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Item 1A. Risk Factors

2026-05-13 compared with 2025-11-12 · 677 added, 732 removed, 1051 unchanged (57% of the section changed)

of risk factors

Risk Factors Summary

We are subject to a number

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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 of this Quarterly Report “Risk Factors”.

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 SEC before making an investment decision regarding the Company.

Risks Related to Our Financial

Condition and Capital Requirements

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

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.

We have not completed any clinical trials and have no products approved for commercial sale.

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.

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Raising 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

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.

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

Risks Related to Our Intellectual

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 patents and our ability to protect our products may be impaired by changes to patent laws, and our patent protection could be reduced or eliminated for non-compliance with legal requirements.

We may fail to identify or interpret relevant third-party patents.

Patent terms may be inadequate to protect our competitive position of our programs.

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

Risks Related to Our Reliance

on Third Parties

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.

Third parties we rely on for the execution of nonclinical studies and clinical trials may fail to carry out their contractual duties.

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.

Risks Related to Employee

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

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 will be harmed if we cannot recruit and retain highly qualified personnel to successfully implement our business strategies.

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 growth.

Significant disruptions of information technology systems or breaches of data security could adversely affect our business.

Changes in and failures to comply with United States and foreign privacy and data protection laws, regulations and standards may adversely affect our business, operations and consolidated financial performance.

We may become exposed to costly and damaging liability claims and our insurance may not cover all damages from such claims.

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.

We do not anticipate paying any dividends in the foreseeable future.

Future sales of shares by existing stockholders could cause our stock price to decline.

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

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

we have not completed any clinical trials,

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

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.

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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 could exhaust our available financial resources sooner

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.

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The current market environment for small and midcap biotechnology

companies and broader macroeconomic factors may preclude us from successfully raising additional capital.

For example, escalating geopolitical

tensions, elevated interest rates and regulatory uncertainty have caused market volatility, and particularly in the biotechnology and

biopharmaceutical industries, which such volatility can have an adverse effect on the ability to raise capital.

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.

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.

Biopharmaceutical product

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If we obtain regulatory approval to market a product

candidate, our future revenue will depend upon the size of any markets in which our product candidates may receive approval, and our ability

to achieve sufficient market acceptance, pricing, coverage and adequate reimbursement from third-party payors, and adequate market

share for our product candidates in those markets.

Even if we obtain adequate market share for our product candidates, we may never become

profitable despite obtaining such market share and acceptance of our products.

candidate, our future revenue will depend upon the size of approved markets, and our ability to achieve sufficient market acceptance,

pricing, coverage and adequate reimbursement from third-party payors, and adequate market share for our products.

However, even if

we obtain adequate market share for our products, we may never become profitable despite obtaining such market share and acceptance of

our products.

We expect to continue to

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

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

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Even if we are successful

in raising new capital, we could be limited in the amount of capital we raise due to investor demand restrictions placed on the amount

of capital we raise, or other reasons.

in raising additional capital, the amount of capital we raise may be limited or restricted due to investor demand, market conditions,

or other factors.

Raising additional

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

For example, in September 2024, we entered into

a Securities Purchase Agreement with certain institutional and accredited investors, whereby the investors purchased an aggregate of 5,600,000

shares of common stock, 2,439 shares of Series A Preferred Stock and pre-funded warrants to purchase an aggregate of 680,000 shares of

common stock and in November 2024, each outstanding share of Series A Preferred Stock converted into 1,000 shares of common stock.

in September 2025, we entered into a Securities Purchase Agreement with certain institutional and accredited investors, whereby the investors

purchased an aggregate of 10,933,405 shares of our common stock and pre-funded warrants to purchase 1,066,666 shares of common stock.

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.

If we raise additional funds

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

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.

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.

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of drugs is highly competitive.

Product candidates developed by us, if approved, will face significant competition and our failure to

effectively compete may prevent us from achieving significant market penetration.

We compete with a variety of biopharmaceutical companies

as well as academic institutions, governmental agencies, and public and private research institutions, among others.

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.

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.

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.

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.

Our competitors have developed,

are developing, or will develop programs and processes competitive with our programs and processes.

Competitive therapeutic treatments

include those that have already been approved and accepted by the medical community and any new treatments.

Our success will depend partially

on our ability to develop and commercialize products that have a competitive safety, efficacy, dosing and/or presentation profile.

commercial opportunity and success will be reduced or eliminated if competing products are safer, more effective, have a more attractive

dosing profile or presentation or are less expensive than the products we develop, or if biosimilars enter the market and are able to

gain market acceptance more quickly than we do or at wider scale.

are developing, or may develop programs and processes that compete with ours.

Our success will depend partially on our ability to develop

and commercialize products that have a competitive safety, efficacy, dosing and/or presentation profile.

Our commercial opportunity and

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

Our product candidates

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to advance our product development plans.

We have no products on the

market, and all of our programs are in preclinical or clinical stages of development.

As a result, we expect it will be many years

We expect it will be many years

before we can obtain regulatory approval for and commercialize any product candidate, if ever.

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

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

to commercialize our product candidates.

We may experience a number

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

our clinical trials may fail to show safety or efficacy, produce negative or inconclusive results, or our product candidates may have undesirable side effects or unexpected characteristics, and we may decide, or regulators may require that we conduct additional preclinical studies or clinical trials or we may decide to abandon product development programs;

the supply or quality of our clinical trial materials or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate;

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.

our failure 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;

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 these 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;

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;

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.

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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.

If our clinical trials do

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

of the United States.

In addition, because of the

competitive landscape for immunology and inflammation (commonly referred to as “I&I”) indications, we may also face

competition for clinical trial enrollment.

Clinical trial enrollment will depend on many factors, including if potential clinical trial

participants choose to undergo treatment with approved products or enroll in competitors’ ongoing clinical trials for programs that

are under development for the same indications as our programs.

An increase in the number of approved products for the indications we

are targeting with our programs may further exacerbate this competition.

Our inability to enroll a sufficient number of participants could,

among other things, delay our development timeline, which may further harm our competitive position and have an adverse effect on our

business and operations.

of the United States, including the European Union (“EU”).

In addition, in part due

to the competitive landscape for immunology and inflammation (commonly referred to as “I&I”) indications, we may

also face increased competition for clinical trial enrollment.

Clinical trial enrollment will depend on many factors, including if potential

clinical trial participants choose to undergo treatment with approved products or enroll in competitors’ clinical trials for programs

that are under development for the same indications as our programs.

An increase in the number of approved products for the indications

we are targeting with our programs may further exacerbate this competition.

Our inability to enroll a sufficient number of participants

could, among other things, delay our development timeline, which may further harm our competitive position and have an adverse effect

on our business and operations.

We are substantially

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of these programs.

Our Phase 1 clinical trial of ORKA-001 in healthy volunteers is ongoing and remains blinded and all subjects have remained

on trial through August 6, 2025.

Moreover, in the third quarter of 2025, we commenced dosing in a Phase 2a clinical trial of ORKA-001

in patients with moderate-to-severe psoriasis and furthermore, we expect to initiate a dose-ranging Phase 2b trial of ORKA-001 in moderate-to-severe

psoriasis in the first half of 2026.

In addition, we have initiated a Phase 1 clinical trial of ORKA-002 in healthy volunteers and plan

to initiate a Phase 2 clinical trial of ORKA-002 in the first half of 2026.

Currently, we believe that the success of our programs is dependent

on our product candidates demonstrating a longer half-life in humans than mAbs currently marketed and in development as we believe this

longer half-life has the potential to result in a more favorable dosing schedule for our product candidates, assuming they successfully

complete clinical development and obtain marketing approval.

To the extent we do not observe this extended half-life, it would significantly

and adversely affect the clinical and commercial potential of our product candidates.

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.

Our Phase 1 clinical trial

of ORKA-002 in healthy volunteers is fully enrolled and remains ongoing for purposes of continued patient follow-up and data collection,

and remains blinded.

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.

Currently, we believe that

the success of our programs is dependent on our product candidates demonstrating a longer half-life in humans than monoclonal antibodies

currently marketed and in development as we believe this longer half-life has the potential to result in a more favorable dosing

schedule for our product candidates, assuming they successfully complete clinical development and obtain marketing approval.

To the extent

we do not observe this extended half-life, it would significantly and adversely affect the clinical and commercial potential of our product

If we do not achieve

our projected development goals in the time frames we announce and expect, the development and potential commercialization of our product

our projected development goals in the time frames we announce or expect, the development and potential commercialization of our product

candidates may be delayed and our expenses may increase and, as a result, our business may be materially harmed and our stock price may

From time to time, we announce

the timing of the anticipated accomplishment of various scientific, clinical, regulatory and other product development goals, which we

the timing of the anticipated accomplishment of various scientific, clinical, regulatory, or other product development goals, which we

sometimes refer to as milestones.

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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, or at all, the development and potential commercialization

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

Additionally, delays relative to our projected timelines are likely to cause overall expenses to increase, which may require

us to raise additional capital sooner than expected and prior to achieving targeted development milestones.

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.

We expect to deliver our

product candidates via a drug delivery device, such as an injector or other delivery system.

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.

If our product candidates are intended to be used with drug delivery devices, we currently expect to utilize drug

delivery devices authorized for marketing under clearances of approvals held by third parties.

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.

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

of the review process may delay approval.

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.

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.

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.

We are delivering and expect

to continue to deliver, our product candidates via a drug delivery device, such as pre-filled syringe, an injector, or other delivery

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.

Our approach to the

discovery and development of our programs is unproven, and we may not be successful in our efforts to build a pipeline of programs with

commercial value.

Our approach to the discovery

and development of the research programs with respect to which we have signed a license agreement, exercised the Option to acquire intellectual

property license rights to or have the Option to acquire intellectual property license rights to pursuant to the Option Agreements, leverages

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

discovery and development of our lead programs is unproven, and we may not be successful in our efforts to build a pipeline of programs

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.

Our programs 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.

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 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 may ultimately discover

that utilizing half-life extension technologies for our specific targets and indications and any programs resulting therefrom does

not possess certain properties required for therapeutic effectiveness.

In addition, programs using half-life extension technologies

may demonstrate different chemical and pharmacological properties in human participants than they do in laboratory studies or preclinical

This technology and any programs resulting therefrom may not demonstrate the same chemical and pharmacological properties in

humans and may interact with human biological systems in unforeseen, ineffective or harmful ways.

that utilizing half-life extension technologies for our specific targets and indications and any programs resulting therefrom does not

possess certain properties required for therapeutic effectiveness.

In addition, programs using half-life extension technologies may demonstrate

different chemical and pharmacological properties in human participants than they do in laboratory studies or preclinical studies, including

the inability to demonstrate the same chemical and pharmacological properties in humans or the potential interaction with human biological

systems in unforeseen, ineffective, or harmful ways.

If the products resulting

from the research programs with respect to which we have signed license agreements with Paragon prove to be ineffective, unsafe or commercially

unviable, such programs would have little, if any, value, which would have a material and adverse effect on our business, financial condition,

results of operations, and prospects.

In addition, we may in the

future seek to discover and develop programs that are based on novel targets and in the applicable technologies that are unproven.

our discovery activities fail to identify novel targets or technologies for drug discovery, or such targets prove to be unsuitable for

treating human disease, we may not be able to develop viable additional programs.

We and our existing or future collaborators may never

receive approval to market and commercialize any product candidate.

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 the products resulting from

the research programs with respect to which we have signed license agreements with Paragon, exercised the option to acquire intellectual

property license rights to or have the option to acquire intellectual property license rights to pursuant to the Option Agreements prove

to be ineffective, unsafe or commercially unviable, such programs would have little, if any, value, which would have a material and adverse

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

future seek to discover and develop programs that are based on novel targets and in the technologies that are unproven.

If our discovery

activities fail to identify novel targets or technologies for drug discovery, or such targets prove to be unsuitable for treating human

disease, we may not be able to develop viable additional programs.

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.

If our preclinical studies and clinical trials are not sufficient to

support regulatory approval of any of our product candidates, we may incur additional costs or experience delays in completing, or ultimately

be unable to complete, the development of such product candidate.

Before obtaining marketing

approval from regulatory authorities for the sale of any product candidate, we must complete preclinical studies and then conduct extensive

clinical trials to demonstrate the safety and efficacy of such product candidate in humans.

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 process.

Clinical testing can take

many years to complete, and its outcome is inherently uncertain.

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.

Differences in trial design between early-stage clinical

trials and later-stage clinical trials make it difficult to extrapolate the results of earlier clinical trials to later clinical trials.

A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of

efficacy or unfavorable safety profiles, notwithstanding promising results in earlier trials.

Moreover, clinical data are often susceptible

to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in clinical

trials have nonetheless failed to obtain marketing approval of such product candidates.

In addition, we expect to rely on participants

to provide feedback on measures such as measures of quality of life, which are subjective and inherently difficult to evaluate.

measures can be influenced by factors outside of our control, and can vary widely from day-to-day for a particular participant,

and from participant to participant and from site to site within a clinical trial.

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

to support regulatory approval of any of our product candidates, we may incur additional costs or experience delays in completing, or

ultimately be unable to complete, the development of such product candidate.

We do not know whether any

clinical trials we may conduct will demonstrate adequate efficacy and safety to result in regulatory approval to market any of our product

Clinical testing can take many years to complete, and its outcome is inherently uncertain.

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

in another indication.

We plan to use the data from our current trials of our ORKA-001 and ORKA-002 programs to support further trials

in PsO, HS, and potentially other I&I indications.

However, differences between early-stage clinical trials and later-stage clinical

trials, including differences in trial design, among other things, make it difficult to extrapolate the results of earlier clinical trials

to later clinical trials.

A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical

trials due to lack of efficacy or unfavorable safety profiles, notwithstanding promising results in earlier trials.

Moreover, clinical

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

satisfactorily in clinical trials have nonetheless failed to obtain marketing approval of such product candidates.

In addition, we rely

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.

We cannot be sure that the

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

We plan to use the data

from our current trials of our ORKA-001 and ORKA-002 programs to support further trials in PsO and potentially other I&I

If 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.

We cannot be sure that submission of an

IND, 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.

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

or terminate such clinical trials.

Events that may prevent successful or timely initiation or completion of clinical trials include:

to generate sufficient preclinical, toxicology or other in vivo or in vitro data to support the initiation or continuation

of clinical trials;

delays in reaching a consensus with regulatory authorities on trial design or implementation of the clinical trials;

delays or failure in obtaining regulatory authorization to commence a trial;

delays in reaching agreement on acceptable terms with prospective

CROs and clinical trial sites;

recruiting and training suitable clinical investigators;

delays or difficulties in recruiting trial patients;

delays in obtaining required IRB approval at each clinical trial site;

delays in manufacturing, testing, releasing, validating or importing/exporting

sufficient stable quantities of our product candidates for use in clinical trials or the inability to do any of the foregoing;

by our CROs, other third parties or us to adhere to clinical trial protocols;

failure to perform in accordance with the FDA’s or

any other regulatory authority’s current Good Clinical Practice (“GCP”) requirements or applicable regulatory guidelines

in other countries;

changes to the clinical trial protocols;

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

delays or failure by our third party vendors or us in the manufacturing, packaging, labeling and proper delivery of clinical trial materials;

and third parties being unwilling or unable to satisfy their contractual obligations to us.

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

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or trial site by the FDA or comparable foreign regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety

issues or adverse side effects, failure to demonstrate a benefit from the programs, changes in governmental regulations or administrative

actions or lack 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 costs.

If we encounter difficulties

enrolling participants in our current and future clinical trials, our clinical development activities could be delayed or otherwise adversely

issues or adverse side effects, failure to demonstrate a benefit, changes in governmental regulations or administrative actions or lack

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

Our clinical development

activities could be delayed or otherwise adversely affected if we encounter difficulties enrolling and maintaining participants in our

current and future clinical trials.

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

We may experience difficulties

in patient participant enrollment in our clinical trials for a variety of reasons.

The timely completion of clinical trials in accordance

with their protocols depends, among other things, on our ability to enroll a sufficient number of participants who remain in the trial

until conclusion.

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 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

Even if we are able to enroll a sufficient number of participants for our clinical trials, it may have difficulty maintaining

participants in our clinical trials.

Our inability to enroll or maintain a sufficient number of participants 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.

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.

Preliminary, “topline”,

or interim data from our clinical trials may change as more participant data becomes available and are subject to audit and verification

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

or interim data from our clinical trials may change and are subject to audit and verification procedures, and should be viewed with caution

until the final data are available.

Our interpretation of such data is based on assumptions that may evolve as additional data become

available, which could result in changes to conclusions regarding the safety, efficacy, timing, or likelihood of success of our clinical

development programs.

From time to time, we may

publicly disclose preliminary or topline data from our preclinical studies and clinical trials that are based on a preliminary analysis

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

review of the data.

We also make assumptions, estimations, calculations and conclusions as part of our analyses of these data without

the 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, or different conclusions or considerations may qualify such results, once additional data have

been received and fully evaluated or subsequently made subject to audit and verification procedures.

From time to time, we may

also disclose interim data from our preclinical studies and clinical trials.

Interim data are subject to the risk that one or more of

the clinical outcomes may materially change as participant enrollment continues and more participant data become available or as participants

from our clinical trials continue other treatments.

Further, others, including regulatory agencies, may not accept or agree with our assumptions,

estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the

value of the particular product candidate, the approvability or commercialization of the particular product candidate and our company

In addition, the information we choose to publicly disclose regarding a particular preclinical study or clinical trial is

based on what is typically extensive information, and you or others may not agree with what we determine is material or otherwise appropriate

information to include in our disclosure.

Moreover, negative or inconclusive

results of clinical trials involving our product candidates could require that we repeat or conduct additional clinical trials.

not know whether any clinical trials we may conduct will demonstrate adequate efficacy and safety to result in regulatory approval to

market any of our product candidates.

If the preliminary, topline 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.

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

We may also make assumptions, estimations, calculations, and conclusions as part of our analyses of these data without the

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.

We may also publicly disclose

interim data from our preclinical studies and clinical trials.

Such interim data are inherently preliminary and subject to the risk that

one or more of the clinical outcomes may change as participant enrollment continues, additional data become available, as participants

from our clinical trials pursue other treatments, or further analyses are conducted.

In addition, third parties, including regulatory

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

importance of data differently, which could impact the perceived value of the particular product candidate, the approvability or commercialization

of the particular product candidate, and our company and our business in general.

In addition, others may not agree with what we determine

is material or otherwise appropriate information to include in our public disclosure of a particular preclinical study or clinical trial.

If the preliminary, topline,

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.

Our clinical trials

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potential or market acceptance of any of our product candidates.

We do not know whether any clinical trials we may conduct will demonstrate

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

Results of our clinical trials

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

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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We, the FDA or other applicable regulatory authorities, or an IRB, may suspend or require

the material modification of any clinical trials of any program at any time for various reasons, including a belief that participants

in such trials are being exposed to unacceptable health risks or adverse side effects.

Moreover, negative or inconclusive results could

cause the FDA or other regulatory agencies to require that we repeat or conduct additional clinical trials.

If our clinical trials do

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

the material modification of any clinical trials of any program or require that we repeat or conduct additional clinical trials at any

time for various reasons, including safety and health risks or exposure to adverse side effects.

Even if side effects do not

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of the approved product due to their tolerability versus other therapies.

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.

Potential side effects associated

with our product candidates may not be appropriately recognized or managed by the treating medical staff, as toxicities resulting from

our product candidates may not be normally encountered in the general patient population and by medical personnel.

Potential side effects associated with our product candidates

may not be appropriately recognized or managed by the treating medical staff, as toxicities resulting from our product candidates may

not be normally encountered in the general patient population and by medical personnel.

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

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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.

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.

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 the research programs with respect to which we have signed a licensed agreement for or exercised the option

to acquire intellectual property license rights to or have the option to acquire intellectual property license rights to pursuant to the

Option Agreements 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.

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

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sole development and commercialization rights to such product candidate.

We may never receive approval to market and commercialize any

product candidate.

Any approved products

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including factors that are not within our control.

While there are several approved products and product candidates in later stages of

development for the treatment of PsO, 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.

Market participants with influence

over acceptance of new treatments, such as clinicians and third-party payors, may not adopt a biologic that incorporates half-life extension

for our targeted indications, and we may not be able to convince the medical community and third-party payors to accept and use,

or to provide favorable reimbursement for, any programs developed by us or our existing or future collaborators.

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.

Sales of medical products

also depend on the willingness of healthcare providers to prescribe the treatment, and if any of our product candidates is approved but

does not achieve an adequate level of acceptance, we may not generate or derive sufficient revenue from that product candidate and may

not become or remain profitable.

Market participants with influence over acceptance of new treatments, such as

clinicians and third-party payors, may not adopt a biologic that incorporates half-life extension for our targeted indications,

and we may not be able to convince the medical community and third-party payors to accept and use, or to provide favorable reimbursement

for, any programs developed by us or our existing or future collaborators.

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.

Certain of our programs

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We are developing product

candidates for the same indication, PsO, and may in the future develop our programs for other I&I indications.

Each such program

targets a different mechanism of action.

However, developing multiple programs for a single indication may negatively impact our business

if the programs compete with each other.

For example, if multiple programs are conducting clinical trials at the same time, they could

compete for the enrollment of participants.

In addition, if multiple product candidates are approved for the same indication, they may

compete for market share, which could limit our future revenue.

We may conduct clinical

trials for programs at sites outside the United States, and the FDA may not accept data from trials conducted in such locations.

Moreover, conducting clinical trials outside of the United States presents additional risks that may delay our clinical trials.

We may choose to conduct

one or more of our future clinical trials outside the United States.

Although the FDA may accept data from clinical 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

candidates for PsO, HS, and may in the future develop our programs for other I&I indications.

Each such program targets a different

mechanism of action.

However, developing multiple programs for a single indication may negatively impact our business if the programs

compete with each other.

For example, concurrent clinical trials across multiple programs may compete for the enrollment of participants.

In addition, the approval of multiple product candidates for the same indication could intensify market competition and limit our future

We are conducting,

and may conduct in the future, clinical trials for programs at sites outside the United States, subjecting us to additional risks that

may delay or adversely affect our product development timelines.

We are currently conducting

clinical trials outside the United States and may continue to do so in the future.

Conducting clinical trials outside the United States

may expose us to additional operational and regulatory risks, including differing regulatory standards and review timelines and increased

complexity in ensuring compliance with applicable laws and data protection requirements.

Although the FDA may accept data from clinical

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.

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

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.

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trials outside of the United States presents additional risks that may delay completion of our clinical trials.

These risks include the

failure of investigators or enrolled participants in foreign countries to adhere to clinical protocol as a result of differences in healthcare

services or cultural customs 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, diminished protection of intellectual property in some countries, as well as political and economic risks relevant

to foreign countries.

These risks include requirements

for local ethics approvals, challenges in monitoring trial conduct and data integrity across jurisdictions, including the potential failure

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

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.

Risks Related to Government

and Regulatory Matters

The regulatory approval

processes of the FDA and other comparable foreign regulatory authorities are lengthy, time-consuming and unpredictable.

If we are not

able to obtain, or if there are delays in obtaining, required regulatory approvals for our product candidates, we may not be able to commercialize,

or may be delayed in commercializing, our product candidates, and our ability to generate revenue may be materially impaired.

We may not be

able to commercialize, or may be delayed in commercializing, our product candidates, and our ability to generate revenue may be materially

impaired if we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for our product candidates.

The lengthy regulatory approval

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

Of the large number

of drugs in development, only a small percentage successfully complete the FDA or foreign regulatory approval processes and are commercialized.

The process of obtaining regulatory approvals, both in the United States and abroad, is unpredictable, expensive and typically takes

many years following commencement of clinical trials.

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.

Further, the FDA and comparable

foreign regulatory authorities may undergo leadership changes, change their policies, issue additional regulations or revise existing

regulations, or take other actions, such as those implemented by the recently established Department of Government Efficiency, which may

impact our clinical development plans or prevent or delay approval of our programs under development on a timely basis.

Such policy or

regulatory changes could impose additional requirements upon us that could delay our ability to obtain approvals and increase the costs

of compliance.

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

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.

Further, our product candidates may not be effective, may be only moderately

effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude our obtaining

marketing approval.

The FDA and comparable foreign regulatory authorities have substantial discretion in the approval process and may

refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical, clinical

or other data.

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

the failure to demonstrate that a product candidate’s benefits outweigh safety risks;

regulatory authorities may disagree with our

interpretation of clinical data or the data collected may not be acceptable or sufficient to support submission;

or the results may not

meet the level of statistical significance required for approval by the relevant regulatory authorities or otherwise considered insufficient

by the FDA or comparable foreign regulatory authorities.

Regulatory authorities may require the addition of labeling statements, such

as black box or other warnings or contraindications that could diminish the usage of the product or otherwise limit the commercial success

of the affected product.

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.

The FDA and comparable foreign

regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that

our data are insufficient for approval and require additional preclinical, clinical, or other data.

Our product candidates could be delayed

in receiving, or fail to receive, regulatory approval for many reasons, including:

the failure to demonstrate that a product candidate’s

benefits outweigh safety risks;

regulatory authorities may disagree with our interpretation of clinical data or the data collected may

not be acceptable or sufficient to support submission;

or the results may not meet the level of statistical significance required for

approval by the relevant regulatory authorities or otherwise considered insufficient by the FDA or comparable foreign regulatory authorities.

Regulatory authorities may require the addition of labeling statements, such as a black box warning or other warnings or contraindications

that could diminish the usage of the product or otherwise limit the commercial success of the affected product.

Moreover, regulatory authorities

may approve any of our product candidates for fewer or more limited indications than we request, including failing to approve the most

commercially promising indications, may grant approval contingent on the performance of costly post-marketing clinical trials, or

may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization

commercially promising indications, may grant approval contingent on the performance of costly post-marketing clinical trials, or may

approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization

of that product candidate.

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candidates, we will not be able to commercialize, or will be delayed in commercializing, our product candidates and our ability to generate

revenue will be materially impaired.

revenue may be materially impaired.

We may not be able

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control and manufacture our drug products safely and in accordance with regulatory requirements.

This includes manufacturing the active

ingredient, developing an acceptable formulation, manufacturing the drug product, performing tests to adequately characterize the formulated

product, documenting a repeatable manufacturing process, and demonstrating that our drug products meet stability requirements.

above, we may deliver our product candidates via a drug delivery device, which also requires us to meet certain chemistry, manufacturing

and control requirements set forth by the FDA and other foreign regulatory authorities.

Meeting these chemistry, manufacturing and control

requirements is a complex task that requires specialized expertise.

If we are not able to meet the chemistry, manufacturing and control

requirements, we may not be successful in getting our products approved.

This includes, among other things, manufacturing

the active ingredient, developing an acceptable formulation, manufacturing the drug product, performing tests to adequately characterize

the formulated product, documenting a repeatable manufacturing process in larger quantities as we move forward in our development programs,

and demonstrating that our drug products meet stability requirements.

As noted above, we may deliver our product candidates via a drug

delivery device, which also requires us to meet certain chemistry, manufacturing and control requirements set forth by the FDA and other

foreign regulatory authorities.

Meeting these chemistry, manufacturing and control requirements is a complex task that requires specialized

If we are not able to meet the chemistry, manufacturing, and control requirements, we may not be successful in our clinical

trials or getting our product candidates approved by regulatory authorities.

Our product candidates

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regulatory factors that are still developing.

Even if we receive

regulatory approval of our product candidates, we will be subject to extensive ongoing regulatory obligations and continued regulatory

review and may result in restrictions on the use of the product, which may result in significant additional expense and we may be subject

to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.

Any regulatory approvals

that we may receive for our product candidates will require the submission of reports to regulatory authorities and surveillance to monitor

the safety and efficacy of the product candidate, may contain significant limitations related to use restrictions for specified age groups,

warnings, precautions or contraindications, and may include burdensome post-approval study or risk management requirements.

the FDA may require a Risk Evaluation and Mitigation Strategy (“REMS”) in order to approve our product candidates.

even if our product candidates receive approval, our product candidates and the activities associated with their development and commercialization,

including their design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale,

distribution, import and export will be subject to comprehensive regulation by the FDA and other regulatory agencies in the United States

and by comparable foreign regulatory authorities.

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

and reports, registration, as well as on-going compliance with current Good Manufacturing Practices (“cGMPs”) and

GCPs for any clinical trials that we conduct following approval.

In addition, manufacturers of drug products and their facilities are

subject to continual review and periodic, unannounced inspections by the FDA and other regulatory authorities for compliance with cGMPs.

If we or a regulatory authority

discover previously unknown problems with a product or problems with the facilities where the product is manufactured, a regulatory authority

may impose restrictions on that product, the manufacturing facility or us, including requiring recall or withdrawal of the product from

the market or suspension of manufacturing, restrictions on our ability to conduct clinical trials, including full or partial clinical

holds on ongoing or planned trials, restrictions on the manufacturing process, warning or untitled letters, civil and criminal penalties,

injunctions, product seizures, detentions or import bans, voluntary or mandatory publicity requirements and imposition of restrictions

on operations, including costly new manufacturing requirements.

Disruptions at the

FDA, the SEC and other government agencies and regulatory authorities could hinder their ability to hire and retain key leadership and

other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those

agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our

Even if our product

candidates receive regulatory approval, we will remain subject to extensive ongoing regulatory obligations and continued regulatory review,

which could result in restrictions on the use of the products, significant additional expenses, and penalties if we fail to comply with

regulatory requirements or experience unanticipated issues with our product candidates.

If any of our product candidates

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.

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.

Disruptions or changes

at the FDA, the SEC and other government agencies and regulatory authorities could hinder their ability to hire and retain key leadership

and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent

those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact

our business.

The ability of the FDA to

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federal regulatory agencies, including the FDA.

Disruptions at the FDA and other agencies or comparable foreign regulatory authorities, may also slow the time necessary for the review and approval

of applications for clinical trial or marketing authorization, which would adversely affect our business.

For example, most recently in

October 2025, the U.S.

government shut down, during which time certain regulatory agencies, such as the FDA and the SEC, furloughed 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

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 the extent to which the Trump administration

may impose or seek to impose leadership or policy changes at the FDA or changes to rules and policies impacting our business and operations.

It is unclear how these executive actions or other potential actions by the federal government will impact the FDA or other regulatory

authorities that oversee our business.

Government proposals to reduce or eliminate budgetary deficits may include reduced allocations

to the FDA and other related government agencies.

These budgetary pressures may reduce the FDA’s ability to perform its responsibilities,

which could result in delays in our clinical trial timelines.

If a significant reduction in the FDA’s workforce occurs, the FDA’s

budget is significantly reduced or a prolonged government shutdown occurs,

Disruptions at the FDA and

other agencies or comparable foreign regulatory authorities, may also slow the time necessary for the review and approval of applications

for clinical trial or marketing authorization, which would adversely affect our business.

For example, in recent years, the U.S.

has experienced shut downs and funding lapses, during which time certain regulatory agencies, such as the FDA and the SEC, furloughed

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.

We are unable to predict

the extent to which the Trump administration may impose or seek to impose leadership or policy changes at the FDA or changes to rules

and policies impacting our business and operations.

It is unclear how these executive actions or other potential actions by the federal

government will impact the FDA or other regulatory authorities that oversee our business.

Government proposals to reduce or eliminate

budgetary deficits may include reduced allocations to the FDA and other related government agencies.

These budgetary pressures may reduce

the FDA’s ability to perform its responsibilities, which could result in delays in our clinical trial timelines.

If a significant

reduction in the FDA’s workforce occurs, the FDA’s budget is significantly reduced or a prolonged government shutdown occurs,

it could significantly impact the ability of the FDA to timely review and process our regulatory submissions or take other actions critical

to the development or manufacturing of our product candidates, which could have a material adverse effect on our business.

If a prolonged government shutdown occurs, or if global health concerns prevent the FDA or other regulatory authorities from conducting their regular inspections,

If a prolonged government

shutdown occurs, or if global health 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

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

and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations.

These laws may constrain

the business or financial arrangements and relationships through which we conduct our operations, including how we research, market, sell

and distribute our product candidates, if approved.

In addition, we may be subject to data privacy and security regulation by the U.S.

federal government and the states and the foreign governments in which we conduct our business.

Restrictions under applicable laws and

regulations include the following:

foreign privacy, data protection, and data security laws and regulations, such as the European Union’s General Data Protection Regulation (EU GDPR), which imposes comprehensive obligations on covered businesses to, among other things, make contractual privacy, data protection and data security commitments, cooperate with European data protection authorities, implement security measures, give data breach notifications, and keep records of personal information processing activities;

Foreign Corrupt Practices Act of 1977, as amended, which prohibits, among other things, U.S.

companies and their employees and agents from authorizing, promising, offering, or providing, directly or indirectly, corrupt or improper payments or anything else of value to foreign government officials, employees of public international organizations and foreign government owned or affiliated entities, candidates for foreign political office, and foreign political parties or officials thereof.

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

These laws may

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

Principal investigators for

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to commercialize any product candidates, we may be subject to unfavorable pricing regulations and/or third-party coverage and reimbursement

policies, and we may not be able to offer such product candidates at competitive prices, which would seriously harm our business.

policies, and we may not be able to offer such product candidates at competitive prices, which could seriously harm our business.

We intend to seek approval

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and we are found to have improperly promoted off-label uses of those product candidates, we may become subject to significant liability,

which would materially adversely affect our business and financial condition.

which could materially adversely affect our business and financial condition.

We are subject to U.S.

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Our ability to obtain,

and protect our patents and other proprietary rights is uncertain, exposing us to the possible loss of competitive advantage.

maintain, and protect our patents and other proprietary rights is uncertain, exposing us to the possible loss of competitive advantage.

We rely upon a combination

of patents, trademarks, trade secret protection, confidentiality agreements and the Option and License Agreements 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.

Paragon has filed, on our behalf, provisional

patent applications and we have filed non-provisional patent applications directed to antibodies that target IL-23, including applications

covering composition of matter, pharmaceutical composition, and methods of using such antibodies, including ORKA-001.

In addition, Paragon

has filed, on our behalf, provisional patent applications and we intend to file one or more additional provisional patent applications

directed to antibodies that target IL-17, including applications covering composition of matter, pharmaceutical composition, and methods

of using such antibodies, 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;

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

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.

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.

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, invalidated

by third parties, or 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

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”).

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In addition to seeking patents

for some of our technology and programs, we may also rely on trade secrets, including unpatented know-how, technology and other

proprietary information, to maintain our competitive position.

Any disclosure, either intentional or unintentional, by our employees,

the personnel of third parties with whom we share our facilities or third-party consultants and vendors that we engage to perform

research, clinical trials or manufacturing activities, or misappropriation by third parties (such as through a cybersecurity breach) of

our trade secrets or proprietary information could enable competitors to duplicate or surpass our technological achievements, thus eroding

our competitive position in our market.

In order to protect our proprietary technology and processes, we rely in part on agreements, such

as confidentiality agreements, with our vendors, collaborators, employees, consultants, outside scientific collaborators and sponsored

researchers and other advisors.

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 party.

Enforcing a claim that a party illegally obtained and is using our trade secrets is challenging and

the outcome is unpredictable.

In addition, courts outside of the U.S.

for some of our technology and programs, we may also rely on trade secrets, including unpatented know-how, technology and other proprietary

information, to maintain our competitive position.

Any disclosure, either intentional or unintentional, by our employees, the personnel

of third parties with whom we share our facilities, or third-party consultants and vendors that we engage to perform research, clinical

trials or manufacturing activities, or misappropriation by third parties (such as through a cybersecurity breach) of our trade secrets

or proprietary information could enable competitors to duplicate or surpass our technological achievements, thus eroding our competitive

position in our market.

In order to protect our proprietary technology and processes, we rely in part on agreements, such as confidentiality

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.

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.

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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We may be unable to acquire or in-license any

compositions, methods of use, processes or other third-party intellectual property rights from third parties that we identify as

necessary for our programs.

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

of operations, and prospects.

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

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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 patent 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

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.

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Failure to obtain licenses

at a reasonable cost or terms may require us to expend significant time and resources to redesign our technology, programs, or the methods

for manufacturing them or to develop or license replacement technology, all of which may not be feasible on a technical or commercial

at a reasonable cost or on reasonable terms may require us to expend significant time and resources to redesign our technology, programs,

or the methods for manufacturing them or to develop or license replacement technology, all of which may not be feasible on a technical

or commercial basis.

If we are unable to do so, we may be unable to develop or commercialize the affected product candidates.

This could have a material

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

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

Disputes may arise between

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of any affected product candidate, and/or seek a license from the patent holder.

Any intellectual property claims brought against us, whether

or not successful, may cause us to incur significant legal expenses and divert the attention of our management and key personnel from

other business concerns.

Any intellectual property claims brought against us,

whether or not successful, may cause us to incur significant legal expenses and divert the attention of our management and key personnel

from other business concerns.

We cannot be certain that patents owned or licensed by us will not be challenged by others in litigation.

of our competitors may be able to sustain the costs of complex intellectual property litigation more effectively than we can because they

may have substantially greater resources.

Some of our competitors may be able to sustain the costs of complex intellectual property litigation more effectively than we can because

they may have substantially greater resources.

In addition, any litigation could have a material adverse effect on our business and operations,

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type of litigation or other proceedings.

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.

As is common in the biopharmaceutical

industry, in addition to our employees, we engage the services of consultants and independent contractors to assist us in the development

of our programs.

Many of these consultants, independent contractors and many of our employees, were 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.

We could in the future be subject to claims that we, our employees, our consultants or our independent

contractors have inadvertently or otherwise used or disclosed alleged intellectual property, such as trade secrets, or other confidential

information of former employers or 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

defend ourselves against these claims, even if we are successful, litigation could result in substantial costs and could be a distraction

to management.

If our defenses to these claims fail, in addition to requiring us to pay monetary damages, a court could prohibit us from

using technologies or features that are essential to our programs, if such technologies or features are found to incorporate or be derived

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, 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.

Even if we are successful in defending against such claims, litigation could result in substantial

costs and be a distraction to management.

Changes to patent laws

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

our products.

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

Changes in either the patent

laws or interpretation of patent laws in the United States and foreign jurisdictions could increase the uncertainties and costs surrounding

the prosecution of our owned and in-licensed patent applications and the maintenance, enforcement or defense of our owned and in-licensed issued

Additionally, there have been proposals for additional changes to the patent laws of the United States and other countries that,

if adopted, could impact our ability to enforce our proprietary technology.

This combination of events has created uncertainty with respect

to the validity and enforceability of patents once obtained.

laws or interpretation of patent laws in the U.S.

and foreign jurisdictions could increase the uncertainties and costs surrounding the

prosecution of our owned and in-licensed patent applications and the maintenance, enforcement or defense of our owned and in-licensed issued

Additionally, there have been proposals for additional changes to the patent laws of the U.S.

and other countries that, if adopted,

could impact our ability to enforce our proprietary technology.

This combination of events has created uncertainty with respect to the

validity and enforceability of patents once obtained.

Depending on future actions by the U.S.

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

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.

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

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

For example, the United States Supreme Court in Amgen,

For example, the U.S.

Supreme Court in Amgen,

Sanofi (Amgen) stated that if patent claims are directed to an entire class of compositions of matter, then the patent specification

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Obtaining and maintaining

patent protection depends on compliance with various procedural, document submissions, fee payment and other requirements imposed by governmental

patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

patent protection depends on compliance with various procedural, document submissions, fee payment, and other requirements imposed by

governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance fees,

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of relevant patents, are complete or thorough, nor can we be certain that we have identified each and every third-party patent and

pending application in the United States and abroad that is relevant to or necessary for the commercialization of our product candidates

in any 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.

pending application in the U.S.

and abroad that is relevant to or necessary for the commercialization of our product candidates in any

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.

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

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

in the United States 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.

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.

In addition, because some

patent applications in the United States may be maintained in secrecy until the patents are issued, patent applications in the United States

patent applications in the U.S.

may be maintained in secrecy until the patents are issued, and because patent applications in the U.S.

and many foreign jurisdictions are typically not published until 18 months after filing, and publications in the scientific literature

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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.

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

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 employees.

Even if we are

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

Patent terms may be

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Patents have a limited lifespan.

In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from

its earliest United States non-provisional filing date.

Various extensions may be available, but the life of a patent,

and the protection it affords, is time limited.

Even if patents covering our product candidates are obtained, once the patent life has

expired, we may be open to competition from competitive products, including generics or biosimilars.

Given the amount of time required

for the development, testing and regulatory review of new product candidates, patents protecting such product candidates might expire

before or shortly after such product candidates 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.

In the U.S., if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest

non-provisional filing date.

Various extensions may be available, but the life of a patent, and the protection it affords,

is time limited.

Even if patents covering our product candidates are obtained, once the patent life has expired, we may be open to competition

from competitive products, including generics or biosimilars.

Given the amount of time required for the development, testing, and regulatory

review of new product candidates, patents protecting such product candidates might expire before or shortly after such product candidates

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.

Our technology licensed

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We currently rely on

licensing arrangements with Paragon through the License Agreements.

If we are unable to maintain collaborations or licensing arrangements,

or if our collaborations or licensing arrangements are not successful, our business could be negatively impacted.

We currently rely on our

licensing arrangements with Paragon through the License Agreements for a substantial portion of our in-licenses, including for ORKA-001

and ORKA-002.

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.

Collaborations or licensing

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or licensors.

If any of our current or future collaborators or licensors experience delays in performance of, or fails to perform our

If any of our current or future collaborators or licensors experience delays in performance of, or fails to perform, their

obligations under their agreement with us, disagrees with our interpretation of the terms of such agreement or terminates their agreement

with us, the research programs with respect to which we have the option to acquire intellectual property license rights to pursuant to

the Option Agreements, the licensing agreements we have pursuant to the License Agreements and our development timeline could be adversely

If we fail to comply with any of the obligations under our collaborations 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.

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

with us, our development timeline could be adversely affected.

We currently rely on our licensing agreements with Paragon for a substantial

portion of our product portfolio, including for ORKA-001 and ORKA-002.

If we fail to comply with any of the obligations under our collaborations

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.

As part of our strategy,

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commercialization capabilities that complement ours.

We may not realize the benefits of such collaborations, alliances or licensing arrangements.

We may not realize the benefits of such collaborations, partnerships, or licensing

arrangements.

Any of these relationships may require us to incur non-recurring and other charges, increase our near and long-term expenditures,

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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.

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.

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 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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We have utilized and plan

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

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

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.

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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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.

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.

In addition, our clinical trials must be conducted with products produced under cGMP regulations.

Our failure to comply with these regulations

may require us to repeat clinical trials, which would delay the regulatory approval process.

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.

Any third parties conducting

our clinical trials will not be our employees and, except for remedies available to us under our agreements with such third parties, we

cannot control whether they devote sufficient time and resources to our programs.

These third parties may have relationships with other

commercial entities, including our competitors, for whom they may also be conducting clinical trials or other product development activities,

which could negatively affect their performance on our behalf and the timing thereof and could lead to products that compete directly

or indirectly with our product candidates.

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

available to us under our agreements, any third parties conducting our preclinical studies or clinical trials will not be our employees

and we cannot control whether they devote sufficient time and resources to our programs.

These third parties may have relationships with

other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other product development

activities, which could negatively affect their performance on our behalf and the timing thereof and could lead to products that compete

directly or indirectly with our product candidates.

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

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product candidates.

We currently rely and

expect to rely in the future on the use of manufacturing suites in third-party facilities or on third parties to manufacture our product

candidates, and we may rely on third parties to produce and process our products, if approved.

Our business could be adversely affected

if we are unable to use third-party manufacturing suites or if the third-party manufacturers encounter difficulties in production.

We rely on the use

of manufacturing suites in third-party facilities or on third parties to manufacture our product candidates, and we may rely on third

parties to produce and process our products, if approved.

Our business could be adversely affected if we are unable to use third-party

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

We do not currently own any

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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 affected.

In addition, our CMOs are responsible for transporting temperature-controlled materials that can be inadvertently degraded during

transport due to several factors, rendering certain batches unsuitable for trial use for failure to meet, among others, our integrity

and purity specifications.

We and any of our CMOs may also face product seizure or detention or refusal to permit the import or export

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 of any of our

product candidates by the FDA, result in higher costs or adversely impact commercialization of our product candidates.

at a cost that allows us to achieve profitability, our business, financial condition, and prospects could be materially and adversely

In addition, our CMOs are responsible for transporting temperature-controlled materials that can be inadvertently

degraded during transport due to several factors, rendering certain batches unsuitable for trial use for failure to meet, among others,

our integrity and purity specifications.

We and any of our CMOs may also face product seizure or detention or refusal to permit the import

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.

Each of these risks could delay or prevent the completion of our preclinical studies and clinical trials or the approval

of any of our product candidates by the FDA, result in higher costs, or adversely impact commercialization of our product candidates.

Foreign CMOs may be subject

legislation, including the proposed BIOSECURE bill, trade restrictions and other foreign regulatory requirements, which could

increase the cost or reduce the supply of material available to us, delay the procurement or supply of such material or have an adverse

effect on our ability to secure significant commitments from governments to purchase our potential therapies.

We currently rely on foreign

CROs and CMOs, including WuXi Biologics (Hong Kong) Limited and its affiliates (“WuXi Biologics”) and will likely continue

to rely on foreign CROs and CMOs in the future.

WuXi Biologics is identified in the U.S.

legislation known as the BIOSECURE Act, which

was proposed in the 118 th Congress, as a “biotechnology company of concern.” The version of the BIOSECURE Act introduced

House of Representatives during the 118 th Congress would prohibit federal agencies from entering into procurement

contracts with, as well as providing grants and loans to, an entity that uses biotechnology equipment or services from a biotechnology

company of concern, and includes a grandfathering provision allowing biotechnology equipment and services provided or produced by named

“biotechnology companies of concern” under a contract or agreement entered into before the effective date until January 1,

The pathway and timing for the BIOSECURE Act or its provisions to become law are uncertain.

Depending on whether the BIOSECURE Act

becomes law, what the final language of the BIOSECURE Act includes, and how the law is interpreted by U.S.

federal agencies, we could

be potentially restricted from pursuing U.S.

federal government business or grants in the future if we continue to use WuXi Biologics

or other parties identified as “biotechnology companies of concern” beyond the grandfathering period.

legislation, including the BIOSECURE Act, trade restrictions, and other foreign regulatory requirements, which could increase

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.

The BIOSECURE Act was enacted

law in December 2025 and restricts U.S.

federal agencies, as well as recipients of certain federal funding, from procuring,

using, or contracting for biotechnology equipment or services from entities designated as “biotechnology companies of concern”.

The law contemplates a designation process to identify such biotechnology companies of concern, and the timing, scope, and implementation

of the Act, including the criteria for designation and the application of any transition or grandfathering provisions, remain subject

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.

Furthermore, our operations

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implement our plans and strategies, we will need to grow the size of our organization and we may experience difficulties in managing this

We expect to experience significant

growth 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.

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.

We are highly dependent

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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.

As is common in the biopharmaceutical

industry, in addition to our employees, we engage the services of consultants and independent contractors to assist us in the development

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.

While we may litigate to

defend ourselves against these claims, even if we are successful, litigation could result in substantial costs and could be a distraction

to management.

If our defenses to these claims fail, in addition to requiring us to pay monetary damages, a court could prohibit us from

using technologies or features that are essential to our programs, if such technologies or features are found to incorporate or be derived

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

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impact our ability to grow and operate our business.

The risk of a cybersecurity incident or other informational technology disruption,

The risk of a cybersecurity incident or other information technology disruption,

particularly through cyber-attacks, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions

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credit, volatility in financial markets, high unemployment, labor availability constraints, public health crises, significant natural

disasters, including as a result of climate change, changes to fiscal and monetary policy or government budget dynamics (particularly

in the pharmaceutical and biotechnology areas), political and military conflict, and uncertainty about economic stability.

In recent months,

has announced tariffs on imports from most countries, including significant tariffs on imports from China.

Historically, tariffs

have led to increased trade and political tensions.

disasters, changes to fiscal and monetary policy, or government budget dynamics (particularly in the pharmaceutical and biotechnology

areas), political and military conflict, and uncertainty about economic stability.

Recently, the U.S.

has announced tariffs on imports

from most countries, including significant tariffs on imports from China.

Historically, tariffs have led to increased trade and political

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 economies, resulting in a material adverse effect on global economic conditions and the stability

of global financial markets.

There 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 with China have created extreme volatility in the global capital markets and may have further

global economic consequences, including disruptions of the global supply chain.

Any such volatility and disruptions may adversely affect

our business or the third parties on whom we rely.

If the equity and credit markets deteriorate, including as a result of economic or

political uncertainty, political unrest or war, it may make any necessary debt or equity financing more costly, more dilutive, or more

difficult to obtain in a timely manner or on favorable terms, if at all.

Increased inflation rates can adversely affect us by increasing

our costs, including materials, operational, labor and employee benefit costs.

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.

Similarly, the ongoing military conflict between Russia and Ukraine and in the Middle East and rising tensions

with China have created extreme volatility in the global capital markets and may have further global economic consequences, including

disruptions of the global supply chain.

Any such volatility and disruptions may adversely affect our business or the third parties on

whom we rely.

If the equity and credit markets deteriorate, including as a result of economic or political uncertainty, political unrest

or war, it may make any necessary debt or equity financing more costly, more dilutive, or more difficult to obtain in a timely manner

or on favorable terms, if at all.

Increased inflation rates can adversely affect us by increasing our costs, including materials, operational,

labor and employee benefit costs.

We may in the future experience

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For example, escalating trade tensions, elevated

interest rates and regulatory uncertainty have caused significant market volatility in recent months, and particularly in the biotechnology

and biopharmaceutical industries.

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

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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 or geopolitical conditions or market conditions in the pharmaceutical and biotechnology sectors;

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;

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Changes in the market valuations of similar companies;

sales of securities by us or our securityholders in the future;

if we fail to raise an adequate amount of capital to fund our operations or continued development of our product candidates;

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;

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indispensable parties named as defendants therein, which for purposes of this risk factor refers 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

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

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.

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Future sales of shares

by existing stockholders could cause our stock price to decline.

If our stockholders sell, or indicate an intention to sell, substantial

amounts of our common stock in the public market, the trading price of our common stock could decline.

In addition, shares of our common

stock that are subject to our outstanding options will become eligible for sale in the public market to the extent permitted by the provisions

of various vesting agreements and Rules 144 and 701 under the Securities Act.

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

If our stockholders sell,

or indicate an intention to sell, substantial amounts of our common stock in the public market, the trading price of our common stock

could decline.

In October 2025 we filed a registration statement on Form S-3 covering the resale of 39,425,806 shares of our common stock

(including shares of common stock issuable upon the conversion of outstanding Series B Preferred Stock, or issuable upon the exercise

of outstanding pre-funded warrants to purchase shares of common stock).

The sale of these shares in the public market or the perception

that holders of a large number of the securities intend to sell their securities could significantly reduce the price of our common stock.

We cannot predict if and when the selling stockholders listed in the registration statement may sell such shares in the public markets.

In addition, shares of our common stock that are subject to our outstanding options will become eligible for sale in the public market

to the extent permitted by the provisions of various vesting agreements and Rules 144 and 701 under the Securities Act.

Furthermore, in

the future, we may issue additional shares of common stock or other equity or debt securities convertible into shares of common stock.

We do not anticipate

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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