What changed in this filing

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Item 1A. Risk Factors

2026-08-10 compared with 2026-05-13 · 817 added, 727 removed, 1001 unchanged (61% of the section changed)

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property rights and the manufacturing, marketing, distribution and sales efforts of any current or future collaborator.

In addition, some

of the factors, events and contingencies discussed below may have occurred in the past, but the disclosures below are not representations

some of the factors, events and contingencies discussed below may have occurred in the past, but the disclosures below are not representations

as to whether or not the factors, events or contingencies have occurred in the past and instead reflect our beliefs and opinions as to

the factors, events, or contingencies that could materially and adversely affect us in the future.

The summary below is not exhaustive and is qualified by reference to

the full set of risk factors set forth in Item 1A “Risk Factors” of this Quarterly Report.

Please carefully consider all the

information in this Quarterly Report, including the full set of risks set forth in the “Risk Factors” section, and in our

other filings with the U.S.

Securities and Exchange Commission (the “SEC”) before making an investment decision regarding

The summary below is not

exhaustive and is qualified by reference to the full set of risk factors set forth in Item 1A “Risk Factors” of this Quarterly

Please carefully consider all the information in this Quarterly Report, including the full set of risks set forth in the “Risk

Factors” section, and in our other filings with the U.S.

Securities and Exchange Commission (the “SEC”) before making

an investment decision regarding the Company.

Risks Related to Our Financial Condition and

Capital Requirements

We are a clinical stage biopharmaceutical company with a limited operating history on which to assess our business.

Our clinical trials remain ongoing and we have no products approved for commercial sale.

We have historically incurred losses and we anticipate that we will continue to incur losses for the foreseeable future.

We have never generated revenue from product sales and may never be profitable.

We may not be able to raise the capital that we need to support our business plans.

Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.

are a clinical stage biopharmaceutical company with a limited operating history on which to assess our business.

Our clinical trials

remain ongoing and we have no products approved for commercial sale.

have historically incurred losses and we anticipate that we will continue to incur losses for the foreseeable future.

have never generated revenue from product sales and may never be profitable.

may not be able to raise the capital that we need to support our business plans.

additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies

or product candidates.

Risks Related to Clinical Development, Regulatory

Approval and Commercialization

Drug development and obtaining and maintaining regulatory approval for drug products is costly, time-consuming, and highly uncertain.

We are substantially dependent on the success of our two most advanced programs, ORKA-001 and ORKA-002.

We may not achieve our projected development goals in the time frames we announce and expect, or at all.

We face competition from entities that have developed or may develop programs for the diseases addressed by our product candidates.

Risks Related to Government

We may not be able to meet requirements for the chemistry, manufacturing and control of our programs.

Food and Drug Administration (“FDA”) and comparable foreign regulatory approval processes are lengthy and time consuming and we may not be able to obtain or may be delayed in obtaining regulatory approvals for our product candidates.

Moreover, even if we obtain regulatory approval, we will be subject to ongoing regulatory obligations.

development and obtaining and maintaining regulatory approval for drug products is costly, time-consuming, and highly uncertain.

are substantially dependent on the success of our two most advanced programs, ORKA-001 and ORKA-002.

We may not achieve our projected

development goals in the time frames we announce and expect, or at all.

face competition from entities that have developed or may develop programs for the diseases addressed by our product candidates.

We may not be able to meet

requirements for the chemistry, manufacturing and control of our programs.

Food and Drug

Administration (“FDA”) and comparable foreign regulatory approval processes are lengthy and time consuming and we may

not be able to obtain or may be delayed in obtaining regulatory approvals for our product candidates.

Moreover, even if we obtain

regulatory approval, we will be subject to ongoing regulatory obligations.

Risks Related to Our Intellectual Property

Our ability to obtain and protect our patents and other proprietary rights is uncertain and we may fail in obtaining or maintaining necessary rights to our programs.

We may become subject to claims challenging the inventorship or ownership of our intellectual property and may be subject to patent infringement claims or may need to file such claims.

Our technology licensed from third parties may be subject to retained rights.

Our ability to obtain and

protect our patents and other proprietary rights is uncertain and we may fail in obtaining or maintaining necessary rights to our

We may become subject to

claims challenging the inventorship or ownership of our intellectual property and may be subject to patent infringement claims or

may need to file such claims.

Our technology licensed

from third parties may be subject to retained rights.

Risks Related to Our Reliance on Third Parties

We currently rely on agreements with third parties to develop our product candidates.

Our business could be negatively impacted if we are unable to maintain these arrangements or if these arrangements are not successful, for example, if such third parties fail to carry out their contractual duties.

Our third-party manufacturing partners and manufacturing sites may fail to perform adequately in their efforts to support the manufacture of our product candidates and we may need to switch or create third-party manufacturer redundancies.

We currently rely on agreements

with third parties to develop our product candidates.

Our business could be negatively impacted if we are unable to maintain these

arrangements or if these arrangements are not successful, for example, if such third parties fail to carry out their contractual

Our third-party manufacturing partners and manufacturing sites may

fail to perform adequately in their efforts to support the manufacture of our product candidates and we may need to switch or create third-party

manufacturer redundancies, which could result in delays to our development timeline and increase our costs.

Risks Related to Employee Matters, Managing

Growth, Other Risks Related to Our Business, and Risks Related to Owning Our Common Stock

Our estimates of market opportunity and forecasts of market growth may prove to be inaccurate, and even if the markets in which we compete achieve the forecasted growth, our business may not grow at similar rates, or at all.

Our business is dependent on key personnel, and we may be harmed if we cannot recruit and retain highly qualified personnel to successfully implement our business strategies.

Our business could be adversely affected by macroeconomic or geopolitical conditions.

Future sales and issuances of equity and debt could result in additional dilution to our stockholders and could cause our stock price to decline.

Future sales of shares, or the anticipation of such sales, by existing stockholders could cause our stock price to decline.

Risks Related to Our Financial

Condition and Capital Requirements

We are a clinical stage

biopharmaceutical company with a limited operating history on which to assess our business;

our clinical trials are ongoing, we have no

products approved for commercial sale, we have historically incurred losses, and we anticipate that we will continue to incur significant

losses for the foreseeable future.

Our estimates of market

opportunity and forecasts of market growth may prove to be inaccurate, and even if the markets in which we compete achieve the forecasted

growth, our business may not grow at similar rates, or at all.

Our business is dependent

on key personnel, and we may be harmed if we cannot recruit and retain highly qualified personnel to successfully implement our business

Our business could be adversely

affected by macroeconomic or geopolitical conditions.

Future sales and issuances

of equity and debt could result in additional dilution to our stockholders and could cause our stock price to decline.

Future sales of shares,

or the anticipation of such sales, by existing stockholders could cause our stock price to decline.

Risks Related to Our

Financial Condition and Capital Requirements

We are a clinical

stage biopharmaceutical company with a limited operating history on which to assess our business;

our clinical trials are ongoing, we

have no products approved for commercial sale, we have historically incurred losses, and we anticipate that we will continue to incur

significant losses for the foreseeable future.

Moreover, we have never generated revenue from product sales and may never be profitable.

We are a clinical stage biopharmaceutical

company with a limited operating history.

We will need to raise substantial additional capital to continue to fund our operations in the

We have based our estimates on assumptions that may prove to be wrong and we could exhaust our available financial resources sooner

than we currently anticipate.

We have devoted substantially all of our financial resources to identifying, acquiring, and developing our

product candidates, organizing and staffing our company, and providing general and administrative support for our operations.

We are a clinical stage

biopharmaceutical company with a limited operating history.

We will need to raise substantial additional capital to continue to fund

our operations in the future.

We have based our estimates on assumptions that may prove to be wrong and we could exhaust our available

financial resources sooner than we currently anticipate.

We have devoted substantially all of our financial resources to identifying,

acquiring, and developing our product candidates, organizing and staffing our company, and providing general and administrative support

for our operations.

Additional capital may not

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companies and broader macroeconomic factors may preclude us from successfully raising additional capital on the timeline we require.

example, escalating geopolitical tensions, elevated interest rates, and economic and regulatory uncertainty have caused market volatility.

For example, escalating geopolitical tensions, elevated interest rates, and economic and regulatory uncertainty have caused market volatility.

Such volatility can have an adverse effect on the ability to raise capital, particularly in the biotechnology and biopharmaceutical industries.

In addition, it may be difficult for us to raise additional capital if we experience any issues that delay or prevent the regulatory approval

or our ability to commercialize any of our product candidates.

In addition, it may be difficult for us to raise additional capital if we experience any issues that delay or prevent the regulatory

approval or our ability to commercialize any of our product candidates.

Biopharmaceutical product

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product candidate approved for commercialization.

We expect to invest significant funds into the research and development of our programs

We expect to invest significant funds in the research and development of our programs

to determine the potential to advance product candidates to regulatory approval.

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incur significant expenses and increasing operating losses for the foreseeable future and our expenses will increase substantially if

continue the clinical development of our product candidates, including advancing our product candidates into larger, more expensive trials;

progress our chemistry, manufacturing and control development, registration, and validation, including the manufacture of our product candidates by third parties, including increasing volumes manufactured by third parties;

continue efforts to discover and develop new product candidates, including initiating preclinical studies or clinical trials;

seek regulatory and marketing approvals and reimbursement for our product candidates;

establish a sales, marketing, and distribution infrastructure to commercialize any products for which we may obtain marketing approval and market for ourselves;

make milestone, royalty, or other payments under third-party license agreements;

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

experience any delays or encounter issues with the development and potential regulatory approval of our product candidates such as safety issues, manufacturing delays, clinical trial delays, longer follow-up for planned studies or trials, additional major studies or trials, or supportive trials necessary to support marketing approval.

continue the clinical development

of our product candidates, including advancing our product candidates into larger, more expensive trials;

progress our chemistry, manufacturing and control development, registration,

and validation, including increasing volumes manufactured by third parties;

continue efforts to discover

and develop new product candidates, including initiating preclinical studies or clinical trials;

seek regulatory and marketing

approvals and reimbursement for our product candidates;

establish a sales, marketing, and distribution infrastructure to commercialize

any products for which we may obtain marketing approval and market ourselves;

make milestone, royalty,

or other payments under third-party license agreements;

seek to maintain, protect,

and expand our intellectual property portfolio;

experience any delays or

encounter issues with the development and potential regulatory approval of our product candidates such as safety issues, manufacturing

delays, clinical trial delays, longer follow-up for planned studies or trials, additional major studies or trials, or supportive

trials necessary to support marketing approval.

If we are unable to raise

additional capital when required or on acceptable terms, we may be required to curtail our product development activities and other activities

commensurate with the magnitude of the shortfall and our product development activities may cease altogether, which could materially harm

our business, financial condition, and results of operations.

To the extent that the costs of our activities exceed our current estimates

and we are unable to raise sufficient additional capital to cover such costs, we will need to reduce operating expenses, sell assets,

enter into strategic transactions, or effect a combination of the above.

No assurance can be given that we will be able to enter into

any of such transactions on acceptable terms, if at all.

Any of the following events could have a material adverse effect on our business,

operating results, and prospects:

a delay, scaling back, or discontinuation of the development or commercialization of our product candidates;

seeking strategic partnerships, or amending existing partnerships, for research and development programs at an earlier stage than otherwise would be desirable or that we otherwise would have sought to develop independently, or on terms that are less favorable than might otherwise be available in the future;

disposal of technology assets, or the relinquishing or licensing of assets on unfavorable terms, of our rights to technologies or any of our product candidates that we otherwise would seek to develop or commercialize ourselves;

pursuing the sale of the company to a third party at a price that may result in a loss on investment for our stockholders;

filing for bankruptcy or ceasing operations altogether.

commensurate with the magnitude of the shortfall and our product development activities may cease altogether, which could materially

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

To the extent that the costs of our activities exceed our current

estimates and we are unable to raise sufficient additional capital to cover such costs, we will need to reduce operating expenses, sell

assets, enter into strategic transactions, or effect a combination of the above.

No assurance can be given that we will be able to enter

into any of such transactions on acceptable terms, if at all.

Any of the following events could have a material adverse effect on our

business, operating results, and prospects:

a delay, scaling back,

or discontinuation of the development or commercialization of our product candidates;

seeking strategic partnerships,

or amending existing partnerships, for research and development programs at an earlier stage than otherwise would be desirable or

that we otherwise would have sought to develop independently, or on terms that are less favorable than might otherwise be available

in the future;

disposal of technology

assets, or the relinquishing or licensing of assets on unfavorable terms, of our rights to technologies or any of our product candidates

that we otherwise would seek to develop or commercialize ourselves;

pursuing the sale of the

company to a third party at a price that may result in a loss on investment for our stockholders;

filing for bankruptcy or

ceasing operations altogether.

Even if we are successful

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capital may cause dilution to our stockholders, restrict our operations, or require us to relinquish rights.

To the extent that we raise additional capital through the sale of

equity securities or convertible debt securities, the ownership interest of our stockholders will be diluted, and the terms of these securities

may include liquidation or other preferences that adversely affect the rights of holders of our common stock.

Debt financing and preferred

equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions,

such as incurring additional debt, making capital expenditures, or declaring dividends.

For example, most recently, in April 2026, we

entered into an underwriting agreement, pursuant to which we issued and sold 9,660,000 shares of common stock for a gross proceeds of

$700.4 million before any underwriting discounts and commissions and related issuance expenses.

We have granted the underwriters a 30-day

option to purchase 1,449,000 additional shares at a price of $72.50 per share, less underwriting discounts and commissions.

in October 2025, we entered into a sales agreement with TD Securities (USA) LLC acting as our sales agent pursuant to which we may issue

and sell shares of our common stock from time to time through an at-the-market equity offering program, for aggregate gross proceeds of

up to $200.0 million, under which we have sold shares of our common stock resulting in net proceeds of $38.9 million as of March 31, 2026.

Previously, in September 2025, we entered into a Securities Purchase Agreement whereby the investors purchased shares of our common stock

and pre-funded warrants for aggregate net proceeds of approximately $169.6 million.

To the extent that we raise

additional capital through the sale of equity securities or convertible debt securities, the ownership interest of our stockholders will

be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of holders

of our common stock.

Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting

or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends.

For example, most recently, in April 2026, we entered into an underwriting agreement, pursuant to which we issued and sold 9,660,000 shares

of common stock for net proceeds of $658.3 million, after deducting underwriting discounts and commissions and related issuance expenses.

In addition, in October 2025, we entered into a sales agreement with TD Securities (USA) LLC acting as our sales agent pursuant to which

we may issue and sell shares of our common stock from time to time through an at-the-market equity offering program, for aggregate gross

proceeds of up to $200.0 million, under which we have sold shares of our common stock resulting in net proceeds of $161.4 million as of

July 31, 2026.

Previously, in September 2025, we entered into a Securities Purchase Agreement whereby the investors purchased shares of

our common stock and pre-funded warrants for aggregate net proceeds of approximately $169.6 million.

Moreover, if we raise additional

funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required

to relinquish valuable rights to our research programs or product candidates or grant licenses on terms that may not be favorable to us.

funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be

required to relinquish valuable rights to our research programs or product candidates or grant licenses on terms that may not be favorable

Risks Related to Clinical

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of drugs is highly competitive.

If approved, our product candidates will face significant competition and our failure to effectively compete

may prevent us from achieving significant market penetration.

Many of the companies with which we are currently competing or will compete

against in the future have significantly greater financial resources and expertise in research and development, manufacturing, preclinical

testing, clinical trials, regulatory approvals, and marketing than we do.

Mergers and acquisitions in the pharmaceutical and biotechnology

industry 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.

competitors also compete with us in establishing clinical trial sites, recruiting participants for clinical trials, as well as in acquiring

technologies complementary to, or necessary for, our product candidates.

If approved, our product candidates will face significant competition and our failure to effectively

compete may prevent us from achieving significant market penetration.

Many of the companies with which we are currently competing or

will compete against in the future have significantly greater financial resources and expertise in research and development, manufacturing,

preclinical testing, clinical trials, regulatory approvals, and marketing than we do.

Mergers and acquisitions in the pharmaceutical

and biotechnology industry may result in even more resources being concentrated among a smaller number of our competitors.

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

These competitors also compete with us in establishing clinical trial sites, recruiting participants for clinical trials,

as well as in acquiring technologies complementary to, or necessary for, our product candidates.

Our competitors have developed,

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success may be reduced or eliminated if competing products are safer, more effective, have a more attractive dosing profile or presentation,

or are less expensive than our products, or if biosimilars enter the market and achieve broader or more rapid market acceptance than our

or are less expensive than our products, or if biosimilars enter the market and achieve broader or more rapid market acceptance than

our products.

Our product candidates

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can occur at any stage of testing.

The outcome of preclinical testing and early clinical trials may not be predictive of the success of

later clinical trials, and interim results of a clinical trial do not necessarily predict final results.

Moreover, preclinical and clinical

data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed

satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval for their products.

The outcome of preclinical testing and early clinical trials may not be predictive of the success

of later clinical trials, and interim results of a clinical trial do not necessarily predict final results.

Moreover, preclinical and

clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates

performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval for their products.

We may experience a number

of events affecting our product development timeline, including the following:

Our clinical trials may fail to show safety or efficacy, show meaningful improvement in efficacy or convenience compared to competitors, produce negative or inconclusive results, or our product candidates may have undesirable side effects or unexpected characteristics.

We may decide, or regulators may require additional preclinical studies or clinical trials or we may decide to abandon a product development program altogether.

The supply or quality of our clinical trial materials or other materials necessary to conduct clinical trials of our product candidates may be insufficient, unsafe or inadequate.

Regulators, Institutional Review Boards (“IRBs”), the FDA, or ethics committees may not authorize us or our investigators to commence or conduct a clinical trial at one or more prospective trial sites;

or may require that we or our investigators materially modify, suspend or terminate clinical research or trials for various reasons, including noncompliance with regulatory requirements or a finding that the participants in our trials are being exposed to unacceptable health risks.

We may fail to establish an appropriate safety profile for a product candidate based on clinical or preclinical data as well as data emerging from other therapies in the same class as our product candidates.

The number of subjects required for clinical trials of any product candidates may be larger than we anticipate, especially if regulatory bodies require completion of non-inferiority or superiority trials.

Enrollment in our clinical trials may be slower than we anticipate or subjects may drop out of these clinical trials or fail to return for post-treatment follow-up at a higher rate than we anticipate.

Trial conduct or data analysis errors may occur, including, but not limited to, failure by investigators or participants to adhere to the study protocol or data entry and/or labeling errors.

We may experience delays in reaching, or fail to reach, agreement on acceptable terms with prospective trial sites and/or contract research organizations.

Our third-party contractors or clinical trial sites may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, or may deviate from the clinical trial protocol or drop out of the trial, which may require that we add new clinical trial sites or investigators and could potentially complicate the analysis of data or affect our product development timeline.

The cost of clinical trials of any of our programs may be greater than we anticipate.

Reports from clinical testing of other therapies may raise safety or efficacy concerns about our programs.

The FDA or other regulatory authorities may require us to submit additional data or impose other requirements and our product development timeline may be adversely affected.

Even if we or an existing or future collaborator obtains regulatory approval, the approval may be for targets, disease indications or patient populations that are not as broad as we intended or desired or may require labeling that includes significant use or distribution restrictions or safety warnings.

Our clinical trials may

fail to show safety or efficacy, show meaningful improvement in efficacy or convenience compared to competitors, produce negative

or inconclusive results, or our product candidates may have undesirable side effects or unexpected characteristics.

We may decide,

or regulators may require additional preclinical studies or clinical trials or we may decide to abandon a product development program

The supply or quality of

our clinical trial materials or other materials necessary to conduct clinical trials of our product candidates may be insufficient,

unsafe or inadequate.

Regulators, Institutional

Review Boards (“IRBs”), the FDA, or ethics committees may not authorize us or our investigators to commence or conduct

a clinical trial at one or more prospective trial sites;

or may require that we or our investigators materially modify, suspend, or

terminate clinical research or trials for various reasons, including noncompliance with regulatory requirements or a finding that

the participants in our trials are being exposed to unacceptable health risks.

We may fail to establish

an appropriate safety profile for a product candidate based on clinical or preclinical data as well as data emerging from other therapies

in the same class as our product candidates.

The number of subjects

required for clinical trials of any product candidates may be larger than we anticipate, especially if regulatory bodies require

completion of non-inferiority or superiority trials.

Enrollment in our clinical

trials may be slower than we anticipate or subjects may drop out of these clinical trials or fail to return for post-treatment follow-up

at a higher rate than we anticipate.

Trial conduct or data analysis

errors may occur, including, but not limited to, failure by investigators or participants to adhere to the study protocol or data

entry and/or labeling errors.

We may experience delays

in reaching, or fail to reach, agreement on acceptable terms with prospective trial sites and/or contract research organizations.

Our third-party contractors

or clinical trial sites may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner,

or at all, or may deviate from the clinical trial protocol or drop out of the trial, which may require that we add new clinical trial

sites or investigators and could potentially complicate the analysis of data or affect our product development timeline.

The cost of clinical trials

of any of our programs may be greater than we anticipate.

Reports from clinical testing

of other therapies may raise safety or efficacy concerns about our programs.

The FDA or other regulatory

authorities may require us to submit additional data or impose other requirements and our product development timeline may be adversely

Even if we or an existing

or future collaborator obtains regulatory approval, the approval may be for targets, disease indications or patient populations that

are not as broad as we intended or desired, or may require labeling that includes significant use or distribution restrictions or

safety warnings.

If our clinical trials do

not produce favorable results, our ability to obtain regulatory approval for our product candidates will be adversely impacted.

the combined data from our trials may be inconclusive or may not be sufficient to ultimately gain marketing approval from the FDA or other

regulatory authorities.

the combined data from our trials may be inconclusive or may not be sufficient to ultimately gain marketing approval from the FDA or

other regulatory authorities.

There are equivalent processes and risks applicable to clinical trial applications in other countries outside

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Our Phase 1 clinical trial of ORKA-001 in healthy volunteers is fully enrolled and is ongoing for purposes of continued

patient follow-up and data collection, and remains blinded.

Our Phase 2a clinical trial of ORKA-001 in patients with moderate-to-severe

psoriasis (“PsO”) remains ongoing and we commenced dosing in a dose-ranging Phase 2b trial of ORKA-001 in moderate-to-severe

PsO in the fourth quarter of 2025.

patient follow-up and data collection.

Our Phase 2a and Phase 2b clinical trials of ORKA-001 in patients with moderate-to-severe psoriasis

(“PsO”) remain ongoing, and eligible patients have the option to roll over into our long-term extension study of ORKA-001

in patients with PsO.

Our Phase 1 clinical trial

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In addition, we commenced a Phase 2 clinical trial of ORKA-002 in patients with moderate-to-severe PsO in February

2026 and plan to initiate a Phase 2 clinical trial of ORKA-002 in hidradenitis suppurativa (“HS”) in the second half of 2026.

2026 and we recently initiated a Phase 2 clinical trial of ORKA-002 in hidradenitis suppurativa (“HS”).

Currently, we believe that

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The actual timing of these milestones can vary dramatically compared to our estimates, in some cases for reasons beyond our control.

we do not meet these milestones or the timing of the milestones as publicly announced, the development and potential commercialization

If we do not meet these milestones or the timing of the milestones as publicly announced, the development and potential commercialization

of our product candidates may be delayed or never achieved and, as a result, our business may be materially harmed and our stock price

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us to raise additional capital sooner than expected and on terms less than desirable, and prior to achieving targeted development milestones.

Any drug delivery device

that we may use to deliver our product candidates may have its own regulatory, development, supply and other risks.

Any drug delivery

device that we may use to deliver our product candidates may have its own regulatory, development, supply and other risks.

We are delivering and expect

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We currently expect to utilize drug delivery devices authorized for marketing under clearances of approvals held by third parties.

Where approval of a drug product and device is sought under a single application, the increased complexity of the review process may delay

Our product candidates may not be approved or may be substantially delayed in receiving approval if the devices that we choose

to develop do not gain and/or maintain their own regulatory approvals or clearances.

In addition, some drug delivery devices are provided

by single-source third-party companies.

We may be dependent on the sustained cooperation and effort of those third-party companies both

to supply the devices and, in some cases, to conduct the studies required for approval or other regulatory clearance of the devices.

if approval is obtained for our products, we may also be dependent on those third-party companies continuing to maintain such approvals

or clearances, if required, for their drug delivery devices once they have been received.

Moreover, there may be unforeseen technical

complications related to the development activities required to bring such a product to market, including primary container compatibility

and/or dose volume requirements.

Failure of third-party companies to supply the devices on time and in accordance with the agreed-upon

specifications, to successfully complete studies on the devices in a timely manner, or to obtain or maintain required approvals or clearances

of the devices could result in increased development costs, delays in or failure to obtain regulatory approval and delays in product candidates

reaching patients.

Where approval of a drug product and device is sought under a single application, the increased complexity of the review process may

delay approval.

Our product candidates may not be approved or may be substantially delayed in receiving approval if the devices that

we choose to develop do not gain and/or maintain their own regulatory approvals or clearances.

In addition, some drug delivery devices

are provided by single-source third-party companies.

We may be dependent on the sustained cooperation and effort of those third-party

companies both to supply the devices and, in some cases, to conduct the studies required for approval or other regulatory clearance of

Even if approval is obtained for our products, we may also be dependent on those third-party companies continuing to maintain

such approvals or clearances, if required, for their drug delivery devices once they have been received.

Moreover, there may be unforeseen

technical complications related to the development activities required to bring such a product to market, including primary container

compatibility and/or dose volume requirements.

Failure of third-party companies to supply the devices on time and in accordance with

the agreed-upon specifications, to successfully complete studies on the devices in a timely manner, or to obtain or maintain required

approvals or clearances of the devices could result in increased development costs, delays in or failure to obtain regulatory approval

and delays in product candidates reaching patients.

Our approach to the

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with commercial value.

We have worked with Paragon

to leverage clinically validated mechanisms of action and incorporate advanced antibody engineering to optimize half-life and other properties

designed to overcome limitations of existing therapies.

We have entered into antibody discovery and option agreements (the “Option

Agreements”) with Paragon Therapeutics, Inc.

(“Paragon”) and Paruka Holding LLC to facilitate the discovery and development

of certain research programs with respect to which we have signed a license agreement with Paragon.

Our two most advanced programs, ORKA-001

and ORKA-002, are licensed from Paragon and are purposefully designed to improve upon existing product candidates and products while maintaining

the same, well-established mechanisms of action.

However, the scientific research that forms the basis of our efforts to develop programs

using half-life extension technologies is ongoing and may not result in viable programs.

There is limited clinical data available on product

candidates utilizing half-life extension technologies, especially in I&I indications, demonstrating whether they are safe or effective

for long-term treatment in humans.

The long-term safety and efficacy of these technologies and the extended half-lives and exposure profiles

of our programs compared to currently approved products are unknown.

We have worked with Paragon to leverage clinically validated mechanisms

of action and incorporate advanced antibody engineering to optimize half-life and other properties designed to overcome limitations of

existing therapies.

Our two most advanced programs, ORKA-001 and ORKA-002, are licensed from Paragon and are purposefully designed to

improve upon existing product candidates and products while maintaining the same, well-established mechanisms of action.

scientific research that forms the basis of our efforts to develop programs using half-life extension technologies is ongoing and may

not result in viable programs.

There is limited clinical data available on product candidates utilizing half-life extension technologies,

especially in I&I indications, demonstrating whether they are safe or effective for long-term treatment in humans.

The long-term safety

and efficacy of these technologies and the extended half-lives and exposure profiles of our programs compared to currently approved products

We may ultimately discover

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Preclinical and clinical

development involves a lengthy and expensive process that is subject to delays and uncertain outcomes and results of earlier studies and

trials may not be predictive of future clinical trial results.

development involves a lengthy and expensive process that is subject to delays and uncertain outcomes and results of earlier studies

and trials may not be predictive of future clinical trial results.

Further, if our preclinical studies and clinical trials are not sufficient

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Our clinical trials may not be

conducted as planned or completed on schedule, if at all, and failure can occur at any time during the preclinical study or clinical trial

The results of preclinical studies and early clinical trials of our product candidates may not be predictive of the results of

later-stage clinical trials and results in one indication may not be predictive of results to be expected for the same product candidate

conducted as planned or completed on schedule, if at all, and failure can occur at any time during the preclinical study or clinical

trial process.

The results of preclinical studies and early clinical trials of our product candidates may not be predictive of the results

of later-stage clinical trials and results in one indication may not be predictive of results to be expected for the same product candidate

in another indication.

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on clinical trial site staff to measure psoriasis area severity index scores (PASI scores) and participants to provide feedback on measures

such as measures of quality of life, which may involve subjective interpretation and variability, although training and standardized measurements

will be provided to individuals in order to minimize subjectivity.

Moreover, these measures can be influenced by factors outside of our

control, and can vary widely within a clinical trial.

such as measures of quality of life, which may involve subjective interpretation and variability, although training and standardized

measurements will be provided to individuals in order to minimize subjectivity.

Moreover, these measures can be influenced by factors

outside of our control, and can vary widely within a clinical trial.

We cannot be sure that the

FDA, or comparable foreign regulatory authority, as applicable, will agree with our clinical development plan.

We cannot assure that the

submission of an Investigational New Drug (IND) application, clinical trial application, or similar application will result in the FDA

or comparable foreign regulatory authorities, as applicable, allowing clinical trials to begin in a timely manner, if at all.

and/or comparable foreign regulatory authority requires us to materially modify our proposed trial designs, conduct additional trials

or enroll additional participants, our development timelines may be delayed.

Moreover, even if these trials begin, issues may arise that

could suspend or terminate such clinical trials, including but not limited to delays or difficulties recruiting trial patients, delays

or difficulties obtaining required IRB or ethics committee approval at each clinical trial site, failure by third parties or us to adhere

to clinical trial protocols or failure to perform in accordance with current Good Clinical Practice or applicable regulatory requirements,

or delays in reaching a consensus with regulatory authorities on trial design or implementation of a clinical trial, or our third party

vendors not satisfying their obligations to us.

We could also encounter delays

if a clinical trial is required to be materially modified or suspended or terminated by us, the IRBs, by a Data Safety Monitoring Board,

if any, or by the FDA or comparable foreign regulatory authorities.

Such authorities may suspend, put on clinical hold, or terminate a

clinical trial due to a number of factors, including not aligning with or supporting our clinical trial designs or our failure to conduct

We cannot assure that

the submission of an Investigational New Drug (IND) application, clinical trial application, or similar application will result in the

FDA or comparable foreign regulatory authorities, as applicable, allowing clinical trials to begin in a timely manner, if at all.

the FDA and/or comparable foreign regulatory authority requires us to materially modify our proposed trial designs, conduct additional

trials or enroll additional participants, our development timelines may be delayed.

Moreover, even if these trials begin, issues may

arise that could suspend or terminate such clinical trials, including but not limited to delays or difficulties recruiting trial patients,

delays or difficulties obtaining required IRB or ethics committee approval at each clinical trial site, failure by third parties or us

to adhere to clinical trial protocols or failure to perform in accordance with current Good Clinical Practice or applicable regulatory

requirements, or delays in reaching a consensus with regulatory authorities on trial design or implementation of a clinical trial, or

our third party vendors not satisfying their obligations to us.

We could also encounter

delays if a clinical trial is required to be materially modified or suspended or terminated by us, the IRBs, by a Data Safety Monitoring

Board, if any, or by the FDA or comparable foreign regulatory authorities.

Such authorities may suspend, put on clinical hold, or terminate

a clinical trial due to a number of factors, including not aligning with or supporting our clinical trial designs or our failure to conduct

the clinical trial in accordance with regulatory requirements or our clinical trial protocols, inspection of the clinical trial operations

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of adequate funding to continue the clinical trial.

If we are required to conduct additional clinical trials or other testing of our product

candidates beyond those that we currently contemplate, if we are unable to successfully complete clinical trials of our product candidates,

if the results of these trials are not positive or are only moderately positive, or if there are safety concerns, our business and results

of operations may be adversely affected and we may need to adjust or abandon our business plans and we may incur significant additional

If we are required to conduct additional clinical trials or other testing of our

product candidates beyond those that we currently contemplate, if we are unable to successfully complete clinical trials of our product

candidates, if the results of these trials are not positive or are only moderately positive, or if there are safety concerns, our business

and results of operations may be adversely affected and we may need to adjust or abandon our business plans and we may incur significant

additional costs.

Our clinical development

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We depend on the successful completion of clinical trials for our product candidates.

Our inability to enroll and

maintain a sufficient number of participants who remain in a trial until conclusion would result in significant delays in completing clinical

trials and increased development costs or may require us to abandon one or more clinical trials altogether.

The enrollment of participants

in current or future trials for any of our programs will depend on many factors, including if participants choose to enroll in our clinical

trials, rather than using approved products, or if our competitors have ongoing clinical trials for programs that are under development

for the same indications as our programs and participants instead enroll in such clinical trials.

Even if we are able to enroll a sufficient

number of participants for our clinical trials, we may have difficulty maintaining participants in such clinical trials.

Our inability to enroll

and maintain a sufficient number of participants who remain in a trial until conclusion would result in significant delays in completing

clinical trials and increased development costs or may require us to abandon one or more clinical trials altogether.

The enrollment of

participants in current or future trials for any of our programs will depend on many factors, including if participants choose to enroll

in our clinical trials, rather than using approved products, or if our competitors have ongoing clinical trials for programs that are

under development for the same indications as our programs and participants instead enroll in such clinical trials.

Even if we are able

to enroll a sufficient number of participants for our clinical trials, we may have difficulty maintaining participants in such clinical

Preliminary, “topline”,

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opportunity to fully and carefully evaluate complete data.

As a result, the preliminary or topline results that we report may differ from

future results of the same studies and our conclusions may change or be qualified as additional data are received, fully evaluated, and

subjected to audit and verification procedures.

As a result, the preliminary or topline results that we report may differ

from future results of the same studies and our conclusions may change or be qualified as additional data are received, fully evaluated,

and subjected to audit and verification procedures.

We may also publicly disclose

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or interim data that we report differ from actual results, or if final data or data from later stage clinical trials do not produce favorable

results, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which could harm our business, operating

results, prospects or financial condition.

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

operating results, prospects or financial condition.

Our clinical trials

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adequate efficacy and safety to result in regulatory approval to market any of our product candidates.

Results of our clinical trials

could reveal an unacceptable severity and prevalence of side effects or patient intolerance, adverse events, or unexpected characteristics,

Results of our clinical

trials could reveal an unacceptable severity and prevalence of side effects or patient intolerance, adverse events, or unexpected characteristics,

and any of these occurrences could harm our business, financial condition, results of operations and prospects significantly.

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In addition, an extended half-life could prolong

the duration of undesirable side effects, which could also affect our clinical trials or inhibit market acceptance.

In addition, even if we successfully

advance our product candidates through clinical trials, such trials will only include a limited number of participants and limited duration

of exposure to our product candidates.

As a result, we cannot be assured that adverse effects of our product candidates will not be uncovered

when a significantly larger number of participants are exposed to the product candidate after approval and potentially over an extended

period of use.

Further, any clinical trials may not be sufficient to determine the effect and safety consequences of using our product

candidates over a multi-year period or longer.

If any of the foregoing events

occur or if one or more of our product candidates prove to be unsafe, our pipeline could be affected, which would have a material adverse

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

We may expend our limited

resources to pursue a particular program and fail to capitalize on programs that may be more profitable or for which there is a greater

likelihood of success.

the duration of undesirable side effects, which could also affect our clinical trials, including our development and commercialization

timelines, or inhibit market acceptance.

In addition, even if we

successfully advance our product candidates through clinical trials, such trials will only include a limited number of participants and

limited duration of exposure to our product candidates.

As a result, we cannot be assured that adverse effects of our product candidates

will not be uncovered when a significantly larger number of participants are exposed to the product candidate after approval and potentially

over an extended period of use.

Further, any clinical trials may not be sufficient to determine the effect and safety consequences of

using our product candidates over a multi-year period or longer.

If any of the foregoing

events occur or if one or more of our product candidates prove to be unsafe, our pipeline could be affected, which would have a material

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

We may expend our

limited resources to pursue a particular program and fail to capitalize on programs that may be more profitable or for which there is

a greater likelihood of success.

We are initially focused

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programs that later prove to have greater commercial potential.

Our resource allocation decisions may cause us to fail to capitalize on

viable commercial products or profitable market opportunities.

Our spending on current and future research and development programs for

specific indications may not yield any commercially viable product candidates.

Our resource allocation decisions may cause us to fail to capitalize

on viable commercial products or profitable market opportunities.

Our spending on current and future research and development programs

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

If we do not accurately evaluate the commercial potential

or target market for a particular product candidate, we may be in a position where we may have to relinquish valuable rights to that product

candidate through collaboration, licensing or other arrangements in cases in which we would have been more advantageous for us to retain

sole development and commercialization rights to such product candidate.

We may never receive approval to market and commercialize any

product candidate.

or target market for a particular product candidate, we may be in a position where we may have to relinquish valuable rights to that

product candidate through collaboration, licensing or other arrangements in cases in which we would have been more advantageous for us

to retain sole development and commercialization rights to such product candidate.

We may never receive approval to market and commercialize

any product candidate.

Any approved products

resulting from our programs may not achieve adequate market acceptance among clinicians, patients, healthcare third-party payors and others

in the medical community necessary for commercial success and we may not generate any future revenue from the sale or licensing of such

resulting from our programs may not achieve adequate market acceptance among clinicians, patients, healthcare third-party payors and

others in the medical community necessary for commercial success and we may not generate any future revenue from the sale or licensing

of such products.

Even if regulatory approval

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Moreover, an extended half-life may make it more difficult

for patients to change treatments and there may be a perception that half-life extension could exacerbate side effects, each of which

may adversely affect our ability to gain market acceptance.

Further, we may not generate or derive sufficient revenue from a product candidate

and may not become or remain profitable if such product candidate is approved, but does not achieve an adequate level of acceptance.

for patients to change treatments and there may be a perception that half-life extension could exacerbate side effects, each of

which may adversely affect our ability to gain market acceptance.

Further, we may not generate or derive sufficient revenue from a product

candidate and may not become or remain profitable if such product candidate is approved, but does not achieve an adequate level of acceptance.

Certain of our programs

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trials conducted outside the United States, acceptance of this data is subject to conditions imposed by the FDA.

If the FDA does not accept

the data from any trial that we conduct outside the United States, it would likely result in the need for additional trials, which would

be costly and time-consuming and would delay or permanently halt our development of the applicable product candidates.

Even if the FDA

accepted such data, it could impose additional conditions, such as requiring us to modify our planned clinical trials to receive clearance

to initiate such trials in the United States or to continue such trials once initiated.

If the FDA does not

accept the data from any trial that we conduct outside the United States, it would likely result in the need for additional trials, which

would be costly and time-consuming and would delay or permanently halt our development of the applicable product candidates.

the FDA accepted such data, it could impose additional conditions, such as requiring us to modify our planned clinical trials to receive

clearance to initiate such trials in the United States or to continue such trials once initiated.

Further, conducting clinical

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of investigators or enrolled participants in foreign countries to adhere to clinical protocol that could restrict or limit our ability

to conduct our clinical trials, the administrative burdens of conducting clinical trials under multiple sets of foreign regulations, potential

restrictions, such as local privacy restrictions, on data generated from the clinical trial, and diminished protection of intellectual

to conduct our clinical trials, the administrative burdens of conducting clinical trials under multiple sets of foreign regulations,

potential restrictions, such as local privacy restrictions, on data generated from the clinical trial, and diminished protection of intellectual

property in some countries.

Operations in foreign jurisdictions are subject to additional risks, including dependence on third party manufacturers

or suppliers outside of the United States, as well as political and economic risks relevant to foreign countries.

Operations in foreign jurisdictions are subject to additional risks, including dependence on third party

manufacturers or suppliers outside of the United States, as well as political and economic risks relevant to foreign countries.

Risks Related to Government

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to market our product candidates, which would significantly harm our business, results of operations and prospects.

Before obtaining regulatory

approvals for the commercial sale of our product candidates, we must demonstrate through lengthy, complex and expensive preclinical studies

and clinical trials that our product candidates are both safe and effective for each targeted indication.

In addition, securing regulatory

approval also requires the submission of information about the drug manufacturing process to, and inspection of manufacturing facilities

by, the relevant regulatory authority.

Of the large number of drugs in development, only a small percentage successfully complete the

FDA or foreign regulatory approval processes and are commercialized.

Approval may never be obtained and the approval process can vary

substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates involved.

are several approved products and product candidates in later stages of development for the treatment of PsO and for the treatment of

HS, our programs incorporate advanced antibody engineering to optimize the half-life and formulation of antibodies, and to date, no such

antibody has been approved by the FDA for the treatment of PsO or for HS.

Before obtaining

regulatory approvals for the commercial sale of our product candidates, we must demonstrate through lengthy, complex and expensive preclinical

studies and clinical trials that our product candidates are both safe and effective for each targeted indication.

In addition, securing

regulatory approval also requires the submission of information about the drug manufacturing process to, and inspection of manufacturing

facilities by, the relevant regulatory authority.

Of the large number of drugs in development, only a small percentage successfully complete

the FDA or foreign regulatory approval processes and are commercialized.

Approval may never be obtained and the approval process can

vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates involved.

there are several approved products and product candidates in later stages of development for the treatment of PsO and for the treatment

of HS, our programs incorporate advanced antibody engineering to optimize the half-life and formulation of antibodies, and to date, no

such antibody has been approved by the FDA for the treatment of PsO or for HS.

The FDA and comparable foreign

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by the FDA until 12 years from the date on which the reference product was first approved.

During this 12-year period of

exclusivity, another company may still market a competing version of the reference product if the FDA approves a full BLA for the competing

product containing the sponsor’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate

the safety, purity, and potency of their product.

During this 12-year period

of exclusivity, another company may still market a competing version of the reference product if the FDA approves a full BLA for the

competing product containing the sponsor’s own preclinical data and data from adequate and well-controlled clinical trials

to demonstrate the safety, purity, and potency of their product.

We believe that any of our

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receive regulatory approval, we will remain subject to ongoing regulatory requirements imposed by the FDA and comparable foreign authorities.

These requirements may include post-approval safety and pharmacovigilance reporting, product labeling restrictions or warnings, risk management

requirements such as a Risk Evaluation and Mitigation Strategy (“REMS”), post-marketing commitments or additional studies

to further assess safety, efficacy, or real-world use, as well as compliance with applicable manufacturing and quality system regulations.

These requirements may include post-approval safety and pharmacovigilance reporting, product labeling restrictions or warnings, risk

management requirements such as a Risk Evaluation and Mitigation Strategy (“REMS”), post-marketing commitments or additional

studies to further assess safety, efficacy, or real-world use, as well as compliance with applicable manufacturing and quality system

Regulatory authorities may

also conduct periodic inspections of our manufacturing facilities or those of our third-party manufacturers and may take enforcement action

if we or such third parties fail to comply with applicable regulatory requirements or if safety, quality, or manufacturing issues arise.

Such actions could include labeling changes, restrictions on use or distribution, clinical holds, recalls or withdrawal of products, warning

or untitled letters, fines, penalties, or other enforcement measures.

Failure to comply with these ongoing obligations, or the emergence

of unexpected safety or quality issues after commercialization, could result in significant additional costs, limit our ability to commercialize,

and may materially harm our business.

also conduct periodic inspections of our manufacturing facilities or those of our third-party manufacturers and may take enforcement

action if we or such third parties fail to comply with applicable regulatory requirements or if safety, quality, or manufacturing issues

Such actions could include labeling changes, restrictions on use or distribution, clinical holds, recalls or withdrawal of products,

warning or untitled letters, fines, penalties, or other enforcement measures.

Failure to comply with these ongoing obligations, or the

emergence of unexpected safety or quality issues after commercialization, could result in significant additional costs, limit our ability

to commercialize, and may materially harm our business.

Disruptions or changes

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the start of the Trump administration in January 2025, the full impact of which is unclear at this time.

Average review times at the agency

have fluctuated in recent years as a result.

In addition, government funding of the SEC, and other government agencies on which our operations

may rely, including those that fund research and development activities is subject to the political process, which is inherently fluid

and unpredictable.

Furthermore, the Trump administration has made and is expected to continue to make changes in the leadership of various

Average review times at the

agency have fluctuated in recent years as a result.

In addition, government funding of the SEC, and other government agencies on which

our operations may rely, including those that fund research and development activities is subject to the political process, which is

inherently fluid and unpredictable.

Furthermore, the Trump administration has made and is expected to continue to make changes in the

leadership of various U.S.

federal regulatory agencies and changes to U.S.

federal government policy that have led to, in some cases, legal challenges and uncertainty

around the funding, functioning and policy priorities of the U.S.

federal regulatory agencies, including the FDA.

federal government policy that have led to, in some cases,

legal challenges and uncertainty around the funding, functioning and policy priorities of the U.S.

federal regulatory agencies, including

Disruptions at the FDA and

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critical employees and stopped critical activities.

Additionally, action by the Trump administration to limit federal agency budgets or

personnel may result in reductions to the FDA’s budget, employees, and operations, which may lead to slower response times and longer

review periods, potentially affecting our ability to progress development of our product candidates or obtain regulatory approval for

our product candidates.

If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review

and process our regulatory submissions, which could have a material adverse effect on our business.

Further, government shutdowns could

impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

Additionally, action by the Trump administration to limit federal agency budgets

or personnel may result in reductions to the FDA’s budget, employees, and operations, which may lead to slower response times and

longer review periods, potentially affecting our ability to progress development of our product candidates or obtain regulatory approval

for our product candidates.

If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely

review and process our regulatory submissions, which could have a material adverse effect on our business.

Further, government shutdowns

could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

We are unable to predict

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or changing regulatory and governmental regulations that could prevent, limit or delay regulatory approval of our product candidates.

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

executive action, either in the United States or abroad.

For example, the Trump administration has discussed several changes to the

reach and oversight of the FDA, which could affect its relationship with the pharmaceutical industry, transparency in decision making

and ultimately the cost and availability of prescription drugs.

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

or executive action, either in the United States or abroad.

For example, the Trump administration has discussed several changes

to the reach and oversight of the FDA, which could affect its relationship with the pharmaceutical industry, transparency in decision

making and ultimately the cost and availability of prescription drugs.

If we are slow or unable to adapt to changes in existing requirements

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reimbursement for drugs;

new or increased requirements to pay prescription drug rebates to government healthcare programs, including if

drug prices increase at a higher rate than inflation;

new or increased requirements to pay prescription drug rebates to government healthcare programs, including

if drug prices increase at a higher rate than inflation;

controls on healthcare providers;

challenges to or limits on the pricing of drugs,

including pricing controls or limits or prohibitions on reimbursement for specific products through other means;

requirements to try less

expensive products or generics before a more expensive branded product;

and public funding for cost effectiveness research, which may

be used by government and private third-party payors to make coverage and payment decisions.

Political, economic and regulatory developments

may further complicate developments in healthcare systems and pharmaceutical drug pricing.

These developments could, for example, impact

our potential licensing agreements as commercial and collaborative partners may also consider the impact of these pressures on their licensing

challenges to or limits on the pricing of

drugs, including pricing controls or limits or prohibitions on reimbursement for specific products through other means;

to try less expensive products or generics before a more expensive branded product;

and public funding for cost effectiveness research,

which may be used by government and private third-party payors to make coverage and payment decisions.

Political, economic and regulatory

developments may further complicate developments in healthcare systems and pharmaceutical drug pricing.

These developments could, for

example, impact our potential licensing agreements as commercial and collaborative partners may also consider the impact of these pressures

on their licensing strategies.

Any new laws or regulations

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and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors, patient organizations

and customers will be subject to applicable healthcare regulatory laws, including conflicts of interest rules, which could expose us to

Our business operations and

current and future arrangements with investigators, healthcare professionals, consultants, third-party payors, patient organizations

and customers will be subject to applicable healthcare regulatory laws, including conflicts of interest rules, which could expose us

to penalties.

Our business operations

and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors, patient organizations

and customers may expose us to broadly applicable healthcare laws and regulations, including conflict of interest laws.

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constrain the business or financial arrangements and relationships through which we conduct our operations.

Principal investigators for

our clinical trials may serve as scientific advisors or consultants to us or may be affiliated with our other service providers, including

CROs or site management organizations, and from time to time may receive cash compensation in connection with such services.

relationships and any related compensation result in perceived or actual conflicts of interest, the integrity of the data generated at

the applicable clinical trial site or in the applicable trial may be questioned or jeopardized.

Principal investigators

for our clinical trials may serve as scientific advisors or consultants to us or may be affiliated with our other service providers,

including CROs or site management organizations, and from time to time may receive cash compensation in connection with such services.

If these relationships and any related compensation result in perceived or actual conflicts of interest, the integrity of the data generated

at the applicable clinical trial site or in the applicable trial may be questioned or jeopardized.

Ensuring that our internal

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which could materially adversely affect our business and financial condition.

We are subject to U.S.

certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations.

We are subject to

and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws

and regulations.

We can face criminal liability and other serious consequences for violations, which can harm our business.

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part of cost containment measures.

Political, economic, and regulatory developments may further complicate pricing negotiations, and pricing

negotiations may continue after reimbursement has been obtained.

Reference pricing used by various EU Member States and parallel distribution,

or arbitrage between low-priced and high-priced EU Member States, can further reduce prices.

To obtain coverage and reimbursement

or pricing approvals in some countries, we or current or future collaborators may be required to conduct a clinical trial or other studies

that compare the cost-effectiveness of our product candidates to other available therapies in order to obtain or maintain reimbursement

or pricing approval.

Publication of discounts by third-party payors or authorities may lead to further pressure on the prices or

reimbursement levels within the country of publication and other countries.

If reimbursement of any product candidate approved for marketing

is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business, financial condition, results

of operations, or prospects could be materially and adversely affected.

If the UK or EU Member States were to significantly alter their

regulations affecting the pricing of prescription pharmaceuticals, we could face significant new costs.

Risks Related to Our Intellectual

Political, economic, and regulatory developments may further complicate pricing negotiations, and

pricing negotiations may continue after reimbursement has been obtained.

Reference pricing used by various EU Member States and parallel

distribution, or arbitrage between low-priced and high-priced EU Member States, can further reduce prices.

To obtain coverage

and reimbursement or pricing approvals in some countries, we or current or future collaborators may be required to conduct a clinical

trial or other studies that compare the cost-effectiveness of our product candidates to other available therapies in order to obtain

or maintain reimbursement or pricing approval.

Publication of discounts by third-party payors or authorities may lead to further

pressure on the prices or reimbursement levels within the country of publication and other countries.

If reimbursement of any product

candidate approved for marketing is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business,

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

If the UK or EU Member States were

to significantly alter their regulations affecting the pricing of prescription pharmaceuticals, we could face significant new costs.

Risks Related to Our

Intellectual Property

Our ability to obtain,

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We rely upon a combination

of patents, trademarks, trade secret protection, confidentiality agreements, and the Option and License Agreements with Paragon to protect

the intellectual property related to our programs and technologies and to prevent third parties from competing unfairly with it.

depends in large part on our ability to obtain and maintain patent protection for our programs and our product candidates and their uses,

as well as our ability to operate without infringing on or violating the proprietary rights of others.

We and Paragon have filed, and

of patents, trademarks, trade secret protection, confidentiality agreements, and the agreements with Paragon to protect the intellectual

property related to our programs and technologies and to prevent third parties from competing unfairly with it.

Our success depends in

large part on our ability to obtain and maintain patent protection for our programs and our product candidates and their uses, as well

as our ability to operate without infringing on or violating the proprietary rights of others.

We and Paragon have filed, and may continue

to file, provisional and non-provisional patent applications directed to antibodies that target IL-23, including applications covering

composition of matter, pharmaceutical formulations, and methods of use, including ORKA-001.

In addition, we and Paragon have filed, and

may continue to file, provisional and non-provisional patent applications directed to antibodies that target IL-17, including applications

covering composition of matter, pharmaceutical formulations, and methods of use, including ORKA-002.

In addition, we and Paragon have

filed, and may continue to file, provisional and non-provisional patent applications directed to antibodies that target IL-17, including

applications covering composition of matter, pharmaceutical formulations, and methods of use, including ORKA-002.

However, we may not

be able to protect our intellectual property rights throughout the world and the legal systems in certain countries may not favor enforcement

or protection of patents, trade secrets, and other intellectual property.

Filing, prosecuting and defending patents on programs worldwide

is expensive and our intellectual property rights in some foreign jurisdictions can be less extensive than those in the United States;

the reverse may also occur.

As such, we may not have patents in all countries or all major markets and may not be able to obtain patents

in all jurisdictions even if we apply for them.

Our competitors may operate in countries where we do not have patent protection and can

freely use our technologies and discoveries in such countries to the extent such technologies and discoveries are publicly known or disclosed

in countries where we do have patent protection or pending patent applications.

However, we may not be able to protect

our intellectual property rights throughout the world and the legal systems in certain countries may not favor enforcement or protection

of patents, trade secrets, and other intellectual property.

Filing, prosecuting and defending patents on programs worldwide is expensive

and our intellectual property rights in some foreign jurisdictions can be less extensive than those in the United States;

may also occur.

As such, we may not have patents in all countries or all major markets and may not be able to obtain patents in all jurisdictions

even if we apply for them.

Our competitors may operate in countries where we do not have patent protection and can freely use our technologies

and discoveries in such countries to the extent such technologies and discoveries are publicly known or disclosed in countries where we

do have patent protection or pending patent applications.

Our pending and future patent

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Any issued patents may not afford sufficient protection of our programs or their

intended uses against competitors, nor can there be any assurance that the patents issued will not be infringed, designed around, or invalidated

by third parties, or will effectively prevent others from commercializing competitive technologies, products, or programs.

Even if these

patents are granted, they may be difficult to enforce.

Further, any issued patents that we may license or own covering our programs could

be narrowed or found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad, including

the United States Patent and Trademark Office (“USPTO”).

Further, if we encounter delays in our clinical trials or delays

in obtaining regulatory approval, the period of time during which we could market our product candidates under patent protection would

intended uses against competitors, nor can there be any assurance that the patents issued will not be infringed, designed around, or

invalidated by third parties, or will effectively prevent others from commercializing competitive technologies, products, or programs.

Even if these patents are granted, they may be difficult to enforce.

Further, any issued patents that we may license or own covering

our programs could be narrowed or found invalid or unenforceable if challenged in court or before administrative bodies in the United

States or abroad, including the United States Patent and Trademark Office (“USPTO”).

Further, if we encounter delays in our

clinical trials or delays in obtaining regulatory approval, the period of time during which we could market our product candidates under

patent protection would be reduced.

Thus, the patents that we may own and license may not afford us any meaningful competitive advantage.

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agreements, with our vendors, collaborators, employees, consultants, outside scientific collaborators and sponsored researchers and other

These agreements may not effectively prevent disclosure of confidential information and may not provide an adequate remedy in

the event of unauthorized disclosure of confidential information.

We may need to share our proprietary information, including trade secrets,

with future business partners, collaborators, contractors and others located in countries at heightened risk of theft of trade secrets,

including through direct intrusion by private parties or state actors and those affiliated with or controlled by state actors.

while we undertake efforts to protect our trade secrets and other confidential information from disclosure, others may independently discover

trade secrets and proprietary information, and in such cases, we may not be able to assert any trade secret rights against such party.

These agreements may not effectively prevent disclosure of confidential information and may not provide an adequate remedy

in the event of unauthorized disclosure of confidential information.

We may need to share our proprietary information, including trade

secrets, with future business partners, collaborators, contractors and others located in countries at heightened risk of theft of trade

secrets, including through direct intrusion by private parties or state actors and those affiliated with or controlled by state actors.

In addition, while we undertake efforts to protect our trade secrets and other confidential information from disclosure, others may independently

discover trade secrets and proprietary information, and in such cases, we may not be able to assert any trade secret rights against such

Enforcing a claim that a party illegally obtained and is using our trade secrets is challenging and the outcome is unpredictable.

courts outside of the U.S.

In addition, courts outside of the U.S.

may be less willing to protect trade secrets.

Costly and time-consuming litigation could be necessary to enforce

and determine the scope of our proprietary rights and failure to obtain or maintain trade secret protection could adversely affect our

competitive business position.

Costly and time-consuming litigation could be necessary

to enforce and determine the scope of our proprietary rights and failure to obtain or maintain trade secret protection could adversely

affect our competitive business position.

Lastly, if our trademarks

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in obtaining or maintaining necessary rights to our programs through acquisitions and in-licenses.

Because our development programs

currently do and may in the future require the use of proprietary rights held by third parties, the growth of our business may depend

in part on our ability to acquire, in-license, or use these third-party proprietary rights.

It is possible that we may

be unable to obtain licenses at a reasonable cost or on reasonable terms, if at all.

Even if we are able to obtain a license, it may be

non-exclusive, thereby giving our competitors access to the same technologies licensed to us.

Because our development

programs currently do and may in the future require the use of proprietary rights held by third parties, the growth of our business may

depend in part on our ability to acquire, in-license, or use these third-party proprietary rights.

It is possible that

we may be unable to obtain licenses at a reasonable cost or on reasonable terms, if at all.

Even if we are able to obtain a license,

it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us.

We may be unable to acquire or in-license any

compositions, methods of use, processes or other intellectual property rights from third parties that we identify as necessary for our

The licensing and acquisition of third-party intellectual property rights is a competitive area, and a number of more established

companies may pursue strategies to license or acquire third-party intellectual property rights that we may consider attractive or

These established companies may have a competitive advantage over us due to their size, capital resources, and greater clinical

development and commercialization capabilities.

In addition, companies that perceive us to be a competitor may be unwilling to assign

or license rights to us.

We also may be unable to license or acquire third-party intellectual property rights on terms that would

allow us to make an appropriate return on our investment or at all.

If we are unable to successfully obtain rights to required third-party intellectual

property or maintain the existing intellectual property rights we do obtain, we may have to abandon the development of the relevant program,

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

While we plan to obtain the

right to control patent prosecution, maintenance, and enforcement of the patents relating to our programs, there may be times when the

filing and prosecution activities for patents and patent applications relating to our programs are controlled by our current and future

licensors or collaboration partners.

The licensing and acquisition of third-party intellectual property rights is a competitive area, and a number of more

established companies may pursue strategies to license or acquire third-party intellectual property rights that we may consider

attractive or necessary.

These established companies may have a competitive advantage over us due to their size, capital resources, and

greater clinical development and commercialization capabilities.

In addition, companies that perceive us to be a competitor may be unwilling

to assign or license rights to us.

We also may be unable to license or acquire third-party intellectual property rights on terms

that would allow us to make an appropriate return on our investment or at all.

If we are unable to successfully obtain rights to required

third-party intellectual property or maintain the existing intellectual property rights we do obtain, we may have to abandon the

development of the relevant program, which could have a material adverse effect on our business, financial condition, results of operations,

and prospects.

While we plan to obtain

the right to control patent prosecution, maintenance, and enforcement of the patents relating to our programs, there may be times when

the filing and prosecution activities for patents and patent applications relating to our programs are controlled by our current and

future licensors or collaboration partners.

If any of our current and future licensors or collaboration partners fail to prosecute, maintain,

and enforce such patents and patent applications in a manner consistent with the best interests of our business, we could lose our rights

to the intellectual property or our exclusivity with respect to those rights, our ability to develop and commercialize those product candidates

may be adversely affected and we may not be able to prevent competitors from making, using, and selling competing products.

even where we have the right to control prosecution of patents and patent applications we have licensed to and from third parties, we

may still be adversely affected or prejudiced by actions or inactions of our licensees, our future licensors, and our counsel that took

place prior to the date upon which we assumed control over patent prosecution.

Moreover, if other third parties have ownership rights

to our future in-licensed patents, they may be able to license such patents to our competitors, and our competitors could market competing

products and technology.

to the intellectual property or our exclusivity with respect to those rights, our ability to develop and commercialize those product

candidates may be adversely affected and we may not be able to prevent competitors from making, using, and selling competing products.

In addition, even where we have the right to control prosecution of patents and patent applications we have licensed to and from third

parties, we may still be adversely affected or prejudiced by actions or inactions of our licensees, our future licensors, and our counsel

that took place prior to the date upon which we assumed control over patent prosecution.

Moreover, if other third parties have ownership

rights to our future in-licensed patents, they may be able to license such patents to our competitors, and our competitors could market

competing products and technology.

Failure to obtain licenses

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our right to transfer or assign the license;

the inventorship and ownership of inventions and know-how resulting

from the joint creation or use of intellectual property by our future licensors and us and our partners;

and the priority of invention

of patented technology.

We may be subject to

patent infringement claims or may need to file claims to protect our intellectual property, which could result in substantial costs and

liability and prevent us from commercializing our potential products.

the inventorship and ownership of inventions

and know-how resulting from the joint creation or use of intellectual property by our future licensors and us and our partners;

and the priority of invention of patented technology.

We may be subject

to patent infringement claims or may need to file claims to protect our intellectual property, which could result in substantial costs

and liability and prevent us from commercializing our potential products.

Because the intellectual

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An adverse determination in any

such submission or proceeding could reduce the scope of, affect the enforceability of, or invalidate, our patent rights, which could adversely

affect our competitive position.

Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in

such submission or proceeding could reduce the scope of, affect the enforceability of, or invalidate, our patent rights, which could

adversely affect our competitive position.

Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard

federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding

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on behalf of those parties or may be required to obtain licenses for the products they use.

Furthermore, because of the

substantial amount of discovery required in connection with intellectual property litigation or other legal proceedings relating to our

intellectual property rights, there is a risk that some of our confidential information could be compromised by disclosure during this

type of litigation or other proceedings.

Changes to patent laws

and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.

Furthermore, because of

the substantial amount of discovery required in connection with intellectual property litigation or other legal proceedings relating

to our intellectual property rights, there is a risk that some of our confidential information could be compromised by disclosure during

this type of litigation or other proceedings.

Changes to patent

laws in the U.S.

and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our

Changes in either the patent

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Congress, the federal courts, the USPTO,

and the relevant law-making bodies in other countries, the laws and regulations governing patents could change in unpredictable ways that

could have a material adverse effect on our patent rights and our ability to protect, defend, and enforce our patent rights in the future.

In addition, geopolitical instability could increase the uncertainties and costs surrounding the prosecution or maintenance of patent

applications and the maintenance, enforcement, or defense of issued patents.

The patent positions of companies

in the development and commercialization of biologics and pharmaceuticals are particularly uncertain.

Supreme Court and U.S.

of Appeals for the Federal Circuit rulings have narrowed the scope of patent protection available in certain circumstances and weakened

the rights of patent owners in certain situations, including in the antibody arts.

and the relevant law-making bodies in other countries, the laws and regulations governing patents could change in unpredictable ways

that could have a material adverse effect on our patent rights and our ability to protect, defend, and enforce our patent rights in the

In addition, geopolitical instability could increase the uncertainties and costs surrounding the prosecution or maintenance of

patent applications and the maintenance, enforcement, or defense of issued patents.

The patent positions of

companies in the development and commercialization of biologics and pharmaceuticals are particularly uncertain.

Supreme Court

Court of Appeals for the Federal Circuit rulings have narrowed the scope of patent protection available in certain circumstances

and weakened the rights of patent owners in certain situations, including in the antibody arts.

For example, the U.S.

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particular antigen.

Even if we are granted claims directed to functionally defined antibodies, it is possible that a third party may challenge

our patents, when issued, relying on the reasoning in Amgen or other recent precedential court decisions.

In addition, a European Unified

Patent Court (“UPC”) entered into force on June 1, 2023.

The UPC is a common patent court that hears patent infringement

and revocation proceedings effective for EU Member States.

This could enable third parties to seek revocation of a European patent in

a single proceeding at the UPC rather than through multiple proceedings in each of the jurisdictions in which the European patent is validated.

Even if we are granted claims directed to functionally defined antibodies, it is possible that a third party may

challenge our patents, when issued, relying on the reasoning in Amgen or other recent precedential court decisions.

In addition, a European

Unified Patent Court (“UPC”) entered into force on June 1, 2023.

The UPC is a common patent court that hears patent

infringement and revocation proceedings effective for EU Member States.

This could enable third parties to seek revocation of a European

patent in a single proceeding at the UPC rather than through multiple proceedings in each of the jurisdictions in which the European

patent is validated.

Although we do not currently

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protection could have a material adverse impact on our business and our ability to commercialize or license our technology and products.

Moreover, the controlling laws and regulations of the UPC will develop over time, and may adversely affect our ability to enforce or defend

the validity of any European patents we may obtain.

We may decide to opt out from the UPC any future European patent applications that

we may file and any patents we may obtain.

If certain formalities and requirements are not met, however, such European patents and patent

applications could be challenged for non-compliance and brought under the jurisdiction of the UPC.

We cannot be certain

that future European patents and patent applications will avoid falling under the jurisdiction of the UPC, if we decide to opt out of

Moreover, the controlling laws and regulations of the UPC will develop over time, and may adversely affect our ability to enforce or

defend the validity of any European patents we may obtain.

We may decide to opt out from the UPC any future European patent applications

that we may file and any patents we may obtain.

If certain formalities and requirements are not met, however, such European patents and

patent applications could be challenged for non-compliance and brought under the jurisdiction of the UPC.

certain that future European patents and patent applications will avoid falling under the jurisdiction of the UPC, if we decide to opt

out of the UPC.

Obtaining and maintaining

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jurisdiction.

The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent, and the patent’s

prosecution history.

The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent, and the

patent’s prosecution history.

Our interpretation of the relevance or the scope of a patent or a pending application may be incorrect.

we may incorrectly determine that our products are not covered by a third-party patent or may incorrectly predict whether a third-party’s

pending application will issue with claims of relevant scope.

Our determination of the expiration date of any patent in the U.S.

that we consider relevant may be incorrect.

Our failure to identify and correctly interpret relevant patents may negatively impact our

ability to develop and market our products.

For example, we may incorrectly determine that our products are not covered by a third-party patent or may incorrectly predict whether

a third-party’s pending application will issue with claims of relevant scope.

Our determination of the expiration date of any patent

or abroad that we consider relevant may be incorrect.

Our failure to identify and correctly interpret relevant patents may

negatively impact our ability to develop and market our products.

In addition, because some

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Inventorship disputes may arise from conflicting views regarding the contributions of different individuals named as inventors,

the effects of foreign laws where foreign nationals are involved in the development of the subject matter of the patent, conflicting obligations

of third parties involved in developing our programs, or as a result of questions regarding co-ownership of potential joint

the effects of foreign laws where foreign nationals are involved in the development of the subject matter of the patent, conflicting

obligations of third parties involved in developing our programs, or as a result of questions regarding co-ownership of potential

joint inventions.

Litigation may be necessary to resolve these and other claims challenging inventorship and/or ownership.

Alternatively, or

additionally, we may enter into agreements to clarify the scope of our rights in such intellectual property.

If we fail in defending any

such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of,

or right to use, valuable intellectual property.

Alternatively,

or additionally, we may enter into agreements to clarify the scope of our rights in such intellectual property.

If we fail in defending

any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership

of, or right to use, valuable intellectual property.

Such an outcome could have a material adverse effect on our business.

Even if we are

successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other

are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and

other employees.

Patent terms may be

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are commercialized.

As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from

commercializing products similar or identical to ours.

As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others

from commercializing products similar or identical to ours.

Our technology licensed

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scholarly disclosures of information relating to the technology.

It is difficult to monitor whether our licensors limit their use of the

technology to these uses, and we could incur substantial expenses to enforce our rights to our licensed technology in the event of misuse.

In addition, our future licensors

may rely on third-party consultants or collaborators or on funds from third parties, such as the U.S.

government, such that

our licensors would not be the sole and exclusive owners of any patents we in-license.

If other third parties have ownership

rights or other rights to our in-licensed patents, they may be able to license such patents to our competitors, and our competitors

could market competing products and technology.

This could have a material adverse effect on our competitive position, business, financial

conditions, results of operations, and prospects.

Risks Related to Our Reliance

on Third Parties

We currently rely on

licensing arrangements for a substantial portion of our product portfolio, including with Paragon for ORKA-001 and ORKA-002.

unable to maintain collaborations or licensing arrangements, or if our collaborations or licensing arrangements are not successful, our

business could be negatively impacted.

It is difficult to monitor whether our licensors limit their use of

the technology to these uses, and we could incur substantial expenses to enforce our rights to our licensed technology in the event of

In addition, our future

licensors may rely on third-party consultants or collaborators or on funds from third parties, such as the U.S.

such that our licensors would not be the sole and exclusive owners of any patents we in-license.

If other third parties have

ownership rights or other rights to our in-licensed patents, they may be able to license such patents to our competitors, and

our competitors could market competing products and technology.

This could have a material adverse effect on our competitive position,

business, financial conditions, results of operations, and prospects.

Risks Related to Our

Reliance on Third Parties

We currently rely

on licensing arrangements for a substantial portion of our product portfolio, including with Paragon for ORKA-001 and ORKA-002.

are unable to maintain collaborations or licensing arrangements, or if our collaborations or licensing arrangements are not successful,

our business could be negatively impacted.

Collaborations or licensing

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or license agreements, including payment terms and diligence terms, our collaborators or licensors may have the right to terminate such

agreements, in which event we may lose intellectual property rights and may not be able to develop, manufacture, market, or sell the products

covered by our agreements or may face other penalties under our agreements.

Our collaborators and licensors may also fail to properly

maintain or defend the intellectual property we have licensed from them, if required by our agreement with them, or even infringe upon,

our intellectual property rights, leading to the potential invalidation of our intellectual property or subjecting us to litigation or

arbitration, any of which would be time-consuming and expensive and could harm our ability to commercialize our product candidates.

addition, collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with

our programs and products if the collaborators believe that the competitive products are more likely to be successfully developed or can

be commercialized under terms that are more economically attractive than ours.

agreements, in which event we may lose intellectual property rights and may not be able to develop, manufacture, market, or sell the

products covered by our agreements or may face other penalties under our agreements.

Our collaborators and licensors may also fail to

properly maintain or defend the intellectual property we have licensed from them, if required by our agreement with them, or even infringe

upon, our intellectual property rights, leading to the potential invalidation of our intellectual property or subjecting us to litigation

or arbitration, any of which would be time-consuming and expensive and could harm our ability to commercialize our product candidates.

In addition, collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with

our programs and products if the collaborators believe that the competitive products are more likely to be successfully developed or

can be commercialized under terms that are more economically attractive than ours.

As part of our strategy,

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issue securities that dilute our existing stockholders or disrupt our management and business.

We may face significant competition

in attracting appropriate collaborators, and more established companies may also be pursuing strategies to license or acquire third-party

intellectual property rights that we consider attractive.

These companies may have a competitive advantage over us due to their size,

financial resources, and greater clinical development and commercialization capabilities.

In addition, companies that perceive us to be

a competitor may be unwilling to assign or license rights to us.

Whether we reach a definitive agreement for a collaboration will depend

upon, among other things, our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed

collaboration and the proposed collaborator’s evaluation of a number of factors.

Collaborations are complex and time-consuming to

negotiate, document, and execute.

In addition, consolidation among large pharmaceutical and biotechnology companies has reduced the number

of potential future collaborators.

We may not be able to negotiate collaborations on a timely basis, on acceptable terms or at all.

we fail to enter into collaborations and do not have sufficient funds or expertise to undertake the necessary development and commercialization

activities, we may not be able to further develop our product candidates or bring them to market.

We may face significant

competition in attracting appropriate collaborators, and more established companies may also be pursuing strategies to license or acquire

third-party intellectual property rights that we consider attractive.

These companies may have a competitive advantage over us due to

their size, financial resources, and greater clinical development and commercialization capabilities.

In addition, companies that perceive

us to be a competitor may be unwilling to assign or license rights to us.

Whether we reach a definitive agreement for a collaboration

will depend upon, among other things, our assessment of the collaborator’s resources and expertise, the terms and conditions of

the proposed collaboration and the proposed collaborator’s evaluation of a number of factors.

Collaborations are complex and time-consuming

to negotiate, document, and execute.

In addition, consolidation among large pharmaceutical and biotechnology companies has reduced the

number of potential future collaborators.

We may not be able to negotiate collaborations on a timely basis, on acceptable terms or at

If we fail to enter into collaborations and do not have sufficient funds or expertise to undertake the necessary development and

commercialization activities, we may not be able to further develop our product candidates or bring them to market.

We currently rely,

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to continue to utilize and depend upon independent investigators and collaborators, such as institutions, CROs, contract testing labs,

CMOs and strategic partners, to supply, conduct, and support our preclinical studies and clinical trials pursuant to agreements with us.

CMOs and strategic partners, to supply, conduct, and support our preclinical studies and clinical trials pursuant to agreements with

We will rely heavily on these third parties over the course of our preclinical studies and clinical trials, and we control only certain

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if we were relying entirely upon our own staff.

Nevertheless, we are responsible for ensuring that each of our studies and trials is conducted

in accordance with the applicable protocol, legal, regulatory, and scientific standards, and our reliance on these third parties does

not relieve us of our regulatory responsibilities.

Nevertheless, we are responsible for ensuring that each of our studies and trials is

conducted in accordance with the applicable protocol, legal, regulatory, and scientific standards, and our reliance on these third parties

does not relieve us of our regulatory responsibilities.

We and our third-party contractors and CROs are required to comply with GCP regulations,

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by a given regulatory authority, such regulatory authority will determine that any of our clinical trials comply with GCP regulations.

Moreover, our business may be implicated if any of these third parties violate federal or state fraud and abuse or false claims laws and

regulations or healthcare privacy and security laws.

Moreover, our business may be implicated if any of these third parties violate federal or state fraud and abuse or false claims laws

and regulations or healthcare privacy and security laws.

Although we have remedies

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directly or indirectly with our product candidates.

If these third parties do not successfully carry out their contractual duties or obligations

or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised

due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our clinical trials may be extended,

delayed or terminated and we may not be able to complete development of, obtain regulatory approval of or successfully commercialize our

product candidates.

If these third parties do not successfully carry out their contractual duties or

obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is

compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our clinical trials

may be extended, delayed or terminated and we may not be able to complete development of, obtain regulatory approval of or successfully

commercialize our product candidates.

We rely on the use

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manufacturing suites or if the third-party manufacturers encounter difficulties in production.

We do not currently own any

facility that may be used as our clinical or commercial manufacturing and processing facility and must currently rely on CMOs to manufacture

our product candidates.

We have not yet caused any product candidates to be manufactured on a commercial scale and may not be able to

do so for any of our product candidates, if approved.

We do not currently own

any facility that may be used as our clinical or commercial manufacturing and processing facility and must currently rely on CMOs to

manufacture our product candidates.

We have not yet caused any product candidates to be manufactured on a commercial scale and may not

be able to do so for any of our product candidates, if approved.

We currently have a sole source relationship for our supply of the ORKA-001 and

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If there should be any disruption in such supply arrangement, including any adverse events affecting our sole

supplier, it could have a negative effect on the clinical development of our programs and other operations while we work to identify and

qualify an alternate supply source.

We do not control the manufacturing process of, and are completely dependent on, our contract manufacturing

partners for compliance with cGMP requirements and any other regulatory requirements of the FDA or comparable foreign regulatory authorities

for the manufacture of our product candidates.

Beyond periodic audits, we have limited control over the ability of our CMOs to maintain

adequate quality control, quality assurance and qualified personnel.

If the FDA or a comparable foreign regulatory authority does not

approve these facilities for the manufacture of our product candidates or if it withdraws any approval in the future, we may need to find

alternative manufacturing facilities, which would require the incurrence of significant additional costs, delays, and materially adversely

affect our ability to develop, obtain regulatory approval for or market our product candidates, if approved.

Similarly, our failure, or

the failure of our CMOs, to comply with applicable regulations could result in sanctions being imposed on us, including fines, injunctions,

civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or drugs,

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

or drugs and harm our business and results of operations.

supplier, it could have a negative effect on the clinical development of our programs and other operations while we work to identify

and qualify an alternate supply source.

We do not control the manufacturing process of, and are completely dependent on, our contract

manufacturing partners for compliance with cGMP requirements and any other regulatory requirements of the FDA or comparable foreign regulatory

authorities for the manufacture of our product candidates.

Beyond periodic audits, we have limited control over the ability of our CMOs

to maintain adequate quality control, quality assurance and qualified personnel.

If the FDA or a comparable foreign regulatory authority

does not approve these facilities for the manufacture of our product candidates or if it withdraws any approval in the future, we may

need to find alternative manufacturing facilities, which would require the incurrence of significant additional costs, delays, and materially

adversely affect our ability to develop, obtain regulatory approval for or market our product candidates, if approved.

Similarly, our

failure, or the failure of our CMOs, to comply with applicable regulations could result in sanctions being imposed on us, including fines,

injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates

or drugs, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our product

candidates or drugs and harm our business and results of operations.

Moreover, our CMOs may experience

manufacturing difficulties due to resource constraints, supply chain issues, proposed or actual legislative changes or requirements, or

as a result of labor disputes or unstable political environments.

If any CMOs on which we will rely fail to manufacture quantities of

our product candidates at quality levels necessary to meet regulatory requirements and at a scale sufficient to meet anticipated demand

manufacturing difficulties due to resource constraints, supply chain issues, proposed or actual legislative changes or requirements,

or as a result of labor disputes or unstable political environments.

If any CMOs on which we will rely fail to manufacture quantities

of our product candidates at quality levels necessary to meet regulatory requirements and at a scale sufficient to meet anticipated demand

at a cost that allows us to achieve profitability, our business, financial condition, and prospects could be materially and adversely

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or export of products.

Our business could be materially adversely affected by business disruptions to our third-party providers that

could materially adversely affect our anticipated timelines, potential future revenue and financial condition, and increase our costs

and expenses.

Our business could be materially adversely affected by business disruptions to our third-party providers

that could materially adversely affect our anticipated timelines, potential future revenue and financial condition, and increase our

costs and expenses.

Each of these risks could delay or prevent the completion of our preclinical studies and clinical trials or the approval

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costs, reduce the availability of materials, delay procurement or supply, or otherwise adversely affect our operations.

We currently rely

on foreign CROs and CMOs, including WuXi Biologics (Hong Kong) Limited and its affiliates (“WuXi Biologics”), and we expect

to continue to rely on foreign CROs and CMOs in the future.

rely on foreign CROs and CMOs, including WuXi Biologics (Hong Kong) Limited and its affiliates (“WuXi Biologics”), and we

expect to continue to rely on foreign CROs and CMOs in the future.

The BIOSECURE Act was enacted

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to ongoing rulemaking and agency interpretation.

WuXi Biologics has been identified

in prior legislative proposals and public discourse as a potential biotechnology company of concern;

however, it has not been automatically

designated as such under the enacted statute.

If WuXi Biologics or other third-party providers we rely on were to be designated as biotechnology

companies of concern in the future, or if the BIOSECURE Act were otherwise interpreted or implemented in a manner that restricts our ability

to use their services, we could be required to transition to alternative providers, experience supply disruptions or increased costs,

or be limited in our ability to access U.S.

federal government contracts, grants, or other funding opportunities, which could materially

adversely affect our business, financial condition, or results of operations.

WuXi Biologics has been

identified in prior legislative proposals and public discourse as a potential biotechnology company of concern;

however, it has not been

automatically designated as such under the enacted statute.

If WuXi Biologics or other third-party providers we rely on were to be designated

as biotechnology companies of concern in the future, or if the BIOSECURE Act were otherwise interpreted or implemented in a manner that

restricts our ability to use their services, we could be required to transition to alternative providers, experience supply disruptions

or increased costs, or be limited in our ability to access U.S.

federal government contracts, grants, or other funding opportunities,

which could materially adversely affect our business, financial condition, or results of operations.

Furthermore, our operations

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In addition, while we have established relationships with CROs and

CMOs outside of China, moving to those suppliers in the event of geopolitical instability affecting our collaborators in China could introduce

delays into the development program.

For example, in April 2025, the United States government imposed significant tariffs on imports from

China and other countries and may impose more restrictions on goods, including biologically derived substances, manufactured in or imported

from China or other countries, or impose other restrictions on companies’ ability to work with Chinese or other foreign counterparties.

To the extent these or future tariffs are applicable to the material we import from China and other countries or if we are not able to

secure supply of our product candidates as a result of applicable legislation, our business and financial condition could be adversely

CMOs outside of China, moving to those suppliers in the event of geopolitical instability affecting our collaborators in China could

introduce delays into the development program.

For example, in April 2025, the United States government imposed significant tariffs on

imports from China and other countries and may impose more restrictions on goods, including biologically derived substances, manufactured

in or imported from China or other countries, or impose other restrictions on companies’ ability to work with Chinese or other

foreign counterparties.

To the extent these or future tariffs are applicable to the material we import from China and other countries

or if we are not able to secure supply of our product candidates as a result of applicable legislation, our business and financial condition

could be adversely affected.

Risks Related to Employee

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In order to successfully

implement our plans and strategies, we will need to grow the size of our organization and we may experience difficulties in managing this

implement our plans and strategies, we will need to grow the size of our organization and we may experience difficulties in managing

We expect to grow the size

of our organization, including an increase in the number of our employees and the scope of our operations, particularly in the areas of

preclinical and clinical drug development, technical operations, clinical operations, regulatory affairs and, potentially, sales and marketing.

To manage our anticipated future growth, we must continue to implement and improve our managerial, operational and financial personnel

and systems, expand our facilities, and continue to recruit and train additional qualified personnel.

Due to our limited financial resources

and the limited experience of our management team working together in managing a company with such anticipated growth, we may not be able

to effectively manage the expansion of our operations or recruit and train additional qualified personnel.

of our organization, including an increase in the number of our employees and the scope of our operations, particularly in the areas

of preclinical and clinical drug development, technical operations, clinical operations, regulatory affairs and, potentially, sales and

To manage our anticipated future growth, we must continue to implement and improve our managerial, operational and financial

personnel and systems, expand our facilities, and continue to recruit and train additional qualified personnel.

Due to our limited financial

resources and the limited experience of our management team working together in managing a company with such anticipated growth, we may

not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel.

We are highly dependent

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objectives and seriously harm our ability to successfully implement our business strategy.

Furthermore, replacing executive officers and

key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with

the breadth of skills and experience required to successfully develop, facilitate regulatory approval of, and commercialize product candidates.

Competition to hire from this limited pool is intense, and we may be unable to hire, train, retain, or motivate these key personnel on

acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel, as well as from

universities and research institutions.

In addition, we rely on consultants

and advisors to assist us in formulating our discovery and nonclinical and clinical development and commercialization strategy.

Our consultants

and advisors may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities

that may limit their availability to us.

We may be subject to

claims that we have wrongfully hired an employee from a competitor or that our employees, consultants or independent contractors have

Furthermore, replacing executive officers

and key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry

with the breadth of skills and experience required to successfully develop, facilitate regulatory approval of, and commercialize product

Competition to hire from this limited pool is intense, and we may be unable to hire, train, retain, or motivate these key

personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel,

as well as from universities and research institutions.

In addition, we rely on

consultants and advisors to assist us in formulating our discovery and nonclinical and clinical development and commercialization strategy.

Our consultants and advisors may be employed by employers other than us and may have commitments under consulting or advisory contracts

with other entities that may limit their availability to us.

We may be subject

to claims that we have wrongfully hired an employee from a competitor or that our employees, consultants or independent contractors have

wrongfully used or disclosed confidential information of third parties.

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of our programs.

Many of these consultants, independent contractors, and our employees, may have been previously employed at, or may have

previously provided or may be currently providing consulting services to, other biotechnology or pharmaceutical companies including our

competitors or potential competitors.

Although we try to ensure that our employees, consultants, and independent contractors do not use

the intellectual property, proprietary information, know-how, or trade secrets of others in their work for us, we may become subject to

claims that we caused an individual to breach the terms of his or her non-competition or non-solicitation agreement, or that we or these

individuals have, inadvertently or otherwise, used or disclosed the alleged trade secrets or other proprietary information of a former

employer or competitor.

Many of these consultants, independent contractors, and our employees, may have been previously employed at, or may

have previously provided or may be currently providing consulting services to, other biotechnology or pharmaceutical companies including

our competitors or potential competitors.

Although we try to ensure that our employees, consultants, and independent contractors do not

use the intellectual property, proprietary information, know-how, or trade secrets of others in their work for us, we may become subject

to claims that we caused an individual to breach the terms of his or her non-competition or non-solicitation agreement, or that we or

these individuals have, inadvertently or otherwise, used or disclosed the alleged trade secrets or other proprietary information of a

former employer or competitor.

While we may litigate to

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from the trade secrets or other proprietary information of the former employers.

Moreover, any such litigation or the threat thereof may

adversely affect our reputation or our ability to form strategic alliances or sublicense our rights to collaborators, engage with scientific

advisors or hire employees, consultants or independent contractors, each of which would have an adverse effect on our business, results

of operations, and financial condition.

Our future growth may

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

and uncertainties.

Moreover, any such litigation or the threat thereof

may adversely affect our reputation or our ability to form strategic alliances or sublicense our rights to collaborators, engage with

scientific advisors or hire employees, consultants or independent contractors, each of which would have an adverse effect on our business,

results of operations, and financial condition.

Our future growth

may depend, in part, on our ability to operate in foreign markets, where we would be subject to additional regulatory burdens and other

risks and uncertainties.

Our future growth may depend,

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business will be adversely affected.

Moreover, even if we obtain approval of our product candidates and ultimately commercialize our product

candidates in foreign markets, we would be subject to the risks and uncertainties, including the burden of complying with complex and

changing foreign regulatory, tax, accounting and legal requirements, and reduced protection of intellectual property rights in some foreign

Moreover, even if we obtain approval of our product candidates and ultimately commercialize our

product candidates in foreign markets, we would be subject to the risks and uncertainties, including the burden of complying with complex

and changing foreign regulatory, tax, accounting and legal requirements, and reduced protection of intellectual property rights in some

foreign countries.

Our employees, independent

contractors, consultants, advisors, commercial collaborators, principal investigators, CROs, CMOs, suppliers, and vendors may engage in

misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

contractors, consultants, advisors, commercial collaborators, principal investigators, CROs, CMOs, suppliers, and vendors may engage

in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

We are exposed to the risk

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and vendors acting for or on our behalf may engage in misconduct or other improper activities.

We have adopted a code of conduct and ethics,

but it is not always possible to identify and deter misconduct by these parties and the precautions we take to detect and prevent this

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

We have adopted a code of conduct and

ethics, but it is not always possible to identify and deter misconduct by these parties and the precautions we take to detect and prevent

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

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

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clinical trial data) or applications, or for it to be believed or reported that any of these occurred, we could incur liability, including

under laws and regulations governing the protection of protected health information and other personal data, and reputational damage and

the development and commercialization of our product candidates could be delayed.

under laws and regulations governing the protection of protected health information and other personal data, and reputational damage

and the development and commercialization of our product candidates could be delayed.

Further, our insurance policies may not be adequate

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that such coverage will continue to be available on commercially reasonable terms or at all, or that such coverage will pay future claims.

We are subject to stringent

and changing laws, regulations and standards, and contractual obligations relating to privacy, data protection, and data security.

actual or perceived failure to comply with such obligations could lead to government enforcement actions (which could include civil or

criminal penalties), fines and sanctions, private litigation and/or adverse publicity and could negatively affect our operating results

We are subject to

stringent and changing laws, regulations and standards, and contractual obligations relating to privacy, data protection, and data security.

The actual or perceived failure to comply with such obligations could lead to government enforcement actions (which could include civil

or criminal penalties), fines and sanctions, private litigation and/or adverse publicity and could negatively affect our operating results

and business.

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If we fail to comply

with environmental, health, and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have

a material adverse effect on the success of our business.

with environmental, health, and safety laws and regulations, we could become subject to fines or penalties or incur costs that could

have a material adverse effect on the success of our business.

We are subject to numerous

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Failure to comply with these laws and regulations also may result in substantial fines, penalties, or other

We may be subject to

We may be subject

to adverse U.S.

legislative or regulatory tax changes that could negatively impact our financial condition.

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our future taxable income.

We cannot predict whether any specific proposals will be enacted, the terms of any such proposals or what effect,

if any, such proposals would have on our business if they were to be enacted.

For example, the United States enacted the IRA, which

implements, among other changes, a 1% excise tax on certain stock buybacks.

In addition, beginning in 2022, the Tax Cuts and Jobs

Act eliminated the previously available option to deduct research and development expenditures and requires taxpayers to amortize

them generally over five years for research activities conducted in the United States and over 15 years for research activities

conducted outside the United States.

We cannot predict whether any specific proposals will be enacted, the terms of any such proposals or what

effect, if any, such proposals would have on our business if they were to be enacted.

Such changes, among others, may adversely affect our effective tax rate, results of operation

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our existing business.

If we acquire businesses with promising markets or technologies, we may not be able to realize the benefit of acquiring

such businesses if we are unable to successfully integrate them with our existing operations and company culture.

We may encounter numerous

difficulties in developing, manufacturing, and marketing any new product candidates or products resulting from a strategic alliance or

acquisition that delay or prevent us from realizing their expected benefits or enhancing our business.

There is no assurance that, following

any such acquisition, we will achieve the synergies expected in order to justify the transaction, which could result in a material adverse

effect on our business and prospects.

If we acquire businesses with promising markets or technologies, we may not be able to realize the benefit of

acquiring such businesses if we are unable to successfully integrate them with our existing operations and company culture.

We may encounter

numerous difficulties in developing, manufacturing, and marketing any new product candidates or products resulting from a strategic alliance

or acquisition that delay or prevent us from realizing their expected benefits or enhancing our business.

There is no assurance that,

following any such acquisition, we will achieve the synergies expected in order to justify the transaction, which could result in a material

adverse effect on our business and prospects.

We maintain our cash

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interest-bearing accounts exceeds the Federal Deposit Insurance Corporation insurance limits.

If such banking institutions were to

fail, we could lose all or a portion of those amounts held in excess of such insurance limitations.

If such banking institutions were

to fail, we could lose all or a portion of those amounts held in excess of such insurance limitations.

In addition, even if account holders

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and growth forecasts are subject to significant uncertainty and are based on assumptions and estimates that may not prove to be accurate.

Even if the markets in which we compete meet our size estimates and growth forecasts, our business may not grow at similar rates, or at

Our growth is subject to many factors, including our success in implementing our business strategy, which is subject to many risks

and uncertainties.

Even if the markets in which we compete meet our size estimates and growth forecasts, our business may not grow at similar rates, or

Our growth is subject to many factors, including our success in implementing our business strategy, which is subject to many

risks and uncertainties.

Our revenue will be dependent,

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We are exposed to potential

product liability and professional indemnity risks that are inherent in the research, development, manufacturing, marketing, and use of

pharmaceutical products.

The use of a product candidate in clinical trials and the sale of any approved products in the future may expose

us to liability claims.

product liability and professional indemnity risks that are inherent in the research, development, manufacturing, marketing, and use

of pharmaceutical products.

The use of a product candidate in clinical trials and the sale of any approved products in the future may

expose us to liability claims.

An individual or group of individuals may bring a liability claim against us if one of our product candidates

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A successful product liability

claim or series of claims brought against us could cause our stock price to decline and, if judgments exceed our insurance coverage, could

decrease our cash and our business operations could be impaired.

claim or series of claims brought against us could cause our stock price to decline and, if judgments exceed our insurance coverage,

could decrease our cash and our business operations could be impaired.

Litigation costs and

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claims by third parties, or to enforce any rights that we may have against third parties, may continue to be necessary, which could result

in substantial costs and diversion of our resources, causing a material adverse effect on our business, financial condition, results of

operations, or cash flows.

in substantial costs and diversion of our resources, causing a material adverse effect on our business, financial condition, results

of operations, or cash flows.

Our business could

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In response to tariffs, other countries have implemented retaliatory tariffs on U.S.

Political tensions as a result of

trade policies could reduce trade volume, investment, technological exchange, and other economic activities between major international

Political tensions as a result

of trade policies could reduce trade volume, investment, technological exchange, and other economic activities between major international

economies, resulting in a material adverse effect on global economic conditions and the stability of global financial markets.

substantial uncertainty about the duration of existing tariffs and whether additional tariffs may be imposed, modified or suspended.

in interest rates, coupled with reduced government spending and volatility in financial markets, may increase economic uncertainty and

affect consumer spending.

is substantial uncertainty about the duration of existing tariffs and whether additional tariffs may be imposed, modified or suspended.

Fluctuation in interest rates, coupled with reduced government spending and volatility in financial markets, may increase economic uncertainty

and affect consumer spending.

Similarly, the ongoing military conflict between Russia and Ukraine and in the Middle East and rising tensions

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on our results of operations and financial condition.

Geopolitical events and global

economic conditions may also affect the ability of the FDA and other regulatory authorities to perform routine functions.

If such concerns

prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews or other regulatory activities, it

could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions,

Geopolitical events and

global economic conditions may also affect the ability of the FDA and other regulatory authorities to perform routine functions.

concerns prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews or other regulatory activities,

it could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions,

which could have a material adverse effect on our business.

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our common stock has been, and may continue to be, volatile.

The market price of our common

stock has been and is likely to be highly volatile and is subject to significant fluctuations.

Moreover, the stock markets in general

have experienced substantial volatility that has often been unrelated to the operating performance of individual companies.

market fluctuations may also adversely affect the trading price of our common stock.

The market price of our

common stock has been and is likely to be highly volatile and is subject to significant fluctuations.

Moreover, the stock markets in

general have experienced substantial volatility that has often been unrelated to the operating performance of individual companies.

broad market fluctuations may also adversely affect the trading price of our common stock.

For example, escalating trade tensions, elevated

interest rates, and regulatory uncertainty have caused significant market volatility recently, and particularly in the biotechnology and

biopharmaceutical industries.

In addition, a recession, depression, or other sustained adverse market event could materially and adversely

affect our business and the value of our common stock.

In the past, following periods of volatility in the market price of a company’s

securities, stockholders have often instituted class action securities litigation against such companies.

interest rates, and regulatory uncertainty have caused significant market volatility recently, and particularly in the biotechnology

and biopharmaceutical industries.

In addition, a recession, depression, or other sustained adverse market event could materially and

adversely affect our business and the value of our common stock.

In the past, following periods of volatility in the market price of

a company’s securities, stockholders have often instituted class action securities litigation against such companies.

Furthermore, market volatility

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may cause the market price of our common stock to fluctuate include:

Timing and results of clinical trials and preclinical studies of our product candidates, or those of our competitors or our existing or future collaborators;

Failure to meet or exceed financial and development projections that we may provide to the public;

Announcements of significant or potential equity or debt sales by us;

Actions taken by regulatory agencies with respect to our product candidates, clinical studies, manufacturing process, or sales and marketing terms;

Failure to meet or exceed the financial and development projections of the investment community or if securities or industry analysts do not publish research or reports about our business, or if they issue adverse or misleading opinions regarding our business and stock;

General market, macroeconomic, geopolitical conditions, or market conditions in the pharmaceutical and biotechnology sectors;

Announcements of significant acquisitions, strategic collaborations, joint ventures, or capital commitments by us or our competitors;

Disputes or other developments relating to proprietary rights, including patents, litigation matters, and our ability to obtain patent protection for our technologies;

Additions or departures of key personnel, including scientific or management personnel;

Significant lawsuits, including patent or stockholder litigation;

Changes in the market valuations of similar companies;

Sales of securities by us or our securityholders in the future, or the anticipation of such events;

Failure to raise an adequate amount of capital to fund our operations or continued development of our product candidates;

Timing and results of clinical

trials and preclinical studies of our product candidates, or those of our competitors or our existing or future collaborators;

Failure to meet or exceed

financial and development projections that we may provide to the public;

Announcements of significant

or potential equity or debt sales by us;

Actions taken by regulatory

agencies with respect to our product candidates, clinical studies, manufacturing process, or sales and marketing terms;

Failure to meet or exceed

the financial and development projections of the investment community or if securities or industry analysts do not publish research

or reports about our business, or if they issue adverse or misleading opinions regarding our business and stock;

General market, macroeconomic,

geopolitical conditions, or market conditions in the pharmaceutical and biotechnology sectors;

Announcements of significant

acquisitions, strategic collaborations, joint ventures, or capital commitments by us or our competitors;

Disputes or other developments

relating to proprietary rights, including patents, litigation matters, and our ability to obtain patent protection for our technologies;

Additions or departures

of key personnel, including scientific or management personnel;

Significant lawsuits, including

patent or stockholder litigation;

Changes in the market valuations

of similar companies;

Sales of securities by

us or our securityholders in the future, or the anticipation of such events;

Failure to raise an adequate

amount of capital to fund our operations or continued development of our product candidates;

Trading volume of our common stock;

Announcements by competitors of new products, clinical progress or lack thereof, significant contracts, commercial relationships, or capital commitments;

The introduction of technological innovations or new therapies that compete with our products;

Period-to-period fluctuations in our financial results.

Announcements by competitors

of new products, clinical progress or lack thereof, significant contracts, commercial relationships, or capital commitments;

The introduction of technological

innovations or new therapies that compete with our products;

Period-to-period fluctuations

in our financial results.

Our certificate of

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Among other things, these provisions:

Establish a classified board of directors such that all members of the board are not elected at one time;

Allow the authorized number of our directors to be changed only by resolution of our board of directors;

Limit the manner in which stockholders can remove directors from the board;

Establish advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on at stockholder meetings;

Require that stockholder actions must be effected at a duly called stockholder meeting and prohibit actions by our stockholders by written consent;

Limit who may call a special meeting of stockholders;

Authorize our board of directors to issue preferred stock without stockholder approval, which could be used to institute a “poison pill” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our board of directors;

Require the approval of the holders of at least 66 2/3% of the votes that all stockholders would be entitled to cast to amend or repeal certain provisions of our charter or bylaws.

Establish a classified

board of directors such that all members of the board are not elected at one time;

Allow the authorized number

of our directors to be changed only by resolution of our board of directors;

Limit the manner in which

stockholders can remove directors from the board;

Establish advance notice

requirements for nominations for election to the board of directors or for proposing matters that can be acted on at stockholder

Require that stockholder

actions must be effected at a duly called stockholder meeting and prohibit actions by our stockholders by written consent;

Limit who may call a special

meeting of stockholders;

Authorize our board of

directors to issue preferred stock without stockholder approval, which could be used to institute a “poison pill” that

would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been

approved by our board of directors;

Require the approval of

the holders of at least 66 2/3% of the votes that all stockholders would be entitled to cast to amend or repeal certain provisions

of our charter or bylaws.

Moreover, because we are

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that is governed by the internal affairs doctrine, in each case subject to the Court of Chancery having personal jurisdiction over the

indispensable parties named as defendants therein, which for purposes of this risk factor refers to herein as the “Delaware Forum

Our governing documents further provide that, unless we consent in writing to an alternative forum, the federal district

courts of the United States will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities

Act, which for purposes of this risk factor refers to herein as the “Federal Forum Provision”.

Neither the Delaware Forum

Provision nor the Federal Forum Provision will apply to any causes of action arising under the Exchange Act.

In addition, any person or

entity purchasing or otherwise acquiring any interest in shares of our capital stock will be deemed to have notice of and consented to

the foregoing Delaware Forum Provision and Federal Forum Provision;

provided, however, that stockholders cannot and will not be deemed

to have waived our compliance with the U.S.

indispensable parties named as defendants therein, which for purposes of this risk factor is referred to herein as the “Delaware

Forum Provision”.

Our governing documents further provide that, unless we consent in writing to an alternative forum, the federal

district courts of the United States will be the exclusive forum for resolving any complaint asserting a cause of action arising under

the Securities Act, which for purposes of this risk factor is referred to herein as the “Federal Forum Provision”.

the Delaware Forum Provision nor the Federal Forum Provision will apply to any causes of action arising under the Exchange Act.

any person or entity purchasing or otherwise acquiring any interest in shares of our capital stock will be deemed to have notice of and

consented to the foregoing Delaware Forum Provision and Federal Forum Provision;

provided, however, that stockholders cannot and will

not be deemed to have waived our compliance with the U.S.

federal securities laws and the rules and regulations thereunder.

The Delaware Forum Provision

and the Federal Forum Provision may impose additional litigation costs on our stockholders in pursuing any such claims, particularly if

such stockholders do not reside in or near the State of Delaware.

and the Federal Forum Provision may impose additional litigation costs on our stockholders in pursuing any such claims, particularly

if such stockholders do not reside in or near the State of Delaware.

Additionally, these forum selection clauses may limit our stockholders’

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that we will pay any cash dividends in the foreseeable future.

We do not anticipate that

we will pay any cash dividends in the foreseeable future.

The current expectation is that we will retain our future earnings, if any,

to fund the development and growth of our business.

As a result, capital appreciation, if any, of our common stock will be your sole source

of gain, if any, for the foreseeable future.

We do not anticipate paying

any cash dividends in the foreseeable future, as we expect to retain our future earnings, if any, to fund the development and growth of

our business.

As a result, capital appreciation, if any, of our common stock will be your sole source of gain, if any, for the foreseeable

Our executive officers,

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for approval.

Our executive officers, directors,

and principal stockholders beneficially own a significant percentage of our outstanding common stock.

As a result, if these stockholders

were to choose to act together, they would be able to control or significantly influence all matters submitted to our stockholders for

approval, as well as our management and affairs.

For example, these stockholders, if they choose to act together, would control or significantly

influence the election of directors and approval of any merger, consolidation, or sale of all or substantially all of our assets.

concentration of voting power could delay or prevent our acquisition on terms that other stockholders may desire.

Our executive officers,

directors, and principal stockholders beneficially own a significant percentage of our outstanding common stock.

As a result, if these

stockholders were to choose to act together, they would be able to control or significantly influence all matters submitted to our stockholders

for approval, as well as our management and affairs.

For example, these stockholders, if they choose to act together, would control or

significantly influence the election of directors and approval of any merger, consolidation, or sale of all or substantially all of our

This concentration of voting power could delay or prevent our acquisition on terms that other stockholders may desire.

If equity research

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Equity research

analysts may elect to not provide research coverage of our common stock, and such lack of research coverage may adversely affect the market

price of our common stock.

If we do have equity research analyst coverage, we will not have any control over the analysts or the content

and opinions included in their reports.

analysts may elect to not provide research coverage of our common stock, and such lack of research coverage may adversely affect the

market price of our common stock.

If we do have equity research analyst coverage, we will not have any control over the analysts or the

content and opinions included in their reports.

The price of our common stock could decline if one or more equity research analysts downgrade

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1A. Risk Factors