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Item 1A. Risk Factors

2026-03-31 compared with 2025-03-31 · 1062 added, 1000 removed, 1063 unchanged (66% of the section changed)

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Position and Need for Additional Capital

● We are a clinical stage biopharmaceutical company and have

not generated any revenue to date from drug sales, and may never become profitable.

● We have incurred significant operating losses in recent periods

and anticipate that we will incur continued losses for the foreseeable future.

● If we are unable to raise capital when needed or on attractive

terms, we would be forced to delay, scale back or discontinue some of our product candidate development programs or commercialization

● Our independent registered public accounting firm has expressed

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

● Our ability to utilize our net operating loss carryforwards

and certain other tax attributes may be limited.

● We are a clinical stage biopharmaceutical

company and have not generated any revenue to date from drug sales, and may never become profitable.

● We have incurred significant

operating losses in recent periods and anticipate that we will incur continued losses for the foreseeable future.

● If we are unable to raise capital

when needed or on attractive terms, we would be forced to delay, scale back or discontinue some of our product candidate development

programs or commercialization efforts.

● Our independent registered public

accounting firm has expressed substantial doubt about our ability to continue as a going concern.

● Our ability to utilize our net

operating loss carryforwards and certain other tax attributes may be limited.

Risks Related to Drug Development

and Regulatory Approval

● We depend heavily on the success of our core product candidates

OST-HER2 and OST-tADC.

We may not be able to obtain regulatory permission to conduct future clinical studies, or may not be able

to obtain regulatory approval for, or successfully commercialize, any of our current or future product candidates.

● If we experience delays or difficulties in the enrollment

of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.

● If we are not able to obtain, or if there are delays in obtaining,

required regulatory approvals both for our current or future product candidates, we will not be able to commercialize, or will be delayed

in commercializing, our current or future product candidates, and our ability to generate revenue will be materially impaired.

● Our current or future product candidates may cause adverse

or other undesirable side effects that could delay or prevent their future testing in clinical studies or delay or prevent regulatory

approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval,

● We may not be able to obtain or maintain orphan drug designation

or exclusivity for any product candidates and, even if we do, that exclusivity may not prevent the FDA or the EMA from approving other

competing products.

● Even if we receive regulatory approval for any of our current

or future product candidates, we will be subject to ongoing obligations and continued regulatory review, which may result in significant

additional expense.

Additionally, our current or future product candidates, if approved, could be subject to labeling and other restrictions

and market withdrawal, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated

problems with our drugs.

● Even if we receive marketing approval for our current or future

product candidates in the U.S., we may never receive regulatory approval to market our current or future product candidates outside of

● Manufacturing our current or future product candidates is

complex and we may encounter difficulties in production.

If we encounter such difficulties, our ability to provide supply of our current

or future product candidates for preclinical studies and clinical trials or for commercial purposes could be delayed or stopped.

● Our future growth may depend, in part, on our ability to penetrate

foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties that could materially adversely

affect our business.

Risks Related to Intellectual Property

● If we or those from whom we in-license patents are unable

to obtain and maintain patent and other intellectual property protection for our technology and product candidates or if the scope of

the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and

drugs similar or identical to ours, and our ability to successfully commercialize our technology and drugs may be impaired.

● If our trademarks and trade names for our products or company

name are not adequately protected in one or more countries where we intend to market our products, we may delay the launch of product

brand names, use different trademarks or tradenames in different countries, or face other potentially adverse consequences to building

our product brand recognition.

● If we are unable to adequately protect and enforce our trade

secrets, our business and competitive position would be harmed.

● We may initiate, become a defendant in, or otherwise become

party to lawsuits to protect or enforce our intellectual property rights, which could be expensive, time-consuming and unsuccessful.

● We may not obtain or grant licenses or sublicenses to intellectual

property rights in all markets on equally or sufficiently favorable terms with third parties.

● If we fail to comply with our obligations in any agreements

under which we may license intellectual property rights from third parties or otherwise experience disruptions to our business relationships

with our licensors, we could lose license rights that are important to our business.

● Any in-license patent covering our current or future product

candidates or other valuable technology could be narrowed or found invalid or unenforceable if challenged in court or before administrative

bodies in the U.S.

● We depend heavily on the success

of our core product candidates, OST-HER2 and OST-tADC.

We may not be able to obtain regulatory approval for, or successfully commercialize, any of our current or future product candidates.

● Delays or difficulties in enrolling patients in clinical trials could delay regulatory approval and increase

development costs.

● If we are not able to obtain,

or if there are delays in obtaining, required regulatory approvals for both our current or future product candidates, we will not be

able to commercialize, or will be delayed in commercializing, our current or future product candidates, and our ability to generate revenue

will be materially impaired.

● Our current or future product

candidates may cause adverse or other undesirable side effects that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences

following marketing approval, if any.

● We may not be able to obtain

or maintain orphan drug designation or exclusivity for any product candidates and, even if we do, that exclusivity may not prevent the

FDA, EMA or other regulatory authorities from approving other competing products.

● Even if we receive regulatory

approval for any of our current or future product candidates, we will be subject to ongoing obligations and continued regulatory review,

which may result in significant additional expense.

Additionally, our current or future product candidates, if approved, could be subject

to labeling and other restrictions and market withdrawal, and we may be subject to penalties if we fail to comply with regulatory requirements

or experience unanticipated problems with our drugs.

● Manufacturing our current or

future product candidates is complex and we may encounter difficulties in production.

If we encounter such difficulties, our ability

to provide supply of our current or future product candidates for preclinical studies and clinical trials or for commercial purposes

could be delayed or stopped.

● Our future growth may depend,

in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and

uncertainties that could materially adversely affect our business.

Risks Related to Intellectual

● If we or those from whom we

in-license patents are unable to obtain and maintain patent and other intellectual property protection for our technology and product

candidates or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop

and commercialize technology and drugs similar or identical to ours, and our ability to successfully commercialize our technology and

drugs may be impaired.

● If our trademarks and trade

names for our products or company name are not adequately protected in one or more countries where we intend to market our products,

we may delay the launch of product brand names, use different trademarks or tradenames in different countries, or face other potentially

adverse consequences to building our product brand recognition.

● If we are unable to adequately

protect and enforce our trade secrets, our business and competitive position would be harmed.

● We may initiate, become a defendant

in, or otherwise become party to lawsuits to protect or enforce our intellectual property rights, which could be expensive, time-consuming

and unsuccessful.

● We may not obtain or grant licenses

or sublicenses to intellectual property rights in all markets on equally or sufficiently favorable terms with third parties.

● If we fail to comply with our

obligations in any agreements under which we may license intellectual property rights from third parties or otherwise experience disruptions

to our business relationships with our licensors, we could lose license rights that are important to our business.

● Any owned, co-owned or in-licensed patent covering our current or

future product candidates or other valuable technology could be narrowed or found invalid or unenforceable if challenged in court or

before administrative bodies in the U.S.

or abroad, including the USPTO and the EPO.

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Our Operations

● In our industry in particular, our future success depends

on our ability to retain key scientific employees and to attract, retain and motivate qualified personnel.

● Our internal computer systems, or those of our third-party

clinical research organizations, or CROs, or other contractors or consultants, may fail or suffer security breaches, which could result

in a material disruption of our current or future product candidates’ development programs.

will incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time

to new compliance initiatives.

● In our industry in particular,

our future success depends on our ability to retain key scientific employees and to attract, retain and motivate qualified personnel.

● Our internal computer systems,

or those of our third-party CROs or other contractors or consultants, may fail or suffer security

breaches, which could result in a material disruption of our current or future product candidates’ development programs.

● We will incur increased costs

as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives.

Risks Related to Our Financial Position and

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company and have not generated any revenue to date from drug sales, and may never become profitable.

Our ability to become profitable

depends upon our ability to generate revenue.

To date, while we have generated significant interest in various research collaboration

revenue, we have not generated any commercial revenue from our current core product candidates, including our lead core product candidate OST-HER2

and our other core product candidate OST-tADC, and we do not know and do not expect to generate any revenue from the sale of drugs

in the near future.

We do not expect to generate revenue unless and until we complete the development of, obtain marketing approval for,

and begin to sell, OST-HER2, which is being evaluated in a Phase IIb clinical trial, or OST-tADC, which is still being

evaluated at the preclinical stage.

We are also unable to predict when, if ever, we will be able to generate revenue from such product

candidates due to the numerous risks and uncertainties associated with drug development, including the uncertainty of:

● our ability to add and retain key research and development personnel;

● our ability to successfully develop, obtain regulatory approval for, and then successfully commercialize,

OST-HER2 and OST-tADC;

● our successful enrollment in and completion of clinical trials, including our ability to generate positive

data from any such clinical trials;

● our ability to establish an appropriate safety profile with IND-enabling toxicology and other

preclinical studies for OST-tADC;

● the costs associated with the development of any additional development programs we identify in-house or

acquire through collaborations or other arrangements;

● our ability to discover, develop and utilize biomarkers to demonstrate target engagement, pathway engagement

and the impact on disease progression, as applicable, of our product candidates;

● our ability to establish and maintain agreements with third-party manufacturers for clinical supply for

our clinical trials and commercial manufacturing;

● our ability to forecast and meet supply requirements for clinical trials and commercialized products using

third-party manufacturers;

● the terms and timing of any additional collaboration, license or other arrangement, including the terms

and timing of any payments thereunder;

● obtaining any necessary licenses to manufacture and distribute OST-HER2 and/or OST-tADC and/or contractual

arrangements with third party logistics providers and/or distributors to distribute our products in the United States;

● obtaining and maintaining third-party coverage and adequate reimbursement, if OST-HER2 and/or OST-tADC

● acceptance of our core product candidates, if and when approved, by patients, the medical community and

third-party payors;

● effectively competing with other therapies, if OST-HER2 and/or OST-tADC are approved;

● our ability and the ability of third parties from which we in-license patents to obtain and maintain patent,

trade secret and other intellectual property protection, OST-HER2 and/or OST-tADC and regulatory exclusivity for OST-HER2 and/or

OST-tADC if and when approved;

● our receipt of marketing approvals for OST-HER2 and/or OST-tADC from applicable regulatory authorities;

● the continued acceptable safety profiles of our core product candidates following approval.

Our ability to achieve profitability

depends on our ability to generate revenue from product sales.

To date, while we have generated interest in potential research collaborations,

we have not generated any commercial revenue from our product candidates, including our lead product candidate OST-HER2 and our OST-tADC

We do not expect to generate revenue from drug sales in the near future.

We will not generate revenue unless and until we successfully

complete the development of, obtain regulatory approval for, and commercialize one or more of our product candidates.

Our lead product

candidate, OST-HER2, has completed a Phase IIb clinical trial in patients with recurrent, fully resected pulmonary metastatic Osteosarcoma

and we are currently pursuing regulatory interactions with the FDA and regulatory authorities in the United Kingdom and European Union

regarding potential approval pathways.

These pathways may include the FDA’s Accelerated Approval Program and conditional approval

pathways in other jurisdictions.

However, there can be no assurance that any such approvals will be granted, that confirmatory trials

will be successful or that we will ultimately be able to commercialize OST-HER2.

Our OST-tADC platform remains in the preclinical stage

of development.

Even if we pursue these regulatory

pathways, we face significant risks and uncertainties that may prevent us from generating revenue, including, but not limited to:

● our ability to attract and retain

qualified scientific, clinical and management personnel;

● our ability to successfully

develop our product candidates, including completing preclinical studies and clinical trials, generating positive safety and efficacy

data, and conducting any confirmatory trials that may be required to support accelerated or conditional approvals;

● our ability to obtain regulatory

approval for our product candidates from the FDA and other regulatory authorities;

● the costs, timing and uncertainties

associated with advancing additional development programs we may identify internally or through collaborations or other strategic arrangements;

● our ability to identify, develop

and utilize biomarkers that support regulatory submissions or demonstrate clinical benefit;

● our ability to establish and

maintain relationships with third-party manufacturers and suppliers for clinical and potential commercial supply, and to accurately forecast

and meet supply requirements;

● our ability to enter into and

maintain collaboration, licensing, manufacturing, distribution and other strategic arrangements on favorable terms;

● our ability to establish commercialization

capabilities, obtain adequate reimbursement and coverage from third-party payors, and achieve market acceptance among physicians, patients

and payors if our products are approved;

● our ability to compete effectively

with existing or future therapies;

● our ability to obtain, maintain

and enforce intellectual property protection and regulatory exclusivity for our product candidates.

In addition, while OST-HER2

has received Rare Pediatric Disease Designation and we may become eligible to receive a Priority Review Voucher if certain regulatory

approvals are obtained within specified timeframes, there can be no assurance that we will meet the requirements to receive such a voucher

or that it will provide any financial or strategic benefit to us.

Because of the numerous risks

and uncertainties associated with drug development and commercialization, we may never generate significant revenue from product sales

or achieve profitability.

We have incurred significant operating losses

in recent periods and anticipate that we will incur continued losses for the foreseeable future.

Since inception, we have focused

substantially all of our efforts on the development of OST-HER2 and OST-tADC and our other clinical developments.

To date, we have financed

our operations primarily through the sale of convertible notes and other securities to outside investors.

From July 2018 to April 2024,

we raised an aggregate of approximately $19.2 million in gross proceeds from sales of our convertible notes.

On July 31, 2024,

we completed our initial public offering, raising $6.4 million in gross offering proceeds.

From December 2024 through January 2025, we

raised an aggregate of $7.1 million in gross proceeds from the Private Placement.

Due to our significant research and development expenditures,

we have experienced negative cash flows from operations, even in periods of operating income.

For each of the years ended December 31,

2024 and 2023, we incurred a loss from operations and negative cash flows from operations.

We expect to continue to incur significant

expenses and operating losses over the next several years and for the foreseeable future.

Our prior losses, combined with expected

future losses, have had and will continue to have an adverse effect on our stockholders’ equity and working capital.

We expect our

expenses to significantly increase in connection with our ongoing activities, as we:

● complete preclinical studies, initiate and complete clinical trials for product candidates;

● consult with the FDA at each stage of development;

● seek a favorable outcome of our toxicology studies;

● contract to manufacture our product candidates;

● advance research and development related activities to expand our product pipeline;

● seek regulatory approval for our core product candidates that successfully complete clinical development;

● develop and scale up our capabilities to support our ongoing preclinical activities and clinical trials

for our drug candidates and commercialization of any of our drug candidates for which we obtain marketing approval;

● maintain, expand, enforce, defend and protect our intellectual property portfolio;

● hire additional staff, including clinical, scientific and management personnel;

● secure facilities to support continued growth in our research, development and commercialization efforts;

● incur additional costs associated with operating as a public company.

A significant number of additional shares

of our common stock may be issued under the terms of existing securities, which issuances would substantially dilute existing stockholders

and may depress the market price of our common stock.

At two closings occurring

on December 31, 2024 and January 14, 2025, we issued an aggregate of (i) 1,775,750 shares of Series A Preferred Stock and (ii) Series

A Warrants initially exercisable into 1,775,750 shares of common stock pursuant to the Private Placement.

Each share of Series A Preferred

Stock is convertible into a number of shares of common stock at a conversion ratio equal to (A) the original issue price of the Series

A Preferred Stock divided by (B) the conversion price of the Series A Preferred Stock.

The original issue price and the conversion price

of the Series A Preferred Stock will initially be $4.00 (resulting in an initial conversion ratio of 1:1) and are subject to adjustment

as set forth in the Certificate of Designation, Preferences, Rights and Limitations of Series A Senior Convertible Preferred Stock.

of the Series A Warrants is exercisable into a number of shares of common stock, at an initial exercise price of $4.40 per share.

Series A Warrants are exercisable by the holder for a period of five years from the later of (a) the Resale Effective Date (as defined

in the Purchase Agreement) and (b) the date Stockholder Approval is obtained.

In consideration of our purchase

of the HER2 Assets, we agreed to pay to Ayala $7.5 million shares of our common stock, based on the volume-weighted average price of our

common stock over the 30 trading days immediately preceding the closing date of the HER2 Purchase Agreement.

The number of shares of common

stock into which the Series A Preferred Stock and the Series A Warrants may be converted or exercised is also subject to potential increase

pursuant to applicable resets and anti-dilution adjustments.

For more detailed information about these adjustments, see “Description

of Capital Stock — Series A Preferred Stock — Resets and Anti-Dilution Adjustments.” The issuance of common stock

pursuant to the Series A Preferred Stock, Series A Warrants and the HER2 Purchase Agreement would substantially dilute the proportionate

ownership and voting power of existing stockholders, and their issuance, or the possibility of their issuance, may depress the market

price of our common stock.

Since our inception, we have

devoted substantially all of our resources to the research and development of our product candidates, including OST-HER2 and our OST-tADC

As a result, we have incurred significant operating losses and negative cash flows from operations.

For each of the years ended

December 31, 2025 and 2024, we incurred operating losses and negative cash flows from operations.

Since July 2018, we have financed our

operations primarily through public and private offerings of our securities, from which we have raised aggregate gross proceeds of approximately

$41.1 million.

We have not generated any revenue from product sales and do not expect to do so unless and until one or more of our

product candidates receives regulatory approval and is successfully commercialized.

We expect to continue to incur significant expenses

and operating losses for the foreseeable future.

Our historical losses, together with expected future losses, have had and will continue

to have an adverse effect on our stockholders’ equity and working capital.

Our expenses are expected to increase substantially as

● advance the development of our

product candidates, including completing preclinical studies and conducting clinical trials, including any confirmatory trials that may

be required to support potential regulatory approvals;

● prepare regulatory submissions

and continue interactions with regulatory authorities in the United States and internationally;

● manufacture clinical trial materials

and establish or expand relationships with third-party manufacturers to support clinical development and potential commercialization;

● continue research and development

activities to expand and advance our product pipeline, including our OST-tADC platform;

● seek regulatory approval for

our product candidates and prepare for potential commercialization;

● expand our internal capabilities,

including hiring additional scientific, clinical, regulatory and management personnel;

● maintain, expand, and protect

our intellectual property portfolio;

● incur additional legal, accounting,

insurance, investor relations and other expenses associated with operating as a public company.

As a result, we will need

to generate significant revenue to achieve profitability, and we may never achieve or sustain profitability.

If we are unable to raise capital when needed

or on attractive terms, we would be forced to delay, scale back or discontinue some of our product candidate development programs or commercialization

The development of pharmaceutical

drugs is capital intensive.

We are currently advancing OST-HER2 through clinical development and OST-tADC through

preclinical development.

The FDA allowed our OST31-164-01 study to be conducted in July 2021, and we initiated a Phase IIb

clinical trial in 2022.

We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the

research and development of, advance the preclinical and clinical activities of, and seek marketing approval for, our current or future

product candidates.

In addition, depending on the status of regulatory approval or, if we obtain marketing approval for any of our current

or future product candidates, we expect to incur significant commercialization expenses related to sales, marketing, product manufacturing

and distribution to the extent that such sales, marketing, product manufacturing and distribution are not the responsibility of our collaborators.

We may also need to raise additional funds sooner if we choose to pursue additional indications and/or geographies for our current or

future product candidates or otherwise expand more rapidly than we presently anticipate.

We expect to incur additional costs associated

with operating as a public company.

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

If we are unable to raise capital on a timely basis or on favorable terms, we would be forced to delay, scale back or discontinue the

development and commercialization of one or more of our product candidates or delay our pursuit of potential in-licenses or

acquisitions, which could materially affect our business, financial condition and results of operations.

The development of biopharmaceutical

product candidates is capital intensive and subject to significant uncertainty.

We are currently advancing our lead product candidate,

OST-HER2, toward potential regulatory submission and approval, and our OST-tADC platform remains in preclinical development.

our expenses to increase substantially as we continue to support regulatory interactions, prepare for potential BLA submissions, conduct

additional analyses, initiate any required confirmatory clinical trials, and expand our research and development activities.

receives regulatory approval, we also expect to incur significant costs related to commercialization, including manufacturing scale-up,

sales, marketing, distribution and medical affairs, whether independently or with collaborators.

Our capital requirements will

depend on many factors, including regulatory outcomes, the scope and timing of any additional clinical trials that may be required by

regulatory authorities, the costs of manufacturing and process development for our product candidates, the pace of expansion into additional

indications or geographies, and our ability to establish collaborations or strategic partnerships.

In particular, despite the positive

results from our Phase IIb clinical trial, regulatory authorities may require additional clinical data, including from randomized controlled

trials, which would significantly increase our funding needs and extend development timelines.

We will require substantial

additional capital to support our ongoing operations and execute our business strategy.

However, we may be unable to obtain financing

on acceptable terms, or at all.

Market conditions, including volatility in the biotechnology sector, and our clinical, regulatory and

commercial progress may adversely impact our ability to raise capital.

If we are unable to secure adequate funding when needed, we may

be required to delay, reduce or terminate development programs, including for OST-HER2 or our OST-tADC platform, limit our ability to

pursue additional indications or regulatory approvals in other jurisdictions, delay or forgo commercialization efforts, or curtail our

operations, any of which could materially harm our business, financial condition and results of operations.

Raising additional capital may cause dilution

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

We may seek additional capital

through a combination of public and private equity offerings, including our Equity Line of Credit as well as other debt financings, strategic

collaborations and alliances and licensing arrangements.

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 would dilute all of 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 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 business.

We could also be required

to seek funds through arrangements with collaborators 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 current or future 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 may seek additional

capital through a combination of public and private securities offerings, including our at-the-market offering program, as well as

other debt financings, strategic collaborations and alliances and licensing arrangements.

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 would dilute all of 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 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 business.

We could also be required to seek funds through arrangements with

collaborators 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 current or future 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.

Our independent registered public accounting

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

We have primarily financed

our operations through proceeds from the sale of shares of common stock in our initial public offering and convertible notes, shares of

our Series A convertible preferred stock and warrants to accredited investors.

We have experienced significant negative cash flows from

operations in each year since our inception.

We do not expect to experience any significant positive cash flows from our existing

collaboration agreements and do not expect to have any product revenue in the near term.

We expect to incur substantial operating losses

and negative cash flows from operations for the foreseeable future as we continue to invest significantly in research and development

of our programs.

As a result, our independent registered public accounting firm has issued a going concern opinion on our financial statements,

expressing substantial doubt that we can continue as an ongoing business for the next 12 months after issuance of their report based

on us having suffered recurring losses from operations and having a net capital deficiency.

Our financial statements do

not include any adjustments that might result from the outcome of this uncertainty.

We will need to raise additional capital to fund our

future operations and remain a going concern.

However, we cannot guarantee that we will be able to obtain sufficient additional funding

or that such funding, if available, will be obtainable on terms favorable to us.

In the event that we are unable to obtain sufficient

additional funding, there can be no assurance that we will be able to continue as a going concern.

We have incurred significant

operating losses and negative cash flows from operations since our inception and expect to continue to incur substantial losses for the

foreseeable future as we advance the development of our product candidates, including OST-HER2, and continue preclinical development of

our OST-tADC platform.

To date, we have financed our operations primarily through the issuance of equity and equity-linked securities,

including common stock, preferred stock, convertible promissory notes and warrants in public and private offerings.

We do not currently generate

product revenue and do not expect to generate any product revenue in the near term.

In addition, we do not expect our existing collaboration

or licensing arrangements, if any, to provide significant cash inflows sufficient to fund our operations.

Our ability to generate revenue,

if any, will depend on the successful development, regulatory approval and commercialization of our product candidates, which is subject

to significant uncertainty and may not occur.

As a result of our recurring losses from operations, negative cash

flows, and net capital deficiency, our independent registered public accounting firm has included an explanatory paragraph in its report

on our consolidated financial statements expressing substantial doubt about our ability to continue as a going concern for at least 12

months from the date of issuance of the consolidated financial statements.

Our consolidated financial statements do not include any adjustments

that might result from the outcome of this uncertainty.

We will need to raise substantial

additional capital to fund our operations and remain a going concern.

However, we cannot guarantee that we will be able to obtain sufficient

additional funding or that such funding, if available, will be obtainable on acceptable terms.

If we are unable to raise additional capital

or otherwise address our liquidity needs, we may be required to significantly delay, scale back or discontinue the development of our

product candidates, including OST-HER2, or otherwise curtail our operations.

In such case, there can be no assurance that we will be able

to continue as a going concern.

In addition, the inclusion of a going concern explanatory paragraph in our auditor’s report may

adversely affect our ability to obtain financing on acceptable terms, or at all, and could negatively impact the market price of our common

Our ability to utilize our net operating

22 unchanged sentences

any of our current or future product candidates.

We currently have no product

candidates approved for sale and may never be able to develop marketable product candidates.

Our business depends heavily on the successful

development, regulatory approval and commercialization of the current or future immunotherapy for Osteosarcoma product candidates, of

which our lead product candidate, OST-HER2, is in Phase IIb clinical development.

OST-tADC will require additional

preclinical development and substantial clinical development, testing and regulatory approval before we are permitted to commence its

commercialization.

The preclinical studies and clinical trials of our current or future product candidates are, and the manufacturing

and marketing of our current or future product candidates will be, subject to extensive and rigorous review and regulation by numerous

government authorities in the United States and in other countries where we intend to test or, if approved, market any of our

current or future product candidates.

Before obtaining regulatory approvals for the commercial sale of any of our current or future product

candidates, we must demonstrate through preclinical studies and clinical trials that each product candidate is safe and effective for

use in each target indication.

Drug development is a long, expensive and uncertain process, and delay or failure can occur at any stage

of any of our clinical trials.

This process can take many years and may include post-marketing studies and surveillance, which will

require the expenditure of substantial resources beyond the proceeds we raise in this offering.

Of the large number of drugs in development

in the United States, only a small percentage will successfully complete the FDA regulatory approval process and will be commercialized,

with similarly low rates of success for drugs in development in the European Union obtaining regulatory approval from the European Medicines

Agency (EMA).

Accordingly, even if we are able to obtain the requisite financing to continue to fund our development and preclinical

studies and clinical trials, we cannot assure you that any of our current or future product candidates will be successfully developed

and commercialized.

We are not permitted to market

our current or future product candidates in the United States until we receive approval of a BLA from the FDA CBER, in the European

Economic Area (EEA) until we receive approval of a marketing authorization applications (MAA) from the EMA, or in any other foreign countries

until we receive the requisite approval from such countries.

Obtaining approval of a BLA or MAA is a complex, lengthy, expensive and uncertain

process, and the FDA or EMA may delay, limit or deny approval of any of our current or future product candidates for many reasons, including,

among others:

● we may not be able to demonstrate that our current or future product candidates are safe and effective

in treating their target indications to the satisfaction of the FDA or applicable foreign regulatory agencies;

● the results of our preclinical studies and clinical trials may not meet the level of statistical or clinical

significance required by the FDA or applicable foreign regulatory agencies for marketing approval;

● the FDA or applicable foreign regulatory agencies may disagree with the number, design, size, conduct

or implementation of our preclinical studies and clinical trials;

● the FDA or applicable foreign regulatory agencies may require that we conduct additional preclinical studies

and clinical trials;

● the FDA or applicable foreign regulatory agencies may not approve the formulation, labeling or specifications

of any of our current or future product candidates;

● the contract research organizations (CROs) that we retain to conduct our preclinical studies and clinical

trials may take actions that materially adversely impact our preclinical studies and clinical trials;

● the FDA or applicable foreign regulatory agencies may find the data from preclinical studies and clinical

trials insufficient to demonstrate that our current or future product candidates’ clinical and other benefits outweigh their safety

● the FDA or applicable foreign regulatory agencies may disagree with our interpretation of data from our

preclinical studies and clinical trials;

● the FDA or applicable foreign regulatory agencies may not accept data generated at our preclinical studies

and clinical trial sites;

● if our BLA, if and when submitted, is reviewed by an advisory committee, the FDA may have difficulties

scheduling an advisory committee meeting in a timely manner or the advisory committee may recommend against approval of our application

or may recommend that the FDA require, as a condition of approval, additional preclinical studies or clinical trials, limitations on approved

labeling or distribution and use restrictions;

● the FDA may require development of a risk evaluation and mitigation strategy (REMS) as a condition of

approval or post-approval;

● the FDA or an applicable foreign regulatory agency may determine that the manufacturing processes or facilities

of third-party manufacturers with which we contract do not conform to applicable requirements, including current good manufacturing practices

● the FDA or applicable foreign regulatory agencies may change their approval requirements or policies or

adopt new regulations.

Any of these factors, many

of which are beyond our control, could jeopardize our ability to obtain regulatory approval for and successfully market our current or

future product candidates.

Any such setback in our pursuit of regulatory approval would have a material adverse effect on our business

and prospects.

If we experience delays or difficulties

in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.

We currently have no products

approved for sale and may never successfully develop marketable product candidates.

Our business depends heavily on the successful development,

regulatory approval, and commercialization of our current and future immunotherapy product candidates for Osteosarcoma, of which our lead

candidate, OST-HER2, is in Phase IIb clinical development.

OST-tADC remains in preclinical development and will require substantial additional

preclinical and clinical testing, as well as regulatory approvals, before we may commercialize it.

The preclinical studies and clinical

trials of our product candidates, as well as the manufacturing and marketing of any approved product, are subject to extensive and rigorous

regulation by government authorities in the United States, the European Economic Area (EEA), and other jurisdictions in which we intend

to test or market our product candidates.

Before obtaining regulatory approvals, we must demonstrate through preclinical studies and clinical

trials that each product candidate is safe and effective for its intended indication.

Drug development is a lengthy, expensive, and uncertain

process, and delay or failure can occur at any stage.

Even with sufficient funding, there can be no assurance that any of our product

candidates will be successfully developed, approved, or commercialized.

We cannot market our product

candidates in the United States without approval of a BLA from the FDA, in the EEA without approval of a MAA from the EMA, or in other

foreign jurisdictions without the requisite approvals.

Obtaining regulatory approval is complex, time-consuming, costly, and uncertain,

and the FDA, EMA, or other foreign authorities may delay, limit, or deny approval for many reasons, including but not limited to:

● inability to demonstrate that

our product candidates are safe and effective for their target indications;

● preclinical or clinical trial

results that fail to meet required statistical or clinical significance;

● disagreement with the number,

design, size, conduct, or implementation of our studies;

● requests to conduct additional

preclinical studies or clinical trials;

● non-approval of formulation,

labeling, or specifications;

● actions by CROs that materially adversely affect study results;

● regulatory authorities’

determination that our data are insufficient to demonstrate that clinical benefits outweigh safety risks;

● disagreement with our interpretation

of study data;

● non-acceptance of data generated

at certain study sites;

● advisory committee recommendations

that are negative or impose conditions;

● requirements to implement a

Risk Evaluation and Mitigation Strategy (REMS);

● determinations that manufacturing

processes or facilities do not comply with regulatory requirements, including cGMPs;

● changes in regulatory policies,

requirements, or procedures.

Many of these factors are

beyond our control and could prevent or delay regulatory approval, limit the indications for which a product may be approved, or impose

significant post-approval obligations.

Any such setback could materially and adversely affect our business, prospects, and ability to

generate revenue.

Delays or difficulties in enrolling patients

in clinical trials could prevent or delay regulatory approval and increase development costs.

We may not be able to initiate

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eligible patients to participate in these trials as required by the FDA or similar regulatory authorities outside the United States.

particular, because we are focused on patients with rare Osteosarcoma, our ability to enroll eligible patients may be limited or may result

in slower enrollment than we anticipate.

Some of our competitors have ongoing clinical trials for current or future product candidates

that treat the same patient populations as our current or future product candidates, and patients who would otherwise be eligible for

our clinical trials may instead enroll in clinical trials of our competitors’ current or future product candidates.

Patient enrollment may be affected

by other factors that we may not be able to control including:

● the willingness of participants to enroll in our clinical trials and available support in our countries

● the obtaining of informed consent from parents or guardians of pediatric patients which meet evolving

regulatory requirements in the United States and other countries;

● the severity of the disease under investigation;

● the eligibility criteria for the clinical trial in question;

● the availability of an appropriate screening test;

● the perceived risks and benefits of the product candidate under study;

● the efforts to facilitate timely enrollment in clinical trials;

● the patient referral practices of physicians;

● the ability to monitor patients adequately during and after treatment;

● the proximity and availability of clinical trial sites for prospective patients.

Rare Osteosarcoma has relatively low prevalence

and it may be difficult to identify patients with driver genes of the disease, which may lead to delays in enrollment for our trials.

Osteosarcoma has relatively

low prevalence and it may be difficult to identify patients with the eligibility criteria we are targeting.

Osteosarcoma has an incident

rate of approximately 1,000 individuals affected per year in the United States.

Our inability to enroll a sufficient number of patients

with the target indication for our clinical trials would result in significant delays and could require us to abandon one or more clinical

trials altogether.

Enrollment delays in our clinical trials may result in increased development costs for our current or future product

candidates, which would cause the value of our company to decline and limit our ability to obtain additional financing.

If we are unable

to include patients with the target indication, this could compromise our ability to seek participation in the FDA’s expedited review

and approval programs, or otherwise to seek to accelerate clinical development and regulatory timelines for our other product candidates.

challenge is particularly significant because we are focused on patients with rare Osteosarcoma, which has a relatively low prevalence,

with an incident rate of approximately 1,000 individuals affected per year in the United States.

Identifying patients who meet our

eligibility criteria, including those with specific molecular or driver gene profiles, may be difficult and could lead to slower-than-expected

Some of our competitors have ongoing clinical trials for current or future product candidates that treat the same patient

populations as our current or future product candidates, and patients who would otherwise be eligible for our clinical trials may instead

enroll in clinical trials of our competitors’ current or future product candidates.

While we successfully enrolled

41 patients in our Phase IIb clinical trial of OST-HER2, patient enrollment in future trials may be slower or more limited due to the

rarity of the disease, competition for patients from other clinical trials, or other factors outside our control, including:

● the willingness of participants

to enroll in our clinical trials and available support in our countries of interest;

● the obtaining of informed consent

from parents or guardians of pediatric patients which meet evolving regulatory requirements in the United States and other countries;

● the severity of the disease

under investigation;

● the eligibility criteria for

the clinical trial in question;

● the availability of an appropriate

screening test;

● the perceived risks and benefits

of the product candidate under study;

● the efforts to facilitate timely

enrollment in clinical trials;

● the patient referral practices

of physicians;

● the ability to monitor patients

adequately during and after treatment;

● the proximity and availability

of clinical trial sites for prospective patients.

Failure to enroll a sufficient number of patients in future trials

could result in significant delays, increased development costs, or the need to suspend or abandon one or more clinical trials.

may also impair our ability to seek participation in expedited regulatory programs, such as the FDA’s priority review or fast track

designations, and could materially impact the timing, cost, and success of regulatory approvals and commercialization.

If we are not able to obtain, or if there

are delays in obtaining, required regulatory approvals both for our current or future product candidates, we will not be able to commercialize,

are delays in obtaining, required regulatory approvals for both our current or future product candidates, we will not be able to commercialize,

or will be delayed in commercializing, our current or future product candidates, and our ability to generate revenue will be materially

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FDA and comparable authorities in other countries have substantial discretion in the approval process and may refuse to accept any application

or may decide that our data are insufficient for approval and require additional preclinical, clinical or other studies.

or may decide that our data is insufficient for approval and require additional preclinical, clinical or other studies.

Our current or

future product candidates could be delayed in receiving, or fail to receive, regulatory approval for many reasons, including the following:

● the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of

our clinical trials;

● we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities

that a product candidate is safe and effective for its proposed indication or that it is suitable to identify appropriate patient populations;

● the results of clinical trials may not meet the level of statistical significance required by the FDA

or comparable foreign regulatory authorities for approval;

● we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh

its safety risks;

● the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from

preclinical studies or clinical trials;

● the data collected from clinical trials of our current or future product candidates may not be sufficient

to support the submission of an NDA, a BLA or other submission or to obtain regulatory approval in the United States or elsewhere;

● the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or

facilities of third-party manufacturers with which we contract for clinical and commercial supplies;

● the approval requirements or policies or regulations of the FDA or comparable foreign regulatory authorities

may significantly change in a manner rendering our clinical data insufficient for approval.

● the FDA or comparable foreign

regulatory authorities may disagree with the design or implementation of our clinical trials;

● we may be unable to demonstrate

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

indication or that it is suitable to identify appropriate patient populations;

● the results of clinical trials

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

● we may be unable to demonstrate

that a product candidate’s clinical and other benefits outweigh its safety risks;

● the FDA or comparable foreign

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

● the data collected from clinical

trials of our current or future product candidates may not be sufficient to support the submission of an NDA, a BLA or other submission

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

● the FDA or comparable foreign

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

for clinical and commercial supplies;

● the approval requirements or

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

data insufficient for approval.

In addition, even if we were

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potentially significant negative consequences could result, including:

● regulatory authorities may place a hold on an ongoing clinical trial or may refuse to allow a future clinical

trial to be conducted;

● regulatory authorities may withdraw or limit their approval of current or future product candidates;

● we may or a regulatory authority might require that the product or products be recalled;

● regulatory authorities may require the addition of labeling statements, such as a “boxed”

warning or a contraindication;

● we may be required to create a medication guide outlining the risks of such side effects for distribution

● we may be required to change the way such current or future product candidates are distributed or administered,

conduct additional clinical trials or change the labeling of the current or future product candidates;

● regulatory authorities may require a REMS plan to mitigate risks, which could include medication guides,

physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk

minimization tools;

● we may be subject to regulatory investigations and government enforcement actions;

● we may decide to remove such current or future product candidates from the marketplace;

● we could be sued and held liable for injury caused to individuals exposed to or taking our current or

future product candidates.

● regulatory authorities may place

a hold on an ongoing clinical trial or may refuse to allow a future clinical trial to be conducted;

● regulatory authorities may withdraw

or limit their approval of current or future product candidates;

● we may or a regulatory authority

might require that the product or products be recalled;

● regulatory authorities may require

the addition of labeling statements, such as a “boxed” warning or a contraindication;

● we may be required to create

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

● we may be required to change

the way such current or future product candidates are distributed or administered, conduct additional clinical trials or change the labeling

of the current or future product candidates;

● regulatory authorities may require

a REMS plan to mitigate risks, which could include medication guides, physician communication plans, or elements to assure safe use,

such as restricted distribution methods, patient registries and other risk minimization tools;

● we may be subject to regulatory

investigations and government enforcement actions;

● we may decide to remove such

current or future product candidates from the marketplace;

● we could be sued and held liable

for injury caused to individuals exposed to or taking our current or future product candidates.

We believe that any of these

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We may not be able to obtain or maintain

orphan drug designation or exclusivity for any product candidates and, even if we do, that exclusivity may not prevent the FDA or EMA

from approving other competing products.

OST-HER2 received orphan drug

designation for Osteosarcoma in the United States, and we may seek orphan drug designation (“ODD”) for other current

or future product candidates.

We are currently preparing to submit required information to the FDA in order to re-establish ODD for OST-HER2

in the first half of 2025.

Regulatory authorities in some jurisdictions, including the United States and the European Union,

may designate drugs for relatively small patient populations as orphan drugs.

Under the Orphan Drug Act of 1983, the FDA may

designate a product as an orphan drug if it is a drug 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.

orphan drug designation or exclusivity for any product candidates and, even if we do, that exclusivity may not prevent the FDA, EMA or

other regulatory authorities from approving other competing products.

OST-HER2 received orphan drug designation for Osteosarcoma in the United States,

and we may seek orphan drug designation (“ODD”) for other current or future product candidates.

We have submitted the required

information to the FDA in order to re-establish ODD for OST-HER2 in 2026.

Regulatory authorities in some jurisdictions, including

the United States and the European Union, may designate drugs for relatively small patient populations as orphan drugs.

the Orphan Drug Act of 1983, the FDA may designate a product as an orphan drug if it is a drug 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.

Generally, if a product with

an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation, the

product is entitled to a period of marketing exclusivity, which precludes the FDA or EMA from approving another marketing application

for the same drug for that time period.

The applicable period is seven years in the United States and ten years in

the European Union.

The exclusivity period in the European Union can be reduced to six years if a drug no longer meets the criteria

for orphan drug designation or if the drug is sufficiently profitable so that market exclusivity is no longer justified.

Orphan drug exclusivity

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

assure sufficient quantity of the drug to meet the needs of patients with the rare disease or condition.

product may be entitled to a period of marketing exclusivity, during which the FDA or EMA generally cannot approve another marketing

application for the same active ingredient for the same indication.

The applicable period is seven years in the United States and ten

years in the European Union, although EU exclusivity may be reduced to six years if a drug no longer meets the orphan criteria or is

considered sufficiently profitable.

Orphan drug exclusivity may be lost if the FDA or EMA determines that the request for designation

was materially defective or if the manufacturer is unable to assure sufficient drug supply to meet patient needs.

Even if we obtain orphan drug

exclusivity for a product, that exclusivity may not effectively protect the product from competition because competing drugs containing

a different active ingredient can be approved for the same condition.

In addition, even after an orphan drug is approved, the FDA can

subsequently approve the same drug for the same condition if the FDA concludes that the later drug is clinically superior in that it is

shown to be safer, more effective or makes a major contribution to patient care.

Further, we may not be the first to obtain marketing

approval for any particular orphan indication due to the uncertainties associated with developing pharmaceutical products, and thus, for

example, approval of our product candidates could be blocked for seven years if another company previously obtained approval and

orphan drug exclusivity in the United States for the same drug and same condition.

On August 3, 2017, the

Congress passed the FDA Reauthorization Act of 2017.

This act, among other things, codified the FDA’s pre-existing regulatory

interpretation to require that a drug sponsor demonstrate the clinical superiority of an orphan drug that is otherwise the same as a previously

approved drug for the same rare disease in order to receive orphan drug exclusivity.

The new legislation reverses prior precedent holding

that the Orphan Drug Act unambiguously requires that the FDA recognize the orphan exclusivity period regardless of a showing of clinical

The FDA may further reevaluate the Orphan Drug Act and its regulations and policies.

We do not know if, when or how the FDA

may change the orphan drug regulations and policies in the future, and it is uncertain how any changes might affect our business.

on what changes the FDA may make to its Orphan Drug regulations and policies, our business could be adversely impacted.

exclusivity for a product, that exclusivity may not effectively protect the product from competition.

Drugs with different active ingredients

can be approved for the same condition, and the FDA or EMA may approve the same drug for the same condition if a later product demonstrates

clinical superiority, such as being safer, more effective, or making a major contribution to patient care.

In addition, we may not be

the first to obtain marketing approval for a particular orphan indication.

Approval of another product for the same active ingredient

and indication could prevent or delay our ability to obtain orphan drug exclusivity, materially affecting our competitive position.

Regulatory authorities may

also revise orphan drug regulations or policies, and it is uncertain how any such changes could impact our business or exclusivity rights.

Although we have obtained rare pediatric

disease designation for OST-HER2 for Osteosarcoma patients, we may not be eligible to receive a priority review voucher in the

event that FDA approval does not occur prior to September 30, 2026.

event that FDA approval does not occur within the timeframe required by the applicable statutory provisions or if future law changes eliminate

or further modify the PRV Program.

The Rare Pediatric Disease

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compared to the standard timeframe of approximately ten months.

Under the 21 st Century Cures Act, a drug that receives

rare disease designation before September 30, 2024, will continue to be eligible for a PRV if the drug is approved before September 30,

If we do not obtain approval of a BLA for OST-HER2 in patients with Osteosarcoma, and if the PRV Program is not extended

by Congressional action, we may not receive a PRV.

Under current law, as amended by the Consolidated Appropriations

Act, 2026, the PRV Program is authorized through September 30, 2029.

The FDA may not award PRVs under this program after that date.

for a PRV generally requires both rare pediatric disease designation and approval of a marketing application for the designated rare pediatric

Even if OST-HER2 receives rare pediatric disease designation and is ultimately approved, we may not receive a PRV if the BLA

is not approved in time to meet statutory requirements or if the PRV Program is subsequently modified or allowed to expire.

even if we are eligible for and obtain a PRV, there can be no assurance that we will be able to realize significant value from the voucher,

as the market for PRVs and their perceived value may vary over time and may be affected by changes in regulatory policies, business conditions

or the supply of available PRVs.

Even if we receive regulatory approval for

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These requirements include submissions of safety and other post-marketing information and reports, registration,

as well as continued compliance with cGMPs and Good Clinical Practices, or GCPs, for any clinical trials that we conduct post-approval.

as well as continued compliance with cGMPs and GCPs for any clinical trials that we conduct post-approval.

Any regulatory approvals that we receive for our current or future product candidates may also be subject to limitations on the approved

4 unchanged sentences

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

● restrictions on the marketing or manufacturing of the drug, withdrawal of the drug from the market, or

drug recalls;

● fines, warning or other letters or holds on clinical trials;

● refusal by the FDA to approve pending applications or supplements to approved applications filed by us,

or suspension or revocation of drug license approvals;

● drug seizure or detention, or refusal to permit the import or export of drugs;

● injunctions or the imposition of civil or criminal penalties.

● restrictions on the marketing

or manufacturing of the drug, withdrawal of the drug from the market, or drug recalls;

● fines, warning or other letters

or holds on clinical trials;

● refusal by the FDA to approve

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

● drug seizure or detention, or

refusal to permit the import or export of drugs;

● injunctions or the imposition

of civil or criminal penalties.

The FDA’s policies may

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of our current or future product candidates may not be replicated in subsequent preclinical studies or clinical trial results.

our later-stage clinical trials could differ in significant ways from our ongoing Phase IIb clinical trial of OST-HER2, which

could cause the outcome of these later-stage trials to differ from our earlier-stage clinical trials.

For example, these differences may

include changes to inclusion and exclusion criteria, final dosage formulation, efficacy endpoints and statistical design.

our later-stage clinical trials could differ in significant ways from our Phase IIb clinical trial of OST-HER2, which could

cause the outcome of these later-stage trials to differ from our earlier-stage clinical trials.

For example, these differences may include

changes to inclusion and exclusion criteria, final dosage formulation, efficacy endpoints and statistical design.

Many companies in the pharmaceutical

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to additional risks and uncertainties, including:

● differing regulatory requirements in foreign countries, which may cause obtaining regulatory approvals

outside of the United States to take longer and be more costly than obtaining approval in the United States;

● the burden of complying with complex and changing foreign regulatory, tax, accounting and legal requirements;

● different medical practices and customs in foreign countries affecting acceptance in the marketplace;

● differing regulatory requirements

in foreign countries, which may cause obtaining regulatory approvals outside of the United States to take longer and be more

costly than obtaining approval in the United States;

● the burden of complying with

complex and changing foreign regulatory, tax, accounting and legal requirements;

● different medical practices

and customs in foreign countries affecting acceptance in the marketplace;

● import or export licensing requirements;

● reduced protection of intellectual property rights and the existence of additional potentially relevant

third-party intellectual property rights;

● economic weakness, including inflation, or political instability in particular foreign economies and markets;

● compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;

● foreign currency fluctuations, which could result in increased operating expenses and reduced revenue,

and other obligations incident to doing business in another country;

● workforce uncertainty in countries where labor unrest is more common than in the United States;

● potential liability under the Foreign Corrupt Practices Act of 1977 or comparable foreign regulations;

● production shortages resulting from any events affecting raw material supply or manufacturing capabilities

● business interruptions resulting from geopolitical actions, including war and terrorism.

● reduced protection of intellectual

property rights and the existence of additional potentially relevant third-party intellectual property rights;

● economic weakness, including

inflation, or political instability in particular foreign economies and markets;

● compliance with tax, employment,

immigration and labor laws for employees living or traveling abroad;

● foreign currency fluctuations,

which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country;

● workforce uncertainty in countries

where labor unrest is more common than in the United States;

● potential liability under the

Foreign Corrupt Practices Act of 1977 or comparable foreign regulations;

● production shortages resulting

from any events affecting raw material supply or manufacturing capabilities abroad;

● business interruptions resulting

from geopolitical actions, including war and terrorism.

Foreign sales of our current

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Because we have limited financial

and management resources, we focus on a limited number of research programs and product candidates and are currently focused on our core

programs, including our lead core product candidate OST-HER2 for the treatment of Osteosarcoma and our other core product candidate OST-tADC for

the treatment of Osteosarcoma.

As a result, we may forego or delay pursuit of opportunities with other current or future product 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 drugs or profitable market opportunities.

Our spending on current and future research and development

programs and current or future product candidates for specific indications may not yield any commercially viable drugs.

If we do not accurately

evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product

candidate through future 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 product candidate.

and management resources, we focus on a limited number of research programs and product candidates and are currently focused on our lead

core product candidate OST-HER2 and our other core product candidate OST-tADC, both targeting the treatment of Osteosarcoma.

As a result, we may forego or delay pursuit of opportunities with other current or future product 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 drugs or profitable market opportunities.

Our spending on current and future research and development programs and current

or future product candidates for specific indications may not yield any commercially viable drugs.

If we do not accurately evaluate the

commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate

through future 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 product candidate.

If any of these events occur,

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prove to be unsuccessful.

In light of the larger population of patients

with Osteosarcoma who reside in foreign countries, our ability to generate meaningful revenues in those jurisdictions may be limited due

to the strict price controls and reimbursement limitations imposed by governments outside of the United States.

There is additionally

a remote possibility that price controls may be enacted in the United States.

Although a larger number of Osteosarcoma

patients reside outside the United States, our ability to generate meaningful revenues in those jurisdictions may be limited due to pricing

controls, reimbursement limitations, and other market access challenges.

The incidence of new cases

of Osteosarcoma is approximately 1,000 individuals in the United States annually and approximately 20,000 individuals globally.

In some countries, particularly in the European Union, the pricing of prescription pharmaceuticals is subject to governmental control.

In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval

To obtain coverage and reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial

that compares the cost-effectiveness of our product candidate to other available therapies.

In addition, many countries outside the United States have

limited government support programs that provide for reimbursement of drugs such as are product candidates, with an emphasis on private

payors for access to commercial products.

If reimbursement of our product candidates is unavailable or limited in scope or amount, or

if pricing is set at unsatisfactory levels, our business could be harmed, possibly materially, based, in part, on the larger population

of patients with Osteosarcoma who reside in foreign countries.

In parts of Africa and certain countries in the Middle East, the lack of

healthcare infrastructure to help adequately diagnose and treat patients may limit our business potential in those otherwise viable markets.

Finally, there is a remote possibility that price controls may be enacted in the United States.

of Osteosarcoma is approximately 1,000 individuals annually in the United States and approximately 20,000 globally.

Although the global

patient population is larger, our ability to generate revenues outside the United States may be limited by pricing regulations, reimbursement

restrictions, and market access barriers.

In many countries, particularly in the European Union and other developed markets, the pricing

of prescription pharmaceuticals is subject to governmental control, and pricing and reimbursement approvals may be required prior to or

following marketing authorization.

Pricing negotiations with governmental authorities can be lengthy and may delay the commercial launch

of a product candidate.

In some jurisdictions, obtaining reimbursement or pricing approval may require the submission of health economic

data or the conduct of additional clinical studies to demonstrate cost-effectiveness relative to existing therapies.

If reimbursement

for our product candidates is unavailable, limited in scope, or subject to significant restrictions, or if pricing is set at unsatisfactory

levels, our ability to generate revenues in those markets may be materially adversely affected.

In addition, in certain regions, including

parts of Africa and the Middle East, limited healthcare infrastructure and diagnostic capabilities may constrain our ability to identify

and treat patients, thereby limiting commercial opportunities.

In the United States, there have been significant efforts to control drug

For example, the Inflation Reduction Act of 2022 introduced measures that allow the federal government to negotiate prices for

certain drugs under Medicare and impose rebates tied to inflation.

These and other pricing reforms may reduce the prices we are able to

charge for any approved products and adversely affect our revenues.

Risks Related to Commercialization

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if approved, will depend on a number of factors, including, among others:

● the efficacy of our current or future product candidates as demonstrated in clinical trials, and, if required

by any applicable regulatory authority in connection with the approval for the applicable indications, to provide patients with incremental

health benefits, as compared with other available medicines;

● limitations or warnings contained in the labeling approved for our current or future product candidates

by the FDA or other applicable regulatory authorities;

● the clinical indications for which our current or future product candidates are approved;

● availability of alternative treatments already approved or expected to be commercially launched in the

● the potential and perceived advantages of our current or future product candidates over current treatment

options or alternative treatments, including future alternative treatments;

● the willingness of the target patient population to try new therapies or treatment methods and of physicians

to prescribe these therapies or methods;

● the need to dose such product candidates in combination with other therapeutic agents, and related costs;

● the strength of marketing and distribution support and timing of market introduction of competitive products;

● the efficacy of our current

or future product candidates as demonstrated in clinical trials, and, if required by any applicable regulatory authority in connection

with the approval for the applicable indications, to provide patients with incremental health benefits, as compared with other available

● limitations or warnings contained

in the labeling approved for our current or future product candidates by the FDA or other applicable regulatory authorities;

● the clinical indications for

which our current or future product candidates are approved;

● availability of alternative

treatments already approved or expected to be commercially launched in the near future;

● the potential and perceived

advantages of our current or future product candidates over current treatment options or alternative treatments, including future alternative

● the willingness of the target

patient population to try new therapies or treatment methods and of physicians to prescribe these therapies or methods;

● the need to dose such product

candidates in combination with other therapeutic agents, and related costs;

● the strength of marketing and

distribution support and timing of market introduction of competitive products;

● pricing and cost effectiveness;

● the effectiveness of our sales and marketing strategies;

● our ability to increase awareness of our current or future product candidates;

● our ability to obtain sufficient third-party coverage and reimbursement, including from federal healthcare

programs such as Medicare and Medicaid;

● the ability or willingness of patients to pay out-of-pocket in the absence of third-party coverage.

● the effectiveness of our sales

and marketing strategies;

● our ability to increase awareness

of our current or future product candidates;

● our ability to obtain sufficient

third-party coverage and reimbursement, including from federal healthcare programs such as Medicare and Medicaid;

● the ability or willingness of

patients to pay out-of-pocket in the absence of third-party coverage.

If our current or future product

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The development and commercialization

of new drugs is highly competitive.

We face competition with respect to our current product candidates and will face competition with

respect to any product candidates that we may seek to develop or commercialize in the future from major pharmaceutical companies, specialty

pharmaceutical companies and biotechnology companies worldwide.

There are a number of large pharmaceutical and biotechnology companies

that currently market and sell drugs or are pursuing the development of therapies for rare diseases and cancers, including Osteosarcoma.

Some of these competitive drugs and therapies are based on scientific approaches that are similar to our approach, and others are based

on entirely different approaches.

Potential competitors also include academic institutions, government agencies and other public and private

research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development,

manufacturing and commercialization.

Specifically, there are a

large number of companies developing or marketing treatments for rare diseases and cancers, including many major pharmaceutical and biotechnology

If OST-HER2 receives marketing approval for the treatment of Osteosarcoma, it may face competition from other product candidates

in development for these indications, including product candidates in development from AstraZeneca, Y-mAbs Therapeutics and MD Anderson

Cancer Center, among others.

of new drugs is highly competitive and constantly evolving.

We face competition with respect to our current product candidates and will

face competition with respect to any product candidates that we may seek to develop or commercialize in the future from major pharmaceutical

companies, specialty pharmaceutical companies, biotechnology companies, academic institutions, government agencies and other public and

private research organizations worldwide.

Some of these competitors currently market or are actively developing therapies for rare diseases

and cancers, including Osteosarcoma, and some programs may be based on scientific approaches that are similar to ours, while others may

employ entirely different approaches.

Specifically, if OST-HER2

receives marketing approval for the treatment of Osteosarcoma, it may face competition from other product candidates in development for

these indications, including programs from AstraZeneca, Y-mAbs Therapeutics, MD Anderson Cancer Center and others.

The competitive landscape

competitors’ programs may advance or be discontinued, and new entrants may emerge, which could materially affect our

ability to capture or maintain market share.

Many of the companies against

which we are competing or against which we may compete in the future have significantly greater financial resources and expertise in research

and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and reimbursement and

marketing approved drugs than we do.

Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more

resources being concentrated among a smaller number of our competitors.

Smaller or early-stage companies may also prove to be significant

competitors, particularly through collaborative arrangements with large and established companies.

These competitors also compete with

us in recruiting and retaining qualified scientific, sales, marketing and management personnel and establishing clinical trial sites and

patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.

which we are competing or may compete in the future have significantly greater financial, technical, regulatory and commercial resources

than we do, including greater expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining

regulatory approvals and reimbursement, and marketing approved drugs.

Mergers and acquisitions in the pharmaceutical and biotechnology

industries may result in further consolidation and concentration of resources among a smaller number of competitors.

Smaller or early-stage

companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

These competitors may also compete with us in recruiting and retaining qualified scientific, sales, marketing, and management personnel,

establishing clinical trial sites and enrolling patients in clinical trials, as well as in acquiring technologies complementary to, or

necessary for, our programs.

Our commercial opportunity

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

● decreased demand for any current or future product candidates that we may develop;

● injury to our reputation and significant negative media attention;

● withdrawal of clinical trial participants;

● significant costs and resources to defend the related litigation;

● substantial monetary awards to trial participants or patients;

● the inability to commercialize any current or future product candidates that we may develop.

● decreased demand for any current

or future product candidates that we may develop;

● injury to our reputation and

significant negative media attention;

● withdrawal of clinical trial

participants;

● significant costs and resources

to defend the related litigation;

● substantial monetary awards

to trial participants or patients;

● the inability to commercialize

any current or future product candidates that we may develop.

Although we maintain product

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Some countries require approval of

the sale price of a drug before it can be marketed.

In many countries, the pricing review period begins after marketing approval is granted.

In some foreign markets, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval

As a result, we might obtain marketing approval for a product candidate in a particular country, but then be subject to price

regulations that delay our commercial launch of the product candidate, possibly for lengthy time periods, and negatively impact the revenues

we are able to generate from the sale of the product candidate in that country.

Adverse pricing limitations may hinder our ability to

recoup our investment in one or more current or future product candidates, even if our current or future product candidates obtain marketing

Our ability to commercialize

any current or future product candidates successfully also will depend in part on the extent to which coverage and reimbursement for these

current or future product candidates and related treatments will be available from government authorities, private health insurers and

other organizations.

Government authorities and other third-party payors, such as private health insurers and health maintenance organizations,

decide which medications they will pay for (i.e., cover) and establish reimbursement levels.

Factors payors consider in determining reimbursement

are based on whether the product is:

● a covered benefit under its health plan;

● safe, effective and medically necessary;

● appropriate for the specific patient;

● cost-effective;

● neither experimental nor investigational.

the sale price of a drug before it can be marketed, and in many countries, the pricing review period begins after marketing approval is

In certain markets, including the European Union, prescription pharmaceutical pricing remains subject to continuing governmental

control even after initial approval.

As a result, we may obtain marketing approval for a product candidate in a particular country but

be subject to price regulations that delay commercial launch or limit the revenues we are able to generate from the sale of the product

candidate in that country.

Adverse pricing limitations may hinder our ability to recoup our investment in one or more current or future

product candidates, even if approved.

In the United States, there

have been significant legislative and regulatory efforts to control drug pricing.

For example, the Inflation Reduction Act of 2022 includes

provisions that permit the U.S.

Department of Health and Human Services, through the CMS,

to negotiate prices for certain high-expenditure drugs covered under Medicare, impose inflation-based rebates, and redesign certain aspects

of the Medicare Part D program.

While the full implementation and long-term impact of these measures are still evolving, they may reduce

the prices we are able to charge for any approved products and adversely affect our revenues and profitability.

Additional federal or

state healthcare reform measures may also be adopted in the future that could further impact pricing and reimbursement.

Our ability to successfully

commercialize any current or future product candidates will depend in part on the extent to which coverage and reimbursement for these

product candidates and related treatments are available from government authorities, private health insurers, and other organizations.

Government authorities and other third-party payors decide which medications they will cover and establish reimbursement levels.

payors consider in determining reimbursement include whether the product is a covered benefit, safe and effective, medically necessary,

appropriate for the patient, and cost-effective, and whether it is considered experimental or investigational.

A primary trend in the U.S.

industry and elsewhere is cost containment.

Government authorities and other third-party payors have attempted to control costs by limiting

coverage and the amount of reimbursement for particular drugs.

Increasingly, third-party payors are requiring that drug companies provide

them with predetermined discounts from list prices and are challenging the prices charged for drugs.

We cannot be sure that coverage will

be available for any product candidate that we commercialize and, if coverage is available, the level of reimbursement.

Reimbursement

may impact the demand for, or the price of, any product candidate for which we obtain marketing approval.

If reimbursement is not available

or is available only to limited levels, we may not be able to successfully commercialize any product candidate for which we obtain marketing

healthcare industry and elsewhere is cost containment.

Government authorities and third-party payors have sought to control costs by limiting

coverage, setting reimbursement levels, requiring rebates and discounts, and challenging the prices charged for drugs.

We cannot be sure

that coverage will be available for any product candidate that we commercialize or, if coverage is available, the level of reimbursement.

Reimbursement levels may impact the demand for, or the price of, any product candidate for which we obtain marketing approval.

There may be significant delays

in obtaining reimbursement for newly approved drugs, and coverage may be more limited than the purposes for which the drug is approved

by the FDA or similar regulatory authorities outside the United States.

Moreover, eligibility for reimbursement does not imply

that any drug will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale and

distribution.

Interim reimbursement levels for new drugs, if applicable, may also not be sufficient to cover our costs and may not be

made permanent.

Reimbursement rates may vary according to the use of the drug and the clinical setting in which it is used, may be based

on reimbursement levels already set for lower cost drugs and may be incorporated into existing payments for other services.

for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future

relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States.

the United States, decisions as to coverage and reimbursement by the Medicare program are typically made by the Centers for Medicare &

Medicaid Services, or CMS, an agency within the U.S.

Department of Health and Human Services, or HHS.

CMS decides whether and

to what extent a new medicine will be covered and reimbursed under Medicare.

Third-party payors often rely upon Medicare coverage policy

and payment limitations in setting their own reimbursement policies.

Our inability to promptly obtain coverage and profitable payment

rates from both government-funded and private payors for any approved drugs that we develop could have a material adverse effect on our

operating results, our ability to raise capital needed to commercialize drugs and our overall financial condition.

by the FDA or comparable foreign regulatory authorities.

Moreover, eligibility for reimbursement does not imply that any drug will be

paid for in all cases or at a rate that covers our costs, including research, development, manufacturing, and distribution.

Reimbursement

rates may vary based on the use of the drug, the clinical setting, and comparisons to lower-cost therapies, and may be incorporated into

bundled payments for other services.

Net prices for drugs may also be reduced by mandatory discounts or rebates required by government

healthcare programs or private payors.

In the United States, coverage and reimbursement decisions for Medicare are made by CMS, and private

payors often follow Medicare coverage policies and payment limitations in setting their own reimbursement practices.

Our inability to

obtain timely and adequate coverage and reimbursement for any approved products could have a material adverse effect on our business,

financial condition, and results of operations.

Healthcare reform measures may have a material

adverse effect on our business and results of operations.

The United States and

many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the healthcare system that could prevent

or delay marketing approval of our current or future product candidates or any future product candidates, restrict or regulate post-approval

activities and affect our ability to profitably sell a product for which we obtain marketing approval.

Changes in regulations, statutes

or the interpretation of existing regulations could impact our business in the future by requiring, for example:

(i) changes to our

manufacturing arrangements;

(ii) additions or modifications to product labeling;

(iii) the recall or discontinuation of our

or (iv) additional record-keeping requirements.

If any such changes were to be imposed, they could adversely affect the

operation of our business.

Our revenue prospects could

be affected by changes in healthcare spending and policy in the United States and abroad.

The United States and many

foreign jurisdictions have enacted and continue to consider legislative and regulatory changes affecting the healthcare system that could

prevent or delay marketing approval of our current or future product candidates, restrict or regulate post-approval activities, and affect

our ability to profitably commercialize any products for which we obtain marketing approval.

Changes in regulations, statutes, or the

interpretation of existing requirements could require, among other things:

(i) changes to our manufacturing arrangements;

(ii) additions

or modifications to product labeling;

(iii) the recall or discontinuation of products;

or (iv) additional recordkeeping, reporting, or

compliance obligations.

Any such changes could adversely affect our operations and increase our costs.

In the United States, there

have been significant efforts to control healthcare costs and drug pricing.

For example, the Inflation Reduction Act of 2022 includes

provisions that, among other things, allow the U.S.

Department of Health and Human Services to negotiate prices for certain drugs covered

under Medicare, impose inflation-based rebates, and redesign certain aspects of the Medicare Part D program.

The implementation and long-term

effects of these measures are still evolving, but they may reduce the revenues we are able to generate from any approved products.

addition, other federal and state legislative and regulatory proposals aimed at controlling drug pricing, increasing transparency, or

reforming reimbursement systems have been introduced and may be enacted in the future.

Our revenue prospects may

also be affected by changes in healthcare spending and policy in the United States and abroad.

We operate in a highly regulated industry,

and new laws, regulations, or judicial decisions, or new interpretations of existing laws, regulations, or decisions, related to healthcare

availability, the method of delivery or payment for healthcare products and services could negatively impact our business, operations

and financial condition.

We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation

or administrative action in the United States or any other jurisdiction.

It is possible that additional governmental action is taken

to address the Covid-19 pandemic.

If we or any third parties we may engage are slow or unable to adapt to changes in existing

requirements or the adoption of new requirements or policies, or if we or such third parties are not able to maintain regulatory compliance,

our product candidates may lose any regulatory approval that may have been obtained and we may not achieve or sustain profitability.

availability, pricing, coverage, or reimbursement may negatively impact our business, financial condition, and results of operations.

We cannot predict the likelihood, nature, or extent of future healthcare reform measures or their potential impact on our business.

we or any third parties we engage are unable to adapt to changes in existing requirements or the adoption of new requirements or policies,

or if we or such third parties fail to maintain regulatory compliance, we may lose any regulatory approvals that we may obtain and may

not achieve or sustain profitability.

If, in the future, we are unable to establish

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efforts to commercialize our current or future product candidates on our own include:

● our inability to recruit and retain adequate numbers of effective sales and marketing personnel;

● the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians

to prescribe any future drugs;

● the lack of complementary drugs to be offered by sales personnel, which may put us at a competitive disadvantage

relative to companies with more extensive product lines;

● unforeseen costs and expenses associated with creating an independent sales and marketing organization.

● our inability to recruit and

retain adequate numbers of effective sales and marketing personnel;

● the inability of sales personnel

to obtain access to physicians or persuade adequate numbers of physicians to prescribe any future drugs;

● the lack of complementary drugs

to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines;

● unforeseen costs and expenses

associated with creating an independent sales and marketing organization.

If we enter into arrangements

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and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could

expose us to criminal sanctions, civil penalties, exclusion from government healthcare programs, contractual damages, reputational harm

and diminished profits and future earnings.

expose us to significant penalties and adversely affect our business.

Although we do not currently

have any drugs on the market, if we begin commercializing our current or future product candidates, we will be subject to additional healthcare

statutory and regulatory requirements and enforcement by the federal government and the states and foreign governments in which we conduct

our business.

Healthcare providers, including physicians, play a primary role in the recommendation and prescription of any current or

future product candidates for which we obtain marketing approval.

Our future arrangements with healthcare providers, as well as third-party

payors and customers, will expose us to broadly applicable fraud and abuse and other healthcare laws and regulations will constrain the

business and/or financial arrangements and relationships through which we market, sell and distribute our current or future product candidates

for which we obtain marketing approval.

Restrictions under applicable federal and state healthcare laws and regulations, include the following:

● the federal Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully

soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the

referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federal

and state healthcare programs such as Medicare, Medicaid and TRICARE.

The Anti-Kickback Statute has been interpreted to apply to

arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers, and formulary managers on the other hand.

The term remuneration has been interpreted broadly to include anything of value.

A person or entity does not need to have actual knowledge

of the statute or specific intent to violate it in order to have committed a violation;

● the federal False Claims Act imposes criminal and civil penalties, including through civil whistleblower

or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims

for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal

In addition, manufacturers can be held liable under the False Claims Act even when they do not submit claims directly to government

payors if they are deemed to “cause” the submission of false or fraudulent claims.

False Claims Act liability is potentially

significant in the healthcare industry because the statute provides for treble damages and mandatory per claim penalties.

Government enforcement

agencies and private whistleblowers have investigated pharmaceutical companies for or asserted liability under the False Claims Act for

a variety of alleged promotional and marketing activities, such as providing free products to customers with the expectation that the

customers would bill federal programs for the products;

providing consulting fees and other benefits to physicians to induce them to prescribe

engaging in promotion for “off-label” uses;

and submitting inflated best price information to the Medicaid

Drug Rebate Program.

In addition, the government may assert that a claim including items and services resulting from a violation of the

federal Anti-Kickback Statute constitutes a false of fraudulent claim for purposes of the False Claims Act;

● the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal

and civil liability for executing a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing

or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits,

items or services;

similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute

or specific intent to violate it in order to have committed a violation;

● the federal physician payment transparency requirements, sometimes referred to as the “Sunshine

Act” under the Affordable Care Act (ACA) require manufacturers of drugs, devices, biologics and medical supplies that are reimbursable

under Medicare, Medicaid, or the Children’s Health Insurance Program to report to the Department of Health and Human Services information

related transfers of value to certain covered recipients (defined to include doctors, dentists, optometrists, podiatrists and chiropractors,

as well as physicians assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists and certified nurse-midwives)

and their immediate family members, and teaching hospitals.

Effective January 1, 2022, these reporting obligations will extend to

include transfers of value made to certain non-physician providers such as physician assistants and nurse practitioners;

● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009,

or HITECH, and its implementing regulations, which also imposes obligations on certain covered entity healthcare providers, health plans,

and healthcare clearinghouses as well as their business associates that perform certain services involving the use or disclosure of individually

identifiable health information, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission

of individually identifiable health information.

HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil

and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions

for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with

pursuing federal civil actions;

● analogous state laws and regulations, such as state anti-kickback and false claims laws that may apply

to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party

payors, including private insurers;

and some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s

voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government in addition to requiring drug

manufacturers to report information related to payments to physicians and other health care providers or marketing expenditures, and state

laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant

ways and often are not preempted by HIPAA, thus complicating compliance efforts.

Ensuring that our future business

have any products on the market, if we begin commercializing our current or future product candidates, we will become subject to additional

healthcare statutory and regulatory requirements and enforcement by federal, state, and foreign governmental authorities.

Healthcare providers,

including physicians, play a primary role in the recommendation and prescription of any products for which we obtain marketing approval.

Our arrangements with healthcare providers, third-party payors, and customers will expose us to broadly applicable fraud and abuse and

other healthcare laws and regulations that constrain the business and financial relationships through which we market, sell, and distribute

our products.

Restrictions under applicable federal and state healthcare laws and regulations include, among others, the following:

● the federal Anti-Kickback Statute

prohibits, among other things, knowingly and willfully soliciting, offering, receiving, or providing remuneration, directly or indirectly,

in cash or in kind, to induce or reward referrals or the purchase, order, or recommendation of any good or service reimbursable under

federal or state healthcare programs such as Medicare, Medicaid, and TRICARE.

The term “remuneration” has been interpreted

broadly to include anything of value, and a person or entity need not have actual knowledge of the statute or specific intent to violate

it to be found in violation;

● the federal False Claims Act

imposes civil and criminal penalties, including through whistleblower (qui tam) actions, against individuals or entities for knowingly

presenting, or causing to be presented, false or fraudulent claims for payment to the federal government or for making false statements

to avoid an obligation to pay money to the government.

Manufacturers may be held liable even when they do not submit claims directly

if they are deemed to “cause” the submission of false claims.

The statute provides for treble damages and significant per-claim

penalties, and has been used to pursue a wide range of pharmaceutical company activities, including alleged improper promotional practices,

off-label promotion, and pricing-related conduct;

● HIPPA imposes criminal and civil liability for executing schemes to defraud

healthcare benefit programs or making false statements in connection with the delivery of or payment for healthcare benefits, items,

● federal physician payment transparency

requirements (commonly referred to as the Open Payments program) require manufacturers of drugs, biologics, and medical supplies reimbursable

under federal healthcare programs to report annually to the U.S.

Department of Health and Human Services information regarding payments

and other transfers of value to physicians, certain non-physician healthcare providers (such as physician assistants and nurse practitioners),

and teaching hospitals, as well as ownership and investment interests held by such individuals;

● HIPAA, as amended by HITECH, and its implementing regulations, impose obligations

on covered entities and their business associates with respect to safeguarding the privacy, security, and transmission of individually

identifiable health information, including breach notification requirements and expanded enforcement authority;

● analogous state and foreign

laws and regulations, including state anti-kickback and false claims laws, transparency laws, and data privacy and security laws, many

of which differ from federal requirements and may not be preempted, thereby complicating compliance efforts.

Ensuring that our business

arrangements with third parties comply with applicable healthcare laws and regulations could involve substantial costs.

It is possible

that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations or

case law involving applicable fraud and abuse or other healthcare laws and regulations.

If our operations were to be found to be in violation

of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and

administrative penalties, damages, fines, exclusion from government funded healthcare programs, such as Medicare and Medicaid, and the

curtailment or restructuring of our operations.

If any of the physicians or other providers or entities with whom we expect to do business

is found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions

from government funded healthcare programs.

We may face potential liability if we obtain

identifiable patient health information from clinical trials sponsored by us.

Most healthcare providers,

including certain research institutions from which we may obtain patient health information, are subject to privacy and security regulations

promulgated under HIPAA, as amended by the HITECH.

We are not currently classified as a covered entity or business associate under

HIPAA and thus are not directly subject to its requirements or penalties.

However, any person may be prosecuted under HIPAA’s criminal

provisions either directly or under aiding-and-abetting or conspiracy principles.

Consequently, depending on the facts and circumstances,

we could face substantial criminal penalties if we knowingly receive individually identifiable health information from a HIPAA-covered

healthcare provider or research institution that has not satisfied HIPAA’s requirements for disclosure of individually identifiable

health information.

In addition, in the future, we may maintain sensitive personally identifiable information, including health information,

that we receive throughout the clinical trial process, in the course of our research collaborations, and directly from individuals (or

their healthcare providers) who may enroll in patient assistance programs if we choose to implement such programs.

As such, we may be

subject to state laws requiring notification of affected individuals and state regulators in the event of a breach of personal information,

which is a broader class of information than the health information protected by HIPAA.

Further, certain health privacy

laws, data breach notification laws, consumer protection laws and genetic testing laws may apply directly to our operations and/or those

of our collaborators and may impose restrictions on our collection, use and dissemination of individuals’ health information.

about whom we or our collaborators may obtain health information, as well as the providers who may share this information with us, may

have statutory or contractual rights that limit our ability to use and disclose the information.

We may be required to expend significant

capital and other resources to ensure ongoing compliance with applicable privacy and data security laws.

Claims that we have violated

individuals’ privacy rights 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.

If we or third-party CMOs,

CROs or other contractors or consultants fail to comply with applicable federal, state/provincial or local regulatory requirements, we

could be subject to a range of regulatory actions that could affect our or our contractors’ ability to develop and commercialize

our therapeutic candidates and could harm or prevent sales of any affected therapeutics that we are able to commercialize, or could substantially

increase the costs and expenses of developing, commercializing and marketing our therapeutics.

Any threatened or actual government enforcement

action could also generate adverse publicity and require that we devote substantial resources that could otherwise be used in other aspects

of our business.

Increasing use of social media could give rise to liability, breaches of data security or reputational damage.

The regulatory

and enforcement environment in the healthcare industry remains active, and governmental authorities have increased their focus on compliance

with these laws.

It is possible that governmental authorities will conclude that our business practices do not comply with current or

future statutes, regulations, or case law.

If our operations are found to be in violation of any of these laws or any other applicable

regulations, we may be subject to significant civil, criminal, and administrative penalties, including damages, fines, exclusion from

government-funded healthcare programs such as Medicare and Medicaid, and the curtailment or restructuring of our operations.

if any of the physicians or other providers or entities with whom we do business are found to be non-compliant, they may be subject to

sanctions, which could also adversely affect our business.

We may face potential liability and increased

regulatory scrutiny if we obtain, use or fail to adequately protect identifiable patient health information in connection with our clinical

trials and operations.

In the course of our clinical

development activities, we may obtain or have access to sensitive personally identifiable information, including protected health information,

from clinical trial participants, healthcare providers, research institutions, contract research organizations, and other third parties.

While most healthcare providers and research institutions are subject to privacy and security regulations under HIPPA, as amended by

HITECH, we may, depending on the nature of our relationships, be deemed a business associate or otherwise contractually subject to certain

HIPAA obligations.

Even where we are not directly subject to HIPAA, we may be subject to criminal liability under HIPAA in certain circumstances,

including if we knowingly obtain or misuse individually identifiable health information in a manner that violates applicable law.

In addition, we are or may become subject to a variety of other federal,

state, and foreign privacy and data protection laws and regulations that govern the collection, use, storage, disclosure, and protection

of personal information.

These include, for example, U.S.

state privacy laws such as the CCPA, as amended by the CPRA, and similar laws

in other jurisdictions, as well as international data protection regulations such as the European Union’s GDPR, to the extent we

conduct clinical trials or otherwise process personal data outside the United States.

These laws are complex, evolving, and may impose

significant compliance obligations, including requirements related to consent, data minimization, cross-border data transfers, breach

notification, and individual rights.

We and our collaborators,

including CROs, CMOs, and other third-party service providers, may also be subject to data breach notification laws and consumer protection

laws that require us to notify affected individuals, regulatory authorities, and others in the event of a data breach involving personal

Failure to comply with these requirements could result in significant penalties, litigation, and reputational harm.

an increasing risk of cybersecurity incidents and data breaches, including those resulting from unauthorized access, system failures,

or cyberattacks.

Any such incident could compromise the confidentiality, integrity, or availability of our data, including clinical trial

data, disrupt our operations, delay our development programs, and expose us to regulatory enforcement actions and liability.

compliance with applicable privacy, data protection, and cybersecurity laws and regulations may require us to expend substantial resources.

Claims that we or our third-party partners have violated individuals’ privacy rights or failed to adequately protect personal information,

even if unfounded, could be costly to defend and could result in adverse publicity, which could materially harm our business, financial

condition, and results of operations.

If we fail to comply with environmental,

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We focus our research and

product development on treatments for Osteosarcoma.

The incidence of new cases of Osteosarcoma is approximately 1,000 individuals in the

United States annually and approximately 20,000 individuals globally.

Given the smaller number of patients who have the diseases that

we are targeting, it is critical to our ability to grow and become profitable that we continue to successfully identify patients with

these rare diseases.

Our projections of both the number of people who have these diseases, are based on our beliefs and estimates.

estimates have been derived from a variety of sources, including the scientific literature, surveys of clinics, patient foundations or

market research that we conducted, and may prove to be incorrect or contain errors.

New studies may change the estimated incidence or

prevalence of these diseases.

The number of patients may turn out to be lower than expected.

The effort to identify patients with diseases

we seek to treat is in early stages, and we cannot accurately predict the number of patients for whom treatment might be possible.

even if we obtain significant market share for OST-HER2 and any of our other current or future product candidates, because the

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

Our target patient populations

are relatively small, and there are currently limited standard of care treatments directed at Osteosarcoma.

As a result, the pricing and

reimbursement of OST-HER2 and any other product candidates we may develop, if approved, is uncertain, but must be adequate to

support commercial infrastructure.

If we are unable to obtain adequate levels of reimbursement, our ability to successfully market and

sell OST-HER2 and any of our other current or future product candidates will be adversely affected.

product development on treatments for osteosarcoma, a rare disease.

The incidence of new cases of Osteosarcoma is approximately 1,000

individuals in the United States annually and approximately 20,000 individuals globally.

Given the limited number of patients with the

diseases we are targeting, our ability to achieve meaningful revenue will depend on our ability to accurately identify eligible patients,

successfully commercialize our product candidates, and capture a significant share of the addressable market.

Our estimates of the number

of patients who may be eligible for treatment with OST-HER2 or any of our other current or future product candidates are based on a variety

of sources, including published literature, clinical experience, and internal analyses, and may prove to be inaccurate.

Although we have

completed enrollment in our Phase IIb clinical trial for OST-HER2, which enrolled a limited number of patients consistent with the rare

nature of the disease, our understanding of the addressable patient population remains subject to significant uncertainty.

or real-world data may change the estimated incidence, prevalence, or treatable population for osteosarcoma, and the number of patients

ultimately eligible for our therapies may be lower than expected.

In addition, identifying, diagnosing, and referring patients with osteosarcoma,

particularly in earlier stages or in certain geographic regions, can be challenging, and we may not be successful in reaching all patients

who could potentially benefit from our therapies.

Even if we obtain regulatory approval and achieve meaningful market penetration, the

small size of the target patient population may limit our ability to generate sufficient revenue to achieve or sustain profitability.

Furthermore, because there

are limited standard-of-care treatments specifically directed at Osteosarcoma, the pricing and reimbursement landscape for OST-HER2 and

any other product candidates we may develop is uncertain.

While therapies for rare diseases may in some cases support premium pricing,

there can be significant variability in reimbursement decisions by governmental authorities and third-party payors.

If we are unable to

obtain adequate reimbursement at levels sufficient to support our anticipated commercial infrastructure, our ability to successfully market

and sell OST-HER2 and any of our other current or future product candidates would be adversely affected.

Risks Related to Our Dependence on Third Parties

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As a result, many important aspects of our clinical development,

including their conduct, timing and response to the ongoing Covid-19 pandemic, will be outside of our direct control.

on third parties to conduct future clinical trials will also result in less direct control over the management of data developed through

clinical trials than would be the case if we were relying entirely upon our own staff.

Communicating with outside parties can also be

challenging, potentially leading to mistakes as well as difficulties in coordinating activities.

including their conduct and timing, will be outside of our direct control.

Our reliance on third parties to conduct future clinical trials

will also result in less direct control over the management of data developed through clinical trials than would be the case if we were

relying entirely upon our own staff.

Communicating with outside parties can also be challenging, potentially leading to mistakes as well

as difficulties in coordinating activities.

These factors may materially

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in the future, and we may not realize the benefits of such collaborations, alliances, acquisitions or licensing arrangements.

We have entered into licensing

arrangements with Advaxis, Inc.

(now Ayala Pharmaceuticals, Inc.) and BlinkBio, Inc.

and a Research Service Agreement with George Clinical,

Inc., and may in the future form or seek strategic alliances or acquisitions, create joint ventures, or enter into additional collaboration

and licensing arrangements with third parties that we believe will complement or augment our development and commercialization efforts

with respect to our current product candidates and any future product candidates that we may develop.

We are party to licensing

arrangements with the Trustees of the University of Pennsylvania and BlinkBio, Inc., and may in the future form or seek strategic alliances

or acquisitions, create joint ventures, or enter into additional collaboration and licensing arrangements with third parties that we believe

will complement or augment our development and commercialization efforts with respect to our current product candidates and any future

product candidates that we may develop.

Going forward, we are seeking

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including OST-tADC.

Any of these relationships may require us to incur non-recurring and other charges, increase our

near and long-term expenditures, issue securities that dilute our existing stockholders or disrupt our management and business.

In addition, we face significant

competition in seeking appropriate strategic partners and the negotiation process is time-consuming and complex.

We may not be successful

in our efforts to establish a strategic partnership or acquisition or other alternative arrangements for our current or future non-core

product candidates because they may be deemed to be at too early of a stage of development for collaborative effort and third parties

may not view our current or future product candidates as having the requisite potential to demonstrate safety, potency, purity and efficacy

and obtain marketing approval.

As a result, we may not be

able to realize the benefit of our existing collaboration and licensing arrangements or any future strategic partnerships or acquisitions,

license arrangements we may enter, if we are unable to successfully integrate them with our existing operations and company culture, which

could delay our timelines or otherwise adversely affect our business.

We also cannot be certain that, following a strategic transaction,

license, collaboration or other business development partnership, we will achieve the revenue or specific net income that justifies such

Any delays in entering into new collaborations or strategic partnership agreements related to our current or future product

candidates could delay the development and commercialization of our current or future product candidates in certain geographies for certain

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

However, identifying appropriate partners is competitive, and the negotiation of these arrangements is complex,

time-consuming, and resource-intensive.

Potential partners may be unwilling to commit to such transactions on acceptable terms, or at

all, particularly if they determine that our product candidates do not have sufficient clinical validation, commercial potential, or likelihood

of regulatory approval.

Even if we are successful in entering into such arrangements, we may not realize the anticipated benefits.

transactions typically involve significant risks, including the potential for loss of control over certain development or commercialization

activities, reliance on third parties to meet development, regulatory and commercialization milestones, disagreements or disputes with

partners, which could delay or terminate development programs, reduced economic returns as a result of profit-sharing, milestone payments

or royalties, and the diversion of management attention and internal resources.

In addition, these transactions

may require us to incur substantial costs, record non-recurring charges, assume contingent liabilities, or issue equity securities that

dilute our existing stockholders.

If we are unable to successfully identify and execute strategic transactions, or if any such transactions

fail to achieve their intended objectives, our ability to advance our product candidates, including OST-HER2 and our other programs, may

be adversely affected, and our business, financial condition and results of operations could be materially harmed.

As a result, we may not realize

the anticipated benefits of our existing collaboration and licensing arrangements or any future strategic transactions, including partnerships,

acquisitions, or licensing arrangements, particularly if we are unable to effectively integrate such arrangements with our existing operations

and company culture.

Any such failure could delay development timelines, disrupt our business, or otherwise adversely affect our results

of operations.

In addition, we cannot assure that any strategic transaction or collaboration will generate the expected revenues, cost

savings, or other anticipated benefits that justified our entry into such arrangement.

Further, delays in identifying or entering into

new collaboration or strategic partnership agreements with respect to our current or future product candidates may delay or limit the

development and commercialization of such product candidates, including in specific geographies or for particular indications, which could

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

Our manufacturing process needs to comply

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Risks Related to Intellectual Property

If we and those third parties from whom

we in-license patents are unable to obtain and maintain patent and other intellectual property protection for our technology and product

candidates or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and

commercialize technology and drugs similar or identical to ours, and our ability to successfully commercialize our technology and drugs

may be impaired.

If we and the third parties from whom we

in-license intellectual property are unable to obtain, maintain, protect, or enforce patent and other intellectual property rights for

our technology and product candidates, or if the scope of such protection is not sufficiently broad, our competitors could develop and

commercialize similar or identical technologies and products, and our ability to successfully commercialize our product candidates may

The patent position of biotechnology

and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years

been the subject of much litigation.

Our commercial success depends in part on our ability and the ability of those third parties from

whom we in-license patents to obtain and maintain intellectual property protection in the United States and other countries for our

current or future product candidates, including our lead core product candidate OST-HER2, our other core product candidate OST-tADC, our

non-core product candidates, our proprietary compound library and other know-how.

We seek to protect our proprietary and intellectual

property position by, among other methods, in-licensing patents and patent applications in the United States and abroad related to

our proprietary technology, inventions and improvements that are important to the development and implementation of our business.

Although we have agreed to

acquire the HER2 Assets pursuant to the HER2 Purchase Agreement, we do not currently own any issued patents.

We in-license patents and

patent applications related to our lead core product candidate OST-HER2 from Advaxis, Inc.

and our other core product candidate OST-tADC

from BlinkBio, Inc.

The intellectual property licensed from Advaxis, Inc.

includes nine granted U.S.

utility patents and a number

of foreign patents and pending patent applications.

The patents and patent applications if granted are expected to expire between 2030

and 2035, not including any patent term extension.

and pharmaceutical companies is highly uncertain and involves complex legal and factual questions, and has been the subject of extensive

litigation in recent years.

Our commercial success depends in part on our ability, and the ability of our licensors and other partners,

to obtain, maintain, protect, and enforce intellectual property rights in the United States and other jurisdictions for our current and

future product candidates, including OST-HER2, OST-tADC, our non-core programs, and our proprietary technologies and know-how.

We rely on a combination of

owned, co-owned and in-licensed patents and patent applications to protect our intellectual property.

For example, we in-license and co-own

certain intellectual property relating to OST-HER2 from the University of Pennsylvania, and we in-license intellectual property relating

to OST-tADC from BlinkBio, Inc.

The intellectual property we own includes six granted U.S.

utility patents and a number of foreign

patents and pending patent applications.

The patents and patent applications if granted are expected to expire between 2029 and 2038,

not including any patent term extension.

The intellectual property licensed from BlinkBio, Inc.

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The degree of patent protection

we require to successfully commercialize our current or future product candidates may be unavailable or severely limited in some cases

and may not adequately protect our rights or permit us to gain or keep any competitive advantage.

We cannot provide any assurances that

any of the patents that we in-license have, or that any of such pending patent applications that mature into issued patents will include,

claims with a scope sufficient to protect OST-HER2 and OST-tADC or our other current or future product candidates.

if the breadth or strength of protection provided by such patent applications or any patents we may in-license is threatened, it

could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.

Other parties have developed

technologies that may be related or competitive to our own or those covered by our in-licensed patents, and such parties may have filed

or may file patent applications, or may have received or may receive patents, claiming inventions that may overlap or conflict with those

claimed in such patent applications or issued patents, with respect to either the same compounds, methods, formulations or other subject

Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the

United States and other jurisdictions are typically not published until at least 18 months after the earliest priority

date of patent filing, or in some cases not at all.

Therefore, we cannot know with certainty whether the holder of our in-licensed patents

was the first to make the inventions claimed in such patents or pending patent applications.

As a result, the issuance, scope, validity,

enforceability and commercial value of these in-licensed patent rights cannot be predicted with any certainty.

The issuance of a patent is

not conclusive as to its inventorship, scope, validity, or enforceability, and our in-licensed patents or patents we may own in the future

may be challenged in the courts or patent offices in the United States and abroad.

Such challenges may result in loss of patent or

product exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part,

which could limit our ability to stop others from using or commercializing similar or identical technology and product candidates, or

limit the duration of the patent protection of our technology and product candidates.

In addition, given the amount of time required for

the development, testing, and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly

after such candidates are commercialized.

Any impairment of our intellectual property rights, or our failure to protect our intellectual

property rights adequately, could give third parties access to our technology and product candidates and could materially and adversely

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

required to successfully commercialize our product candidates may be unavailable or limited.

We cannot assure that any of the patents

we own or in-license, or any pending patent applications, will issue with claims of sufficient scope to protect our product candidates

or provide a meaningful competitive advantage.

If the scope or strength of our intellectual property protection is reduced or challenged,

it could adversely affect our ability to attract collaborators or commercial partners.

Third parties may have developed

or may develop technologies that compete with ours, and they may have filed or may file patent applications, or may obtain patents, that

overlap with or conflict with our intellectual property.

Because patent applications are typically not published until 18 months after

filing and scientific publications often lag behind discoveries, we cannot be certain that we or our licensors were the first to make

the inventions claimed in our patents or pending applications.

As a result, the validity, enforceability, scope, and commercial value

of our intellectual property cannot be predicted with certainty.

Even if our patents are issued,

they may be challenged, invalidated, narrowed, or held unenforceable in administrative proceedings or litigation in the United States

Such challenges could result in the loss of exclusivity, freedom to operate, or other competitive advantages.

given the time required for clinical development and regulatory review, patent protection for our product candidates may expire before

or shortly after commercialization, thereby limiting our ability to realize the full commercial value of our intellectual property.

failure to obtain, maintain, protect, or enforce our intellectual property rights, or any loss or narrowing of such rights, could allow

third parties to use our technology or develop competing products and could materially adversely affect our business, financial condition,

results of operations, and prospects.

If our trademarks and trade names for our

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In addition to the protection

afforded by patents we may own or in-license, we seek to rely on trade secret protection, confidentiality agreements, and license

agreements to protect proprietary know-how that may not be patentable, processes for which patents are difficult to enforce

and any other elements of our product discovery and development processes that involve proprietary know-how, information, or

technology that may not be covered by patents.

Although it is our policy to require all of our employees, consultants, advisors and any

third parties who have access to our proprietary know-how, information or technology to enter into confidentiality and assignment

afforded by patents we may own, co-own or in-license, we seek to rely on trade secret protection, confidentiality agreements,

and license agreements to protect proprietary know-how that may not be patentable, processes for which patents are difficult

to enforce and any other elements of our product discovery and development processes that involve proprietary know-how, information,

or technology that may not be covered by patents.

Although it is our policy to require all of our employees, consultants, advisors and

any third parties who have access to our proprietary know-how, information or technology to enter into confidentiality and assignment

of inventions agreements, trade secrets can be difficult to protect and we have limited control over the protection of trade secrets used

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Competitors may infringe any

patents we may own or in-license.

In addition, any patents we may own or in-license also may become involved in inventorship,

priority, validity or unenforceability disputes.

To counter infringement or unauthorized use, we may be required to file infringement

claims, which can be expensive and time-consuming.

We may not prevail in any lawsuits that we initiate, and the damages or other remedies

awarded, if any, may not be commercially meaningful.

In addition, in an infringement proceeding, a court may decide that one or more of

any patents we may own or in-license is not valid or is unenforceable or that the other party’s use of our technology

that may be patented falls under the safe harbor to patent infringement under 35 U.S.C.

There is also the risk that,

even if the validity of these patents is upheld, the court may refuse to stop the other party from using the technology at issue on the

grounds that any patents we may own or in-license do not cover the technology in question or that such third-party’s activities

do not infringe the patent applications or any patents we in-license or may in the future own.

An adverse result in any litigation

or defense proceedings could put one or more of any patents we may own or in-license at risk of being invalidated, held unenforceable,

or interpreted narrowly and could put those patent applications at risk of not issuing.

Such litigation or proceedings could substantially

increase our operating losses and reduce the resources available for development activities or any future sales, marketing, patient support

or distribution activities.

We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately.

Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their

greater financial resources and more mature and developed intellectual property portfolios.

Uncertainties resulting from the initiation

and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace.

patents we may own, co-own or in-license.

In addition, any patents we may own, co-own or in-license also may become involved

in inventorship, priority, validity or unenforceability disputes.

To counter infringement or unauthorized use, we may be required to file

infringement claims, which can be expensive and time-consuming.

We may not prevail in any lawsuits that we initiate, and the damages or

other remedies awarded, if any, may not be commercially meaningful.

In addition, in an infringement proceeding, a court may decide that

one or more of any patents we may own, co-own or in-license is not valid or is unenforceable or that the other party’s use

of our technology that may be patented falls under the safe harbor to patent infringement under 35 U.S.C.

There is also

the risk that, even if the validity of these patents is upheld, the court may refuse to stop the other party from using the technology

at issue on the grounds that any patents we may own, co-own or in-license do not cover the technology in question or that such third-party’s

activities do not infringe the patent applications or any patents we in-license or may in the future own or co-own.

An adverse result

in any litigation or defense proceedings could put one or more of any patents we may own, co-own or in-license at risk of being invalidated,

held unenforceable, or interpreted narrowly and could put those patent applications at risk of not issuing.

Such litigation or proceedings

could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing,

patient support or distribution activities.

We may not have sufficient financial or other resources to conduct such litigation or proceedings

Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because

of their greater financial resources and more mature and developed intellectual property portfolios.

Uncertainties resulting from the

initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in

the marketplace.

Post-grant proceedings provoked

by third parties or brought by the USPTO may be necessary to determine the validity or priority of inventions with respect to the patent

applications or any patents we in-license or may in the future own.

These proceedings are expensive and an unfavorable outcome could

result in a loss of our current patent rights and could require us to cease using the related technology or to attempt to license rights

to it from the prevailing party.

Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable

In addition to potential USPTO post-grant proceedings, we may become a party to patent opposition proceedings in the EPO, or similar

proceedings in other foreign patent offices or courts where these patents may be challenged.

The costs of these proceedings could be substantial,

and may result in a loss of scope of some claims or a loss of the entire patent.

An unfavorable result in a post-grant challenge proceeding

may result in the loss of our right to exclude others from practicing one or more of our inventions in the relevant country or jurisdiction,

which could have a material adverse effect on our business.

Litigation or post-grant proceedings within patent offices may result in a

decision adverse to our interests and, even if we are successful, may result in substantial costs and distract our management and other

We may not be able to prevent, misappropriation of our trade secrets or confidential information, particularly in countries

where the laws may not protect those rights as fully as in the United States.

applications or any patents we in-license or may in the future own or co-own.

These proceedings are expensive and an unfavorable

outcome could result in a loss of our current patent rights and could require us to cease using the related technology or to attempt to

license rights to it from the prevailing party.

Our business could be harmed if the prevailing party does not offer us a license on commercially

reasonable terms.

In addition to potential USPTO post-grant proceedings, we may become a party to patent opposition proceedings in the

EPO, or similar proceedings in other foreign patent offices or courts where these patents may be challenged.

The costs of these proceedings

could be substantial, and may result in a loss of scope of some claims or a loss of the entire patent.

An unfavorable result in a post-grant

challenge proceeding may result in the loss of our right to exclude others from practicing one or more of our inventions in the relevant

country or jurisdiction, which could have a material adverse effect on our business.

Litigation or post-grant proceedings within patent

offices may result in a decision adverse to our interests and, even if we are successful, may result in substantial costs and distract

our management and other employees.

We may not be able to prevent, misappropriation of our trade secrets or confidential information,

particularly in countries where the laws may not protect those rights as fully as in the United States.

We may not be able to detect

infringement against any patents we may own or in-license.

Even if we detect infringement by a third-party of any patents we

may own or in-license, we may choose not to pursue litigation against or settlement with the third-party.

If we later sue such

third-party for patent infringement, the third-party may have certain legal defenses available to it, which otherwise would not be available

except for the delay between when the infringement was first detected and when the suit was brought.

Such legal defenses may make it impossible

for us to enforce any patents we may own or in-license against such third-party.

infringement against any patents we may own, co-own or in-license.

Even if we detect infringement by a third-party of any patents

we may own, co-own or in-license, we may choose not to pursue litigation against or settlement with the third-party.

sue such third-party for patent infringement, the third-party may have certain legal defenses available to it, which otherwise would not

be available except for the delay between when the infringement was first detected and when the suit was brought.

Such legal defenses

may make it impossible for us to enforce any patents we may own, co-own or in-license against such third-party.

Intellectual property litigation and administrative

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particularly those relating to pharmaceutical products, which could make it difficult for us to stop the infringement of any patents we

may own or in-license or marketing of competing products in violation of our proprietary rights generally.

may own, co-own or in-license or marketing of competing products in violation of our proprietary rights generally.

Many countries have compulsory

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The degree of future protection

afforded by our intellectual property rights, whether owned or in-licensed, is uncertain because intellectual property rights

have limitations, and may not adequately protect our business, provide a barrier to entry against our competitors or potential competitors,

or permit us to maintain our competitive advantage.

Moreover, if a third party has intellectual property rights that cover the practice

of our technology, we may not be able to fully exercise or extract value from our intellectual property rights.

The following examples

are illustrative:

● patent applications that we own or may in-license may not lead to issued patents;

● patents, should they issue, that we may own or in-license, may not provide us with any competitive

advantages, may be narrowed in scope, or may be challenged and held invalid or unenforceable;

● others may be able to develop and/or practice technology, including compounds that are similar to the

chemical compositions of our current or future product candidates, that is similar to our technology or aspects of our technology but

that is not covered by the claims of any patents we may own or in-license, should any patents issue;

● third parties may compete with us in jurisdictions where we do not pursue and obtain patent protection;

● we, or our future licensors or collaborators, might not have been the first to make the inventions covered

by a patent application that we own or may in-license;

● we, or our future licensors or collaborators, might not have been the first to file patent applications

covering a particular invention;

● others may independently develop similar or alternative technologies without infringing, misappropriating

or otherwise violating our intellectual property rights;

● our competitors might conduct research and development activities in the United States and other

countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries

where we do not have patent rights, and may then use the information learned from such activities to develop competitive products for

sale in our major commercial markets;

● we may not be able to obtain and/or maintain necessary licenses on reasonable terms or at all;

● third parties may assert an ownership interest in our intellectual property and, if successful, such disputes

may preclude us from exercising exclusive rights, or any rights at all, over that intellectual property;

● we may choose not to file a patent in order to maintain certain trade secrets or know-how, and

a third-party may subsequently file a patent covering such trade secrets or know-how;

● we may not be able to maintain the confidentiality of our trade secrets or other proprietary information;

● we may not develop or in-license additional proprietary technologies that are patentable.

afforded by our intellectual property rights, whether owned, co-owned or in-licensed, is uncertain because intellectual property

rights have limitations, and may not adequately protect our business, provide a barrier to entry against our competitors or potential

competitors, or permit us to maintain our competitive advantage.

Moreover, if a third party has intellectual property rights that cover

the practice of our technology, we may not be able to fully exercise or extract value from our intellectual property rights.

The following

examples are illustrative:

● patent applications that we

own, co-own or may in-license may not lead to issued patents;

● patents, should they issue,

that we may own, co-own or in-license, may not provide us with any competitive advantages, may be narrowed in scope, or may

be challenged and held invalid or unenforceable;

● others may be able to develop

and/or practice technology, including compounds that are similar to the chemical compositions of our current or future product candidates,

that is similar to our technology or aspects of our technology but that is not covered by the claims of any patents we may own, co-own

or in-license, should any patents issue;

● third parties may compete with

us in jurisdictions where we do not pursue and obtain patent protection;

● we, or our future licensors

or collaborators, might not have been the first to make the inventions covered by a patent application that we own, co-own or may in-license;

● we, or our future licensors

or collaborators, might not have been the first to file patent applications covering a particular invention;

● others may independently develop

similar or alternative technologies without infringing, misappropriating or otherwise violating our intellectual property rights;

● our competitors might conduct

research and development activities in the United States and other countries that provide a safe harbor from patent infringement

claims for certain research and development activities, as well as in countries where we do not have patent rights, and may then use

the information learned from such activities to develop competitive products for sale in our major commercial markets;

● we may not be able to obtain

and/or maintain necessary licenses on reasonable terms or at all;

● third parties may assert an

ownership interest in our intellectual property and, if successful, such disputes may preclude us from exercising exclusive rights, or

any rights at all, over that intellectual property;

● we may choose not to file a

patent in order to maintain certain trade secrets or know-how, and a third-party may subsequently file a patent covering such

trade secrets or know-how;

● we may not be able to maintain

the confidentiality of our trade secrets or other proprietary information;

● we may not develop or in-license additional

proprietary technologies that are patentable.

Should any of these events

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Our management has concluded that our internal control over financial reporting was not effective as of December 31, 2025 due inadequate

segregation of duties within account processes due to limited personnel, as well as insufficient written policies and procedures for accounting,

IT, and financial reporting and record keeping.

Disclosing deficiencies or weaknesses in our internal controls, failing to remediate these

deficiencies or weaknesses in a timely fashion or failing to achieve and maintain an effective internal control environment may cause

investors to lose confidence in our reported financial information, which could have a material adverse effect on the price of the common

segregation of duties as a result of limited personnel and insufficient written policies and procedures for accounting, information

technology and financial reporting (no control procedures in place).

Disclosing deficiencies or weaknesses in our internal controls, failing to remediate

these deficiencies or weaknesses in a timely fashion or failing to achieve and maintain an effective internal control environment may

cause investors to lose confidence in our reported financial information, which could have a material adverse effect on the price of the

common stock.

If we cannot provide reliable financial reports or prevent fraud, our operating results could be harmed.

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of our clinical data or patients’ personal data could result in significant liability under state (e.g., state breach notification

laws), federal (e.g., HIPAA, as amended by HITECH), and international law (e.g., the EU General Data Protection Regulation, or GDPR)

laws), federal (e.g., HIPAA, as amended by HITECH), and international law (e.g., the EU GDPR)

and may cause a material adverse impact to our reputation, affect our ability to use collected data, conduct new studies and potentially

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to operate our business and our results of operations.

Use of artificial intelligence, machine

learning and algorithmic tools involves risks that could materially and adversely affect our business, results of operations and development

We use, and expect to increasingly

use, artificial intelligence (“AI”), machine learning (“ML”) and other data-driven models to support discovery,

clinical trial design and operations, manufacturing planning, and other aspects of our business.

The effectiveness of these systems depends

on the quality and completeness of the underlying data, proper training and validation of models, human oversight, and adherence to applicable

regulatory expectations.

Errors, bias, software vulnerabilities, or misuse of AI, ML, or other algorithmic tools could compromise scientific

conclusions, produce flawed clinical trial protocols, generate inaccurate operational or manufacturing forecasts, or result in breaches

of data integrity or privacy.

Such events could delay development, regulatory review, or commercialization, or could otherwise adversely

affect patient safety.

Regulatory authorities, including

FDA, the EMA and other global agencies, are increasingly scrutinizing the use of AI and ML in drug development, including claims regarding

AI-assisted decision making.

If our public statements regarding AI capabilities are inaccurate, incomplete, or become outdated, or if

regulators adopt new expectations regarding AI governance, model validation, data transparency, or reporting in drug development, we could

face investigations, enforcement actions, fines, or litigation.

Such regulatory scrutiny could also require operational rework, additional

documentation or validation, and delays in regulatory submissions or approvals.

In addition, malfunction,

misuse, bias, or inaccuracies in AI, ML, or other algorithmic tools could materially and adversely affect the quality and reliability

of our research and development programs, clinical data, manufacturing processes, and commercial operations.

Any of these outcomes could

materially delay development timelines, increase costs, negatively impact regulatory review, and reduce our ability to successfully develop,

obtain marketing approval for, or commercialize our product candidates, which could have a material adverse effect on our business, financial

condition, and prospects.

Geopolitical events, trade restrictions,

sanctions and export controls could adversely affect our clinical operations, supply chain, data flows and financial transactions.

Our development, manufacturing,

and supply chains, as well as certain aspects of our research and clinical programs, may be adversely affected by geopolitical events,

including military conflicts, escalating international tensions, trade or investment restrictions, sanctions regimes, export controls,

or retaliatory measures by foreign governments.

Such actions could limit our ability, or the ability of our CROs, CMOs and other third-party

partners, to source active pharmaceutical ingredients, starting materials, consumables, equipment, or software, to transfer biological

materials, clinical samples, or data across international borders, or to make or receive payments in affected jurisdictions.

Geopolitical events may also

increase cybersecurity threats targeting life sciences companies, potentially compromising sensitive research, patient data, or operational

Any of these factors could result in delays in our clinical trials, interruptions in the supply of materials or products, increased

costs, or the need to rapidly identify and qualify alternative suppliers, manufacturing sites, or trial locations.

Such disruptions could

materially and adversely affect our business, results of operations, development timelines, and prospects for successfully developing

and commercializing our product candidates.

Risks Related to Our Common Stock

The issuance of shares in connection with

the Private Placement and the HER2 Purchase Agreement could adversely affect the prevailing market price of our shares.

At two closings occurring

on December 31, 2024 and January 14, 2025, we issued to the selling stockholders an aggregate of (i) 1,775,750 shares of Series A Preferred

Stock and (ii) Series A Warrants initially exercisable into 1,775,750 shares of common stock pursuant to the Private Placement.

of shares of common stock into which the Series A Preferred Stock and Series A Warrants may be converted or exercised is also subject

to potential increase pursuant to applicable resets and anti-dilution adjustments.

For more detailed information about these adjustments,

see “ Description of Capital Stock — Series A Preferred Stock — Resets and Anti-Dilution Adjustments .” We

have also agreed to issue to Ayala $7.5 million shares of our common stock, based on the 30-day VWAP of our common stock immediately preceding

the closing date of our purchase of the HER2 Assets.

In the future, we may issue additional shares or other equity or debt securities

convertible into shares.

These issuances and any future issuance could result in substantial dilution to our existing stockholders and

could cause our share price to decline.

It is not possible to predict the actual

number of ELOC Shares, if any, we will sell under the ELOC Purchase Agreement to Square Gate, or the actual gross proceeds resulting from

On October 31, 2024, we entered

into an Equity Purchase Agreement (the “ELOC Purchase Agreement”) with Square Gate Capital Master Fund, LLC — Series

3 (the “Square Gate”), pursuant to which Square Gate has committed to purchase shares of our common stock in an offering amount

up to $15,000,000 (the “ELOC Shares”), subject to certain limitations and conditions set forth in the ELOC Purchase Agreement.

The ELOC Shares that may be issued under the ELOC Purchase Agreement may be sold by us to Square Gate at our discretion from time to time

until the earliest of (i) the date on which Square Gate has purchased ELOC Shares pursuant to the ELOC Purchase Agreement equal to the

maximum amount of the committed equity facility (the “Facility” or “Equity Line of Credit”), (ii) October 31,

2026, (iii) written notice of termination by us to Square Gate (which cannot occur at any time that Square Gate holds any of the ELOC

Shares), or (iv) written notice of termination by Square Gate to us upon certain events occurring.

We generally have the right

to control the timing and amount of any sales of the ELOC Shares to Square Gate under the ELOC Purchase Agreement.

Sales of the ELOC Shares,

if any, to Square Gate under the ELOC Purchase Agreement will depend upon market conditions and other factors to be determined by us.

We may ultimately decide to sell to Square Gate all, some or none of the ELOC Shares that may be available for us to sell to Square Gate

pursuant to the ELOC Purchase Agreement.

Because the purchase price

per share to be paid by Square Gate for the ELOC Shares that we may elect to sell to Square Gate under the ELOC Purchase Agreement, if

any, will fluctuate based on the market prices of our shares at the time we elect to sell the ELOC Shares to Square Gate pursuant to the

ELOC Purchase Agreement, if any, it is not possible for us to predict, as of the date of this annual report and prior to any such sales,

the number of ELOC Shares that we will sell to Square Gate under the ELOC Purchase Agreement, the purchase price per share that Square

Gate will pay for ELOC Shares purchased from us under the ELOC Purchase Agreement, or the aggregate gross proceeds that we will receive

from those purchases by Square Gate under the ELOC Purchase Agreement.

The ELOC Purchase Agreement

provides that we may, in our discretion, from time to time during the term of the ELOC Purchase Agreement, direct Square Gate to purchase

the ELOC Shares from us in one or more purchases under the ELOC Purchase Agreement, for a maximum aggregate gross purchase price of up

to $15,000,000 of the ELOC Shares.

Because the market prices of the ELOC Shares may fluctuate from time to time after the date of this

annual report, the actual purchase prices to be paid by Square Gate for the ELOC Shares that we direct it to purchase under the ELOC Purchase

Agreement, if any, also may fluctuate significantly based on the market price of the ELOC Shares.

Any issuance and sale by us

under the ELOC Purchase Agreement of a substantial number of ELOC Shares could cause substantial dilution to our stockholders.

We registered

resale under a registration statement 6,212,761 ELOC Shares, which was declared effective by the SEC on January 13, 2025.

The number of

ELOC Shares ultimately offered for sale by Square Gate is dependent upon the number of ELOC Shares, if any, we ultimately elect to sell

to Square Gate under the ELOC Purchase Agreement.

However, even if we elect to sell ELOC Shares to Square Gate pursuant to the ELOC Purchase

Agreement, Square Gate may resell all, some or none of such shares at any time or from time to time in its sole discretion and at different

Investors who buy ELOC Shares from Square

Gate at different times will likely pay different prices.

Pursuant to the ELOC Purchase

Agreement, we will have discretion to vary the timing, price and number of shares sold to Square Gate.

If and when we elect to sell the

ELOC Shares to Square Gate pursuant to the ELOC Purchase Agreement, after Square Gate has acquired such ELOC Shares, Square Gate may resell

all, some or none of such shares at any time or from time to time in its sole discretion and at different prices.

As a result, investors

who purchase shares from Square Gate in this offering at different times will likely pay different prices for those shares and so may

experience different levels of dilution and in some cases substantial dilution and different outcomes in their investment results.

may experience a decline in the value of the shares they purchase from Square Gate in this offering as a result of future sales made by

us to Investor at prices lower than the prices such investors paid for their shares in this offering.

In addition, if we sell a substantial

number of shares to Square Gate under the ELOC Purchase Agreement, or if investors expect that we will do so, the actual sales of shares

or the mere existence of our arrangement with Square Gate may make it more difficult for us to sell equity or equity-related securities

in the future at a time and at a price that we might otherwise wish to effect such sales.

A significant number of additional shares

of our common stock may be issued pursuant to outstanding preferred stock, warrants, stock options and convertible securities, which issuances

could substantially dilute existing stockholders and may depress the market price of our common stock.

We have issued, and may issue

in the future, a significant number of shares of our common stock upon the conversion or exercise of outstanding preferred stock, warrants,

stock options and other convertible securities.

In connection with the PIPE Financing completed in December 2024 and

January 2025, we issued shares of our Series A Preferred Stock, each share of which is convertible into a number of shares of common stock

at a conversion ratio equal to (x) the original issue price of the Series A Preferred Stock divided by (y) the conversion price of the

Series A Preferred Stock.

The Series A Preferred Stock was initially convertible at a 1:1 ratio, subject to adjustment as set forth in

the Certificate of Designation, Preferences, Rights and Limitations of Series A Senior Convertible Preferred Stock.

The number of shares

of common stock into which the Series A Preferred Stock may be converted is also subject to potential increase pursuant to applicable

resets and anti-dilution adjustments.

During 2025 and the first quarter of 2026, we completed three warrant

exercise inducement and exchange transactions pursuant to which holders exercised certain existing warrants for cash and received new

warrants to purchase a number of shares of our common stock equal to the number of shares received upon such exercise.

In March 2026,

we completed the Bridge Financing that included the issuance of the Bridge Notes and the Bridge Warrants.

The Bridge Notes are convertible

into shares of our common stock under certain circumstances.

If we complete a “Qualified Offering,” defined as a registered

public offering or registered direct offering resulting in at least $2.5 million in gross proceeds from new money investments, the outstanding

principal, together with all accrued and unpaid interest, will automatically convert into the securities sold in such offering at the

offering price.

Additionally, prior to any such Qualified Offering or repayment of the Bridge Notes, holders may elect to convert the

Bridge Notes, in whole or in part, into shares of our common stock at a conversion price equal to 90% of the average daily volume-weighted

average price of our common stock during the 10 trading days immediately preceding the holder’s conversion notice, subject to adjustment.

As of the date of this Form

10-K, (i) 1,401,786 shares of our common stock are issuable upon the conversion of outstanding shares of our Series A Preferred Stock,

with a conversion ratio of 3.571429 per share, (ii) 10,399,522 shares of our common stock are issuable upon the exercise of outstanding

warrants, (iii) 6,771,250 shares of our common stock are issuable upon the exercise of outstanding and vested stock options under our

2023 Incentive Compensation Plan and (iv) 1,392,805 shares of our common stock are issuable upon the conversion of outstanding Bridge

Notes (assuming full conversion of such notes into common stock at a conversion price of $1.39, which was the closing price of our common

stock on March 26, 2026).

As a result of these features,

declines in the market price of our common stock or future issuances of securities at lower prices could result in additional shares of

our common stock becoming issuable upon conversion or exercise of these securities.

The issuance of such shares would substantially dilute

the ownership interests and voting power of existing stockholders.

In addition, we have agreed,

or may agree, to file registration statements covering the resale of shares of common stock issuable upon conversion or exercise of these

The availability of a significant number of shares for sale in the public market, or the perception that such sales could

occur, could adversely affect the market price of our common stock and make it more difficult for us to raise additional capital in the

Sales of a substantial number of shares

of our common stock, including those issued pursuant to the Sales Agreement, could cause the market price of our common stock to decline.

The sale of a substantial

number of shares of our common stock in the public market, or the perception that such sales may occur, could cause the market price of

our common stock to decline.

Although we cannot predict the exact number of shares that may be sold pursuant to the Sales Agreement or

the price at which any sales may occur, the issuance and sale of up to $17,469,838 of our common stock pursuant to the Sales Agreement

may result in the issuance of 12,568,228 additional shares (based on an assumed offering price of $1.39 per share, the closing price of

our common stock on the NYSE American on March 26, 2026).

Based on our shares outstanding as of March 26, 2026, and assuming full issuance

of such shares, we would have 52,101,455 shares of common stock outstanding (excluding any shares issuable upon the conversion or exercise,

as applicable, of outstanding convertible notes, preferred stock, warrants, or stock options).

A substantial majority of the outstanding

shares of our common stock are, and all of the shares sold pursuant to the Sales Agreement upon issuance will be, freely tradable without

restriction or further registration under the Securities Act, unless such shares are owned or purchased by “affiliates” as

that term is defined in Rule 144 under the Securities Act.

In addition, as of the date

of this Form 10-K, there were outstanding (i) 392,500 shares of Series A Preferred Stock convertible into an aggregate of 1,401,786

shares of common stock, (ii) warrants to purchase an aggregate of 10,399,522 shares of common stock, (iii) options to purchase an

aggregate of 6,771,250 shares of our common stock, of which options to purchase 2,866,750 shares of our common stock were then exercisable,

and (iv) $2,200,000 in aggregate principal amount of convertible notes convertible into 1,392,805 shares of common stock (including the

conversion of accrued interest and assuming a conversion price of $1.39, which was the closing price of our common stock on March 26,

The shares of our common stock issuable upon conversion or exercise, as applicable, of such securities may be immediately eligible

for resale in the open market.

Any such sales, or the perception that such sales could occur, could cause the market price of our common

stock to decline and may make it more difficult for us to raise capital in the future.

It is not possible to predict the aggregate

proceeds resulting from sales made under the Sales Agreement.

Subject to certain limitations

in the Sales Agreement and compliance with applicable law, we have the discretion to deliver a placement notice to the Sales Agents at

any time throughout the term of the Sales Agreement.

The number of shares that are sold through the Sales Agents, if any, after delivering

a placement notice will fluctuate based on a number of factors, including the market price of our common stock during the sales period,

the limits we set with the Sales Agents in any applicable placement notice, and the demand for our common stock during the sales period.

Because the price per share of each share sold will fluctuate during the sales period, it is not currently possible to predict the aggregate

proceeds to be raised in connection with those sales.

The common stock offered pursuant to the

Sales Agreement will be sold in “at the market offerings,” and investors who buy shares at different times will likely pay

different prices.

Investors who purchase shares

pursuant to the Sales Agreement at different times will likely pay different prices, and so may experience different levels of dilution

and different outcomes in their investment results.

We will have discretion, subject to market demand, to vary the timing, prices, and

number of shares sold pursuant to the Sales Agreement.

In addition, subject to the final determination by our board of directors, there

is no minimum or maximum sales price for shares to be sold pursuant to the Sales Agreement.

Investors may experience a decline in the

value of the shares they purchase pursuant to the Sales Agreement as a result of sales made at prices lower than the prices they paid.

Romness, MPH, and our other

1 unchanged sentence

corporate matters and could delay or prevent a change in corporate control.

Romness, MPH,

our Chairman, President and Chief Executive Officer, beneficially owns approximately 11.4% of the outstanding shares of common stock of

our company, and other executive officers and directors beneficially own another approximately 3.6% of our outstanding shares.

holdings of Mr.

Romness and other executive officers, directors and their affiliates represent beneficial ownership in the aggregate

of approximately 15.1% of our outstanding common stock.

As a result, these stockholders will be able to influence our management and affairs

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

or sale of all or substantially all of our assets.

These stockholders may have interests, with respect to their common stock, that are

different from those of other investors and the concentration of voting power among these stockholders may have an adverse effect on the

price of our common stock.

In addition, this concentration of ownership might adversely affect the market price of our common stock by:

● delaying, deferring or preventing a change of control our

● impeding a merger, consolidation, takeover or other business

combination involving our company;

● discouraging a potential acquirer from making a tender offer

or otherwise attempting to obtain control of our company.

Romness, MPH, our Chairman, President and Chief Executive

Officer, beneficially owns approximately 8.3% of the outstanding shares of common stock of our company, and other executive officers and

directors beneficially own another approximately 3.4% of our outstanding shares.

The existing holdings of Mr.

Romness and other executive

officers, directors and their affiliates represent beneficial ownership in the aggregate of approximately 11.7% of our outstanding common

As a result, these stockholders will be able to influence our management and affairs and the outcome of matters submitted to our

stockholders for approval, including the election of directors and any sale, merger, consolidation or sale of all or substantially all

of our assets.

These stockholders may have interests, with respect to their common stock, that are different from those of other investors

and the concentration of voting power among these stockholders may have an adverse effect on the price of our common stock.

this concentration of ownership might adversely affect the market price of our common stock by:

● delaying, deferring or preventing

a change of control our company;

● impeding a merger, consolidation,

takeover or other business combination involving our company;

● discouraging a potential acquirer

from making a tender offer or otherwise attempting to obtain control of our company.

We are incurring increased costs as a result

43 unchanged sentences

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What changed 10-K

Item 1A. Risk Factors