What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2026-03-31 compared with 2025-03-26 · 1122 added, 1676 removed, 412 unchanged (87% of the section changed)

12 unchanged sentences

of your investment.

Related to Our Financial Position and Need for Additional Capital

have a limited operating history, which may make it difficult to evaluate our current business and predict our future performance.

are a clinical-stage biopharmaceutical company with a limited operating history upon which you can evaluate our business and prospects.

We commenced operations in 2017, have no products approved for commercial sale and have not generated any revenue.

Drug development is

a highly uncertain undertaking and involves a substantial degree of risk.

Since our inception, we have spent the first three years developing

and refining our technology, and since 2019, we have focused our efforts on advancing the development of our product candidate, HSB-1216,

which we recently deprioritized, as well as HS3215, HS0059 and HS1940.

In November 2023, we entered into the Avior Patent License Agreement for a clinical-stage asset, TH104, and TH103, a compound which we

intend to potentially file an IND for.

have not yet commenced human clinical trials for any of our product candidates, nor have we demonstrated an ability to initiate or successfully

complete any large-scale or pivotal clinical trials, obtain marketing approvals, manufacture a commercial-scale product or arrange for

a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization.

a result, it may be more difficult for you to accurately predict our likelihood of success and viability than it could be if we had a

longer operating history.

plan to initiate a hepatic impairment study in 2025 prior to starting the Phase 2 clinical trial in TH104.

In addition, we intend to submit

INDs to the FDA for our early-stage pre-clinical programs to gain approval to initiate clinical studies in 2025 for both HS3215 and HS1940;

however, no assurance can be provided that our Phase 2 trial will be completed or that our INDs will be accepted

by the FDA based on our anticipated timeline, if at all.

Our early-stage programs are in pre-clinical discovery and research stages.

As a result, we expect that it will take several years, if ever, before we have a commercialized product and generate revenue from product

Even if we succeed in receiving marketing approval for and commercializing one or more of our product candidates, we expect that

we will continue to incur substantial research and development and other expenses in order to discover, develop and market additional

potential products.

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

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

for our products or therapeutic utility.

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

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

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

in our efforts to identify biomarkers.

If we are unable to identify suitable biomarkers for pre-clinical and clinical development,

our ability to stratify patients could be compromised, which could result in significant harm to our financial position and adversely

impact our stock price;

biomarkers may not demonstrate correlation to efficacy, safety or tolerability;

data that seeks to correlate genomic or biomarker signatures with certain diseases may be influenced by the race of the patient which

may limit the efficacy of our drug candidates;

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

may develop alternative approaches that render our potential biomarkers non-competitive or less attractive.

expect to continue to incur losses for the foreseeable future, and we expect these losses to increase as we continue our development

of, and seek regulatory approvals for, our product candidates, and begin to commercialize approved drugs, if any.

Typically, it takes

many years to develop a new drug from the time it is discovered to when it is available for treating patients.

We may encounter unforeseen

expenses, difficulties, complications, delays and other unknown factors that may increase our expenses and adversely affect our ability

to generate revenue.

The size of our future net losses will depend, in part, on our ability to manage these aspects of our business.

have incurred significant losses since inception, we expect to incur losses in the future and we may not be able to generate sufficient

revenue to achieve and maintain profitability.

have never been profitable and have incurred significant losses in each year since inception.

For the years ended December 31, 2024 and

2023 we reported a net loss of $12.2 million and $9.3 million, respectively.

As of December 31, 2024, we had an accumulated deficit of

$36.9 million.

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

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

The net losses we incur

may fluctuate significantly from quarter to quarter such that a period-to-period comparison of our results of operations may not be a

good indication of our future performance.

The size of our future net losses will depend, in part, on the rate of future growth of our

expenses and our ability to generate revenue.

Our prior losses and expected future losses have had and will continue to have an adverse

effect on our working capital, our ability to achieve and maintain profitability and the performance of our stock.

ability to generate revenue and achieve profitability depends significantly on our ability to achieve several milestones relating to

the discovery, development and commercialization of our product candidates.

financial condition and operating results have varied significantly in the past and are expected to continue to fluctuate significantly

due to a variety of factors, many of which are beyond our control.

Factors relating to our business that may contribute to these fluctuations

ability to continue our current research and development programs, including conducting laboratory, pre-clinical studies for product

ability to initiate clinical trials for product candidates;

success of our clinical trials through all phases of clinical development;

in the commencement, enrollment and timing of clinical trials;

ability to secure and maintain collaborations, licensing or other arrangements for the future development and/or commercialization

of our product candidates, as well as the terms of those arrangements;

ability to obtain, as well as the timeliness of obtaining, additional funding to develop our product candidates;

results of clinical trials or marketing applications for product candidates that may compete with our product candidates;

from existing products or new products that may receive marketing approval;

side effects of our product candidates that could delay or prevent approval or cause an approved drug to be taken off the market;

delays in regulatory review and approval of our product candidates;

ability to identify and develop additional product candidates;

ability of patients or healthcare providers to obtain coverage or sufficient reimbursement for our products;

ability, and the ability of third parties such as Clinical Research Organizations (“CROs”) to adhere to clinical study

and other regulatory requirements;

ability of third-party manufacturers to manufacture our product candidates and key ingredients needed to conduct clinical trials

and, if approved, successfully commercialize our products;

costs to us, and our ability as well as the ability of any third-party collaborators, to obtain, maintain and protect our intellectual

property rights;

related to and outcomes of potential intellectual property litigation;

ability to adequately support future growth;

ability to attract and retain key personnel to manage our business effectively;

ability to build our finance infrastructure and, to the extent required, improve our accounting systems and controls.

new products and services is a speculative and risky endeavor.

Products or services that initially show promise may fail to achieve the

desired results or may not achieve acceptable levels of analytical accuracy or clinical utility.

We may need to alter our products in

development and repeat clinical studies before we identify a potentially successful product or service.

Product development is expensive,

may take years to complete and can have uncertain outcomes.

Failure can occur at any stage of the development.

If, after development,

a product or service appears successful, we may, depending on the nature of the product or service, still need to obtain FDA and other

regulatory clearances, authorizations or approvals before we can market it.

The FDA’s clearance, authorization or approval pathways

are likely to involve significant time, as well as additional research, development and clinical study expenditures.

The FDA may not

clear, authorize or approve any future product or service we develop.

Even if we develop a product or service that receives regulatory

clearance, authorization or approval, we would need to commit substantial resources to commercialize, sell and market it before it could

be profitable, and the product or service may never be commercially successful.

Additionally, development of any product or service may

be disrupted or made less viable by the development of competing products or services.

potential products and services may fail any stage of development or commercialization and if we determine that any of our current or

future products or services are unlikely to succeed, we may abandon them without any return on our investment.

If we are unsuccessful

in developing additional products or services, our potential for growth may be impaired.

cases where we are successful in obtaining regulatory approval to market one or more of our drug candidates, our revenue will be dependent,

in part, upon the size of the markets in the territories for which we gain regulatory approval, the accepted price for the product, the

ability to obtain coverage and reimbursement, and whether we own the commercial rights for that territory.

If the number of our addressable

patients is not as significant as we estimate, the indication approved by regulatory authorities is narrower than we expect, or the treatment

population is narrowed by competition, physician choice or treatment guidelines, we may not generate significant revenue from sales of

such products, even if approved.

expect our research and development expenses to continue to be significant in connection with our continued investment in our ongoing

and planned clinical trials for our current product candidates and any future product candidates we may develop.

Furthermore, if we obtain

regulatory approval for our product candidates, we expect to incur increased sales and marketing expenses.

As a result, we expect to

continue to incur significant and increasing operating losses and negative cash flows for the foreseeable future.

These losses have had

and will continue to have a material adverse effect on our stockholders’ equity, financial position, cash flows and working capital.

will require substantial additional funding.

If we are unable to raise capital on favorable terms when needed, we could be forced to

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

intend to advance TH104, a clinical stage asset, as well as our early-stage candidates, HS3215, HS0059 and HS1940, through development.

Developing drugs is expensive and we expect our research and development expenses to increase substantially in connection with our ongoing

activities, particularly as we advance our product candidates through clinical studies.

of December 31, 2024, we had cash of $3.6 million;

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

to commercialize, our product candidates.

Raising funds may present challenges.

Even if we believe we have sufficient funds for our current

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

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

develop and commercialize our product candidates.

In addition, we cannot guarantee that future financing will be available in sufficient

amounts or on terms acceptable to us, if at all.

Moreover, the terms of any financing may adversely affect the holdings or the rights

of our stockholders and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may

cause the market price of our shares to decline.

The sale of additional equity or convertible securities may dilute our stockholders.

The incurrence of indebtedness would result in increased fixed payment obligations, and we may be required to agree to certain restrictive

covenants, such as limitations on our ability to make certain dividends, incur additional debt, limitations on our ability to acquire,

sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our

We could also be required to seek funds through arrangements with collaborative partners or otherwise at an earlier stage than

otherwise would be desirable, and we may be required to relinquish rights to some of our technologies or product candidates or otherwise

agree to terms unfavorable to us, any of which may have a material adverse effect on our business, operating results and prospects.

we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our

research or development programs or the commercialization of any product candidates or be unable to expand our operations or otherwise

capitalize on our business opportunities, as desired, which could materially affect our business, financial condition and results of

has performed an analysis and concluded that there exists a substantial doubt about our ability to continue as a going concern, which

may hinder our ability to obtain future financing on terms acceptable to us, if at all.

financial statements as of December 31, 2024 have been prepared under the assumption that we will continue as a going concern for the

next twelve months.

Management has performed an analysis and concluded that there exists a substantial doubt about our ability to continue

as a going concern.

Separately, our independent registered public accounting firm included in its opinion for the year ended December

31, 2024 an explanatory paragraph referring to our recurring losses from operations and expressing substantial doubt in our ability to

continue as a going concern without additional capital becoming available.

Our ability to continue as a going concern is dependent upon

our ability to obtain additional equity or debt financing, obtain government grants, reduce expenditures and generate significant revenue.

Our financial statements as of December 31, 2024 did not include any adjustments that might result from the outcome of this uncertainty.

The reaction of investors to the inclusion of a goingconcern statement in the accompanying financial statement, and our potential inability

to continue as a going concern, in future years could materially adversely affect our share price and our ability to raise new capital

or enter into strategic alliances.

Related to the Discovery and Development of Our Product Candidates

Related to Our CC Strategy and Holdings

are shifting our business strategy from biotechnology operations to a CC treasury strategy, which represents a fundamental change in

our risk profile and may not be successful.

Historically,

our company’s core operations centered on biotechnological solutions.

In late 2025, we began to integrate digital asset management

into our business, but this was not our primary focus.

In February 2026, we rebranded as Canton Strategic Holdings, Inc.

to reflect our

new emphasis on acquiring, holding, and managing CC assets as our principal treasury and operational strategy.

This pivot presents several

material risks:

of Revenue Streams :

Management’s prioritization of the CC treasury strategy will

require the substantial allocation of executive time, attention, and resources, which will

necessarily reduce the level of focus devoted to our biotechnology operations.

management may have limited capacity to pursue commercial initiatives and other revenue-generating

opportunities within our biotechnology business.

This shift in managerial focus could effectively

result in the foregoing or delay of potential revenue streams and strategic opportunities

that might otherwise be captured if management were fully dedicated to the biotech segment.

Consequently, our operational performance and future revenue growth from biotechnology activities

may be adversely affected.

Liabilities :

Despite our strategic shift, we remain exposed to potential liabilities

from our prior business activities, including contractual obligations, intellectual property

disputes, or customer claims.

These legacy issues could require significant financial resources

and distract management from executing our new strategy.

Uncertainty and Realignment :

Investors who initially invested in our company for exposure

to our legacy business may choose to divest as a result of our new focus, potentially increasing

volatility in our stock price and reducing market support during the transition.

we are unable to effectively manage these risks and execute our new strategy, our business, financial condition, and the market price

of our common stock could be materially and adversely affected.

may be subject to regulatory developments related to crypto assets and crypto asset markets, which could adversely affect our business,

financial condition, and results of operations.

CC and other digital assets are relatively novel and the application of state and federal securities laws and other laws and regulations

to digital assets is unclear in certain respects, it is possible that regulators in the United States or foreign countries may interpret

or apply existing laws and regulations in a manner that adversely affects the price of CC.

The application of state and federal securities

laws and other laws and regulations to CC and other digital assets is unclear in certain respects.

federal government, states,

regulatory agencies, and foreign countries may also enact new laws and regulations, or pursue regulatory, legislative, enforcement or

judicial actions, that could materially impact the price of CC or the ability of individuals or institutions such as us to own or transfer

2018, the SEC has initiated a number of crypto and digital-asset-related enforcement actions.

While the SEC has since requested the dismissal

of several of these cases, the SEC or other regulatory agencies may initiate similar actions in the future, which could materially impact

the price of CC.

In January 2025, the SEC launched a crypto task force dedicated to developing a comprehensive and clear regulatory framework

for crypto assets.

Since then, the task force has sought written input and hosted roundtables with market participants to further task

force goals of drawing clear regulatory lines, providing paths to registration, crafting disclosure frameworks, and deploying enforcement

resources judiciously.

We cannot predict the output of the new crypto task force or whether any recommendations will be adopted by the

SEC or maintained under future administrations.

is not possible to predict whether, or when, new laws will be enacted that change the legal framework governing digital assets or provide

additional authorities to the SEC or other regulators, or whether, or when, any other federal, state or foreign legislative bodies will

take any similar actions.

It is also not possible to predict the nature of any such additional laws or authorities, how additional legislation

or regulatory oversight might impact the ability of digital asset markets to function, the willingness of financial and other institutions

to continue to provide services to the digital assets industry, or how any new laws or regulations, or changes to existing laws or regulations,

might impact the value of digital assets generally and CC tokens specifically.

The consequences of any new law or regulation relating

to digital assets and digital asset activities could adversely affect the market price of CC tokens, as well as our ability to hold or

transact in CC tokens, and in turn adversely affect the market price of our listed securities.

CC is determined to constitute a security for purposes of the federal securities laws, the additional regulatory restrictions imposed

by such a determination could adversely affect the market price of CC and in turn adversely affect the market price of our common stock.

digital asset treasury exposure to CC involves novel and significant risks, including market volatility, accounting, regulatory, custody,

cybersecurity, liquidity and reputational risks, which could have a material adverse effect on our business, results of operations and

financial condition.

have implemented a digital asset treasury strategy by holding our treasury assets in CC, a privately issued digital asset that is not

legal tender and is not backed or insured by any government or governmental program.

The market for CC may be less mature than markets

for traditional assets and can exhibit extreme price volatility driven by factors beyond our control, including market sentiment, macroeconomic

conditions, regulatory developments, protocol or governance changes, technological vulnerabilities and the actions of significant market

participants.

These price movements could result in substantial realized and unrealized gains or losses.

Under applicable U.S.

crypto assets that meet the relevant criteria are measured at fair value each reporting period with changes recognized in earnings, which

can produce meaningful volatility in our reported results and adversely affect the market price of our securities.

CC activities depend on third-party service providers-such as trading venues, custodians, wallet-infrastructure vendors and banking or

payment partners-over which we have limited control.

Failures or outages at these providers, trading suspensions or delistings, withdrawal

moratoria, insolvencies, hacking, fraud, operational errors, inadequate asset segregation or adverse legal determinations could lead

to the partial or total loss of CC, delays or an inability to access or deploy CC, or disputes regarding ownership and control.

the private keys necessary to access and transfer CC presents unique cybersecurity and internal-control challenges;

loss, theft or compromise

of keys-through cyberattack, insider malfeasance, software defects, misconfiguration, phishing or social engineering-may be irreversible.

legal and regulatory framework for digital assets, including CC, continues to evolve and may be subject to inconsistent interpretation

federal, state and international jurisdictions.

Authorities could determine that CC is a security, commodity or other regulated

instrument, which could impose registration, licensing, disclosure, custody, capital or other obligations.

Changes in, or differing interpretations

of, securities, commodities, money-transmission, sanctions/AML, consumer-protection, tax and data-security laws and regulations could

increase our compliance costs, restrict or prohibit aspects of our CC activities, limit access to fiat banking or payment rails, or subject

us to examinations, enforcement actions, penalties or private litigation.

in markets for CC may be limited or impaired during periods of stress due to exchange outages, extreme volatility, order-book dislocations,

widening spreads and slippage, or adverse developments in related market infrastructure (including stablecoins and key service providers).

If we seek to sell, transfer or hedge CC during such periods, we may be unable to do so on acceptable terms, or at all.

may also be concentrated in CC, increasing our exposure to idiosyncratic risks and potentially causing our stock price to correlate with

movements in the price of CC.

cash, offering proceeds or debt financing to acquire or hold CC could affect our capital needs and financing plans, increase dilution

or leverage, and subject us to covenant constraints.

In addition, certain stakeholders may view digital-asset exposure unfavorably-whether

due to environmental, social or governance concerns, perceived risk or other reasons-which could impair our reputation and access to

capital, customers and partners.

We may modify, suspend or discontinue our CC activities at any time, and there can be no assurance that

our digital asset treasury strategy will achieve its objectives or that losses will not occur.

of the Canton Network to achieve broad market acceptance would materially and adversely affect our business, financial condition, and

results of operations.

business depends on the growth and widespread adoption of the Canton Network by major financial institutions and market infrastructure

participants.

Any failure of the Canton Network to achieve broad institutional acceptance would materially and adversely affect our business,

financial condition, and results of operations.

Canton Network is a relatively new technology, and its long-term viability and acceptance in the financial services industry remain uncertain.

Unlike open, public cryptocurrencies, CC tokens and the Canton Network are designed for permissioned, compliance-oriented institutional

Canton Network infrastructure emphasizes configurable privacy, identity-aware access, regulatory controls, and interoperability

between applications operated by known financial entities.

While these features are attractive to regulated institutions, they also mean

that adoption depends on formal onboarding, institutional alignment, and integration with existing financial systems, each of which can

slow network growth and increase adoption risk compared to public, permissionless networks.

addition, because CC tokens differ in design and purpose from established public coins, they do not benefit from the same level of public

awareness, liquidity history, or market-driven network effects.

Their value proposition is tied more directly to enterprise usage, transaction

volume, and institutional trust frameworks.

If institutions do not recognize sufficient operational, capital efficiency, or risk-reduction

benefits from Canton-based assets compared to existing payment rails, bank money, stablecoins, or public blockchain assets, adoption

may be limited.

digital treasury strategy is built to operate on, interoperate with, or derive value from activity on the Canton Network.

If the Canton

Network does not achieve broad adoption among institutional participants, or if adoption occurs more slowly than we anticipate, our profitability

and results of operations could be adversely impacted.

change reclassifying CC as a security could lead to our classification as an “investment company” under the Investment Company

Act of 1940, as amended, or the 1940 Act, and could adversely affect the market price of CC and the market price of our common stock.

Sections 3(a)(1)(A) and (C) of the 1940 Act, a company generally will be deemed to be an “investment company” for purposes

of the 1940 Act if (i) it is, or holds itself out as being, engaged primarily, or proposes to engage primarily, in the business of investing,

reinvesting or trading in securities or (ii) it engages, or proposes to engage, in the business of investing, reinvesting, owning, holding

or trading in securities and it owns or proposes to acquire investment securities having a value exceeding 40% of the value of its total

assets (exclusive of U.S.

government securities and cash items) on an unconsolidated basis.

We do not believe that we are an “investment

company,” as such term is defined in the 1940 Act, and are not registered as an “investment company” under the 1940

Act as of the date hereof.

senior SEC officials have not stated their view as to whether CC is or is not a “security” for purposes of the federal securities

laws, a contrary determination by the SEC could lead to our classification as an “investment company” under the 1940 Act,

if the portion of our assets consists of investments in CC exceeds 40% safe harbor limits prescribed in the 1940 Act, which would subject

us to significant additional regulatory controls that could have a material adverse effect on our business and operations and may also

require us to change the manner in which we conduct our business.

monitor our assets and income for compliance under the 1940 Act and seek to conduct our business activities in a manner such that we

do not fall within its definitions of “investment company” or that we qualify under one of the exemptions or exclusions provided

by the 1940 Act and corresponding SEC regulations.

Furthermore, if CC is determined to constitute a security for purposes of the federal

securities laws, we would take steps to reduce the percentage of CC that constitute investment assets under the 1940 Act.

may include, among others, selling CC that we might otherwise hold for the long term and deploying our cash in non-investment assets,

and we may be forced to sell our CC at unattractive prices.

We may also seek to acquire additional non-investment assets to maintain

compliance with the 1940 Act, and we may need to incur debt, issue additional equity or enter into other financing arrangements that

are not otherwise attractive to our business.

Any of these actions could have a material adverse effect on our results of operations

and financial condition.

Moreover, we can make no assurance that we would successfully be able to take the necessary steps to avoid being

deemed to be an investment company in accordance with the safe harbor.

If we were unsuccessful, and if CC is determined to constitute

a security for purposes of the federal securities laws, then we would have to register as an investment company, and the additional regulatory

restrictions imposed by 1940 Act could adversely affect the market price of CC and in turn adversely affect the market price of our common

financial results and the market price of our common stock may be affected by the prices of CC.

part of our capital allocation strategy for assets that are not required to provide working capital for our ongoing operations, we have

invested, and plan to continue to invest, in CC.

The price of CC has historically been subject to dramatic price fluctuations and is

highly volatile.

Moreover, digital assets, such as CC, are relatively novel and the application of securities laws and other regulations

to such assets is unclear in many respects.

It is possible that regulators may interpret laws in a manner that adversely affects the

liquidity or value of CC.

decrease in the fair value of CC below our carrying value for such assets could require us to incur a loss due to the decrease in fair

market value, and such charge could be material to our financial results for the applicable reporting period, which may create significant

volatility in our reported earnings.

Any decrease in reported earnings or increased volatility of such earnings could have a material

adverse effect on the market price of our common stock.

In addition, the application of generally accepted accounting principles in the

United States, with respect to CC, may change in the future and could have a material adverse effect on our financial results and the

market price of our common stock.

addition, if investors view the value of our common stock as dependent upon or linked to the value or change in the value of our CC holdings,

the price of CC may significantly influence the market price of our common stock.

Additionally, if the price of CC falls, and our common

stock price falls as a result, then certain notes may not be converted and we may, in certain situations, need to repay them in cash.

To the extent the value of the notes exceeds the value of the CC held as collateral, we may need to obtain additional financing, which

might not be available on satisfactory terms, or at all.

Any deficiency could substantially exceed the value of our other assets and

could be many multiples of our historical earnings.

concentration of CC ownership could increase the risk of malicious activity, including potential attacks on the Canton Network.

CC was designed as a digital asset with no pre-allocation to founders or venture capital firms, the initial distribution of CC is

intrinsically linked to network utility and participation.

Therefore, a significant portion of the outstanding supply of Canton Coin

may be held by a limited number of participants, such as founding members, early adopters, consortium participants, or affiliated

In addition, the Canton Network is designed as a permissioned or selectively permissioned distributed ledger in which

transaction validation and block finalization are performed by approved validator nodes rather than an open mining community.

and control over network validation may be concentrated in a relatively small group of participants.

addition, because transactions on the CC network are generally measured in fiat terms and converted into CC using exchange rates or pricing

quotes generated or approved through system mechanisms, validators, super validators, or other designated participants may have significant

influence over the pricing inputs used for transaction settlement and fee calculations.

If a malicious actor or group of actors (whether

through conflict of interest, error, inadequate controls, or collusive or manipulative conduct) publish or rely on inaccurate, stale,

or biased quotes, they may be able to exert control over the conversion rates, which may result in inflated effective transaction costs,

inconsistent settlement outcomes, or opportunities for arbitrage that disadvantage network users and token holders.

face risks relating to the custody of our CC tokens, including the loss or destruction of private keys required to access our CC tokens

and cyberattacks or other data loss relating to our CC tokens, including smart contract related losses and vulnerabilities.

hold our CC tokens with qualified custodians.

We custody our CC tokens across multiple custodians to diversify our potential risk exposure

to any one custodian.

However, multiple custodians may utilize similar wallet infrastructure, cloud service providers or software systems,

which could increase systemic technology risk.

there is a decrease in the availability of digital asset custodians that we believe can safely custody our CC tokens, for example, due

to regulatory developments or enforcement actions that cause custodians to discontinue or limit their services in the United States,

we may need to enter into agreements that are less favorable than our current agreements or take other measures to custody our CC tokens,

and our ability to seek a greater degree of diversification in the use of custodial services would be materially adversely affected.

While we will conduct due diligence on our custodians and any smart contract platforms we may use, there can be no assurance that such

diligence will uncover all risks, including operational deficiencies, hidden vulnerabilities or legal noncompliance.

the insurance that covers losses of our CC holdings may cover none or only a small fraction of the value of the entirety of our CC holdings,

and there can be no guarantee that such insurance will be maintained as part of the custodial services we have or that such coverage

will cover losses with respect to our CC.

Moreover, our use of custodians exposes us to the risk that the CC our custodians hold on our

behalf could be subject to insolvency proceedings and we could be treated as a general unsecured creditor of the custodian, inhibiting

our ability to exercise ownership rights with respect to such CC.

Any loss associated with such insolvency proceedings is unlikely to

be covered by any insurance coverage we maintain related to our CC.

The legal framework governing digital asset ownership and rights

in custodial or insolvency contexts remains uncertain and continues to evolve, which could result in unexpected losses, protracted recovery

processes or adverse treatment in insolvency proceedings.

tokens are controllable only by the possessor of both the unique public key and private key(s) relating to the local or online digital

wallet in which the CC is held.

While the CC blockchain ledger requires a public key relating to a digital wallet to be published when

used in a transaction, private keys must be safeguarded and kept private in order to prevent a third party from accessing the CC held

in such wallet.

To the extent the private key(s) for a digital wallet are lost, destroyed, or otherwise compromised and no backup of

the private key(s) is accessible, neither we nor our custodians will be able to access the CC held in the related digital wallet.

we cannot provide assurance that our digital wallets, nor the digital wallets of our custodians held on our behalf, will not be compromised

as a result of a cyberattack.

The CC and blockchain ledger, as well as other digital assets and blockchain technologies, have been, and

may in the future be, subject to security breaches, cyberattacks, or other malicious activities.

part of our treasury management strategy, we may engage in staking, restaking, or other permitted activities that involve the use of

“smart contracts” or decentralized applications.

The use of smart contracts or decentralized applications entails certain

risks including risks stemming from the existence of an “admin key” or coding flaws that could be exploited, potentially

allowing a bad actor to issue or otherwise compromise the smart contract or decentralized application, potentially leading to a loss

of our CC tokens.

Like all software code, smart contracts are exposed to risk that the code contains a bug or other security vulnerability,

which can lead to loss of assets that are held on or transacted through the contract or decentralized application.

Smart contracts and

decentralized applications may contain bugs, security vulnerabilities or poorly designed permission structures that could result in the

irreversible loss of CC tokens or other digital assets.

Exploits, including those stemming from admin key misuse, admin key compromise,

or protocol flaws, have occurred in the past and may occur in the future.

will operate in a highly competitive environment and will compete against companies and other entities with similar strategies, including

companies with significant CC holdings and spot exchange traded funds and spot ETPs for digital assets.

market for companies and investment vehicles focused on digital assets is intensely competitive and rapidly evolving.

Even though CC

is a relatively new digital asset, we will face competition from a variety of sources, including other public companies with significant

CC holdings, as well as spot exchange traded funds and spot ETPs that provide investors with exposure to digital assets.

Many of these

competitors may have greater financial resources, more established operating histories, broader access to capital markets, and more extensive

relationships with key market participants.

In addition, the entry of new competitors, including large financial institutions and technology

companies, could further intensify competition.

If we are unable to effectively differentiate our business model, attract and retain

investors, or respond to competitive pressures, our business, operating results, and financial condition could be materially and adversely

Increased competition may also lead to downward pressure on the market price of our stock and could impair our ability to achieve

our strategic objectives.

availability of spot ETPs for CC and other digital assets may adversely affect the market price of our listed securities.

the relative novelty of CC and digital assets, the selective nature of the Canton Network and lack of familiarity with the processes

needed to hold CC directly, investors may seek exposure to CC through investment vehicles that hold CC and issue shares representing

fractional undivided interests in their underlying CC holdings.

These vehicles, which were previously offered only to “accredited

investors” on a private placement basis, have in the past traded at substantial premiums to net asset value, possibly due to the

relative scarcity of traditional investment vehicles providing investment exposure to CC.

the extent investors view our common stock as providing exposure to CC, it is possible that the value of our common stock may also have

included a premium over the value of our CC due to the prior scarcity of traditional investment vehicles providing investment exposure

to CC, and that the value of our common stock may decline due to investors having a greater range of options to gain exposure to CC and

investors choosing to gain such exposure through ETPs rather than our common stock.

Additionally, on May 23, 2024, the SEC approved rule

changes permitting the listing and trading of spot ETPs that invest in ether, the main crypto asset supporting the Ethereum blockchain.

The approved spot ETPs commenced trading directly to the public on July 23, 2024.

The listing and trading of spot ETPs for ether offers

investors another alternative to gain exposure to digital assets, which could result in a decline in the trading price of CC as well

as a decline in the value of our common stock relative to the value of our CC.

we are an operating company, and we believe we offer a different value proposition than a CC investment vehicle such as a spot CC ETP,

investors may nevertheless view our common stock as an alternative to an investment in an ETP, and choose to purchase shares of a spot

CC ETP instead of our common stock.

They may do so for a variety of reasons, including if they believe that ETPs offer a “pure

play” exposure to CC that is generally not subject to federal income tax at the entity level as we are, or the other risk factors

applicable to an operating business, such as ours.

Additionally, unlike spot CC ETPs, we (i) do not seek for our shares of common stock

to track the value of the underlying CC we hold before payment of expenses and liabilities, (ii) do not benefit from various exemptions

and relief under the Exchange Act, as amended, including Regulation M, and other securities laws, which enable ETPs to continuously align

the value of their shares to the price of the underlying assets they hold through share creation and redemption, (iii) are a Delaware

corporation rather than a statutory trust, and do not operate pursuant to a trust agreement that would require us to pursue one or more

stated investment objectives, and (iv) are not required to provide daily transparency as to our CC holdings or our daily net asset value.

Furthermore, recommendations by broker-dealers to buy, hold, or sell complex products and non-traditional ETPs, or an investment strategy

involving such products, may be subject to additional or heightened scrutiny that would not be applicable to broker-dealers making recommendations

with respect to our common stock.

Based on how we are viewed in the market relative to ETPs, and other vehicles which offer economic

exposure to CC, any premium or discount in our common stock relative to the value of our CC holdings may increase or decrease in different

market conditions.

a result of the foregoing factors, availability of spot ETPs for CC and other digital assets could have a material adverse effect on

the market price of our listed securities.

we or our third-party service providers experience a security breach or cyberattack and unauthorized parties obtain access to our CC,

or if our private keys are lost or destroyed, or other similar circumstances or events occur, we may lose some or all of our CC and our

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

Substantially

all of the CC we own is held in custody accounts at U.S.-based institutional-grade digital asset custodians.

Security breaches and cyberattacks

are of particular concern with respect to our CC.

CC and other blockchain-based cryptocurrencies and the entities that provide services

to participants in the CC ecosystem have been, and may in the future be, subject to security breaches, cyberattacks, or other malicious

For example, in October 2021 it was reported that hackers exploited a flaw in the account recovery process and stole from

the accounts of at least 6,000 customers of the Coinbase exchange, although the flaw was subsequently fixed and Coinbase reimbursed affected

Similarly, in November 2022, hackers exploited weaknesses in the security architecture of the FTX Trading digital asset exchange

and reportedly stole over $400 million in digital assets from customers.

A successful security breach or cyberattack could result in:

partial or total loss of our CC in a manner that may not be covered by insurance or the liability provisions of the custody agreements

with the custodians who hold our CC;

disclosure of data and violations of applicable data privacy and other laws;

regulatory scrutiny, investigations, fines, penalties, and other legal, regulatory, contractual and financial exposure.

any actual or perceived data security breach or cybersecurity attack directed at other companies with digital assets or companies that

operate digital asset networks, regardless of whether we are directly impacted, could lead to a general loss of confidence in the broader

CC ecosystem or in the use of the CC network to conduct financial transactions, which could negatively impact the market price of CC

and in turn negatively impact our financial condition and results of operations and the market price of our common stock.

upon systems across a variety of industries, including industries related to CC, are increasing in frequency, persistence, and sophistication,

and, in many cases, are being conducted by sophisticated, well-funded and organized groups and individuals, including state actors.

techniques used to obtain unauthorized, improper or illegal access to systems and information (including personal data and digital assets),

disable or degrade services, or sabotage systems are constantly evolving, may be difficult to detect quickly, and often are not recognized

or detected until after they have been launched against a target.

These attacks may occur on our systems or those of our third-party

service providers or partners.

We may experience breaches of our security measures due to human error, malfeasance, insider threats,

system errors or vulnerabilities or other irregularities.

In particular, we expect that unauthorized parties will attempt to gain access

to our systems and facilities, as well as those of our partners and third-party service providers, through various means, such as hacking,

social engineering, phishing and fraud.

Threats can come from a variety of sources, including criminal hackers, hacktivists, state-sponsored

intrusions, industrial espionage, and insiders.

In addition, certain types of attacks could harm us even if our systems are left undisturbed.

For example, certain threats are designed to remain dormant or undetectable, sometimes for extended periods of time, or until launched

against a target and we may not be able to implement adequate preventative measures.

Further, there has been an increase in such activities

due to the increase in work-from-home arrangements.

The risk of cyberattacks could also be increased by cyberwarfare in connection with

ongoing or future armed conflicts, including potential proliferation of malware into systems unrelated to such conflicts.

breach of our operations or those of others in the CC industry, including third-party services on which we rely, could materially and

adversely affect our financial condition and results of operations.

face other risks related to our CC digital asset treasury reserve business model.

CC treasury reserve business model exposes us to various risks, including the following:

and other digital assets are subject to significant legal, commercial, regulatory, and technical uncertainty, and our CC strategy

subjects us to enhanced regulatory oversight;

changes could impact our ability to operate validators or receive rewards;

scrutiny of the Company’s activities may increase, potentially limiting our operations;

litigation risks exist related to smart contract vulnerabilities, validator operations, or our business activities;

around CC’s regulatory status may impact our ability to list on certain exchanges;

in political administration may not guarantee a favorable regulatory environment for CC;

regulatory focus on Layer-1 blockchains beyond Bitcoin and Ethereum could result in new compliance requirements.

foregoing factors could lead to disruption in the market for CC, which could adversely affect the market price of CC and in turn adversely

affect the market price of our common stock.

developments in the cryptocurrency industry — including fraud, cybercrime or platform failures — may result in unfavorable

publicity and could impact investor sentiment with respect to us even if we are not directly involved in any of the reported events.

cryptocurrency industry has been subject to a number of high-profile negative developments, including instances of fraud, theft, cyberattacks,

regulatory enforcement actions, and failures or insolvencies of major trading platforms and custodians.

Even if we are not directly involved

in or affected by such events, negative publicity and heightened scrutiny of the cryptocurrency industry as a whole could adversely impact

investor sentiment toward companies with significant exposure to digital assets, including us.

For example, reports of security breaches,

mismanagement, or criminal activity at other cryptocurrency companies or exchanges may lead to increased concerns about the safety and

legitimacy of digital assets generally, which could result in reduced demand for our stock, increased volatility in its share price,

and greater difficulty in raising capital or maintaining business relationships.

In addition, negative industry developments may prompt

regulatory authorities to impose stricter requirements or oversight, which could increase our compliance costs and operational risks.

The perception of heightened risk in the cryptocurrency sector, regardless of our actual involvement or risk profile, could therefore

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

CC holdings are and will be less liquid than our existing cash and cash equivalents and may not be able to serve as a source of liquidity

for us to the same extent as cash and cash equivalents.

Historically,

the crypto market has been characterized by significant volatility in price, limited liquidity and trading volumes compared to sovereign

currencies markets, relative anonymity, a developing regulatory landscape, potential susceptibility to market abuse and manipulation,

compliance and internal control failures at exchanges, and various other risks inherent in its entirely electronic, virtual form and

decentralized network.

During times of market instability, we may not be able to sell our CC at favorable prices or at all.

a number of digital asset trading venues temporarily halted deposits and withdrawals in 2022, although Coinbase has, to date, not done

As a result, our CC holdings may not be able to serve as a source of liquidity for us to the same extent as cash and cash equivalents.

Further, CC we hold with our custodians and transact with our trade execution partners will not enjoy the same protections as are available

to cash or securities deposited with or transacted by institutions subject to regulation by the Federal Deposit Insurance Corporation

or the Securities Investor Protection Corporation.

Additionally, we may be unable to enter into term loans or other capital raising transactions

collateralized by our unencumbered CC or otherwise generate funds using our CC holdings, including in particular during times of market

instability or when the price of CC tokens has declined significantly.

If we are unable to sell our CC, enter into additional capital

raising transactions, including capital raising transactions using CC as collateral, or otherwise generate funds using our CC holdings,

or if we are forced to sell our CC at a significant loss, in order to meet our working capital requirements, our business and financial

condition could be negatively impacted.

we elect to use derivative instruments to hedge the price risk of holding CC, such derivatives are highly volatile and subject to market

and liquidity risks, which could negatively impact our digital asset treasury strategy.

may invest and trade in a variety of derivative instruments to hedge the price risk associated with CC.

Derivatives, such as futures

and swaps, are financial instruments or arrangements in which the risk and return are related to changes in the value of other assets,

reference rates or indices.

These instruments are highly volatile and expose investors to a high risk of loss.

The low initial margin

deposits normally required to establish a position in such instruments permit a high degree of leverage.

As a result, depending on the

type of instrument, a relatively small movement in the price of a contract may result in a profit or a loss which is high in proportion

to the amount of funds actually placed as initial margin and may result in unquantifiable further loss exceeding any margin deposited.

Our ability to profit or avoid risk through investment or trading in derivatives will depend on our ability to anticipate changes in

the underlying assets, reference rates or indices.

Engaging in hedging may result in poorer overall performance for us than we could

have achieved had we not engaged in such hedging transactions.

In addition, although we may utilize a variety of instruments, including

options and other derivatives, for hedging and risk management purposes, we are not obligated to, and may not, hedge against certain

Furthermore, our portfolio may be exposed to risks that cannot be hedged.

Use of hedging and risk management products may also

increase our regulatory burden and costs of compliance.

will be exposed to the default risk of our clearing broker if we hedge the price risk of CC through the purchase of futures contracts.

we use a clearing broker to help manage financial transactions — such as buying or selling CC futures contracts to hedge against

CC price swings — then we will be exposed to the clearing broker’s credit risk.

Under the CEA and CFTC regulations, futures

contracts must be cleared through a clearing broker known as a registered futures commission merchant (“FCM”).

a certain amount of the customer collateral that customers deposit in connection with their futures trading, and are responsible for

posting that collateral to the clearinghouse on the customer’s behalf when the clearinghouse issues a margin call.

FCMs are required

to maintain such collateral and all customer assets in a segregated account.

If the FCM fails to do so, or is unable to satisfy a substantial

deficit in a customer account, its customers (including us) may be subject to risk of loss of their funds in the event of the FCM’s

In such event, under the current U.S.

Bankruptcy Code, the FCM’s customers (including us) are entitled to recover only

a proportional share of all property available for distribution to all of that FCM’s customers.

We may therefore be exposed to

material losses in the event of an FCM’s or fellow FCM customer’s default or insolvency.

face risks relating to the use of third-party exchanges in connection with our CC strategy.

intend to use third-party exchanges, which we believe are reputable, such as Kraken, Anchorage and Coinbase, to purchase CC tokens for

our treasury.

As part of our process in determining transactions with third-party exchanges, we search for reputable exchanges that have

industry standard policies and procedures in place regarding data security and customer diligence related to anti-money laundering, Office

of Foreign Assets Control and know-your customer rules and regulations.

If any of these third-party exchanges no longer meet our standards

or if there is a decrease in reputable third-party exchanges, we may need to find additional counterparties and enter into additional

agreements that could be on less favorable terms, which could have a material adverse effect on our business, financial condition or

the results of our operations.

developments regarding the treatment of crypto assets for U.S.

and foreign tax purposes could adversely impact our business.

tax treatment of CC and other digital assets is subject to significant uncertainty and evolving guidance from U.S.

federal, state, and

local tax authorities, as well as foreign tax authorities.

Changes in tax laws, regulations, or interpretations could have a material

impact on our business, including our ability to acquire, hold, or dispose of CC tokens in a tax-efficient manner.

For example, future

legislation or regulatory guidance could result in the imposition of new or increased taxes on the acquisition, holding, or transfer

of CC tokens, or could require us to report additional information to tax authorities.

In addition, differences in the tax treatment

of digital assets across jurisdictions could create compliance challenges and increase our administrative and operational costs.

adverse developments in the tax treatment of digital assets could reduce the attractiveness of our business model, increase our tax liabilities,

and negatively affect our financial results and the value of our stock.

are not subject to legal and regulatory obligations that apply to investment companies such as mutual funds and exchange-traded funds,

or to obligations applicable to investment advisers.

funds, ETFs and their directors and management are subject to extensive regulation as “investment companies” and “investment

advisers” under U.S.

federal and state law;

this regulation is intended for the benefit and protection of investors.

subject to, and do not otherwise voluntarily comply with, these laws and regulations.

This means, among other things, that the execution

of or changes to our CC strategy, our use of leverage, the manner in which our CC tokens are custodied, our ability to engage in transactions

with affiliated parties and our operating and investment activities generally are not subject to the extensive legal and regulatory requirements

and prohibitions that apply to investment companies and investment advisers.

Our board of directors has broad discretion over the investment,

leverage and cash management policies it authorizes, whether in respect of our CC token holdings or other activities we may pursue, and

has the power to change our current policies, including our strategy of acquiring and holding CC tokens.

Related to Our Therapeutic Candidates Developments

are substantially dependent on the success of our product candidates.

If we are unable to complete development of, obtain approval for,

and commercialize our product candidates for one or more indications in a timely manner, our business may be harmed.

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

commercialize our product candidates.

We currently have no products approved for sale.

The success of our business, including our ability

to finance our Company and generate any revenue in the future, will primarily depend on the successful development, regulatory approval

and commercialization of our product candidates, which may never occur.

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

however, no product candidates based

on our technology have been tested in humans and given our early stage of development, it may be many years, if at all, before we may

be able to demonstrate the safety and efficacy of our product candidates to warrant approval for commercialization.

clinical and commercial success of our current and any future product candidates will depend on a number of factors, including the following:

ability to raise any additional required capital on acceptable terms, or at all;

ability to complete IND-enabling studies and successfully submit an IND to the FDA;

completion of our pre-clinical studies and clinical trials, which may be slower or cost more than we currently anticipate and will

depend substantially upon the performance of third-party contractors;

by the FDA or similar foreign regulatory agencies to conduct additional clinical trials or other studies beyond those planned to

support approval of our product candidates;

of our proposed indications and primary endpoint assessments relating to the proposed indications of our product candidates by the

FDA and similar foreign regulatory authorities;

ability to consistently manufacture our product candidates on a timely basis;

ability, and the ability of any third parties with whom we contract, to remain in good standing with regulatory agencies and develop,

validate and maintain commercially viable manufacturing processes that are compliant with current good manufacturing practice (“cGMP”);

ability to demonstrate to the satisfaction of the FDA and similar foreign regulatory authorities the safety, efficacy and acceptable

risk-benefit profile of our product candidates;

prevalence, duration and severity of potential side effects or other safety issues experienced with our product candidates or future

approved products, if any;

timely receipt of necessary marketing approvals from the FDA and similar foreign regulatory authorities;

and maintaining, and, where applicable, ensuring that our third-party contractors achieve and maintain, compliance with our contractual

obligations and with all regulatory requirements applicable to our current and future product candidates or approved products, if

ability to successfully develop a commercial strategy and thereafter commercialize our product candidates in the United States and

internationally, if approved for marketing, sale and distribution in such countries and territories, whether alone or in collaboration

availability of coverage and adequate reimbursement from managed care plans, private insurers, government payors (such as Medicare

and Medicaid) and other third-party payors for any of our product candidates that may be approved;

convenience of our treatment or dosing regimen;

by physicians, payors and patients of the benefits, safety and efficacy of our product candidates, if approved, including relative

to alternative and competing treatments;

willingness of physicians, operators of hospitals and clinics and patients to utilize or adopt our therapeutic approaches;

demand for our current or future product candidates, if approved;

ability to establish and enforce intellectual property rights in and to our product candidates;

ability to avoid third-party patent interference, intellectual property challenges or intellectual property infringement claims.

factors, many of which are beyond our control, could cause us to experience significant delays or an inability to obtain regulatory approvals

or commercialize our current or future product candidates.

Even if regulatory approvals are obtained, we may never be able to successfully

commercialize our product candidates.

Accordingly, we cannot provide assurances that we will be able to generate sufficient revenue through

the sale of our product candidates to continue our business or achieve profitability.

or successfully commercialize our product candidates, our business may be harmed.

future success depends on our ability to complete clinical trials, obtain marketing approval, and successfully commercialize our product

We currently have no approved products, and may never generate sufficient revenue to achieve profitability.

and commercial success of our product candidates depends on numerous factors beyond our control, which could cause significant delays

or prevent regulatory approvals or commercialization.

pipeline is based on novel ideas and technologies that are unproven and may not result in marketable products, which exposes us to unforeseen

risks and makes it difficult for us to predict the time and cost of product development and potential for regulatory approval.

are using our technology to develop product candidates to treat rare diseases, inflammatory disorders and cancer.

Our foundational science

and product development approach are based on our ability to deliver our drug candidates to target receptors and specified cells or tissues

at the site of disease to boost efficacy while abating adverse effects on healthy tissue.

We believe that this approach may offer an

improved therapeutic effect by delivering drug candidates to areas which may alleviate symptoms and/or treat diseased tissue.

this approach to treating these diseases is novel and the clinical research that results in a product candidate has had limited testing

For our early-stage, preclinical compounds, we are in the process of validating different tumor-specific therapeutic product

We may spend substantial funds attempting to develop these products with our approach and never succeed in developing a marketable

such, we cannot assure you that even if we are able to develop product candidates to treat the diseases we are targeting, such therapies

would safely and effectively treat such diseases.

We may spend substantial funds attempting to develop this approach and never succeed

in developing a marketable therapeutic.

We are unable to predict when or if our drug candidates will prove effective or safe in humans

or if we will obtain marketing approval.

Before obtaining marketing approval from regulatory authorities for the sale of any drug candidate,

we must complete pre-clinical development and then conduct extensive clinical trials to demonstrate the safety and efficacy of our drug

candidates in humans.

Clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain

as to the outcome.

A failure of one or more clinical trials can occur at any stage of testing.

The outcome of pre-clinical testing and

early clinical trials may not be predictive of the success of later clinical trials, and interim or preliminary results of a clinical

trial do not necessarily predict final results.

In particular, the small number of patients in our early clinical trials may make the

results of these trials less predictive of the outcome of later clinical trials.

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

marketing approval or commercialize our drug candidates, including:

or institutional review boards (“IRBs”)/ethics committees (“ECs”) may not authorize us or our investigators

to commence a clinical trial or conduct a clinical trial at a prospective trial site;

may experience delays in reaching, or fail to reach, agreement on acceptable clinical trial contracts or clinical trial protocols

with prospective trial sites;

trials for our drug candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to

conduct additional clinical trials, delay clinical trials or abandon product development programs;

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

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

the duration of these clinical trials may be longer than we anticipate;

for clinical trial participants from investigational and approved therapies may make it more difficult to enroll patients in our

clinical trials;

or third-party collaborators may fail to obtain the clearance or approval of companion diagnostic tests, if required, on a timely

basis, or at all;

third-party contractors may fail to meet their contractual obligations to us in a timely manner, or at all, or may fail to comply

with regulatory requirements;

may have to suspend or terminate clinical trials for our drug candidates for various reasons, including a finding that the participants

are being exposed to unacceptable health risks;

drug candidates may have undesirable or unexpected side effects or other unexpected characteristics, causing us or our investigators,

regulators or IRBs/ECs to suspend or terminate the trials;

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

supply or quality of our drug candidates or other materials necessary to conduct clinical trials for our drug candidates may be insufficient

or inadequate and result in delays or suspension of our clinical trials;

or a diagnostic development partner may fail to receive regulatory approval of a companion diagnostic for use with a marketed product.

product development costs will increase if we experience delays in pre-clinical studies or clinical trials or in obtaining marketing

We do not know whether any of our planned pre-clinical studies or clinical trials will begin on a timely basis or at all,

will need to be restructured or will be completed on schedule, or at all.

For example, the FDA may place a partial or full clinical hold

on any of our clinical trials for a variety of reasons.

pre-clinical or clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our

drug candidates or allow our competitors to bring products to market before we do and impair our ability to successfully commercialize

our drug candidates and may harm our business and results of operations.

delays in the commencement or completion, or termination or suspension, of our ongoing, planned or future clinical trials could result

in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects.

we can initiate clinical trials of a drug candidate in any indication, we must submit the results of pre-clinical studies to the FDA

along with other information, including information about the drug candidate’s chemistry, manufacturing and controls and our proposed

clinical trial protocol, as part of an IND or similar regulatory filing.

obtaining marketing approval from the FDA for the sale of our product candidate in any indication, we must conduct extensive clinical

studies to demonstrate safety and efficacy.

Clinical testing is expensive, time consuming and uncertain as to outcome.

In addition, we

expect to rely in part on pre-clinical, clinical and quality data generated by our CROs and other third parties for regulatory submissions

for our drug candidates.

While we have or will have agreements governing these third parties’ services, we have limited influence

over their actual performance.

If these third parties do not make data available to us, or, if applicable, make regulatory submissions

in a timely manner, in each case pursuant to our agreements with them, our development programs may be significantly delayed and we may

need to conduct additional studies or collect additional data independently.

In either case, our development costs would increase.

addition, we will need to initiate clinical trials for TH104.

In addition, we will need to receive FDA clearance of our IND for HS3215, HS0059 and HS1940 before we can begin clinical trials and would require the same acceptance by the FDA prior to initiating any clinical

trials in the United States for any of our other drug candidates.

The FDA may require us to conduct additional pre-clinical studies for

any drug candidate before it allows us to initiate clinical trials under any IND, which may lead to additional delays and increase the

costs of our pre-clinical development programs.

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

We do not know whether our planned trials will begin on time or at all, or be completed on schedule, if at all.

The commencement

and completion of clinical trials can be delayed for a number of reasons, including delays related to:

FDA disagreeing as to the design or implementation of our clinical trials or with our recommended dose for any of our pipeline programs;

FDA authorization to commence a trial or reaching a consensus with the FDA on trial design;

to obtain regulatory clearance or approval of companion diagnostics we may use to identify patients for enrollment in our clinical

failure or delay in reaching an agreement with CROs and clinical trial sites, the terms of which can be subject to extensive negotiation

and may vary significantly among different CROs and trial sites;

approval from one or more IRBs/ECs;

refusing to approve, suspending or terminating the trial at an investigational site, precluding enrollment of additional subjects,

or withdrawing their approval of the trial;

to clinical trial protocol;

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

to manufacture or obtain sufficient quantities of drug candidate or, if applicable, combination therapies for use in clinical trials;

failing to enroll or remain enrolled in our trials at the rates we expect, or failing to return for post-treatment follow-ups;

choosing an alternative treatment, or participating in competing clinical trials;

of adequate funding to continue clinical trials;

experiencing severe or unexpected drug-related adverse effects;

of serious adverse events in trials of the same class of agents conducted by other companies;

or being required to use clinical end points that require prolonged periods of clinical observation or analysis of the resulting

facility manufacturing our drug candidates or any of their components being ordered by the FDA to temporarily or permanently shut

down due to violations of cGMP regulations or other applicable requirements, or infections or cross-contaminations of drug candidates

in the manufacturing process;

changes to our manufacturing process that may be necessary or desired;

clinical investigators losing the licenses or permits necessary to perform our clinical trials, not performing our clinical trials

on our anticipated schedule or consistent with the clinical trial protocol Good Clinical Practice (“GCP”) or other regulatory

requirements;

or our third-party contractors not performing data collection or analysis in a timely or accurate manner or improperly disclosing

data prematurely or otherwise in violation of a clinical trial protocol;

contractors becoming debarred or suspended or otherwise penalized by the FDA or other government or regulatory authorities for violations

of regulatory requirements, in which case we may need to find a substitute contractor, and we may not be able to use some or all

of the data produced by such contractors in support of our marketing applications.

could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs/ECs of the institutions in which such trials

are being conducted, by a Data Safety Monitoring Board for such trial or by the FDA.

Such authorities may impose such a suspension or

termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or

our clinical protocols, inspection of the clinical trial operations or trial site by the FDA resulting in the imposition of a clinical

hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a pharmaceutical, 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/ECs for reexamination, which may impact the costs, timing or successful completion

of a clinical trial.

of our scientific advisors or consultants who receive compensation from us are investigators for our clinical trial.

Under certain circumstances,

we may be required to report some of these relationships to the FDA.

Although we believe our existing relationships are within the FDA’s

guidelines, the FDA may conclude that a financial relationship between us and a principal investigator has created a conflict of interest

or otherwise affected interpretation of the study.

The FDA may therefore question the integrity of the data generated at the applicable

clinical trial site and the utility of the clinical trial itself may be jeopardized.

This could result in a delay in approval, or rejection,

of our marketing applications by the FDA and may ultimately lead to the denial of marketing approval of our product candidates.

experience delays in the completion of, or termination of, any clinical trial of our drug candidates, the commercial prospects of such

drug candidate will be harmed, and our ability to generate product revenues will be delayed.

Moreover, any delays in completing our clinical

trials will increase our costs, slow down our development and approval process and jeopardize our ability to commence product sales and

generate revenues which may harm our business, financial condition, results of operations and prospects significantly.

outcome of pre-clinical testing and early clinical trials may not be predictive of the success of later clinical trials, and the results

of our clinical trials may not satisfy the requirements of the FDA, European Medicines Agency (“EMA”) or other comparable

foreign regulatory authorities.

will be required to demonstrate with substantial evidence through well-controlled clinical trials that our product candidates are safe

and effective for use in a diverse population before we can seek marketing approvals for their commercial sale.

Success in pre-clinical

studies and early-stage clinical trials does not mean that future clinical trials will be successful.

risks and makes it difficult to predict development timelines, costs, and regulatory approval.

are developing product candidates using novel approaches to treat rare diseases, inflammatory disorders, and cancer.

Our technology aims

to deliver drug candidates to target receptors and specified cells or tissues at disease sites.

However, this approach has had limited

testing in humans, and we may spend substantial funds attempting to develop these products without ever succeeding in developing a marketable

We cannot assure you that our product candidates will safely and effectively treat the targeted diseases.

obtaining marketing approval, we must complete pre-clinical development and conduct extensive clinical trials to demonstrate safety and

efficacy in humans.

Clinical testing is expensive, can take many years, and outcomes are uncertain.

A failure can occur at any stage,

and the outcome of early trials may not predict later trial success.

Our product development costs will increase if we experience delays,

which could also shorten any exclusive commercialization periods, allow competitors to bring products to market before us, and harm our

business and results of operations.

suspension, or termination of clinical trials could limit our ability to commercialize products and affect our business prospects.

obtaining marketing approval from the FDA, we must conduct extensive clinical studies to demonstrate safety and efficacy.

Clinical testing

is expensive, time consuming, and uncertain.

We rely in part on pre-clinical, clinical and quality data generated by CROs and other third

The FDA may require additional pre-clinical studies before allowing us to initiate clinical trials, which could delay our development

programs and increase costs.

may not be able to initiate or continue clinical trials if we cannot identify and enroll sufficient eligible patients.

Patient enrollment

is a significant factor in clinical trial timing.

Clinical trials may be suspended or terminated by us, by IRBs/ECs, by a Data Safety

Monitoring Board, or by the FDA due to factors including:

failure to conduct trials in accordance with regulatory requirements;

findings resulting in clinical holds;

unforeseen safety issues or adverse side effects;

failure to demonstrate benefit;

changes in governmental

or lack of adequate funding.

Changes in regulatory requirements may require us to amend clinical trial protocols and resubmit

them to IRBs/ECs for reexamination, impacting costs, timing, or successful completion.

Additionally, financial relationships between

us and clinical investigators could create perceived conflicts of interest that the FDA may conclude affect interpretation of data, potentially

jeopardizing trial utility and resulting in approval delays or denial.

of our scientific advisors or consultants who receive compensation from us are investigators for our clinical trials.

We cannot guarantee

that the FDA will not deem the financial relationship between us and a principal investigator as creating a conflict of interest or otherwise

affecting interpretation of the study.

The FDA may therefore question the integrity of the data generated at the applicable clinical

trial site and the utility of the clinical trial itself may be jeopardized.

outcome of pre-clinical testing and early clinical trials may not be predictive of later success.

must demonstrate through well-controlled clinical trials that our product candidates are safe and effective before seeking marketing

Success in pre-clinical studies and early-stage clinical trials does not guarantee future success.

Product candidates in later-stage

clinical trials may fail to demonstrate sufficient safety and efficacy to the satisfaction of the FDA, EMA and other comparable foreign

regulatory authorities despite having progressed through pre-clinical studies and early-stage clinical trials.

Regulatory authorities

may also limit the scope of later-stage trials until we have demonstrated satisfactory safety, which could delay regulatory approval,

limit the size of the patient population to which we may market our product candidates, or prevent regulatory approval.

some instances, there can be significant variability in safety and efficacy results between different clinical trials of the same product

candidate due to numerous factors, including changes in trial protocols, differences in size and type of the patient populations, differences

in and adherence to the dose and dosing regimen and other trial protocols and the rate of dropout among clinical trial participants.

Patients treated with our product candidates may also be undergoing surgical, radiation and chemotherapy treatments and may be using

other approved products or investigational new drugs, which can cause side effects or adverse events that are unrelated to our product

As a result, assessments of efficacy can vary widely for a particular patient and from patient to patient and site to site

within a clinical trial.

This subjectivity can increase the uncertainty of, and adversely impact, our clinical trial outcomes.

do not know whether any clinical trials we may conduct will demonstrate consistent or adequate efficacy and safety sufficient to obtain

approval to market any of our product candidates.

topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data becomes

available, and are subject to audit and verification procedures that could result in material changes in the final data.

time to time, we may publicly disclose preliminary, interim or topline data from our clinical trials, such as the interim data from clinical

trials related to TH104, or preclinical data for HS3215, HS0059 or HS1940.

These interim updates are based on a preliminary analysis

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

of the data related to the particular study or trial.

For example, we may report responses in certain patients that are unconfirmed at

the time and which do not ultimately result in confirmed responses to treatment after follow-up evaluations.

We also make assumptions,

estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully

and carefully evaluate all data.

As a result, the topline results that we report may differ from future results of the same studies,

or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated.

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

we may report interim analyses of only certain endpoints rather than all endpoints.

Interim 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 changes between interim data and final data could significantly harm our business and prospects.

additional disclosure of interim data by us or by our competitors in the future could result in volatility in the price of our common

addition, the information we choose to publicly disclose regarding a particular study or clinical trial is typically selected from a

more extensive amount of available information.

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 candidate or our business.

the preliminary or topline data that we report differs from late, final or actual results, or if others, including regulatory authorities,

disagree with the conclusions reached, our ability to obtain approval for and commercialize our product candidates may be harmed, which

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

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

approval could be delayed or prevented.

may not be able to initiate or continue our ongoing or planned clinical trials for our 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.

Even once enrolled, we may

be unable to retain a sufficient number of patients to complete any of our trials.

Patient enrollment is a significant factor in the

timing of clinical trials.

Our ability to enroll eligible patients may be limited or may result in slower enrollment than we anticipate.

enrollment may be affected if our competitors have ongoing clinical trials for programs that are under development for the same indications

as our product candidates, and patients who would otherwise be eligible for our clinical trials instead enroll in clinical trials of

our competitors’ programs.

Patient enrollment for our current or any future clinical trials may be affected by other factors, including:

and nature of the patient population;

of the disease under investigation;

design of the trial and the complexity for patients and clinical sites;

and efficacy of approved drugs for the disease under investigation;

eligibility criteria for the trial in question as defined in the protocol;

risks and benefits of the product candidate under study;

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

therapies, including any new products that may be approved or other product candidates being investigated for the indications we

are investigating;

willingness to screen their patients for biomarkers to indicate which patients may be eligible for enrollment in our clinical trials;

ability to obtain and maintain patient consents;

referral practices of physicians;

ability to monitor patients adequately during and after treatment;

and availability of clinical trial sites for prospective patients;

risk that patients enrolled in clinical trials will drop out of the trials before completion or, because they may be late-stage disease

patients and will not survive the full terms of the clinical trials.

inability to enroll a sufficient number of patients for our clinical trials would result in significant delays or may require us to abandon

one or more clinical trials altogether.

Any negative results we may report in clinical trials of our product candidates may make it difficult

or impossible to recruit and retain patients in other clinical trials of that same product candidate.

Enrollment delays in our clinical

trials may result in increased development costs for our product candidates and jeopardize our ability to obtain marketing approval for

the sale of our product candidates.

Furthermore, even if we are able to enroll a sufficient number of patients for our clinical trials,

we may have difficulty maintaining participation in our clinical trials through the treatment and any follow-up periods.

may never receive approval to market and commercialize any product candidate.

Even if we obtain regulatory approval, the approval may

be for targets, disease indications, lines of therapy or patient populations that are not as broad as we intended or desired or may require

labeling that includes significant use or distribution restrictions or safety warnings.

have not previously submitted an NDA to the FDA or similar regulatory approval filings to comparable foreign authorities, for any product

candidate, and we cannot be certain that our product candidates will be successful in clinical trials or receive regulatory approval.

Further, any future product candidates may not receive regulatory approval even if they are successful in clinical trials.

receive regulatory approvals for our product candidates, we may not be able to continue our operations.

Even if we successfully obtain

regulatory approvals to market a product candidate, our revenue will be dependent, in part, upon the size of the markets in the territories

for which we gain regulatory approval and have commercial rights.

If the markets or patient subsets that we are targeting are not as

significant as we estimate, we may not generate significant revenues from sales of such products, if approved.

plan to seek regulatory approval to commercialize our product candidates both in the United States and in selected foreign countries.

While the scope of regulatory approval generally is similar in other countries, in order to obtain separate regulatory approval in other

countries we must comply with numerous and varying regulatory requirements of such countries regarding safety and efficacy.

Other countries

also have their own regulations governing, among other things, clinical trials and commercial sales, as well as pricing and distribution

of our product candidates, and we may be required to expend significant resources to obtain regulatory approval and to comply with ongoing

regulations in these jurisdictions.

may be required to perform additional or unanticipated clinical trials to obtain approval or be subject to post-marketing testing requirements

to maintain regulatory approval.

If our candidates prove to be ineffective, unsafe or commercially unviable, our pipeline would have

little, if any, value, which would have a material and adverse effect on our business, financial condition, results of operations and

HS3215, HS0059 and HS1940 are novel product candidates, making it difficult to predict the time, cost and potential success of these

product candidates.

We have not yet been able to assess the safety and efficacy of any product candidates in humans.

Our success depends

on our ability to develop and commercialize product candidates.

The novel nature of some of our technology makes it difficult to accurately

predict the developmental challenges we may face for product candidates as they proceed through research, pre-clinical or greenhouse

studies and clinical or field trials.

our pre-clinical research programs are all research or pre-clinical stages, we have not yet been able to assess the safety or efficacy

of any product candidates in humans.

If our product candidates do not achieve projected development milestones or commercialization in

the announced or expected timeframes, the further development or commercialization of such product candidates may be delayed, and our

business may be harmed.

Current or future product candidates may not meet safety and efficacy requirements for continued development

or ultimate approval in humans and may cause significant adverse events or toxicities.

side effects or other safety risks associated with our drug candidates could delay or preclude approval, cause us to suspend or discontinue

clinical trials or abandon further development, limit the commercial profile of an approved label, or result in significant negative

consequences following marketing approval, if any.

of our planned clinical trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics.

Undesirable side effects caused by our drug candidates could result in the delay, suspension or termination of clinical trials by us

or the FDA for a number of reasons.

If we elect or are required to delay, suspend or terminate any clinical trial, the commercial prospects

of our drug candidates will be harmed and our ability to generate product revenues from this drug candidate will be delayed or eliminated.

Serious adverse events observed in clinical trials could hinder or prevent market acceptance of our drug candidates.

Any of these occurrences

may harm our business, prospects, financial condition and results of operations significantly.

if our drug candidates are associated with undesirable side effects in clinical trials or have characteristics that are unexpected, we

may elect to abandon 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 our drug candidates, if approved.

We may also be required to modify our study plans based on findings in our clinical trials.

drugs that initially showed promise in early-stage testing have later been found to cause side effects that prevented further development.

In addition, regulatory authorities may draw different conclusions or require additional testing to confirm these determinations.

is possible that as we test our drug candidates in larger, longer and more extensive clinical trials, including with different dosing

regimens, or as the use of our drug candidates becomes more widespread following any regulatory approval, illnesses, injuries, discomforts

and other adverse events that were observed in earlier trials, as well as conditions that did not occur or went undetected in previous

trials, will be reported by patients.

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.

addition, if any of our drug candidates receive marketing approval, and we or others later identify undesirable side effects caused by

treatment with such drug, a number of potentially significant negative consequences could result, including:

authorities may withdraw approval of the drug;

may be required to recall a product, change the dosage of a product, or change the way the drug is administered to patients;

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

safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings or other safety information

about the product;

may be required to implement a REMS or create a medication guide outlining the risks of such side effects for distribution to patients;

restrictions may be imposed on the marketing or promotion of the particular product or the manufacturing processes for the product

or any component thereof;

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

drug could become less competitive;

reputation may suffer.

of these events could prevent us from achieving or maintaining market acceptance of our drug candidates, if approved, and could significantly

harm our business, financial condition, results of operations and prospects.

sometimes estimate, or may in the future estimate, the timing of the accomplishment of various scientific, clinical, manufacturing, regulatory

and other product development objectives.

These milestones may include our expectations regarding the commencement or completion of scientific

studies or clinical trials, the submission of regulatory filings, the receipt of marketing approval or the realization of other commercialization

trials may fail to demonstrate sufficient safety and efficacy to the satisfaction of the FDA, EMA, and other regulatory authorities.

There can be significant variability in safety and efficacy results between different clinical trials of the same product candidate due

to factors including changes in trial protocols, differences in patient populations, adherence to dosing regimens, and dropout rates.

Patients may also be using other treatments that cause side effects unrelated to our product candidates, increasing uncertainty in clinical

trial outcomes.

topline, and preliminary clinical trial data may change as more patient data becomes available and are subject to audit and verification

time to time, we may publicly disclose preliminary, interim, or topline data from clinical trials.

These are based on preliminary analysis

and are subject to change following more comprehensive review.

The topline 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

Topline data remain subject to audit and verification procedures that may result in material changes.

Adverse changes between

interim and final data could significantly harm our business.

In addition, we may report interim analyses of only certain endpoints rather

than all endpoints.

Interim 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.

Information we choose to disclose is typically

selected from a more extensive amount of available information.

If the data we report differs from final results, or if others disagree

with our conclusions, our ability to obtain approval and commercialize our product candidates may be harmed.

side effects or safety risks could delay or preclude approval, cause us to suspend clinical trials, or result in negative consequences

following any marketing approval.

trials could reveal unacceptable side effects or unexpected characteristics.

Undesirable side effects could result in the delay, suspension,

or termination of clinical trials.

Serious adverse events could hinder market acceptance of our drug candidates.

We may elect to abandon

or limit development to narrower uses or subpopulations where side effects are less prevalent or more acceptable from a risk-benefit

Many drugs that initially showed promise have later been found to cause side effects that prevented further development.

It is possible that as we test our drug candidates in larger, longer, and more extensive clinical trials, adverse events that were not

detected in earlier trials will be reported.

If such side effects become known later in development or upon approval, such findings may

significantly harm our business.

may not achieve our development milestones on our projected timelines.

achievement of milestones such as the timing of the accomplishment of various scientific, clinical, manufacturing, regulatory, and other

7 unchanged sentences

of our common stock may decline.

a product liability claim is successfully brought against us for uninsured liabilities, or such claim exceeds our insurance coverage,

we could be forced to pay substantial damage awards that could materially harm our business.

use of any of our existing or future product candidates in clinical trials and the sale of any approved pharmaceutical products may expose

us to significant product liability claims.

We currently do not have product liability insurance coverage but we intend to obtain such

Such insurance coverage may not protect us against any or all of the product liability claims that may be brought against

us in the future.

We may not be able to acquire or maintain adequate product liability insurance coverage at a commercially reasonable

cost or in sufficient amounts or scope to protect us against potential losses.

In the event a product liability claim is brought against

us, we may be required to pay legal and other expenses to defend the claim, as well as uncovered damage awards resulting from a claim

brought successfully against us.

In the event our product candidate is approved for sale by the FDA or other regulatory agency and commercialized,

we may need to substantially increase the amount of our product liability coverage.

Defending any product liability claim or claims could

require us to expend significant financial and managerial resources, which could have an adverse effect on our business.

liability claims could materially harm our business.

use of our product candidates in clinical trials and the sale of any approved products may expose us to significant product liability

We currently do not have product liability insurance coverage but intend to obtain such insurance.

Such insurance may not protect

us against all claims, and we may not be able to acquire adequate coverage at a commercially reasonable cost.

If our product candidates

are approved for sale, we may need to substantially increase our coverage.

Defending product liability claims could require us to expend

significant financial and managerial resources, which could have an adverse effect on our business.

current and future products may never achieve significant commercial market acceptance.

success depends on the market’s confidence that we can provide therapeutic products that improve clinical outcomes, lower healthcare

costs and enable better biopharmaceutical development.

Failure of our products, or those jointly developed with our collaborators, to

perform as expected could significantly impair our operating results and our reputation.

We believe patients, clinicians, academic institutions

and biopharmaceutical companies are likely to be particularly sensitive to defects, errors, inaccuracies, delays and toxicities in or

success depends on the market’s confidence that we can provide therapeutic products that improve clinical outcomes and lower healthcare

Failure of our products to perform as expected could impair our operating results and reputation.

Patients, clinicians, academic

institutions, and biopharmaceutical companies are likely to be particularly sensitive to defects, errors, inaccuracies, delays, and toxicities

associated with our products.

Furthermore, inadequate performance of these products may result in lower confidence in our pipeline in

may not succeed in achieving significant commercial market acceptance for our current or future products due to a number of factors,

8 unchanged sentences

impact of our investments in product innovation and commercial growth.

Additionally,

our customers and collaborators may decide to decrease or discontinue their use of our products due to changes in their research and

development plans, failures in their clinical trials, financial constraints, the regulatory environment, negative publicity about our

products, competing products or the reimbursement landscape, all of which are circumstances outside of our control.

We may not be successful

in addressing these or other factors that might affect the market acceptance of our products.

Failure to achieve widespread market acceptance

of our pipeline and related products would materially harm our business, financial condition and results of operations.

such as COVID-19, may adversely impact our business, results of operations, financial condition, liquidity and cash flows and that of

COVID-19 pandemic and efforts to control its spread had an impact on our operations.

For example, as a result of COVID-19, we previously

experienced delays from our manufacturers with respect to the shipping of our materials as well as delays in completion of analytical

testing as a result of the shelter-in-place order restrictions.

Pandemics, such as COVID-19, may have a material economic effect on our

business because our research and development may be affected as a result of delays in study monitoring and data analysis;

some participants

and clinical investigators may not be able to comply with clinical trial protocols;

any quarantines or other travel limitations (whether

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

in our inability to conduct our research activities, including our clinical trials;

and infections and deaths related to a pandemic may

disrupt the United States’ healthcare and healthcare regulatory systems which could divert healthcare resources away from, or materially

delay FDA review and/or approval of our product candidates.

While the potential economic impact brought by such pandemics may be difficult

to assess or predict, it has caused, and may result in further significant disruption of global financial markets, which may reduce our

ability to access capital either at all or on favorable terms.

In addition, a recession, depression or other sustained adverse market

event resulting from a health pandemic could materially and adversely affect our business and the value of our common stock.

may expend our limited resources to pursue a particular drug candidate or indication and fail to capitalize on drug candidates or indications

that may be more profitable or for which there is a greater likelihood of success.

we have limited financial and managerial resources, we focus on research programs and drug candidates that we identify for specific indications.

As a result, we may forego or delay pursuit of opportunities with other drug candidates or for other indications that later prove to

have greater commercial potential.

Our resource allocation decisions may cause us to fail to capitalize on viable commercial products

or profitable market opportunities.

Our spending on current and future research and development programs and drug candidates for specific

indications may not yield any commercially viable products.

If we do not accurately evaluate the commercial potential or target market

for a particular drug candidate, we may relinquish valuable rights to that drug candidate through collaboration, licensing or other royalty

arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to

such drug candidate.

may not be successful in our efforts to design additional potential drug candidates.

therapeutic design and development activities that we are conducting may not be successful in developing drug candidates that are useful

in treating rare diseases, inflammatory conditions, cancer or other diseases.

Our research programs may initially show promise in identifying

potential drug candidates, yet fail to yield drug candidates for clinical development for a number of reasons, including:

research methodology used may not be successful in identifying potential drug candidates;

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

unlikely to be drugs that will obtain marketing approval or achieve market acceptance;

drug candidates may not be effective in treating their targeted diseases.

programs to identify and design new drug candidates require substantial technical, financial and human resources.

We may choose to focus

our efforts and resources on a potential drug candidate that ultimately proves to be unsuccessful.

If we are unable to identify and design

suitable drug candidates for pre-clinical and clinical development, we will not be able to obtain revenues from the sale of products

in future periods, which likely would result in significant harm to our financial position and adversely impact our stock price.

face significant competition, and if our competitors develop and market technologies or products more rapidly than we do or that are

more effective, safer or less expensive than the products we develop, our commercial opportunities will be negatively impacted.

biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis

on proprietary and novel products and product candidates.

Our competitors have developed, are developing or may develop products, product

candidates and processes competitive with ours.

Any product candidates that we successfully develop and commercialize will compete with

existing therapies and new therapies that may become available in the future.

We believe that a significant number of products are currently

under development, and may become commercially available in the future, for the treatment of conditions for which we may attempt to develop

product candidates.

In addition, our products may need to compete with drugs physicians use off-label to treat the indications for which

we seek approval.

This may make it difficult for us to replace existing therapies with our products.

particular, there is intense competition in the fields of rare diseases, inflammatory conditions and oncology.

We have competitors both

in the United States and internationally, including major multinational pharmaceutical companies, established biotechnology companies,

specialty pharmaceutical companies, emerging and start-up companies, universities and other research institutions.

We also compete with

these organizations to recruit management, scientists and clinical development personnel, which could negatively affect our level of

expertise and our ability to execute our business plan.

We will also face competition in establishing clinical trial sites, enrolling

subjects for clinical trials and in identifying and in-licensing new product candidates.

commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective,

have fewer side effects, are more convenient, have a broader label, are marketed more effectively, are more widely reimbursed or are

less expensive than any products that we may develop.

Our competitors also may obtain marketing approval from the FDA, EMA or other comparable

foreign regulatory authorities 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.

Even if the product candidates we develop achieve marketing

approval, they may be priced at a significant premium over competitive products if any have been approved by then, resulting in reduced

competitiveness.

Technological advances or products developed by our competitors may render our technologies or product candidates obsolete,

less competitive or not economical.

If we are unable to compete effectively, our opportunity to generate revenue from the sale of our

products we develop may be adversely affected.

and collaborators may decrease or discontinue use of our products due to changes in their plans, financial constraints, the regulatory

environment, negative publicity, competing products, or reimbursement landscape.

Failure to achieve widespread market acceptance would

materially harm our business, financial condition, and results of operations.

face significant competition from companies that may develop more effective, safer, or less expensive products.

biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition, and strong emphasis

on proprietary products.

Our competitors have developed, are developing, or may develop products competitive with ours.

Any product candidates

we successfully commercialize will compete with existing and new therapies.

We may need to compete with drugs physicians use off-label

to treat our targeted indications, making it difficult to replace existing therapies.

is intense competition in rare diseases, inflammatory conditions, and oncology.

We have competitors including major multinational pharmaceutical

companies, established biotechnology companies, specialty pharmaceutical companies, and research institutions.

We also compete with these

organizations to recruit management and scientific personnel and to establish clinical trial sites and enroll subjects.

commercial opportunity could be reduced or eliminated if competitors develop safer, more effective, more convenient, or less expensive

products, or if they obtain marketing approval before us.

Technological advances by our competitors may render our technologies or product

candidates obsolete or not economical.

are subject to healthcare laws and regulations.

of our product candidates, if approved, or any other future product candidate will be subject to healthcare regulation and enforcement

by the federal government and the states and foreign governments in which we might conduct our business.

The healthcare laws and regulations

that may affect our ability to operate include the following:

federal Anti-Kickback Statute makes it illegal for any person or entity to knowingly and willfully, directly or indirectly, solicit,

receive, offer, or pay any remuneration that is in exchange for or to induce the referral of business, including the purchase, order,

lease of any good, facility, item or service for which payment may be made under a federal healthcare program, such as Medicare or

The term “remuneration” has been broadly interpreted to include anything of value.

false claims and false statement laws, including the federal civil False Claims Act and the Civil Monetary Penalties Law (“CMPL”),

prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented, for payment to, or approval

by, federal programs, including Medicare and Medicaid, claims for items or services, including drugs, that are false or fraudulent.

Insurance Portability and Accountability Act of 1996 (“HIPAA”) created additional federal criminal statutes that prohibit

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

including private third-party payors or making any false, fictitious or fraudulent statement in connection with the delivery of or

payment for healthcare benefits, items or services.

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

impose obligations on certain types of individuals and entities regarding the electronic exchange of information in common healthcare

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

Federal Food, Drug and Cosmetic Act, which governs the production, sale, distribution, promotion and sampling of drugs, biologics

and medical devices and prohibits, among other things, the adulteration or misbranding of drugs, biologics and medical devices including

marketing drug products for off-label use;

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

payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report

annually to the Centers for Medicare & Medicaid Services information related to payments or other transfers of value made to

physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors), certain other healthcare professionals

(such as physician assistants and nurse practitioners), and teaching hospitals, as well as ownership and investment interests held

by physicians and their immediate family members and applicable group purchasing organizations.

many states have similar laws and regulations, such as anti-kickback and false claims laws that may be broader in scope and may apply

regardless of payor, in addition to items and services reimbursed under Medicaid and other state programs.

Additionally, we may be subject

to state laws that require pharmaceutical companies to comply with the federal government’s and/or pharmaceutical industry’s

voluntary compliance guidelines, state laws that require drug manufacturers to report information related to payments and other transfers

of value to physicians and other healthcare providers or marketing expenditures and state laws requiring the registration of sales representatives,

as well as state and foreign laws governing the privacy and security of health information, many of which differ from each other in significant

ways and often are not preempted by HIPAA.

of our product candidates, if approved, will be subject to healthcare regulation and enforcement by federal, state, and foreign governments.

Applicable laws include the federal Anti-Kickback Statute, federal false claims and false statement laws, HIPAA, and the federal Physician

Payments Sunshine Act.

Many states have similar laws that may be broader in scope and apply regardless of payor, including laws requiring

drug manufacturers to report payments to healthcare providers, to comply with voluntary compliance guidelines, and to register sales

representatives.

laws and regulations applicable to our business are complex, changing, and often subject to varying interpretations.

As a result, we may

not be able to adhere to all applicable laws and regulations.

Any violation or alleged violation of any of these laws or regulations

by us could have a material adverse effect on our business, financial condition, cash flows and results of operations.

We may be a party

to various lawsuits, demands, claims, qui tam suits, third-party complaints to the FDA, government investigations and audits,

of which any could result in, among other things, substantial financial penalties or awards against us, reputational harm, termination

of relationships or contracts related to our business, mandated refunds, substantial payments made by us, required changes to our business

practices, exclusion from future participation in Medicare and other healthcare programs and possible criminal penalties.

we are found in violation of applicable laws or regulations, we could suffer severe consequences that would have a material adverse effect

on our business, results of operations, financial condition, cash flows, reputation and stock price, including:

or termination of our participation in federal healthcare programs;

or civil liability, fines, damages or monetary penalties for violations of healthcare fraud and abuse laws, including the federal

False Claims Act, CMPL, and Anti-Kickback Statute;

actions by governmental agencies or claims for monetary damages by patients under federal or state patient privacy laws, including

of amounts received in violation of law or applicable payment program requirements, and related monetary penalties;

changes to our practices or procedures that materially increase operating expenses;

of corporate integrity agreements that could subject us to ongoing audits and reporting requirements as well as increased scrutiny

of our business practices;

of various relationships or contracts related to our business;

to our reputation which could negatively affect our business relationships, decrease our ability to attract or retain patients and

physicians, decrease access to new business opportunities and impact our ability to obtain financing, among other things.

to lawsuits and other proceedings as well as defending ourselves in such matters will continue to require management’s attention

and cause us to incur significant legal expense.

It is also possible that criminal proceedings may be initiated against us or individuals

in our business in connection with investigations by the federal government.

to the extent that our product is sold in a foreign country, we may be subject to similar foreign laws.

we are unable to effectively adapt to changes in the healthcare industry, including changes to laws and regulations regarding or affecting

healthcare reform, our business may be harmed.

state and local legislative bodies frequently pass legislation and promulgate regulations relating to healthcare reform or that affect

the healthcare industry.

We anticipate that there will continue to be increased government oversight and regulation of the healthcare

industry in the future.

We cannot predict the ultimate content, timing or effect of any new healthcare legislation or regulations, nor

is it possible at this time to estimate the impact of potential new legislation or regulations on our business.

It is possible that future

legislation enacted by Congress or state legislatures, or regulations promulgated by regulatory authorities at the federal or state level,

could adversely affect our business.

We also cannot predict the outcome of any current or future litigation that may affect interpretation

of, or deference to, agency regulations and guidance.

FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and if we are

found to have improperly promoted off-label uses of our drugs or drug candidates, if approved, we may become subject to significant liability.

we are found to have improperly promoted off-label uses of our drugs or drug candidates, we may become subject to significant liability.

The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription drug products, such

as our drug candidates.

In particular, a drug may not be promoted for uses that are not approved by the FDA or such other regulatory

agencies as reflected in the drug’s approved labeling, including a different dosage, delivery or patient population than is contained

in the label.

If we receive marketing approval for our drug candidates for our proposed indications, physicians may nevertheless use

our drugs for their patients in a manner that is inconsistent with the approved label.

However, if we are found to have promoted our

drugs for any off-label uses, the federal government could levy civil, criminal and/or administrative penalties, and seek fines against

The FDA or other regulatory authorities could also request that we enter into a consent decree or a corporate integrity agreement,

or seek a permanent injunction against us under which specified promotional conduct is monitored, changed or curtailed.

successfully manage the promotion of our drug candidates, we could become subject to significant liability, which would materially adversely

affect our business and financial condition.

Any violation could

result in substantial financial penalties, termination of business relationships, mandated refunds, required changes to business practices,

exclusion from healthcare programs, and possible criminal penalties.

If found in violation, we could suffer severe consequences that

would materially adversely affect our business, results of operations, financial condition, and stock price.

state, and local legislative bodies frequently pass legislation relating to healthcare reform.

We anticipate continued government oversight

and regulation of the healthcare industry.

We cannot predict the content, timing, or effect of new healthcare legislation or regulations,

nor their impact on our business.

may not be able to obtain or maintain Fast Track designation or accelerated approval for our drug candidates.

15 unchanged sentences

may not be able to obtain or maintain orphan drug designation or exclusivity for our drug candidates.

authorities in some jurisdictions, including the United States, may designate drugs for relatively small patient populations as “orphan

drugs.” Under the Orphan Drug Act, the FDA may designate a drug candidate as an orphan drug if it is intended to treat a rare disease

or condition, which is generally defined as a patient population of fewer than 200,000 individuals in the United States, or if the disease

or condition affects more than 200,000 individuals in the United States and there is no reasonable expectation that the cost of developing

and making a drug product available in the United States for the type of disease or condition will be recovered from sales of the product.

drug designation entitles a party to financial incentives, such as opportunities for grant funding towards clinical trial costs, tax

advantages and user-fee waivers.

Additionally, if a product that has orphan designation subsequently receives the first FDA approval

for the disease or condition for which it has such designation, the product is entitled to orphan drug exclusivity.

This means that the

FDA may not approve any other applications to market the same drug or biological product for the same indication for seven years, except

in certain circumstances, including proving clinical superiority (i.e., another product is safer, more effective or makes a major contribution

to patient care) to the product with orphan exclusivity.

Competitors, however, may receive approval of different products for the indication

for which the orphan product has exclusivity, or obtain approval for the same product but for a different indication than that for which

the orphan product has exclusivity.

In addition, exclusive marketing rights in the United States may be limited if we seek approval for

an indication broader than the orphan-designated indication or may be lost if the FDA later determines that the request for designation

was materially defective.

Breakthrough Therapy designation by the FDA for our drug candidates may not lead to a faster development or regulatory review or approval

process, and it does not increase the likelihood that our drug candidates will receive marketing approval.

the Orphan Drug Act, the FDA may designate a drug candidate as an orphan drug if intended to treat a rare disease or condition (generally

defined as a patient population of fewer than 200,000 in the United States).

Orphan drug designation provides financial incentives including

grant funding opportunities, tax advantages, and user-fee waivers.

If a product with orphan designation receives the first FDA approval

for that indication, it is entitled to seven years of exclusivity during which the FDA may not approve competing applications for the

same drug and indication, except in certain circumstances.

may receive approval of different products for the same indication or the same product for different indications.

Exclusive marketing

rights may be limited if we seek approval for an indication broader than the orphan-designated indication or may be lost if the FDA later

determines the designation request was materially defective.

Therapy designation may not lead to faster development, review, or approval.

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

Accordingly, even if we believe one of our drug candidates meets the criteria

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

Even if we receive

Breakthrough Therapy designation, the receipt of such designation for a drug candidate may not result in a faster development process,

review or approval compared to drugs considered for approval under conventional FDA procedures and does not assure ultimate approval

In addition, even if one or more of our drug candidates qualify as breakthrough therapies, the FDA may later decide that

the drugs no longer meet the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.

We may seek a breakthrough therapy designation for some of our drug candidates.

A breakthrough therapy is defined as a drug that is intended,

alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical

evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant

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

For drugs and biologics that have been designated

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

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

Drugs designated as breakthrough

therapies by the FDA are also eligible for accelerated approval.

Related to Our Reliance on Third Parties

rely on third parties to conduct our pre-clinical studies and clinical trials.

If these third parties do not successfully perform their

contractual and regulatory duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our

drug candidates and our business could be substantially harmed.

do not have the ability to independently conduct all aspects of our pre-clinical testing or clinical trials.

As a result, we have relied

upon and plan to continue to rely upon third-party medical institutions, clinical investigators, contract laboratories and other third

party CROs to monitor and manage data for our ongoing pre-clinical and clinical programs.

We rely on these parties for the execution

of our pre-clinical studies and clinical trials, and control only certain aspects of their activities.

Nevertheless, we are responsible

for ensuring that each of our studies is conducted in accordance with the applicable protocol, legal, regulatory, and scientific standards,

and our reliance on the CROs does not relieve us of our regulatory responsibilities.

We and our CROs are required to comply with current

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

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

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

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

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

marketing applications.

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

that any of our clinical trials comply with GCP regulations.

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

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

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

to do so on commercially reasonable terms.

In addition, our CROs are not our employees, and except for remedies available to us under

our agreements with such CROs, we cannot control whether or not they devote sufficient time and resources to our on-going clinical, nonclinical

and pre-clinical or clinical programs.

If CROs do not successfully carry out their contractual duties or obligations or meet expected

deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure

to adhere to our clinical protocols, regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated

and we may not be able to obtain regulatory approval for or successfully commercialize our drug candidates.

As a result, our results

of operations and the commercial prospects for our drug candidates would be harmed, our costs could increase and our ability to generate

revenues could be delayed.

of the third parties with whom we contract may also have relationships with other commercial entities, including our competitors, for

whom they may also be conducting clinical trials or other drug development activities that could harm our competitive position.

third parties conducting our pre-clinical studies or our clinical trials do not perform their contractual duties or obligations, experience

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

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

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

Switching or adding additional CROs involves

additional cost and requires management time and focus.

In addition, there is a natural transition period when a new CRO commences work.

As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines.

Though we carefully

manage our relationships with our CROs, there can be no assurance that we will not encounter similar challenges or delays in the future

or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects.

Even if we believe our drug candidates meet the criteria, the FDA may

Receipt of Breakthrough Therapy designation may not result in faster development, review, or approval compared to conventional

procedures and does not assure ultimate approval.

The FDA may later decide that drugs no longer meet qualification conditions.

A breakthrough

therapy is defined as a drug intended to treat a serious or life-threatening condition for which preliminary clinical evidence indicates

substantial improvement over existing therapies.

Drugs designated as breakthrough therapies are eligible for accelerated approval and

enhanced FDA interaction during development.

rely on third parties to conduct our pre-clinical studies and clinical trials, and their failure to perform could substantially harm

our business.

rely on third-party medical institutions, clinical investigators, contract laboratories, and CROs to conduct and manage our pre-clinical

and clinical programs.

We control only certain aspects of their activities but remain responsible for ensuring studies comply with applicable

protocols, legal, regulatory, and scientific standards.

We and our CROs must comply with current Good Clinical Practice (GCP) regulations

enforced by the FDA, EMA, and comparable foreign regulatory authorities.

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

If we or our CROs fail

to comply with applicable GCPs, clinical data may be deemed unreliable by relevant authorities and additional trials may be required.

Our clinical trials must also be conducted with products produced under cGMP.

If our relationships with CROs terminate, we may not be

able to enter into alternative arrangements on commercially reasonable terms.

In addition, CROs are not our employees, and we cannot

control their operations-including their conduct of our clinical, nonclinical and pre-clinical or clinical programs.

If CROs do not successfully

carry out their duties, meet deadlines, or if data quality is compromised, our clinical trials may be extended, delayed, or terminated,

harming our commercial prospects and ability to generate revenues.

third parties with whom we contract may also have relationships with our competitors.

If they do not perform their duties, experience

work stoppages, or need to be replaced, we may need to enter into new arrangements with alternative third parties.

Switching CROs involves

additional cost and management time, and transition periods can materially impact our clinical development timelines.

rely on third-party manufacturers for our drug candidates and expect to continue doing so for commercialization.

rely entirely on third-party manufacturers for the production of our drug candidates for pre-clinical and clinical testing and any potential

commercial supply, as we do not own or operate manufacturing facilities.

This dependence exposes us to risks related to insufficient

supply, inadequate quality, and unfavorable cost structures, which could delay development timelines or impair commercialization efforts.

We may be unable to secure or maintain manufacturing agreements on acceptable terms, and our limited supply arrangements generally do

not extend to commercial-scale production.

Many key materials are sourced on a purchase order basis without long-term commitments, increasing

the risk of supply interruptions.

manufacturing arrangements subject us to additional operational and compliance risks beyond our direct control, including regulatory

noncompliance, quality failures, contract breaches, operational disruptions, logistics delays, improper storage or transport, and potential

misappropriation of proprietary information.

Manufacturers may fail to comply with cGMP or other regulatory standards, which could result

in clinical holds, fines, product recalls, approval delays, or other enforcement actions that disrupt supply.

These manufacturers are

also subject to environmental, health, and safety laws, and regulatory actions against them could lead to facility shutdowns or restricted

operations, adversely affecting our access to necessary manufacturing and packaging services.

Manufacturing

pharmaceutical products is complex and subject to product loss for a variety of reasons.

We contract with third parties for the manufacture

of our drug candidates for pre-clinical testing and clinical trials and expect to continue to do so for commercialization.

This reliance

on third parties increases the risk that we will not have sufficient quantities of our drug candidates or products or such quantities

at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts.

do not have any manufacturing facilities.

We produce very small quantities of small molecules for evaluation in our research programs

in our laboratory.

We rely, and expect to continue to rely, on third parties for the manufacture of our drug candidates for pre-clinical

and clinical testing, as well as for commercial manufacture if any of our drug candidates obtain marketing approval.

This reliance on

third parties increases the risk that we will not have sufficient quantities of our drug candidates or products or such quantities at

an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts.

may be unable to establish any agreements with third-party manufacturers or to do so on favorable terms.

Even if we are able to establish

agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

on the third party for regulatory, compliance and quality assurance;

of our third-party manufacturers or suppliers could be disrupted by conditions unrelated to our business or operations, including

the bankruptcy of the manufacturer or supplier or the issuance of an FDA Form 483 notice or warning letter;

possible breach of the manufacturing agreement by the third party;

possible misappropriation of our proprietary information, including our trade secrets and know how;

possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us;

disruptions or increased costs that are beyond our control;

to deliver our drugs under specified storage conditions and in a timely manner.

have only limited supply arrangements in place with respect to our drug candidates, and these arrangements do not extend to commercial

We acquire many key materials on a purchase order basis.

As a result, we do not have long-term committed arrangements with respect

to our drug candidates and other materials.

If we obtain marketing approval for any of our drug candidates, we will need to establish

an agreement for commercial manufacture with a third party;

however, no assurance can be provided that we will be able to enter into

a commercial manufacture agreement on reasonable terms, if at all.

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

Our failure, or the

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

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

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

and adversely affect supplies of our products.

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

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

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

for such third parties.

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

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

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

As a result, we may not obtain access to these facilities on a priority basis or at all.

There are a limited number of manufacturers

that operate under cGMP and that may be capable of manufacturing our product candidates.

we prepare for later-stage clinical trials and potential commercialization, we will need to take steps to increase the scale of production

of our drug candidates.

Even minor deviations from normal manufacturing processes could result in reduced production yields, product

defects and other supply disruptions.

If microbial, viral or other contaminations are discovered in our drug candidates or in the manufacturing

facilities in which our drug candidates are made, such manufacturing facilities may need to be closed for an extended period of time

to investigate and remedy the contamination.

performance failure on the part of our existing or future manufacturers could delay clinical development or marketing approval.

not currently have arrangements in place for redundant supply or a second source for bulk drug substance.

If our current contract manufacturers

for pre-clinical and clinical testing cannot perform as agreed, we may be required to replace such manufacturers.

Although we believe

that there are several potential alternative manufacturers who could manufacture our drug candidates, we may incur added costs and delays

in identifying and qualifying any such replacement manufacturer or be able to reach agreement with any alternative manufacturer.

current and anticipated future dependence upon others for the manufacture of our drug candidates or products may adversely affect our

future profit margins and our ability to commercialize any products that obtain marketing approval on a timely and competitive basis.

capacity is limited among qualified cGMP-compliant providers, and our drug candidates may compete with other products for facility access,

reducing our ability to secure priority production slots.

As we scale production for later-stage trials or commercialization, manufacturing

complexity increases and even minor process deviations or contamination events could lead to reduced yields, batch failures, or facility

We currently lack redundant suppliers for bulk drug substance, and replacing underperforming manufacturers could involve significant

time and cost.

Any manufacturing failure or transition to alternative suppliers may delay development or approval and could negatively

affect our margins and ability to commercialize approved products on a timely and competitive basis.

currently depend on a sole source supplier and manufacturer for the active ingredient in our product candidates and the inability to

2 unchanged sentences

In addition, we anticipate that

we will also source the active ingredient in TH104 from a sole supplier/manufacturer.

we will also source the active ingredient in GV104 from a sole supplier/manufacturer.

Although we believe that we can obtain the active

ingredient for HS1940, HS3215, HS0059 and TH104 from other suppliers, supply shortages for these particular raw material may delay our

ingredient for HS1940, HS3215, HS0059 and GV104 from other suppliers, supply shortages for these particular raw materials may delay our

clinical trials.

8 unchanged sentences

biotechnology companies, academic institutions and other entities.

Third-party collaborators may assist us in:

research, pre-clinical development, clinical trials and manufacturing;

and obtaining regulatory approvals;

commercializing any future drug candidates.

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

at our own expense.

Such an undertaking may limit the number of drug candidates that we will be able to develop, significantly increase

our capital requirements and place additional strain on our internal resources.

Our failure to enter into additional collaborations could

materially harm our business, financial condition and results of operations.

addition, our dependence on licensing, collaboration and other agreements with third parties may subject us to a number of risks.

agreements may not be on terms that prove favorable to us and may require us to relinquish certain rights in our drug candidates.

the extent we agree to work exclusively with one collaborator in a given area, our opportunities to collaborate with other entities could

be curtailed.

Lengthy negotiations with potential new collaborators may lead to delays in the research, development or commercialization

of drug candidates.

The decision by our collaborators to pursue alternative technologies or the failure of our collaborators to develop

or commercialize successfully any drug candidate to which they have obtained rights from us could materially harm our business, financial

condition and results of operations.

Related to Commercialization of Our Drug Candidates

if we are successful in completing all pre-clinical studies and clinical trials, we may not be successful in commercializing one or more

of our drug candidates.

if we complete the necessary pre-clinical studies and clinical trials, the marketing approval process is expensive, time-consuming and

uncertain and may prevent us from obtaining approvals for the commercialization of some or all of our drug candidates.

If we are not

able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize our drug candidates,

and our ability to generate revenue will be materially impaired.

drug candidates and the activities associated with their development and commercialization, including their design, testing, manufacture,

safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, export and import are subject

to comprehensive regulation by the FDA and other regulatory agencies in the United States and by the EMA and similar regulatory authorities

outside of the United States.

Failure to obtain marketing approval for a drug candidate will prevent us from commercializing the drug

We have not submitted an application for or received marketing approval for any of our drug candidates in the United States

or in any other jurisdiction.

have only limited experience in filing and supporting the applications necessary to gain marketing approvals and expect to rely on third-party

Third-party collaborators may assist us in funding research and development

activities, clinical trials and manufacturing, obtaining regulatory approvals, and commercializing any future drug candidates.

we are not able to establish collaboration, we may be required to undertake drug development and commercialization at our own expense.

Such an undertaking may limit the number of drug candidates that we will be able to develop, significantly increase our capital requirements

and place additional strain on our internal resources.

Our failure to enter into additional collaborations could materially harm our

business, financial condition and results of operations.

dependence on licensing and collaboration with third parties may subject us to additional risks.

We may not be able to secure such relationships

on terms that prove favorable to us.

Our agreements with such partners may contain exclusivity terms that limit other collaboration opportunities.

Lengthy negotiations with potential new collaborators may lead to delays in the research, development or commercialization of drug candidates.

Our collaborators may decide to pursue other technologies or fail to develop or commercialize our drug candidates, which could materially

harm our business, financial condition and results of operations.

may not be successful in commercializing one or more of our drug candidates.

have not submitted an application for or received marketing approval for any of our drug candidates in the United States or in any other

jurisdiction.

The marketing approval process is expensive, time-consuming and uncertain, which may prevent us from obtaining approvals

for the commercialization of some or all of our drug candidates.

If we are not able to obtain, or if there are delays in obtaining, required

regulatory approvals, we will not be able to commercialize our drug candidates, and our ability to generate revenue will be materially

drug candidates and the activities associated with the development and commercialization are subject to comprehensive regulation by the

FDA and other regulatory agencies.

have only limited experience in filing and supporting the applications for marketing approvals, and we expect to rely on third-party

clinical research organizations or other third-party consultants or vendors to assist us in this process.

4 unchanged sentences

about the drug manufacturing process to, and inspection of manufacturing facilities by, the regulatory authorities.

Our drug candidates

may not be effective, may be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other

characteristics that may preclude our obtaining marketing approval or prevent or limit commercial use.

New therapeutics frequently are

indicated only for patient populations that have not responded to an existing therapy or have relapsed.

If any of our drug candidates

receives marketing approval, the accompanying label may limit the approved use of our drug in this way, which could limit sales of the

process of obtaining marketing approvals, both in the United States and abroad, is expensive, may take many years, if approval is obtained

at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the drug candidates

Changes in marketing approval policies during the development period, changes in or the enactment of additional statutes or

regulations, or changes in regulatory review for each submitted drug application, may cause delays in the approval or rejection of an

Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may

decide that our data is insufficient for approval and require additional pre-clinical, clinical or other studies.

In addition, varying

interpretations of the data obtained from pre-clinical studies and clinical trials could delay, limit or prevent marketing approval of

a drug candidate.

Any marketing approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments

that render the approved drug not commercially viable.

process of obtaining marketing approvals, both in the United States and abroad, is lengthy and expensive.

Changes in marketing approval

policies during the development period, adoption of new statutes or regulations, or changes in regulatory review process, may cause delays

in the approval or rejection of an application.

Regulatory authorities have broad discretion in the approval process.

They may interpret

our study and trial data differently, which may also delay, limit, or prevent approval.

Any approval obtained may be subject to restrictions

or post-approval obligations that could adversely affect commercial viability.

we are unable to develop satisfactory sales and marketing capabilities, we may not succeed in commercializing our drug candidates.

22 unchanged sentences

for our drug candidates on a timely basis, or at all.

time required to obtain approval or other marketing authorizations by the FDA is unpredictable, and it typically takes many years following

the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities.

In addition, approval policies, regulations, and the type and amount of clinical data necessary to gain approval may change during the

course of a product candidate’s clinical development and may vary among jurisdictions.

We have not obtained regulatory approval

for any product candidate, and it is possible that we may never obtain regulatory approval for any product candidates we may seek to

develop in the future.

Neither we nor any current or future collaborator is permitted to market any drug product candidates in the United

States until we receive regulatory approval from the FDA.

time required to obtain FDA approval is unpredictable and typically takes many years following the commencement of clinical trials.

depends upon numerous factors, including the substantial discretion of regulatory authorities, and approval policies, regulations, and

the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical

We have not obtained regulatory approval for any product candidate, and it is possible that we may never obtain regulatory

approval for any product candidates we may seek to develop in the future.

to obtaining approval to commercialize any drug product candidate in the United States, we must demonstrate with substantial evidence

1 unchanged sentence

their intended uses.

Results from pre-clinical studies and clinical trials can be interpreted in different ways.

Even if we believe the

pre-clinical or clinical data for our product candidates are promising, such data may not be sufficient to support approval by the FDA.

The FDA may also require us to conduct additional pre-clinical studies or clinical trials for our product candidates either prior to

or after approval, or it may object to elements of our clinical development programs.

product candidates could fail to receive regulatory approval for many reasons, including the following:

FDA may disagree with the design or implementation of our clinical trials;

may be unable to demonstrate to the satisfaction of the FDA that a product candidate is safe and effective for its proposed indication;

results of clinical trials may not meet the level of statistical significance required by the FDA for approval;

may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;

FDA may fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical

and commercial supplies;

approval policies or regulations of the FDA may significantly change in a manner rendering our clinical data insufficient for approval.

Even if we believe pre-clinical or clinical data for our product candidates are promising, such data may not be

sufficient to support approval by the FDA, and the FDA may require us to conduct additional pre-clinical studies or clinical trials either

prior to or after approval.

product candidates could fail to receive regulatory approval for many reasons, including:

the FDA may disagree with the design or implementation

of our clinical trials;

we may be unable to demonstrate that a product candidate is safe and effective for its proposed indication;

results of clinical trials may not meet the level of statistical significance required for approval;

we may be unable to demonstrate

that a product candidate’s clinical benefits outweigh its safety risks;

the FDA may fail to approve the manufacturing processes

or facilities of third-party manufacturers with which we contract;

and the approval policies or regulations of the FDA may significantly

change in a manner rendering our clinical data insufficient for approval.

the large number of products in development, only a small percentage successfully complete the FDA approval processes and are commercialized.

The lengthy approval and marketing authorization process as well as the unpredictability of future clinical trial results may result

in our failing to obtain regulatory approval and marketing authorization to market our product candidates, which would significantly

harm our business, financial condition, results of operations and prospects.

have invested a significant portion of our time and financial resources in the development of our pre-clinical product candidates.

business is dependent on our ability to successfully complete pre-clinical and clinical development, obtain regulatory approval for,

and, if approved, successfully commercialize our product candidates in a timely manner.

if we eventually complete clinical testing and receive approval for our product candidates, the FDA, may grant approval or other marketing

authorization contingent on the performance of costly additional clinical trials, including post-marketing clinical trials.

also may approve or authorize for marketing a product candidate for a more limited indication or patient population than we originally

request, and the FDA may not approve or authorize the labeling that we believe is necessary or desirable for the successful commercialization

of a product candidate.

Any delay in obtaining, or inability to obtain, applicable regulatory approval or other marketing authorization

would delay or prevent commercialization of that product candidate and would materially adversely impact our business and prospects.

addition, the FDA may change their policies, issue additional regulations or revise existing regulations, or take other actions, which

may prevent or delay approval of our future products under development on a timely basis.

Such policy or regulatory changes could impose

additional requirements upon us that could delay our ability to obtain approvals, increase the costs of compliance or restrict our ability

to maintain any marketing authorizations we may have obtained.

Even if we complete clinical testing and receive approval, the FDA may grant approval contingent on costly additional post-marketing

clinical trials, or may approve a product candidate for a more limited indication or patient population than originally requested.

FDA may also change its policies, issue additional regulations, or take other actions that could impose additional requirements, delay

our ability to obtain approvals, increase compliance costs, or restrict our ability to maintain any marketing authorizations we may have

to obtain marketing approval in foreign jurisdictions would prevent our drug candidates from being marketed abroad.

18 unchanged sentences

able to file for marketing approvals and may not receive necessary approvals to commercialize our drugs in any market.

drug candidate that we obtain marketing approval for could be subject to post-marketing restrictions or withdrawal from the market and

we may be subject to substantial penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems

with our drugs, when and if any of them are approved.

it is possible that one or more of our drug candidates may require a companion diagnostic to select the patients who will likely respond

to a therapy involving one of our drug candidates as a condition of approval, it is too early in our drug candidates development to identify

which drug candidate, if any, would require a companion diagnostic.

According to FDA guidance, if the FDA determines that a companion

diagnostic device is essential to the safe and effective use of a novel therapeutic drug or indication, the FDA generally will not approve

the therapeutic drug or new therapeutic drug indication if the companion diagnostic is not also approved or cleared for that indication.

Under the Federal Food, Drug and Cosmetic Act (“FDCA”), companion diagnostics are regulated as medical devices, and the FDA

has generally required companion diagnostics intended to select the patients who will respond to treatment to obtain Premarket Approval

(“PMA”) for the diagnostic.

The PMA process, including the gathering of clinical and pre-clinical data and the submission

to and review by the FDA, involves a rigorous premarket review during which the applicant must prepare and provide the FDA with reasonable

assurance of the device’s safety and effectiveness and information about the device and its components regarding, among other things,

device design, manufacturing and labeling.

A PMA is not guaranteed and may take considerable time, and the FDA may ultimately respond

to a PMA submission with a “not approvable” determination based on deficiencies in the application and require additional

clinical trial or other data that may be expensive and time-consuming to generate and that can substantially delay approval.

if we are required by the FDA to obtain approval of a companion diagnostic for a therapeutic drug candidate, and we do not obtain or

there are delays in obtaining FDA approval of a diagnostic device, we may not be able to commercialize the drug candidate on a timely

basis or at all and our ability to generate revenue will be materially impaired.

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

advertising and promotional activities for such drug, will be subject to continual requirements of and review by the FDA and other regulatory

These requirements include submissions of safety and other post-marketing information and reports, registration and listing

requirements, cGMP requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of records

and documents, requirements regarding the distribution of samples to physicians and recordkeeping.

Even if marketing approval of a drug

candidate is granted, the approval may be subject to limitations on the indicated uses for which the drug may be marketed or to the conditions

of approval, including the requirement to implement a REMS.

New drugs frequently are indicated only for patient populations that have

not responded to an existing therapy or have relapsed.

If any of our drug candidates receives marketing approval, the accompanying label

may limit the approved use of our drug in this way, which could limit sales of the drug.

FDA may also impose requirements for costly post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy

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

The FDA and other agencies, including the Department of Justice (“DOJ”),

closely regulate and monitor the post-approval marketing and promotion of drugs to ensure they are marketed and distributed only for

the approved indications and in accordance with the provisions of the approved labeling.

The FDA and DOJ impose stringent restrictions

on manufacturers’ communications regarding off-label use, and if we do not market our drugs for their approved indications, we

may be subject to enforcement action for off-label marketing.

Violations of the FDCA and other statutes, including the False Claims Act,

relating to the promotion and advertising of prescription drugs may lead to investigations and enforcement actions alleging violations

of federal and state healthcare fraud and abuse laws, as well as state consumer protection laws.

In addition, later discovery of previously

unknown adverse events or other problems with our drugs, manufacturers or manufacturing processes, or failure to comply with regulatory

requirements, may have various consequences, including:

on such drugs, manufacturers or manufacturing processes;

and warnings on the labeling or marketing of a drug;

on drug distribution or use;

to conduct post-marketing studies or clinical trials;

letters or untitled letters;

of the drugs from the market;

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

restitution or disgorgement of profits or revenues;

or withdrawal of marketing approvals;

to relationships with any potential collaborators;

press coverage and damage to our reputation;

to permit the import or export of our drugs;

or the imposition of civil or criminal penalties;

involving patients using our drugs.

approved drug candidates may be subject to post-marketing requirements, restrictions, or withdrawal, and noncompliance could result in

FDA may require a companion diagnostic for certain product candidates.

When a diagnostic is essential to the safe and effective use of

a therapeutic, the FDA generally expects the diagnostic to be authorized contemporaneously.

Companion diagnostics are regulated as medical

devices and often require Premarket Approval (PMA), an uncertain and time-consuming process.

If we must obtain approval of a companion

diagnostic and are delayed or unable to do so, commercialization of the related therapeutic could be delayed or prevented.

product approved for marketing, and its manufacturing, labeling, advertising, promotion, and post-approval studies, will be subject to

ongoing FDA and other regulatory oversight, including safety reporting, registration and listing, cGMP, recordkeeping, and, where applicable,

Risk Evaluation and Mitigation Strategies (REMS).

Approvals may include limitations on use or other conditions that could restrict commercialization.

including the FDA and the Department of Justice, closely monitor post-approval promotion.

Promotion outside the approved labeling can

trigger enforcement under the FDCA and other laws, including the False Claims Act, and may result in civil or criminal liability.

previously unknown safety issues or compliance problems arise, regulators may require labeling changes or warnings;

restrict distribution

mandate additional post-marketing studies or clinical trials;

issue warning or untitled letters;

require recalls or withdrawals;

refuse to approve supplements;

suspend or withdraw approvals;

impose fines, disgorgement, injunctions, seizures, or import/export restrictions;

or pursue other remedies.

These actions, as well as related litigation, reputational harm, and impacts on collaborations, could materially

adversely affect our business.

reform initiatives in the United States may impact our business and results of operations.

the United States, there have been, and continue to be, a number of legislative and regulatory changes and proposed changes to the healthcare

system that could affect the future results of pharmaceutical manufactures’ operations.

In particular, there have been and continue

to be a number of initiatives at the federal and state levels that seek to reduce healthcare and prescription drug costs.

On the federal

level, the Affordable Care Act (“ACA”) was enacted in March 2010, and included measures to significantly change the way healthcare

is financed by both governmental and private insurers.

Among the provisions of the ACA that have been of greatest importance to the pharmaceutical

and biotechnology industry are the following:

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

among these entities according to their market share in certain government healthcare programs;

implementation

of the federal physician payment transparency requirements, sometimes referred to as the “Physician Payments Sunshine Act”;

licensure framework for follow-on biologic products;

of Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness

research, along with funding for such research;

establishment

of a Center for Medicare Innovation at the Centers for Medicare & Medicaid Services to test innovative payment and service delivery

models to lower Medicare and Medicaid spending, potentially including prescription drug spending;

increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program, to 23.1% and 13% of the

average manufacturer price for most branded and generic drugs, respectively, and capped the total rebate amount for innovator drugs

at 100% of the Average Manufacturer Price;

of methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for certain drugs and

biologics, including our product candidates, that are inhaled, infused, instilled, implanted or injected;

of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed

care organizations;

of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals

and by adding new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby

potentially increasing manufacturers’ Medicaid rebate liability;

of a Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated

prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s

outpatient drugs to be covered under Medicare Part D;

of the entities eligible for discounts under the Public Health program.

there have been legal and political challenges to certain aspects of the ACA, the Biden Administration has affirmed support for the law,

entered its own executive orders to enforce and strengthen it, and committed to examining and, where appropriate, reversing contrary

Trump Administration policies.

The Tax Cuts and Jobs Act of 2017 includes a provision repealing, effective January 1, 2019, the tax-based

shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part

of a year that is commonly referred to as the “individual mandate.”

of the volatility surrounding the implementation and enforcement of the ACA since its passage, the full effect that the ACA would have

on a pharmaceutical manufacturer remains unclear.

This uncertainty is heightened by President Biden’s January 28, 2021 Executive

Order on Strengthening Medicaid and the ACA which indicates that the Biden Administration may significantly modify the ACA and further

reform the ACA and other federal programs in manner that may impact our operations.

The Biden Administration has indicated that a goal

of its administration is to expand and support Medicaid and the ACA and to make high-quality healthcare accessible and affordable.

potential increase in patients covered by government funded insurance may impact our pricing.

Further, it is possible that the Biden

Administration may further increase scrutiny of drug pricing.

the United States, there have been and continue to be a number of legislative initiatives to contain healthcare costs.

For example, in

March 2010, the Patient Protection and Affordable Care Act (the ACA) was passed, which substantially changed the way healthcare is financed

by both government and private insurers, and significantly impacts the U.S.

pharmaceutical industry.

The ACA, among other things, increased

the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extended the rebate program to individuals

enrolled in Medicaid managed care organizations, established annual fees and taxes on manufacturers of certain branded prescription drugs.

Since its enactment, there have been judicial, executive and Congressional challenges to certain aspects of the ACA.

In June 2021, the

Supreme Court dismissed the most recent judicial challenge to the ACA brought by several states without specifically ruling on the

constitutionality of the ACA.

legislative changes have been proposed and adopted in the United States since the ACA was enacted.

In March 2021, the American Rescue

Plan Act of 2021 was signed into law, which eliminated the statutory cap on the Medicaid drug rebate beginning January 1, 2024.

was previously capped at 100% of a drug’s average manufacturer price.

expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts

that federal and state governments will pay for healthcare products and services, which could result in reduced demand for our product

candidates, complementary diagnostics or companion diagnostics, or impose additional pricing pressures.

Additionally,

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

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

However, on appeal, the Supreme Court

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

It is unclear how any other potential

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

We cannot predict

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

either in the United States or abroad.

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

future, any of which could limit the amounts that federal and state governments will pay for health care products and services.

prescription drug pricing and transparency has been a recent focus of federal policymaking.

The Inflation Reduction Act, signed into

law in August 2022, contained multiple provisions aimed at lowering the cost of prescription drugs.

The law allows Medicare to negotiate

the price of certain high-cost drugs with pharmaceutical manufacturers and puts a limit on out-of-pocked costs for Medicare Part D members.

Pharmaceutical manufacturers will also have to pay rebates to Medicare if the prices of their drugs under Medicare increase fast than

the rate of inflation.

The Biden Administration also issued an executive order in October 2022 aimed at evaluating new health care payment

and delivery models that would lower costs for prescription drugs and promote access to emerging therapies.

there is uncertainty surrounding the applicability of the biosimilars provisions under the ACA.

The FDA has issued several guidance documents,

but no implementing regulations, on biosimilars.

A number of biosimilar applications have been approved over the past few years.

regulations that are ultimately promulgated and their implementation are likely to have considerable impact on the way pharmaceutical

manufacturers conduct their business and may require changes to current strategies.

A biosimilar is a biological product that is highly

similar to an approved drug notwithstanding minor differences in clinically inactive components, and for which there are no clinically

meaningful differences between the biological product and the approved drug in terms of the safety, purity, and potency of the product.

states have become increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and

biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access,

and marketing cost disclosure and transparency measures, and to encourage importation from other countries and bulk purchasing.

mandated price controls on payment amounts by third-party payors or other restrictions could harm a pharmaceutical manufacturer’s

business, results of operations, financial condition 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 ultimate demand for certain products or put pressure product pricing, which could

negatively affect a pharmaceutical manufacturer’s business, results of operations, financial condition and prospects.

addition, given recent federal and state government initiatives directed at lowering the total cost of healthcare, Congress and state

legislatures will likely continue to focus on healthcare reform, the cost of prescription drugs and biologics and the reform of the Medicare

and Medicaid programs.

While no one cannot predict the full outcome of any such legislation, it may result in decreased reimbursement

for drugs and biologics, which may further exacerbate industry-wide pressure to reduce prescription drug prices.

This could harm a pharmaceutical

manufacturer’s ability to generate revenue.

Increases in importation or re-importation of pharmaceutical products from foreign

countries into the United States could put competitive pressure on a pharmaceutical manufacturer’s ability to profitably price

products, which, in turn, could adversely affect business, results of operations, financial condition and prospects.

A pharmaceutical

manufacturer might elect not to seek approval for or market products in foreign jurisdictions in order to minimize the risk of re-importation,

which could also reduce the revenue generated from product sales.

It is also possible that other legislative proposals having similar

effects will be adopted.

regulatory authorities’ assessment of the data and results required to demonstrate safety and efficacy can change over time and

can be affected by many factors, such as the emergence of new information, including on other products, changing policies and agency

funding, staffing and leadership.

We cannot be sure whether future changes to the regulatory environment will be favorable or unfavorable

to our business prospects.

For example, average review times at the FDA for marketing approval applications can be affected by a variety

of factors, including budget and funding levels and statutory, regulatory and policy changes.

there has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices.

Specifically, there have been several recent Congressional inquiries and proposed and enacted federal and state legislation designed

to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship

between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs.

addition, FDA regulations and guidance may be revised or reinterpreted by the FDA in ways that may significantly affect our business.

Any new regulations or guidance, or revisions or reinterpretations of existing regulations or guidance, may impose additional costs or

lengthen FDA review times for our product candidates.

We cannot determine how changes in regulations, statutes, policies or interpretations

when and if issued, enacted or adopted may affect our business in the future.

we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur

costs that could harm our business.

are subject to numerous foreign, federal, state and local environmental, health and safety laws and regulations, including those governing

laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes.

Our operations involve

the use of hazardous and flammable materials, including chemicals and biological materials.

Our operations also produce hazardous waste

We generally contract with third parties for the disposal of these materials and wastes.

We cannot eliminate the risk of contamination

or injury from these materials.

In the event of contamination or injury resulting from our use of hazardous materials, we could be held

liable for any resulting damages, and any liability could exceed our resources, including any available insurance.

addition, our leasing and operation of real property may subject us to liability pursuant to certain of these laws or regulations.

existing U.S.

environmental laws and regulations, current or previous owners or operators of real property and entities that disposed

or arranged for the disposal of hazardous substances may be held strictly, jointly and severally liable for the cost of investigating

or remediating contamination caused by hazardous substance releases, even if they did not know of and were not responsible for the releases.

could incur significant costs and liabilities which may adversely affect our financial condition and operating results for failure to

comply with such laws and regulations, including, among other things, civil or criminal fines and penalties, property damage and personal

injury claims, costs associated with upgrades to our facilities or changes to our operating procedures, or injunctions limiting or altering

our operations.

are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the

handling, use, storage, treatment and disposal of hazardous materials and wastes.

Our operations involve the use of hazardous and flammable

materials, including chemicals and biological and radioactive materials.

Our operations also produce hazardous waste products.

contract with third parties for the disposal of these materials and wastes.

We cannot eliminate the risk of contamination or injury from

these materials.

In the event of contamination or injury resulting from our use of hazardous materials, we could be held liable for any

resulting damages, and any liability could exceed our resources.

We also could incur significant costs associated with civil or criminal

fines and penalties.

we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting

3 unchanged sentences

of biological, hazardous or radioactive materials.

addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations.

These current or future laws and regulations, which are becoming increasingly more stringent, may impair our research, development or

production efforts.

Our failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.

Related to Our Intellectual Property

we do not obtain patent term extension for any drug candidates we may develop, our business may be materially harmed.

21 unchanged sentences

of operations, and prospects could be materially harmed.

Related to Our Operations and Financial Conditions

have incurred significant losses since inception, we expect to incur losses in the future and we may not be able to generate sufficient

revenue to achieve and maintain profitability.

have never been profitable and have incurred significant losses in each year since inception.

For the years ended December 31, 2025 and

2024, we reported a net loss of $35.9 million and $12.2 million, respectively.

As of December 31, 2025, we had an accumulated deficit

of $72.8 million.

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

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

The net losses we incur

may fluctuate significantly from quarter to quarter such that a period-to-period comparison of our results of operations may not be a

good indication of our future performance.

The size of our future net losses will depend, in part, on the rate of future growth of our

expenses and our ability to generate revenue.

Our prior losses and expected future losses have had and will continue to have an adverse

effect on our working capital, our ability to achieve and maintain profitability and the performance of our stock.

to our limited operating history and the concentration of our CC token holdings, it will be difficult to evaluate our business and future

prospects, and we may not be able to achieve or maintain profitability in any given period.

have a limited operating history, particularly with respect to our current business model, which is highly concentrated in the acquisition

and holding of CC.

As a result, there is limited historical information available to evaluate our business, our management’s ability

to execute our strategy, or our prospects for future growth and profitability.

The lack of a diversified operating history increases

the difficulty for investors and analysts to assess our performance, business model viability, and the likelihood of achieving or maintaining

profitability.

Furthermore, our financial results and prospects are highly dependent on the value and performance of our CC token holdings,

which are subject to significant volatility and risk.

If we are unable to effectively manage our CC token portfolio, respond to market

changes, or adapt our business strategy as necessary, we may not be able to achieve or sustain profitability in any given period.

uncertainty may adversely affect the market price of our stock and the value of an investment in us.

will need additional financing in the future, which may not be available when needed or may be costly and dilutive.

will require additional financing to support our working capital needs in the future.

The amount of additional capital we may require,

the timing of our capital needs and the availability of financing to fund those needs will depend on a number of factors, including our

strategic initiatives and operating plans, the performance of our business and the market conditions for debt or equity financing.

Additionally,

the amount of capital required will depend on our ability to meet our sales goals and otherwise successfully execute our operating plan.

We believe it is imperative that we meet these sales objectives in order to lessen our reliance on external financing in the future.

We intend to continually monitor and adjust our operating plan as necessary to respond to developments in our business, our markets and

the broader economy.

Although we believe various debt and equity financing alternatives will be available to us to support our working

capital needs, financing arrangements on acceptable terms may not be available to us when needed.

senior management team has limited experience managing and operating a U.S.

public company.

members of our management team have limited experience managing and operating a U.S.

publicly traded company, interacting with U.S.

company investors, and complying with the increasingly complex laws pertaining to U.S.

public companies.

These new obligations and constituents

will require significant attention from our senior management and could divert their attention away from the day-to-day management of

our business.

To support our operations as a U.S.

public company, we may need to recruit additional qualified employees or external consultants

with relevant experience, which will increase our operating costs in future periods.

Should any of these factors materialize, the Company’s

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

fair value gains on the Company’s CC holdings may cause the Company to become subject to the corporate alternative minimum tax

under the Inflation Reduction Act of 2022.

enacted the Inflation Reduction Act of 2022 (“IRA”) in August 2022.

Unless an exemption applies, the IRA imposes a 15%

corporate alternative minimum tax (“CAMT”) on a corporation with respect to an initial tax year and subsequent tax years

if the average annual adjusted financial statement income for any consecutive three-tax-year period preceding the initial tax year exceeds

On September 12, 2024, the Department of Treasury and the IRS issued proposed regulations with respect to the application

Additionally,

the Company has adopted ASU 2023-08, under which the Company’s CC holdings must be measured at fair value in the Company’s

statement of financial position, with gains and losses from changes in the fair value of our CC tokens recognized in net income each

reporting period.

When determining whether the Company is subject to CAMT and when calculating any related tax liability for an applicable

tax year, the proposed regulations provide that, among other adjustments, the Company’s adjusted financial statement income must

include any unrealized gains or losses reported in the applicable tax year.

as a result of the enactment of the IRA and the Company’s adoption of ASU 2023-08, the Company may be subject to CAMT

in the 2026 taxable year and beyond.

If the Company becomes subject to CAMT, it could result in a material tax obligation that the Company

would need to satisfy in cash, which could materially affect the Company’s financial results, including its earnings and cash flow,

and its financial condition.

Related to Cybersecurity, Information Technology, and Intellectual Property

we or our third-party service providers experience a security breach or cyberattack and unauthorized parties obtain access to our CC

tokens, or if our private keys are lost or destroyed, or other similar circumstances or events occur, we may lose some or all of our

CC tokens and our financial condition and results of operations could be materially adversely affected.

Substantially

all of the CC tokens we own will be held in custody accounts at institutional-grade digital asset custodians.

Security breaches and cyberattacks

are of particular concern with respect to our CC tokens.

Cryptocurrencies and the entities that provide services to participants in the

ecosystem have been, and may in the future be, subject to security breaches, cyberattacks, or other malicious activities.

security breach or cyberattack could result in:

partial or total loss of our CC tokens in a manner that may not be covered by insurance or

the liability provisions of the custody agreements with the custodians who hold our CC tokens;

to our reputation and brand;

disclosure of data and violations of applicable data privacy and other laws;

● significant

regulatory scrutiny, investigations, fines, penalties, and other legal, regulatory, contractual

and financial exposure.

any actual or perceived data security breach or cybersecurity attack directed at other companies with digital assets or companies that

operate digital asset networks, regardless of whether we are directly impacted, could lead to a general loss of confidence in the broader

CC ecosystem or in the use of the Canton Network to conduct financial transactions, which could negatively impact us.

business and operations would be adversely impacted in the event of a failure or interruption of our information technology infrastructure

or as a result of a cybersecurity attack.

proper functioning of our own information technology (IT) infrastructure is critical to the efficient operation and management of our

We may not have the necessary financial resources to update and maintain our IT infrastructure, and any failure or interruption

of our IT system could adversely impact our operations.

Breaches with respect to protected health information could result in violations

of HIPAA and analogous state laws and risk the imposition of significant fines and penalties.

In addition, our IT is vulnerable to cyberattacks,

computer viruses, worms and other malicious software programs, physical and electronic break-ins, sabotage and similar disruptions from

unauthorized tampering with our computer systems.

Failure of our information technology systems could delay billing and otherwise disrupt

or adversely affect our business, profitability and financial condition.

We believe that we have adopted appropriate measures to mitigate

potential risks to our technology infrastructure and our operations from these IT-related and other potential disruptions.

However, given

the unpredictability of the timing, nature and scope of any such IT failures or disruptions, we could potentially be subject to downtimes,

transactional errors, processing inefficiencies, operational delays, other detrimental impacts on our operations or ability to provide

products to our customers, the compromising of confidential or personal information, destruction or corruption of data, security breaches,

other manipulation or improper use of our systems and networks, financial losses from remedial actions, loss of business or potential

liability, and/or damage to our reputation, any of which could have a material adverse effect on our cash flows, competitive position,

financial condition or results of operations.

to patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability

to protect our drugs.

is the case with other pharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents.

and enforcing patents in the pharmaceutical industry involves both technological and legal complexity and is therefore costly, time consuming

and inherently uncertain.

Changes in either the patent laws or interpretation of the patent laws in the United States could increase

the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents.

patent reform legislation in the United States and other countries, including the Leahy-Smith America Invents Act (the Leahy-Smith Act)

signed into law in September 2011, could increase those uncertainties and costs.

The Leahy-Smith Act includes a number of significant

changes to U.S.

These include provisions that affect the way patent applications are prosecuted, redefine prior art and provide

more efficient and cost-effective avenues for competitors to challenge the validity of patents.

For example, the Leahy-Smith Act allows

third-party submission of prior art to the U.S.

Patent and Trademark Office (“USPTO”) during patent prosecution and additional

procedures to attack the validity of a patent by USPTO administered post-grant proceedings, including post-grant review, inter parties

review, and derivation proceedings.

and enforcing patents involves both technological and legal complexity and is therefore costly, time consuming and inherently uncertain.

Changes in either the patent laws or interpretation of the patent laws in the United States could increase the uncertainties and costs

surrounding the prosecution of patent applications and the enforcement or defense of issued patents.

Recent patent reform legislation

in the United States and other countries, including the Leahy-Smith America Invents Act (the “Leahy-Smith Act”) signed into

law in September 2011, could increase those uncertainties and costs.

The Leahy-Smith Act includes a number of significant changes to

These include provisions that affect the way patent applications are prosecuted, redefine prior art and provide more

efficient and cost-effective avenues for competitors to challenge the validity of patents.

For example, the Leahy-Smith Act allows third-party

submission of prior art to the U.S.

Patent and Trademark Office (“USPTO”) during patent prosecution and additional procedures

to attack the validity of a patent by USPTO administered post-grant proceedings, including post-grant review, inter parties review, and

derivation proceedings.

In addition, the Leahy-Smith Act has transformed the U.S.

12 unchanged sentences

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

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

could be expensive, time-consuming and unsuccessful.

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

be expensive, time-consuming and unsuccessful.

and other third parties may infringe, misappropriate or otherwise violate our or our future licensors’ issued patents or other

28 unchanged sentences

rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.

commercial success depends upon our ability, and the ability of our collaborators, to develop, manufacture, market and sell our drug

candidates and use our proprietary technologies without infringing, misappropriating or otherwise violating the intellectual property

and proprietary rights of third parties.

There is considerable patent and other intellectual property litigation in the pharmaceutical

and biotechnology industries.

We may become party to, or threatened with, adversarial proceedings or litigation regarding intellectual

property rights with respect to our technology and drug candidates, including interference proceedings, post grant review, inter parties

review, and derivation proceedings before the USPTO and similar proceedings in foreign jurisdictions such as oppositions before the European

Patent Office.

legal threshold for initiating litigation or contested proceedings is low, so that even lawsuits or proceedings with a low probability

of success might be initiated and require significant resources to defend.

Litigation and contested proceedings can also be expensive

and time-consuming, and our adversaries in these proceedings may have the ability to dedicate substantially greater resources to prosecuting

these legal actions than we can.

The risks of being involved in such litigation and proceedings may increase if and as our drug candidates

near commercialization and as we gain the greater visibility associated with being a public company.

Third parties may assert infringement

claims against us based on existing patents or patents that may be granted in the future, regardless of merit.

We may not be aware of

all such intellectual property rights potentially relating to our technology and drug candidates and their uses.

Thus, we do not know

with certainty that our technology and drug candidates, or our development and commercialization thereof, do not and will not infringe,

misappropriate or otherwise violate any third party’s intellectual property.

if we believe that third party intellectual property claims are without merit, there is no assurance that a court would find in our favor

on questions of misappropriation, infringement, validity, enforceability, or priority.

A court of competent jurisdiction could hold these

third-party patents are valid, enforceable, and infringed, which could materially and adversely affect our ability to commercialize any

technology or drug candidate covered by the asserted third-party patents.

In order to successfully challenge the validity of any such

commercial success may depend in part upon our ability to develop, manufacture, market and sell our product candidates and use our proprietary

technologies without infringing, misappropriating or otherwise violating the intellectual property and other proprietary rights of third

There is considerable intellectual property litigation in the pharmaceutical industry.

may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect

to our product candidates and their manufacture and our other technology, including re-examination, interference, post-grant review,

inter partes review or derivation proceedings before the USPTO or an equivalent foreign body.

Numerous U.S.

and foreign issued

patents and pending patent applications owned by third parties exist in the fields in which we are developing our product candidates.

Third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future, regardless

of their merit.

if we believe third-party intellectual property claims are without merit, there is no assurance that a court would find in our favor

on questions of infringement, validity, enforceability or priority.

A court of competent jurisdiction could hold that third-party patents

asserted against us are valid, enforceable and infringed, which could materially and adversely affect our ability to commercialize any

of our product candidates and any other product candidates or technologies covered by the asserted third-party patents.

In order to successfully

challenge the validity of a U.S.

patent in federal court, we would need to overcome a presumption of validity.

As this burden is a high one requiring us to present

clear and convincing evidence as to the invalidity of any such U.S.

patent claim, there is no assurance that a court of competent jurisdiction

would invalidate the claims of any such U.S.

we are found to infringe, misappropriate or otherwise violate a third party’s intellectual property rights, we could be required

to obtain a license from such third party to continue developing, manufacturing and marketing our drug candidates.

However, we may not

be able to obtain any required license on commercially reasonable terms or at all.

Even if we were able to obtain a license, it could

be non-exclusive;

thereby giving our competitors and other third parties access to the same technologies licensed to us and could require

us to make substantial licensing and royalty payments.

We could be forced, including by court order, to cease developing, manufacturing

and commercializing the infringing technology or drug.

In addition, we could be found liable for significant monetary damages, including

treble damages and attorneys’ fees, if we are found to have willfully infringed a patent or other intellectual property right and

could be forced to indemnify our collaborators or others.

A finding of infringement could prevent us from commercializing our drug candidates

or force us to cease some of our business operations, which could materially harm our business.

In addition, we may be forced to redesign

our drug candidates, seek new regulatory approvals and indemnify third parties pursuant to contractual agreements.

Claims that we have

misappropriated the confidential information or trade secrets of third parties could have a similar material adverse effect on our business,

financial condition, results of operations, and prospects.

As this burden is a high

one requiring us to present clear and convincing evidence as to the invalidity of a U.S.

patent claim, there is no assurance that a court

of competent jurisdiction would invalidate the claims of any such U.S.

If we are found to infringe, misappropriate or otherwise

violate a third party’s intellectual property rights, and we are unsuccessful in demonstrating that these rights are invalid or

unenforceable, we could be required to obtain a license from such a third party in order to continue developing and marketing our products

and technology.

However, we may not be able to obtain any required license on commercially reasonable terms or at all.

Even if we were

able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies licensed to us.

could be forced, including by court order, to cease commercializing the infringing technology or product.

A finding of infringement could

prevent us from commercializing our product candidates or force us to cease some of our business operations.

In the event of a successful

claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful

infringement, pay royalties and other fees, redesign our infringing product candidate or obtain one or more licenses from third parties,

which may be impossible or require substantial time and monetary expenditure.

Claims that we have misappropriated the confidential information

or trade secrets of third parties could have a similar negative impact on our business.

property litigation or other legal proceedings relating to intellectual property could cause us to spend substantial resources and distract

14 unchanged sentences

could compromise our ability to compete in the marketplace.

we fail to comply with our obligations in our future intellectual property licenses and funding arrangements with third parties, we could

lose rights that are important to our business.

may be party to license and funding agreements that impose diligence, development and commercialization timelines, milestone payment,

royalty, insurance and other obligations on us.

If we fail to comply with such obligations, our counterparties may have the right to

terminate our agreements or require us to grant them certain rights.

Such an occurrence could materially adversely affect the value of

any drug candidate being developed under any such agreement.

Termination of these agreements or reduction or elimination of our rights

under these agreements may result in our having to negotiate new or reinstated agreements with less favorable terms, or cause us to lose

our rights under these agreements, including our rights to important intellectual property or technology, which would have a material

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

we fail to comply with our obligations in license arrangements with third parties, we could lose rights that are important to our business.

are and may continue to be party to license agreements.

If we fail to comply with such obligations, our counterparties may have the right

to terminate our agreements or seek other remedies, which could materially adversely affect our operations.

We may lose our rights under

such agreements or may need to renew these agreements with less favorable terms, which would have a material adverse effect on our business,

financial condition, results of operations, and prospects.

Additionally,

these and other license agreements may not provide exclusive rights to use the licensed intellectual property and technology in all relevant

fields of use and in all territories in which we may wish to develop or commercialize our technology and drugs in the future.

we may not be able to prevent competitors from developing and commercializing competitive products and technology in fields of use and

territories not included in such agreements.

In addition, we may not have the right to control the preparation, filing, prosecution,

maintenance, enforcement, and defense of patents and patent applications covering the technology that we may license from third parties.

Therefore, we cannot be certain that these patents and patent applications will be prepared, filed, prosecuted, maintained, and defended

in a manner consistent with the best interests of our business.

If our licensors fail to prosecute, maintain, enforce, and defend such

patents, or lose rights to those patents or patent applications, the rights we have licensed may be reduced or eliminated, and our right

to develop and commercialize any of our drugs that are the subject of such licensed rights could be adversely affected.

may need to obtain additional licenses from others to advance our research or allow commercialization of our drug candidates.

It is possible

that we may be unable to obtain additional licenses at a reasonable cost or on reasonable terms, if at all, or such licenses may be non-exclusive.

The licensing or acquisition of third-party intellectual property rights is a competitive area, and several more established companies

may pursue strategies to license or acquire third-party intellectual property rights that we may consider attractive or necessary.

established companies may have a competitive advantage over us due to their size, capital resources and greater clinical development

and commercialization capabilities.

In addition, companies that perceive us to be a competitor may be unwilling to assign or license

rights to us.

We also may be unable to license or acquire third-party intellectual property rights on terms that would allow us to make

an appropriate return on our investment or at all.

we are unable to obtain rights to required third-party intellectual property rights or maintain the existing intellectual property rights

we have, we may be required to expend significant time and resources to redesign our technology, drug candidates, or the methods for

manufacturing them or to develop or license replacement technology, all of which may not be feasible on a technical or commercial basis.

If we are unable to do so, we may be unable to develop or commercialize the affected technology and drug candidates, which could harm

our business, financial condition, results of operations, and prospects significantly.

may arise regarding intellectual property subject to a licensing agreement, including:

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

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

sublicensing of patent and other rights under our collaborative development relationships;

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

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

and us and our partners;

priority of invention of patented technology.

fields of use and in all territories.

As a result, we may not be able to prevent competitors from developing and commercializing competitive

products and technology in fields of use and territories not included in such agreements.

In addition, we may not have the right to control

the preparation, filing, prosecution, maintenance, enforcement, and defense of patents and patent applications covering the technology

that we may license from third parties.

Therefore, we cannot be certain that these patents and patent applications will be prepared,

filed, prosecuted, maintained, and defended in a manner consistent with the best interests of our business.

If our licensors fail to

prosecute, maintain, enforce, and defend such patents, or lose rights to those patents or patent applications, the rights we have licensed

may be reduced or eliminated, and our right to develop and commercialize any of our drugs that are the subject of such licensed rights

could be adversely affected.

addition, any agreements under which we license intellectual property or technology from third parties may be complex, and certain provisions

8 unchanged sentences

on our business, financial conditions, results of operations, and prospects.

future licensors may rely on third-party consultants or collaborators or on funds from third parties such that our licensors are not

the sole and exclusive owners of the patents and patent applications we in-licensed.

If other third parties have ownership rights to

our in-licensed patents, they may be able to license such patents to our competitors, and our competitors could market competing products

and technology.

This could have a material adverse effect on our competitive position, business, financial conditions, results of operations,

and prospects.

spite of our best efforts, our future licensors might conclude that we have materially breached our license agreements and might therefore

terminate our license agreements, thereby removing our ability to develop and commercialize drug candidates and technology covered by

such agreements.

If these in-licenses are terminated, or if the underlying intellectual property fails to provide the intended exclusivity,

competitors would have the freedom to seek regulatory approval of, and to market, products and technologies identical to ours.

have a material adverse effect on our competitive position, business, financial conditions, results of operations, and prospects.

may not be able to protect our intellectual property and proprietary rights throughout the world.

we are unable to obtain licenses from third parties on commercially reasonable terms or at all, our business could be harmed.

may be necessary for us to use the patented or proprietary technology of third parties to commercialize our products, in which case we

would be required to obtain a license from these third parties.

The licensing of third-party intellectual property rights is a competitive

area, and more established companies may pursue strategies to license or acquire third-party intellectual property rights that we may

consider attractive or necessary.

More established companies may have a competitive advantage over us due to their size, capital resources

and greater development and commercialization capabilities.

In addition, companies that perceive us to be a competitor may be unwilling

to assign or license rights to us.

We also may be unable to license or acquire third-party intellectual property rights on terms that

would allow us to make an appropriate return on our investment or at all.

If we are unable to obtain a necessary license, we may be unable

to develop or commercialize the affected product candidates, and the third parties owning such intellectual property rights could seek

either an injunction prohibiting our sales, or, with respect to our sales, an obligation on our part to pay royalties or other forms

of compensation.

Even if we are able to obtain a license, it may be non-exclusive, thereby giving our competitors access to the same

technologies licensed to us.

If we are unable to license needed technology, or if we are forced to license this technology on unfavorable

terms, our business could be materially harmed.

may not be able to protect our intellectual property and proprietary rights.

prosecuting, and defending patents on drug candidates in all countries throughout the world would be prohibitively expensive, and the

24 unchanged sentences

owner may have limited remedies, which could materially diminish the value of such patent.

If we or any of our licensors is forced to

If we or any of our licensors are forced to

grant a license to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and

our business, financial condition, results of operations, and prospects may be adversely affected.

Related to Managing Our Business and Operations

may encounter difficulties in managing our growth, which could adversely affect our operations.

of March 1, 2025, we had 2 full-time employees and 1 part-time employee.

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 parties.

Our future growth

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

recruiting, integrating, maintaining and motivating additional employees;

our development and commercialization efforts effectively, including the clinical and FDA review process for our product candidates,

while complying with our contractual obligations to contractors and other third parties;

our operational, financial and management controls, reporting systems and procedures.

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.

Our 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.

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 and discovery

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.

There can be no assurance that we will be able to manage our existing

consultants or find other competent outside contractors and consultants on economically reasonable terms, or at all.

we are not able to effectively expand our organization by hiring new employees and expanding our groups of consultants and contractors,

we may not be able to successfully implement the tasks necessary to further develop and commercialize our product candidates and, accordingly,

may not achieve our research, development and commercialization goals.

may acquire additional technology and complementary businesses in the future.

Acquisitions involve many risks, any of which could materially

harm our business, including the diversion of management’s attention from core business concerns, failure to effectively exploit

acquired technologies, failure to successfully integrate the acquired business or realize expected synergies or the loss of key employees

from either our business or the acquired businesses.

internal computer systems, or those of our collaborators or other contractors or consultants, may fail or suffer security breaches, which

could result in a material disruption of our product development programs.

internal computer systems and those of our current and any future collaborators and other contractors or consultants are vulnerable to

damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures.

we have not experienced any such material system failure, accident or security breach to date, if such an event were to occur and cause

interruptions in our operations, it could result in a disruption of our development programs and our business operations, whether due

to a loss of our trade secrets or other proprietary information or other similar disruptions.

For example, the loss of clinical trial

data from future clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover

or reproduce the data.

To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications,

or inappropriate disclosure of confidential or proprietary information, we could incur liability, our competitive position could be harmed

and the further development and commercialization of our product candidates could be delayed.

could be subject to risks caused by misappropriation, misuse, leakage, falsification or intentional or accidental release or loss of

information maintained in the information systems and networks of our company and our vendors, including personal information of our

employees and study subjects, and company and vendor confidential data.

In addition, outside parties may attempt to penetrate our systems

or those of our vendors or fraudulently induce our personnel or the personnel of our vendors to disclose sensitive information in order

to gain access to our data and/or systems.

We may experience threats to our data and systems, including malicious codes and viruses,

phishing and other cyberattack.

The number and complexity of these threats continue to increase over time.

If a material breach of, or

accidental or intentional loss of data from, our information technology systems or those of our vendors occurs, the market perception

of the effectiveness of our security measures could be harmed and our reputation and credibility could be damaged.

We could be required

to expend significant amounts of money and other resources to repair or replace information systems or networks.

In addition, we could

be subject to regulatory actions and/or claims made by individuals and groups in private litigation involving privacy issues related

to data collection and use practices and other data privacy laws and regulations, including claims for misuse or inappropriate disclosure

of data, as well as unfair or deceptive practices.

Although we develop and maintain systems and controls designed to prevent these events

from occurring, and we have a process to identify and mitigate threats, the development and maintenance of these systems, controls and

processes is costly and requires ongoing monitoring and updating as technologies change and efforts to overcome security measures become

increasingly sophisticated.

Moreover, despite our efforts, the possibility of these events occurring cannot be eliminated entirely.

we outsource more of our information systems to vendors, engage in more electronic transactions with payors and patients, and rely more

on cloud-based information systems, the related security risks will increase and we will need to expend additional resources to protect

our technology and information systems.

In addition, there can be no assurance that our internal information technology systems or those

of our third-party contractors, or our consultants’ efforts to implement adequate security and control measures, will be sufficient

to protect us against breakdowns, service disruption, data deterioration or loss in the event of a system malfunction, or prevent data

from being stolen or corrupted in the event of a cyberattack, security breach, industrial espionage attacks or insider threat attacks

which could result in financial, legal, business or reputational harm.

disruptions of information technology systems or breaches of data security could adversely affect our business.

business is increasingly dependent on critical, complex, and interdependent information technology systems, including Internet-based

systems, to support business processes as well as internal and external communications.

These systems are also critical to enable remote

working arrangements, which have been growing in importance.

The size and complexity of our computer systems make us potentially vulnerable

to IT system breakdowns, internal and external malicious intrusion, and computer viruses and ransomware, which may impact product production

and key business processes.

We also have outsourced significant elements of our information technology infrastructure and operations

to third parties, which may allow them to access our confidential information and may also make our systems vulnerable to service interruptions

or to security breaches from inadvertent or intentional actions by such third parties or others.

addition, our systems are potentially vulnerable to data security breaches - whether by employees or others - which may expose sensitive

data to unauthorized persons.

Data security breaches could lead to the loss of trade secrets or other intellectual property, result in

demands for ransom or other forms of blackmail, or lead to the public exposure of personal information (including sensitive personal

information) of our employees, clinical trial patients, customers, and others.

Such attacks are of ever-increasing levels of sophistication

and are made by groups and individuals with a wide range of motives (including industrial espionage or extortion) and expertise, including

by organized criminal groups, “hacktivists,” nation states, and others.

As a company with an increasingly global presence,

our systems are subject to frequent attacks.

There is the potential that our systems may be directly or indirectly affected as nation-states

conduct global cyberwarfare, including in connection with the current Russia-Ukraine or Hamas-Israel armed conflict.

to the nature of some of these attacks, there is a risk that an attack may remain undetected for a period of time.

While we continue

to make investments to improve the protection of data and information technology, and to oversee and monitor the security measures of

our suppliers and/or service providers, there can be no assurance that our efforts will prevent service interruptions or security breaches.

In addition, we depend in part on third-party security measures over which we do not have full control to protect against data security

we or our suppliers and/or service providers fail to maintain or protect our information technology systems and data security effectively

and in compliance with U.S.

and foreign laws, or fail to anticipate, plan for, or manage significant disruptions to these systems, we

or our suppliers and/or service providers could have difficulty preventing, detecting, or controlling such disruptions or security breaches,

which could result in legal proceedings, liability under U.S.

and foreign laws that protect the privacy of personal information, disruptions

to our operations, government investigations, breach of contract claims, and damage to our reputation (in each case in the U.S.

or globally),

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

current operations are concentrated in one location, and we or the third parties upon whom we depend may be adversely affected by earthquakes

or other natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster,

including earthquakes, outbreak of disease or other natural disasters.

unplanned event, such as flood, fire, explosion, earthquake, extreme weather condition, medical epidemics, power shortage, telecommunication

failure or other natural or manmade accidents or incidents that result in us being unable to fully utilize our facilities, or the manufacturing

facilities of our third-party contract manufacturers, may have a material and adverse effect on our ability to operate our business,

particularly on a daily basis, and have significant negative consequences on our financial and operating conditions.

Loss of access to

these facilities may result in increased costs, delays in the development of our product candidates or interruption of our business operations.

Earthquakes or other natural disasters could further disrupt our operations, and have a material and adverse effect on our business,

financial condition, results of operations and prospects.

If a natural disaster, power outage or other event occurred that prevented

us from using all or a significant portion of our headquarters, that damaged critical infrastructure, such as our research facilities

or the manufacturing facilities of our third-party contract manufacturers, or that otherwise disrupted operations, it may be difficult

or, in certain cases, impossible, for us to continue our business for a substantial period of time.

disaster recovery and business continuity plans we have in place may prove inadequate in the event of a serious disaster or similar event.

We may incur substantial expenses as a result of the limited nature of our disaster recovery and business continuity plans, which, could

have a material adverse effect on our business.

As part of our risk management policy, we maintain insurance coverage at levels that

we believe are appropriate for our business.

However, in the event of an accident or incident at these facilities, we cannot assure you

that the amounts of insurance will be sufficient to satisfy any damages and losses.

If our facilities, or the manufacturing facilities

of our third-party contract manufacturers, are unable to operate because of an accident or incident or for any other reason, even for

a short period of time, any or all of our research and development programs may be harmed.

global economic conditions could adversely affect our business, financial condition or results of operations.

results of operations could be adversely affected by general conditions in the global economy and in the global financial markets.

of our future clinical trials may be conducted outside of the United States and unfavorable economic conditions resulting in the weakening

dollar would make those clinical trials more costly to operate.

Furthermore, the most recent global financial crisis caused

extreme volatility and disruptions in the capital and credit markets.

A severe or prolonged economic downturn could result in a variety

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

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

States, possibly resulting in supply disruption.

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

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

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

media is increasingly being used to communicate about our clinical development programs and the diseases our therapeutics are being developed

to treat, and we intend to utilize appropriate social media in connection with our commercialization efforts following approval of our

product candidates, if any.

Social media practices in the biopharmaceutical industry continue to evolve and regulations and regulatory

guidance relating to such use are evolving and not always clear.

This evolution creates uncertainty and risk of noncompliance with regulations

applicable to our business, resulting in potential regulatory actions against us, along with the potential for litigation related to

off-label marketing or other prohibited activities.

For example, patients may use social media channels to comment on their experience

in an ongoing blinded clinical trial or to report an alleged adverse event.

When such disclosures occur, there is a risk that trial enrollment

may be adversely impacted, we fail to monitor and comply with applicable adverse event reporting obligations or that we may not be able

to defend our business or the public’s legitimate interests in the face of the political and market pressures generated by social

media due to restrictions on what we may say about our product candidates.

There is also a risk of inappropriate disclosure of sensitive

information or negative or inaccurate posts or comments about us on any social networking website.

If any of these events were to occur

or we otherwise fail to comply with applicable regulations, we could incur liability, face regulatory actions or incur other harm to

our business.

estimates of market opportunity and forecasts of market growth included in this prospectus may prove to be inaccurate, and even if the

markets in which we compete achieve the forecasted growth, our business may not grow at similar rates, or at all.

opportunity estimates and growth forecasts included in this prospectus are subject to significant uncertainty and are based on assumptions

and estimates which may not prove to be accurate.

The estimates and forecasts included in this prospectus relating to size and expected

growth of our target market may prove to be inaccurate.

Even if the markets in which we compete meet the size estimates and growth forecasts

included in this prospectus, our business may not grow at similar rates, or at all.

Our growth is subject to many factors, including

our success in implementing our business strategy, which is subject to many risks and uncertainties.

employees, independent contractors, consultants, commercial partners, collaborators and vendors may engage in misconduct or other improper

activities, including noncompliance with regulatory standards and requirements.

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

partners, collaborators and vendors.

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

to comply with the laws of the FDA and other similar foreign regulatory bodies, provide true, complete and accurate information to the

FDA and other similar foreign regulatory bodies, comply with manufacturing standards we have established, comply with healthcare fraud

and abuse laws in the United States and similar foreign fraudulent misconduct laws, or report financial information or data accurately

or to disclose unauthorized activities to us.

If we obtain FDA approval of any of our product candidates and begin commercializing those

products in the United States, our potential exposure under such laws will increase significantly, and our costs associated with compliance

with such laws will also increase.

These laws may impact, among other things, our current activities with principal investigators and

research patients, as well as proposed and future sales, marketing and education programs.

Although we have adopted a code of business

conduct and ethics, it is not always possible to identify and deter misconduct by our employees, independent contractors, consultants,

commercial partners and vendors, and the precautions we take to detect and prevent this activity may not be effective in controlling

unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from

a failure to comply with these laws or regulations.

If any actions are instituted against us and we are not successful in defending ourselves

or asserting our rights, those actions could result in the imposition of civil, criminal and administrative penalties, damages, monetary

fines, imprisonment, disgorgement, possible exclusion from participation in government healthcare programs, additional reporting obligations

and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with

these laws, contractual damages, reputational harm, diminished profits and future earnings and the curtailment of our operations.

to comply with health and data protection laws and regulations could lead to government enforcement actions (which could include civil

or criminal penalties), private litigation and/or adverse publicity and could negatively affect our operating results and business.

and any potential collaborators may be subject to federal, state and foreign data protection laws and regulations (i.e., laws and regulations

that address privacy and data security).

In the United States, numerous federal and state laws and regulations, including federal health

information privacy laws, state data breach notification laws, state health information privacy laws and federal and state consumer protection

laws (e.g., Section 5 of the Federal Trade Commission Act), that govern the collection, use, disclosure and protection of health-related

and other personal information 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.

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.

International

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

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

The GDPR went into effect on May

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

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

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

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

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

and delete their data).

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

The GDPR will increase our responsibility

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

with the new EU data protection rules.

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

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

information obtained outside of the United States.

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

restrict our ability to collect, use and disclose data, or in some cases, impact our ability to operate in certain jurisdictions.

to comply with U.S.

and international data protection laws and regulations could result in government enforcement actions (which could

include civil, criminal, and administrative penalties), private litigation and/or adverse publicity and could negatively affect our operating

results and business.

Moreover, clinical trial subjects about whom we or our potential collaborators obtain information, as well as the

providers who share this information with us, may contractually limit our ability to use and disclose the information.

Claims that we

have violated individuals’ privacy rights, failed to comply with data protection laws, or breached our contractual obligations,

even if we are not found liable, could be expensive and time consuming to defend and could result in adverse publicity that could harm

our business.

tax law could adversely affect our financial condition and results of operations.

rules dealing with U.S.

federal, state, and local income taxation are constantly under review by persons involved in the legislative

process and by the Internal Revenue Service and the U.S.

Treasury Department.

Changes to tax laws (which changes may have retroactive

application) could adversely affect us or holders of our common stock.

In recent years, many such changes have been made and changes

are likely to continue to occur in the future.

Future changes in U.S.

tax laws could have a material adverse effect on our business,

cash flow, financial condition or results of operations.

We urge investors to consult with their legal and tax advisors regarding the

implications of potential changes in U.S.

tax laws on an investment in our common stock.

Related to Our Common Stock

Related to Our Securities and Being a Public Company

price of our stock may be volatile, and you could lose all or part of your investment.

3 unchanged sentences

section and elsewhere in this prospectus, these factors include:

commencement, enrollment or results of clinical trials and pre-clinical studies of our drug candidates or those of our competitors;

delay in identifying and advancing a clinical candidate for our other development programs;

delay in our regulatory filings for our drug candidates and any adverse development or perceived adverse development with respect

to the applicable regulatory authority’s review of such filings, including, without limitation, the FDA’s issuance of

a “refusal to file” letter or a request for additional information;

results or delays in future clinical trials;

decision to initiate a clinical trial, not to initiate a clinical trial or to terminate an existing clinical trial;

regulatory decisions, including failure to receive regulatory approval of for our drug candidates;

in laws or regulations applicable to our drug candidates, including, but not limited to, clinical trial requirements for approvals;

developments concerning our manufacturers;

inability to obtain adequate product supply for any approved product or inability to do so at acceptable prices;

inability to establish collaborations, if needed;

failure to commercialize our product candidates, if approved;

or departures of key scientific or management personnel;

unanticipated

serious safety concerns related to the use of our drug candidates;

of new products offered by us or our competitors;

announcements

of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;

ability to effectively manage our growth;

or anticipated variations in quarterly operating results;

cash position;

failure to meet the estimates and projections of the investment community or that we may otherwise provide to the public;

of research reports about us or our industry, or product candidates in particular, or positive or negative recommendations or withdrawal

of research coverage by securities analysts;

in the market valuations of similar companies;

in the structure of the healthcare payment systems;

performance of the equity markets;

of our common stock by us or our stockholders in the future;

volume of our common stock;

in accounting practices;

ineffectiveness

of our internal controls;

or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection

for our technologies;

lawsuits, including patent or stockholder litigation;

political and economic conditions;

events or factors, many of which are beyond our control.

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

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

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

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

of a company’s securities.

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

attention and resources.

we fail to comply with the continued listing requirements of The Nasdaq Capital Market, our common stock may be delisted and the price

of our common stock and our ability to access the capital markets could be negatively impacted.

we are unable to maintain our listing on Nasdaq and we are unable to obtain listing on another national securities exchange, a reduction

in some or all of the following may occur, each of which could have a material adverse effect on our stockholders:

liquidity of our common stock;

market price of our common stock;

ability to obtain financing for the continuation of our operations;

number of investors that will consider investing in our common stock;

number of market makers in our common stock;

availability of information concerning the trading prices and volume of our common stock;

number of broker-dealers willing to execute trades in shares of our common stock.

or anticipated variations in our periodic operating results;

in market interest rates that lead investors of our common stock to demand a higher investment

in earnings estimates;

in market valuations of similar companies;

or announcements by our competitors;

market reaction to any increased indebtedness we may incur in the future;

or departures of key personnel;

by shareholders;

● speculation

in the media, online forums, or investment community;

ability to maintain the listing of our common stock on the Nasdaq.

volatility may affect the price at which you could sell the shares of our common stock, and the sale of substantial amounts of our common

stock could adversely affect the price of our common stock.

Our stock price is likely to continue to be volatile and subject to significant

price and volume fluctuations in response to market and other factors.

of our common stock, or the perception that such sales may occur, could cause the market price of our common stock to fall.

expect that we may need additional capital in the future to continue our planned operations.

To the extent we raise additional capital

by issuing equity securities, our stockholders may experience substantial dilution.

We may sell common stock, convertible securities

or other equity securities in one or more transactions at prices and in a manner we determine from time to time.

If we sell common stock,

convertible securities or other equity securities in more than one transaction, investors may be materially diluted by subsequent sales.

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

stockholders.

March 3, 2026, we entered into an amended and restated sales agreement (the “Sales Agreement”) pursuant to which we may

offer and sell common stock from time to time (the “ATM Program”).

Investors who purchase common stock at different times

will likely pay different prices and may experience different outcomes in their investment results.

We will have discretion, subject

to the effect of market conditions, to vary the timing, prices and numbers of shares of our common stock sold pursuant to the Sales Agreement.

Investors may experience a decline in the value of their shares of common stock.

sales of common stock, if any, under the ATM Program will depend upon market conditions and other factors to be determined by us and

may be made in negotiated transactions or transactions that are deemed to be “at the market offerings” as defined in Rule

415 under the Securities Act.

Future sales of our common stock are not guaranteed, and there are no firm commitments to receive funding

under the ATM Program.

The issuance from time to time of these new shares of common stock, or the perception that such sales may occur,

could have the effect of depressing the market price of our common stock.

have issued warrants exercisable for our securities, which if exercised, would increase the number of shares eligible for future resale

in the public market and result in dilution to our stockholders.

of March 26, 2026, we had (i) 169,184,318 prefunded warrants outstanding, and (ii)

2,921,618 non-tradable warrants outstanding (the “Warrants”).

Each of these securities are exercisable for shares of common

stock at various exercises prices.

If the Warrants are exercised, it will result in dilution to the then existing holders of common stock

and increase the number of shares of common stock eligible for resale in the public market.

Sales of substantial numbers of such shares

of common stock could adversely affect the market price of our common stock.

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

65 unchanged sentences

others could exacerbate market and economic instability.

More recently, the closures of Silicon Valley Bank and Signature Bank and their

placement into receivership with the Federal Deposit Insurance Corporation (“FDIC”) created bank-specific and broader financial

institution liquidity risk and concerns.

Although the Department of the Treasury, the Federal Reserve, and the FDIC jointly confirmed

that depositors at SVB and Signature Bank would continue to have access to their funds, even those in excess of the standard FDIC insurance

limits, under a systemic risk exception, future adverse developments with respect to specific financial institutions or the broader financial

services industry may lead to market-wide liquidity shortages, impair the ability of companies to access near-term working capital needs,

and create additional market and economic uncertainty.

There can be no assurance that future credit and financial market instability

and a deterioration in confidence in economic conditions will not occur.

Our general business strategy may be adversely affected by any

such economic downturn, liquidity shortages, volatile business environment or continued unpredictable and unstable market conditions.

If the equity and credit markets deteriorate, or if adverse developments are experienced by financial institutions, it may cause short-term

liquidity risk and also make any necessary debt or equity financing more difficult, more costly and more dilutive.

Failure to secure

any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial

performance and stock price and could require us to delay or abandon our business plans.

In addition, there is a risk that one or more

of our current clients, financial institutions or other third parties with whom we do business may be adversely affected by the foregoing

risks, which may have an adverse effect on our business.

More recently, the closures of Silicon Valley Bank (“SVB”) and Signature

Bank and their placement into receivership with the Federal Deposit Insurance Corporation (“FDIC”) created bank-specific

and broader financial institution liquidity risk and concerns.

Although the Department of the Treasury, the Federal Reserve, and the

FDIC jointly confirmed that depositors at SVB and Signature Bank would continue to have access to their funds, even those in excess of

the standard FDIC insurance limits, under a systemic risk exception, future adverse developments with respect to specific financial institutions

or the broader financial services industry may lead to market-wide liquidity shortages, impair the ability of companies to access near-term

working capital needs, and create additional market and economic uncertainty.

There can be no assurance that future credit and financial

market instability and a deterioration in confidence in economic conditions will not occur.

Our general business strategy may be adversely

affected by any such economic downturn, liquidity shortages, volatile business environment or continued unpredictable and unstable market

If the equity and credit markets deteriorate, or if adverse developments are experienced by financial institutions, it may

cause short-term liquidity risk and also make any necessary debt or equity financing more difficult, more costly and more dilutive.

to secure any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy,

financial performance and stock price and could require us to delay or abandon our business plans.

In addition, there is a risk that

one or more of our counterparties, financial institutions or other third parties with whom we do business may be adversely affected

by the foregoing risks, which may have an adverse effect on our business.

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

11 unchanged sentences

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

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

our share price to fall.

expect that significant additional capital will be needed in the future to continue our planned operations, including research and development,

increased marketing, hiring new personnel, commercializing our products, and continuing activities as an operating public company.

the extent we raise additional capital by issuing equity securities, our stockholders may experience substantial dilution.

common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from

time to time.

If we sell common stock, convertible securities or other equity securities in more than one transaction, investors may

be materially diluted by subsequent sales.

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

could gain rights superior to our existing stockholders.

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

43 unchanged sentences

and risk becoming subject to litigation or being delisted, among other potential problems.

we fail to maintain an effective system of internal controls, we may not be able to accurately determine our financial results or prevent

As a result, our stockholders could lose confidence in our financial results, which could harm our business and the value of our

common stock.

internal controls are necessary for us to provide reliable financial reports and effectively prevent fraud.

Section 404 of the Sarbanes-Oxley

Act of 2002 (“Section 404”) requires us establish and maintain an adequate internal control structure and procedures for

financial reporting and to evaluate and report on such controls.

internal controls and financial reporting are not subject to attestation by our independent registered public accounting firm pursuant

to the exemption provided to issuers that are not “large accelerated filers” or “accelerated filers” under the

Dodd-Frank Act of 2010.

However, our Annual Reports on Form 10-K must contain an annual assessment by management of the effectiveness

of our internal control over financial reporting and must include disclosure of any material weaknesses in internal control over financial

reporting that we have identified.

cannot be certain that we will be successful maintaining adequate internal controls over our financial reporting and financial processes

in the future or remediating any material weaknesses that we identify.

We may in the future discover areas of our internal controls that

need improvement.

Additionally, the existence of any material weakness or significant deficiency requires management to devote significant

time and incur significant expense to remediate any such material weaknesses or significant deficiencies and management may not be able

to remediate any such material weaknesses or significant deficiencies in a timely manner.

Furthermore, to the extent our business grows,

our internal controls may become more complex, and we would require significantly more resources to ensure our internal controls remain

we cannot assure you that material weaknesses or significant deficiencies will not exist or otherwise be discovered in the future.

material weaknesses or other significant deficiencies continue to occur, such weaknesses or deficiencies could result in misstatements

of our results of operations, restatements of our financial statements, a decline in the market value of our common stock, or other material

adverse effects on our business, reputation, results of operations, financial condition or liquidity.

securities or industry analysts do not publish research or reports, or publish unfavorable research or reports about our business, our

17 unchanged sentences

resources, which could harm our business.

should carefully consider the risks described herein and in other public filings which could materially affect our business, financial

condition or future results.

The risks described herein and therein are not the only risks we face.

Additional risks and uncertainties

not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition,

and/or operating results.

If any of the risks actually occur, our business, financial condition, and/or results of operations could be

negatively affected.

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