What changed in this filing

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Item 1A. Risk Factors

2025-03-18 compared with 2024-02-29 · 160 added, 189 removed, 613 unchanged (36% of the section changed)

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our inception and will continue to incur substantial operating losses for the foreseeable future.

Since our inception, we have

been engaged primarily in the research and development of our electro-optic polymer materials technologies and products.

of these activities, we incurred significant losses and experienced negative cash flow since our inception.

We incurred a net loss

of $21,038,032 for the year ended December 31, 2023, $17,230,480 for the year ended December 31, 2022, and $18,631,381 for the year

ended December 31, 2021.

We anticipate that we will continue to incur operating losses through at least 2024.

Since our inception, we have been

engaged primarily in the research and development of our electro-optic polymer materials technologies and products.

As a result of these

activities, we incurred significant losses and experienced negative cash flow since our inception.

We incurred a net loss of $22,535,041

for the year ended December 31, 2024, and $21,038,032 for the year ended December 31, 2023.

We anticipate that we will continue to incur

operating losses through at least 2025.

We may not be able to generate

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Identify, attract, retain and motivate qualified personnel;

Continue to develop and upgrade our technologies to keep pace with changes in technology and the growth of markets using polymer based materials;

Develop expanded product production facilities, along with silicon-based foundry and other outside contractor relationships;

Continue to develop and upgrade our technologies to

keep pace with changes in technology and the growth of markets using polymer-based materials;

Develop expanded product production facilities, along

with silicon-based foundry and other outside contractor relationships;

Maintain our reputation and build trust with customers.

Scale up from small pilot or prototype quantities to large quantities of product on a consistent basis;

Contract for or develop the internal skills needed to master large volume production of our products;

Fund the capital expenditures required to develop volume production due to the limits of our available financial resources.

If we fail to effectively manage our growth, and

effectively transition from our focus on research and development activities to commercially successful products, our business could suffer.

Our failure to effectively manage our growth and

effectively transition from our focus on research and development activities to commercial operations could harm our business.

Failure to manage growth of operations

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Based on our current operating plan and budgeted cash requirements,

we believe that we have sufficient funds to finance our operations through July 2025;

we believe that we have sufficient funds to finance our operations through April 2026;

however, we will need to obtain additional future

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Park on February 28, 2023 (the “ 2023 Purchase Agreement ”);

and (ii) the sales agreement for up to $35 million we entered

into with Roth Capital Partners, LLC (“ Roth Capital ”) on December 9, 2022 (the

“ Roth Sales Agreement ”) ;

we have no plans or arrangements with respect

to the possible acquisition of additional financing, and such financing may be unavailable when we need it or may not be available on

acceptable terms.

We currently have a remaining amount of $10.5 million that is available to our Company pursuant to the 2023 Purchase

Agreement with Lincoln Park, and $33.4 million that is available to our Company pursuant to the Roth Sales Agreement with Roth Capital.

(ii) the purchase agreement for up to $30 million we entered

into with Lincoln Park on March 17, 2025 (the “ 2025 Purchase Agreement ");

and (iii) the sales agreement for up to $35

million we entered into with Roth Capital Partners, LLC (“ Roth Capital ”) on December 9, 2022 (the “ Roth Sales

Agreement ”);

we have no plans or arrangements with respect to the possible acquisition of additional financing, and such financing

may be unavailable when we need it or may not be available on acceptable terms.

We currently have a remaining amount of $0 million and

$30 million pursuant to the 2023 Purchase Agreement and 2025 Purchase Agreement with Lincoln Park, subject to the conditions set forth

therein, respectively, and $31.5 million that is available to our Company pursuant to the Roth Sales Agreement with Roth Capital.

Our forecast of the period of

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accurately predict growth in these new markets, we may suffer substantial losses.

We are devoting significant resources

to develop next generation proprietary photonic devices that are based on our advanced electro-optical polymer material systems for future

applications in data communications and telecommunications markets and we are exploring other applications that include automotive/LIDAR,

sensing, displays etc.

initially targeting applications in fiber optic data communications and telecommunications markets, in particular ultra-high bandwidth

optical connections deployed inside and between datacenters and/or AI clusters.

In addition, we are exploring other applications that

include automotive/LIDAR, sensing, displays, storage, aerospace and defense, satellites, quantum computing etc., for our polymer technology

We expect to continue to develop products for these markets and to seek to identify new markets.

These markets

change rapidly, and we cannot assure you that they will grow or that we will be able to accurately forecast market demand, or lack thereof,

in time to respond appropriately.

Our investment of resources to develop products for these markets may either be insufficient to meet

actual demand or result in expenses that are excessive in light of actual sales volumes.

Failure to predict growth and demand accurately

in new markets may cause us to suffer substantial losses.

These markets change rapidly,

and we cannot assure you that they will grow or that we will be able to accurately forecast market demand, or lack thereof, in time to

respond appropriately.

Our investment of resources to develop products for these markets may either be insufficient to meet actual demand

or result in expenses that are excessive in light of actual sales volumes.

Failure to predict growth and demand accurately in new markets

may cause us to suffer substantial losses.

In addition, as we enter new markets, there is a significant risk that:

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We are initially targeting applications

in data communications and telecommunications markets and are exploring other applications that include automotive/LIDAR, sensing, displays

Our ability to generate significant revenues depends significantly on the extent to which potential customers and other potential

industry partners develop, promote and sell systems that incorporate our products, which, of course, we cannot control.

Any failure by

potential customers and other potential industry partners to successfully develop and market systems that incorporate our products could

adversely affect our sales.

The extent to which potential customers and other industry partners develop, promote and sell systems incorporating

our products is based on a number of factors that are largely beyond our ability to control.

in fiber optic data communications and telecommunications markets, in particular ultra-high bandwidth optical connections deployed inside

and between datacenters and/or AI clusters.

In addition, we are exploring other applications that include automotive/LIDAR, sensing, displays,

storage, aerospace and defense, satellites, quantum computing etc., for our polymer technology platform.

Our ability to generate significant

revenues depends significantly on the extent to which potential customers and other potential industry partners develop, promote and sell

systems that incorporate our products, which, of course, we cannot control.

Any failure by potential customers and other potential industry

partners to successfully develop and market systems that incorporate our products could adversely affect our sales.

The extent to which

potential customers and other industry partners develop, promote and sell systems incorporating our products is based on a number of factors

that are largely beyond our ability to control.

We may participate in joint ventures that expose us to operational and

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Our future growth will suffer if we do not achieve

sufficient market acceptance of our organic nonlinear optical material products or our proprietary photonic devices.

sufficient market acceptance of our organic nonlinear optical materials.

We expect our patented and patent-pending

optical materials along with trade secrets and licensed materials, to be the core of and the enabling technology for future generations

of optical devices, modules, sub-systems and systems that we will develop or potentially out-license to electro-optic device manufacturers.

Most of our products are still in the development stage, and we do not know when a market for these products will develop, if at all.

Our success depends, in part, upon our ability to gain market acceptance of our products.

To be accepted, our products must meet the technical

and performance requirements of our potential customers.

OEMs, suppliers or government agencies may not accept polymer-based products.

In addition, even if we achieve some degree of market acceptance for our products in one industry, we may not achieve market acceptance

in other industries for which we are developing products.

Achieving widespread market acceptance

for our products will require marketing efforts and the expenditure of financial and other resources to create product awareness and demand

by customers.

We may be unable to offer products that compete effectively due to our limited resources and operating history.

Also, certain

large corporations may be predisposed against doing business with a company of our limited size and operating history.

Failure to achieve

broad acceptance of our products by customers and to compete effectively would harm our operating results.

of optical devices, modules, sub-systems and systems that we will develop or out-license to electro-optic device manufacturers.

our materials are still in the development stage, and we do not know when a market for our materials will develop, if at all.

depends, in part, upon our ability to gain market acceptance of our organic nonlinear optical materials.

To be accepted, our materials

must meet the technical and performance requirements of our potential customers.

OEMs, suppliers or government agencies may not accept

polymer-based materials.

In addition, even if we achieve some degree of market acceptance for our materials in one industry, we may not

achieve market acceptance in other industries that we are targeting.

Also, certain large corporations may be predisposed against doing

business with a company of our limited size and operating history.

Our potential customers require our products to

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Another of our significant target

markets is the data communications (datacenter and/or high performance computing) market, which may be subject to heavy competition from

other PIC based technologies such as silicon photonics and Indium Phosphide.

As the demands for high performance, low cost ($/Gbps) is

implemented into next generation architectures, polymer modulators and polymer based PIC products may be subject to significant competition.

Furthermore, there is a potential that technologies such as silicon photonics and Indium Phosphide might reach the metric of $1/Gbps at

400Gbps before ours .

Customers may then be less willing to purchase new technology such as ours

or invest in new technology development such as ours for next generation systems.

markets is the fiber optic data communications market, in particular ultra-high bandwidth optical connections deployed inside and between

datacenters and/or AI clusters, which may be subject to heavy competition from other PIC based technologies such as silicon photonics

and Indium Phosphide.

As the demands for high performance, low cost ($/Gbps) is implemented into next generation architectures, polymer

modulators and polymer based PIC products may be subject to significant competition.

Furthermore, there is a potential that technologies

such as silicon photonics and Indium Phosphide might reach the metric of $1/Gbps at 800Gbps before ours.

Customers may then be less willing

to purchase new technology such as ours or invest in new technology development such as ours for next generation systems.

Our inability to successfully acquire and integrate

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compliance practices, revenue recognition or other accounting practices, or employee or customer issues.

Additionally, in connection with

any acquisitions we complete, we may not achieve the synergies or other benefits we expected to achieve, and we may incur write-downs,

impairment charges or unforeseen liabilities that could negatively affect our operating results or financial position or could otherwise

harm our business.

If we finance acquisitions using existing cash, the reduction of our available cash could cause us to face liquidity

issues or cause other unanticipated problems in the future.

If we finance acquisitions by issuing convertible debt or equity securities,

the ownership interest of our existing stockholders may be diluted, which could adversely affect the market price of our stock.

contemplating or completing an acquisition and integrating an acquired business, product or technology could divert management and employee

time and resources from other matters, which could harm our business, financial condition and operating results.

Public health emergencies or outbreaks of epidemics,

pandemics, or contagious diseases have disrupted, and could in the future disrupt, our operations and materially and adversely affect

our business, financial condition, and results of operations.

public health emergencies or outbreaks of epidemics, pandemics, or contagious diseases, such as the COVID-19 pandemic, have had, and could

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

The full extent to which

a global health crisis may impact our business and operating results would depend on future developments that are highly uncertain and

cannot be accurately predicted, including new medical and other information that may emerge as a result and the actions by governmental

entities or others to contain it or treat its impact.

of a severe health crisis could pose the risk that we or our employees, suppliers, customers and others may be restricted or prevented

from conducting, or adversely modify, our business activities for indefinite or intermittent periods of time, including as a result of

employee health and safety concerns, shutdowns, shelter in place orders, travel restrictions and other actions and restrictions that may

be prudent or required by governmental authorities.

A global health crisis could also impact our customers’ purchasing behavior

or decisions, including reduced demand for our products that could continue for an extended period of time.

all of the foregoing in jurisdictions where we or our customers, suppliers, or operations are located have had and could in the future

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

In addition, fluctuations

in demand and other implications associated with public health emergencies have resulted in, and could in the future result in, certain

supply chain constraints and challenges.

Additionally,

in connection with any acquisitions we complete, we may not achieve the synergies or other benefits we expected to achieve, and we may

incur write-downs, impairment charges or unforeseen liabilities that could negatively affect our operating results or financial position

or could otherwise harm our business.

If we finance acquisitions using existing cash, the reduction of our available cash could cause

us to face liquidity issues or cause other unanticipated problems in the future.

If we finance acquisitions by issuing convertible debt

or equity securities, the ownership interest of our existing stockholders may be diluted, which could adversely affect the market price

of our stock.

Further, contemplating or completing an acquisition and integrating an acquired business, product or technology could divert

management and employee time and resources from other matters, which could harm our business, financial condition and operating results.

We may incur debt in the future that might be secured

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As a result, these competitors may:

succeed in developing products that are equal to or superior to our products and future products or that will achieve greater market acceptance than our products and future products;

succeed in developing materials and product integration expertise that is equal to or superior to our offerings or that will achieve greater market acceptance than our offerings and future offerings;

devote greater resources to developing, marketing or selling their products;

respond more quickly to new or emerging technologies or scientific advances and changes in customer requirements, which could render our technologies or products obsolete;

introduce products that make the continued development of our products and future products uneconomical;

obtain patents that block or otherwise inhibit our ability to develop and commercialize our products and future products;

respond more quickly to new or emerging technologies or scientific advances and changes in customer requirements, which could render our technologies obsolete;

introduce products that make the continued development of our materials and future materials uneconomical;

obtain patents that block or otherwise inhibit our ability to develop and commercialize our materials and future materials;

withstand price competition more successfully than we can;

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Our technology may be subject to government rights.

We may have obligations to government

agencies in connection with the technology that we have developed, including the right to require that a compulsory license be granted

to one or more third parties selected by certain government agencies.

It may be difficult to monitor whether these third parties will

limit their use of our technology to these licensed uses, and we could incur substantial expenses to enforce our rights to our licensed

technology in the event of misuse.

We may have obligations to government agencies in connection with the

technology that we have developed, including the right to require that a compulsory license be granted to one or more third parties selected

by certain government agencies.

It may be difficult to monitor whether these third parties will limit their use of our technology to

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

The loss of certain of our key personnel, or any

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Our future success depends to

a significant extent on the continued service of our key management personnel, particularly Dr.

Michael Lebby, our Chief Executive Officer

Marcelli our President, Chief Operating Officer, Secretary and Principal Financial Officer.

Accordingly, the loss of the

services of either of these persons would adversely affect our business and our ability to continue to commercialize our products, and

impede the attainment of our business objectives.

a significant extent on the continued service of our key management personnel, particularly Yves LeMaitre, our Chief Executive Officer,

Zelibor, our President and James S.

Marcelli our Chief Financial Officer, Chief Operating Officer, and Secretary.

the loss of the services of any of these persons would adversely affect our business and our ability to continue to commercialize our

products, and impede the attainment of our business objectives.

Our future success will also depend

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If we fail to develop and maintain the quality of our manufacturing

processes, our operating results would be harmed.

The manufacture of our products

is a multi-stage process that requires the use of high-quality materials and advanced manufacturing technologies.

Also, polymer-related

device development and manufacturing must occur in a highly controlled, clean environment to minimize particles and other yield and quality-limiting

contaminants.

In spite of stringent quality controls, weaknesses in process control or minute impurities in materials may cause a substantial

percentage of a product in a lot to be defective.

If we are not able to develop and continue to improve on our manufacturing processes

or to maintain stringent quality controls, or if contamination problems arise, our operating results would be harmed.

The complexity of our products may lead to errors,

defects and bugs, which could result in the necessity to redesign products and could negatively, impact our reputation with customers.

Products as complex as those we

market and intend to market might contain errors, defects and bugs when first introduced or as new versions are released.

products with production defects or reliability, quality or compatibility problems could significantly delay or hinder market acceptance

of our products or result in a costly recall and could damage our reputation and adversely affect our ability to sell our products.

our products experience defects, we may need to undertake a redesign of the product, a process that may result in significant additional

integration and design processes, our operating results would be harmed.

The manufacture and integration

of our materials for devices is a multi-stage process that requires the use of high-quality materials and advanced manufacturing technologies

Also, polymer-related device development and manufacturing, whether performed by a silicon photonics design house or elsewhere,

must occur in a highly controlled, clean environment to minimize particles and other yield and quality-limiting contaminants.

of stringent quality controls, weaknesses in process control or minute impurities in materials may cause a substantial percentage of a

product in a lot to be defective.

If we are not able to develop and continue to improve our manufacturing design processes, if stringent

quality controls are not maintained, or if contamination problems arise, our operating results would be harmed.

The complexity of our organic nonlinear optical

materials may lead to errors, defects and bugs, which could result in the necessity to redesign materials and could negatively impact

our reputation with customers.

Organic nonlinear optical materials

as complex as those we market and intend to market might contain errors, defects and bugs when first introduced or as new versions are

Delivery and integration of materials with production defects or reliability, quality or compatibility problems could significantly

delay or hinder market acceptance of our materials or result in a costly recall and could damage our reputation and adversely affect our

ability to sell our materials.

If our organic nonlinear optical materials experience defects, we may need to undertake a redevelopment

of the materials, a process that may result in significant additional expenses.

We may also be required to make

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cessation of operations or other actions, which could severely harm our business.

Our data and information systems and network

infrastructure may be subject to hacking or other cybersecurity threats.

If our security measures are breached and an unauthorized

party obtains access to our proprietary business information, our information systems may be perceived as being unsecure, which

could harm our business and reputation, and our proprietary business information could be misappropriated which could have an

adverse effect on our business and results of operations.

Our Company stores and transmits

its proprietary information on its computer systems.

Despite our security measures, our information systems and network infrastructure

may be vulnerable to cyber-attacks or could be breached due to an employee error or other disruption that could result in unauthorized

disclosure of sensitive information that has the potential to significantly interfere with our business operations.

Breaches of our security

measures could expose us to a risk of loss or misuse of this information, litigation and potential liability.

Since techniques used to

obtain unauthorized access or to sabotage information systems change frequently and generally are not recognized until launched against

a target, we may be unable to anticipate these techniques or to implement adequate preventive measures in advance of such an attack on

In addition, we use third party vendors to store our proprietary information who use cyber or “Cloud” storage

of information as part of their service or product offerings, and despite our attempts to validate the security of such services, our

proprietary information may be misappropriated by other parties.

In the event of an actual or perceived breach of our security, or the

security of one of our vendors, the market perception of the effectiveness of our security measures could be harmed and we could suffer

damage to our reputation or our business.

Additionally, misappropriation of our proprietary business information could prove competitively

harmful to our business.

Our data and information systems and network infrastructure

may be subject to hacking or other cybersecurity threats.

If our security measures are breached and an unauthorized party obtains access

to our proprietary business information, our information systems may be perceived as being unsecure, which could harm our business and

reputation, and our proprietary business information could be misappropriated which could have an adverse effect on our business and results

of operations.

Our Company stores and transmits its proprietary information on its computer systems.

Despite our security measures, our information systems and network infrastructure may be vulnerable to cyber-attacks or could be breached due to an employee error or other disruption that could result in unauthorized disclosure of sensitive information that has the potential to significantly interfere with our business operations.

Breaches of our security measures could expose us to a risk of loss or misuse of this information, litigation and potential liability.

Since techniques used to obtain unauthorized access or to sabotage information systems change frequently and generally are not recognized until launched against a target, we may be unable to anticipate these techniques or to implement adequate preventive measures in advance of such an attack on our systems.

In addition, we use third party vendors to store our proprietary information who use cyber or “Cloud” storage of information as part of their service or product offerings, and despite our attempts to validate the security of such services, our proprietary information may be misappropriated by other parties.

In the event of an actual or perceived breach of our security, or the security of one of our vendors, the market perception of the effectiveness of our security measures could be harmed and we could suffer damage to our reputation or our business.

Additionally, misappropriation of our proprietary business information could prove competitively harmful to our business.

We conduct significantly all of our research and

development activities at our Englewood, CO facility, and circumstances beyond our control may result in considerable business interruptions.

We conduct significantly all of

our research and development activities at our Englewood, CO facility.

Our operations are vulnerable to interruption by fire, earthquake,

floods or other natural disaster, quarantines or other disruptions associated with infectious diseases, national catastrophe, terrorist

activities, war, disruptions in our computing and communications infrastructure due to power loss, telecommunications failure, human error,

physical or electronic security breaches and computer viruses, and other events beyond our control.

We do not have a detailed disaster

recovery plan.

conduct significantly all of our research and development activities at our Englewood, CO facility.

Our operations are vulnerable to interruption

by fire, earthquake, floods or other natural disaster, quarantines or other disruptions associated with infectious diseases, national

catastrophe, terrorist activities, war, disruptions in our computing and communications infrastructure due to power loss, telecommunications

failure, human error, physical or electronic security breaches and computer viruses, and other events beyond our control.

We do not have

a detailed disaster recovery plan.

We could be negatively affected as a result

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In addition, changing laws, regulations

and standards relating to corporate governance and public disclosure are creating uncertainty for public companies, increasing legal and

financial compliance costs and making some activities more time consuming.

and standards relating to corporate governance and public disclosure are creating uncertainty for public companies, increasing legal

and financial compliance costs and making some activities more time consuming.

These laws, regulations and standards are subject to varying

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issuances of shares of common stock or securities convertible into common stock will dilute your interest.

Our Board may determine from time

to time that it needs to raise additional capital by issuing additional shares of our common stock or other securities and we are not

restricted from issuing additional common stock, including securities that are convertible into or exchangeable for, or that represent

the right to receive, shares of our common stock.

Because our decision to issue securities in any future offering will depend on market

conditions and other factors beyond our control, we cannot predict or estimate the amount, timing, or nature of any future offerings,

or the prices at which such offerings may be affected.

Additional equity offerings may dilute the holdings of existing stockholders or

reduce the market price of our common stock.

Board may determine from time to time that it needs to raise additional capital by issuing additional shares of our common stock or other

securities and we are not restricted from issuing additional common stock, including securities that are convertible into or exchangeable

for, or that represent the right to receive, shares of our common stock.

Because our decision to issue securities in any future offering

will depend on market conditions and other factors beyond our control, we cannot predict or estimate the amount, timing, or nature of

any future offerings, or the prices at which such offerings may be affected.

Additional equity offerings may dilute the holdings of existing

stockholders or reduce the market price of our common stock.

As of December 31, 2024, we have

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issuance of shares of our capital stock in connection with any collaboration (although none are contemplated at this time) or in connection

with other financing efforts, including pursuant to the 2023 Purchase Agreement with Lincoln Park, and the Roth Sales Agreement with Roth

Any issuance of our common stock that is not made solely to then-existing stockholders proportionate to their interests, such

as in the case of a stock dividend or stock split, will result in dilution to each stockholder by reducing his, her or its percentage

with other financing efforts, including pursuant to the 2025 Purchase Agreement with Lincoln Park, and the Roth Sales Agreement

with Roth Capital.

Any issuance of our common stock that is not made solely to then-existing stockholders proportionate to their interests,

such as in the case of a stock dividend or stock split, will result in dilution to each stockholder by reducing his, her or its percentage

ownership of the total outstanding shares.

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volatility, as well as general market conditions, may cause our stock price to fluctuate greatly and even potentially expose us to litigation.

Our common stock may be

subject to continued volatility.

During the past 52 weeks, the share price for our common stock ranged from a low of $3.79 to a high

Our common stock may be subject

to continued volatility.

During the past 52 weeks, the share price for our common stock ranged from a low of $1.00 to a high of $4.82.

We cannot assure you that the market price for our common stock will be less volatile or will remain at its current level.

A decrease in the market price for our shares could result in substantial losses for investors.

The market price of our common stock

may be significantly affected by one or more of the following factors, many of which are beyond our control, including:

in the market price for our shares could result in substantial losses for investors.

The market price of our common stock may be significantly

affected by one or more of the following factors, many of which are beyond our control, including:

our Company’s ability to execute on its business plan;

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that have experienced volatility in the market price of their stock have been subject to securities class action litigation or derivative

A sale of a substantial number of shares of our common stock may cause

the price of our common stock to decline and may impair our ability to raise capital in the future.

A sale of a substantial number of shares of our

common stock may cause the price of our common stock to decline and may impair our ability to raise capital in the future.

Our common stock is traded on

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or the market perceives that our stockholders intend to sell, substantial amounts of our common stock in the public market, including

shares issued upon the exercise of outstanding options or warrants or pursuant to the 2023 Purchase Agreement with Lincoln Park, and the

Roth Sales Agreement with Roth Capital, the market price of our common stock could decline.

Sales of a substantial number of shares of

our common stock may make it more difficult for us to sell equity or equity-related securities in the future at a time and price that

shares issued upon the exercise of outstanding options or warrants or pursuant to the 2025 Purchase Agreement with Lincoln Park,

and the Roth Sales Agreement with Roth Capital, the market price of our common stock could decline.

Sales of a substantial number of shares

of our common stock may make it more difficult for us to sell equity or equity-related securities in the future at a time and price that

we deem reasonable or appropriate.

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on The NASDAQ Capital Market on September 1, 2021.

We cannot assure you that that an active trading market for our common stock will continue

We cannot assure you that an active trading market for our common stock will continue

to be sustained.

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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-K

Item 1A. Risk Factors