectual property;

in staffing and managing foreign operations;

associated with managing multiple payor reimbursement regimes, government payors or patient self-pay systems;

in our ability to penetrate international markets;

risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises

on demand and payment for our therapeutic candidates and exposure to foreign currency exchange rate fluctuations;

natural disasters, political and economic instability, including wars, terrorism and political unrest, outbreak of disease;

expenses including, among others, expenses for travel, translation and insurance;

and compliance risks that relate to anti-corruption compliance and record-keeping that may fall within the purview of the U.S.

Corrupt Practices Act, its accounting provisions or its anti-bribery provisions or provisions of anti-corruption or anti-bribery

laws in other countries.

conflicting and changing laws and regulations such as privacy regulations, tax laws, export

and import restrictions, employment laws, regulatory requirements and other governmental

approvals, permits and licenses;

failure by us to obtain

and maintain regulatory approvals for the use of our products in various countries;

rejection or qualification

of foreign clinical trial data by the competent authorities of other countries;

delays or interruptions

of clinical trial due to backup at ethical committees and staff shortages causing delays in processing the trials at investigator

sites resulting in delayed and slow patient enrollment.

additional potentially

relevant third-party patent and other intellectual property rights;

complexities and difficulties

in obtaining, maintaining, protecting and enforcing our intellectual property;

difficulties in staffing

and managing foreign operations;

complexities associated

with managing multiple payor reimbursement regimes, government payors or patient self-pay systems;

limits in our ability to

penetrate international markets;

financial risks, such as

longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and

payment for our therapeutic candidates and exposure to foreign currency exchange rate fluctuations;

natural disasters, political

and economic instability, including wars, terrorism and political unrest, outbreak of disease;

certain expenses including,

among others, expenses for travel, translation and insurance;

regulatory and compliance

risks that relate to anti-corruption compliance and record-keeping that may fall within the purview of the U.S.

Foreign Corrupt Practices

Act, its accounting provisions or its anti-bribery provisions or provisions of anti-corruption or anti-bribery laws in other countries.

of these factors could harm our future international expansion and operations and, consequently, our results of operations.

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to unknown liabilities;

of our business and diversion of our management’s and technical personnel’s time and attention to develop acquired therapeutic

candidates or technologies;

of substantial debt or dilutive issuances of securities to pay for acquisition costs;

than expected acquisition costs;

amortization expenses.

disruption of our business

and diversion of our management’s and technical personnel’s time and attention to develop acquired therapeutic candidates

or technologies;

incurrence of substantial

debt or dilutive issuances of securities to pay for acquisition costs;

higher than expected acquisition

increased amortization

therapeutic candidate that we acquire may require additional development efforts prior to commercial sale or out-licensing, including

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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

sublicensing of patent and other rights under our collaborative development relationships;

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

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

and us and our partners;

the extent to which our

technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;

the sublicensing of patent

and other rights under our collaborative development relationships;

our diligence obligations

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

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

use of intellectual property by our licensors and us and our partners;

priority of invention of patented technology.

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and may not adequately protect our business or permit us to maintain our competitive advantage.

on applicable law, we, or our license partners or current or future collaborators, might not have been the first to invent or file

patent applications for or may have derived from a later-filed patent application the inventions covered by the issued patent or

pending patent applications that we license or may own in the future;

may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our owned or

in-licensed intellectual property rights;

is possible that some or all of our owned and in-licensed pending patent applications or those we may own or in-license in the future

will not result in issued patents or the claims that issue may be narrow in scope and not provide us with a competitive advantage,

including as a result of actions by our competitors;

patents that we hold rights to may be held invalid or unenforceable, including as a result of legal challenges by our competitors;

competitors might conduct research and development activities in countries where we do not have patent rights and then use the information

learned from such activities to develop competitive products for sale in our major commercial markets;

may not develop additional proprietary technologies or investigational products that are patentable or protectable as a trade secret;

patents of others may harm our business, including by preventing us from discovering, developing or commercializing our investigational

we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third-party may subsequently file a patent covering such intellectual property or may independently develop such trade secret and be free to exploit it.

on applicable law, we, or our license partners or current or future collaborators, might

not have been the first to invent or file patent applications for or may have derived from

a later-filed patent application the inventions covered by the issued patent or pending patent

applications that we license or may own in the future;

others may independently

develop similar or alternative technologies or duplicate any of our technologies without infringing our owned or in-licensed intellectual

property rights;

it is possible that some

or all of our owned and in-licensed pending patent applications or those we may own or in-license in the future will not result in

issued patents or the claims that issue may be narrow in scope and not provide us with a competitive advantage, including as a result

of actions by our competitors;

issued patents that we

hold rights to may be held invalid or unenforceable, including as a result of legal challenges by our competitors;

our competitors might conduct

research and development activities in countries where we do not have patent rights and then use the information learned from such

activities to develop competitive products for sale in our major commercial markets;

we may not develop additional

proprietary technologies or investigational products that are patentable or protectable as a trade secret;

the patents of others may

harm our business, including by preventing us from discovering, developing or commercializing our investigational products;

we may choose not to file

a patent in order to maintain certain trade secrets or know-how, and a third-party may subsequently file a patent covering such intellectual

property or may independently develop such trade secret and be free to exploit it.

any of these events occur, they could have a material adverse effect on our business, financial condition, results of operations, and

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Form 10-Q for the quarterly periods ended March 31 and June 30, 2022.

On August 23, 2022 we received

a letter from Nasdaq Regulation advising that we were not in compliance with the Nasdaq Listing Rules (the “Rules”) for failing

to file our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2022.

We were given 60 days to submit a plan to regain

compliance and, if our plan is accepted by Nasdaq, we may be granted an exception of up to 180 calendar days, or until February 20, 2023,

to regain compliance.

August 23, 2022 we received a letter from Nasdaq Regulation advising that we were not in compliance with the Nasdaq Listing Rules (the

“Rules”) for failing to file our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2022.

We were given

60 days to submit a plan to regain compliance and, if our plan is accepted by Nasdaq, we may be granted an exception of up to 180 calendar

days, or until February 20, 2023, to regain compliance.

On October 7, 2022, we filed the delinquent Form 10-Q and regained compliance.

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but there is no assurance that we will be able to satisfy the listing requirements for the Nasdaq Capital Market.

On December 20, 2022, the

Company received a notification letter from Nasdaq Regulation of non-compliance with the Rules requiring listed securities to maintain

a minimum market value of publicly held shares of $5,000,000 and if the Company does not regain compliance with the Rule prior to the

expiration of the compliance period on June 19, 2023, it will receive written notification that its securities are subject to delisting.

December 20, 2022, the Company received a notification letter from Nasdaq Regulation of non-compliance with the Rules requiring listed

securities to maintain a minimum market value of publicly held shares of $5,000,000 and if the Company does not regain compliance with

the Rule prior to the expiration of the compliance period on June 19, 2023, it will receive written notification that its securities

are subject to delisting.

February 8, 2023, the Company received a notification letter from Nasdaq notifying the Company that due to the resignation of Soren G.

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held before August 3, 2023, then the Company must evidence compliance no later than August 3, 2023.

we fail to meet the Nasdaq listing requirements and do not regain compliance, we will be subject to delisting by Nasdaq.

our common stock is no longer listed for trading on The Nasdaq Global Market and we are unable to transfer to The Nasdaq Capital Market,

our trading volume and share price may decrease and you may have a difficult time selling your shares of common stock.

In addition, we

may experience difficulties in raising capital which could materially adversely affect our operations and financial results.

delisting from Nasdaq markets could also have other negative effects, including potential loss of confidence by partners, lenders, suppliers

and employees.

Finally, delisting could make it harder for you and the Company to sell the securities and hard for us to raise capital.

Series C Preferred Stock has super-voting power.

of the date of this report, we had 30,000,000 shares of common stock, 10,650 shares of Series A Preferred Stock and 50,000 shares of

Series B Preferred Stock issued and outstanding.

Each share of common stock is entitled to one vote per share, and each share of Series

C Preferred Stock is entitled to six hundred twenty (620) votes.

The Series A Preferred Stock do not have any voting rights.

otherwise required or limited by law, and our Certificate of Incorporation, as amended (“Certificate of Incorporation”) and/or

Certificate of Designation for the Series C Preferred Stock (“COD”), the holders of common stock and Series C Preferred Stock

are entitled to vote as a single class, only on proposals relating to authorized share increase, and reverse stock split (“Amendment

As of the date of this report, based on 50,000 shares of Series C Preferred Stock outstanding, the holder of

Series C Preferred Stock had voting power equal to approximate 50.8% of the voting power.

Therefore, to the extent the voting rights

of Series C Preferred Stock are not otherwise extinguished or redeemed, as the case may be, or limited to vote only the Amendment Proposals,

certain matters requiring stockholder approval may be achieved with only the votes of the Series C Preferred Stock, which limits the

weight of voting rights of a holder of common stock.

June 6, 2023, we received a letter from the Nasdaq hearings panel that granted the Company’s request for continued listing on the

Nasdaq Stock Market LLC until July 1, 2023, and the Company’s transfer to The Nasdaq Capital Market, subject to the following conditions:

(1) on or before July 1, 2023, the Company demonstrates compliance with Nasdaq Listing Rule 5450(b)(1) dealing with primary equity securities

listed on the Global Market, and on or before July 1, 2023, the Company demonstrates compliance with Nasdaq Listing Rule 5450(a)(1) dealing

with a minimum bid of $1.00 per share.

On June 14, 2023, we received a clarification letter from Nasdaq granting the Company’s

request for continued listing on The Nasdaq Capital Market and transfer to The Nasdaq Capital Market, subject to the following:

or before July 10, 2023, the Company demonstrates compliance with Listing Rule 5550(a)(2);

and (2) on or before July 14, 2023, the Company

demonstrates compliance with Listing Rule 5550(b).

July 14, 2023, the Company received a letter from Nasdaq confirming that the Company has regained compliance with the bid price and equity

concerns, as required by the Nasdaq hearings panel decision dated June 6, 2023, as amended.

The Company is subject to a panel monitor

for a period of one year from the July 14, 2023, letter pursuant to Nasdaq Listing Rule 5815(d)(4)(B), which includes continued compliance

with the stockholders’ equity requirement and other continued listing requirements.

Failure to meet the stockholders’ equity

requirement of $2,500,000 would result in immediate delisting, subject to the Company’s right to appeal.

As of June 30, 2023, the

Company had a stockholders’ deficit of $723,000.

Subsequent to June 30, 2023, on July 10, 2023, the Company completed a public

offering of common stock or pre-funded warrants and warrants to purchase common stock raising gross proceeds of approximately $11 million.

After giving effect to the July 10, 2023, public offering, the Company’s stockholders’ equity as of June 30, 2023, on a pro

forma basis, was $4.355 million.

As of September 30, 2023, the Company had a stockholders’ deficit and will need to raise capital

in order to meet Nasdaq’s stockholders’ equity requirement.

October 27, 2023, we received notification from Nasdaq that it has determined that the bid price of our Common Stock had closed at less

than $1 per share over the previous 30 consecutive business days, and, as a result, did not comply with Listing Rule 5550(a)(2).

Nasdaq also noted that we effected a 1:35 reverse stock split on March 24, 2023, and a 1:40 reverse stock split on June 28, 2023.

we effected one or more reverse stock splits over the prior two-year period with a cumulative ratio of 250 shares or more to one, we

will not be afforded a 180-calendar day period to demonstrate compliance with the Listing Rule 5550(a)(2) pursuant to Listing Rule 5810(c)(3)(A)(iv).

that regard, unless we requested an appeal from such determination, trading of our Common Stock would have been suspended at the opening

of business on November 7, 2023, and a Form 25-NSE would have been filed with the SEC which would have removed our Common Stock from

listing and registration on The Nasdaq Stock Market.

We filed a notice of appeal and received a hearing date of February 1, 2024.

such appeal, our Common Stock will continue to be listed on The Nasdaq Capital Market.

On November 16, 2023, we received an additional

notification indicating that the Company’s stockholders’ equity as reported in its Quarterly Report on Form 10-Q for the

period ended September 30, 2023, did not satisfy the continued listing requirement under Nasdaq Listing Rule 5810(c)(3) which serves

as an additional basis for delisting.

The Company intends to present its views with respect to this additional deficiency at the Panel

Hearing on February 1, 2024.

November 2023, we received correspondence from Nasdaq Regulatory Compliance seeking more information surrounding our determination that

our April and July 2023 offerings were deemed “Public Offerings” within the meaning of Listing Rule IM5635-3 to avoid shareholder

approval for such offerings.

We provided our response to Nasdaq Regulatory Compliance’s questions.

In November 2023, we received

additional correspondence from Nasdaq Regulatory Compliance seeking information in connection with the issuance of warrants in September

2023 pursuant to inducement letters sent to holders of public warrants issued in the April and July 2023 public offerings.

that our April and July 2023 offerings were public offerings within the meaning of Listing Rule IM 5635-3, and that the issuance of the

warrants in September 2023 was structured in manner that such issuance did not require shareholder approval.

In this regard, we sought

advice from consultants in structuring these issuances to comply with Nasdaq Listing Rules.

No assurance can be given that Nasdaq Regulatory

Compliance will agree with our analysis and determine that the April and July 2023 public offerings and issuance of the September 2023

warrants required shareholder approval.

If Nasdaq Listing Qualifications determines that we should have sought shareholder approval for

the April and July 2023 public offerings and September 2023 warrant issuance, we may be subject to delisting.

February 1, 2024 we attended a hearing with Nasdaq to present our case for extending the time we have to achieve minimum listing status.

We are awaiting the outcome of that hearing.

addition, if we fail to meet the Nasdaq listing requirements and do not regain compliance, we will be subject to delisting by Nasdaq.

In the event our common stock is no longer listed for trading on The Nasdaq Global Market and we are unable to transfer to The Nasdaq

Capital Market, our trading volume and share price may decrease and you may have a difficult time selling your shares of common stock.

In addition, we may experience difficulties in raising capital which could materially adversely affect our operations and financial results.

Further, delisting from Nasdaq markets could also have other negative effects, including potential loss of confidence by partners, lenders,

suppliers and employees.

Finally, delisting could make it harder for you and the Company to sell the securities and hard for us to raise

our business developments and achievements do not meet the expectations of investors or securities analysts or for other reasons the

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regulatory decisions;

delay in our regulatory filings for our therapeutic candidates and any adverse development or perceived adverse development with

respect to the applicable regulatory authority’s review of such filings, including without limitation the FDA’s issuance

of a “refusal to file” letter or a request for additional information;

impacts of the ongoing COVID-19 pandemic and related restrictions as they may related to our clinical trials;

commencement, enrollment or results of any future clinical trials we may conduct, or changes in the development status of our therapeutic

results from, delays in or termination of clinical trials;

unanticipated

serious safety concerns related to the use of our therapeutic candidates;

than expected market acceptance of our therapeutic candidates following approval for commercialization, if approved;

in financial estimates by us or by any securities analysts who might cover our securities;

or trends in our industry;

in the market valuations of similar companies;

market price and volume fluctuations of comparable companies and, in particular, those that operate in the biopharmaceutical industry;

of research reports about us or our industry or positive or negative recommendations or withdrawal of research coverage by securities

announcements

by us or our competitors of significant acquisitions, strategic partnerships or divestitures;

announcements

of investigations or regulatory scrutiny of our operations or lawsuits filed against us;

general perception of our business prospects or management;

or departure of key personnel;

performance of the equity markets;

volume of our common stock;

or other developments relating to intellectual property rights, including patents, litigation matters and our ability to obtain,

maintain, defend, protect and enforce patent and other intellectual property rights for our technologies;

lawsuits, including patent or stockholder litigation;

changes to healthcare laws in the U.S.

any delay in our regulatory

filings for our therapeutic candidates and any adverse development or perceived adverse development with respect to the applicable

regulatory authority’s review of such filings, including without limitation the FDA’s issuance of a “refusal to

file” letter or a request for additional information;

the impacts of the ongoing COVID-19 pandemic

and related restrictions as they may related to our clinical trials;

the commencement, enrollment

or results of any future clinical trials we may conduct, or changes in the development status of our therapeutic candidates;

adverse results from, delays

in or termination of clinical trials;

unanticipated serious safety

concerns related to the use of our therapeutic candidates;

lower than expected market

acceptance of our therapeutic candidates following approval for commercialization, if approved;

changes in financial estimates

by us or by any securities analysts who might cover our securities;

conditions or trends in

our industry;

changes in the market valuations

of similar companies;

stock market price and

volume fluctuations of comparable companies and, in particular, those that operate in the biopharmaceutical industry;

publication of research

reports about us or our industry or positive or negative recommendations or withdrawal of research coverage by securities analysts;

announcements by us or

our competitors of significant acquisitions, strategic partnerships or divestitures;

announcements of investigations

or regulatory scrutiny of our operations or lawsuits filed against us;

investors’ general

perception of our business prospects or management;

recruitment or departure

of key personnel;

overall performance of

the equity markets;

trading volume of our common

or other developments relating to intellectual property rights, including patents, litigation

matters and our ability to obtain, maintain, defend, protect and enforce patent and other

intellectual property rights for our technologies;

significant lawsuits, including

patent or stockholder litigation;

proposed changes to healthcare

laws in the U.S.

or foreign jurisdictions, or speculation regarding such changes;

political and economic conditions;

events or factors, many of which are beyond our control.

general political and economic

other events or factors,

many of which are beyond our control.

addition, in the past, stockholders have initiated class action lawsuits against biopharmaceutical and biotechnology companies following

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of our common stock by our stockholders, executives, and directors;

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

ability to obtain financings to conduct and complete research and development activities including, but not limited to, our proposed

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 drugs by 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;

lack of market acceptance and sales growth for our therapeutic candidates, if any, that receive marketing approval;

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 therapeutic candidates or any future clinical trials we may conduct;

in the development status of our therapeutic candidates;

delays or adverse developments or perceived adverse developments with respect to the FDA’s review of our planned NDA, PMA and

clinical trials;

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

for our therapeutic candidates;

unanticipated

safety concerns related to the use of our therapeutic candidates;

to meet external expectations or management guidance;

in our capital structure or dividend policy and future issuances of securities;

of large blocks of common stock by our stockholders, including, but not limited to, sales by 3i, LP as a result of the exercise of

the warrant issued in our PIPE Financing (“PIPE Warrant”) and conversion of Series A Preferred Stock into common stock

and the liquidation of the PIPE Financing, and exchange of outstanding secured promissory notes for common stock;

cash position;

announcements

and events surrounding financing efforts, including debt and equity securities;

inability to enter into new markets or develop new drugs;

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

announcements

of acquisitions, partnerships, collaborations, joint ventures, new drugs, 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;

and additions of key personnel;

and litigations related to intellectual properties, proprietary rights, and contractual obligations;

in applicable laws, rules, regulations, or accounting practices and other dynamics;

events or factors, many of which may be out of our control.

volatility and limitations

in trading volumes of our shares of common stock;

our ability to obtain financings

to conduct and complete research and development activities including, but not limited to, our proposed clinical trials, and other

business activities;

possible delays in the

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

the timing and success

of introductions of new drugs by our competitors or any other change in the competitive dynamics of our industry, including consolidation

among competitors, customers or strategic partners;

network outages or security

the lack of market acceptance

and sales growth for our therapeutic candidates, if any, that receive marketing approval;

our 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 therapeutic candidates or any future clinical trials we may conduct;

changes in the development

status of our therapeutic candidates;

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

review of our planned NDA, PMA and clinical trials;

any delay in our submission

for studies or drug approvals or adverse regulatory decisions, including failure to receive regulatory approval for our therapeutic

unanticipated safety concerns

related to the use of our therapeutic candidates;

failures to meet external

expectations or management guidance;

changes in our capital

structure or dividend policy and future issuances of securities;

sales of large blocks of

common stock by our stockholders, including, but not limited to, sales by 3i, LP as a result of the exercise of the warrant issued

in our PIPE Financing (“PIPE Warrant”) and conversion of Series A Preferred Stock into common stock and the liquidation

of the PIPE Financing, and exchange of outstanding secured promissory notes for common stock;

our cash position;

announcements and events

surrounding financing efforts, including debt and equity securities;

our inability to enter

into new markets or develop new drugs;

reputational issues;

competition from existing

technologies and drugs or new technologies and drugs that may emerge;

announcements of acquisitions,

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

changes in general economic,

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

changes in industry conditions

or perceptions;

changes in valuations of

similar companies or groups of companies;

analyst research reports,

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

departures and additions

of key personnel;

disputes and litigations

related to intellectual properties, proprietary rights, and contractual obligations;

changes in applicable laws,

rules, regulations, or accounting practices and other dynamics;

other events or factors,

many of which may be out of our control.

addition, if the market for stocks in our industry or industries related to our industry, or the stock market in general, experiences

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related registration rights agreement.

We are authorized to issue

up to 500,000 shares of preferred stock, 20,000 shares of which have been designated as Series A Preferred Stock and sold in connection

with the PIPE Financing, 200,000 shares of Series B Preferred Stock of which all of the 190,786 shares of Series B Preferred Stock issued

have been redeemed, and 50,000 shares of which has been designated as Series C Preferred Stock and sold in a private placement.

issue a series of preferred stock that could, depending on the terms of the series, impede or discourage an acquisition attempt or other

transaction that some, or a majority, of the holders of our common stock might believe to be in their best interests or in which the holders

of our common stock might receive a premium over the market price of the common stock.

Additionally, the issuance of preferred stock may

adversely affect the rights of holders of our common stock by restricting dividends on our common stock, diluting the voting power of

our common stock or subordinating the liquidation rights of our common stock.

If certain defined “triggering

events” defined in the Certificate of Designations occur, such as a breach of the Registration Rights Agreement, suspension of trading,

or our failure to convert the Series A Preferred Stock into common stock when a conversion right is exercised, failure to issue our common

stock when the PIPE Warrant is exercised, failure to declare and pay to any holder any dividend on any dividend date, certain defaults

on our debts or contractual obligations, or upon a “bankruptcy triggering event” (as defined in the Certificate of Designations),

then we may be required to pay a dividend that is added to the stated value on the Series A Preferred Stock in the amount of 18% per annum,

but paid quarterly in cash, so long as the triggering event is continuing, or to redeem the Series A Preferred Stock for cash in an amount

of 125% of the stated value of the Series A Preferred Stock and in the event that we experience a “Change of Control” (as

defined in the Certificate of Designations) we may also be required to redeem the Shares at a premium of 125% of their stated value.

addition, if thirty days after our common stock commences trading on Nasdaq the average daily dollar volume for the 10 days previous to

conversion divided by 10 is less than $2,500,000, then the Series A Preferred Stock shall be entitled to a one-time dividend equal to

an 8% increase in the stated value of the Preferred Share, or an $80 increase per share in stated value, resulting in a stated value of

$1,080 per Preferred Share.

This dividend was paid during the first quarter of 2022.

are authorized to issue up to 500,000 shares of preferred stock, 20,000 shares of which have been designated as Series A Preferred Stock

and sold in connection with the PIPE Financing, 200,000 shares of Series B Preferred Stock of which all of the 190,786 shares of Series

B Preferred Stock issued have been redeemed, and 50,000 shares of which has been designated as Series C Preferred Stock and sold in a

private placement.

We could issue a series of preferred stock that could, depending on the terms of the series, impede or discourage

an acquisition attempt or other transaction that some, or a majority, of the holders of our common stock might believe to be in their

best interests or in which the holders of our common stock might receive a premium over the market price of the common stock.

Additionally,

the issuance of preferred stock may adversely affect the rights of holders of our common stock by restricting dividends on our common

stock, diluting the voting power of our common stock or subordinating the liquidation rights of our common stock.

certain defined “triggering events” defined in the Certificate of Designations occur, such as a breach of the Registration

Rights Agreement, suspension of trading, or our failure to convert the Series A Preferred Stock into common stock when a conversion right

is exercised, failure to issue our common stock when the PIPE Warrant is exercised, failure to declare and pay to any holder any dividend

on any dividend date, certain defaults on our debts or contractual obligations, or upon a “bankruptcy triggering event” (as

defined in the Certificate of Designations), then we may be required to pay a dividend that is added to the stated value on the Series

A Preferred Stock in the amount of 18% per annum, but paid quarterly in cash, so long as the triggering event is continuing, or to redeem

the Series A Preferred Stock for cash in an amount of 125% of the stated value of the Series A Preferred Stock and in the event that

we experience a “Change of Control” (as defined in the Certificate of Designations) we may also be required to redeem the

Shares at a premium of 125% of their stated value.

In addition, if thirty days after our common stock commences trading on Nasdaq the

average daily dollar volume for the 10 days previous to conversion divided by 10 is less than $2,500,000, then the Series A Preferred

Stock shall be entitled to a one-time dividend equal to an 8% increase in the stated value of the Preferred Share, or an $80 increase

per share in stated value, resulting in a stated value of $1,080 per Preferred Share.

This dividend was paid during the first quarter

May 4, 2022, the Company and the Investor entered into a Forbearance Agreement and Waiver, dated April 27, 2022, wherein the Investor

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Section 4(c)(ii) of the PIPE Warrant that may have arisen prior to the date of the Forbearance Agreement and Waiver.

connection with the private placement of Series C Preferred Stock (“Series C Offering”), we also entered into a registration

rights agreement with 3i, LP (“Series C RRA”).

Under the Series C RRA and Certificate of Designation for the Series C Preferred

Stock we have obligations and are subject to terms similar to provisions of the Registration Rights Agreement and the Certificate of

Designation for the Series A Preferred Stock.

addition, under the Series C Offering and PIPE Financing, we are under an obligation to use our best efforts to call a meeting of stockholders

to seek stockholder approval for the Amendment Proposals.

Since we do not have authorized shares of common stock reserved to be issued

upon the potential conversion of the Series A Preferred Stock and exercise of PIPE Warrant, we are in technical default under the terms

of the Certificate of Designation for the Series A Preferred Stock and PIPE Warrant, which we have obtained a waiver from 3i, LP in connection

with any default arising in connection with the Series C Preferred Stock.

As a result of these or other

factors, the issuance of preferred stock could diminish the rights of holders of our common stock, or delay or prevent a change of control

of the Company and could have an adverse impact on the market price of our common stock.

a result of these or other factors, the issuance of preferred stock could diminish the rights of holders of our common stock, or delay

or prevent a change of control of the Company and could have an adverse impact on the market price of our common stock.

sales, or the perception of future sales, by us or our stockholders in the public market could cause the market price for our common

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us to sell equity securities in the future at a time and at a price that it deems appropriate.

Our Certificate of Incorporation,

as amended, authorizes capital stock consisting of 30,000,000 shares of common stock, par value $0.0001 per share, and 500,000 shares

of preferred stock, par value $0.0001 per share.

We held a meeting on February 3, 2023, to among other things have our stockholders vote

for (i) proposals to approve an amendment to our Certificate of Incorporation to increase the number of authorized shares from 30,500,000

to 150,500,000, and to increase the number of our common stock from 30,000,000 to 150,000,000, and (ii) a proposal to approve an amendment

to our Certificate of Incorporation to approve a reverse stock split.

Such proposals were not approved by our stockholders.

of March 3, 2023, we have issued all of our authorized shares of common stock.

We are scheduled to hold a Special Meeting of Stockholders

on March 20, 2023 (the “Special Meeting”) to approve the following proposals:

(1) to approve an amendment to our Certificate

of Incorporation to increase the number of authorized shares from 30,500,000 to 750,500,000, and to increase the number of our common

stock from 30,000,000 to 750,000,000 (the “Share Increase Proposal”), and (2) to approve an amendment to our Certificate

of Incorporation to effect a reverse stock split with respect to the Company’s issued and outstanding common stock, par value $0.0001

per share, at a ratio between 1-for-20 and 1-for-35 (the “Range”), with the ratio within such Range to be determined at the

discretion of the Board (the “Reverse Stock Split Proposal”) and included in a public announcement (collectively, the “Amendment

Such amendments are subject to the approval of our stockholders at our Special Meeting and will only become effective

upon receipt of the requisite approval.

If the proposals are approved, we will have additional shares of common stock available for issuance

from time to time, and the authority to issue additional shares of common stock.

As of the date of this report,

we had 30,000,000 authorized shares of Common Stock, $0.0001 par value per share, of which 30,000,000 shares were issued and outstanding;

and 500,000 authorized shares of preferred stock, $0.0001 par value, of which 10,650 shares of Series A Preferred Stock and 50,000 shares

of Series C Preferred Stock were issued and outstanding.

As of the date of this report, we do not have sufficient shares of Common

Stock authorized for the following:

2,018,958 shares for the issuance upon the exercise of issued and outstanding PIPE Warrant based on

initial exercise price, 676,949 shares for issuance upon the exercise of issued and outstanding equity awards, 1,960,266 shares to be

reserved for future issuance under our 2021 Equity Incentive Plan (“2021 Plan”), and additional shares for issuance upon the

conversion of remaining outstanding shares of Series A Preferred Stock.

However, if the Amendment Proposals are approved we will have

to reserve the foregoing and such shares will be available for issuance, which issuances will result in dilution to our stockholders.

In addition, we expect to file one or more registration statements on Form S-1 for the shares of common stock issuable upon conversion

of Series C Preferred Stock and we have ongoing obligations for the registration of the shares of common stock issuable upon conversion

of the remainder Series A Preferred Stock and exercise of the PIPE Warrant.

In addition, we expect to file one or more registration statements

on Form S-8 under the Securities Act to register shares of our common stock or securities convertible into or exchangeable for

shares of our common stock issued pursuant to our 2021 Plan.

Any such registration statements on Form S-8 will automatically become effective

Accordingly, shares registered under such registration statements will be available for sale in the open market.

the future, we may also issue our securities in connection with investments or acquisitions.

The amount of shares of our common stock

issued in connection with an investment or acquisition could constitute a material portion of our then-outstanding shares of common stock.

Any issuance of additional securities in connection with investments or acquisitions may result in additional dilution to our stockholders.

We do not have authorized shares of common

stock available for issuance, which limits our ability to satisfy our contractual obligations and limit our ability to seek equity financing

which may cause us to be unable to continue operations.

As of the date of this report,

we have issued all of our authorized shares of common stock.

As mentioned above, we are schedule to hold a Special Meeting to seek the

required stockholder approval for the Share Increase Proposal and Reverse Stock Split Approval.

If the stockholders do not approve such

proposals, we will not have shares of common stock authorized available and reserved, this could trigger a right of redemption under the

Certificate of Designations for the Series A Preferred Stock, and other adjustments and rights under existing agreements with 3i, L.P.

In addition, this could adversely impact our ability to pursue opportunities in which shares of our common stock could be issued that

our Board may determine would otherwise be in the best interest of the Company and our stockholders, including financing and strategic

transaction opportunities and employee recruitment and retention purposes.

Failure to obtain equity financing through the issuance of

our securities, including our common stock, may cause us to be unable to continue our operations.

of January 18, 2024, we had (i) 1,417 shares of Series A Preferred Stock outstanding that could be converted into 3,419,035 shares of

Common Stock based upon a conversion price of $0.4476 and stated value of $1,080, subject to adjustment, (ii) 255,556 shares of Common

Stock issuable upon exercise of warrants to purchase shares of Common Stock at an exercise price of $1.00 per share which were issued

in a public offering that closed in April 2023 and July 2023;

(iii) 9,846,339 shares of Common Stock issuable upon exercise of a warrant

to purchase Common Stock at an exercise price of $0.4476 per share issued pursuant to a Modification and Exchange Agreement dated April

20, 2023, as amended, and (iv) 4,877,778 shares of Common Stock issuable upon exercise of warrants to purchase shares of Common Stock

at an exercise price of $1.00 per share issued to the September Investors.

The holder of the Series A Preferred Stock and holders of

our warrants may convert, exercise or exchange their securities into shares of Common Stock, which sales thereof could adversely affect

the market price of shares of our Common Stock, and dilute stockholders ownership of our Common Stock.

there are no current plans to pay cash dividends on shares of our Common Stock for the foreseeable future, you may not receive any return

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may incur substantial penalties if we fail to maintain the effectiveness of our registration statement covering the resale of our Common

stock issued to 3i, LP upon conversion of our Series A Preferred Stock.

Under the terms of the Registration

Rights Agreement entered into in connection with the PIPE Financing, or Series A RRA, with 3i, LP, if we fail to maintain the effectiveness

of the registration statement beyond defined allowable grace periods, we will incur certain registration delay payments equal to 2% of

3i, LP’s investment that has not yet been converted to common stock and sold pursuant to the registration statement upon our failure

to maintain the effectiveness of the registration statement and every 30 days thereafter.

As a result of the Company’s delay in

filing its periodic reports with the SEC, a Triggering Event under Section 5(a)(ii) occurred on or about April 29, 2022, and that in consideration

for the Registration Delay Payments that the Company was obligated to pay under the Series A RR, and additional amounts the Company was

obligated to pay under the Certificate of Designations together with 3i, LP’s legal fees incurred in the preparation of the Forbearance

Agreement and Waiver, the Company agreed to pay 3i, LP an aggregate amount of $538,823.00 which was paid pursuant to that certain Forbearance

Stock issued to 3i, LP upon conversion of our Series A Preferred Stock, and the Common Stock issuable upon the exercise of the Inducement

Warrants by the September Investors.

the terms of the First Amendment to Registration Right Agreement with 3i, L.P.

dated April 20, 2023 (“Amended RRA”) with

3i, LP, if we fail to maintain the effectiveness of the registration statement beyond defined allowable grace periods, we will incur

certain registration delay payments equal to 2% of 3i, LP’s investment that has not yet been converted to Common Stock and sold

pursuant to the registration statement upon our failure to maintain the effectiveness of the registration statement and every 30 days

For example, as a result of the Company’s delay in filing its periodic reports with the SEC in 2022, a Triggering Event

under Section 5(a)(ii) of the Original Series A COD, occurred on or about April 29, 2022, and that in consideration for the Registration

Delay Payments that the Company was obligated to pay under the Amended RRA, and additional amounts the Company was obligated to pay under

the Original Series A COD, together with 3i, LP’s legal fees incurred in the preparation of the Forbearance Agreement and Waiver

dated April 27, 2022, the Company agreed to pay 3i, LP an aggregate amount of $538,823 which was paid pursuant to that certain Forbearance

Agreement and Waiver with 3i, LP.

Failure to maintain the effectiveness of the registration statement also constitutes a “triggering

event” under the Certificate of Designations for the Series A Preferred Stock that would result in the accrual and payment of a

dividend and provide 3i, LP the right to have its remaining Series A Preferred Stock redeemed for a premium of 125% of the stated value

of the Series A Preferred Stock.

If 3i, LP were to exercise its option to redeem its Series A Preferred Stock, our available cash for

the development of our therapeutic candidates and for our continued operations would be materially and adversely effected.

In addition, if we fail to file a registration statement related to the Exchange Shares and Exchange

Warrants by a specific date pursuant to the Modification and Exchange Agreement, we will incur registration delay payments equal to 2%

of 3i, LP’s investment on the date of the filing failure and each thirty-day period thereafter until the filing failure is cured.

connection with the Inducement Warrants, we agreed to file a Resale Registration Statement on or before October 15, 2023, and to use

commercially reasonable efforts to have such Resale Registration Statement declared effective by the SEC within 90 days following the

date of the issuance of the Inducement Warrants and to keep the Resale Registration Statements effective at all times until no holder

of the Inducement Warrants owns any Inducement Warrants or Inducement Warrant Shares.

We also granted liquidated damages to the September

Investors in the event of (i) a Public Information Failure or (ii) a Stockholder Approval Failure, and the September Investors are unable

to sell their Inducement Warrant Shares.

In either event, or both events, we will be required to pay the September Investors an amount

in cash equal to 1.5% of the aggregate exercise price of the Inducement Warrants held by the Holder on the day of a Public Information

Failure and/or Stockholder Approval Failure and on every 30th day (pro rated for periods totaling less than 30 days) thereafter until

the Public Information Failure and Stockholder Approval Failure are cured.

is no assurance that an active and liquid trading market in our common stock will develop.

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a change in control, which may cause our stock price to decline.

Our Certificate of Incorporation

and our by-laws could make it more difficult for a third-party to acquire us, even if closing such a transaction would be beneficial to

our stockholders.

We are authorized to issue up to 500,000 shares of preferred stock, of which 20,000 shares have been designated as Series

A Preferred Stock, of which 10,650 shares are issued and outstanding;

200,000 shares have been designated as Series B Preferred Stock

of which 190,786 outstanding shares have been redeemed;

and 50,000 shares have been designated as Series C Preferred Stock, of which 50,000

shares are issued and outstanding.

The remaining preferred stock may be issued in one or more series, the terms of which may be determined

at the time of issuance by our Board of Directors without further action by stockholders.

The terms of any series of preferred stock may

include voting rights (including the right to vote as a series on particular matters), preferences as to dividend, liquidation, conversion

and redemption rights and sinking fund provisions.

The issuance of any preferred stock could materially adversely affect the rights of

the holders of our common stock, and therefore, reduce the value of our common stock.

In particular, specific rights granted to future

holders of preferred stock could be used to restrict our ability to merge with, or sell our assets to, a third-party and thereby preserve

control by the present management.

Certificate of Incorporation and our bylaws could make it more difficult for a third-party to acquire us, even if closing such a transaction

would be beneficial to our stockholders.

We are authorized to issue up to 500,000 shares of preferred stock, of which 20,000 shares have

been designated as Series A Preferred Stock, of which 1,417 are outstanding as of January 8, 2024, 200,000 shares have been designated

as Series B Preferred Stock, $0.0001 par value per share (“Series B Preferred Stock”) of which none are issued and outstanding,

and 50,000 shares have been designated as Series C Preferred Stock, none of which are issued and outstanding.

The remaining preferred

stock may be issued in one or more series, the terms of which may be determined at the time of issuance by our Board of Directors without

further action by stockholders.

The terms of any series of preferred stock may include voting rights (including the right to vote as

a series on particular matters), preferences as to dividend, liquidation, conversion and redemption rights and sinking fund provisions.

The issuance of any preferred stock could materially adversely affect the rights of the holders of our Common Stock, and therefore, reduce

the value of our Common Stock.

In particular, specific rights granted to future holders of preferred stock could be used to restrict

our ability to merge with, or sell our assets to, a third-party and thereby preserve control by the present management.

of our Certificate of Incorporation, by-laws and Delaware law also could have the effect of discouraging potential acquisition proposals

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for a classified board of directors;

the board of directors with the ability to alter the by-laws without stockholder approval;

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.

provide the board of directors

with the ability to alter the by-laws without stockholder approval;

establishing advance notice

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

provide 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 designates the Court of Chancery of the State of Delaware (or, if the Court of Chancery does not have jurisdiction,

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reporting obligations of being a public company in the United States require well defined disclosure and procedures and internal

control over financial reporting that Allarity A/S did not have as a Danish company and that are expensive and time-consuming requiring

our management to devote substantial time to compliance matters.

a publicly traded company in the U.S., we will continue to incur significant additional legal, accounting and other expenses that Allarity

A/S did not incur as a Danish company.

For example, as a Danish company with our ordinary shares listed on the Nasdaq First North Growth

Market in Stockholm, we were not required to have, and did not have, well defined disclosure controls and procedures and internal controls

over financial reporting that are generally required of U.S.

publicly held companies.

In connection with our review of our previously

existing internal controls as part of our preparations for becoming a U.S.

publicly traded company, we determined that our internal

control over financial reporting for prior periods were ineffective and included material weaknesses that needed to be remedied.

“ Risk Factors — We have identified material weaknesses in our internal controls over financial reporting.

are unable to remediate these material weaknesses, or if we identify additional material weaknesses in the future or otherwise fail to

maintain an effective system of internal controls, we may not be able to accurately or timely report our financial condition or results

of operations, which may adversely affect our business and stock price ” and “We have determined that our disclosure

controls and procedures were not effective based on the material weaknesses identified in our internal control over financial reporting

and our failure to timely file our period reports.” Although we have taken, and are continuing to take, additional steps to

remedy these material weaknesses in order to assure compliance with our future financial reporting obligations, there can be no assurance

that we will be able to do so in a timely manner or at all, or that additional material weaknesses may not exist.

control over financial reporting that that are expensive and time-consuming requiring our management to devote substantial time to compliance

reporting obligations associated with being a public company in the United States require significant expenditures and will place

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controls over financial reporting, our stock price could decline significantly and raising capital could be more difficult.

of the Sarbanes-Oxley Act requires annual management assessments of the effectiveness of our internal controls over financial reporting

after a transition period ending with our second annual report on Form 10-K filed under Section 13(a) of the Exchange Act.

If we fail to comply with the rules under the Sarbanes-Oxley Act related to disclosure controls and procedures in the future, or, if

in the future we discover additional material weaknesses and other deficiencies in our internal controls over financial reporting, our

stock price could decline significantly and raising capital could be more difficult.

may acquire other companies or technologies, which could divert our management’s attention, result in dilution to our stockholders

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to integrate or benefit from acquired technologies or services in a profitable manner;

unanticipated

costs or liabilities associated with the acquisition;

integrating the accounting systems, operations and personnel of the acquired business;

unanticipated costs or

liabilities associated with the acquisition;

difficulty integrating

the accounting systems, operations and personnel of the acquired business;

and additional expenses associated with supporting legacy drugs and hosting infrastructure of the acquired business;

converting the customers, if any, of the acquired business onto our platform and contract terms, including disparities in the revenue,

licensing, support or professional services model of the acquired company;

of management’s attention from other business concerns;

effects to our existing business relationships with business partners and customers as a result of the acquisition;

potential loss of key employees;

of resources that are needed in other parts of our business;

of substantial portions of our available cash to consummate the acquisition.

difficulty converting the

customers, if any, of the acquired business onto our platform and contract terms, including disparities in the revenue, licensing,

support or professional services model of the acquired company;

diversion of management’s

attention from other business concerns;

adverse effects to our

existing business relationships with business partners and customers as a result of the acquisition;

the potential loss of key

use of resources that are

needed in other parts of our business;

use of substantial portions

of our available cash to consummate the acquisition.

addition, a significant portion of the purchase price of companies we acquire may be allocated to acquired goodwill and other intangible

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to our operations or the operations of our collaborators and third-party providers.

In many jurisdictions, enforcement

actions and consequences for noncompliance are rising.

In the U.S., these include enforcement actions in response to rules and regulations

promulgated under the authority of federal agencies and state attorneys general and legislatures and consumer protection agencies.

addition, privacy advocates and industry groups have regularly proposed, and may propose in the future, self-regulatory standards that

may legally or contractually apply to us.

If we fail to follow these security standards, even if no customer information is compromised,

we may incur significant fines or experience a significant increase in costs.

Many state legislatures have adopted legislation that regulates

how businesses operate online, including measures relating to privacy, data security and data breaches.

Laws in all 50 states require

businesses to provide notice to customers whose personally identifiable information has been disclosed because of a data breach.

are not consistent, and compliance in the event of a widespread data breach is costly.

States are also constantly amending existing laws,

requiring attention to frequently changing regulatory requirements.

Furthermore, California recently enacted the California Consumer Privacy

Act (the “CCPA”), which became effective in January 2020.

The CCPA gives California residents expanded rights to access

and delete their personal information, opt out of certain personal information sharing and receive detailed information about how their

personal information is used.

The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches

that is expected to increase data breach litigation.

At this time, we do not collect personal data on residents of California, but should

we begin to do so, the CCPA will impose new and burdensome privacy compliance obligations on our business and will raise new risks for

potential fines and class actions.

many jurisdictions, enforcement actions and consequences for noncompliance are rising.

In the U.S., these include enforcement actions

in response to rules and regulations promulgated under the authority of federal agencies and state attorneys general and legislatures

and consumer protection agencies.

In addition, privacy advocates and industry groups have regularly proposed, and may propose in the

future, self-regulatory standards that may legally or contractually apply to us.

If we fail to follow these security standards, even

if no customer information is compromised, we may incur significant fines or experience a significant increase in costs.

Many state legislatures

have adopted legislation that regulates how businesses operate online, including measures relating to privacy, data security and data

Laws in all 50 states require businesses to provide notice to customers whose personally identifiable information has been

disclosed because of a data breach.

The laws are not consistent, and compliance in the event of a widespread data breach is costly.

are also constantly amending existing laws, requiring attention to frequently changing regulatory requirements.

Furthermore, California

recently enacted the California Consumer Privacy Act (the “CCPA”), which became effective in January 2020.

gives California residents expanded rights to access and delete their personal information, opt out of certain personal information sharing

and receive detailed information about how their personal information is used.

The CCPA provides for civil penalties for violations,

as well as a private right of action for data breaches that is expected to increase data breach litigation.

At this time, we do not collect

personal data on residents of California, but should we begin to do so, the CCPA will impose new and burdensome privacy compliance obligations

on our business and will raise new risks for potential fines and class actions.

data protection laws, including EU General Data Protection Regulation (the “GDPR”), may also apply to health-related and

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of investing in our common stock.

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