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Item 1A. Risk Factors

2025-08-11 compared with 2025-05-14 · 354 added, 356 removed, 1444 unchanged (33% of the section changed)

Factor Summary

We are subject to a number of risks that could

harm our business, financial condition, results of operations and/or growth prospects or cause our actual results to differ materially

from those contained in forward-looking statements we have made in this Form 10-Q and those we may make from time to time.

of our product candidates will depend on a variety of factors.

We do not have complete control over many of these factors, including certain

aspects of clinical development and the regulatory submission process, potential threats to our intellectual property rights and the manufacturing,

marketing, distribution and sales efforts of any current or future collaborator.

In addition, some of the factors, events and contingencies

discussed below may have occurred in the past, but the disclosures below are not representations as to whether or not the factors, events

or contingencies have occurred in the past and instead reflect our beliefs and opinions as to the factors, events, or contingencies that

could materially and adversely affect us in the future.

The summary below is not exhaustive and is qualified

by reference to the full set of risk factors set forth in Item 1A of this Form 10-Q “Risk Factors”.

Please carefully consider

all the information in this Form 10-Q, 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.

We are subject to a number

of risks that could harm our business, financial condition, results of operations and/or growth prospects or cause our actual results

to differ materially from those contained in forward-looking statements we have made in this Quarterly Report and those we may make from

time to time.

The success of our product candidates will depend on a variety of factors.

We do not have complete control over many of

these factors, including certain aspects of clinical development and the regulatory submission process, potential threats to our intellectual

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

In addition, some

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

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

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

The summary below is not

exhaustive and is qualified by reference to the full set of risk factors set forth in Item 1A 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

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

Our projected development goals, including our clinical trials, may not be successful or we may fail to achieve our projected development goals in the time frames we announce and expect.

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

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

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

Risks Related to Government

● We may not be able to meet requirements for the chemistry,

manufacturing and control of our programs.

Food and Drug Administration (“FDA”)

and comparable foreign regulatory approval processes are lengthy and time consuming and we may not be able to obtain or may be delayed

in obtaining regulatory approvals for our product candidates.

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

ongoing regulatory obligations.

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

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

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

Risks Related to Our Intellectual

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

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.

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.

We may be unable to use third-party manufacturing sites, our third-party manufacturers may encounter difficulties in production or we may need to switch or create third-party manufacturer redundancies.

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

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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 strategy.

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.

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than we currently anticipate.

We have devoted substantially all of our financial resources to identify, acquire, and develop our product

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

Additional capital may not be available in sufficient amounts or on

reasonable terms, if at all.

The current market environment for small and midcap biotechnology companies, like Oruka, and broader macroeconomic

factors may preclude us from successfully raising additional capital.

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

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

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

Additional capital may not

be available in sufficient amounts or on reasonable terms, if at all.

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 significant market volatility in recent months, and particularly

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

Biopharmaceutical product

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operating results, and prospects:

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

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

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

be available in the future;

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

candidates that we otherwise would seek to develop or commercialize ourselves;

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

for bankruptcy or cease operations altogether.

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

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

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

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

filing for bankruptcy or ceasing operations altogether.

Even if we are successful

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

Debt financing, if available, would likely involve agreements that include covenants limiting or restricting our ability to take specific

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

Risks Related to Clinical

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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;

or 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;

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;

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;

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

organizations (“CROs”);

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;

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

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

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.

● 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;

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;

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;

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;

the cost of clinical trials of any of our programs may be greater than we anticipate;

reports from clinical testing of other therapies may raise safety or efficacy concerns about our programs;

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

If our clinical trials do

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dependent on the success of our two most advanced programs, ORKA-001 and ORKA-002, and our clinical trials of such programs may not be

Our future success is substantially

dependent on our ability to develop and timely obtain marketing approval for, and then successfully commercialize, our two most advanced

programs, ORKA-001 and ORKA-002.

We are investing a majority of our efforts and financial resources into the research and development

of these programs.

We have initiated a Phase 1 clinical trial of ORKA-001 in healthy volunteers and anticipate initiating a Phase

1 clinical trial of ORKA-002 in healthy volunteers in the second half of 2025, subject to the filing of an IND or foreign equivalent

and regulatory approval.

Currently, we believe that the success of our programs is dependent on observing a longer half-life of our

product candidates 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

Our future success is

substantially dependent on our ability to develop and timely obtain marketing approval for, and then successfully commercialize, our

two most advanced programs, ORKA-001 and ORKA-002.

We are investing the majority of our efforts and financial resources into

the research and development of these programs.

We have initiated a Phase 1 clinical trial of ORKA-001 in healthy volunteers

and have also initiated a Phase 2 clinical trial of ORKA-001 in patients with moderate-to-severe psoriasis in the third

quarter of 2025.

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

Currently, we believe that the success of our programs is dependent on observing a longer half-life of our product

candidates 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.

This is based in part on the assumption that the longer half-life we have observed in NHPs will translate

into an extended half-life of our product candidates in humans.

To the extent we do not observe this extended half-life in humans,

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

This is based in part on the assumption that the longer half-life we have observed in non-human

primates will translate into an extended half-life of our product candidates in humans.

To the extent we do not observe this

extended half-life in humans, it would significantly and adversely affect the clinical and commercial potential of our product

If we do not achieve

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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 estimate

From time to time, we announce

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

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These milestones may include the commencement or completion of scientific studies and clinical trials,

such as the expected timing of our clinical trials in our target indications, anticipated data analysis and results from our clinical

trials, as well as the submission of regulatory filings.

From time to time, we may publicly announce the expected timing of some of these

such as the expected timing of our clinical trials in our target indications, anticipated data analysis and the data results from our

clinical trials, as well as the submission of regulatory filings.

All of these milestones are and will be based on numerous assumptions.

The actual timing of these milestones can vary dramatically

compared to our estimates, in some cases for reasons beyond our control.

If we do not meet these milestones as publicly announced, or

at all, 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 may decline.

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.

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

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.

Any drug delivery device

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volume requirements.

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

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.

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In addition, we may in the

future seek to discover and develop programs that are based on novel targets and 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.

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 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.

Preclinical and clinical

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

Furthermore, a failure of

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

Clinical data is often susceptible to varying interpretations and analyses,

and 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.

These 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.

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.

We cannot be sure that the

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delays in reaching a consensus with regulatory authorities

on study design or implementation of the clinical trials;

on trial design or implementation of the clinical trials;

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

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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;

failure 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 GCP requirements or applicable regulatory guidelines in other countries;

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;

failure 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.

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 could also encounter delays

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until conclusion.

The enrollment of participants in 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 trials.

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.

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.

Preliminary, “topline”

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From time to time, we may

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

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

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information to include in our disclosure.

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

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

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.

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is obtained for a product candidate resulting from one of our current or future programs, it may not gain market acceptance among physicians,

patients, healthcare payors or the medical community.

Market acceptance of our product candidates will depend on many factors, 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

patients, third-party payors or others in the medical community.

Market acceptance of our product candidates will depend on many factors,

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,

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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 U.S.

presents additional risks that may delay our clinical trials.

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

We may choose to conduct

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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.

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

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

If the FDA does not accept the

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

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

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

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

Further, conducting clinical

trials outside of the U.S.

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

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

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Affordable Care Act, as amended by the Healthcare and Education Reconciliation Act (the “ACA”), includes a subtitle called

the BPCIA, which created an abbreviated approval pathway for biological products that are biosimilar to or interchangeable with an FDA-licensed reference

biological product.

Under the BPCIA, an application for a highly similar or “biosimilar” product may not be submitted to the

FDA until four years following the date that the reference product was first approved by the FDA.

In addition, the approval

of a biosimilar product may not be made effective by the FDA until 12 years from the date on which the reference product was first

During this 12-year period of exclusivity, another company may still market a competing version of the reference product

if the FDA approves a full BLA for the competing product containing the sponsor’s own preclinical data and data from adequate and

well-controlled clinical trials to demonstrate the safety, purity and potency of their product.

the Biologics Price Competition and Innovation Act (the “BPCIA”), which created an abbreviated approval pathway for biological

products that are biosimilar to or interchangeable with an FDA-licensed reference biological product.

Under the BPCIA, an application

for a highly similar or “biosimilar” product may not be submitted to the FDA until four years following the date that

the reference product was first approved by the FDA.

In addition, the approval of a biosimilar product may not be made effective

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

During this 12-year period of

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

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

the safety, purity and potency of their product.

We believe that any of our

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

the FDA may require a REMS in order to approve our product candidates.

In addition, 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 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.

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

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may rely, which could negatively impact our business.

The ability of the FDA to

review regulatory filings and our ability to commence human clinical trials can be affected by a variety of factors, including government

budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, statutory, regulatory and policy

changes, disruptions caused by government shutdowns and public health crises.

There have been mass layoffs of federal government employees

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

Average review times

at the agency have fluctuated in recent years as a result.

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

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

is inherently fluid and unpredictable.

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

in the leadership of various U.S.

federal regulatory agencies and changes to U.S.

federal government policy that have led to, in some

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

The ability of the FDA to review regulatory filings and our ability

to commence clinical trials can be affected by a variety of factors, including government budget and funding levels, ability to hire and

retain key personnel and accept the payment of user fees, statutory, regulatory and policy changes, disruptions caused by government shutdowns

and public health crises.

There have been mass layoffs of federal government employees since the start of the Trump administration in

January 2025, the full impact of which is unclear at this time.

Average review times at the agency have fluctuated in recent years as

In addition, government funding of the SEC, and other government agencies on which our operations may rely, including those

that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.

the Trump administration has made and is expected to continue to make changes in the leadership of various U.S.

federal regulatory agencies

including the FDA.

and changes to U.S.

federal government policy that have led to, in some cases, legal challenges and uncertainty around the funding, functioning

and policy priorities of the U.S.

federal regulatory agencies, including the FDA.

Disruptions at the FDA and

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employees and stop critical activities.

Additionally, action by the new Trump Administration to limit federal agency budgets or personnel

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

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We are unable to predict

the extent to which the presidential 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.

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

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The price of pharmaceuticals

has been a topic of considerable public discussion that could lead to price controls or other price-limiting strategies by payors that

have the effect of lowering payment and reimbursement rates for drugs or otherwise making the commercialization of pharmaceuticals less

Many federal and state legislatures have considered, and adopted, healthcare policies intended to curb rising healthcare costs,

such as the IRA.

has been a topic of considerable public discussion that could lead to price controls or other price-limiting strategies by third-party

payors that have the effect of lowering payment and reimbursement rates for drugs or otherwise making the commercialization of pharmaceuticals

less profitable.

Many federal and state legislatures have considered, and adopted, healthcare policies intended to curb rising healthcare

costs, such as the Inflation Reduction Act (“IRA”).

These cost-containment measures may include, among other measures:

requirements for pharmaceutical companies to negotiate

prescription drug prices with government healthcare programs;

controls on government-funded reimbursement for drugs;

new or increased

requirements to pay prescription drug rebates to government healthcare programs, including if drug prices increase at a higher rate than

for pharmaceutical companies to negotiate prescription drug prices with government healthcare programs;

controls on government-funded

reimbursement for drugs;

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

drug prices increase at a higher rate than inflation;

controls on healthcare providers;

challenges to or limits on the pricing of drugs, including pricing controls or limits or

prohibitions on reimbursement for specific products through other means;

requirements to try less expensive products or generics before

a more expensive branded product;

and public funding for cost effectiveness research, which may be used by government and private third-party

payors to make coverage and payment decisions.

Political, economic and regulatory developments may further complicate developments in

healthcare systems and pharmaceutical drug pricing.

These developments could, for example, impact our potential licensing agreements as

commercial and collaborative partners may also consider the impact of these pressures on their licensing strategies.

challenges to or limits on the pricing of drugs,

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

requirements to try less

expensive products or generics before a more expensive branded product;

and public funding for cost effectiveness research, which may

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

Political, economic and regulatory developments

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

These developments could, for example, impact

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

Any new laws or regulations

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controls, caps on prescription drugs or price transparency requirements could adversely affect our business, operating results and financial

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

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

expose us to penalties.

Our business operations

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

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

to penalties.

Our business operations and

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and distribute our product candidates, if approved.

Principal investigators for our clinical trials may serve as scientific advisors or

consultants to us or may be affiliated with our other service providers, including CROs or site management organizations, and from time

to time may receive cash compensation in connection with such services.

If these relationships and any related compensation result in

perceived or actual conflicts of interest, the integrity of the data generated at the applicable clinical trial site or in the applicable

trial may be questioned or jeopardized.

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:

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,

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.

Principal investigators for

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

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

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

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

Ensuring that our internal

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

Because our development programs

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

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

It is possible that we may

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

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

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

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 rights 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.

Because our development programs currently do and may in the future

require the use of proprietary rights held by third parties, the growth of our business may depend in part on our ability to acquire, in-license, or

use these third-party proprietary rights.

It is possible that we may be unable to obtain licenses at a reasonable cost or on reasonable

terms, if at all.

Even if we are able to obtain a license, it may be non-exclusive, thereby giving our competitors access to the same

technologies licensed to us.

We may be unable to acquire or in-license any compositions, methods of use, processes or other

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

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.

While we plan to obtain the

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

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

or collaboration partners.

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

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

property or our exclusivity with respect to those rights, our ability to develop and commercialize those product candidates may be adversely

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

In addition, 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 place prior

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

Moreover, if other third parties have ownership rights to our future

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

and technology.

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

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

licensors or collaboration partners.

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

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

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

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

even where we have the right to control 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

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

Moreover, if other third parties have ownership rights

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

products and technology.

Failure to obtain licenses

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Similarly, if we assert

trademark infringement claims, a court or administrative body may determine that the marks we have asserted are invalid or unenforceable

or that the party against whom we have asserted trademark infringement has superior rights to the marks in question.

In such a case, we

could ultimately be forced to cease use of such marks.

In any intellectual property litigation, even if we are successful, any award of

monetary damages or other remedy we receive may not be commercially valuable.

trademark (“marks”) infringement claims, a court or administrative body may determine that the marks we have asserted are

invalid or unenforceable or that the party against whom we have asserted trademark infringement has superior rights to the marks in question.

In such a case, we could ultimately be forced to cease use of such marks.

In any intellectual property litigation, even if we are successful,

any award of monetary damages or other remedy we receive may not be commercially valuable.

Further, we may be required

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As is common in the biopharmaceutical

industry, in addition to our employees, we engage the services of consultants to assist us in the development of our programs.

these consultants, 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.

the future be subject to claims that we, our employees or our consultants 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 and consultants 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,

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

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adversely affect our reputation, our ability to form strategic alliances or sublicense our rights to collaborators, engage with scientific

advisors or hire employees or consultants, each of which would have an adverse effect on our business, results of operations and financial

Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction

to management.

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

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We currently rely on our

licensing arrangements with Paragon through the License Agreements for a substantial portion of our in-licenses.

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

and ORKA-002.

Collaborations or licensing

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qualify an alternate supply source.

We may not control the manufacturing process of, and may be completely dependent on, our contract

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

authorities for the manufacture of our product candidates.

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

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

If the FDA or a comparable foreign regulatory authority

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

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

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

Similarly, our

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

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

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

candidates or drugs and harm our business and results of operations.

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

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

for the manufacture of our product candidates.

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

adequate quality control, quality assurance and qualified personnel.

If the FDA or a comparable foreign regulatory authority does not

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

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

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

Similarly, our failure, or

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

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

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

or drugs and harm our business and results of operations.

Moreover, our CMOs may experience

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be potentially restricted from pursuing U.S.

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

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

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.

Furthermore, our operations

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changing foreign regulatory, tax, accounting and legal requirements and reduced protection of intellectual property rights in some foreign

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 market opportunity estimates

and growth forecasts are subject to significant uncertainty and are based on assumptions and estimates that may not prove to be accurate.

Even if the markets in which we compete meet our size estimates and growth forecasts, our business may not grow at similar rates, or at

Our revenue will be dependent,

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

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

If the number of our addressable

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

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

such products, even if approved.

Our employees, independent

contractors, consultants, commercial collaborators, principal investigators, CROs, CMOs, suppliers and vendors may engage in misconduct

or other improper activities, including noncompliance with regulatory standards and requirements.

contractors, consultants, advisors, commercial collaborators, principal investigators, CROs, CMOs, suppliers and vendors may engage in

misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

We are exposed to the risk

that our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, CMOs, suppliers and

vendors acting for or on our behalf may engage in misconduct or other improper activities.

that our employees, independent contractors, consultants, advisors, commercial collaborators, principal investigators, CROs, CMOs, suppliers

and vendors acting for or on our behalf may engage in misconduct or other improper activities.

We have adopted a code of conduct and ethics,

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among countries, or conflict with other rules.

We are or may become subject to the terms of contractual obligations related to privacy,

data protection and data security.

We are or may become subject to the terms of contractual

obligations related to privacy, data protection and data security.

Our obligations may also change or expand as our business grows.

The actual or perceived failure by

us or third parties related to us to comply with such laws, regulations and obligations could increase our compliance and operational

costs, expose us to regulatory scrutiny, actions, fines and penalties, result in reputational harm, lead to a loss of customers, result

in litigation and liability, and otherwise cause a material adverse effect on our business, financial condition, and results of operations.

actual or perceived failure by us or third parties related to us to comply with such laws, regulations and obligations could increase

our compliance and operational costs, expose us to regulatory scrutiny, actions, fines and penalties, result in reputational harm, lead

to a loss of customers, result in litigation and liability, and otherwise cause a material adverse effect on our business, financial condition,

and results of operations.

If we fail to comply

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We may become exposed

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

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

We are exposed to potential

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and financial condition.

The global economy, including

credit and financial markets, has experienced and may experience in the future extreme volatility and disruptions, including, among other

things, diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, supply chain shortages,

new or increased tariffs and other barriers to trade, especially in light of recent executive orders made by the presidential administration,

trade and other international disputes, increases in inflation rates, fluctuation in interest rates, slower growth or recession, tighter

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.

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.

The global economy, including credit and financial markets, has experienced

and may experience in the future extreme volatility and disruptions, including, among other things, diminished liquidity and credit availability,

declines in consumer confidence, declines in economic growth, supply chain shortages, new or increased tariffs and other barriers to trade,

especially in light of recent executive orders made by the Trump administration, trade and other international disputes, increases in

inflation rates, fluctuation in interest rates, slower growth or recession, tighter 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, 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 tensions.

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

We may in the future experience

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Among other things, these provisions:

establish a classified board of directors such that all members of the board are not elected at one time;

● establish a classified board of

directors such that all members of the board are not elected at one time;

allow the authorized number of our directors to be changed only by resolution of our board of directors;

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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