What changed in this filing

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Item 1A. Risk Factors

2026-03-26 compared with 2025-03-13 · 964 added, 2564 removed, 804 unchanged (81% of the section changed)

Risk Factors.

Investing in our common stock involves a high degree

Before you decide to invest in our common stock, you should consider carefully the risks described below, together with the other

information contained in this Report, including “Management’s Discussion and Analysis of Financial Condition and Results of

Operations” and our consolidated financial statements and related notes.

We believe the risks described below are the risks that

are material to us as of the date of this Report.

The occurrence of any of the events or developments discussed in the risk factors below

could have a material and adverse impact on our business, financial condition, results of operations and cash flows and, in such case,

our future prospects would likely be materially and adversely affected.

In these circumstances, the market price of our common stock could

decline, and you may lose all or part of your investment.

Risk Factor Summary

Below is a summary of material

factors that make an investment in our common stock speculative or risky.

Importantly, this summary does not address all of the risks

and uncertainties that we face and you should not consider this section to be a complete discussion of all potential risks or uncertainties

that may substantially impact our business.

Risks Related to Our Limited Operating History,

Financial Condition and Capital Requirements

· We have a limited operating history, have incurred

significant operating losses and expect to incur significant operating losses for the foreseeable future.

We have a high risk of never

generating revenue or becoming profitable or, if we achieve profitability, it may not be sustained.

· Our financial condition raises substantial doubt

as to our ability to continue as a going concern.

· We will require substantial additional capital

to finance our operations, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to

delay, limit, reduce or terminate our development programs, commercialization efforts or other operations.

· Raising additional capital may cause dilution

to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.

any capital obtained by us may be obtained on terms that are unfavorable to us, our investors, or both.

Risks Related to Clinical Development and Potential

Regulatory Approval

· We do not have, and may never have, any approved

products on the market.

Our business is highly dependent upon receiving approvals from various governmental agencies and will be severely

harmed if we are not granted approval to manufacture and sell our product candidates.

· We currently depend entirely on the success of

elraglusib, which is our only product candidate.

If we are unable to advance elraglusib in clinical development, obtain regulatory approval

and ultimately commercialize elraglusib in a timely manner, our business will be materially harmed.

· Even if we complete all planned clinical trials

including a Phase 3 trial in the future, there is no guarantee that at the time of submission the FDA will accept our NDA.

· Clinical and preclinical drug development involves

a lengthy and expensive process with uncertain timelines and outcomes, and results of prior preclinical studies and early clinical trials

are not necessarily predictive of future results.

Elraglusib or any future product candidates may not achieve favorable results or receive

regulatory approval on a timely basis, if at all.

· We may not be successful in our efforts to advance

elraglusib in additional indications.

We may expend our limited resources to pursue a new product candidate or a particular indication

for elraglusib and fail to capitalize on more profitable or successful alternatives.

· Use of elraglusib or any future product candidates

could be associated with side effects, adverse events or other properties or safety risks, which could delay or preclude regulatory approval,

cause us to suspend or discontinue clinical trials, abandon elraglusib or any future product candidate, limit the commercial profile of

an approved label or result in other significant negative consequences that could severely harm our business, financial condition, results

of operations and prospects.

· If we experience delays or difficulties in the

enrollment of subjects to our clinical trials, our receipt of necessary regulatory approvals could be delayed or otherwise adversely affected.

· Interim, topline, and preliminary data from our

clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit

and verification procedures that could result in material changes in the final data.

Risks Related to Our Reliance on Third Parties

· The termination of third-party licenses could

adversely affect our rights to important technologies.

· Our current elraglusib DS manufacturer is in

China, and it is unknown how current or future geopolitical relationships with China may affect our ability to obtain DS, increase our

costs, delay clinical trials and potential regulatory approval, and adversely impact our financial condition.

· We rely on third parties to conduct our non-clinical

studies and clinical trials.

If these parties do not successfully carry out their duties or meet deadlines, we may be unable to obtain

regulatory approval for or commercialize our product candidates and adversely affect our financial condition.

· Data provided by collaborators and other parties

upon which we rely have not been independently verified and could turn out to be inaccurate, misleading, or incomplete.

Risks Related to Commercialization of Elraglusib

and any Future Product Candidates

· We have a limited operating history and no products

approved for commercial sale, which may make it difficult to evaluate our prospects and likelihood of success.

· Our business is highly dependent on the success

of our lead product candidate, elraglusib, and any other future product candidates that we advance into clinical development, all of which

will require significant additional development before we can seek regulatory approval for and launch a product commercially.

Risks Related to Our Intellectual Property

· We may not be able to enforce our intellectual

property rights throughout the world.

· If we and our third-party licensors do not obtain

and preserve protection for key intellectual property rights, our competitors may be able to take advantage of our development efforts.

· If we fail to comply with our license, collaboration

or other intellectual property-related agreements, we may incur damages and could lose rights that may be necessary for developing, commercializing

and protecting our current or future technologies or drug candidates or granting sublicenses.

Risks Related to Our Business Operations and Industry

· If we lose key management leadership, and/or

scientific personnel, and if we cannot recruit qualified employees or other significant personnel, we may experience program delays and

increased compensation costs, and our business may be materially disrupted.

· Competition and technological change may make

our product candidates less competitive or obsolete.

· We face significant competition from other

biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.

· Our anticipated operating expenses and capital

expenditures are based upon our management’s estimates of possible future events.

Actual amounts could differ materially from those

Risks Associated to our Common Stock

· Concentration of ownership by our principal stockholders

limits the ability of others to influence the outcome of director elections and other transactions requiring stockholder approval, creates

the potential for conflicts of interest, may negatively impact our stock price and may deter or prevent efforts by others to acquire us,

preventing our stockholders from realizing a control premium.

· Current and new investors will experience dilution

due to future sales or issuances of our common stock.

· The trading price of the shares of our common

stock could be highly volatile regardless of our operating performance, and purchasers of our common stock could incur substantial losses.

· Numerous shares may now be sold into the open

market upon expiry of the IPO lock-up in February 2025.

Substantial sales of shares could cause the price of our common stock to decline.

Investing in our common

stock involves a high degree of risk.

Before you decide to invest in our common stock, you should consider carefully the risks described

below, together with the other information contained in this Report, including “Management’s Discussion and Analysis of Financial

Condition and Results of Operations” and our consolidated financial statements and related notes.

We believe the risks described

below are the risks that are material to us as of the date of this Report.

The occurrence of any of the events or developments discussed

in the risk factors below could have a material and adverse impact on our business, financial condition, results of operations and cash

flows and, in such case, our future prospects would likely be materially and adversely affected.

In these circumstances, the market price

of our common stock could decline, and you may lose all or part of your investment.

Risks Related to Our Limited Operating History, Financial Condition

and Capital Requirements

We have a limited operating history, have incurred

significant operating losses since our inception and expect to incur significant operating losses for the foreseeable future.

a high risk of never generating revenue or becoming profitable or, if we achieve profitability, it may not be sustained.

Biopharmaceutical product development

is a highly speculative undertaking and involves a substantial degree of risk.

We are a clinical-stage biopharmaceutical company with

a relatively limited operating history upon which you can evaluate our business and prospects.

We have a limited operating history, have

incurred significant operating losses since our inception and expect to incur significant operating losses for the foreseeable future.

We may never generate revenue or achieve profitability, and if we do achieve profitability, it may not be sustained.

Biopharmaceutical product

development is a highly speculative undertaking and involves a substantial degree of risk.

We are a clinical-stage biopharmaceutical company

with a relatively limited operating history upon which you can evaluate our business and prospects.

We commenced operations in January

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We have incurred losses since

our inception in January 2015 through December 31, 2024 and our accumulated deficit was approximately $132.4 million at December 31, 2024.

Substantially all of our losses have resulted from expenses incurred in connection with our research and development activities and from

general and administrative costs associated with our operations.

We expect to continue to incur substantial and increasing operating losses

over the next several years as we continue the clinical development of, seek regulatory approval for and potentially commercialize elraglusib

and any future product candidates, as well as operate as a public company.

The magnitude of our future losses

and when, if ever, we will become profitable are uncertain.

our inception and our accumulated deficit was approximately $154.6 million at December 31, 2025.

Substantially all of our losses have

resulted from expenses incurred in connection with our research and development activities and from general and administrative costs associated

with our operations.

We expect to continue to incur substantial and increasing operating losses over the next several years as we continue

the clinical development of, seek regulatory approval for and potentially commercialize elraglusib and any future product candidates,

as well as operate as a public company.

The magnitude of our future

losses and when, if ever, we will become profitable are uncertain.

We do not have any products that have generated any revenues from commercial

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develop, obtain requisite approval for and commercialize elraglusib or any future product candidates, we may never generate revenue.

ability to generate revenue and achieve profitability will depend on, among other things, successful completion of the development of

our product candidates;

obtaining necessary regulatory approvals from the FDA and international regulatory agencies;

establishing manufacturing,

sales, and marketing arrangements with third parties;

obtaining adequate reimbursement by third-party payers;

and raising sufficient funds

to finance our activities.

If we are unsuccessful at some or all of these undertakings, our business, financial condition, and results

of operations are expected to be materially and adversely affected.

ability to generate revenue and achieve profitability will depend on, among other things:

· successful completion of the development of our

product candidates;

· obtaining necessary regulatory approvals from

the FDA and international regulatory agencies;

· establishing manufacturing, sales, and marketing

arrangements with third parties;

· obtaining adequate reimbursement by third-party

· raising sufficient funds to finance our activities.

There can be no assurance

we will be successful in all or any of these undertakings.

If we are unsuccessful at some or all of these undertakings, our business,

financial condition, and results of operations are expected to be materially and adversely affected.

To become and remain profitable,

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

Our financial condition raises substantial doubt

as to our ability to continue as a going concern.

As of December 31, 2024, we had

approximately $8.6 million in cash and cash equivalents and working capital of approximately $0.4 million.

We will require substantial additional capital

to finance our operations, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to

delay, limit, reduce or terminate our development programs, commercialization efforts or our operations.

As of December 31, 2025,

we had approximately $13.2 million in cash and cash equivalents and working capital of approximately $7.9 million.

Based on our current

operating plan, we estimate that our existing cash and cash equivalents as of the date of this Report will not satisfy the Company’s

operational and capital requirements beyond July 2026.

Our estimates and assumptions regarding our operating costs may prove to be wrong,

and we could use our capital resources sooner than we currently expect.

Our operating plans and other demands on our cash resources may

change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned.

We have incurred and expect

to continue to incur significant costs in the development of our sole drug candidate, elraglusib.

Our consolidated financial statements

have been prepared assuming that we will continue to operate as a going concern, which contemplates the realization of assets and the

satisfaction of liabilities in the normal course of business.

To date, we have not generated product revenues from our activities and

have incurred substantial operating losses.

We expect that we will continue to generate substantial operating losses for the foreseeable

future until we complete development and approval of our product candidates.

We expect to continue to fund our operations primarily through

utilization of our current financial resources and additional raises of capital.

These conditions raise substantial

doubt about our ability to continue as a going concern.

Additionally, our independent registered public accounting firm included in its

Accordingly, in the near term, we intend

to seek and will need to continue to rely on additional financing to achieve our business objectives.

Adequate additional financing may

not be available to us on acceptable terms, or at all, including as a result of financial and credit market deterioration or instability,

market-wide liquidity shortages, geopolitical events or otherwise.

If we are unable to raise capital in the near term or on attractive

terms, we could be forced to delay, reduce or eliminate our research and development programs or any future commercialization efforts,

or even curtail or cease operations.

Even if we secure necessary financing in the near term, we expect to continue to require substantial

funding as the timing for and ability to generate sufficient funds from operations will remain uncertain until such time as we are able

to progress elraglusib through development and potential commercialization.

We expect to finance our cash

needs through public or private equity or debt financings or other capital sources, including potential collaborations, licenses, and

other similar arrangements.

However, as of the date of this Report, we have no agreements or understandings in place concerning our receipt

of additional financing.

The foregoing conditions raise

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

Our independent registered public accounting firm included in its

audit opinion for the year ended December 31, 2025 an explanatory paragraph that there is substantial doubt as to our ability to continue

as a going concern.

We plan to address these conditions by raising funds from public or private offerings of equity or debt securities

and other funding sources.

However, there can be no assurance that such funding will be available to us, will be obtained on terms favorable

to us or will provide us with sufficient funds to meet our objectives.

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

by our auditors and our potential inability to continue as a going concern may materially adversely affect our ability to raise new capital

or enter into partnerships.

If we become unable to continue as a going concern, we may have to liquidate our assets and the value we receive

for our assets in liquidation or dissolution could be significantly lower than the value reflected in our consolidated financial statements.

We will require substantial additional capital

to finance our operations, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to

delay, limit, reduce or terminate our development programs, commercialization efforts or other operations.

The development of biopharmaceutical

product candidates, including conducting preclinical studies and clinical trials, is a very time-consuming, capital-intensive and uncertain

Our operations have consumed substantial amounts of cash since inception.

We expect our expenses to substantially increase in

connection with our ongoing activities, particularly as we conduct our ongoing and planned clinical trials of elraglusib and potentially

seek regulatory approval for elraglusib and any future product candidates we may develop.

In addition, if we are able to progress elraglusib

through development and commercialization, we expect to be required to make milestone and royalty payments pursuant to various license

or collaboration agreements with third parties.

If we obtain regulatory approval for elraglusib or any future product candidates, we also

expect to incur significant commercialization expenses related to product manufacturing, marketing, sales, and distribution.

outcome of any clinical trial or preclinical study is highly uncertain, we cannot reliably estimate the actual amount of capital necessary

to successfully complete the development and commercialization of elraglusib or any future product candidates.

Furthermore, we incur additional

costs associated with operating as a public company.

Based on our current operating

plan, we believe that our existing cash and cash equivalents will not be sufficient to fund our operations for the twelve (12) months

following the date of this Report.

Our estimates and assumptions

regarding our operating costs may prove to be wrong, and we could use our capital resources sooner than we currently expect.

Our operating

plans and other demands on our cash resources may change as a result of many factors currently unknown to us, and we may need to seek

additional funds sooner than planned.

Our existing capital will not

be sufficient to complete development of elraglusib in any form, or any future product candidates, and we require substantial capital

in order to advance elraglusib and any future product candidates through clinical trials, regulatory approval and commercialization.

we will need to obtain substantial additional funding in connection with our continuing operations.

Our ability to raise additional funds

may be adversely impacted by global economic conditions, disruptions to, and volatility in, the credit and financial markets in the United

States and worldwide, and diminished liquidity and credit availability.

If the equity and credit markets deteriorate, it may make any

necessary debt or equity financing more difficult, more costly and more dilutive.

If we are unable to raise capital when needed or on

attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or any future commercialization

efforts, or even cease operations.

We expect to finance our cash needs through public or private equity or debt financings or other capital

sources, including potential collaborations, licenses, and other similar arrangements.

In addition, we may seek additional capital due

to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating

Attempting to secure additional financing may divert our management from our day-to-day activities, which may adversely affect

our ability to develop elraglusib or any future product candidates.

Our future capital requirements

will depend on many factors, including without limitation:

· the initiation, type, number, scope, progress,

expansions, results, costs and timing of, and invoicing for, clinical trials and preclinical studies of elraglusib and any future product

candidates we may choose to pursue, including the costs of modification to clinical development plans (including an increase in the number,

size, duration and/or complexity of a trial) based on feedback that we may receive from regulatory authorities and any third-party products

used as combination agents in our clinical trials;

· the costs and timing of manufacturing for elraglusib

or any future product candidate, including commercial manufacturing at sufficient scale and encountering higher than expected costs to

manufacture our current and future active pharmaceutical ingredients, if any product candidate is approved, including as a result of inflation,

any supply chain issues or component shortages;

· slower than expected progress in developing elraglusib

or a future product candidate, including without limitation, additional costs caused by such program delays;

· the costs, timing and outcome of regulatory meetings

and reviews of elraglusib and developing certain formulations of elraglusib or any future product candidates in any jurisdictions in which

we or our current or any future collaborators may seek approval for elraglusib or any future product candidates;

· our efforts to enhance operational systems and

hire additional personnel to satisfy our obligations as a public company, including enhanced internal control over financial reporting;

· the timing and payment of milestone, royalty

or other payments we must make pursuant to our existing and potential future license or collaboration agreements with third parties;

· the costs and timing of establishing or securing

sales and marketing capabilities and commercial compliance programs if elraglusib or any future product candidate is approved;

· higher than expected personnel, consulting or

other costs, such as adding personnel or industry expert consultants or pursuing the licensing/acquisition of additional assets;

· higher than expected costs to obtain, maintain,

enforce and protect our patents and other intellectual property and proprietary rights;

· our ability to achieve sufficient market acceptance,

coverage and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products;

· our ability and strategic decision to develop

future product candidates other than elraglusib, and the timing of such development, if any;

· patients’ willingness to pay out-of-pocket

for any approved products in the absence of coverage and/or adequate reimbursement from third-party payors;

· the terms and timing of establishing and maintaining

collaborations, licenses and other similar arrangements;

· our ability to raise sufficient funds when, and

if, required.

Conducting clinical

trials and preclinical studies and potentially identifying future product candidates is a time-consuming, expensive and uncertain process

that takes years to complete, and we may never generate the necessary data or results required to obtain regulatory approval and commercialize

elraglusib or any future product candidates.

If approved, elraglusib and any future product candidates may not achieve commercial success.

We expect that our commercial revenue, if any, will initially be derived from sales of elraglusib, which we do not expect to be commercially

available for several years, if at all.

Commercial success in the United States may depend upon acceptance and coverage by federal healthcare

program and third-party payors, and it can be time consuming and costly to demonstrate that any of our products should be covered.

Accordingly, in the near term,

we intend to seek and will need to continue to rely on additional financing to achieve our business objectives.

Adequate additional financing

may not be available to us on acceptable terms, or at all, including as a result of financial and credit market deterioration or instability,

market-wide liquidity shortages, geopolitical events or otherwise.

Raising additional capital may cause dilution

to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.

any capital obtained by us may be obtained on terms that are unfavorable to us, our investors, or both.

Until such time, if ever, as we

can generate substantial product revenue, we expect to finance our cash needs through equity offerings, debt financings or other capital

sources, including potential collaborations, licenses and other similar arrangements.

We do not have any committed external source of

As we attempt to raise additional financing, which we intend to do in the near term, there can be no assurance that we will be

able to secure such additional financing in sufficient quantities or at all.

We may be unable to raise additional capital for reasons

including, without limitation, our operational and/or financial performance, investor confidence in us and the biopharmaceutical industry,

credit availability from banks and other financial institutions, the status of current projects and our prospects for obtaining any necessary

regulatory approvals.

Potential investors’ capital investments may have shifted to other opportunities with perceived greater returns

and/or lower risk thereby reducing capital available to us, if available at all.

In addition, any additional financing

might not be available, and even if available, may not be available on terms favorable to us or our then-existing investors.

to raise funds through public or private equity offerings, debt financings, corporate collaboration or licensing arrangements, mergers,

acquisitions, sales of intellectual property or other financing vehicles or arrangements.

To the extent that we raise additional capital

by issuing equity securities or other securities (including convertible debt), our then-existing investors will experience dilution, and

the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder.

If we raise funds through debt financings or bank loans, we may become subject to restrictive covenants, such as incurring additional

debt, making capital expenditures or declaring dividends.

Such restrictions could adversely impact our ability to conduct our operations

and execute our business plan.

Moreover, if we raise funds through debt financings or bank loans, our assets may be pledged as collateral

for the debt, and the interests of our then-existing investors would be subordinated to the debt holders or banks.

In addition, our use

of and ability to exploit assets pledged as collateral for debt or loans may be restricted or forfeited.

To the extent that we raise additional

funds through collaboration or licensing arrangements, we may be required to relinquish valuable rights to our future revenue streams,

product candidates, research programs, intellectual property or proprietary technology, or grant licenses on terms that are not favorable

to us and/or that may reduce the value of our common stock.

If we are not able to raise funding when needed under acceptable terms or

at all, then we would be required to delay, limit, reduce, curtail, abandon or terminate our product development or future commercialization

efforts, or grant rights to develop and market product candidates that we might otherwise prefer to develop and market ourselves, or on

less favorable terms than we would otherwise choose, or sell assets, or cease operations entirely.

Risks Related to Clinical Development and Potential

Regulatory Approval

Raising additional capital or acquiring

or licensing assets by issuing equity or debt securities may cause dilution to our stockholders, and raising funds through lending and

licensing arrangements may restrict our operations or require us to relinquish proprietary rights.

We may seek additional capital

through a combination of public and private equity offerings, debt financings, strategic partnerships and alliances and licensing arrangements.

To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will

be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a stockholder.

The incurrence of indebtedness would result in increased fixed payment obligations and could involve certain restrictive covenants, such

as limitations on our ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights

and other operating restrictions that could adversely impact our ability to conduct our business.

If we raise additional capital through

future collaborations, strategic alliances or third-party licensing arrangements, we may have to relinquish valuable rights to our intellectual

property, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us.

If we are unable to raise

additional capital when needed, we may be required to delay, reduce or eliminate our research and development programs or any future commercialization

efforts, or even curtail or cease operations.

Risks Related to the Development and Commercialization of Our Product Candidates

We currently depend entirely on the success

of elraglusib, which is our only product candidate.

If we are unable to advance elraglusib in clinical development, obtain regulatory

approval and ultimately commercialize elraglusib in a timely manner, our business will be materially harmed.

We currently only have one

product candidate, elraglusib, which is in Phase 2 clinical development for the treatment of mPDAC as its lead indication.

presently depends entirely on our ability to successfully develop, obtain regulatory approval for, and commercialize elraglusib in a timely

This may make an investment in our company riskier than similar companies that have multiple product candidates in active development

and may be able to better sustain the delay or failure of a lead product candidate.

The success of elraglusib will depend on several factors,

including the following:

· successful initiation and enrollment of clinical

trials and completion of clinical trials with favorable results;

· acceptance of regulatory submissions by the FDA

or comparable foreign regulatory authorities for the conduct of clinical trials of elraglusib and of our proposed designs of planned clinical

trials of elraglusib;

· the frequency and severity of adverse events

observed in clinical trials and preclinical studies;

· maintaining and establishing relationships with

contract research organizations (“CROs”) and clinical sites for the clinical development of elraglusib, and ability of such

CROs and clinical sites to comply with clinical trial protocols, GCPs and other applicable requirements;

· demonstrating the safety and efficacy of elraglusib

to the satisfaction of applicable regulatory authorities, including by establishing a safety database of a size satisfactory to regulatory

· receipt and maintenance of regulatory approvals

from applicable regulatory authorities, including approvals of NDAs from the FDA;

· maintaining relationships with our third-party

manufacturers and their ability to comply with cGMPs as well as entering into agreements with our third-party manufacturers for, or establishing

our own, commercial manufacturing capabilities at a cost and scale sufficient to support commercialization;

· establishing sales, marketing and distribution

capabilities and launching commercial sales of elraglusib, if and when approved, whether alone or in collaboration with others;

· obtaining, maintaining, protecting and enforcing

patent and any potential trade secret protection or regulatory exclusivity for elraglusib;

· maintaining an acceptable safety profile of elraglusib

following regulatory approval, if any;

· maintaining and growing an organization of people

who can develop and, if approved, commercialize, market and sell elraglusib;

· acceptance and coverage of our products, if approved,

by patients, the medical community and federal healthcare program and other third-party payors.

If we are unable to develop,

obtain regulatory approval for, or if approved, successfully manufacture and commercialize elraglusib, or if we experience delays as a

result of any of the above factors or otherwise, our business would be materially harmed.

We do not have and may never have any approved

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approval for any treatment we develop even if such safety and effectiveness are demonstrated.

Any delays or difficulties we

encounter in our clinical trials may delay or preclude regulatory approval from the FDA or from international regulatory organizations.

Any delays or difficulties

we encounter in our clinical trials may delay or preclude regulatory approval from the FDA or from international regulatory organizations.

Any delay or preclusion of regulatory approval would be expected to delay or preclude the commercialization of our products.

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whether or not a treatment is effective;

· patients involved in our clinical trials may

suffer severe adverse side effects even up to death, whether as a result of treatment with our products, the withholding of such treatment,

or other reasons (whether within or outside of our control);

· we may fail to be able to enroll a sufficient

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if problems with our products emerge or are suggested by the data arising from their use or if there is a change in law or regulation.

Any success we may achieve at

a given stage of our clinical trials does not guarantee that we will achieve success at any subsequent stage, including without limitation

Any success we may achieve

at a given stage of our clinical trials does not guarantee that we will achieve success at any subsequent stage, including without limitation

final FDA approval.

We may encounter delays or rejections

in the regulatory approval process because of additional government regulation resulting from future legislation or administrative action,

or from changes in the policies of the FDA or other regulatory bodies during the period of product development, clinical trials, or regulatory

In addition, legislative and regulatory agendas, as they relate to healthcare and pharmaceutical industries and the economy as

a whole, of the Trump administration and the U.S.

We may encounter delays or

rejections in the regulatory approval process because of additional government regulation resulting from future legislation or administrative

action, or from changes in the policies of the FDA or other regulatory bodies during the period of product development, clinical trials,

or regulatory review.

In addition, legislative and regulatory agendas, as they relate to healthcare and pharmaceutical industries and

the economy as a whole, of the Trump administration and the U.S.

Congress currently remain uncertain.

Failure to comply with any current or future applicable

regulatory requirements may result in criminal prosecution, civil penalties, recall or seizure of products, total or partial suspension

of production, or an injunction preventing certain activity, as well as other regulatory action against our product candidates or us.

As a company, we have no experience in successfully obtaining regulatory approval for a product and thus may be poorly equipped to gauge,

and may prove unable to manage, risks relating to obtaining such approval.

Outside the United States, our

ability to market a product is contingent upon receiving clearances from appropriate non-U.S.

Failure to comply with any current

or future applicable regulatory requirements may result in criminal prosecution, civil penalties, recall or seizure of products, total

or partial suspension of production, or an injunction preventing certain activity, as well as other regulatory action against our product

candidates or us.

As a company, we have no experience in successfully obtaining regulatory approval for a product and thus may be poorly

equipped to gauge, and may prove unable to manage, risks relating to obtaining such approval.

Outside the United States,

our ability to market a product is contingent upon receiving clearances from appropriate non-U.S.

regulatory authorities.

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pricing restrictions and practices can make achieving even limited profitability very difficult.

We currently depend entirely on the success

of elraglusib, which is our only product candidate.

If we are unable to advance elraglusib in clinical development, obtain regulatory

approval and ultimately commercialize elraglusib in a timely manner, our business will be materially harmed.

We currently only have one product

candidate, elraglusib, which is in Phase 2 clinical development for the treatment of mPDAC as its lead indication.

Our business presently

depends entirely on our ability to successfully develop, obtain regulatory approval for, and commercialize elraglusib in a timely manner.

This may make an investment in our company riskier than similar companies that have multiple product candidates in active development

and may be able to better sustain the delay or failure of a lead product candidate.

The success of elraglusib will depend on several factors,

including the following:

· successful initiation and enrollment of clinical

trials and completion of clinical trials with favorable results;

· acceptance of regulatory submissions by the FDA

or comparable foreign regulatory authorities for the conduct of clinical trials of elraglusib and of our proposed designs of planned clinical

trials of elraglusib;

· the frequency and severity of adverse events

observed in clinical trials and preclinical studies;

· maintaining and establishing relationships with

contract research organizations (“CROs”) and clinical sites for the clinical development of elraglusib, and ability of such

CROs and clinical sites to comply with clinical trial protocols, GCPs and other applicable requirements;

· demonstrating the safety, purity and potency

(or efficacy) of elraglusib to the satisfaction of applicable regulatory authorities, including by establishing a safety database of a

size satisfactory to regulatory authorities;

· receipt and maintenance of regulatory approvals

from applicable regulatory authorities, including approvals of NDAs from the FDA;

· maintaining relationships with our third-party

manufacturers and their ability to comply with cGMPs as well as entering into agreements with our third-party manufacturers for, or establishing

our own, commercial manufacturing capabilities at a cost and scale sufficient to support commercialization;

· establishing sales, marketing and distribution

capabilities and launching commercial sales of elraglusib, if and when approved, whether alone or in collaboration with others;

· obtaining, maintaining, protecting and enforcing

patent and any potential trade secret protection or regulatory exclusivity for elraglusib;

· maintaining an acceptable safety profile of elraglusib

following regulatory approval, if any;

· maintaining and growing an organization of people

who can develop and, if approved, commercialize, market and sell elraglusib;

· acceptance and coverage of our products, if approved,

by patients, the medical community and federal healthcare program and other third-party payors.

If we are unable to develop,

obtain regulatory approval for, or if approved, successfully manufacture and commercialize elraglusib, or if we experience delays as a

result of any of the above factors or otherwise, our business would be materially harmed.

Even if we complete all planned clinical trials

including a Phase 3 trial in the future, there is no guarantee that at the time of submission the FDA will accept our NDA.

The regulation and control of

new drugs in the United States is based on the NDA, and every new drug is the subject of an approved NDA before U.S.

commercialization.

Through the NDA application, the developer of a drug candidate formally proposes that the FDA approve a new pharmaceutical for sale and

marketing in the United States.

The data gathered during the animal studies and human clinical trials of an IND become part of the NDA.

Clinical trials must be conducted

in accordance with the FDA and other applicable regulatory authorities’ legal requirements, regulations or guidelines, and are subject

to oversight by these governmental agencies and ethics committees or one or more IRBs at the medical institutions and clinical trial sites

where the clinical trials are conducted.

We could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs

of the institutions in which such trials are being conducted, or by a data safety monitoring board for such trial or by the FDA or comparable

foreign regulatory authorities.

Such authorities may impose such a suspension, including a clinical hold, or termination due to a number

of factors, including, among other reasons, failure to conduct the clinical trial in accordance with GCP and other regulatory requirements

or our clinical protocols, inspection of the clinical trial operations or trial site, or investigation of principal or sub-investigators

conducting our clinical trials, by the FDA or comparable foreign regulatory authorities resulting in the imposition of a clinical hold,

unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations

or administrative actions or lack of adequate funding to continue the clinical trial.

In addition, changes in regulatory requirements

and policies may occur, and we may need to amend clinical trial protocols to comply with these changes.

Amendments may require us to resubmit

our clinical trial protocols to IRBs for reexamination, which may impact the costs, timing or successful completion of a clinical trial.

Failure by us or any of our third-party

vendors, manufacturers, or trial sites to comply with applicable regulatory requirements may result in criminal prosecution, civil penalties,

recall or seizure of products, total or partial suspension of production, or an injunction preventing certain activity, as well as other

regulatory action against our product candidates or us.

As a company, we have no experience in successfully obtaining regulatory approval

for a product and thus may be poorly equipped to gauge, and may prove unable to manage, risks relating to obtaining such approval.

Outside the United States, our

ability to market a product is contingent upon receiving clearances from appropriate non-U.S.

regulatory authorities.

approval typically includes all of the risks associated with FDA clearance discussed above as well as the failure of enrolled patients

in foreign countries to adhere to clinical protocols as a result of differences in healthcare services or cultural customs, managing additional

administrative burdens associated with foreign regulatory schemes, and political and economic risks, including war or embargoes, relevant

to such foreign countries.

In certain cases, pricing restrictions and practices can make achieving even limited profitability very difficult.

Clinical and preclinical drug development involves

a lengthy and expensive process with uncertain timelines and outcomes, and the results of preclinical studies and early clinical trials

are not necessarily predictive of future results.

Elraglusib or any future product candidates may not achieve favorable results or receive

regulatory approval on a timely basis, if at all.

Clinical and preclinical drug development

involves a lengthy and expensive process with uncertain timelines and outcomes, and the results of preclinical studies and early clinical

trials are not necessarily predictive of future results.

Elraglusib or any future product candidates may not achieve favorable results

or receive regulatory approval on a timely basis, if at all.

Drug development is expensive

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The historical failure rate for product candidates in our industry is high.

The results from preclinical studies

or clinical trials of elraglusib, any future product candidate, or a competitor’s product candidate in the same class may not predict

the results of later clinical trials of elraglusib or any future product candidate, and interim, topline or preliminary results of a clinical

trial are not necessarily indicative of final results.

Elraglusib or any future product candidate in later stages of clinical trials may

fail to show the desired characteristics despite having progressed through preclinical studies and initial clinical trials.

uncommon to observe results in clinical trials that are unexpected based on preclinical studies and early clinical trials, and many product

candidates fail in clinical trials despite very promising early results.

Moreover, preclinical and clinical

data may be susceptible to varying interpretations and analyses.

A number of companies in the biopharmaceutical and biotechnology industries

have suffered significant setbacks in clinical development even after achieving promising results in earlier studies.

Such setbacks have

occurred and may occur for many reasons, including, but not limited to:

clinical sites and investigators may deviate from clinical trial

protocols, whether due to lack of training or otherwise, and we may fail to detect any such deviations in a timely manner;

fail to adhere to any required clinical trial procedures, including any requirements for post-treatment follow-up;

our product candidates

may fail to demonstrate safety, purity or potency (or efficacy) in certain patient subpopulations, which has not been observed in earlier

trials due to limited sample size, lack of analysis or otherwise;

or our clinical trials may not adequately represent the patient populations

we intend to treat, whether due to limitations in our trial designs or otherwise, such as where one patient subgroup is overrepresented

in the clinical trial.

There can be no assurance that we will not suffer similar setbacks despite the data we observed in earlier or ongoing

Based upon negative or inconclusive results, we or any current or any future collaborator may decide, or regulators may require

us, to conduct additional preclinical studies or clinical trials, which would cause us to incur additional operating expenses and delays

and may not be sufficient to support regulatory approval on a timely basis or at all.

We may not be successful in our efforts to advance

elraglusib in additional indications.

We may expend our limited resources to pursue a new product candidate or a particular indication

for elraglusib and fail to capitalize on more profitable or successful alternatives.

The results from preclinical

studies or clinical trials of elraglusib, any future product candidate, or a competitor’s product candidate in the same class may

not predict the results of later clinical trials of elraglusib or any future product candidate, and interim, topline or preliminary results

of a clinical trial are not necessarily indicative of final results.

Elraglusib or any future product candidate in later stages of clinical

trials may fail to show the desired characteristics despite having progressed through preclinical studies and initial clinical trials.

It is not uncommon to observe results in clinical trials that are unexpected based on preclinical studies and early clinical trials, and

many product candidates fail in clinical trials despite very promising early results.

Moreover, preclinical and

clinical data may be susceptible to varying interpretations and analyses.

A number of companies in the biopharmaceutical and biotechnology

industries have suffered significant setbacks in clinical development even after achieving promising results in earlier studies.

setbacks have occurred and may occur for many reasons, including, but not limited to:

· clinical sites and investigators may deviate

from clinical trial protocols, whether due to lack of training or otherwise, and we may fail to detect any such deviations in a timely

· patients may fail to adhere to any required clinical

trial procedures, including any requirements for post-treatment follow-up;

· our product candidates may fail to demonstrate

safety efficacy in certain patient subpopulations, which has not been observed in earlier trials due to limited sample size, lack of analysis

or otherwise;

· our clinical trials may not adequately represent

the patient populations we intend to treat, whether due to limitations in our trial designs or otherwise, such as where one patient subgroup

is overrepresented in the clinical trial;

· others, including regulatory agencies, may not

accept or agree with our assumptions, estimates, calculations, conclusions, or analyses or may interpret or weigh the importance of data

differently, which could impact the value of the particular program, the approvability, or commercialization of the particular product

candidate or product.

There can be no assurance

that we will not suffer similar setbacks despite the data we observed in earlier or ongoing studies.

Based upon negative or inconclusive

results, we or any current or any future collaborator may decide, or regulators may require us, to conduct additional preclinical studies

or clinical trials, which would cause us to incur additional operating expenses and delays and may not be sufficient to support regulatory

approval on a timely basis or at all.

We may not be successful in our efforts

to advance elraglusib in additional indications.

We may expend our limited resources to pursue a new product candidate or a particular

indication for elraglusib and fail to capitalize on more profitable or successful alternatives.

Because we have limited financial

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less advantageous terms for any such arrangements than is optimal.

Additionally, we may pursue additional

in-licenses or acquisitions of development-stage assets or programs, which entails additional risk to us.

Identifying, selecting and acquiring

promising product candidates requires substantial technical, financial and human resources expertise.

Efforts to do so may not result

in the actual acquisition or license of a particular product candidate, potentially resulting in a diversion of our management’s

Additionally, we may pursue

additional in-licenses or acquisitions of development-stage assets or programs, which entails additional risk to us.

Identifying, selecting

and acquiring promising product candidates requires substantial technical, financial and human resources expertise.

Efforts to do so may

not result in the actual acquisition or license of a particular product candidate, potentially resulting in a diversion of our management’s

time and the expenditure of our resources with no resulting benefit.

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that ultimately do not provide a return on our investment.

Use of elraglusib or any future product candidates

could be associated with side effects, adverse events or other properties or safety risks, which could delay or preclude regulatory approval,

cause us to suspend or discontinue clinical trials, abandon elraglusib or any future product candidate, limit the commercial profile of

an approved label or result in other significant negative consequences that could severely harm our business, financial condition, results

of operations and prospects.

As is the case with oncology

drugs generally, it is likely that there may be side effects and adverse events associated with use of elraglusib or any future product

candidates’ use.

Results of our clinical trial collaborators or any future collaborators could reveal a high and unacceptable severity

and prevalence of expected or unexpected side effects or unexpected characteristics.

Undesirable side effects caused by our product candidates

when used alone or in combination with approved or investigational drugs could cause us or regulatory authorities to interrupt, delay

or halt clinical trials and could result in a more restrictive label or lead to the delay or denial of regulatory approval by the FDA

or comparable foreign regulatory authorities.

The drug-related side effects could affect patient recruitment or the ability of enrolled

patients to complete the trial or result in potential product liability claims.

Any of these occurrences may harm our business, financial

condition, results of operations and prospects significantly.

Moreover, if elraglusib or any

future product candidates are associated with undesirable side effects in clinical trials or demonstrate characteristics that are unexpected,

we may elect to abandon their development or limit their development to more narrow uses or subpopulations in which the undesirable side

effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective, which may limit

the commercial expectations for such product candidate if approved.

Unacceptable enhancement of certain toxicities may be seen when elraglusib

or any future product candidates are combined with standard of care therapies, or when they are used as single agents.

We may also be

required to modify our development and clinical trial plans based on findings in our ongoing clinical trials.

Many compounds that initially

showed promise in early-stage testing for treating cancer have later been found to cause side effects that prevented further development

of the compounds.

It is possible that as we, our

collaborators or any future collaborators test elraglusib or any future product candidates in larger, longer and more extensive clinical

trials, including with different dosing regimens, or as the use of these product candidates becomes more widespread following any regulatory

approval, more illnesses, injuries, discomforts and other adverse events than were observed in earlier trials, as well as new conditions

that did not occur or went undetected in previous trials, may be discovered.

If such side effects become known later in development or

upon approval, if any, such findings may harm our business, financial condition, results of operations and prospects significantly.

With regard to our lead product

candidate, elraglusib, unforeseen side effects from elraglusib could arise either during clinical development or, if approved, after

elraglusib has been marketed.

This could cause regulatory approvals for, or market acceptance of, elraglusib harder and costlier to obtain.

To date, elraglusib as a single

agent and in combination with a variety of chemotherapy has been shown in a Phase 1 trial to be well-tolerated.

However, these data were

obtained in advanced cancer patients across many different cancer types and at different doses of elraglusib.

The results of our planned

or any future clinical trials in single cancer types may show that the side effects of elraglusib are unacceptable or intolerable, especially

when compared with standard of care and in earlier stage patients, which could interrupt, delay or halt clinical trials.

This could result

in delay of, or failure to obtain, marketing approval from the FDA or EMA and other regulatory authorities or result in marketing approval

from the FDA or EMA and other regulatory authorities with restrictive label warnings.

If elraglusib receives marketing approval and we

or others later identify undesirable or unacceptable side effects caused by the use of elraglusib:

· regulatory authorities may withdraw their approval

of the product, which would force us to remove elraglusib from the market;

· regulatory authorities may require the addition

of labeling statements, specific warnings, a contraindication, or field alerts to physicians and pharmacies;

· we may be required to change instructions regarding

the way the product is administered, conduct additional clinical trials or change the labeling of the product;

· we may be subject to limitations on how we may

promote the product;

· sales of the product may decrease significantly;

· we may be subject to litigation or product liability

· our reputation may suffer.

Any of these events could prevent

us or our potential future collaborators from achieving or maintaining market acceptance of elraglusib and/or could substantially increase

commercialization costs and expenses, which in turn could delay or prevent us from generating significant revenues from the sale of elraglusib.

If we experience delays or difficulties in the

enrollment of subjects to our clinical trials, our receipt of necessary regulatory approvals could be delayed or otherwise adversely affected.

Identifying, screening and enrolling

patients to participate in clinical trials of our product candidates is critical to our success, and we may not be able to identify, recruit,

enroll and dose a sufficient number of patients with the required or desired characteristics to complete our clinical trials in a timely

We may not be able to initiate or continue certain clinical trials for elraglusib or any future product candidates if we are unable

to identify and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or similar regulatory

authorities outside the United States.

The timing of our clinical trials depends on our ability to recruit patients to participate as

well as to subsequently dose these patients and complete required follow-up periods.

Patient enrollment, a significant factor in the timing

of clinical trials, is affected by many factors, including the size and characteristics of the patient population, the proximity of patients

to clinical sites, the eligibility and exclusion criteria for the trial, the design of the clinical trial, the risk that enrolled patients

will not complete a clinical trial, our ability to recruit clinical trial investigators with the appropriate competencies and experience,

and competing clinical trials and clinicians’ and patients’ perceptions as to the potential advantages and risks of the product

candidates being studied in relation to other available therapies, including any new products that may be approved for the indications

we are investigating as well as any product candidates under development.

We will be required to identify and enroll a sufficient number

of patients for each of our clinical trials and monitor such patients adequately during and after treatment.

Potential patients for any

planned clinical trials may not be adequately diagnosed or identified with the diseases which we are targeting, which could adversely

impact the outcomes of our trials and could have safety concerns for the potential patients.

Potential patients for any planned clinical

trials may also not meet the entry criteria for such trials.

In particular, because our planned clinical trials of elraglusib are focused

on indications with relatively small patient populations, our ability to enroll eligible patients may be limited or may result in slower

enrollment than we anticipate.

If we experience delays or difficulties

enrolling subjects to our clinical trials, our receipt of necessary regulatory approvals could be delayed or otherwise adversely affected.

Identifying, screening and

enrolling patients to participate in clinical trials of our product candidates is critical to our success, and we may not be able to identify,

recruit, enroll and dose a sufficient number of patients with the required or desired characteristics to complete our clinical trials

in a timely manner.

We may not be able to initiate or continue certain clinical trials for elraglusib or any future product candidates

if we are unable to identify and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA

or similar regulatory authorities outside the United States.

The timing of our clinical trials depends on our ability to recruit patients

to participate as well as to subsequently dose these patients and complete required follow-up periods.

Patient enrollment, a significant

factor in the timing of clinical trials, is affected by many factors, including:

· the size and characteristics of the patient population;

· the proximity of patients to clinical sites;

· the eligibility and exclusion criteria for the

· the design of the clinical trial;

· the risk that enrolled patients will not complete

a clinical trial;

· our ability to recruit clinical trial investigators

with the appropriate competencies and experience;

· competing clinical trials and clinicians’

and patients’ perceptions as to the potential advantages and risks of the product candidates being studied in relation to other

available therapies, including any new products that may be approved for the indications we are investigating as well as any product candidates

under development.

We will be required to identify

and enroll a sufficient number of patients for each of our clinical trials and monitor such patients adequately during and after treatment.

Potential patients for any planned clinical trials may not be adequately diagnosed or identified with the diseases which we are targeting,

which could adversely impact the outcomes of our trials and could have safety concerns for the potential patients.

Potential patients

for any planned clinical trials may also not meet the entry criteria for such trials.

In particular, because our planned clinical trials

of elraglusib are focused on indications with relatively small patient populations, our ability to enroll eligible patients may be limited

or may result in slower enrollment than we anticipate.

In addition, we may experience

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delays in testing the effectiveness of our product candidates or in termination of the clinical trials altogether.

We may not be able to fully enroll

our clinical trials if other pharmaceutical companies with ongoing clinical trials for products with similar indications as our product

candidates recruit from these patient populations.

The timing of our clinical trials depends, in part, on the speed at which we can recruit

patients to participate in our trials, as well as completion of required follow-up periods.

Patient enrollment may also be affected by

other factors, including:

· coordination with clinical research organizations

to enroll and administer the clinical trials;

· coordination and recruitment of collaborators

and investigators at individual sites;

· size of the patient population and process for

identifying patients;

· design of the clinical trial protocol;

· eligibility and exclusion criteria;

· perceived risks and benefits of the product candidates

· availability of competing commercially available

therapies and other competing products’ clinical trials;

· time of year in which the trials are initiated

or conducted;

· severity of the diseases under investigation;

· ability to obtain and maintain subject consents;

· ability to enroll and treat patients in a timely

· risk that enrolled subjects will drop out before

completion of the trials;

· proximity and availability of clinical trial

sites for prospective patients;

· ability to monitor subjects adequately during

and after treatment;

· patient referral practices of physicians.

If patients are unwilling or unable

to participate in our trials for any reason, including the existence of concurrent clinical trials for similar target populations, the

availability of approved therapies, or the fact that enrolling in our trials may prevent patients from taking a different product, or

we otherwise have difficulty enrolling a sufficient number of patients, the timeline for recruiting patients, conducting trials and obtaining

regulatory approval of elraglusib or any future product candidates may be delayed.

Our inability to enroll a sufficient number of patients

for clinical trials would result in significant delays and could require us to abandon one or more clinical trials altogether.

Enrollment delays in these clinical

trials may result in increased time and development costs for our product candidates, which could materially affect our financial condition.

As a company, we have not yet completed a Phase

2 clinical trial and have limited experience in completing regulatory filings, and any delays in regulatory filings could materially affect

our financial condition.

We will need to successfully complete

clinical trials in order to obtain FDA or comparable foreign regulatory approval to market elraglusib or any future product candidates.

If patients are unwilling

or unable to participate in our trials for any reason, including the existence of concurrent clinical trials for similar target populations,

the availability of approved therapies, or the fact that enrolling in our trials may prevent patients from taking a different product,

or we otherwise have difficulty enrolling a sufficient number of patients, the timeline for recruiting patients, conducting trials and

obtaining regulatory approval of elraglusib or any future product candidates may be delayed.

Our inability to enroll a sufficient number

of patients for clinical trials would result in significant delays and could require us to abandon one or more clinical trials altogether.

Enrollment delays in these

clinical trials may result in increased time and development costs for our product candidates, which could materially affect our financial

As a company, we have not yet initiated

nor completed a Phase 3 clinical trial and have limited experience in completing regulatory filings, and any delays in regulatory filings

could materially affect our financial condition.

We will need to successfully

complete clinical trials in order to obtain FDA or comparable foreign regulatory approval to market elraglusib or any future product candidates.

Carrying out clinical trials and the submission of a successful NDA or other comparable foreign regulatory submission is a complicated

As a company, we have not yet completed a Phase 2 clinical trials of our product candidates, nor have we demonstrated the ability

to obtain marketing approvals, manufacture product candidates at a commercial scale, or conduct sales and marketing activities necessary

for the successful commercialization of a product.

As a company, we have not yet initiated nor completed a Phase 3 clinical trial of our product candidates, nor have we demonstrated

the ability to obtain marketing approvals, manufacture product candidates at a commercial scale, or conduct sales and marketing activities

necessary for the successful commercialization of a product.

We may also choose to conduct a number of additional clinical trials of elraglusib

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Consequently, we have no historical basis as a company by which you can evaluate or predict reliably our future success or

We have limited experience with

regulatory filings with agencies such as the FDA or EMA, and we have not yet completed a Phase 2 clinical trial for elraglusib or any

other product candidate.

We also have limited experience as a company in preparing and submitting marketing applications and have not

previously submitted an NDA or other comparable foreign regulatory submission for any product candidate.

In addition, we have had limited

interactions with the FDA and cannot be certain how many additional clinical trials of elraglusib or any future product candidate will

be required or how such additional trials should be designed.

Consequently, we may be unable to successfully and efficiently execute and

complete necessary clinical trials in a way that leads to submission of an NDA and regulatory approval of any of our product candidates.

We may require more time and incur greater costs than our competitors and may not succeed in obtaining regulatory approvals of product

candidates that we develop.

Failure to commence or complete, or delays in, our ongoing or planned clinical trials could prevent us from

or delay us in submitting NDAs or other comparable foreign regulatory submissions for and commercializing our product candidates.

delay in our regulatory filings for our product 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 “refuse

to file” letter or a request for additional information, could materially affect our financial condition.

As a result, we cannot be certain

that our ongoing and planned clinical trials or preclinical studies will be successful.

Any safety concerns observed in any one of our

clinical trials in our targeted indications could limit the prospects for regulatory approval of elraglusib in those and other indications,

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

As a result, we cannot be

certain that our ongoing and planned clinical trials or preclinical studies will be successful.

Any safety concerns observed in any one

of our clinical trials in our targeted indications could limit the prospects for regulatory approval of elraglusib in those and other

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

Interim, topline, and preliminary data from

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audit and verification procedures that could result in material changes in the final data.

From time to time, we may publicly

disclose interim, topline, or preliminary data from our clinical trials, based on a preliminary analysis of then-available data, and the

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

study or trial.

We also make assumptions, estimations, calculations, and conclusions as part of our analyses of data, and we may not have

received or had the opportunity to fully and carefully evaluate all data.

As a result, the interim, topline, or preliminary results that

we report may differ from future results of the same studies, or different conclusions or considerations may qualify such results once

additional data have been received and fully evaluated.

Interim, topline, and preliminary data also remain subject to audit and verification

procedures that may result in the final data being materially different from the preliminary data we previously published.

such data should be viewed with caution until the final data are available.

Interim, topline, and preliminary data from clinical trials

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

and more patient data become available.

Adverse differences between preliminary, interim or topline data and final data could significantly

harm our business prospects.

Further, others, including regulatory

agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions, or analyses or may interpret or weigh the

importance of data differently, which could impact the value of the particular program, the approvability, or commercialization of the

particular product candidate or product and our company in general.

In addition, the information we choose to publicly disclose regarding

a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we

determine is the material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose

may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular

product, product candidate, or our business.

If the interim, topline, or preliminary data that we report differ from actual results, or

if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize

elraglusib and any future product candidates may be harmed, which could harm our business, operating results, prospects, or financial

Serious adverse events, undesirable side effects

(including emergent drug-drug interactions between elraglusib and any of the other therapeutic agents given to the clinical trial subjects)

or other unexpected properties of our current or future product candidates may be identified during development or after approval, which

could halt their development or lead to the discontinuation of our clinical development programs, refusal by regulatory authorities to

approve our product candidates or, if discovered following marketing approval, revocation of marketing authorizations or limitations on

the use of our product candidates thereby limiting the commercial potential of such product candidate.

To date, elraglusib is the only

product candidate we have tested in humans.

As we continue our development of elraglusib and initiate clinical trials of any future product

candidates, serious adverse events, undesirable side effects or unexpected characteristics may emerge or be reported, causing us to abandon

these product candidates or limit their development to more narrow uses or subpopulations in which the serious adverse events, undesirable

side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective.

product candidates initially show promise in early clinical trials, the side effects of therapies are frequently only detectable after

they are tested in large, Phase 2 or Phase 3 clinical trials or, in some cases, after they are made available to patients on a commercial

scale after approval.

Sometimes, it can be difficult to determine if the serious adverse or unexpected side effects were caused by the

product candidate or another factor, especially in oncology subjects who may suffer from other medical conditions and be taking other

If serious adverse or unexpected side effects are identified during development and are determined to be attributed to our

product candidates, or the result of drug-drug interactions between our product candidate and any of the concomitant therapies given

to the trial subjects, we, the FDA or comparable foreign regulatory authorities, or IRBs and other reviewing entities, could interrupt,

delay, or halt clinical trials and could result in a more restrictive label, a REMS or the delay or denial of regulatory approval by

the FDA or comparable foreign regulatory authorities.

The FDA or comparable foreign regulatory authorities may also require, or we may

voluntarily develop strategies for managing adverse events during clinical development, which could include restrictions on our enrollment

criteria, the use of stopping criteria, adjustments to a study’s design, or the monitoring of safety data by a data monitoring

committee, among other strategies.

Any requests from the FDA or comparable foreign regulatory authority for additional data or information

could also result in substantial delays in the approval of our product candidates.

Drug-related side effects could also affect subject

recruitment or the ability of enrolled subjects to complete the trial or result in potential product liability claims.

Any of these occurrences

may harm our business, financial condition and prospects significantly.

In addition, if one or more of our product candidates receives

marketing approval, and we or others later identify undesirable side effects caused by such products, a number of potentially significant

negative consequences could result, including:

· regulatory authorities may withdraw approvals

of such product;

· regulatory authorities may require additional

warnings on the label;

· we may be required to create a medication guide

outlining the risks of such side effects for distribution to patients;

· we may be forced to suspend marketing of that

product, or decide to remove the product from the marketplace;

· we may be required to change the way the product

is administered;

· we could be subject to fines, injunctions, or

the imposition of criminal or civil penalties;

· we could be sued and held liable for harm caused

· the product may become less competitive, and

our reputation may suffer.

The therapeutic-related side

effects could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability

Any of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved,

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

From time to time, we may

publicly disclose interim, topline, or preliminary data from our clinical trials, based on a preliminary analysis of then-available data,

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

the particular study or trial.

We also make assumptions, estimations, calculations, and conclusions as part of our analyses of data, and

we may not have received or had the opportunity to fully and carefully evaluate all data.

As a result, the interim, topline, or preliminary

results that we report may differ from future results of the same studies, or different conclusions or considerations may qualify such

results once additional data have been received and fully evaluated.

Interim, topline, and preliminary data also remain subject to audit

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

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

Interim, topline, and preliminary data from clinical

trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment

continues and more patient data become available.

Adverse differences between preliminary, interim or topline data and final data could

significantly harm our business prospects.

In addition, the information

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

you or others may not agree with what we determine is the material or otherwise appropriate information to include in our disclosure,

and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views,

activities or otherwise regarding a particular product, product candidate, or our business.

If the interim, topline, or preliminary data

that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our

ability to obtain approval for, and commercialize elraglusib and any future product candidates may be harmed, which could harm our business,

operating results, prospects, or financial condition.

We anticipate that many of our product candidates

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and we have limited or no control over the supply, regulatory status or regulatory approval of such drugs and/or devices.

We anticipate developing our product

candidates for use in combination with other oncology pharmaceuticals, including chemotherapies and cellular and targeted therapies (e.g.,

immune checkpoint inhibitors).

We cannot be certain that current or potential future commercial relationships will provide us with a steady

supply of such drugs or devices on commercially reasonable terms or at all.

Any failure to maintain or enter

into new successful commercial relationships, or the expense of purchasing platinum-based and other chemotherapies, or any other combination

products, or any devices in the market, may delay our development timelines, increase our costs and jeopardize our ability to develop

our product candidates as commercially viable therapies.

If any of these occur, our business, financial condition, results of operations,

stock price and prospects may be materially harmed.

Moreover, the development of product candidates for use in combination with another

product or product candidate may present challenges that are not faced for single agent product candidates.

For our product candidates

that may be used in combination with other chemotherapies, or any other combination products or any devices, the FDA may require us to

use more complex clinical trial designs in order to evaluate the contribution of each product and product candidate to any observed effects.

It is possible that the results of these trials could show that there are adverse events tied to the interaction of elraglusib with any

of the other therapies, or that any positive previous trial results are attributable to the combination therapy and not our product candidates.

Moreover, following product approval, the FDA may require that products or devices used in conjunction with each other be cross labeled

for combined use.

To the extent that we do not have rights to the other product or device, this may require us to work with a third party

to satisfy such a requirement.

The ability to obtain cooperation from the third party may impact our ability to respond to the FDA’s

requests which could impact our ability to achieve regulatory approval.

Moreover, developments related to the other product or device

may impact our clinical trials as well as our commercial prospects should we receive marketing approval.

Such developments may include

changes to the safety or efficacy profile of the other product or device, changes to the availability of the approved product or device,

and changes to the standard of care.

In the event that any future collaborator

or supplier of other chemotherapies, or any other products administered in combination, or any devices used, with our product candidates

does not supply their products on commercially reasonable terms or in a timely fashion, we would need to identify alternatives for accessing

these products.

This could cause our clinical trials to be delayed and limit the commercial opportunities for our product candidates,

in which case our business, financial condition, results of operations, stock price and prospects may be materially harmed.

We may seek additional Orphan Drug, Fast Track, Breakthrough or orphan

and priority (“PRIME”) designations for one or more of our current and future product candidates, but we might not receive

any such designation, and even if we do, such designation may not actually lead to a faster development or regulatory review or approval

Our lead product candidate, elraglusib,

has been given FTD from the FDA for development in the treatment of pancreatic cancer, and we may seek FTD for other indications or future

product candidates.

The FTD program is intended to expedite or facilitate the process for reviewing product candidates that meet certain

Specifically, biologics are eligible for Fast Track designation if they are intended, alone or in combination with one or more

drugs or biologics, to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical

needs for the disease or condition.

Fast Track designation applies to the combination of the product candidate and the specific indication

for which it is being studied.

The sponsor of a Fast Track product candidate has opportunities for more frequent interactions with the

applicable FDA review team during product development and, once an NDA is submitted, the application may be eligible for priority review.

An NDA submitted for a Fast Track product candidate may also be eligible for rolling review, where the FDA may consider for review sections

of the NDA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the

sections of the NDA, the FDA agrees to accept sections of the NDA and determines that the schedule is acceptable, and the sponsor pays

any required user fees upon submission of the first section of the NDA.

Fast Track designation does not ensure that we will receive marketing

approval or that approval will be granted within any particular timeframe or at all.

We may not experience a faster development, regulatory

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

Additionally, the FDA may withdraw Fast

Track designation, for reasons such as it comes to believe a drug candidate no longer adequately addresses an unmet medical need or that

the designation is no longer supported by data from our clinical development program.

We anticipate developing our

product candidates for use in combination with other oncology pharmaceuticals, including chemotherapies and cellular and targeted therapies

(e.g., immune checkpoint inhibitors).

We cannot be certain that current or potential future commercial relationships will provide us with

a steady supply of such drugs or devices on commercially reasonable terms or at all.

Any failure to maintain or

enter into new successful commercial relationships, or the expense of purchasing platinum-based and other chemotherapies, or any other

combination products, or any devices in the market, may delay our development timelines, increase our costs and jeopardize our ability

to develop our product candidates as commercially viable therapies.

If any of these occur, our business, financial condition, results

of operations, stock price and prospects may be materially harmed.

Moreover, the development of product candidates for use in combination

with another product or product candidate may present challenges that are not faced for single agent product candidates.

For our product

candidates that may be used in combination with other chemotherapies, or any other combination products or any devices, the FDA may require

us to use more complex clinical trial designs in order to evaluate the contribution of each product and product candidate to any observed

It is possible that the results of these trials could show that there are adverse events tied to the interaction of elraglusib

with any of the other therapies, or that any positive previous trial results are attributable to the combination therapy and not our product

Moreover, following product approval, the FDA may require that products or devices used in conjunction with each other be

cross labeled for combined use.

To the extent that we do not have rights to the other product or device, this may require us to work with

a third party to satisfy such a requirement.

The ability to obtain cooperation from the third party may impact our ability to respond

to the FDA’s requests which could impact our ability to achieve regulatory approval.

Moreover, developments related to the other

product or device may impact our clinical trials as well as our commercial prospects should we receive marketing approval.

Such developments

may include changes to the safety or efficacy profile of the other product or device, changes to the availability of the approved product

or device, and changes to the standard of care.

In the event that any future

collaborator or supplier of other chemotherapies, or any other products administered in combination, or any devices used, with our product

candidates does not supply their products on commercially reasonable terms or in a timely fashion, we would need to identify alternatives

for accessing these products.

This could cause our clinical trials to be delayed and limit the commercial opportunities for our product

candidates, in which case our business, financial condition, results of operations, stock price and prospects may be materially harmed.

We may seek additional Orphan Drug, Fast

Track (“FTD”), Breakthrough (“BTD”) or orphan and priority (“PRIME”) designations for one or more

of our current and future product candidates, but we might not receive any such designation, and even if we do, such designation may not

actually lead to a faster development or regulatory review or approval process.

Our lead product candidate,

elraglusib, has been given FTD from the FDA for development in the treatment of pancreatic cancer, and we may seek FTD for other indications

or future product candidates.

The FTD program is intended to expedite or facilitate the process for reviewing product candidates that

meet certain criteria.

Specifically, biologics are eligible for Fast Track designation if they are intended, alone or in combination with

one or more drugs or biologics, to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet

medical needs for the disease or condition.

Fast Track designation applies to the combination of the product candidate and the specific

indication for which it is being studied.

The sponsor of a Fast Track product candidate has opportunities for more frequent interactions

with the applicable FDA review team during product development and, once an NDA is submitted, the application may be eligible for priority

An NDA submitted for a Fast Track product candidate may also be eligible for rolling review, where the FDA may consider for review

sections of the NDA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission

of the sections of the NDA, the FDA agrees to accept sections of the NDA and determines that the schedule is acceptable, and the sponsor

pays any required user fees upon submission of the first section of the NDA.

Fast Track designation does not ensure that we will receive

marketing approval or that approval will be granted within any particular timeframe or at all.

We may not experience a faster development,

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

Additionally, the FDA may withdraw

Fast Track designation, for reasons such as it comes to believe a drug candidate no longer adequately addresses an unmet medical need

or that the designation is no longer supported by data from our clinical development program.

Fast Track designation alone does not guarantee

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received Fast Track designation have ultimately failed to obtain approval.

We, or any future collaborators, may not be

able to obtain and maintain orphan drug exclusivity for our product candidates in the United States and Europe.

Elraglusib has been granted ODD

for the treatment of pancreatic cancer, glioblastomas, neuroblastoma and soft tissue sarcomas in the United States.

We may seek additional

ODD or regulatory incentives for other indications, for the oral dosage form of elraglusib, or for future product candidates in the United

States, EU, Japan or Australia.

We, or any future collaborators, may not

be able to obtain and maintain orphan drug exclusivity for our product candidates in the United States and Europe.

Elraglusib has been granted

orphan drug designation (“ODD”) for the treatment of pancreatic cancer, glioblastomas, neuroblastoma and soft tissue sarcomas

in the United States.

We may seek additional ODD or regulatory incentives for other indications, for the oral dosage form of elraglusib,

or for future product candidates in the United States, EU, Japan or Australia.

We may not be able to obtain such designations.

While elraglusib currently has

been granted ODD from the FDA for limited indications, we may not be able to maintain this orphan drug exclusivity.

Further, even if we

obtain ODD for a future product candidate or for elraglusib with respect to a different indication, we may not be able to maintain orphan

drug exclusivity for that drug or indication.

For example, ODD may be removed if the prevalence of an indication increases beyond the

patient number limit required to maintain designation.

Generally, if a drug with an ODD subsequently receives the first marketing approval

for the indication for which it has such designation, the drug is entitled to a period of marketing exclusivity, which precludes the EMA

or the FDA from approving another marketing application for the same product in the same indication for that time period.

exclusivity may be lost if the FDA or EMA determines that the request for designation was materially defective or if the manufacturer

While elraglusib currently

has been granted ODD from the FDA for limited indications, we may not be able to maintain this orphan drug exclusivity.

Further, even

if we obtain ODD for a future product candidate or for elraglusib with respect to a different indication, we may not be able to maintain

orphan drug exclusivity for that drug or indication.

For example, ODD may be removed if the prevalence of an indication increases beyond

the patient number limit required to maintain designation.

Generally, if a drug with an ODD subsequently receives the first marketing

approval for the indication for which it has such designation, the drug is entitled to a period of marketing exclusivity, which precludes

the EMA or the FDA from approving another marketing application for the same product in the same indication for that time period.

drug exclusivity may be lost if the FDA or EMA determines that the request for designation was materially defective or if the manufacturer

is unable to assure sufficient quantity of the product to meet the needs of patients with the rare disease or condition.

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to our product.

The FDA may reevaluate the Orphan

Drug Act and its regulations and policies, and similarly the EMA may reevaluate its policies and regulations.

We do not know if, when,

or how the FDA or EMA may change their orphan drug regulations and policies in the future, and it is uncertain how any changes might affect

our business.

Depending on what changes the FDA and/or EMA may make to their orphan drug regulations and policies, our business could

be adversely impacted.

We rely on third parties for the manufacture

and shipping of elraglusib for clinical development and expect to continue to do so for the foreseeable future.

If we or our licensees,

development collaborators, or suppliers are unable to manufacture our products in sufficient quantities or at defined quality specifications,

or are unable to obtain regulatory approvals for the manufacturing facility, we may be unable to develop and/or meet demand for our products

and lose time to market and potential revenues.

Completion of our clinical trials

and commercialization of our product candidates require access to, or development of, facilities to manufacture a sufficient supply of

our product candidates.

We do not own or operate manufacturing facilities and have no plans to develop our own clinical or commercial-scale

manufacturing capabilities.

We rely on a third-party manufacturer for the production of elraglusib and expect to continue to rely on third-party

manufacturers for commercial manufacture if elraglusib or any future product candidates receive regulatory approval.

The facilities used

by third-party manufacturers to manufacture elraglusib or any future product candidate must be approved for the manufacture of such product

candidate by the FDA and any comparable foreign regulatory authority pursuant to inspections that will be conducted after we submit an

NDA to the FDA or any comparable submission to a foreign regulatory authority.

We do not control the manufacturing process of, and are

completely dependent on, third-party manufacturers for compliance with cGMP requirements for the manufacture of products.

we have no control over the ability of third-party manufacturers to maintain adequate quality control, quality assurance and qualified

If the FDA or any comparable foreign

regulatory authority does not approve these facilities for the manufacture of elraglusib or any future product candidates or if it withdraws

any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability

to develop, obtain regulatory approval for or market elraglusib or any future product candidates, if approved.

Our failure, or the failure

of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including clinical

holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, seizures or recalls of elraglusib or any future

product candidates, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of

elraglusib or any future product candidates.

We may not be successful in identifying additional or replacement third-party manufacturers,

or in negotiating acceptable terms with any we do identify.

We may face competition for access to these manufacturers’ facilities

and may be subject to manufacturing delays if the manufacturers give other clients higher priority than they give to us.

Even if we are

able to identify an additional or replacement third-party manufacturer, the delays and costs associated with establishing and maintaining

a relationship with such manufacturer may have a material adverse effect on us.

Before we begin to commercially

manufacture elraglusib or any other product candidate, we must obtain regulatory approval of the manufacturing facility and process by

the FDA and any comparable foreign regulatory authority pursuant to inspections that will be conducted after we submit an NDA to the FDA

or any comparable submission to a foreign regulatory authority.

Manufacturing of drugs for clinical and commercial purposes must comply

We do not control the manufacturing process of, and are completely dependent on, third-party manufacturers’ for compliance

with cGMP requirements for the manufacture of products.

If these third-party manufacturers cannot successfully manufacture material that

conforms to our specifications and the strict regulatory requirements of the FDA or any comparable foreign regulatory authority, they

will not be able to secure and/or maintain regulatory approval for their manufacturing facilities.

The cGMP requirements govern quality

control and documentation policies and procedures.

Complying with cGMP and non-U.S.

regulatory requirements will require that we expend

time, money, and effort in production, recordkeeping, and quality control to ensure that the product meets applicable specifications and

other requirements.

We or our contracted manufacturing facility must also pass a pre-approval inspection prior to FDA approval.

to pass a pre-approval inspection may significantly delay or prevent FDA approval of our products.

If we fail to comply with these requirements,

we would be subject to possible regulatory action and may be limited in the jurisdictions in which we are permitted to market and sell

our products, which could adversely impact and delay our ability to potentially generate revenue.

We depend on a third-party manufacturer for

certain drug substances, drug products, raw materials, samples, components, and other materials used in our product candidates.

our supplies on a purchase order basis and do not have any long-term supply agreements in place.

If we are unable to source these supplies

on a timely basis, or establish longer-term contracts with suppliers, we will not be able to complete our clinical trials or studies on

time and the development of our product candidates may be delayed.

We depend on a third-party manufacturer

for certain drug substances, drug products, raw materials, samples, components and other materials used in our product candidates.

obtain our supplies on a purchase order basis and do not currently have long-term supply contracts with our supplier, and our supplier

is not obligated to supply drug products to us for any period, in any specified quantity or at any certain price beyond the delivery contemplated

by the relevant purchase orders.

As a result, our supplier could stop selling to us at commercially reasonable prices, or at all.

we intend to enter into long-term supply agreements in the future as we advance our clinical trials or commercialization plans, we may

not be successful in negotiating such agreements on favorable terms, or at all.

If we do enter into such long-term supply agreements,

we could be subject to binding long-term purchase obligations that are less favorable than purchasing on a purchase order basis, and which

may be harmful to our business, including in the event that we do not conduct our trials on planned timelines or utilize the drug products

that we are required to purchase.

Any change in our relationship with our supplier or changes to our arrangement with our supplier could

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

Furthermore, our supplier could

stop producing our supplies, cease operations or be acquired by, or enter into exclusive arrangements with, our competitors.

additional or replacement suppliers for these supplies, and obtaining regulatory clearance or approvals that may result from adding or

replacing suppliers, could take a substantial amount of time, result in increased costs and impair our ability to produce our products

or conduct timely trials, which would adversely impact our business, financial condition, results of operations and prospects.

interruption or delay may force us to seek similar supplies from alternative sources, which may not be available at reasonable prices,

Any interruption in the supply of source components for our product candidates would adversely affect our ability to meet scheduled

timelines and budget for the development and commercialization of our product candidates, could result in higher expenses and would harm

our business.

Although we have not experienced any significant disruption as a result of our reliance on our supplier, we have a limited

operating history and cannot assure you that we will not experience disruptions in our supply chain in the future as a result of such

reliance or otherwise.

It is uncertain whether product liability insurance

will be adequate to address product liability claims, or that insurance against such claims will be affordable or available on acceptable

terms in the future.

Clinical research involves the

testing of new drugs on human volunteers pursuant to a clinical trial protocol.

The FDA may reevaluate the

Orphan Drug Act and its regulations and policies, and similarly the EMA may reevaluate its policies and regulations.

We do not know if,

when, or how the FDA or EMA may change their orphan drug regulations and policies in the future, and it is uncertain how any changes might

affect our business.

Depending on what changes the FDA and/or EMA may make to their orphan drug regulations and policies, our business

could be adversely impacted.

It is uncertain whether product liability

insurance will be adequate to address product liability claims, or that insurance against such claims will be affordable or available

on acceptable terms in the future.

Clinical research involves

the testing of new drugs on human volunteers pursuant to a clinical trial protocol.

Such testing involves a risk of liability for personal

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with which we enter into development, marketing, or distribution collaborations.

Although we are contracting for general liability insurance

in connection with our ongoing business, there can be no assurance that the amount and scope of such insurance coverage will be appropriate

and sufficient in the event any claims arise, that we will be able to secure additional coverage should we attempt to do so, or that our

insurers would not contest or refuse any attempt by us to collect on such insurance policies.

Furthermore, there can be no assurance that

suitable product liability insurance (at the clinical stage and/or commercial stage) will continue to be available on terms acceptable

While we do have liability insurance coverage, regardless

of their merit or eventual outcome, product liability claims may result in:

· withdrawal of clinical trial volunteers;

· decreased demand for our products when approved;

· injury to our reputation and significant, adverse

media attention;

· potentially significant litigation costs, including

without limitation, any damages awarded to the plaintiffs if we lose or settle claims.

There can be no assurance

that suitable product liability insurance (at the clinical stage and/or commercial stage) will continue to be available on terms acceptable

to us or at all, or that, if obtained, the insurance coverage will be appropriate and sufficient to cover any potential claims or liabilities.

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populations are very small, we may never achieve profitability despite obtaining such significant market share.

Our product development efforts are at

an early stage.

We have not yet undertaken any marketing efforts, and there can be no assurance that future anticipated market testing

and analyses will validate our marketing strategy.

We may need to modify the products, or we may not be successful in either developing

or marketing those products.

As a company, we have not

completed the development or clinical trials of any product candidate and, accordingly, have not yet begun to market or generate revenue

from the commercialization of any products.

Obtaining approvals of these product candidates will require substantial additional research

and development as well as costly clinical trials.

There can be no assurance that we will successfully complete the development of our

product candidates or successfully market them.

We may encounter problems and delays relating to research and development, regulatory

approval, intellectual property rights of product candidates, or other factors.

There can be no assurance that our development programs

will be successful, that our product candidates will prove to be safe and effective in or after clinical trials, that the necessary regulatory

approvals for any product candidates will be obtained, or, even if obtained, will be as broad as sought or will be maintained for any

period thereafter, that patents will issue on our patent applications, that any intellectual property protections we secure will be adequate,

or that our collaboration arrangements will not diminish the value of our intellectual property through licensing or other arrangements.

Furthermore, elraglusib and

any future product candidates may not be commercially successful.

Even if elraglusib or any future product candidates receive regulatory

approval, they may not gain market acceptance among physicians, patients, healthcare payors, or the medical community.

The commercial

success of elraglusib or any future product candidates will depend significantly on the broad adoption and use of the resulting product

by these individuals and organizations for approved indications, and there can be no assurance that competitive products will not perform

better and/or be marketed more successfully.

Additionally, there can be no assurances that any future market testing and analyses will

validate our marketing strategies.

We may need to seek to modify the product labels through additional studies in order to be able to

market them successfully to reach their commercial potential.

If elraglusib or any future product candidates is approved but does not

achieve an adequate level of acceptance by physicians, hospitals, healthcare payors or patients, we may not generate sufficient revenue

from that product and may not become or remain profitable.

Our efforts to educate the medical community and third-party payors regarding

the benefits of our products may require significant resources and may never be successful.

We currently have no marketing and sales

organization and have no experience as a company in commercializing products, and we may need to invest significant resources to develop

these capabilities.

If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market,

sell and distribute our products, we may not be able to generate product revenue.

We have no internal sales,

marketing or distribution capabilities, nor have we ever commercialized a product.

If elraglusib or any future product candidate ultimately

receives regulatory approval, we must build a marketing and sales organization with technical expertise and supporting distribution capabilities

to commercialize each such product in major markets, which will be expensive and time consuming, or collaborate with third parties that

have direct sales forces and established distribution systems, either to augment our own sales force and distribution systems or in lieu

of our own sales force and distribution systems.

For example, if elraglusib is approved, we will need to scale up a cost-effective and

reliable cold chain distribution and logistics network, which we may be unable to accomplish and which will require us to rely on third-party

distributors.

Failure to scale up our cold chain supply logistics, by us or third parties, could in the future lead to additional manufacturing

costs and delays in our ability to supply required quantities for commercial supply.

We have no prior experience

as a company with the marketing, sale or distribution of biopharmaceutical products and there are significant risks involved in the building

and managing of a sales organization, including our ability to hire, retain and incentivize qualified individuals, generate sufficient

sales leads, provide adequate training to and develop appropriate compliance programs for sales and marketing personnel and effectively

manage a geographically dispersed sales and marketing team.

Any failure or delay in the development of our internal sales, marketing and

distribution capabilities would adversely impact the commercialization of these products.

We may not be able to enter into collaborations

or hire consultants or external service providers to assist us in sales, marketing and distribution functions on acceptable financial

terms, or at all.

In addition, our product revenue and our profitability, if any, may be lower if we rely on third parties for these functions

than if we were to market, sell and distribute any products that we develop ourselves.

We likely will have little control over such third

parties, and any of them may fail to devote the necessary resources and attention to sell and market our products effectively.

not successful in commercializing our products, either on our own or through arrangements with one or more third parties, we may not be

able to generate any future product revenue and we would incur significant additional losses.

If we are unable to establish relationships

with licensees or collaborators to carry out sales, marketing, and distribution functions or to create effective marketing, sales, and

distribution capabilities, we will be unable to market our products successfully.

Our business strategy may

include selling product candidates, out-licensing product candidates to or collaborating with larger firms with experience in marketing

and selling pharmaceutical products.

There can be no assurance that we will successfully be able to establish marketing, sales, or distribution

relationships with any third-party, that such relationships, if established, will be successful, or that we will be successful in gaining

market acceptance for any products we might develop.

To the extent that we enter into any marketing, sales, or distribution arrangements

with third parties, our product revenues per unit sold are expected to be lower than if we marketed, sold, and distributed our products

directly, and any revenues we receive will depend upon the efforts of such third parties.

The successful commercialization of elraglusib

or any future product candidates, if approved, will depend in part on the extent to which governmental authorities and health insurers

establish coverage, adequate reimbursement levels and favorable pricing policies.

Failure to obtain or maintain coverage and adequate

reimbursement for our products could limit our ability to market those products and decrease our ability to generate revenue.

The availability of coverage

and the adequacy of reimbursement by governmental healthcare programs such as Medicare and Medicaid, private health insurers and other

third-party payors are essential for most patients to be able to afford prescription medications such as elraglusib or any future product

candidates, if approved.

Our ability to achieve coverage and acceptable levels of reimbursement for our products by third-party payors

will have an effect on our ability to successfully commercialize those products.

Accordingly, we will need to successfully implement a

coverage and reimbursement strategy for any approved product candidate.

Even if we obtain coverage for a given product by a third-party

payor, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high.

If we participate in the Medicaid

Drug Rebate Program or other governmental pricing programs, in certain circumstances, our products would be subject to ceiling prices

set by such programs, which could reduce the revenue we may generate from any such products.

Participation in such programs would also

expose us to the risk of significant civil monetary penalties, sanctions and fines should we be found to be in violation of any applicable

obligations thereunder.

Third-party payors increasingly

are challenging prices charged for biopharmaceutical products and services, and many third-party payors may refuse to provide coverage

and reimbursement for particular drugs when an equivalent generic drug or a less expensive therapy is available.

It is possible that a

third-party payor may consider our products as substitutable and offer to reimburse patients only for the less expensive product.

if we are successful in demonstrating improved efficacy or improved convenience of administration with our products, pricing of existing

drugs may limit the amount we will be able to charge for our products.

These payors may deny or revoke the reimbursement status of a given

product or establish prices for new or existing marketed products at levels that are too low to enable us to realize an appropriate return

on our investment in product development.

If reimbursement is not available or is available only at limited levels, we may not be able

to successfully commercialize our products and may not be able to obtain a satisfactory financial return on products that we may develop.

There is significant uncertainty

related to third-party payor coverage and reimbursement of newly approved products.

In the United States, third-party payors, including

private and governmental payors, such as the Medicare and Medicaid programs, play an important role in determining the extent to which

new drugs will be covered.

Some third-party payors may require pre-approval of coverage for new or innovative devices or drug therapies

before they will reimburse healthcare providers who use such therapies.

It is difficult to predict at this time what third-party payors

will decide with respect to the coverage and reimbursement for elraglusib or any future product candidates.

Risks Related to Our Reliance on Third Parties

The termination of third-party licenses could

adversely affect our rights to important technologies.

The termination of third-party licenses

could adversely affect our rights to important technologies.

In connection with our efforts

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Our existing licensing agreements with UIC and NU contain diligence obligations to maintain each license agreement.

Moreover, disputes may arise regarding

intellectual property subject to a licensing agreement, including:

Moreover, disputes may arise

regarding intellectual property subject to a licensing agreement, including:

· the scope of rights granted under the license

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· the priority of invention of patented technology.

In addition, the

agreements under which we currently license intellectual property or technology from third parties are complex, and certain provisions

in such agreements may be susceptible to multiple interpretations.

The resolution of any contract interpretation disagreement that may

arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology or increase what

we believe to be our consolidated financial or other obligations under the relevant agreement, either of which could have a material adverse

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

Moreover, if disputes over intellectual property that

we have licensed prevent or impair our ability to maintain our current licensing arrangements on commercially acceptable terms, we may

be unable to successfully develop and commercialize the affected product candidates, which could have a material adverse effect on our

business, financial conditions, results of operations and prospects.

In addition, the agreements under which

we currently license intellectual property or technology from third parties are complex, and certain provisions in such agreements may

be susceptible to multiple interpretations.

The resolution of any contract interpretation disagreement that may arise could narrow what

we believe to be the scope of our rights to the relevant intellectual property or technology or increase what we believe to be our consolidated

financial or other obligations under the relevant agreement, either of which could have a material adverse effect on our business, financial

condition, results of operations and prospects.

Moreover, if disputes over intellectual property that we have licensed prevent or impair

our ability to maintain our current licensing arrangements on commercially acceptable terms, we may be unable to successfully develop

and commercialize the affected product candidates, which could have a material adverse effect on our business, financial conditions,

results of operations and prospects.

We may also have limited control

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is possible that the licensors’ infringement proceeding or defense activities may be less vigorous than had we conducted them ourselves.

Our current elraglusib DS manufacturer is in

China, and it is unknown how current or future geopolitical relationships with China may affect our ability to obtain DS, increase our

costs, delay clinical trials and potential regulatory approval, and adversely impact our financial condition.

Our current drug substance (“DS”) manufacturer of

elraglusib is in China, and it is unknown how current or future geopolitical relationships with China may affect our ability to obtain

DS, increase our costs, delay clinical trials and potential regulatory approval, and adversely impact our financial condition.

We rely upon a single company

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This company manufactures DS under cGMP that is suitable

for formulating into a therapeutic used in humans, which manufacturing process is substantially completed in the United States.

not have any exclusive contractual commitments for this company to manufacture for us in the future or to ever become a sole provider

for formulating into a therapeutic used in humans, which drug product manufacturing process is substantially completed in the United States.

We do not have any exclusive contractual commitments for this company to manufacture for us in the future or to ever become a sole provider

of DS and thus, we do have the ability to seek out other GMP manufacturers if needed.

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increase, adversely impacting our financial condition.

We may be unable to identify additional

manufacturers with whom we might establish appropriate arrangements on acceptable terms, if at all.

Even if we are able to find replacement

manufacturers, suppliers, vendors and service providers when needed, we may not be able to enter into agreements with them on terms and

conditions favorable to us or there could be a substantial delay before such manufacturer, vendor or supplier, or a related new facility

is properly qualified and registered with the FDA or other foreign regulatory authorities.

A new manufacturer currently not qualified

with the FDA would have to be educated in, or develop substantially equivalent processes for, production of our approved products after

receipt of FDA approval.

We may be unable to identify

additional manufacturers with whom we might establish appropriate arrangements on acceptable terms, if at all.

Even if we are able to

find replacement manufacturers, suppliers, vendors and service providers when needed, we may not be able to enter into agreements with

them on terms and conditions favorable to us or there could be a substantial delay before such manufacturer, vendor or supplier, or a

related new facility is properly qualified and registered with the FDA or other foreign regulatory authorities.

A new manufacturer currently

not qualified with the FDA would have to be educated in, or develop substantially equivalent processes for, production of our approved

products after receipt of FDA approval.

To qualify and receive regulatory approval for a new manufacturer could take as long as two years.

of changing a supplier could have an adverse impact on our current clinical development programs if supplies of DS or materials on hand

are insufficient to satisfy demand.

The process of changing a supplier could have an adverse impact on our current clinical development programs if supplies of DS or materials

on hand are insufficient to satisfy demand.

Such delays could have a material adverse effect on our development activities and our business.

changes in the political and economic policies of the Chinese government could have a material adverse effect on the overall economic

Adverse changes in the political and economic policies of the Chinese government could have a material adverse effect on the overall economic

growth of China, which could adversely affect our ability to conduct business in China.

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ability to manufacture and develop our product candidates in China.

We rely on third parties to conduct our non-clinical

studies and clinical trials.

If these parties do not successfully carry out their duties or meet deadlines, we may be unable to obtain

regulatory approval for or commercialize our product candidates and adversely affect our financial condition.

We do not have the ability to

independently conduct non-clinical studies and clinical trials.

We rely on third parties for the manufacture

and shipping of elraglusib for clinical development and expect to continue to do so for the foreseeable future.

If we or our licensees,

development collaborators, or suppliers are unable to manufacture our products in sufficient quantities or at defined quality specifications,

or are unable to obtain regulatory approvals for the manufacturing facility, we may be unable to develop and/or meet demand for our products

and lose time to market and potential revenues.

Completion of our clinical

trials and commercialization of our product candidates require access to, or development of, facilities to manufacture a sufficient supply

of our product candidates.

We do not own or operate manufacturing facilities and have no plans to develop our own clinical or commercial-scale

manufacturing capabilities.

We rely on a third-party manufacturer for the production of elraglusib and expect to continue to rely on third-party

manufacturers for commercial manufacture if elraglusib or any future product candidates receive regulatory approval.

The facilities used

by third-party manufacturers to manufacture elraglusib or any future product candidate must be approved for the manufacture of such product

candidate by the FDA and any comparable foreign regulatory authority pursuant to inspections that will be conducted after we submit an

NDA to the FDA or any comparable submission to a foreign regulatory authority.

We do not control the manufacturing process of, and are

completely dependent on, third-party manufacturers for compliance with cGMP requirements for the manufacture of products.

we have no control over the ability of third-party manufacturers to maintain adequate quality control, quality assurance and qualified

If the FDA or any comparable

foreign regulatory authority does not approve these facilities for the manufacture of elraglusib or any future product candidates or if

it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact

our ability to develop, obtain regulatory approval for or market elraglusib or any future product candidates, if approved.

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

including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, seizures or recalls of elraglusib

or any future product candidates, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect

supplies of elraglusib or any future product candidates.

We may not be successful in identifying additional or replacement third-party

manufacturers, or in negotiating acceptable terms with any we do identify.

We may face competition for access to these manufacturers’

facilities and may be subject to manufacturing delays if the manufacturers give other clients higher priority than they give to us.

if we are able to identify an additional or replacement third-party manufacturer, the delays and costs associated with establishing and

maintaining a relationship with such manufacturer may have a material adverse effect on us.

We depend on a third-party manufacturer

for certain drug substances, drug products, raw materials, samples, components, and other materials used in our product candidates.

obtain our supplies on a purchase order basis and do not have any long-term supply agreements in place.

If we are unable to source these

supplies on a timely basis, or establish longer-term contracts with suppliers, we will not be able to complete our clinical trials or

studies on time and the development of our product candidates may be delayed.

We depend on a third-party

manufacturer for certain drug substances, drug products, raw materials, samples, components and other materials used in our product candidates.

We obtain our supplies on a purchase order basis and do not currently have long-term supply contracts with our supplier, and our supplier

is not obligated to supply drug products to us for any period, in any specified quantity or at any certain price beyond the delivery contemplated

by the relevant purchase orders.

As a result, our supplier could stop selling to us at commercially reasonable prices, or at all.

we intend to enter into long-term supply agreements in the future as we advance our clinical trials or commercialization plans, we may

not be successful in negotiating such agreements on favorable terms, or at all.

If we do enter into such long-term supply agreements,

we could be subject to binding long-term purchase obligations that are less favorable than purchasing on a purchase order basis, and which

may be harmful to our business, including in the event that we do not conduct our trials on planned timelines or utilize the drug products

that we are required to purchase.

Any change in our relationship with our supplier or changes to our arrangement with our supplier could

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

Furthermore, our supplier

could stop producing our supplies, cease operations or be acquired by, or enter into exclusive arrangements with, our competitors.

additional or replacement suppliers for these supplies, and obtaining regulatory clearance or approvals that may result from adding or

replacing suppliers, could take a substantial amount of time, result in increased costs and impair our ability to produce our products

or conduct timely trials, which would adversely impact our business, financial condition, results of operations and prospects.

interruption or delay may force us to seek similar supplies from alternative sources, which may not be available at reasonable prices,

Any interruption in the supply of source components for our product candidates would adversely affect our ability to meet scheduled

timelines and budget for the development and commercialization of our product candidates, which could result in higher expenses and would

harm our business.

Although we have not experienced any significant disruption as a result of our reliance on our supplier, we have a

limited operating history and cannot assure you that we will not experience disruptions in our supply chain in the future as a result

of such reliance or otherwise.

We rely on third parties to conduct our

non-clinical studies and clinical trials.

If these parties do not successfully carry out their duties or meet deadlines, we may be unable

to obtain regulatory approval for or commercialize our product candidates and adversely affect our financial condition.

We do not have the ability

to independently conduct non-clinical studies and clinical trials.

We rely on medical institutions, clinical investigators, contract laboratories,

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to control the amount or timing of resources that they devote to our programs.

Although we rely on third parties

to conduct our non-clinical studies and clinical trials, we remain responsible for ensuring that each of our non-clinical studies and

clinical trials is conducted in accordance with its investigational plan and protocol.

Although we rely on third

parties to conduct our non-clinical studies and clinical trials, we remain responsible for ensuring that each of our non-clinical studies

and clinical trials is conducted in accordance with its investigational plan and protocol.

Moreover, the FDA, EMA and other foreign regulatory

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that the trial subjects are adequately informed of the potential risks of participating in clinical trials.

In addition, the execution of

non-clinical studies and clinical trials, and the subsequent compilation and analyses of the data produced, requires coordination among

In addition, the execution

of non-clinical studies and clinical trials, and the subsequent compilation and analyses of the data produced, requires coordination among

various parties.

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our financial condition will be adversely affected.

Our reliance on third parties requires us to

share our trade secrets, which increases the possibility that a competitor or other third party will discover them or that our trade secrets

will be misappropriated or disclosed.

Because we currently rely on third

parties to manufacture elraglusib and to perform quality testing, we must, at times, share our proprietary technology and confidential

Our reliance on third parties requires us

to share our trade secrets, which increases the possibility that a competitor or other third party will discover them or that our trade

secrets will be misappropriated or disclosed.

Because we currently rely

on third parties to manufacture elraglusib and to perform quality testing, we must, at times, share our proprietary technology and confidential

information, including trade secrets, with them.

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results of operations and prospects.

Corporate, non-profit, and academic collaborators

may take actions (including lack of effective actions) to delay, prevent, or undermine the success of our products.

We may continue to

seek new collaborations or alliances in the future with respect to elraglusib or any future product candidates, but we may be unable to

do so or to realize the potential benefits of such transactions, which may cause us to alter or delay our development and commercialization

Our operating and financial strategy

for the development, clinical testing, manufacture, and commercialization of product candidates is heavily dependent on us entering into

collaborations with corporations, non-profit organizations, academic institutions, licensors, licensees, and other parties.

be no assurance that we will be successful in establishing such collaborations.

Current and future collaborations are and may be terminable

at the sole discretion of the collaborator.

The activities of any collaborator will not be within our direct control and may not be in

our power to influence.

There can be no assurance that any collaborator will perform its obligations to our satisfaction or at all;

we will derive any revenue, profits, or benefit from such collaborations;

or that any collaborator will not compete with us.

If any collaboration

is not pursued, we may require substantially greater capital to undertake development and commercialization of our proposed products,

and we may not be able to develop and commercialize such products effectively, if at all.

In addition, a lack of development and commercialization

collaborations may lead to significant delays in introducing proposed products into certain markets and/or reduced sales of proposed products

in such markets.

We also face significant competition

in seeking appropriate strategic partners, and the negotiation process can be time-consuming, costly and complex.

Even if we are successful

in our efforts to establish or maintain such collaborations, the terms that we agree upon may not be favorable to us.

As a result, we

may need to relinquish valuable rights to our future revenue streams, research programs, intellectual property, elraglusib or any future

product candidates, or grant licenses on terms that may not be favorable to us, as part of any such arrangement, and such arrangements

may restrict us from entering into additional agreements with other potential collaborators.

In addition, our current collaborations limit,

and potential future collaborations may limit, our control over the amount and timing of resources that our collaborators will dedicate

to the development or commercialization of elraglusib or any future product candidates.

Our ability to generate revenue from these arrangements

will depend on any current or future collaborators’ abilities to successfully perform the functions assigned to them in these arrangements.

We cannot be certain that, following a collaboration, license, or strategic transaction, we will achieve an economic benefit that justifies

such transaction, and such transaction may not yield additional development product candidates for our pipeline.

Furthermore, we may not

be able to maintain such collaborations if, for example, the development or approval of elraglusib or any future product candidate is

delayed, the safety of any such product candidate is questioned, or the sales of elraglusib, if approved, or an approved future product

candidate, are unsatisfactory.

In addition, our current collaborations

are, and potential future collaborations may be, terminable by our strategic partners, and we may not be able to adequately protect our

rights under these agreements.

Furthermore, strategic partners may negotiate for certain rights to control decisions regarding the development

and, if approved, commercialization of elraglusib or any future product candidates, and may not conduct those activities in the same manner

Any termination of collaborations we enter into in the future, or any delay in entering into collaborations related to elraglusib

or any future product candidates, could delay the development and, if approved, commercialization of such product candidates, and reduce

their competitiveness if they reach the market, which could have a material adverse effect on our business, financial condition, results

of operations and prospects.

Data provided by collaborators and other parties

upon which we rely have not been independently verified and could turn out to be inaccurate, misleading, or incomplete.

Data provided by collaborators and other

parties upon which we rely have not been independently verified and could turn out to be inaccurate, misleading, or incomplete.

We rely on third-party vendors,

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As a result, such data may be inaccurate, misleading, or incomplete.

In certain cases, we may need to rely on a single

supplier for a particular manufacturing material or service, and any interruption in or termination of service by such supplier could

delay or disrupt the commercialization of our products.

In certain cases, we may need to rely on

a single supplier for a particular manufacturing material or service, and any interruption in or termination of service by such supplier

could delay or disrupt the commercialization of our products.

We rely on third-party suppliers

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an alternative source of supply or in negotiating acceptable terms with such prospective supplier.

We may also rely on certain third-party vendors

located in China or who are owned by or are associated with certain Chinese companies to assist in non-clinical or clinical trials or

provide laboratory services.

It is unknown how current or future geopolitical relationships with China or specific Chinese-owned or associated

vendors may affect our ability to complete our non-clinical or clinical trials.

We do not currently, but may in

the future, rely upon one or more companies located in China, or are owned or operated by Chinese companies to provide non-clinical or

clinical trial support services.

If so, the process of changing these vendors could have an adverse impact on our current clinical development

programs if they were no longer permitted to provide services or products due to geopolitical pressures, including legislative activities

or executive orders aimed at prohibiting certain Chinese or Chinese-owned biotechnology companies from engaging in biotechnology or biopharmaceutical

research activities.

We could experience delays in finding suitable replacement service providers located outside China or not otherwise

owned by or associated with Chinese companies, which could have a material adverse effect on our development activities and our business.

We are unable to predict whether or when proposed legislative or executive actions would be effective, and whether such changes would

materially and adversely affect our liquidity, access to capital and our ability to conduct business.

Any failure on our part to comply

with changing government regulations and policies could result in the loss of our ability to manufacture and develop our product candidates.

Risks Related to Commercialization of Elraglusib and any Future Product

We have a limited operating history and no products

approved for commercial sale, which may make it difficult to evaluate our prospects and likelihood of success.

We are a clinical-stage biopharmaceutical

company with a limited operating history.

We were originally incorporated in 2015, have no products approved for commercial sale and have

not generated any revenue to date.

Our operations to date have been limited to organizing and staffing our company, business planning,

raising capital, establishing our intellectual property portfolio and performing clinical trials and research and development of our product

Our approach to the research and development of product candidates is unproven, and we do not know whether we will be able

to develop any products of commercial value.

In addition, our lead product candidate, elraglusib, will require substantial additional

development and clinical research time and resources before we would be able to apply for or receive regulatory approvals and begin generating

revenue from product sales.

We have not yet demonstrated the ability to progress any product candidate beyond Phase 2 clinical trials,

obtain regulatory approvals, manufacture products at commercial scale or arrange for a third party to do so on our behalf, or conduct

sales and marketing activities necessary for successful product commercialization.

Investment in biopharmaceutical

product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential

product candidate will fail to demonstrate adequate efficacy or an acceptable safety profile, gain regulatory approval and become commercially

In addition, as a business with a limited operating history, we may encounter unforeseen expenses, difficulties, complications,

delays and other known and unknown factors and risks frequently experienced by early-stage biopharmaceutical companies in rapidly evolving

Consequently, we have no meaningful history of operations upon which to evaluate our business, and predictions about our future

success or viability may not be as accurate as they could be if we had a longer operating history or a history of successfully developing

and commercializing drug products.

Even if we receive regulatory approval for elraglusib

or any future product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result

in significant additional expense.

Any regulatory approvals that

we may receive for elraglusib or any future product candidates will require the submission of reports to regulatory authorities, subject

us to surveillance to monitor the safety and efficacy of the product, may contain significant limitations related to use restrictions

for specified age groups, warnings, precautions or contraindications, and may include burdensome post-approval study or risk management

requirements.

For example, the FDA may require a REMS as a condition of approval of elraglusib or any future product candidates, which

could include requirements for a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted

distribution methods, patient registries and other risk minimization tools.

In addition, if the FDA or a comparable

foreign regulatory authority approves elraglusib or any future product candidates, the manufacturing processes, labeling, packaging, distribution,

adverse event reporting, storage, advertising, promotion, import, export and recordkeeping for our products will be subject to extensive

and ongoing regulatory requirements.

These requirements include submissions of safety and other post-marketing information and reports,

registration, as well as continued compliance with cGMPs and GCP requirements for any clinical trials that we conduct post-approval.

Manufacturers

of approved products and their facilities are subject to continual review and periodic, unannounced inspections by the FDA and other regulatory

authorities for compliance with cGMP regulations and standards.

Failure to comply with regulatory requirements or later discovery of previously

unknown problems with our products, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers

or manufacturing processes, may result in, among other things:

· restrictions on the marketing or manufacturing

of our products, withdrawal of the product from the market or voluntary or mandatory product recalls;

· restrictions on product distribution or use,

or requirements to conduct post-marketing studies or clinical trials;

· restrictions on our ability to conduct clinical

trials, including full or partial clinical holds on ongoing or planned trials;

· fines, restitutions, disgorgement of profits

or revenue, warning letters, untitled letters, adverse publicity requirements or holds on clinical trials;

· refusal by the FDA or other regulatory authorities

to approve pending applications or supplements to approved applications submitted by us or suspension or revocation of approvals;

· product seizure or detention, or refusal to permit

the import or export of our products;

· injunctions and the imposition of civil or criminal

The occurrence of any event or

penalty described above may inhibit our ability to commercialize elraglusib or any future product candidates and generate revenue and

could require us to expend significant time and resources in response and could generate negative publicity.

The FDA’s and other regulatory

authorities’ policies may change and additional government regulations may be promulgated that could prevent, limit or delay marketing

authorization of elraglusib or any future product candidates.

We also cannot predict the likelihood, nature or extent of government regulation

that may arise from future legislation or administrative action, either in the United States or abroad.

If we are slow or unable to adapt

to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance,

we may be subject to enforcement action and we may not achieve or sustain profitability.

The FDA and other regulatory agencies actively

enforce the laws and regulations prohibiting the promotion of off-label uses.

The FDA and other regulatory agencies

strictly regulate the promotional claims that may be made about prescription products, such as elraglusib or any future product candidates,

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

as reflected in the product’s approved labeling.

If we receive regulatory approval for elraglusib or any future product candidates,

physicians may nevertheless prescribe it to their patients in a manner that is inconsistent with the approved label.

If we are found to

have promoted such off-label uses, we may become subject to significant liability.

federal government has levied large civil

and criminal fines against companies for alleged improper promotion of off-label use and has enjoined several companies from engaging

in off-label promotion.

The government has also required companies to enter into consent decrees or imposed permanent injunctions under

which specified promotional conduct is changed or curtailed.

If we cannot successfully manage the promotion of elraglusib or any future

product candidates, if approved, we could become subject to significant liability, which would materially adversely affect our business

and financial condition.

Our business is highly dependent on the success

of our lead product candidate, elraglusib, and any other future product candidates that we advance into clinical development, all of which

will require significant additional development before we can seek regulatory approval for and launch a product commercially.

We currently have no products

that are approved for commercial sale and may never be able to develop marketable products.

We have one clinical product candidate, elraglusib,

in clinical development.

Because elraglusib is our only product candidate, if elraglusib encounters safety or efficacy problems, development

delays, regulatory issues or other problems, our development plans and business would be significantly harmed.

For each product candidate,

we must demonstrate its safety and efficacy in humans, obtain regulatory approval in one or more jurisdictions, obtain manufacturing supply,

capacity and expertise, and substantially invest in marketing efforts before we will be able to generate any revenue from such product

These efforts will require substantial investment, and we may not have the financial resources to continue development of our

We may also rely on certain third-party

vendors located in China or who are owned by or are associated with certain Chinese companies to assist in non-clinical or clinical trials

or provide laboratory services.

It is unknown how current or future geopolitical relationships with China or specific Chinese-owned or

associated vendors may affect our ability to complete our non-clinical or clinical trials.

We do not currently, but may

in the future, rely upon one or more companies located in China, or are owned or operated by Chinese companies to provide non-clinical

or clinical trial support services.

If so, the process of changing these vendors could have an adverse impact on our current clinical

development programs if they were no longer permitted to provide services or products due to geopolitical pressures, including legislative

activities or executive orders aimed at prohibiting certain Chinese or Chinese-owned biotechnology companies from engaging in biotechnology

or biopharmaceutical research activities.

We could experience delays in finding suitable replacement service providers located outside

China or not otherwise owned by or associated with Chinese companies, which could have a material adverse effect on our development activities

and our business.

We are unable to predict whether or when proposed legislative or executive actions would be effective, and whether such

changes would materially and adversely affect our liquidity, access to capital and our ability to conduct business.

Any failure on our

part to comply with changing government regulations and policies could result in the loss of our ability to manufacture and develop our

product candidates.

We may experience setbacks that

could delay or prevent regulatory approval of, or our ability to commercialize, our product candidates, including:

· negative or inconclusive results from our clinical

trials or preclinical studies or the clinical trials or preclinical studies of others for product candidates similar to ours, leading

to a decision or requirement to conduct additional clinical trials or preclinical studies or to abandon a program;

· drug-related side effects experienced by subjects

in our clinical trials or by individuals using drugs or therapeutics similar to our product candidates;

· delays in submitting Investigational New Drug

applications, or INDs, or comparable foreign regulatory applications or delays or failure in obtaining the necessary approvals from regulators

to commence a clinical trial, or a suspension or termination of a clinical trial once commenced;

· conditions imposed by FDA or comparable foreign

authorities regarding the scope or design of our clinical trials or our drug development strategy;

· delays in enrolling subjects in clinical trials;

· high drop-out rates of subjects from clinical

· inadequate or delayed supply or quality of product

candidates or other materials necessary for the conduct of our clinical trials;

· greater than anticipated clinical trial costs;

· inability to compete with other therapies;

· unfavorable FDA or other regulatory agency inspection

and review of a clinical trial site;

· failure of our third-party manufacturers, contractors

or investigators to comply with regulatory requirements or otherwise meet their contractual obligations in a timely manner, or at all;

· delays in obtaining any pre-market inspections

required by FDA or other regulatory agencies;

· delays and changes in regulatory requirements,

policy and guidelines, including the imposition of additional regulatory oversight around clinical testing generally or with respect to

our technology in particular;

· varying interpretations of data by FDA and similar

foreign regulatory agencies.

We do not have complete control

over many of these factors, including certain aspects of clinical development and the regulatory submission process, potential threats

to our intellectual property rights and our manufacturing, marketing, distribution and sales efforts or that of any future collaborator.

Our product development efforts are at an early

We have not yet undertaken any marketing efforts, and there can be no assurance that future anticipated market testing and analyses

will validate our marketing strategy.

We may need to modify the products, or we may not be successful in either developing or marketing

those products.

As a company, we have not completed

the development or clinical trials of any product candidates and, accordingly, have not yet begun to market or generate revenue from the

commercialization of any products.

Obtaining approvals of these product candidates will require substantial additional research and development

as well as costly clinical trials.

There can be no assurance that we will successfully complete the development of our product candidates

or successfully market them.

We may encounter problems and delays relating to research and development, regulatory approval, intellectual

property rights of product candidates, or other factors.

There can be no assurance that our development programs will be successful, that

our product candidates will prove to be safe and effective in or after clinical trials, that the necessary regulatory approvals for any

product candidates will be obtained, or, even if obtained, will be as broad as sought or will be maintained for any period thereafter,

that patents will issue on our patent applications, that any intellectual property protections we secure will be adequate, or that our

collaboration arrangements will not diminish the value of our intellectual property through licensing or other arrangements.

Furthermore, elraglusib and any

future product candidates may not be commercially successful.

Even if elraglusib or any future product candidates receive regulatory approval,

they may not gain market acceptance among physicians, patients, healthcare payors, or the medical community.

The commercial success of

elraglusib or any future product candidates will depend significantly on the broad adoption and use of the resulting product by these

individuals and organizations for approved indications, and there can be no assurance that competitive products will not perform better

and/or be marketed more successfully.

Additionally, there can be no assurances that any future market testing and analyses will validate

our marketing strategies.

We may need to seek to modify the product labels through additional studies in order to be able to market them

successfully to reach their commercial potential.

If elraglusib or any future product candidates is approved but does not achieve an adequate

level of acceptance by physicians, hospitals, healthcare payors or patients, we may not generate sufficient revenue from that product

and may not become or remain profitable.

Our efforts to educate the medical community and third-party payors regarding the benefits of

our products may require significant resources and may never be successful.

We currently have no marketing and sales organization

and have no experience as a company in commercializing products, and we may need to invest significant resources to develop these capabilities.

If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market, sell and distribute

our products, we may not be able to generate product revenue.

We have no internal sales, marketing

or distribution capabilities, nor have we ever commercialized a product.

If elraglusib or any future product candidate ultimately receives

regulatory approval, we must build a marketing and sales organization with technical expertise and supporting distribution capabilities

to commercialize each such product in major markets, which will be expensive and time consuming, or collaborate with third parties that

have direct sales forces and established distribution systems, either to augment our own sales force and distribution systems or in lieu

of our own sales force and distribution systems.

For example, if elraglusib is approved, we will need to scale up a cost-effective and

reliable cold chain distribution and logistics network, which we may be unable to accomplish and which will require us to rely on third-party

distributors.

Failure to scale up our cold chain supply logistics, by us or third parties, could in the future lead to additional manufacturing

costs and delays in our ability to supply required quantities for commercial supply.

We have no prior experience as

a company with the marketing, sale or distribution of biopharmaceutical products and there are significant risks involved in the building

and managing of a sales organization, including our ability to hire, retain and incentivize qualified individuals, generate sufficient

sales leads, provide adequate training to and develop appropriate compliance programs for sales and marketing personnel and effectively

manage a geographically dispersed sales and marketing team.

Any failure or delay in the development of our internal sales, marketing and

distribution capabilities would adversely impact the commercialization of these products.

We may not be able to enter into collaborations

or hire consultants or external service providers to assist us in sales, marketing and distribution functions on acceptable financial

terms, or at all.

In addition, our product revenue and our profitability, if any, may be lower if we rely on third parties for these functions

than if we were to market, sell and distribute any products that we develop ourselves.

We likely will have little control over such third

parties, and any of them may fail to devote the necessary resources and attention to sell and market our products effectively.

not successful in commercializing our products, either on our own or through arrangements with one or more third parties, we may not be

able to generate any future product revenue and we would incur significant additional losses.

If we are unable to establish relationships

with licensees or collaborators to carry out sales, marketing, and distribution functions or to create effective marketing, sales, and

distribution capabilities, we will be unable to market our products successfully.

Our business strategy may include

selling product candidates, out-licensing product candidates to or collaborating with larger firms with experience in marketing and selling

pharmaceutical products.

There can be no assurance that we will successfully be able to establish marketing, sales, or distribution relationships

with any third-party, that such relationships, if established, will be successful, or that we will be successful in gaining market acceptance

for any products we might develop.

To the extent that we enter into any marketing, sales, or distribution arrangements with third parties,

our product revenues per unit sold are expected to be lower than if we marketed, sold, and distributed our products directly, and any

revenues we receive will depend upon the efforts of such third parties.

The successful commercialization of elraglusib

or any future product candidates, if approved, will depend in part on the extent to which governmental authorities and health insurers

establish coverage, adequate reimbursement levels and favorable pricing policies.

Failure to obtain or maintain coverage and adequate

reimbursement for our products could limit our ability to market those products and decrease our ability to generate revenue.

The availability of coverage and

the adequacy of reimbursement by governmental healthcare programs such as Medicare and Medicaid, private health insurers and other third-party

payors are essential for most patients to be able to afford prescription medications such as elraglusib or any future product candidates,

Our ability to achieve coverage and acceptable levels of reimbursement for our products by third-party payors will have an

effect on our ability to successfully commercialize those products.

Accordingly, we will need to successfully implement a coverage and

reimbursement strategy for any approved product candidate.

Even if we obtain coverage for a given product by a third-party payor, the

resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high.

If we participate in the Medicaid

Drug Rebate Program or other governmental pricing programs, in certain circumstances, our products would be subject to ceiling prices

set by such programs, which could reduce the revenue we may generate from any such products.

Participation in such programs would also

expose us to the risk of significant civil monetary penalties, sanctions and fines should we be found to be in violation of any applicable

obligations thereunder.

Third-party payors increasingly

are challenging prices charged for biopharmaceutical products and services, and many third-party payors may refuse to provide coverage

and reimbursement for particular drugs when an equivalent generic drug or a less expensive therapy is available.

It is possible that a

third-party payor may consider our products as substitutable and offer to reimburse patients only for the less expensive product.

if we are successful in demonstrating improved efficacy or improved convenience of administration with our products, pricing of existing

drugs may limit the amount we will be able to charge for our products.

These payors may deny or revoke the reimbursement status of a given

product or establish prices for new or existing marketed products at levels that are too low to enable us to realize an appropriate return

on our investment in product development.

If reimbursement is not available or is available only at limited levels, we may not be able

to successfully commercialize our products and may not be able to obtain a satisfactory financial return on products that we may develop.

There is significant uncertainty

related to third-party payor coverage and reimbursement of newly approved products.

In the United States, third-party payors, including

private and governmental payors, such as the Medicare and Medicaid programs, play an important role in determining the extent to which

new drugs will be covered.

Some third-party payors may require pre-approval of coverage for new or innovative devices or drug therapies

before they will reimburse healthcare providers who use such therapies.

It is difficult to predict at this time what third-party payors

will decide with respect to the coverage and reimbursement for elraglusib or any future product candidates.

Obtaining and maintaining reimbursement

status is time-consuming, costly and uncertain.

The Medicare and Medicaid programs increasingly are used as models for how private payors

and other governmental payors develop their coverage and reimbursement policies for drugs.

However, no uniform policy for coverage and

reimbursement for products exists among third-party payors in the United States.

Therefore, coverage and reimbursement for products can

differ significantly from payor to payor.

As a result, the coverage determination process is often a time consuming and costly process

that will require us to provide scientific and clinical support for the use of our products to each payor separately, with no assurance

that coverage and adequate reimbursement will be applied consistently or obtained in the first instance.

Furthermore, rules and regulations

regarding reimbursement change frequently, and, in some cases, at short notice, and we believe that changes in these rules and regulations

For products administered under the supervision of a physician, obtaining coverage and adequate reimbursement may be particularly

difficult because of the higher prices often associated with such drugs.

Additionally, separate reimbursement for the product itself or

the treatment or procedure in which the product is used may not be available, which may impact physician utilization.

Outside the United States, international

operations are generally subject to extensive governmental price controls and other market regulations, and we believe the increasing

emphasis on cost-containment initiatives in Europe and other countries has and will continue to put pressure on the pricing and usage

of elraglusib or any future product candidates, if approved in these jurisdictions.

In many countries, the prices of medical products

are subject to varying price control mechanisms as part of national health systems.

Other countries allow companies to fix their own prices

for medical products but monitor and control company profits.

Additional foreign price controls or other changes in pricing regulation

could restrict the amount that we are able to charge for our products.

Accordingly, in markets outside the United States, the reimbursement

for our products may be reduced compared with the United States and may be insufficient to generate commercially reasonable revenue and

Moreover, increasing efforts by

governmental and third-party payors in the United States and abroad to cap or reduce healthcare costs may cause such organizations to

limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate

payment for our products.

We expect to experience pricing pressures in connection with the sale of any of our products due to the trend

toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes.

pressure on healthcare costs in general, and prescription drugs, surgical procedures and other treatments in particular, has become very

As a result, increasingly high barriers are being erected to the entry of new products.

If we obtain FDA approval for any of our product

candidates, we will be subject to various federal and state fraud and abuse laws;

these laws may impact, among other things, our proposed

sales, marketing and education programs.

Fraud and abuse laws are expected to increase in breadth and in detail, which will likely increase

our operating costs and the complexity of our programs to ensure compliance with such enhanced laws.

If we obtain FDA approval for

any of our product candidates and begin commercializing those products in the United States, our operations may be directly, or indirectly

through our customers, distributors, or other business partners, subject to various federal and state fraud and abuse laws, including,

without limitation, anti-kickback statutes and false claims statutes which may increase our operating costs.

These laws may impact, among

other things, our proposed sales, marketing and education programs.

In addition, we may be subject to data privacy and security regulation

by both the federal government and the states in which we conduct business.

If our operations are found to be in violation of any of the federal

and state fraud and abuse laws or any other governmental regulations that apply to us, we may be subject to criminal actions and significant

civil monetary penalties, which would adversely affect our ability to operate our business and our results of operations.

If our operations are found to

be in violation of any of the federal and state fraud and abuse laws, including, without limitation, anti-kickback statutes and false

claims statutes or any other governmental regulations that apply to us, we may be subject to penalties, including criminal and significant

civil monetary penalties, damages, fines, imprisonment, exclusion from participation in government healthcare programs, and the curtailment

or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

To the extent that any of our product candidates are ultimately sold in a foreign country, we may be subject to similar foreign laws and

regulations, which may include, for instance, applicable post-marketing requirements, including safety surveillance, anti-fraud and abuse

laws, and implementation of corporate compliance programs and reporting of payments or transfers of value to healthcare professionals.

Risks Related to Our Intellectual Property

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In these countries, patents may provide limited or no benefit.

Proceedings to enforce our patent

rights in foreign jurisdictions, whether or not successful, could result in substantial costs and divert our efforts and attention from

other aspects of our business.

Furthermore, while we intend to protect our intellectual property rights in our expected significant markets,

we cannot ensure that we will be able to initiate or maintain similar efforts in all jurisdictions in which we may wish to market elraglusib

or any future products.

Proceedings to enforce our

patent rights in foreign jurisdictions, whether or not successful, could result in substantial costs and divert our efforts and attention

from other aspects of our business.

Furthermore, while we intend to protect our intellectual property rights in our expected significant

markets, we cannot ensure that we will be able to initiate or maintain similar efforts in all jurisdictions in which we may wish to market

elraglusib or any future products.

Accordingly, our efforts to protect our intellectual property rights in such countries may be inadequate.

changes in the law and legal decisions by courts in the United States and foreign countries may affect our ability to obtain and enforce

adequate intellectual property protection for our products and technology.

If we and our third-party licensors do not obtain

and preserve protection for key intellectual property rights, our competitors may be able to take advantage of our (and our licensors’)

In addition, changes in the law and legal decisions by courts in the United States and foreign countries may affect our ability to obtain

and enforce adequate intellectual property protection for our products and technology.

If we and our third-party licensors do not

obtain and preserve protection for key intellectual property rights, our competitors may be able to take advantage of our (and our licensors’)

development efforts.

We rely, and may in the future

rely, upon a combination of patent, trade secret and trademark protection for elraglusib and any future product candidates and proprietary

technologies to prevent third parties from exploiting our achievements, thus eroding our competitive position in our market.

measures afford only limited protection, and competitors or others may gain access to or use our intellectual property and proprietary

information to our detriment.

Our commercial success will depend in part on our ability to obtain, maintain, expand, enforce, and defend

the scope, ownership or control, validity and enforceability of our intellectual property protection in the United States and other countries

with respect to elraglusib and any future product candidates and other proprietary technologies we may develop.

We may also seek to protect

our proprietary position by acquiring or in-licensing relevant issued patents or pending patent applications from third parties.

licensed patents on the original composition of matter patents covering elraglusib from UIC.

In addition, we own and have filed several

new composition of matter patent applications that cover elraglusib polymorphs, which expire in 2038, with possibility for patent term

extensions (“PTEs”).

The patent process is subject

to numerous risks and uncertainties, and there can be no assurance that we will be successful in obtaining and defending patents.

risks and uncertainties include without limitation the following:

We rely, and may in the

future rely, upon a combination of patent, trade secret and trademark protection for elraglusib and any future product candidates and

proprietary technologies to prevent third parties from exploiting our achievements, thus eroding our competitive position in our market.

These legal measures afford only limited protection, and competitors or others may gain access to or use our intellectual property and

proprietary information to our detriment.

Our commercial success will depend in part on our ability to obtain, maintain, expand, enforce,

and defend the scope, ownership or control, validity and enforceability of our intellectual property protection in the United States and

other countries with respect to elraglusib and any future product candidates and other proprietary technologies we may develop.

also seek to protect our proprietary position by acquiring or in-licensing relevant issued patents or pending patent applications from

third parties.

We have licensed patents on the original composition of matter patents covering elraglusib from UIC.

In addition, we own

and have filed several new composition of matter patent applications that cover elraglusib polymorphs, which expire in 2038, with possibility

for patent term extensions (“PTEs”).

The patent process is

subject to numerous risks and uncertainties, and there can be no assurance that we will be successful in obtaining and defending patents.

These risks and uncertainties include without limitation the following:

· patents that may be issued or licensed may be

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intellectual property regulations is very weak or actively evaded in some cases with government aid.

In addition, the

In addition, the U.S.

Patent and Trademark Office (“USPTO”) and patent offices in other jurisdictions have often required that patent applications

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our licensors are able to obtain patents, the patents may be substantially narrower than anticipated.

If we permit our patents to lapse

or expire, we will not be protected and will have less of a competitive advantage.

The value of our products may be greatly reduced if

If we permit our patents to

lapse or expire, we will not be protected and will have less of a competitive advantage.

The value of our products may be greatly reduced

if this occurs.

Our patents expire at different

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these where appropriate.

In addition to patents, we also

rely on trade secrets and proprietary know-how.

While we take measures to protect this information by entering into confidentiality and

invention agreements with our consultants and collaborators, we cannot provide any assurances that these agreements will be fully enforceable

and will not be breached, that we will be able to protect ourselves from the harmful effects of disclosure if they are not fully enforceable

or are breached, that any remedy for a breach will adequately compensate us, that these agreements will achieve their intended aims, or

that our trade secrets will not otherwise become known or be independently discovered by competitors.

If any of these events for which

we cannot provide assurances occurs, or we otherwise lose protection for our trade secrets or proprietary know-how, the value of this

information may be greatly reduced.

In addition to patents, we

also rely on trade secrets and proprietary know-how.

While we take measures to protect this information by entering into confidentiality

and invention agreements with our consultants and collaborators, we cannot provide any assurances that these agreements will be fully

enforceable and will not be breached, that we will be able to protect ourselves from the harmful effects of disclosure if they are not

fully enforceable or are breached, that any remedy for a breach will adequately compensate us, that these agreements will achieve their

intended aims, or that our trade secrets will not otherwise become known or be independently discovered by competitors.

If any of these

events for which we cannot provide assurances occurs, or we otherwise lose protection for our trade secrets or proprietary know-how, the

value of this information may be greatly reduced.

The patent protection we obtain and preserve

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developed by a competitor, our competitive position would be harmed.

Changes to the patent law in the United States

and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.

As is the case with other biopharmaceutical

companies, our success is heavily dependent on intellectual property, particularly patents.

Changes in either the patent laws or their

interpretation in the United States and other jurisdictions may diminish our ability to protect our intellectual property, obtain, maintain,

expand, enforce and defend our intellectual property rights and, more generally, could affect the value of our intellectual property or

narrow the scope of our protection.

Obtaining and enforcing patents in the biopharmaceutical industry involves both technological and

legal complexity.

We cannot predict whether the patent applications we currently or may in the future pursue or may in-license will issue

as patents in any particular jurisdiction, whether the claims of any issued patents will provide sufficient protection against competitors

or other third parties, or if these patents are challenged by our competitors, whether the patents will be found to be invalid, unenforceable,

or not infringed or not owned or controlled by us.

The patent prosecution process is expensive, time-consuming, and complex, and we may

not be able to file, prosecute, maintain, enforce, defend or license all necessary or desirable patent applications or patents at a reasonable

cost or in a timely manner or in all jurisdictions.

It is also possible that we will fail to identify patentable aspects of our research

and development output in time to obtain patent protection.

Therefore, obtaining and enforcing biopharmaceutical patents is costly, time

consuming and inherently uncertain.

In addition, the United States has recently enacted and is currently implementing wide ranging patent

Changes to the patent law in the United

States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.

Changes in either the patent

laws or their interpretation in the United States and other jurisdictions may diminish our ability to protect our intellectual property,

obtain, maintain, expand, enforce and defend our intellectual property rights and, more generally, could affect the value of our intellectual

property or narrow the scope of our protection.

The United States has recently enacted and is currently implementing wide ranging patent

reform legislation.

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new patents or to enforce our existing patents and patents that we might obtain in the future.

Obtaining and maintaining our patent protection

depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent

agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

The USPTO and various foreign

governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the

patent process.

There are situations in which noncompliance can result in abandonment or lapse of a patent or patent application, resulting

in partial or complete loss of patent rights in the relevant jurisdiction.

In such an event, competitors might be able to enter the market

earlier than would otherwise have been the case.

Patent terms may be inadequate to protect the

competitive position of elraglusib or any future product candidates for an adequate amount of time.

Patent terms may be inadequate to protect

the competitive position of elraglusib or any future product candidates for an adequate amount of time.

Patents have a limited lifespan.

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is terminally disclaimed over an earlier-filed patent.

Various extensions may be available,

but the life of a patent, and the protection it affords, is limited.

Even if patents covering elraglusib or any future product candidates

are obtained, once the patent has expired, we may be vulnerable to competition from competitive products, including generics.

amount of time required for the development, testing and regulatory review of elraglusib or any future product candidates, patents protecting

such product candidates might expire before or shortly after such product candidates are commercialized.

In the United States, the Drug

Price Competition and Patent Term Restoration Act of 1984 permits a PTE of up to five years beyond the normal expiration of the patent

to compensate patent owners for loss of enforceable patent term due to the lengthy regulatory approval process.

A PTE grant cannot extend

the remaining term of a patent beyond a total of 14 years from the date of the product approval.

Further, PTE may only be applied once

per product, and only with respect to an approved indication - in other words, only one patent (for example, covering the

product itself, an approved use of said product, or a method of manufacturing said product) can be extended by PTE.

We anticipate applying

for PTE in the United States.

Similar extensions may be available in other countries where we are prosecuting patents, and we likewise

anticipate applying for such extensions.

The granting of such PTEs is not

guaranteed and is subject to numerous requirements.

We might not be granted an extension because of, for example, failure to apply within

applicable periods, failure to apply prior to the expiration of relevant patents or otherwise failure to satisfy any of the numerous applicable

requirements.

In addition, to the extent we wish to pursue PTE based on a patent that we in-license from a third party, we would need

the cooperation of that third party.

Moreover, the applicable authorities, including the FDA and the USPTO in the United States, and any

equivalent regulatory authority in other countries, may not agree with our assessment of whether such extensions are available, and may

refuse to grant extensions to our patents, or may grant more limited extensions than we request.

If this occurs, our competitors may be

able to obtain approval of competing products following our patent expiration by referencing our clinical and preclinical data and launching

their product earlier than might otherwise be the case.

If this were to occur, it could have a material adverse effect on our ability

to generate revenue.

If we fail to comply with our license, collaboration

or other intellectual property-related agreements, we may incur damages and could lose rights that may be necessary for developing, commercializing

and protecting our current or future technologies or drug candidates or granting sublicenses.

Any license, collaboration or

other intellectual property-related agreements impose, and any future license, collaboration or other intellectual property-related agreements

we enter into are likely to impose, various development, commercialization, funding, milestone, royalty, diligence, sublicensing, insurance,

patent prosecution and enforcement or other obligations on us.

If we breach any of these obligations, or use the intellectual property

licensed to us in an unauthorized manner, we may be required to pay damages and the licensor may have the right to terminate the license.

In spite of our best efforts, any of our future licensors might conclude that we have materially breached our license agreements and might

therefore terminate the license agreements, thereby removing our ability to develop and commercialize products and technologies covered

by these license agreements.

Any license agreements we enter into may be complex, and certain provisions in such agreements may be susceptible

to multiple interpretations.

The resolution of any contract interpretation disagreement that may arise could narrow what we believe to

be the scope our rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other

obligations under the relevant agreement, either of which could have a material adverse effect on our business, financial condition, results

of operations, and prospects.

We may seek to obtain licenses

from licensors in the future, however, we may be unable to obtain any such licenses at a reasonable cost or on reasonable terms, if at

In addition, if any of our future licensors terminate any such license agreements, such license termination could result in our inability

to develop, manufacture and sell products that are covered by the licensed technology or could enable a competitor to gain access to the

licensed technology.

Any of these events could have a material adverse effect on our competitive position, business, financial condition,

results of operations, and ability to achieve profitability.

Furthermore, we may not have the

right to control the preparation, filing, prosecution, maintenance, enforcement and defense of patents and patent applications that we

license from third parties.

Therefore, we cannot be certain that these patents and patent applications will be prepared, filed, prosecuted,

maintained, enforced and defended in a manner consistent with the best interests of our business.

If our future licensors fail to prosecute,

maintain, enforce and defend patents we may in-license, or lose rights to licensed patents or patent applications, our license rights

may be reduced or eliminated.

In such circumstances, our right to develop and commercialize any of our products or drug candidates that

is the subject of such licensed rights could be materially adversely affected.

In certain circumstances, our licensed patent rights are

subject to our reimbursing our licensors for their patent prosecution and maintenance costs.

Moreover, our licensors may own

or control intellectual property that has not been licensed to us and, as a result, we may be subject to claims, regardless of their merit,

that we are infringing, misappropriating or otherwise violating the licensor’s intellectual property rights and the amount of any

damages or future royalty obligations that would result, if any such claims were successful, would depend on the technology and intellectual

property we use in products that we successfully develop and commercialize, if any.

Therefore, even if we successfully develop and commercialize

products, due to such obligations, we may be unable to achieve or maintain profitability.

We may be subject to claims challenging the

inventorship or ownership of our patents and other intellectual property.

We may be subject to claims that

former employees, consultants, licensees, collaborators or other third parties have an interest in our patent rights, trade secrets, or

other intellectual property as an inventor, co-inventor or owner of trade secrets.

Various extensions may be

available, but the life of a patent, and the protection it affords, is limited.

Even if patents covering elraglusib or any future product

candidates are obtained, once the patent has expired, we may be vulnerable to competition from competitive products, including generics.

Given the amount of time required for the development, testing and regulatory review of elraglusib or any future product candidates, patents

protecting such product candidates might expire before or shortly after such product candidates are commercialized.

We may be subject to claims challenging

the inventorship or ownership of our patents and other intellectual property.

We may be subject to claims

that former employees, consultants, licensees, collaborators or other third parties have an interest in our patent rights, trade secrets,

or other intellectual property as an inventor, co-inventor or owner of trade secrets.

For example, we may have inventorship or ownership

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be available on commercially reasonable terms, or at all.

There are numerous companies that

have pending patent applications and issued patents broadly covering small molecules directed against the same targets as, or targets

There are numerous companies

that have pending patent applications and issued patents broadly covering small molecules directed against the same targets as, or targets

similar to, those we are pursuing.

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aware that may result in issued patents, which could be alleged to be infringed by our current or future technologies or drug candidates.

Should such an infringement claim

be successfully brought, we may be required to pay substantial damages or be forced to abandon our current or future technologies or drug

candidates or to seek a license from any patent holders.

No assurances can be given that a license will be available on commercially reasonable

terms, if at all.

Third-party intellectual property rights holders may also actively bring infringement, misappropriation or other claims

alleging violations of intellectual property rights against us.

We cannot guarantee that we will be able to successfully settle or otherwise

resolve such claims.

If we are unable to successfully settle future claims on terms acceptable to us, we may be required to engage in

or to continue costly, unpredictable and time-consuming litigation and may be prevented from, or experience substantial delays in, marketing

our drug candidates.

If we fail in any such dispute, in addition to being forced to pay damages, we may be temporarily or permanently

prohibited from commercializing any of our current or future technologies or drug candidates that are held to be infringing, misappropriating

or otherwise violating third-party intellectual property rights.

We might, if possible, also be forced to redesign current or future technologies

or drug candidates so that we no longer infringe, misappropriate or violate the third-party intellectual property rights.

events, even if we were ultimately to prevail, could require us to divert substantial financial and management resources that we would

otherwise be able to devote to our business, which could have a material adverse effect on our financial condition and results of operations.

We may be subject to claims that our employees, consultants, or advisors

have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we

regard as our own intellectual property.

Should such an infringement

claim be successfully brought, we may be required to pay substantial damages or be forced to abandon our current or future technologies

or drug candidates or to seek a license from any patent holders.

No assurances can be given that a license will be available on commercially

reasonable terms, if at all.

Third-party intellectual property rights holders may also actively bring infringement, misappropriation or

other claims alleging violations of intellectual property rights against us.

We cannot guarantee that we will be able to successfully

settle or otherwise resolve such claims.

If we are unable to successfully settle future claims on terms acceptable to us, we may be required

to engage in or to continue costly, unpredictable and time-consuming litigation and may be prevented from, or experience substantial delays

in, marketing our drug candidates.

If we fail in any such dispute, in addition to being forced to pay damages, we may be temporarily or

permanently prohibited from commercializing any of our current or future technologies or drug candidates that are held to be infringing,

misappropriating or otherwise violating third-party intellectual property rights.

We might, if possible, also be forced to redesign current

or future technologies or drug candidates so that we no longer infringe, misappropriate or violate the third-party intellectual property

Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial and management resources

that we would otherwise be able to devote to our business, which could have a material adverse effect on our financial condition and results

of operations.

We may be subject to claims that our employees,

consultants, or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting

ownership of what we regard as our own intellectual property.

Some of our employees, consultants

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

In addition, while it is our policy

to require our employees and contractors who may be involved in the conception or development of intellectual property to execute agreements

assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who, in fact, conceives

or develops intellectual property that we regard as our own.

In addition, while it is our

policy to require our employees and contractors who may be involved in the conception or development of intellectual property to execute

agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who, in fact,

conceives or develops intellectual property that we regard as our own.

The assignment of intellectual property rights may not be self-executing,

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

Some intellectual property which we own or have

licensed, or which may acquire or license in the future, may have been, or may be, discovered through government funded programs and thus

may be subject to federal regulations such as “march-in” rights, certain reporting requirements, and a preference for United

States industry.

Compliance with such regulations may limit our exclusive rights, subject us to expenditure of resources with respect

to reporting requirements and limit our ability to contract with non-U.S.

Some intellectual property which we own

or have licensed, or which may acquire or license in the future, may have been, or may be, discovered through government funded programs

and thus may be subject to federal regulations such as “march-in” rights, certain reporting requirements, and a preference

for United States industry.

Compliance with such regulations may limit our exclusive rights, subject us to expenditure of resources with

respect to reporting requirements and limit our ability to contract with non-U.S.

manufacturers.

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Risks Related to Our Business Operations and Industry

If we lose key management leadership, and/or

scientific personnel, and if we cannot recruit qualified employees, managers, directors, officers, or other significant personnel, we

may experience program delays and increases in compensation costs, and our business may be materially disrupted.

Our future success is highly dependent

on the continued service of principal members of our management, leadership, and scientific personnel, who are able to terminate their

employment with us at any time and may be able to compete with us.

The loss of any of our key management, leadership, or scientific personnel

including, in particular, Daniel M, Schmitt, our President and CEO, and Andrew P.

Mazar, Ph.D., our Chief Operating Officer, could materially

disrupt our business and materially delay or prevent the successful product development and commercialization of our product candidates.

We have employment agreements with Mr.

Schmitt and Dr.

Mazar which have no term but are for at-will employment, meaning the executives

have the ability to terminate their employment at any time.

Our Chief Financial Officer, Paul

Lytle, was appointed in February 2024 and had been providing such services as a consultant rather than as a full-time employee, following

his consulting engagement to assist with our finance and accounting matters from December 20, 2023.

We entered into an employment agreement

Lytle under which he became a full-time employee effective June 1, 2024.

In addition, Mr.

Lytle is also co-founder of a private

biopharmaceutical company, where he currently also serves as its chief financial officer, as well as a co-founder of a public development-stage

biotechnology company, where he currently serves on its board of directors and as its executive vice president, chief financial officer.

While we believe that Mr.

Lytle will devote adequate time to our business to perform the role and duties of our Chief Financial Officer,

we cannot guarantee that he will continue to do so in the future.

Additionally, while we do not believe that Mr.

Lytle currently faces

any conflicts of interest, including conflicts in allocating time to our business, Mr.

Lytle may face conflicts of interest in the future.

Lytle cannot devote adequate time to us to fulfill his role and duties as Chief Financial Officer or if any conflicts of interest

arise, it could have a material adverse impact on our operations.

Our future success will also depend

on our continuing ability to identify, hire, and retain highly skilled personnel for all areas of the organization.

Competition in the

biopharmaceutical industry for scientifically and technically qualified personnel is intense, and we may be unsuccessful in identifying,

hiring, and retaining qualified personnel.

Our continued requirement to identify, hire, and retain highly competent personnel may cause

our compensation costs to increase materially.

As of December 31, 2024, we had ten (10) full-time employees.

As our clinical development

and commercialization plans and strategies develop, we will need to expand our managerial, clinical, regulatory, sales, marketing, financial,

development, manufacturing and legal capabilities or contract with third parties to provide these capabilities for us.

As our operations

expand, we expect that we will need to manage additional relationships with various strategic collaborators, suppliers and other third

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

· identifying, recruiting, integrating, maintaining

and motivating additional employees;

· managing our development and commercialization

efforts effectively, while complying with our contractual obligations to contractors and other third parties;

· improving our operational, financial and management

controls, reporting systems and procedures.

Our ability to continue to develop

and, if approved, commercialize our product candidates will depend, in part, on our ability to effectively manage any future growth.

management may also have to divert a disproportionate amount of its attention away from day-to-day activities in order to devote a substantial

amount of time to managing these growth activities.

We currently rely, and for the

foreseeable future will continue to rely, in substantial part on certain independent organizations, advisors and consultants to provide

certain services, including contract manufacturers and companies focused on research and development activities.

There can be no assurance

that the services of independent organizations, advisors and consultants will continue to be available to us on a timely basis when needed,

or that we can find qualified replacements.

In addition, if we are unable to effectively manage our outsourced activities or if the quality,

accuracy or quantity of the services provided is compromised for any reason, our clinical trials may be extended, delayed or terminated,

and we may not be able to obtain, or may be substantially delayed in obtaining, regulatory approval of our product candidates or otherwise

advance our business.

Competition and technological change may make

our product candidates less competitive or obsolete.

The biopharmaceutical industry

is subject to rapid technological change.

We have many potential competitors, including major drug and chemical companies, specialized

biopharmaceutical firms, universities and other research institutions.

These companies, firms, and other institutions may develop products

that are more effective than our product candidates or that would make our product candidates less competitive or obsolete.

Many of these

companies, firms, and other institutions have greater financial resources than us and may be better able to withstand and respond to adverse

market conditions within the biopharmaceutical industry, including without limitation the lengthy regulatory approval process for product

We face significant competition from other biotechnology and pharmaceutical

companies, and our operating results will suffer if we fail to compete effectively.

The development and commercialization

of new drug products is highly competitive.

We may face competition with respect to any product candidates that we seek to develop or

commercialize in the future from major biopharmaceutical companies, specialty biopharmaceutical companies and biotechnology companies

Potential competitors also include academic institutions, government agencies, and other public and private research organizations

that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing, and commercialization.

A highly effective treatment for

cancer is a desirable target for the pharmaceutical industry.

There is significant activity in this space.

Although none of the active

pharmaceutical ingredients in current clinical trials are directed toward the mechanism of action of elraglusib, there can be no assurance

that a large biopharmaceutical or biotechnology company will not pursue the commercialization or development of products competitive with

elraglusib in the future.

Many of these potential competitors, either alone or with their strategic partners, have significantly greater

financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining

regulatory approvals, and marketing approved products than we do.

Mergers and acquisitions in the

biopharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our potential

Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements

with large and established companies.

These competitors also compete with us in recruiting and retaining qualified scientific and management

personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary

to, or necessary for, our programs.

Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize

products that are safer, more effective, more convenient, or less expensive than any products that we may develop.

Our competitors also

may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in

our competitors establishing a strong market position before we are able to enter the market.

Additionally, products or technologies developed

by our competitors may render our potential product candidates uneconomical or obsolete and we may not be successful in marketing any

product candidates we may develop against competitors.

The availability of competitive products could limit the demand, and the price

we are able to charge, for any products that we may develop and commercialize.

As a recently established entity, we have a

limited operating history.

We have engaged exclusively in

licensing rights to product candidates and entering into collaboration agreements with respect to key services or technologies for our

drug product development, and have not received any governmental approvals, brought any product to market, manufactured products commercial

quantities or sold any pharmaceutical products.

As a company, we have limited experience in negotiating, establishing, and maintaining

strategic relationships, conducting clinical trials, and managing the regulatory approval process, all of which will be necessary if we

are to be successful.

Our lack of experience in these critical areas makes it difficult for a prospective investor to evaluate our abilities

and increases the risk that we will fail to successfully execute our strategies.

Furthermore, if our business grows

rapidly, our operational, managerial, legal, and financial resources will be strained.

Our development will require continued improvement

and expansion of our management team and our operational, managerial, legal, and financial systems and controls.

In the normal course of business,

we have evaluated and expect to evaluate potential acquisitions and/or licenses of patents, compounds, and technologies that our management

believes could complement or expand our business.

We have a limited history of conducting acquisitions and negotiating and acquiring licenses.

In the event that we identify an acquisition or license candidate we find attractive, there is no assurance that we will be successful

in negotiating an agreement to acquire or license, or in financing or profitably exploiting, such patents, compounds, or technologies.

Furthermore, such an acquisition or license could divert management time and resources away from other activities that would further our

current business development.

We may be subject to various U.S.

federal, state

and foreign healthcare laws and regulations, which could increase compliance costs, and our failure to comply with these laws and regulations

could harm our reputation, subject us to significant fines and liability or otherwise adversely affect our business.

Our business operations and current

and future arrangements with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers

expose us to broadly applicable foreign, federal and state fraud and abuse and other healthcare laws and regulations.

These laws may constrain

the business or financial arrangements and relationships through which we conduct our operations, including how we research, market, sell

and distribute any products for which we obtain regulatory approval.

Such laws include:

· the federal Anti-Kickback Statute, which prohibits,

among other things, persons or entities from knowingly and willfully soliciting, offering, receiving or providing any remuneration (including

any kickback, bribe or certain rebates), directly or indirectly, overtly or covertly, in cash or in kind, in return for, either the referral

of an individual or the purchase, lease, or order, or arranging for or recommending the purchase, lease, or order of any good, facility,

item or service, for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid.

A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it in order

to have committed a violation;

· the federal false claims laws, including the

civil False Claims Act, and civil monetary penalties laws, which prohibit, among other things, individuals or entities from knowingly

presenting, or causing to be presented, to the 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

or causing to be made a false statement to avoid, decrease or conceal an obligation to pay money to the federal government.

the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes

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

· the federal Health Insurance Portability and

Accountability Act of 1996 (“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 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;

· the federal Physician Payments Sunshine Act,

which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare,

Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the CMS, information related

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

and chiropractors), certain non-physician practitioners (physician assistants, nurse practitioners, clinical nurse specialists, certified

nurse anesthetists, anesthesiology assistants and certified nurse-midwives), and teaching hospitals and other healthcare providers, as

well as ownership and investment interests held by physicians and their immediate family members;

· analogous state and foreign laws and regulations,

such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare

items or services reimbursed by non-governmental third-party payors, including private insurers;

some state laws require biopharmaceutical

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

by the federal government and may require drug manufacturers to report information related to payments and other transfers of value to

physicians and other healthcare providers or marketing expenditures;

some state laws that require biopharmaceutical companies to report

information on the pricing of certain drug products;

and some state and local laws that require the registration or pharmaceutical sales

representatives.

Efforts to ensure that our current

and future business arrangements with third parties will comply with applicable healthcare and privacy laws and regulations will involve

ongoing substantial costs.

It is possible that governmental authorities will conclude that our business practices, including certain consulting

agreements and advisory board agreements we have entered into with physicians who are paid, in part, in the form of stock or stock options,

may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws

and regulations.

Due to the breadth of these laws, the narrowness of statutory exceptions and regulatory safe harbors available, and the

range of interpretations to which they are subject, it is possible that some of our current or future practices might be challenged under

one or more of these laws.

If our operations are found to be in violation of any of these laws or any other governmental regulations that

may apply to us, we may be subject to significant penalties, including civil, criminal and administrative penalties, damages, fines, disgorgement,

imprisonment, exclusion from participation in government-funded healthcare programs, such as Medicare and Medicaid, integrity oversight

and reporting obligations, contractual damages, reputational harm, diminished profits and future earnings and the curtailment or restructuring

of our operations.

Defending against any such actions can be costly and time-consuming and may require significant financial and personnel

Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may

Further, if any of the physicians or other healthcare providers or entities with whom we expect to do business are found

not to be in compliance with applicable laws or regulations, they may be subject to significant criminal, civil or administrative sanctions,

including exclusions from government-funded healthcare programs.

state and foreign healthcare laws and regulations, which could increase compliance costs, and our failure to comply with these laws and

regulations could harm our reputation, subject us to significant fines and liability or otherwise adversely affect our business.

Our business operations and

current and future arrangements with investigators, healthcare professionals, consultants, third-party payors, patient organizations and

customers expose us to broadly applicable foreign, federal and state fraud and abuse and other healthcare laws and regulations.

laws may constrain the business or financial arrangements and relationships through which we conduct our operations, including how we

research, market, sell and distribute any products for which we obtain regulatory approval.

Efforts to ensure that our

current and future business arrangements with third parties will comply with applicable healthcare and privacy laws and regulations will

involve ongoing substantial costs.

It is possible that governmental authorities will conclude that our business practices, including certain

consulting agreements and advisory board agreements we have entered into with physicians who are paid, in part, in the form of stock or

stock options, may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare

laws and regulations.

Due to the breadth of these laws, the narrowness of statutory exceptions and regulatory safe harbors available,

and the range of interpretations to which they are subject, it is possible that some of our current or future practices might be challenged

under one or more of these laws.

If our operations are found to be in violation of any of these laws or any other governmental regulations

that may apply to us, we may be subject to significant penalties, including civil, criminal and administrative penalties, damages, fines,

disgorgement, imprisonment, exclusion from participation in government-funded healthcare programs, such as Medicare and Medicaid, integrity

oversight and reporting obligations, contractual damages, reputational harm, diminished profits and future earnings and the curtailment

or restructuring of our operations.

Defending against any such actions can be costly and time-consuming and may require significant financial

and personnel resources.

Therefore, even if we are successful in defending against any such actions that may be brought against us, our

business may be impaired.

Further, if any of the physicians or other healthcare providers or entities with whom we expect to do business

are found not to be in compliance with applicable laws or regulations, they may be subject to significant criminal, civil or administrative

sanctions, including exclusions from government-funded healthcare programs.

Congress, the Trump administration,

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the FDA and other federal agencies, which may negatively impact our clinical development plans, timelines, and the cost of product development.

We are an emerging growth company and a smaller

reporting company, and the reduced disclosure requirements applicable to emerging growth companies and smaller reporting companies may

make our common stock less attractive to investors.

We are an emerging growth company,

as defined in the JOBS Act, and may remain an emerging growth company until the last day of the fiscal year following the fifth anniversary

of the completion of the IPO.

However, if certain events occur prior to the end of such five-year period, including if we become a “large

accelerated filer”, as defined under the Exchange Act, our annual gross revenue exceeds $1.235 billion or we issue more than $1.0

billion of non-convertible debt in any three-year period, we will cease to be an emerging growth company prior to the end of such five-year

For so long as we remain an emerging growth company, we are permitted and intend to rely on exemptions from certain disclosure

requirements that are applicable to other public companies that are not emerging growth companies.

These exemptions include:

· being permitted to provide only two years of

audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s

Discussion and Analysis of Financial Condition and Results of Operations” disclosure;

· not being required to comply with the auditor

attestation requirements in the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002

(“Sarbanes-Oxley”);

· not being required to comply with any requirement

that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s

report providing additional information about the audit and the financial statements, unless the SEC determines the new rules are necessary

for protecting the public;

· reduced disclosure obligations regarding executive

compensation;

· exemptions from the requirements of holding a

nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.

We have taken advantage

of reduced reporting burdens in this Report.

We cannot predict whether investors will find our common stock less attractive if we rely

on these exemptions.

If some investors find our common stock less attractive as a result, there may be a less active trading market for

our common stock and our stock price may be reduced or more volatile.

In addition, the JOBS Act provides that an emerging growth company

can take advantage of an extended transition period for complying with new or revised accounting standards.

This allows an emerging growth

company to delay the adoption of these accounting standards until they would otherwise apply to private companies.

We have irrevocably

elected to avail ourselves of this exemption and, therefore, we may not be subject to the same new or revised accounting standards as

other public companies that are not emerging growth companies.

We intend to rely on other exemptions provided by the JOBS Act, including,

without limitation, not being required to comply with the auditor attestation requirements of Section 404(b) of Sarbanes-Oxley.

We are also a smaller reporting

company as defined in the Exchange Act.

We may continue to be a smaller reporting company even after we are no longer an emerging growth

We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take

advantage of these scaled disclosures for so long as our voting and non-voting common stock held by non-affiliates is less than $250.0

million measured on the last business day of our second fiscal quarter, or our annual revenue is less than $100.0 million during the most

recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is less than $700.0 million measured

on the last business day of our second fiscal quarter.

We may engage in strategic transactions that could impact our liquidity,

increase our expenses and present significant distractions to our management.

From time to time, we may consider

strategic transactions, such as acquisitions of companies, asset purchases, and out-licensing or in-licensing of products, product candidates

or technologies.

Additional potential transactions that we may consider include a variety of different business arrangements, including

spin-offs, strategic partnerships, joint ventures, restructurings, divestitures, business combinations and investments.

Any such transaction

may require us to incur non-recurring or other charges, may increase our near- and long-term expenditures and may pose significant integration

challenges or disrupt our management or business, which could adversely affect our operations and financial results.

For example, these

transactions may entail numerous operational and financial risks, including:

We may engage in strategic transactions that could impact our

liquidity, increase our expenses and present significant distractions to our management.

From time to time, we may

consider strategic transactions, such as acquisitions of companies, asset purchases, and out-licensing or in-licensing of products, product

candidates or technologies.

Additional potential transactions that we may consider include a variety of different business arrangements,

including spin-offs, strategic partnerships, joint ventures, restructurings, divestitures, business combinations and investments.

such transaction may require us to incur non-recurring or other charges, may increase our near- and long-term expenditures and may pose

significant integration challenges or disrupt our management or business, which could adversely affect our operations and financial results.

For example, these transactions may entail numerous operational and financial risks, including:

· exposure to unknown liabilities;

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· inability to retain key employees of any acquired

Accordingly, although there can

be no assurance that we will undertake or successfully complete any transactions of the nature described above, any transactions that

Accordingly, although there

can be no assurance that we will undertake or successfully complete any transactions of the nature described above, any transactions that

we do complete may be subject to the foregoing or other risks, and could have a material adverse effect on our business, results of operations,

financial condition and prospects.

If product liability lawsuits are brought against us, we may incur

substantial costs to defend them and address any damages awarded, and demand for our products could be reduced as a result of such lawsuits.

The testing and marketing of medical

products is subject to an inherent risk of product liability claims, including a possibility in some states for product liability claims

being made based on generic copies of our drugs.

While we do have liability insurance coverage, regardless of their merit or eventual

outcome, product liability claims may result in:

· withdrawal of clinical trial volunteers;

· decreased demand for our products when approved;

· injury to our reputation and significant, adverse

media attention;

· potentially significant litigation costs, including

without limitation, any damages awarded to the plaintiffs if we lose or settle claims.

Our information technology systems, or those

of any of our service providers, may fail or suffer security incidents and other disruptions, which could result in a material disruption

of our development programs, compromise sensitive information related to our business or prevent us from accessing critical information,

potentially exposing us to liability or otherwise adversely affecting our business.

In the ordinary course of business,

we collect, store and transmit confidential information (including but not limited to intellectual property, proprietary and confidential

business information and personal information).

Our information technology systems and those of our third-party service providers, strategic

partners and other contractors or consultants are vulnerable to attack, damage and interruption from computer viruses and malware (e.g.

ransomware), malicious code, natural disasters, terrorism, war, telecommunication and electrical failures, hacking, cyberattacks, phishing

attacks and other social engineering schemes, employee theft or misuse, human error, fraud, denial or degradation of service attacks,

sophisticated nation-state and nation-state-supported actors or unauthorized access or use by persons inside our organization, or persons

with access to systems inside our organization.

In addition, attacks upon information technology systems are increasing in their frequency,

levels of persistence, sophistication and intensity, and are being conducted by sophisticated and organized groups and individuals with

a wide range of motives and expertise.

Furthermore, because the techniques used to obtain unauthorized access to, or to sabotage, systems

change frequently and often are not recognized until launched against a target, we may be unable to anticipate these techniques or implement

adequate preventative measures.

We may also experience security incidents that may remain undetected for an extended period.

Even if identified,

we may be unable to adequately investigate or remediate incidents or breaches due to attackers increasingly using tools and techniques

that are designed to circumvent controls, to avoid detection, and to remove or obfuscate forensic evidence.

Our information

technology systems, or those of any of our service providers, may fail or suffer security incidents and other disruptions, which could

result in a material disruption of our development programs, compromise sensitive information related to our business or prevent us from

accessing critical information, potentially exposing us to liability or otherwise adversely affecting our business.

In the ordinary course of

business, we collect, store and transmit confidential information (including but not limited to intellectual property, proprietary and

confidential business information and personal information).

Our information technology systems and those of our third-party service providers,

strategic partners and other contractors or consultants are vulnerable to attack, damage and interruption from computer viruses and malware

ransomware), malicious code, natural disasters, terrorism, war, telecommunication and electrical failures, hacking, cyberattacks,

phishing attacks and other social engineering schemes, employee theft or misuse, human error, fraud, denial or degradation of service

attacks, sophisticated nation-state and nation-state-supported actors or unauthorized access or use by persons inside our organization,

or persons with access to systems inside our organization.

In addition, attacks upon information technology systems are increasing in

their frequency, levels of persistence, sophistication and intensity, and are being conducted by sophisticated and organized groups and

individuals with a wide range of motives and expertise.

Furthermore, because the techniques used to obtain unauthorized access to, or

to sabotage, systems change frequently and often are not recognized until launched against a target, we may be unable to anticipate these

techniques or implement adequate preventative measures.

We may also experience security incidents that may remain undetected for an extended

Even if identified, we may be unable to adequately investigate or remediate incidents or breaches due to attackers increasingly

using tools and techniques that are designed to circumvent controls, to avoid detection, and to remove or obfuscate forensic evidence.

We and certain of our service

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insurance, the costs related to significant security breaches or disruptions could be material and cause us to incur significant expenses.

Failure to comply with health privacy and other

data protection laws and regulations could lead to government enforcement actions (which could include civil or criminal penalties), private

litigation or adverse publicity and could negatively affect our operating results and business.

We and our service providers maintain

and will maintain a large quantity of sensitive and/or regulated information, including confidential business and patient health information,

personal data about our employees and collaborators, and information relating to our clinical trials.

The global data protection landscape

is rapidly evolving, and we, our service providers and our collaborators may be affected by or subject to existing, amended, or new laws

and regulations in the future, including as our operations continue to expand or if we operate in foreign jurisdictions.

These laws and

regulations may be subject to differing interpretations, thus creating potentially complex compliance issues for us and our service providers,

strategic partners and future customers.

The cost of compliance with these laws, regulations and standards is high and is likely to increase

in the future.

Any failure or perceived failure by us to comply with federal, state or foreign laws or regulations, our internal policies

and procedures or our contracts governing our processing of personal information could result in negative publicity, government investigations

and enforcement actions, claims by third parties and damage to our reputation, any of which could have a material adverse effect on our

business, financial condition, results of operations and prospects.

Failure to comply with health privacy and

other data protection laws and regulations could lead to government enforcement actions (which could include civil or criminal penalties),

private litigation or adverse publicity and could negatively affect our operating results and business.

We and our service providers

maintain and will maintain a large quantity of sensitive and/or regulated information, including confidential business and patient health

information, personal data about our employees and collaborators, and information relating to our clinical trials.

The global data protection

landscape is rapidly evolving, and we, our service providers and our collaborators may be affected by or subject to existing, amended,

or new laws and regulations in the future, including as our operations continue to expand or if we operate in foreign jurisdictions.

laws and regulations may be subject to differing interpretations, thus creating potentially complex compliance issues for us and our service

providers, strategic partners and future customers.

The cost of compliance with these laws, regulations and standards is high and is likely

to increase in the future.

Any failure or perceived failure by us to comply with federal, state or foreign laws or regulations, our internal

policies and procedures or our contracts governing our processing of personal information could result in negative publicity, government

investigations and enforcement actions, claims by third parties and damage to our reputation, any of which could have a material adverse

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

In the United States, numerous

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could apply to our operations or the operations of our collaborators.

In addition, we may obtain health information from third parties

(including research institutions from which we obtain clinical trial data) that are subject to privacy and security requirements under

HIPAA, as amended by HITECH, or other privacy and data security laws.

Depending on the facts and circumstances, we could be subject to

criminal penalties if we knowingly obtain, use, or disclose individually identifiable health information maintained by a HIPAA-covered

entity in a manner that is not authorized or permitted by HIPAA.

State legislatures in Washington, Nevada, and Connecticut have recently

enacted legislation to protect consumer health information that is not covered by HIPAA.

In addition to detailed and specific requirements

for the collection, use, disclosure, retention, and safeguarding of consumer health data, the Washington My Health My Data Act (“MHMDA”)

(effective March 31, 2024) provides a private right of action to consumers for violations of the Act.

Our uses of personal data may

also be subject to state comprehensive data privacy laws, including, without limitation, the California Consumer Privacy Act and regulations

promulgated thereunder (“CCPA”), which came into effect in 2020.

At the start of 2023, the CCPA was expanded in several ways,

including by extending its application to employees, job applicants and business-to-business contacts in addition to consumers.

requires us to make disclosures about our data collection, use, and sharing practices with respect to personal information, and allows

California residents to request access, deletion and correction of their personal data, as well as providing the right to opt out of certain

data use and sharing practices.

The CCPA is primarily enforced by the California Privacy Protection Agency and the California Attorney

General, which have the power to seek penalties of up to $7,500 per violation.

The CCPA also allows the recovery of statutory damages

in the event of a data breach.

Ongoing rulemaking by the California Privacy Protection Agency is likely to result in additional requirements,

increasing the level of risk associated with CCPA compliance.

Several other U.S.

also passed comprehensive data privacy laws, which are currently in effect or will take effect over the next few years.

Generally, these

laws apply to consumer personal data.

For example, Virginia enacted the Virginia Consumer Data Protection Act, which came into effect

on January 1, 2023;

Colorado enacted the Colorado Privacy Act, which came into effect on July 1, 2023;

Connecticut enacted the Connecticut

Data Privacy Act, which came into effect on July 1, 2023;

and Utah enacted the Utah Consumer Privacy Act, which came into effect on December

Other states have enacted similar laws that will come into effect on future dates:

Texas has enacted the Texas Data Privacy

and Security Act (effective July 1, 2024);

Florida has enacted the Florida Digital Bill of Rights (effective July 1, 2024);

passed the Oregon Consumer Privacy Act (effective July 1, 2024);

Montana has enacted the Montana Consumer Data Privacy Act (effective

October 1, 2024);

Iowa has enacted the Iowa Consumer Data Protection Act (effective January 1, 2025);

the New Hampshire Legislature has

passed the New Hampshire Privacy Act (effective January 1, 2025);

Delaware has enacted the Delaware Personal Data Privacy Act (effective

January 1, 2025);

New Jersey has enacted New Jersey S332/A1971 (effective January 15, 2025);

Tennessee has enacted the Tennessee Information

Protection Act (effective July 1, 2025);

and Indiana has enacted the Indiana Consumer Data Protection Act (effective January 1, 2026).

Similar legislation is pending in several other states.

At a high level, these comprehensive state privacy laws require us to make new

disclosures about personal data collection, use, and sharing practices and to adjust or develop internal compliance measures, such as

those related to personal data security, vendor contracting, personal data retention and privacy assessments.

They grant certain privacy

rights to consumers, including the rights to access, collect and delete personal data.

Consumers also have opt-in and opt-out rights that

vary based on the applicable state law and the type of personal data, but broadly include the ability to tell a company not to use personal

data for targeted advertising or not to sell personal data, which can include sales for monetary or other valuable consideration in most

These state comprehensive privacy laws are generally enforced by state attorneys general, and typically provide for fines of up

to $7,500 per violation, with higher penalties in some states.

In addition, several states and

localities have enacted statutes restricting the collection and use of biometric information.

For example, the Illinois Biometric Information

Privacy Act (“BIPA”), Texas Biometric Privacy Act, the Washington Biometric Privacy Law, and the Washington MHMDA regulate

the collection, use, safeguarding, and storage of biometric information and provide for substantial penalties and statutory damages, with

BIPA and MHMDA also creating a private right of action for violations.

Since its enactment, BIPA has generated significant class action

International data protection

laws may also apply to health-related and other personal information we collect.

In the EU, the collection, use, disclosure, transfer,

and other processing of personal data is governed by the EU General Data Protection Regulation 2016/679 (“EU GDPR”), which

came into effect in May 2018.

The GDPR has also been implemented in the UK (“UK GDPR,” and together with the EU GDPR, the

The GDPR, among other things, imposes:

(i) accountability and transparency requirements, which require controllers

to demonstrate and record compliance with the GDPR and provide detailed information to data subjects regarding processing of personal

(ii) requirements for obtaining valid consent;

(iii) obligations to consider data protection as new products or services are developed

and to limit the amount of personal data processed;

(iv) obligations to comply with data protection rights of data subjects including

a right of access to and rectification of personal data, a right to obtain restriction of processing or to object to processing of personal

data, and a right to ask for a copy of personal data to be provided to a third party in a useable format and erasing personal data in

certain circumstances;

(v) obligations to implement appropriate technical and organizational security measures to safeguard personal data;

and (vi) obligations to report certain personal data breaches to the relevant supervisory authority without undue delay (and no later

than 72 hours where feasible).

Both the EU GDPR and the UK GDPR prohibit the transfer of personal data to other countries that are not

recognized as having “adequate” data protection laws.

For personal data transfers from the EU or UK to the United States,

additional safeguards such as adoption of standard contractual clauses or compliance with the Trans-Atlantic Data Privacy Framework (DPF)

and the UK and Swiss extensions of the DPF are required.

Data transfers from the EU to the US have been the subject or repeated legal

challenges, including a July 2020 decision by the Court of Justice of the EU that invalidated a prior transfer mechanism known as Privacy

The EU GDPR provides for fines for violations of up to the higher of 4% of annual worldwide turnover or €20,000,000 (and

in respect of the UK GDPR, GBP17,500,000).

The GDPR identifies a list of points to consider when determining the level of fines to impose

(including the nature, gravity and duration of the infringement).

Data subjects also have a right to compensation for financial or non-financial

losses (e.g., distress).

Other countries in which we have

or plan to do business have also enacted laws regulating the collection, use, disclosure, transfer and processing of personal data.

example, China has enacted the Personal Information Protection Law (“PIPL”) and Cybersecurity Law, Canada the Personal Information

Protection and Electronic Documents Act (“PIPEDA”), Australia the Privacy Act 1988 (the “Australian Privacy Act”),

Japan the Act on the Protection of Personal Information (“APPI”), Brazil the General Data Protection Law (“LGPD”),

and Mexico the Federal Law on the Protection of Personal Data held by Private Parties (“FLPPDPP”), all of which govern the

collection, use, disclosure and transfer of personal data.

Other countries have already enacted, or considering enacting, similar legislation.

To the extent that the GDPR, PIPL, Chinese Cybersecurity Law, PIPEDA, Australian Privacy Act, APPI, LGPD, FLPPDPP, and similar laws apply

or will in the future apply to us, complying with their requirements may require substantial amendments to our procedures and policies.

The changes could adversely impact our business by increasing its operational and compliance costs, and further, there is a risk that

the measures will not be implemented correctly or that individuals within the business will not be fully compliant with the new procedures.

The legal framework around privacy

issues is rapidly evolving, as various federal, state and foreign government bodies are considering adopting new privacy laws and regulations

and providing guidance on current laws and regulations, which could result in significant limitations on or changes to the ways in which

we can collect, use, host, store, or transmit personal data.

The legal framework around

privacy issues is rapidly evolving, as various federal, state and foreign government bodies are considering adopting new privacy laws

and regulations and providing guidance on current laws and regulations, which could result in significant limitations on or changes to

the ways in which we can collect, use, host, store, or transmit personal data.

Compliance with U.S.

and international data protection laws and regulations

could require us to take on more onerous obligations in our contracts, restrict our ability to collect, use and disclose data, or in some

cases, impact our ability to operate in certain jurisdictions.

and international data protection

laws and regulations could require us to take on more onerous obligations in our contracts, restrict our ability to collect, use and disclose

data, or in some cases, impact our ability to operate in certain jurisdictions.

Failure to comply with U.S.

and international data protection laws and

regulations could result in government enforcement actions (which could include civil or criminal penalties), private litigation or adverse

publicity and could negatively affect our operating results and business.

If we do not comply with laws regulating the

protection of the environment and health and human safety, our business could be adversely affected.

Our research and development and

drug candidates and future commercial manufacturing may involve the use of hazardous materials and various chemicals.

We currently do

not maintain a research laboratory, but we engage third-party research organizations and manufacturers to conduct our preclinical studies,

clinical trials and manufacturing.

These third-party laboratories and manufacturers are subject to federal, state and local laws and regulations

governing the use, manufacture, storage, handling and disposal of these hazardous materials.

We must rely on the third parties’

procedures for storing, handling and disposing of these materials in their facilities to comply with the relevant guidelines of the states

in which they operate and the Occupational Safety and Health Administration of the U.S.

Department of Labor.

Although we believe that

their safety procedures for handling and disposing of these materials comply with the standards mandated by applicable regulations, the

risk of accidental contamination or injury from these materials cannot be eliminated.

If an accident occurs, this could result in significant

delays in our development.

We are also subject to numerous environmental, health and workplace safety laws and regulations.

maintain workers’ compensation insurance to cover us for costs and expenses, we may incur due to injuries to our employees, this

insurance may not provide adequate coverage against potential liabilities.

Additional federal, state and local laws and regulations affecting

our operations may be adopted in the future.

We may incur substantial costs to comply with, and substantial fines or penalties if we violate,

any of these laws or regulations.

Current and future healthcare reform legislation

or regulation may increase the difficulty and cost for us to obtain coverage for and commercialize elraglusib or any future product candidates

and may adversely affect the prices we may set.

In the United States and some

foreign jurisdictions, there have been, and we expect there will continue to be, a number of legislative and regulatory changes to the

healthcare system, including cost-containment measures that may reduce or limit coverage and reimbursement for newly approved drugs and

affect our ability to profitably sell elraglusib or any future product candidates for which we obtain regulatory approval.

In particular,

there have been and continue to be a number of initiatives at the U.S.

federal and state levels that seek to reduce healthcare costs and

improve the quality of healthcare.

For example, in March 2010, the

Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (“ACA”)

was enacted in the United States.

The ACA established an annual, nondeductible fee on any entity that manufactures or imports specified

branded prescription drugs and biologic agents;

extended manufacturers’ Medicaid rebate liability to covered drugs dispensed to

individuals who are enrolled in Medicaid managed care organizations;

expanded eligibility criteria for Medicaid programs;

entities eligible for discounts under the 340B drug pricing program;

increased the statutory minimum rebates a manufacturer must pay under

the Medicaid Drug Rebate Program;

established a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in and

conduct comparative clinical effectiveness research, along with funding for such research;

and established a Center for Medicare &

Medicaid Innovation at CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending.

Since its enactment, there have

been executive, judicial and Congressional challenges to certain aspects of the ACA.

On June 17, 2021, the U.S.

Supreme Court dismissed

the most recent judicial challenge to the ACA brought by several states without specifically ruling on the constitutionality of the ACA.

In addition, other legislative

changes have been proposed and adopted since the ACA was enacted.

For example, beginning April 1, 2013, Medicare payments to providers

were reduced under the sequestration required by the Budget Control Act of 2011, which will remain in effect until 2032, unless additional

Congressional action is taken.

Additionally, on January 2, 2013, the American Taxpayer Relief Act of 2012 was signed into law, which,

among other things, further reduced Medicare payments to several providers, including hospitals, imaging centers and cancer treatment

centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

On March 11, 2021, the American Rescue Plan Act of 2021 was signed into law, which eliminates the statutory cap on the Medicaid drug rebate,

beginning January 1, 2024.

The rebate was previously capped at 100% of a drug’s average manufacturer price.

Further, there has been

heightened governmental scrutiny in the United States of pharmaceutical pricing practices in light of the rising cost of prescription

Such scrutiny has resulted in several recent congressional inquiries and proposed and enacted federal and state legislation designed

to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient assistance

programs, and reform government program reimbursement methodologies for products.

Most recently, on August 16, 2022,

President Biden signed the Inflation Reduction Act of 2022 (“IRA”) into law.

This statute marks the most significant action

by Congress with respect to the pharmaceutical industry since adoption of the ACA in 2010.

Among other things, the IRA (i) directs the

HHS to negotiate the price of certain high-expenditure, single-source drugs and biologics covered under Medicare and (ii) imposes rebates

under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation.

The IRA permits the Secretary of the HHS

to implement many of these provisions through guidance, as opposed to regulation, for the initial years.

HHS has and will continue to

issue and update guidance as these programs are implemented.

On August 29, 2023, HHS announced the list of the first ten drugs that will

be subject to price negotiations, although the Medicare drug price negotiation program is currently subject to legal challenges.

of the IRA on the pharmaceutical industry cannot yet be fully determined but is likely to be significant.

Additional drug pricing proposals

could appear in future legislation.

At the state level, legislatures

have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including

price or reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures,

and, in some cases, designed to encourage importation from other countries and bulk purchasing.

Legally mandated price controls on payment

amounts by third-party payors or other restrictions could harm our business, financial condition, results of operations and prospects.

In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical

products and which suppliers will be included in their prescription drug and other healthcare programs.

This could reduce the ultimate

demand for elraglusib and any future product candidates, if approved, or put pressure on our product pricing, which could negatively affect

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

We expect that these existing

laws and other healthcare reform measures that may be adopted in the future may result in additional reductions in Medicare and other

healthcare funding, more rigorous coverage criteria, new payment methodologies and additional downward pressure on the price that we receive

for any approved product.

Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction

in payments from private payors.

The implementation of cost containment measures or other healthcare reforms may prevent us from being

able to generate revenue, attain profitability or commercialize elraglusib or any future product candidates, if approved.

Even if we are able to commercialize any drug

candidate, such drug candidate may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies,

which would harm our business.

Our ability to commercialize any

products successfully will depend, in part, on the extent to which coverage and adequate reimbursement for these products and related

treatments will be available from third-party payors, such as government authorities, private healthcare insurers and health maintenance

organizations.

Patients who are prescribed medications for the treatment of their conditions generally rely on third-party payors to reimburse

all or part of the costs associated with their prescription drugs.

Coverage and adequate reimbursement from government healthcare programs,

such as Medicare and Medicaid, and private healthcare insurers are critical to new product acceptance.

Patients are unlikely to use our

future products, if any, unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost.

Cost-containment is a priority

healthcare industry and elsewhere.

As a result, government authorities and other third-party payors have attempted to control

costs by limiting coverage and the amount of reimbursement for particular medications.

Increasingly, third-party payors are requiring

that drug companies provide them with predetermined discounts from list prices and are challenging the prices charged for medical products.

Third-party payors also may request additional clinical evidence beyond the data required to obtain marketing approval, requiring a company

to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of its products.

Commercial third-party payors

often rely upon Medicare coverage policy and payment limitations in setting their reimbursement rates, but also have their own methods

and approval process apart from Medicare determinations.

Therefore, coverage and reimbursement for pharmaceutical products in the United

States can differ significantly from payor to payor.

We cannot be sure that coverage and adequate reimbursement will be available for

any product that we commercialize and, if reimbursement is available, that the level of reimbursement will be adequate.

Coverage and reimbursement

may impact the demand for, or the price of, any drug candidate for which we obtain marketing approval.

If coverage and reimbursement are

not available or are available only at limited levels, we may not be able to successfully commercialize any drug candidate for which we

obtain marketing approval.

Additionally, the regulations

that govern regulatory approvals, pricing and reimbursement for new drugs and therapeutic biologics vary widely from country to country.

Some countries require approval of the sale price of a drug or therapeutic biologic before it can be marketed.

In many countries, the

pricing review period begins after marketing approval is granted.

In some foreign markets, prescription pharmaceutical pricing remains

subject to continuing governmental control even after initial approval is granted.

As a result, we might obtain regulatory approval for

a product in a particular country, but then be subject to price regulations that delay our commercial launch of the product, possibly

for lengthy time periods, and negatively impact the revenues we are able to generate from the sale of the product in that country.

pricing limitations may hinder our ability to recoup our investment in one or more drug candidates, even if our drug candidates obtain

regulatory approval.

and international data protection

laws and regulations could result in government enforcement actions (which could include civil or criminal penalties), private litigation

or adverse publicity and could negatively affect our operating results and business.

Disruptions at the FDA and other government

agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and

other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or

at all, which could negatively impact our business.

The ability of the FDA and other

government agencies to review and approve new products can be affected by a variety of factors, including government budget and funding

levels, statutory, regulatory and policy changes, a government agency’s ability to hire and retain key personnel and accept the

payment of user fees, and other events that may otherwise affect the government agency’s ability to perform routine functions.

review times at the FDA and other government agencies have fluctuated in recent years as a result.

In addition, government funding of

other government agencies that fund research and development activities is subject to the political process, which is inherently fluid

agencies caused by funding shortages, changes in personnel, or global health concerns could hinder their ability to hire, retain or deploy

key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in

a timely manner or at all, which could negatively impact our business.

The ability of the FDA and

other government agencies to review and approve new products can be affected by a variety of factors, including government budget and

funding levels, statutory, regulatory and policy changes, a government agency’s ability to hire and retain key personnel and accept

the payment of user fees, and other events that may otherwise affect the government agency’s ability to perform routine functions.

Average review times at the FDA and other government agencies have fluctuated in recent years as a result.

In addition, government funding

of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid

and unpredictable.

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approval for our product candidates.

Separately, in response to the

COVID-19 pandemic, the FDA postponed most inspections of domestic and foreign manufacturing facilities at various points.

Separately, in response to

the COVID-19 pandemic, the FDA postponed most inspections of domestic and foreign manufacturing facilities at various points.

the FDA has since resumed standard inspection operations of domestic facilities where feasible, future pandemics may lead to similar inspectional

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effect on our business.

Our business is subject to risks arising from

pandemics and epidemic diseases.

The COVID-19 worldwide pandemic

presented substantial public health and economic challenges and affected our employees, patients, physicians and other healthcare providers,

communities and business operations, as well as the U.S.

and global economies and financial markets.

Any future pandemic or epidemic disease

outbreaks could disrupt the supply chain and the manufacture or shipment of drug substances and finished drug products for elraglusib

or any future product candidates for use in our, our collaborators’ or any future collaborators’ clinical trials and research

and preclinical studies and, delay, limit or prevent our employees and CROs from continuing research and development activities, impede

our clinical trial initiation and recruitment and the ability of patients to continue in clinical trials, alter the results of the clinical

trial based on participants contracting the disease or otherwise increasing the number of observed adverse events, impede testing, monitoring,

data collection and analysis and other related activities, any of which could delay our preclinical studies and clinical trials and increase

our development costs, and have a material adverse effect on our business, financial condition, results of operations and prospects.

future pandemic or epidemic disease outbreak could also potentially further affect the business of the FDA, EMA or other regulatory authorities,

which could result in delays in meetings related to our planned clinical trials, as well have an adverse impact on global economic conditions

which could have an adverse effect on our business and financial condition, including impairing our ability to raise capital when needed.

Effective collaboration with the FDA’s

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result in increased time and expense to gain approvals.

Our lead drug development program,

elraglusib, will be reviewed by CDER.

Efficient and professional collaboration with the FDA’s CDER is essential for the timely clinical

testing, test evaluations, analysis and approval of our drug candidates.

CDER has an outstanding record of drug approvals and substantial

funds to operate a highly professional organization but is also very demanding as to the quality of clinical research and applications

for marketing approvals for drug candidates.

Our lead drug development

program, elraglusib, will be reviewed by CDER.

Efficient and professional collaboration with the FDA’s CDER is essential for the

timely clinical testing, test evaluations, analysis and approval of our drug candidates.

CDER has an outstanding record of drug approvals

and substantial funds to operate a highly professional organization but is also very demanding as to the quality of clinical research

and applications for marketing approvals for drug candidates.

We do not have in-house expertise

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adverse financial results and will likely impact the price of our stock.

Our ability to use net operating loss carryforwards

and other tax attributes may be limited in connection with the IPO or other ownership changes.

We have incurred substantial losses

during our history, do not expect to become profitable in the near future and may never achieve profitability.

As of December 31, 2024,

we had net operating loss (“NOL”) carryforwards, which may be available to offset our future taxable income, if any.

carryforwards and other tax attributes are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities.

In addition, under Section 382

Internal Revenue Code of 1986, as amended, our federal NOL carryforwards may be or become subject to an annual limitation

in the event we have had or have in the future an “ownership change.” For these purposes, an “ownership change”

generally occurs if one or more stockholders or groups of stockholders who own at least 5% of a company’s stock increase their ownership

by more than 50 percentage points over their lowest ownership percentage within a rolling three-year period.

The annual limitation amount

is determined based on the Company’s value immediately prior to the ownership change.

Similar rules may apply under state tax laws.

Although we believe there have been one or more ownership changes resulting from past transactions, we have not determined the amount

of the cumulative change in our ownership resulting from the IPO or other transactions, or any resulting limitations on our ability to

utilize our NOL carryforwards and other tax attributes.

However, we believe that our ability to utilize our NOL carryforwards and other

tax attributes to offset future taxable income or tax liabilities may be limited as a result of ownership changes, including potential

changes in connection with the IPO.

If we earn taxable income, such limitations could result in increased future income tax liability

to us and our future cash flows could be adversely affected.

We have recorded a full valuation

allowance related to our NOL carryforwards and other deferred tax assets due to the uncertainty of the ultimate realization of the future

benefits of those assets.

Foreign currency exchange rates may adversely affect our consolidated

financial statements.

Our primary operations are transacted

Dollars, but certain service agreements with third parties are denominated in currencies other than the U.S.

Dollar, primarily

the British pound and the Euro.

All of our employees and operations are currently located in the United States and our expenses are generally

denominated in U.S.

As we continue to develop our business, our results of operations and cash flows will likely be more affected

by fluctuations in foreign currency exchange rates, including the British pound, Euro and other currencies, which could adversely affect

our results of operations.

Sales and purchases in currencies other than the U.S.

Dollar expose us to fluctuations in foreign currencies

relative to the U.S.

Dollar and may adversely affect our consolidated financial statements.

Increased strength of the U.S.

Dollar increases

the effective price of our future drug products sold in U.S.

Dollars into other countries, which may require us to lower our prices or

adversely affect sales to the extent we do not increase local currency prices.

Decreased strength of the U.S.

Dollar could adversely affect

the cost of materials, products and services we purchase overseas.

Sales and expenses of our non-U.S.

businesses are also translated into

Dollars for reporting purposes and the strengthening or weakening of the U.S.

Dollar could result in unfavorable foreign currency

translation and transaction effects.

In addition, certain of our businesses may in the future invoice customers in a currency other than

the business’ functional currency, and movements in the invoiced currency relative to the functional currency could also result

in unfavorable foreign currency translation and transaction effects.

We also face exchange rate risk from our investments in subsidiaries

owned and operated in foreign countries.

Our anticipated operating expenses and capital

expenditures are based upon our management’s estimates of possible future events.

Actual amounts could differ materially from those

Development of pharmaceuticals

and cancer drugs is extremely risky and unpredictable.

We have estimated operating expenses and capital expenditures over the next year

based on certain assumptions.

Any change in the assumptions could and will cause the actual results to vary substantially from the anticipated

expenses and expenditures and could result in material differences in actual versus forecasted expenses or expenditures.

all of the factors are subject to the effect of unforeseeable future events.

The estimates of operating expenses and capital expenditures

represent forward-looking statements within the meaning of the federal securities laws.

Prospective investors are cautioned that any such

forward-looking statements are not guarantees of future performance and involve risks and uncertainties.

Actual events or results may

differ materially from those discussed in the forward-looking statements as a result of various factors, including the risk factors set

forth under this “Risk Factors” section in this Report.

In view of the foregoing, investors should not rely on these estimates

in making a decision to invest in us.

Our present and potential future international

operations may expose us to business, political, operational, and financial risks associated with doing business outside of the United

Our business is subject to

risks associated with conducting business internationally.

Some of our suppliers and clinical research organizations and clinical trial

sites are located outside of the United States.

Furthermore, if we or any future collaborator succeeds in developing any products, we

anticipate marketing them in the EU and other jurisdictions in addition to the United States.

If approved, we or our collaborator may

hire sales representatives and conduct physician and patient association outreach activities outside of the United States.

Doing business

internationally involves a number of risks, including but not limited to:

· multiple, 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;

· additional potentially relevant third-party patent

and other intellectual property rights that may be necessary to develop and commercialize our products and drug candidates;

· complexities and difficulties in obtaining, maintaining,

enforcing and defending our patent and other intellectual property rights;

· difficulties in staffing and managing foreign

· complexities associated with managing multiple

payor reimbursement regimes, government payors or patient self-pay systems;

· limits in our ability to penetrate international

· 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 products and

exposure to foreign currency exchange rate fluctuations;

· natural disasters, political and economic instability,

including wars, terrorism and political unrest, outbreak of disease, boycotts, curtailment of trade and other business restrictions, implementation

· 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.

Any of these factors could

harm our ongoing international clinical operations and supply chain, as well as any future international expansion and operations and,

consequently, our business, financial condition, prospects and results of operations.

Our future growth may depend, in part, on our

ability to operate in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.

Our future growth may depend,

in part, on our ability to develop and commercialize elraglusib or any future drug candidates in foreign markets for which we may rely

on partnering with third parties.

We will not be permitted to market or promote elraglusib or any future drug candidate before we receive

regulatory approval from the applicable regulatory authority in a foreign market, and we may never receive such regulatory approval for

elraglusib or any future drug candidate.

To obtain separate regulatory approval in foreign countries, we generally must comply with numerous

and varying regulatory requirements of such countries regarding safety and efficacy and governing, among other things, clinical trials

and commercial sales, pricing and distribution of elraglusib or any future drug candidate, and we cannot predict success in these jurisdictions.

Approval procedures may be more onerous than those in the United States and may require that we conduct additional preclinical studies

or clinical trials.

If we obtain approval of any of our current or potential future drug candidates and ultimately commercialize any such

drug candidate in foreign markets, we would be subject to risks and uncertainties, including the burden of complying with complex and

changing foreign regulatory, tax, accounting and legal requirements, foreign reimbursement, pricing, and insurance regimes, workforce

uncertainty in countries where labor unrest is common, production shortages resulting from any events affecting raw material supply or

manufacturing capabilities abroad, business interruptions resulting from geopolitical actions, including war and terrorism, public health

pandemics or epidemics, or natural disasters including earthquakes, typhoons, floods and fires, and the reduced protection of intellectual

property rights in some foreign countries.

Risks Associated to our Common Stock

Risks Related to our Common Stock

Concentration of ownership by our principal

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to our stockholders for vote.

The Bios Equity Affiliated Funds’

significant interest in us also creates the potential for conflicts of interest which may be viewed unfavorably by minority stockholders,

thereby hurting our stock price.

In addition, the Bios Equity Affiliated Funds are not subject to any contractual restrictions on their

ability to acquire additional shares of common stock.

Any future purchases of equity securities, including in connection with any rights

offerings or any alternative equity or equity-linked offering that we may conduct, could result in the Bios Equity Affiliated Funds again

attaining beneficial ownership of a majority of our common stock.

As a result of the Bios Equity Affiliated Funds’ significant ownership

Fletcher’s position as our Chairman, others may be less inclined to pursue an acquisition of us and therefore we may not

have the opportunity to be acquired in a transaction that stockholders might otherwise deem favorable, including transactions in which

our stockholders might realize a substantial premium for their shares.

Current and new investors will experience dilution

due to future sales or issuances of our common stock.

Our employees, non-employee directors

and other consultants, advisors and other persons who provide services to the Company are eligible to receive incentive awards under the

2024 Stock Incentive Plan (“2024 Plan”), including stock options grants, stock appreciation rights (“SARs”), restricted

stock awards (“RSAs”), restricted stock units (“RSUs”), and other awards.

As of December 31, 2024, up to a total

of 3,709,790 shares of our common stock may be issued pursuant to awards issued and outstanding and awards available for grant under the

2024 Stock Incentive Plan and 2015 Stock Incentive Plan (collectively, the “Incentive Plans”).

As of December 31, 2024, there

were 2,385,140 shares available for grant under the Incentive Plans.

In addition, our current and our

new investors will likely also experience substantial dilution resulting from the issuance by us of equity securities in connection with

certain transactions, including without limitation, future offering of shares, intellectual property licensing, acquisition, or commercialization

arrangements.

If our shares become subject to the penny stock

rules, it would become more difficult to trade our shares.

The SEC has adopted rules that

regulate broker-dealer practices in connection with transactions in penny stocks.

Penny stocks are generally equity securities with a

price of less than $5.00 per share, other than securities registered on certain national securities exchanges or authorized for quotation

on certain automated quotation systems, provided that current price and volume information with respect to transactions in such securities

is provided by the exchange or system.

If we do not retain a listing on the Nasdaq Global Market and if the price of our common stock

is less than $5.00 per share, our common stock will be deemed a penny stock.

The penny stock rules require a broker-dealer, before a transaction

in a penny stock not otherwise exempt from those rules, to deliver a standardized risk disclosure document containing specified information.

In addition, the penny stock rules require that before effecting any transaction in a penny stock not otherwise exempt from those rules,

a broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive

(i) the purchaser’s written acknowledgment of the receipt of a risk disclosure statement;

(ii) a written agreement to transactions

involving penny stocks;

and (iii) a signed and dated copy of a written suitability statement.

These disclosure requirements may have the

effect of reducing the trading activity in the secondary market for our common stock.

There was no public market for our common stock

prior to the IPO in August 2024.

An active, liquid and orderly market for our common stock may not be sustained, or we may in the future

fail to satisfy the continued listing requirements of Nasdaq, and you may not be able to resell your shares at or above your purchase

The Bios Equity Affiliated

Funds’ significant interest in us also creates the potential for conflicts of interest which may be viewed unfavorably by minority

stockholders, thereby hurting our stock price.

In addition, the Bios Equity Affiliated Funds are not subject to any contractual restrictions

on their ability to acquire additional shares of common stock.

Any future purchases of equity securities, including in connection with

any rights offerings or any alternative equity or equity-linked offering that we may conduct, could result in the Bios Equity Affiliated

Funds again attaining beneficial ownership of a majority of our common stock.

As a result of the Bios Equity Affiliated Funds’ significant

ownership and Dr.

Fletcher’s position as our Chairman, others may be less inclined to pursue an acquisition of us and therefore

we may not have the opportunity to be acquired in a transaction that stockholders might otherwise deem favorable, including transactions

in which our stockholders might realize a substantial premium for their shares.

There was no public market for our common

stock prior to the IPO in August 2024.

An active, liquid and orderly market for our common stock may not be sustained, or we may in the

future fail to satisfy the continued listing requirements of Nasdaq, and you may not be able to resell your shares at or above your purchase

price or at all.

There was no public market for

our common stock prior to the IPO.

Although our common stock is listed on the Nasdaq Global Market, an active trading market for our common

stock may not be sustained.

The lack of an active market may impair your ability to sell your shares at the time you wish to sell them

or at a price that you consider reasonable.

An inactive market may also impair our ability to raise capital by selling shares and may

impair our ability to acquire other businesses or technologies using our shares as consideration, which, in turn, could materially adversely

affect our business.

If we fail to satisfy the continued

listing requirements of Nasdaq, such as the corporate governance requirements or the minimum closing bid price or stockholders’

There was no public market

for our common stock prior to the IPO.

Although our common stock is listed on the Nasdaq Global Market, an active trading market for our

common stock may not be sustained.

The lack of an active market may impair your ability to sell your shares at the time you wish to sell

them or at a price that you consider reasonable.

An inactive market may also impair our ability to raise capital by selling shares and

may impair our ability to acquire other businesses or technologies using our shares as consideration, which, in turn, could materially

adversely affect our business.

If we fail to satisfy the

continued listing requirements of Nasdaq, such as the corporate governance requirements or the minimum closing bid price or stockholders’

equity requirement, Nasdaq may take steps to delist our common stock.

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the Nasdaq minimum bid price requirement or prevent future non-compliance with the listing requirements of Nasdaq.

The trading price of the shares of our common stock could be highly

volatile regardless of our operating performance, and purchasers of our common stock could incur substantial losses.

Our stock price is likely to be

The stock market in general and the market for securities of biotechnology and pharmaceutical companies in particular have historically

been highly volatile, and the market has from time-to-time experienced significant price and volume fluctuations that are unrelated to

the operating performance of particular companies.

As a result of this volatility, investors may not be able to sell their common stock

at or above their purchase price.

The trading price of the shares of our common stock could be

highly volatile regardless of our operating performance, and purchasers of our common stock could incur substantial losses.

Our stock price is likely

to be volatile.

The stock market in general and the market for securities of biotechnology and pharmaceutical companies in particular

have historically been highly volatile, and the market has from time-to-time experienced significant price and volume fluctuations that

are unrelated to the operating performance of particular companies.

As a result of this volatility, investors may not be able to sell

their common stock at or above their purchase price.

The market price of our common

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· sales of our stock by us, our insiders or our

stockholders, including shares available for sale as a result of the recent expiration of the IPO lock-up in February 2025 or expiration

of other market stand-off or lock-up agreements;

stockholders;

· healthcare reform legislation, including measures

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and scientific press and in online investor communities.

In addition, in the past, stockholders

have initiated class action lawsuits against biopharmaceutical companies following periods of volatility in the market prices of these

companies’ stock.

In addition, in the past,

stockholders have initiated class action lawsuits against biopharmaceutical companies following periods of volatility in the market prices

of these companies’ stock.

Such litigation, if instituted against us, could cause us to incur substantial costs, divert our management’s

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of operations and prospects.

Our executive officers, directors, and principal

stockholders, if they choose to act together, will continue to have the ability to significantly influence all matters submitted to stockholders

for approval.

As of December 31, 2024, our executive

officers, directors and greater than 5% stockholders, in the aggregate, owned approximately 69% of our outstanding common stock.

result, such persons, acting together, will have the ability to significantly influence all matters submitted to our board of directors

or stockholders for approval, including the appointment of our management, the election and removal of directors and approval of any significant

transaction, as well as our management and business affairs.

This concentration of ownership may have the effect of delaying, deferring

or preventing a change in control, impeding a merger, consolidation, takeover or other business combination involving us, or discouraging

a potential acquiror from making a tender offer or otherwise attempting to obtain control of our business, even if such a transaction

would benefit other stockholders.

Numerous shares may now be sold into the open

market upon expiry of the IPO lock-up in February 2025.

Substantial sales of shares could cause the price of our common stock to decline.

Sales of a substantial number

of shares of our common stock in the public market or the perception that these sales might occur could significantly reduce the market

price of our common stock and impair our ability to raise adequate capital through the sale of additional equity or equity-linked securities.

As of December 31, 2024, we had 19,531,636 shares of our common stock outstanding.

Of the total shares outstanding, after the IPO lock-up

agreements expired in February 2025, up to 19,485,173 shares of common stock are eligible for sale in the public market, of which 13,560,349

shares will be held by directors, executive officers and other affiliates and will be subject to volume limitations under Rule 144 under

the Securities Act.

In addition, under our stock incentive

plans, we have outstanding options, RSAs, and RSUs for holders to purchase and/or acquire up to 1,371,113 shares of common stock as of

December 31, 2024 that, when exercised (or when vesting occurs in the case of RSAs and RSUs), will become eligible for sale in the public

market to the extent permitted by the provisions of various vesting schedules, the lock-up agreements and Rule 144 and Rule 701 under

the Securities Act.

The holders of 13,768,044 shares

of our outstanding common stock, or approximately 70.5% of our total outstanding common stock as of December 31, 2024, are entitled to

rights with respect to the registration of their shares of common stock.

Registration of these shares under the Securities Act would result

in the shares becoming freely tradable without restriction under the Securities Act, except for shares held by affiliates (which currently

represent a significant portion of the shares with registration rights), as defined in Rule 144 under the Securities Act.

securities by these stockholders could have a material adverse effect on the trading price of our common stock.

We have broad discretion in the use of the net

proceeds from the IPO and likely any future financing, and our use of those proceeds may not yield a favorable return on your investment.

Our management has broad discretion

in the application of the net proceeds received from the IPO, and will likely have broad discretion in the use of proceeds from any future

Because of the number and variability of factors that will determine our use of the net proceeds from the IPO or any future

financing, their ultimate use may vary substantially from their initial intended use.

We intend to use the remaining net proceeds from

the IPO, along with available cash, for general corporate purposes, which may include advancing our other pipeline programs, supporting

the requirements of being a public company, including legal, audit, investor relations and board fees and providing competitive salaries

and benefits to attract and retain highly qualified employees.

We have not specifically allocated the amount of remaining net proceeds

that will be used for these purposes, and our management will have broad discretion over how these remaining proceeds are used and could

spend the proceeds in ways with which you may not agree.

In addition, we may not use the proceeds of the IPO or any future financing effectively

or in a manner that increases our market value or enhances our potential profitability.

We do not intend to pay dividends in the foreseeable

future and, as a result, your ability to achieve a return on your investment will depend on appreciation in the price of our common stock.

We have never declared or paid

any cash dividends on our capital stock and we do not intend to pay any cash dividends in the foreseeable future.

We do not intend to pay dividends in the

foreseeable future and, as a result, your ability to achieve a return on your investment will depend on appreciation in the price of our

common stock.

We have never declared or

paid any cash dividends on our capital stock and we do not intend to pay any cash dividends in the foreseeable future.

We currently anticipate

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after price appreciation, which may never occur, as the only way to realize any future potential gains as a return on their investments.

There can be no assurance that we will ever

provide liquidity to our investors through a sale of our Company.

While acquisitions of pharmaceutical

companies like ours are not uncommon, potential investors are cautioned that no assurances can be given that any form of merger, combination,

or sale of our company will take place or that any merger, combination, or sale, even if consummated, would provide liquidity or a profit

for our investors.

You should not invest in our company with the expectation that we will be able to sell the business in order to provide

liquidity or a profit for our investors.

Delaware law and provisions in our amended and

restated bylaws could make a merger, tender offer or proxy contest difficult, thereby depressing the potential trading price of our common

Delaware law and provisions in our amended

and restated bylaws could make a merger, tender offer or proxy contest difficult, thereby depressing the potential trading price of our

common stock.

Our amended and restated

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The provisions in our charter documents include the following:

· a classified board of directors with three-year

staggered terms, which may delay the ability of stockholders to change the membership of a majority of our board of directors;

· no cumulative voting in the election of directors,

which limits the ability of minority stockholders to elect director candidates;

· the exclusive right of our board of directors,

unless the board of directors grants such right to the stockholders, to elect a director to fill a vacancy created by the expansion of

the board of directors or the resignation, death or removal of a director, which prevents stockholders from being able to fill vacancies

on our board of directors;

· the required approval of at least 66-2/3% of

the shares entitled to vote to remove a director for cause, and the prohibition on removal of directors without cause;

· the ability of our board of directors to authorize

the issuance of shares of preferred stock and to determine the price and other terms of those shares, including preferences and voting

rights, without stockholder approval, which could be used to significantly dilute the ownership of a hostile acquiror;

· the ability of our board of directors to alter

our amended and restated bylaws without obtaining stockholder approval;

· the required approval of at least 66-2/3% of

the shares entitled to vote to adopt, amend or repeal our amended and restated bylaws or repeal the provisions of our amended and restated

certificate of incorporation regarding the election and removal of directors;

· a prohibition on stockholder action by written

consent, which forces stockholder action to be taken at an annual or special meeting of our stockholders;

· an exclusive forum provision providing that the

Court of Chancery of the State of Delaware will be the exclusive forum for certain actions and proceedings;

· the requirement that a special meeting of stockholders

may be called only by the board of directors, which may delay the ability of our stockholders to force consideration of a proposal or

to take action, including the removal of directors;

· advance notice procedures that stockholders must

comply with in order to nominate candidates to our board of directors or to propose matters to be acted upon at a stockholders’

meeting, which may discourage or deter a potential acquiror from conducting a solicitation of proxies to elect the acquiror’s own

slate of directors or otherwise attempting to obtain control of us.

We are also subject to the anti-takeover

provisions contained in Section 203 of the Delaware General Corporation Law.

Under Section 203, a corporation may not, in general, engage

in a business combination with any holder of 15% or more of its capital stock unless the holder has held the stock for three years or,

among other exceptions, the board of directors has approved the transaction.

Our amended and restated certificate of incorporation

provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and

our stockholders and that the federal district courts shall be the exclusive forum for the resolution of any complaint asserting a cause

of action arising under the Securities Act, which could limit our stockholders’ ability to obtain a favorable judicial forum for

disputes with us or our directors, officers or employees or the underwriters of any offering giving rise to such claim .

classified board of directors with three-year staggered terms, which may delay the ability of stockholders to change the membership of

a majority of our board of directors;

cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates;

exclusive right of our board of directors, unless the board of directors grants such right to the stockholders, to elect a director to

fill a vacancy created by the expansion of the board of directors or the resignation, death or removal of a director, which prevents

stockholders from being able to fill vacancies on our board of directors;

required approval of at least 66-2/3% of the shares entitled to vote to remove a director for cause, and the prohibition on removal of

directors without cause;

ability of our board of directors to authorize the issuance of shares of preferred stock and to determine the price and other terms of

those shares, including preferences and voting rights, without stockholder approval, which could be used to significantly dilute the

ownership of a hostile acquiror;

ability of our board of directors to alter our amended and restated bylaws without obtaining stockholder approval;

required approval of at least 66-2/3% of the shares entitled to vote to adopt, amend or repeal our amended and restated bylaws or repeal

the provisions of our amended and restated certificate of incorporation regarding the election and removal of directors;

prohibition on stockholder action by written consent, which forces stockholder action to be taken at an annual or special meeting of

our stockholders;

exclusive forum provision providing that the Court of Chancery of the State of Delaware will be the exclusive forum for certain actions

and proceedings;

requirement that a special meeting of stockholders may be called only by the board of directors, which may delay the ability of our stockholders

to force consideration of a proposal or to take action, including the removal of directors;

notice procedures that stockholders must comply with in order to nominate candidates to our board of directors or to propose matters

to be acted upon at a stockholders’ meeting, which may discourage or deter a potential acquiror from conducting a solicitation

of proxies to elect the acquiror’s own slate of directors or otherwise attempting to obtain control of us.

We are also subject to the

anti-takeover provisions contained in Section 203 of the Delaware General Corporation Law.

Under Section 203, a corporation may not, in

general, engage in a business combination with any holder of 15% or more of its capital stock unless the holder has held the stock for

three years or, among other exceptions, the board of directors has approved the transaction.

Our amended and restated certificate of

incorporation provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes

between us and our stockholders and that the federal district courts shall be the exclusive forum for the resolution of any complaint

asserting a cause of action arising under the Securities Act, which could limit our stockholders’ ability to obtain a favorable

judicial forum for disputes with us or our directors, officers or employees or the underwriters of any offering giving rise to such claim .

Our amended and restated certificate

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General Risk Factors

Unstable market and economic conditions may

have serious adverse consequences on our ability to raise funds, which may cause us to cease or delay our operations.

Unstable market and economic conditions

may have serious adverse consequences on our ability to raise funds, which may cause us to cease or delay our operations.

From time to time, the global

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

in the United States, military conflict, including the conflicts between Russia and Ukraine and in the Middle East, terrorism or other

in the United States, military conflict, including the conflicts in the Middle East and between Russia and Ukraine, terrorism or other

acts of violence or geopolitical events.

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our ability to attain our operating goals on schedule and on budget.

We incur increased costs as a result of operating

as a public company, and our management is required to devote substantial time to new compliance initiatives and corporate governance

As a public company, we incur

significant legal, accounting and other expenses.

Sarbanes-Oxley, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing

requirements of the Nasdaq Global Market and other applicable securities rules and regulations impose various requirements on public companies,

including establishment and maintenance of effective disclosure and financial controls and corporate governance practices.

Our management

and other personnel need to devote a substantial amount of time to these compliance initiatives.

Moreover, these rules and regulations

increase our legal and financial compliance costs and make some activities more time-consuming and costly.

For example, these rules and

regulations may make it more difficult and more expensive for us to obtain director and officer liability insurance, which in turn could

make it more difficult for us to attract and retain qualified members of our board of directors.

However, these rules and regulations

are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice

may evolve over time as new guidance is provided by regulatory and governing bodies.

This could result in continuing uncertainty regarding

compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

We are subject to U.S.

and foreign anti-corruption

and anti-money laundering laws with respect to our operations and non-compliance with such laws can subject us to criminal or civil liability

and harm our business.

We are subject to export control

and import laws and regulations, including the U.S.

Export Administration Regulations, U.S.

Customs regulations, and various economic

and trade sanctions regulations administered by the U.S.

Treasury Department’s Office of Foreign Assets Controls and anti-corruption

and anti-money laundering laws and regulations, including the U.S.

Foreign Corrupt Practices Act of 1977, as amended, the U.S.

bribery statute contained in 18 U.S.C.

§ 201, the U.S.

Travel Act, the USA PATRIOT Act and other state and national anti-bribery

and anti-money laundering laws in the countries in which we conduct activities.

Anti-corruption laws are interpreted broadly and prohibit

companies and their employees, agents, CROs, contractors and other collaborators and partners from authorizing, promising, offering, providing,

soliciting or receiving, directly or indirectly, improper payments or anything else of value to or from recipients in the public or private

We may engage third parties for clinical trials outside of the United States, to sell our products abroad if and when we enter

a commercialization phase, and/or to obtain necessary permits, licenses, patent registrations and other regulatory approvals.

direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities and

other organizations.

We can be held liable for the corrupt or other illegal activities of our employees, agents, CROs, contractors and

other collaborators and partners, even if we do not explicitly authorize or have actual knowledge of such activities, and any training

or compliance programs or other initiatives we undertake to prevent such activities may not be effective.

Any violations of the laws and

regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import

privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm and other consequences.

Furthermore, U.S.

export control

laws and economic sanctions prohibit the provision of certain products and services to countries, governments, and persons targeted by

sanctions that have been or may be imposed may impact our ability to continue activities at future clinical trial

sites within regions covered by such sanctions.

If we fail to comply with export and import regulations and such economic sanctions, penalties

could be imposed, including fines and/or denial of certain export privileges.

These export and import controls and economic sanctions

could also adversely affect our supply chain.

Changes in tax law may materially adversely

affect our financial condition, results of operations and cash flows, or adversely impact the value of an investment in our common stock.

New income, sales, use or other

tax laws, statutes, rules, regulations or ordinances could be enacted at any time, or interpreted, changed, modified or applied adversely

to us, any of which could adversely affect our business operations and financial performance.

If securities or industry analysts do not publish

research or reports or publish unfavorable research or reports about our business, our stock price and trading volume could decline.

The trading market for our common

stock will depend in part on the research and reports that securities or industry analysts publish about us, our business, our market

or our competitors.

If current or future analysts who covers us downgrades our stock, or if we fail to meet the expectations of one or

more of these analysts, our stock price would likely decline.

If securities or industry analysts do not

publish research or reports or publish unfavorable research or reports about our business, our stock price and trading volume could decline.

The trading market for our

common stock will depend in part on the research and reports that securities or industry analysts publish about us, our business, our

market or our competitors.

If current or future analysts who cover us downgrade our stock, or if we fail to meet the expectations of one

or more of these analysts, our stock price would likely decline.

If one or more of these analysts ceases to cover us or fails to regularly

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may lose confidence in our financial reporting and the trading price of our common stock may decline.

Pursuant to Section 404 of Sarbanes-Oxley,

our management will be required to report upon the effectiveness of our internal control over financial reporting beginning with the second

annual report following the closing of the IPO.

When we lose our status as an “emerging growth company” and do not otherwise

qualify as a “smaller reporting company” with less than $100.0 million in annual revenue, our independent registered public

accounting firm will be required to attest to the effectiveness of our internal control over financial reporting.

The rules governing

the standards that must be met for our management to assess our internal control over financial reporting are complex and require significant

documentation, testing and possible remediation.

To comply with the requirements of being a reporting company under the Exchange Act,

we may need to upgrade our information technology systems;

implement additional financial and management controls, reporting systems and

and hire additional accounting and finance staff.

If we or, if required, our auditors are unable to conclude that our internal

control over financial reporting is effective, investors may lose confidence in our financial reporting and the trading price of our common

stock may decline.

As of December 31, 2023, we identified

a material weakness in internal control over financial reporting as a result of an inadequate review of our clinical trial costs that

resulted in improper accruals of expenses.

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

financial reporting such that there is a reasonable possibility that a material misstatement of our consolidated financial statements

would not be prevented or detected on a timely basis.

In order to remediate the material weakness, management has implemented additional

processes and controls to properly review and monitor the accrual of clinical trial costs during the year ended December 31, 2024.

of December 31, 2024, the material weakness was remediated.

We cannot assure you that there

will not be further material weaknesses or significant deficiencies in our internal control over financial reporting in the future.

failure to maintain internal control over financial reporting could severely inhibit our ability to accurately report our financial condition,

results of operations or cash flows.

If we are unable to conclude that our internal control over financial reporting is effective, or

if our independent registered public accounting firm determines we have a material weakness or significant deficiency in our internal

control over financial reporting once that firm begins its Section 404 reviews, investors may lose confidence in the accuracy and completeness

of our financial reports, the market price of our common stock could decline, and we could be subject to sanctions or investigations by

Nasdaq, the SEC or other regulatory authorities.

Failure to remedy any material weakness in our internal control over financial reporting,

or to implement or maintain other effective control systems required of public companies, could also restrict our future access to the

capital markets.

We could be subject to securities class action

In the past, securities class

action litigation has often been brought against a company following a decline in the market price of its securities.

This risk is especially

relevant for us because biotechnology and biopharmaceutical companies have experienced significant stock price volatility in recent years.

If we face such litigation, even if ultimately decided in our favor, it could result in substantial costs and a diversion of our management’s

attention and resources, which could harm our business.

Pursuant to Section 404 of

Sarbanes-Oxley, once we lose our status as an “emerging growth company” and do not otherwise qualify as a “smaller reporting

company” with less than $100.0 million in annual revenue, our independent registered public accounting firm will be required to

attest to the effectiveness of our internal control over financial reporting.

The rules governing the standards that must be met for our

management to assess our internal control over financial reporting are complex and require significant documentation, testing and possible

To comply with the requirements of being a reporting company under the Exchange Act, we may need to upgrade our information

technology systems;

implement additional financial and management controls, reporting systems and procedures;

and hire additional accounting

and finance staff.

If we or, if required, our auditors are unable to conclude that our internal control over financial reporting is effective,

investors may lose confidence in our financial reporting and the trading price of our common stock may decline.

In addition, any failure to

maintain internal control over financial reporting could severely inhibit our ability to accurately report our financial condition, results

of operations or cash flows.

If we are unable to conclude that our internal control over financial reporting is effective, or if our independent

registered public accounting firm determines we have a material weakness or significant deficiency in our internal control over financial

reporting once that firm begins its Section 404 reviews, investors may lose confidence in the accuracy and completeness of our financial

reports, the market price of our common stock could decline, and we could be subject to sanctions or investigations by Nasdaq, the SEC

or other regulatory authorities.

Failure to remedy any material weakness in our internal control over financial reporting, or to implement

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

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