What changed in this filing

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Item 1A. Risk Factors

2025-03-31 compared with 2024-03-28 · 1213 added, 1064 removed, 14 unchanged (99% of the section changed)

Investing in our securities carries a significant

degree of risk.

You should carefully consider the risks described below, together with all of the other information in this Form 10-K,

including our consolidated financial statements and related notes included elsewhere in this Form 10-K, before deciding whether to invest

in our securities.

If any or a combination of the following risks were to materialize, our results of operations, financial condition

and prospects could be materially adversely affected.

If that were to be the case, the market price of our securities could decline, and

investors could lose all or part of their investment.

The risks and uncertainties described below are not the only ones we face.

risks and uncertainties not presently known to us or that we currently believe to be immaterial may also adversely affect our business.

Risks Related to Our Financial Condition and

Capital Requirements

We have incurred significant losses since

inception and we will continue to incur net losses for the foreseeable future.

Since our inception, we have engaged primarily

in development activities, including planning and implementing clinical trials to support commercialization and FDA approval of our Symphony

We have funded our operations primarily through debt and equity financings, and have incurred losses since inception, including

a net loss of approximately $9.8 million and approximately $9.3 million for the years ended December 31, 2023 and 2022, respectively.

We currently have no product revenue and we may

not be able to commercialize our Symphony technology platform or achieve significant revenues or profitability.

Our ability to generate

revenue and achieve profitability depends upon our ability, alone or with others, to complete the development process of our product candidates,

including regulatory approvals, and thereafter achieve substantial acceptance in the marketplace for our products.

We may be unable to

achieve any or all of these goals.

We will require additional funding to finance

our operations to continue as a going concern, which may not be available to us on acceptable terms, or at all, and our lack of cash resources

has slowed the timeline of our clinical trial work and could cause us to run out of cash resources in the near-term.

To date, we have relied primarily on private debt

and equity financing to carry on our business.

We have limited financial resources, negative cash flow from operations and no assurance

that sufficient funding will be available to us to fund our operating expenses and to further our product development efforts and pursue

clinical trials for FDA approval.

Based on these and other factors, in our audited consolidated financial statements for the years ended

December 31, 2023 and 2022, we concluded that this circumstance raised substantial doubt about our ability to continue as a going concern

within one year from the original issuance date of such financial statements.

Similarly, in its report on the consolidated financial statements

for the years ended December 31, 2023 and 2022, our independent registered public accounting firm included an emphasis of matter paragraph

stating that our recurring losses from operations and continued cash outflows from operating activities raised substantial doubt about

our ability to continue as a going concern.

Our consolidated financial statements for the years ended December 31, 2023 and 2022 do not

include any adjustments that may result from the outcome of this uncertainty.

Absent further funding, we currently expect to

run out of available cash resources during the third quarter of 2024.

As such, we anticipate that we will need to raise additional capital

to fund our operations while we implement and execute our business plan.

There can be no assurance that such additional capital will be

available on a timely basis or on terms that will be acceptable to us.

We currently do not have any contracts or commitments for additional

In addition, any additional equity financing may involve substantial dilution to our existing stockholders.

As a result of our lack of cash resources, we

have recently slowed the timeline of our clinical trial work to preserve cash resources in the near-term, and we expect that this will

delay our Symphony platform regulatory submission timeline until 2025.

If we fail to obtain additional financing, this timeline could

be delayed further, and we could be forced to abandon such activities entirely, with the possible loss of such properties or assets.

may also be forced to pursue strategic alternatives, such as a potential sale of the Company or its assets or other restructuring efforts.

As a result, any inability to obtain additional financing in the near-term could have a material adverse effect on our business, results

of operations, cash flow, financial condition and prospects.

The number of shares

of common stock underlying our outstanding warrants is significant in relation to our currently outstanding common stock, which could

have a negative effect on the market price of our common stock and make it more difficult for us to raise funds through future equity

In addition, in connection with any merger, consolidation or sale of all or substantially all of our assets, holders of our

outstanding warrants would be entitled to receive consideration in excess of their reported beneficial ownership of our common stock and

this could adversely impact the consideration our other stockholders would receive.

As part of our public

offerings of common stock in August 2023 and January 2024, we issued common stock warrants to purchase an aggregate of 2,908,308 shares

of our common stock, and pre-funded warrants to purchase up to an aggregate of 2,154,540 shares of our common stock.

As of the date hereof,

the two holders of pre-funded warrants, Armistice Capital Master Fund Ltd.

and Sabby Volatility Warrant Master Fund, have collectively

exercised pre-funded warrants to purchase 911,540 shares of common stock, and pre-funded warrants remain exercisable to purchase 1,243,000

shares of common stock.

Each pre-funded warrant has an exercise price per share of common stock equal to $0.0001 per share, which has

previously been funded by the Company, and is exercisable from the date of issuance until exercised in full, and the exercise price has

previously been funded to the Company.

Common stock warrants to purchase 216,000 shares of common stock are exercisable at a price of

$7.24 per share, and common stock warrants to purchase 2,692,308 shares of common stock are exercisable at a price of $1.30 per share.

Each common stock warrant is exercisable for five years from the date of issuance (until August 24, 2028 or January 2, 2029, respectively).

The common stock warrants

are generally only exercisable solely by means of a cash exercise.

The common stock warrants include certain rights upon “fundamental

transactions” as described in the common stock warrants, including the right of the holders thereof to receive from us or a successor

entity the same type or form of consideration (and in the same proportion) that is being offered and paid to the holders of common stock

in such fundamental transaction in the amount of the Black Scholes value (as described in such common stock warrants) of the unexercised

portion of the applicable common stock warrants on the date of the consummation of such fundamental transaction.

A holder of common stock

warrants (together with its affiliates) may not exercise any portion of a common stock warrant to the extent that the holder would beneficially

own more than 4.99% (or, at the election of the holder, 9.99%) of our outstanding common stock immediately after exercise.

Although these warrants

are subject to beneficial ownership limitations, upon exercise in full of the warrants, the shares issuable upon exercise would represent

a significant portion of our outstanding common stock.

As a result, the holders of these warrants may be able to exert substantial influence

over our business.

The concentration of voting power resulting from the exercise of the warrants could delay, defer or prevent a change

of control, or delay or prevent a merger, consolidation, takeover or other business combination involving us on terms that other stockholders

In addition, conflicts of interest could arise in the future between us, on the one hand, and the holders of these warrants,

concerning the issuance of additional securities and other matters.

In addition, sales of these shares could cause the market price of

our common stock to decline significantly.

We have registered the

issuance of shares upon exercise of these warrants under registration statements.

As a result, the shares issuable upon exercise of these

warrants can be freely sold in the public market upon issuance.

Sales of these shares could cause the market price of our common stock

to decline significantly.

Furthermore, if our stock price rises, the holders of these warrants may be more likely to exercise their warrants

and sell a large number of shares, which could negatively impact the market price of our common stock and reduce or eliminate any appreciation

in our stock price that might otherwise occur.

Given the amount and

terms of these warrants, we may find it more difficult to raise additional equity capital on favorable terms or at all while these warrants

are outstanding.

As a result of

our January 2024 public offering, we have reserved for issuance substantially all of our available authorized shares of common stock,

and will not be able to issue additional shares for future capital raising transactions or strategic transactions unless and until we

obtain stockholder approval to amend our restated certificate of incorporation to increase the number of authorized shares of common stock.

our amended and restated certificate of incorporation, as amended, w e have 7,500,000 shares of common stock and 5,000,000 shares

of preferred stock authorized for issuance.

As of March 28, 2024, we had (i) 2,688,448 shares of common stock outstanding, (ii) zero shares

of preferred stock outstanding, (iii) 37,645 shares of common stock issuable upon the exercise of outstanding stock options or settlement

of outstanding restricted stock units, 4,523,454 shares of common stock issuable upon the exercise of outstanding warrants, and 53,490

shares reserved for future issuance under our 2018 Stock Incentive Plan or 2021 Stock Incentive Plan.

As a result, as of such date, we

had only 196,963 additional authorized shares of common stock available for issuance (in addition to the 5,000,000 shares of preferred

stock that remain available).

We intend to seek shareholder approval at our 2024 annual meeting of shareholders to amend our amended

and restated certificate of incorporation to further increase the number of authorized shares of common stock available for issuance.

Unless and until such amendment is approved by our shareholders, we will be limited in our ability to issue further shares of common stock,

including in connection with potential future capital raising transactions.

Our ability to

raise additional capital via a registered public offering on Form S-3 will be limited in the near-term as a result of the SEC’s

“baby shelf” rules.

In June 2023 we filed a shelf registration statement

on Form S-3, which was declared effective by the SEC on June 20, 2023 (the “Shelf Registration Statement”).

The Shelf Registration

Statement allows us to sell from time to time up to $25 million of common stock, preferred stock, debt securities, debentures,

warrants, rights or units comprised of any combination of these securities, for our own account in one or more offerings.

In August 2023,

we completed a public offering under the Shelf Registration Statement pursuant to which we raised gross proceeds of approximately $1.6

Under applicable SEC rules, smaller companies like us are only permitted to raise up to 1/3 rd of their public float

under Form S-3 over a 12-month period.

As a result, based on our current public float, we are unable to use Form S-3 for further offerings

by us at the present time, and absent a significant increase in the trading price of our common stock, we will be unable to raise further

capital under Form S-3 until late August of 2024 (at which time we will again be able to sell up to 1/3 rd of our public float

pursuant to Form S-3, assuming we continue the applicable eligibility requirements thereof.

Our inability to use Form S-3 in the near-term

may make it more difficult for us to raise equity capital in the public markets, as we expect to be required to conduct any such fundraising

via private placements, or sales on Form S-1, which sales of Form S-1 may be more difficult for us to execute in a timely manner.

We have received a notification letter from

the Nasdaq Listing Qualifications Staff that our common stock does not satisfy Nasdaq’s $1.00 minimum price per share rule and we

could face delisting by Nasdaq if we are unable to regain compliance with this requirement, which could adversely affect our ability to

sell stock in the public markets, the liquidity of our common stock and our general ability to raise additional capital.

Our common stock currently is listed for quotation

on the Nasdaq Capital Market.

We are required to meet specified financial requirements in order to maintain such listing.

28, 2024, we received a notification letter from the Nasdaq Listing Qualifications Staff of the Nasdaq Stock Market LLC (“Nasdaq”)

notifying us that the closing bid price for our common stock had been below $1.00 for the previous 30 consecutive business days and that

we therefore are not in compliance with the minimum bid price requirement for continued inclusion on the Nasdaq Capital Market under Nasdaq

Listing Rule 5550(a)(2).

The notification has no immediate effect on the listing of our common stock on the Nasdaq Capital Market.

Under the Nasdaq Listing Rules, we have a period

of 180 calendar days to regain compliance.

To regain compliance, the closing bid price of our common stock must be at least $1.00 or higher

for a minimum of ten consecutive business days, and in such case, Nasdaq will provide us with written confirmation of compliance.

do not regain compliance by August 26, 2024, we may be eligible for an additional 180 calendar days, provided that we meet the continued

listing requirement for market value of publicly held shares and all other initial listing standards for Nasdaq, except the bid price

If we are not eligible or it appears to Nasdaq that we will not be able to cure the deficiency during the second compliance

period, Nasdaq will provide written notice to us that our common stock will be subject to delisting.

In the event of such notification,

we may appeal Nasdaq’s determination to delist its securities, but there can be no assurance that Nasdaq would grant our request

for continued listing.

We intend to take all reasonable measures available

to us to achieve compliance to allow for continued listing on the Nasdaq Capital Market.

However, there can be no assurance that we will

be able to regain compliance with the minimum bid price requirement or will otherwise be in compliance with other Nasdaq listing criteria.

If our common stock does not regain compliance with the minimum price requirement during the applicable compliance period, we may need

to effect a reverse stock split, whereby shares of our common stock are consolidated so that the per-share trading price becomes greater

than $1.00 per share.

We intend to seek shareholder approval for such a reverse stock split at our 2024 annual meeting of shareholders.

If our common stock is delisted, we may seek to

have our common stock quoted on an over-the-counter marketplace, such as on the OTCQX.

The OTCQX is not a stock exchange, and if our common

stock trades on the OTCQX rather than a securities exchange, there may be significantly less trading volume and analyst coverage of, and

significantly less investor interest in, our common stock, which may lead to lower trading prices for our common stock.

Any potential delisting

of our common stock from the Nasdaq Capital Market may have materially adverse consequences to our stockholders, including:

A reduced market price and liquidity with respect to our shares of common stock;

limited dissemination of the market price of our common stock;

limited news coverage;

limited interest by investors in our common stock;

volatility of the prices of our common stock, due to low trading volume;

our common stock being considered a “penny stock,” which would result in broker-dealers participating in sales of our common stock being subject to the regulations set forth in Rules 15g-2 through 15g-9 promulgated under the Exchange Act;

increased difficulty in selling our common stock in certain states due to “blue sky” restrictions;

limited ability to issue additional securities or to secure additional financing.

Risks Related to Our Business

We are subject to the risks associated with

new businesses.

We are effectively a new business with a plan

to commercialize our licensed technology.

Our limited operating history may not be adequate to enable you to fully assess our ability

to develop and market our Symphony platform and test cartridges, assuming we receive regulatory clearances, for which there is no assurance,

and respond to competition.

Our efforts to date have related to the organization and formation of our Company, research and development

and performing clinical trials.

We have no approved products, have not yet generated sustainable revenue, and we cannot guarantee we will

ever be able to generate future revenues.

Therefore, we are, and expect for the foreseeable future to be, subject to all the risks and

uncertainties, inherent in a new business focused on the development and sale of new medical devices.

As a result, we may be unable to

further develop, obtain regulatory approval for, manufacture, market, sell and derive revenues from our Symphony platform and test cartridges

and the other product candidates in our pipeline, and our inability to do so would materially and adversely impact our viability.

we still must optimize many functions necessary to operate a business, including expanding our managerial, personnel and administrative

structure, continuing product research and development, and assessing and commencing our marketing activities.

Accordingly, you should consider our prospects

in light of the costs, uncertainties, delays and difficulties frequently encountered by companies that have not yet commercialized their

products, particularly those in the medical device field.

In particular, potential investors should consider that there is a significant

risk that we will not be able to:

implement or execute our current business plan, or that our business plan is sound;

maintain our management team and Board of Directors;

determine that the technologies that have been developed are commercially viable;

attract, enter into or maintain contracts with, and retain customers;

raise any necessary additional funds in the capital markets or otherwise to effectuate our business plan.

In the event that we do not successfully address

these risks, our business, prospects, financial condition, and results of operations could be materially and adversely affected.

The New License

Agreement with Toray, which covers the license of the core technology used in our Symphony Cartridges , and the New Supply

Agreement with Toray, which covers the supply of cartridge intermediates from Toray to SanyoSeiko for SanyoSeiko to manufacture cartridges

for Bluejay, contain significant risks that may threaten our viability or otherwise have a material adverse effect on us and our business,

assets and its prospects.

We have an exclusive license with Toray for the

entire world, excluding Japan, to use their patents and know-how related to our Symphony test cartridges for the manufacturing, marketing

and sale of such products.

We also have a nonexclusive license for manufacturing purposes in Japan.

We have a right to sublicense these

Toray patents and know-how (upon either (a) obtaining consent from Toray prior to obtaining FDA approval or (b) giving notice to Toray

after obtaining FDA approval), and for the purpose of obtaining FDA approval, we will need to exercise this sublicence to have the cartridges

manufactured for Bluejay by a Japanese manufacturer, SanyoSeiko, Inc.

in our securities carries a significant degree of risk.

You should carefully consider the risks described below, together with all of

the other information in this Form 10-K, including our consolidated financial statements and related notes included elsewhere in this

Form 10-K, before deciding whether to invest in our securities.

If any or a combination of the following risks were to materialize, our

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

If that were to be the case, the market

price of our securities could decline, and investors could lose all or part of their investment.

The risks and uncertainties described

below are not the only ones we face.

Additional risks and uncertainties not presently known to us or that we currently believe to be

immaterial may also adversely affect our business.

Related to Our Financial Condition and Capital Requirements

have incurred significant losses since our inception, do not currently generate any operating income, and expect to continue incurring

losses as we work to obtain product approval, and thus we may never achieve or maintain profitability.

our inception, we have engaged primarily in development activities, including planning and implementing clinical trials to support commercialization

and FDA approval of our Symphony platform.

We have funded our operations primarily through debt and equity financings, and have incurred

losses since inception, including a net loss of approximately $7.7 million and approximately $10.0 million for the years ended December

31, 2024 and 2023, respectively, and from our inception through December 31, 2024, we had an accumulated deficit of approximately $34.7

currently have no product revenue and we may not be able to commercialize our Symphony technology platform or achieve significant revenues

or profitability.

Our ability to generate revenue and achieve profitability depends upon our ability, alone or with others, to complete

the development process of our product candidates, including regulatory approvals, and thereafter achieve substantial acceptance in the

marketplace for our products.

We may be unable to achieve any or all of these goals.

will require additional funding to finance our operations to continue as a going concern, which may not be available to us on acceptable

terms, or at all, and our lack of cash resources has slowed the timeline of our clinical trial work and could cause us to run out of

cash resources in the near-term.

date, we have relied primarily on private debt and equity financing to carry on our business.

We have limited financial resources, negative

cash flow from operations and no assurance that sufficient funding will be available to us to fund our operating expenses and to further

our product development efforts and pursue clinical trials for FDA approval.

Based on these and other factors, in our audited consolidated

financial statements for the years ended December 31, 2024 and 2023, we concluded that this circumstance raised substantial doubt about

our ability to continue as a going concern within one year from the original issuance date of such financial statements.

Similarly, in

its report on the consolidated financial statements for the years ended December 31, 2024 and 2023, our independent registered public

accounting firm included an emphasis of matter paragraph stating that our recurring losses from operations and continued cash outflows

from operating activities raised substantial doubt about our ability to continue as a going concern.

Our consolidated financial statements

for the years ended December 31, 2024 and 2023 do not include any adjustments that may result from the outcome of this uncertainty.

further funding, we currently expect to run out of available cash resources during the third quarter of 2025.

To achieve our current

strategic plan, which strives to be in position to submit a 510(k) regulatory application to the FDA in the fourth quarter of 2027 and

achieve FDA approval as early as the third quarter of 2028, we expect to need to raise at least $30 million of capital between the

second quarter of 2025 and the end of the 2027 fiscal year, which we hope to do in various tranches during this time period.

be no assurance that such additional capital will be available on a timely basis or on terms that will be acceptable to us.

do not have any contracts or commitments for additional financing.

In addition, any additional equity financing may involve substantial

dilution to our existing stockholders, or provide that an equity or debt financing source obtains rights to control the membership of

our board of directors.

a result of our lack of cash resources, we have slowed the timeline of our clinical trial work to preserve cash resources in the near-term.

If we fail to obtain additional financing, we likely will be forced to abandon such activities entirely and file for bankruptcy protection,

with the possible loss of such properties or assets (including the license to our core technology).

Based on our explorations to date,

we do not expect that any other strategic alternatives, such as a potential sale of the Company or its assets or other restructuring

efforts, will be available to us in the near-term.

As a result, any inability to obtain additional financing in the near-term, including

a material amount of financing over the next 2-3 years, would likely result in a material adverse effect on our business, results of

operations, cash flow, financial condition and prospects and cause our stockholders to receive little or no return on their shares of

common stock.

the initial public offering of our common stock in November 2021, the market price of our common stock has fallen by more than 99.9%,

and we expect to need additional funding amounts substantially greater than the current market capitalization of our common stock, which

may result in future dilution that coincides with further material declines in the trading price of our common stock beyond the substantial

declines that have occurred in recent years.

the initial public offering of our common stock in November 2021, the market price of our common stock has fallen by more than 99.9%,

including declines of greater than 80% per year in each of 2022, 2023 and 2024.

During such period of time, we have conducted several

public offerings of securities to raise additional capital, and in each case, the market price of our common stock has fallen substantially

after the consummation of such offerings.

As described above, we expect to need to raise at least $30 million of funding over the next 2-3

years – an aggregate amount approximately 15 times the current market capitalization of our outstanding common stock, and we do

not expect to be able to complete necessary product re-development, troubleshooting and clinical trial work absent such material funding.

This may cause new investors to demand terms in future offerings that substantially dilute existing shareholders, or result in such holders

obtaining or being granted shareholder voting or board governance control positions, which could cause our common stock to fall further

from current levels on a per share basis.

number of shares of common stock underlying our outstanding warrants is several times greater than our currently outstanding common stock,

which could have a negative effect on the market price of our common stock and make it more difficult for us to raise funds through future

equity offerings.

In addition, in connection with any merger, consolidation or sale of all or substantially all of our assets, holders

of our outstanding warrants would be entitled to receive the Black Scholes value of such warrants, which may reduce the consideration

otherwise available for payment to holders of our common stock.

part of our public offerings of common stock in June 2024, January 2024 and August 2023, we issued warrants to purchase shares of our

common stock.

As of December 31, 2024, remaining warrants exercisable from these transactions included (i) Class C Common stock warrants

to purchase 1,372,586 shares of common stock which are exercisable at a price of $16.30 per share, (ii) January 2024 Common Stock Warrants

to purchase up to an aggregate of 7,201 shares of common stock at an exercise prices ranging from $520.00 to $650.00 per share and (iii)

August 2023 Common Stock Warrants to purchase up to an aggregate of 576 shares of common stock at exercise prices ranging from $2,896.00

to $3,684.00 per share.

The June Class C Warrants, January 2024 Common Stock Warrants and August 2023 Common Stock Warrants are exercisable

for five years from the date of issuance until various dates in 2029 or 2028, respectively.

The Class C Warrants, January 2024 Common Stock Warrants

and August 2023 Common Stock Warrants are generally only exercisable solely by means of a cash exercise.

A holder of these warrants (together

with its affiliates) may not exercise any portion of the warrants to the extent that the holder would beneficially own more than 4.99%

(or, at the election of the holder, 9.99%) of our outstanding common stock immediately after exercise.

The common stock warrants include

certain rights upon “fundamental transactions” as described in the warrants, including the right of the holders thereof to

receive from us or a successor entity cash or the same type or form of consideration (and in the same proportion) that is being offered

and paid to the holders of common stock in such fundamental transaction in the amount of the Black Scholes value (as described in such

warrants) of the unexercised portion of the applicable warrants on the date of the consummation of such fundamental transaction.

these warrants are subject to beneficial ownership limitations, upon exercise in full of the warrants, the shares issuable upon exercise

would represent a significant portion of our outstanding common stock.

As a result, the holders of these warrants may be able to exert

substantial influence over our business.

The concentration of voting power resulting from the exercise of the warrants could delay, defer

or prevent a change of control, or delay or prevent a merger, consolidation, takeover or other business combination involving us on terms

that other stockholders may desire.

In addition, conflicts of interest could arise in the future between us, on the one hand, and the

holders of these warrants, concerning the issuance of additional securities and other matters.

In addition, sales of these shares could

cause the market price of our common stock to decline significantly.

have registered the issuance of shares upon exercise of these warrants under registration statements.

As a result, the shares issuable

upon exercise of these warrants can be freely sold in the public market upon issuance.

Sales of these shares could cause the market price

of our common stock to decline significantly.

Furthermore, if our stock price rises, the holders of these warrants may be more likely

to exercise their warrants and sell a large number of shares, which could negatively impact the market price of our common stock and

reduce or eliminate any appreciation in our stock price that might otherwise occur.

the amount and terms of these warrants, we may find it more difficult to raise additional equity capital on favorable terms or at all

while these warrants are outstanding.

ability to raise additional capital via a registered public offering on Form S-3 will be limited in the near-term as a result of the

SEC’s “baby shelf” rules.

June 2023 we filed a shelf registration statement on Form S-3, which was declared effective by the SEC on June 20, 2023 (the “Shelf

Registration Statement”).

The Shelf Registration Statement allows us to sell from time to time up to $25 million of common

stock, preferred stock, debt securities, debentures, warrants, rights or units comprised of any combination of these securities, for

our own account in one or more offerings.

In August 2023, we completed a public offering under the Shelf Registration Statement pursuant

to which we raised gross proceeds of approximately $1.6 million.

Under applicable SEC rules, smaller companies like us are only permitted

to raise up to 1/3 rd of their public float under Form S-3 over a 12-month period.

As a result, based on our current public

float, we are only able to sell up to approximately $700,000 as of the date of this filing pursuant to our Form S-3, assuming we continue

the applicable eligibility requirements thereof.

This limit on our use of Form S-3 in the near-term may make it more difficult for us

to raise equity capital in the public markets, as we expect to be required to conduct any such fundraising via private placements, or

sales on Form S-1, which sales of Form S-1 may be more difficult for us to execute in a timely manner.

may be obligated to current and/or prior financial advisors under engagement letters that we enter into from time to time, and we are

currently subject to such an obligation.

part of our capital raising and financial planning measures, we have entered into, and may in the future enter into, various engagement

letters with financial advisors.

Such engagement letters have included, and may in the future include, rights of first offer or refusal

and similar provisions that require us to offer such financial advisors the right to serve as underwriter, placement agent or in similar

roles in connection with certain future public or private financing transactions, or that require us to pay prior financial advisors

fees in connection with certain transactions consummated using other financial advisors.

example, our existing engagement letter with Aegis Capital Corp.

(“Aegis”) provides that until June 3, 2025, Aegis shall

have the right to act as sole book-running manager, sole underwriter, sole placement agent or sole agent, as applicable, if we decide

to finance any indebtedness or decide to raise funds by means of a public offering, private placement or any other capital raising financing

of equity, equity-linked or debt securities.

If Aegis decides to accept such assignment, we are required to provide Aegis customary fees

for transactions of similar size and nature (but in no event less than the fees provided to Aegis in the transactions they advised the

Company on in mid-2024).

It is possible that potential investors who would otherwise seek to invest in the Company will prefer to work

with other banks, in which case we may be unable to pursue such transaction unless Aegis declines its right of first refusal with respect

to such transaction.

placement agent from our August 2023 Registered Direct Offering and January 2024 Public Offering could assert that they are entitled

to a fee in connection with our June 2024 Public Offering.

August 2023, we entered into an engagement letter with H.C.

Wainwright & Co., LLC (the “Prior Placement Agent”), which

was amended in October 2023, and pursuant to which the Prior Placement Agent served as the placement agent in our August 2023 public

offering, August 2023 private placement and January 2024 public offering.

Pursuant to this engagement letter, we provided the Prior Placement

Agent a right of first refusal to serve as underwriter in any public offering or private placement we engaged in prior to January 2,

2025, and the right to receive compensation comparable to what it received in the August 2023 public offering and January 2024 public

offering (e.g., 7% of the gross proceeds of such an offering and additional warrants exercisable at 125% of the offering price) in connection

with such offering or placement.

Prior to filing the registration statement with respect to our June 2024 public offering, we provided

the Prior Placement Agent the opportunity to serve as underwriter for that transaction and it declined such opportunity.

While we believe

that the Prior Placement Agent is not entitled to any fees in connection with the June 2024 public offering given that it declined to

serve as underwriter, the Prior Placement Agent could assert that it is nevertheless entitled to compensation under a separate “tail”

provision included in the letter.

While we believe such a position would be unreasonable and invalid, and we would intend to challenge

it, any such assertion that is ultimately successful could cause us to pay an addition substantial fee (such as up to 7% of the proceeds

from our June 2024 public offering) in connection with that offering.

common stock currently is listed for quotation on the Nasdaq Capital Market.

We are required to meet specified financial requirements

in order to maintain such listing, including a requirement that the bid price for our common stock remain above $1.00, and that the market

value of our publicly held securities be at least $1 million.

Listing Rule 5550(a)(2) requires listed companies to maintain a minimum bid price of $1.00 for continued inclusion on the Nasdaq Capital

As of the close of business on March 17, 2025, the most recent closing price of our common stock on the Nasdaq Capital Market.

was $4.07 per share.

If the trading price were to fall below $1.00 per share, we would not be compliant this requirement.

event, we would be subject to delisting, and because we consummated reverse stock splits during 2024 with a cumulative ratio of 1-for-400

(following an earlier reverse stock split in 2023 with a ratio of 1-for-20), we would be ineligible for any compliance period under recently

implemented Nadsaq listing rules if this event occurred prior to June 20, 2026.

As a result, such a decline in the price of our common

stock, if it were to occur, would be expected to result in the prompt delisting of our common stock from the Nasdaq Capital Market.

addition, Nasdaq Listing Rule 5550(a)(5) requires the market value of our publicly held common stock (which is our only outstanding class

of capital stock) to be at least $1 million.

As of the close of business on March 17, 2025, such market value of our publicly held common

stock was approximately $1.7 million.

If the market value of our publicly held common stock declines below $1 million, we would also

be subject to Nasdaq delisting proceedings on that basis.

staff also maintains discretionary authority under its listing rules to delist companies whose capital structure or public offerings

raise public interest and investor protection concerns, including as a result of highly dilutive issuances, and it is possible that Nasdaq

could assert that past offerings that we have consummated, or future offerings we may consummate, raise such concerns.

In addition, to

raise the significant amount of capital that we expect to need to fund our strategic plan, potential investors may require us to accept

terms (such as board representation rights in excess of an investor’s beneficial ownership of our common stock) that could conflict

with Nasdaq listing standards and result in us being delisted.

our common stock is delisted, we may seek to have our common stock quoted on an over-the-counter marketplace, such as on the OTCQX.

OTCQX is not a stock exchange, and if our common stock trades on the OTCQX rather than a securities exchange, there may be significantly

less trading volume and analyst coverage of, and significantly less investor interest in, our common stock, which may lead to lower trading

prices for our common stock.

potential delisting of our common stock from the Nasdaq Capital Market may have materially adverse consequences to our stockholders,

reduced market price and liquidity with respect to our shares of common stock;

dissemination of the market price of our common stock;

news coverage;

interest by investors in our common stock;

of the prices of our common stock, due to low trading volume;

common stock being considered a “penny stock,” which would result in broker-dealers participating in sales of our common

stock being subject to the regulations set forth in Rules 15g-2 through 15g-9 promulgated under the Exchange Act;

difficulty in selling our common stock in certain states due to “blue sky” restrictions;

ability to issue additional securities or to secure additional financing.

Related to Our Business

are subject to the risks associated with new businesses.

are effectively a new business with a plan to commercialize our licensed technology.

Our limited operating history may not be adequate

to enable you to fully assess our ability to develop and market our Symphony platform and test cartridges, assuming we receive regulatory

clearances, for which there is no assurance, and respond to competition.

Our efforts to date have related to the organization and formation

of our Company, research and development and performing clinical trials.

We have no approved products, have not yet generated sustainable

revenue, and we cannot guarantee we will ever be able to generate future revenues.

Therefore, we are, and expect for the foreseeable

future to be, subject to all the risks and uncertainties, inherent in a new business focused on the development and sale of new medical

As a result, we may be unable to further develop, obtain regulatory approval for, manufacture, market, sell and derive revenues

from our Symphony platform and test cartridges and the other product candidates in our pipeline, and our inability to do so would materially

and adversely impact our viability.

In addition, we still must optimize many functions necessary to operate a business, including expanding

our managerial, personnel and administrative structure, continuing product research and development, and assessing and commencing our

marketing activities.

you should consider our prospects in light of the costs, uncertainties, delays and difficulties frequently encountered by companies that

have not yet commercialized their products, particularly those in the medical device field.

In particular, potential investors should

consider that there is a significant risk that we will not be able to:

or execute our current business plan, or that our business plan is sound;

our management team and Board of Directors;

that the technologies that have been developed are commercially viable;

enter into or maintain contracts with, and retain customers;

any necessary additional funds in the capital markets or otherwise to effectuate our business plan.

the event that we do not successfully address these risks, our business, prospects, financial condition, and results of operations could

be materially and adversely affected.

license and supply agreements with Toray, which relate to the license of the core technology used in our Symphony Cartridges and the

supply of cartridge intermediates from Toray to SanyoSeiko for SanyoSeiko to manufacture cartridges for Bluejay, are subject to significant

risks that may threaten our viability or otherwise have a material adverse effect on us and our business, assets and its prospects.

have an exclusive license with Toray for the entire world, excluding Japan, to use their patents and know-how related to our Symphony

test cartridges for the manufacturing, marketing and sale of such products.

We also have a nonexclusive license for manufacturing purposes

We have a right to sublicense these Toray patents and know-how (upon either (a) obtaining consent from Toray prior to obtaining

FDA approval or (b) giving notice to Toray after obtaining FDA approval), and for the purpose of obtaining FDA approval, we will need

to exercise this sublicence to have the cartridges manufactured for Bluejay by a Japanese manufacturer, SanyoSeiko, Inc.

(“SanyoSeiko”).

We have no contractual rights to the

intellectual property covered in the New Toray License Agreement other than as expressly set forth therein.

Our plans, business, prospects

and viability are substantially dependent on that intellectual property and subject to the limitations relating thereto as set forth in

the New Toray License Agreement.

We have no contractual rights to the intellectual property covered in the license agreement other than as expressly set forth therein.

Our plans, business, prospects and viability are substantially dependent on that intellectual property and subject to the limitations

relating thereto as set forth in the license agreement.

Some of the risks this may give rise to are described below.

After the receipt of regulatory approval in a country, we are required to pay Toray a minimum royalty of $60,000 for the initial year that royalties are payable increasing to a minimum of $100,000 thereafter, regardless of the actual amount of sales by us of licensed products.

are currently preparing to transfer this intellectual property and know-how on the Symphony cartridge manufacturing to an in-house

facility for redevelopment.

After the cartridge redevelopment is completed, we plan to transfer the manufacturing process to an

FDA-registered CMO for validation testing and commercial manufacturing.

We do not expect to be able to complete this transfer prior

to the end of 2026, at the earliest.

If Toray were to assert that we have not established a facility to manufacture our cartridges

prior to the expiration of the supply agreement (which is currently expected to occur in October 2025), Toray could assert that we

are in material breach of the license agreement and seek to terminate it as early as November 2025.

If Toray sought to terminate the

license, and was successful in doing so, we would lose access to certain technology required to produce the cartridges that our

Symphony system relies on to function, which would likely result in a material adverse effect on our commercialization efforts.

are in the process of negotiating an agreement with Toray to, among other things, clarify that Toray will not seek to terminate the

license agreement in connection with the expiration of the supply agreement.

the receipt of regulatory approval in a country, we are required to pay Toray a minimum royalty of $60,000 for the initial year that

royalties are payable increasing to a minimum of $100,000 thereafter, regardless of the actual amount of sales by us of licensed

Accordingly, we could be obligated to pay royalties even though we have generated no or limited revenue.

Such payments could materially and adversely affect our profitability and could limit our investment in our business.

Toray is only required to supply cartridge intermediates for a period of, in principle, two years ending in October 2025, and with extension for a maximum of six months thereafter.

If Sanyoseiko is unable to manufacture intermediates within that period or we are unable to extend that period further, we could be without any cartridge supply in the future.

Toray may not be able to provide all necessary know-how related to the test cartridges, which may increase the time and cost of remediating product defects, or impair our ability to timely scale up cartridge manufacturing.

The license and regulatory approvals (once obtained) are non-assignable.

These restrictions may limit our flexibility to structure our operations in the most advantageous manner.

At our sole expense, we must file for, prosecute the application for, and obtain all regulatory approvals for the licensed products and obtain all legal permits necessary for promoting, marketing, offering or selling each licensed product.

The regulatory approval process can be expensive and time consuming, and there can be no assurances that we will be able to obtain or maintain any or all required permits.

We are required to use reasonable efforts to obtain market approval for the products in the United States or the European Union by October 2026 or the License Agreement could be terminated by Toray.

Toray has the right to terminate the New Toray License Agreement or make it non-exclusive if we do not generate commercial sales by October 2028, or by October 2030 if the lack of commercial sales is due to events within our control and not due to Toray’s failure to perform its obligations in a timely manner.

The exclusive license shall be extended for an additional six months, repeatedly if necessary, provided that such additional extension period shall not exceed twenty four months.

Except with respect to (a) Toray’s ownership of, or rights to license, all intellectual property rights in respect of the licensed property and (b) Toray’s applicable patents being duly maintained and in effect, Toray provides no, and disclaims all, representations, warranties or covenants relating to the licensed intellectual property or any other matters under the New Toray License Agreement and in particular disclaims any fitness of the intellectual property for any purpose or any warranty against infringement of any third-party patent.

These provisions limit our recourse in the event that the licensed intellectual property is flawed, defective, inadequate, incomplete, uncommercial, wrongly described or otherwise not useful for our purposes.

We have not independently verified any of the technical, scientific, commercial, legal, medical or other circumstances or nature of the licensed intellectual property and therefore there can be no assurances that any of the foregoing risks have been reduced or eliminated.

These provisions represent a significant risk of a material adverse impact on us, our business and our prospects.

While Bluejay is in principle permitted, even after the New Toray License Agreement expires or is terminated, to continue manufacturing and selling products that incorporate Toray intellectual property and the royalties for which are fully paid up, if Bluejay commits certain material breaches of the agreement, Bluejay may be obligated to use reasonable efforts to arrange for the transfer to Toray of FDA or any other regulatory approvals for any products the royalties for which are not fully paid up.

Where any such transfer is possible and approved by the regulator (if necessary), then depending on the nature of the material breach, Bluejay may be required to undertake the transfer at no cost to Toray or on reasonable terms and conditions.

The loss of any such market approvals, especially if we are unable to receive any consideration for them, could have a material adverse impact on us, our business and our prospects, and depending on the timing and extent of the loss, it could even threaten our viability.

In addition, see the risks in “ Risks

Related to Our Intellectual Property ” below.

These risks are not the only risks inherent in the New Toray License Agreement.

You are encouraged to read the complete text of the New Toray License Agreement, which was filed as an exhibit to our Form 8-K filed on

October 26, 2023.

We depend on, and

are liable for, SanyoSeiko as our primary contract manufacturing organization (CMO), so its inability or failure to perform appropriately

in that capacity may threaten our viability or have a material adverse effect on us and our business, assets and its prospects.

We are dependent on SanyoSeiko

not only to appropriately utilize Toray’s know-how and other intellectual property, but also to continuously manufacture and supply

us with our Symphony cartridges.

If SanyoSeiko is unable to do so for any reason and we are unable to activate a new CMO to produce cartridges,

we may be unable to obtain FDA approval and commence any commercial sales or unable to supply products to our customers in a timely manner

or at all, either of which could threaten our viability.

We are also liable for

SanyoSeiko’s performance and actions as our CMO, and any breach by SanyoSeiko of the New Toray License Agreement or the New Toray

Supply Agreement may have a material adverse effect on us and our business.

We have not yet launched any products and

the ability to do so will depend on the acceptance of our Symphony platform in the healthcare market.

We have not yet launched or received regulatory

approvals in any country or territory for our Symphony platform or test cartridges.

Even if we receive regulatory approvals, we are faced

with the risk that our Symphony platform will not be accepted over competing products and that we will be unable to enter the marketplace

or compete effectively.

We cannot assure you that our Symphony platform or test cartridges will gain market acceptance.

If the market

for our future products fails to develop or develops more slowly than expected, or if any of the technology and standards supported by

us do not achieve or sustain market acceptance, our business and operating results would be materially and adversely affected.

We cannot accurately predict the volume

or timing of any sales, making the timing of any revenues difficult to predict.

We may be faced with lengthy and unpredictable

customer evaluation and approval processes associated with our Symphony platform.

Consequently, we may incur substantial expenses and

devote significant management effort and expense in developing customer adoption of our Symphony platform, which may not result in revenue

We must also obtain regulatory approvals of our Symphony platform and test cartridges in jurisdictions in which we pursue

approvals, which is subject to risk and potential delays.

The same risks apply to other tests we may develop based on our Symphony platform.

Such payments

could materially and adversely affect our profitability and could limit our investment in our business.

may not be able to provide all necessary know-how related to the test cartridges, which may increase the time and cost of remediating

product defects, or impair our ability to timely scale up cartridge manufacturing.

license and regulatory approvals (once obtained) are non-assignable.

These restrictions may limit our flexibility to structure our

operations in the most advantageous manner.

our sole expense, we must file for, prosecute the application for, and obtain all regulatory approvals for the licensed products

and obtain all legal permits necessary for promoting, marketing, offering or selling each licensed product.

The regulatory approval

process can be expensive and time consuming, and there can be no assurances that we will be able to obtain or maintain any or all

required permits.

are required to use reasonable efforts to obtain market approval for the products in the United States or the European Union by October

2026 or we may lose exclusivity in territory of the license agreement with Toray.

We will not obtain market approval by this date, and we are in the process of negotiating with Toray to, among other things, extend this

We are required to use reasonable efforts to start commercial

sales by October 2028, though this period may be extended in 6-month increments for up to 2 years in total if such inability to start

commercial sales is due to reasons not attributable to us.

If we are unable to start commercial sales by such later date, Toray

would have the right to terminate the license agreement or make it non-exclusive.

with respect to (a) Toray’s ownership of, or rights to license, all intellectual property rights in respect of the licensed

property and (b) Toray’s applicable patents being duly maintained and in effect, Toray provides no, and disclaims all, representations,

warranties or covenants relating to the licensed intellectual property or any other matters under the license agreement and in particular

disclaims any fitness of the intellectual property for any purpose or any warranty against infringement of any third-party patent.

These provisions limit our recourse in the event that the licensed intellectual property is flawed, defective, inadequate, incomplete,

uncommercial, wrongly described or otherwise not useful for our purposes.

We have not independently verified all of the technical,

scientific, commercial, legal, medical or other circumstances or nature of the licensed intellectual property and therefore there

can be no assurances that any of the foregoing risks have been reduced or eliminated.

We have performed numerous evaluations of the

Symphony product and have identified numerous risks.

These risks are described below.

These provisions represent a significant risk

of a material adverse impact on us, our business and our prospects.

we are in principle permitted, even after the license agreement expires or is terminated, to continue manufacturing and selling products

that incorporate Toray intellectual property and the royalties for which are fully paid up, if we commit certain material breaches

of the agreement, Bluejay may be obligated to use reasonable efforts to arrange for the transfer to Toray of FDA or any other regulatory

approvals for any products the royalties for which are not fully paid up.

Where any such transfer is possible and approved by the

regulator (if necessary), then depending on the nature of the material breach, we may be required to undertake the transfer at no

cost to Toray or on reasonable terms and conditions.

The loss of any such market approvals, especially if we are unable to receive

any consideration for them, could have a material adverse impact on us, our business and our prospects, and depending on the timing

and extent of the loss, it could even threaten our viability.

addition, see the risks in “ Risks Related to Our Intellectual Property ” below.

These risks are not the only risks

inherent in the license agreement with Toray.

an intermediate step to commercial viability, we need to demonstrate that our IL-6 samples do not degrade over time, and our premise

would be undermined if we fail to do so.

are currently conducting testing to demonstrate specimen stability, which will be important to our future development efforts.

stability of the samples collected from the SYMON-II clinical study is one of the integral aspects that we will have to establish before

we can proceed to FDA clearance.

We plan to establish sample stability using standard plate ELISA technology.

Once Symphony is operational,

we plan to perform a bridging study to demonstrate specimen stability commutability.

If we fail to prove that IL-6 is stable over time,

we might have to redesign our business plan.

is a risk that validation of the primary outcome measure of our SYMON-I study will not achieve statistical significance.

our SYMON-I study found promising results, there is a risk that subsequent validation will not achieve statistical significance, which

would render those results subject to scrutiny and subject us to setbacks, including having to redesign our preliminary study at considerable

expense and time delay.

is a risk of our cartridges not passing analytical validation, one of the key requirements of FDA approval.

is a risk that our cartridges, a core component of our Symphony system, will not pass analytical validation due to failures in performance.

We are working on plans to redevelop the cartridges in order to reduce this risk, but we cannot be sure that our attempts will be successful

until they have been tested and have successfully passed analytical validation themselves.

are currently only pursuing one aspect of analytical validation and we cannot be certain how long the remaining tests will take us.

validation is comprised of a series of studies to validate test performance by testing precision, reproducibility, interference, linearity,

detection capability, high-dose hook, hematocrit tolerance, specimen stability, cartridge stability, sample carry-over, reference range,

and matrix comparison.

Currently, we are only pursuing specimen stability and have paused all other analytical testing until the Symphony

IL-6 redevelopment and manufacturing transfer has been completed and Symphony IL-6 cartridges are available, which we expect will not

occur sooner than the end of 2026.

Uncertainties in the timeline make it difficult for us to precisely forecast when we will be able

to move on to the rest of the FDA-required studies needed in order to gain approval for our product.

requirements could change prior to submission and lead to delays and additional costs.

Symphony analyzer has previously passed all safety validations required by the FDA.

However, we plan to reperform some of the validations

surrounding electromagnetic compatibility and safety standards due to a recent FDA requirement changes.

Should other FDA standards change,

we could need to perform those tests as well, incurring additional expenses and delays that are impossible to predict due to the uncertain

nature of what standards the FDA might change in the future.

FDA could request additional data or testing after our application submission, requiring additional costs and delaying approval.

we have had a pre-submission meeting with FDA and included FDA feedback into our plan, the FDA could decide to request additional data

or testing after we have submitted our FDA application.

This could result in significant additional costs generated in the process of

gathering whatever additional data or developing and running the additional testing requested by the FDA.

Furthermore, it can take several

months to years to conduct testing and collect data, and depending on the extent of the FDA’s additional request, the delay caused

could be significant.

During any such period of delay, not only would we be incurring the additional expenses of the testing, but we

would also continue to not generate any revenue.

depend on, and are liable for, SanyoSeiko as our Symphony analyzer contract manufacturing organization (CMO), so its inability or failure

to perform appropriately in that capacity may threaten our viability or have a material adverse effect on us and our business, assets

and its prospects.

are dependent on SanyoSeiko to maintain compliance with the FDA requirements, and continuously manufacture and supply us with our Symphony

If SanyoSeiko is unable to do so for any reason and we are unable to activate a new CMO to produce analyzers, we may be unable

to obtain FDA approval and commence any commercial sales or unable to supply products to our customers in a timely manner or at all,

either of which could threaten our viability.

are also liable for SanyoSeiko’s performance and actions as our CMO, and any breach by SanyoSeiko of our license and/or supply

agreements with Toray may have a material adverse effect on us and our business.

we can not find a suitable CMO for the manufacturing of our Symphony cartridges, requiring additional costs and delaying FDA approval.

plan to redevelop the Symphony cartridge and once redevelopment is completed, we plan to transfer manufacturing to a FDA-registered CMO

for the manufacturing of Symphony cartridges to support validations and commercialization.

If we are unable to find a suitable CMO, we

will have to establish manufacturing internally, which may result in additional costs and delays to our FDA application submission.

have not yet launched any products and the ability to do so will depend on the acceptance of our Symphony platform in the healthcare

have not yet launched or received regulatory approvals in any country or territory for our Symphony platform or test cartridges.

if we receive regulatory approvals, we are faced with the risk that our Symphony platform will not be accepted over competing products

and that we will be unable to enter the marketplace or compete effectively.

We cannot assure you that our Symphony platform or test cartridges

will gain market acceptance.

If the market for our future products fails to develop or develops more slowly than expected, or if any

of the technology and standards supported by us do not achieve or sustain market acceptance, our business and operating results would

be materially and adversely affected.

cannot accurately predict the volume or timing of any sales, making the timing of any revenues difficult to predict.

may be faced with lengthy and unpredictable customer evaluation and approval processes associated with our Symphony platform.

Consequently,

we may incur substantial expenses and devote significant management effort and expense in developing customer adoption of our Symphony

platform, which may not result in revenue generation.

We must also obtain regulatory approvals of our Symphony platform and test cartridges

in jurisdictions in which we pursue approvals, which is subject to risk and potential delays.

The same risks apply to other tests we

may develop based on our Symphony platform.

As such, we cannot accurately predict the volume, if any, or timing of any future sales.

If third-party payors do not provide coverage

and reimbursement for the use of our platform, our business and prospects may be negatively impacted.

Third-party payors, whether governmental or commercial,

are developing increasingly sophisticated methods of controlling healthcare costs.

In addition, in certain countries, no uniform policy

of coverage and reimbursement for medical device products and services exists among third-party payors.

Therefore, coverage and reimbursement

for medical device products and services can differ significantly from payor to payor.

In addition, payors continually review new technologies

for possible coverage and can, without notice, deny coverage for these new products and procedures.

As a result, the coverage determination

process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our

products to each payor separately, with no assurance that coverage and adequate reimbursement will be obtained.

Our Symphony platform, including its software

and systems, may contain undetected errors, which could limit our ability to provide our products and diminish the attractiveness of our

Our Symphony platform may contain undetected errors,

defects, or bugs.

As a result, our customers or end users may discover errors or defects in our products, software or systems, or our

products, software or systems may not operate as expected.

We may discover significant errors or defects in the future that we may not

be able to fix.

Our inability to fix any of those errors could limit our ability to provide our products and services, impair the reputation

of our brand and diminish the attractiveness of our product and service offerings to our customers.

In addition, we may utilize third party technology

or components in our products, and we rely on those third parties to provide support services to us.

The existence of errors, defects,

or bugs in third party technology or components, or the failure of those third parties to provide necessary support services to us, could

materially adversely impact our business.

We will rely on the proper function, security

and availability of our information technology systems and data to operate our business, and a breach, cyber-attack or other disruption

to these systems or data could materially and adversely affect our business, results of operations, financial condition, cash flows, reputation,

or competitive position.

We will depend on sophisticated software and other

information technology systems to operate our business, including to process, transmit and store sensitive data, and our future products

and services may include information technology systems that collect data regarding patients.

We could experience attempted or actual

interference with the integrity of, and interruptions in, our technology systems, as well as data breaches, such as cyber-attacks, malicious

intrusions, breakdowns, interference with the integrity of our products and data or other significant disruptions.

Furthermore, we may

rely on third-party vendors to supply and/or support certain aspects of our information technology systems.

These third-party systems

could also become vulnerable to cyber-attack, malicious intrusions, breakdowns, interference, or other significant disruptions, and may

contain defects in design or manufacture or other problems that could result in system disruption or compromise the information security

of our own systems.

If in the future we pursue foreign jurisdictions,

such international operations will mean that we are subject to laws and regulations, including data protection and cybersecurity laws

and regulations, in many jurisdictions.

Furthermore, there has been a developing trend of civil lawsuits and class actions relating to

breaches of consumer data held by large companies or incidents arising from other cyber-attacks.

Any data security breaches, cyber-attacks,

malicious intrusions or significant disruptions could result in actions by regulatory bodies and/or civil litigation, any of which could

materially and adversely affect our business, results of operations, financial condition, cash flows, reputation, or competitive position.

In addition, our information technology systems

require an ongoing commitment of significant resources to maintain, protect, and enhance existing systems and develop new systems to keep

pace with continuing changes in information processing technology, evolving legal and regulatory standards, the increasing need to protect

patient and customer information, changes in the techniques used to obtain unauthorized access to data and information systems, and the

information technology needs associated any new products and services.

There can be no assurance that our process of consolidating, protecting,

upgrading and expanding our systems and capabilities, continuing to build security into the design of our products, and developing new

systems to keep pace with continuing changes in information processing technology will be successful or that additional systems issues

will not arise in the future.

If our information technology systems, products

or services or sensitive data are compromised, patients or employees could be exposed to financial or medical identity theft or suffer

a loss of product functionality, and we could lose existing customers, have difficulty attracting new customers, have difficulty preventing,

detecting, and controlling fraud, be exposed to the loss or misuse of confidential information, have disputes with customers, physicians,

and other health care professionals, suffer regulatory sanctions or penalties, experience increases in operating expenses or an impairment

in our ability to conduct our operations, incur expenses or lose revenues as a result of a data privacy breach, product failure, information

technology outages or disruptions, or suffer other adverse consequences including lawsuits or other legal action and damage to our reputation.

If we are not able to attract and retain

highly skilled managerial, scientific and technical personnel, we may not be able to implement our business model successfully, and our

limited cash resources could require us to make further cost reductions.

We believe that our management team must be able

to act decisively to apply and adapt our business model in the markets in which we will compete.

Our future performance depends to a large

extent on the continued services of members of our current management, including our President and Chief Executive Officer, Neil Day,

and our Chief Technology Officer, Jason Cook.

At present, our Interim Chief Financial Officer, Frances Scally, is not an employee of ours,

but instead provides services to us pursuant to a scope of work agreement and master services agreement with DLA LLC, where Ms.

is an employee.

In addition, we rely upon technical and scientific employees or third-party contractors to effectively establish, manage

and grow our business.

Consequently, we believe that our future viability will depend largely on our ability to attract and retain highly

skilled managerial, sales, scientific and technical personnel.

In order to do so, we may need to pay higher compensation or fees to our

employees or consultants than we currently expect, and such higher compensation payments would have a negative effect on our operating

Competition for experienced, high-quality personnel is intense and we cannot assure that we will be able to recruit and retain

such personnel, or that we will possess the cash resources to do so.

For example, our limited cash resources could require us to implement

personnel-related cost reductions in the near-term.

As such, we may not be able to hire or retain the necessary personnel to implement

our business strategy.

Our failure to hire and retain such personnel could impair our ability to develop new products and manage our business

In the event that we lose the continued services of such key personnel for any reason, this could have a material adverse

effect on our business, operations and prospects.

If we or our manufacturers fail to comply

with the regulatory quality system regulations or any applicable equivalent regulations, our proposed operations could be interrupted,

and our operating results would suffer.

We and any third-party manufacturers and suppliers

of ours will be required, to the extent of applicable regulation, to follow the quality system regulations of each jurisdiction we will

seek to penetrate and also will be subject to the regulations of these jurisdictions regarding the manufacturing processes.

third-party manufacturers or suppliers of ours are found to be in significant non-compliance or fail to take satisfactory corrective action

in response to adverse regulatory findings in this regard, regulatory agencies could take enforcement actions against us and such manufacturers

or suppliers, which could impair or prevent our ability to produce our products in a cost-effective and timely manner in order to meet

customers’ demands.

third-party payors do not provide coverage and reimbursement for the use of our platform, our business and prospects may be negatively

payors, whether governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs.

in certain countries, no uniform policy of coverage and reimbursement for medical device products and services exists among third-party

Therefore, coverage and reimbursement for medical device products and services can differ significantly from payor to payor.

In addition, payors continually review new technologies for possible coverage and can, without notice, deny coverage for these new products

and procedures.

As a result, the coverage determination process is often a time-consuming and costly process that will require us to

provide scientific and clinical support for the use of our products to each payor separately, with no assurance that coverage and adequate

reimbursement will be obtained.

Symphony platform, including its software and systems, may contain undetected errors, which could limit our ability to provide our products

and diminish the attractiveness of our offerings.

Symphony platform may contain undetected errors, defects, or bugs.

As a result, our customers or end users may discover errors or defects

in our products, software or systems, or our products, software or systems may not operate as expected.

We may discover significant errors

or defects in the future that we may not be able to fix.

Our inability to fix any of those errors could limit our ability to provide

our products and services, impair the reputation of our brand and diminish the attractiveness of our product and service offerings to

our customers.

addition, we may utilize third party technology or components in our products, and we rely on those third parties to provide support

services to us.

The existence of errors, defects, or bugs in third party technology or components, or the failure of those third parties

to provide necessary support services to us, could materially adversely impact our business.

will rely on the proper function, security and availability of our information technology systems and data to operate our business, and

a breach, cyber-attack or other disruption to these systems or data could materially and adversely affect our business, results of operations,

financial condition, cash flows, reputation, or competitive position.

will depend on sophisticated software and other information technology systems to operate our business, including to process, transmit

and store sensitive data, and our future products and services may include information technology systems that collect data regarding

We could experience attempted or actual interference with the integrity of, and interruptions in, our technology systems, as

well as data breaches, such as cyber-attacks, malicious intrusions, breakdowns, interference with the integrity of our products and data

or other significant disruptions.

Furthermore, we may rely on third-party vendors to supply and/or support certain aspects of our information

technology systems.

These third-party systems could also become vulnerable to cyber-attack, malicious intrusions, breakdowns, interference,

or other significant disruptions, and may contain defects in design or manufacture or other problems that could result in system disruption

or compromise the information security of our own systems.

in the future we pursue foreign jurisdictions, such international operations will mean that we are subject to laws and regulations, including

data protection and cybersecurity laws and regulations, in many jurisdictions.

Furthermore, there has been a developing trend of civil

lawsuits and class actions relating to breaches of consumer data held by large companies or incidents arising from other cyber-attacks.

Any data security breaches, cyber-attacks, malicious intrusions or significant disruptions could result in actions by regulatory bodies

and/or civil litigation, any of which could materially and adversely affect our business, results of operations, financial condition,

cash flows, reputation, or competitive position.

addition, our information technology systems require an ongoing commitment of significant resources to maintain, protect, and enhance

existing systems and develop new systems to keep pace with continuing changes in information processing technology, evolving legal and

regulatory standards, the increasing need to protect patient and customer information, changes in the techniques used to obtain unauthorized

access to data and information systems, and the information technology needs associated any new products and services.

There can be no

assurance that our process of consolidating, protecting, upgrading and expanding our systems and capabilities, continuing to build security

into the design of our products, and developing new systems to keep pace with continuing changes in information processing technology

will be successful or that additional systems issues will not arise in the future.

our information technology systems, products or services or sensitive data are compromised, patients or employees could be exposed to

financial or medical identity theft or suffer a loss of product functionality, and we could lose existing customers, have difficulty

attracting new customers, have difficulty preventing, detecting, and controlling fraud, be exposed to the loss or misuse of confidential

information, have disputes with customers, physicians, and other health care professionals, suffer regulatory sanctions or penalties,

experience increases in operating expenses or an impairment in our ability to conduct our operations, incur expenses or lose revenues

as a result of a data privacy breach, product failure, information technology outages or disruptions, or suffer other adverse consequences

including lawsuits or other legal action and damage to our reputation.

we are not able to attract and retain highly skilled managerial, scientific and technical personnel, we may not be able to implement

our business model successfully, and our limited cash resources could require us to make further cost reductions.

believe that our management team must be able to act decisively to apply and adapt our business model in the markets in which we will

Our future performance depends to a large extent on the continued services of members of our current management, including our

President and Chief Executive Officer, Neil Dey, and our Chief Technology Officer, Jason Cook.

In addition, we rely upon technical and

scientific employees or third-party contractors to effectively establish, manage and grow our business.

Consequently, we believe that

our future viability will depend largely on our ability to attract and retain highly skilled managerial, sales, scientific and technical

order to do so, we may need to pay higher compensation or fees to our employees or consultants than we currently expect, and such higher

compensation payments would have a negative effect on our operating results.

Competition for experienced, high-quality personnel is intense

and we cannot assure that we will be able to recruit and retain such personnel, or that we will possess the cash resources to do so.

For example, our limited cash resources have caused us to reduce our overall full-time employment headcount to 7 persons, and we could

need to implement further personnel-related cost reductions in the near-term.

As such, we may not be able to hire or retain the necessary

personnel to implement our business strategy.

For example, Mr.

Dey is currently serving as our principal financial and accounting officer,

in addition to serving as our principal executive officer.

Our failure to hire and retain such personnel could impair our ability to

develop new products and manage our business effectively.

In the event that we lose the continued services of such key personnel for

any reason, this could have a material adverse effect on our business, operations and prospects.

we are not able to attract and retain highly skilled managerial, scientific and technical personnel, we may not be able to implement

our business model successfully, and our limited cash resources could require us to make further cost reductions.

believe that our management team must be able to act decisively to apply and adapt our business model in the markets in which we will

Our future performance depends to a large extent on the continued services of members of our current management, including our

President and Chief Executive Officer, Neil Dey, and our Chief Technology Officer, Jason Cook.

In addition, we rely upon technical and

scientific employees or third-party contractors to effectively establish, manage and grow our business.

Consequently, we believe that

our future viability will depend largely on our ability to attract and retain highly skilled managerial, sales, scientific and technical

In addition, given our small headcount, the loss of existing employees (including our President and Chief Executive Officer

and Chief Technology Officer) could result in the loss of institutional knowledge relating to our product development that would be difficult

for us to replace.

do not have a meaningful amount of authorized shares remaining under our equity compensation plans and therefore cannot incentivize our

directors and employees with non-cash compensation.

have undergone a series of reverse stock splits at a cumulative ratio of 1-for-8,000 over the last two years.

As a result, the authorized

shares in our stock compensation plans have been correspondingly reduced, and we only possess a de minimus amount of equity under our

2018 Stock Incentive Plan and our 2021 Stock Plan.

As a result, we currently cannot incentivize our directors and employees with non-cash

compensation, and even if we possessed such available shares, the substantial declines in the value of our common stock in each of the

prior three years may substantially depress the desired incentive effects of using such shares for compensatory purposes.

that stock incentive plans serve to closely align the interests of directors and officers with the interests of the Company’s shareholders,

and without this tool we are left paying all compensation in cash.

In 2024, cash fees paid to non-employee directors were $380,000 in

the aggregate and cash fees paid to our two executive officers were $526,000.

Given our lack of available equity incentives as a compensatory

tool, we expect to continue incurring significant cash compensation expense relative to our overall market capitalization.

we or our manufacturers fail to comply with the regulatory quality system regulations or any applicable equivalent regulations, our proposed

operations could be interrupted, and our operating results would suffer.

and any third-party manufacturers and suppliers of ours will be required, to the extent of applicable regulation, to follow the quality

system regulations of each jurisdiction we will seek to penetrate and also will be subject to the regulations of these jurisdictions

regarding the manufacturing processes.

If we or any third-party manufacturers or suppliers of ours are found to be in significant non-compliance

or fail to take satisfactory corrective action in response to adverse regulatory findings in this regard, regulatory agencies could take

enforcement actions against us and such manufacturers or suppliers, which could impair or prevent our ability to produce our products

in a cost-effective and timely manner in order to meet customers’ demands.

Accordingly, our operating results would suffer.

Product liability suits, whether or not

meritorious, could be brought against us due to an alleged defective product or for the misuse of our Symphony platform or test cartridges.

These suits could result in expensive and time-consuming litigation, payment of substantial damages, and an increase in our insurance

If our Symphony platform or test cartridges, or

any future tests based on our Symphony platform, are defectively designed or manufactured, contain defective components or are misused,

or if someone claims any of the foregoing, whether or not meritorious, we may become subject to substantial and costly litigation.

our devices or failing to adhere to the operating guidelines or our devices producing inaccurate readings could cause significant harm

In addition, if our operating guidelines are found to be inadequate, we may be subject to liability.

Product liability claims

could divert management’s attention from our core business, be expensive to defend and result in sizable damage awards against us.

While we expect to maintain product liability insurance, we may not have sufficient insurance coverage for all future claims.

liability claims brought against us, with or without merit, could increase our product liability insurance rates or prevent us from securing

continuing coverage, could harm our reputation in the industry and could reduce revenue.

Product liability claims in excess of our insurance

coverage would be paid out of cash reserves harming our financial condition and adversely affecting our results of operations.

If we are found to have violated laws protecting

the confidentiality of patient health information, we could be subject to civil or criminal penalties, which could increase our liabilities

and harm our reputation or our business.

There are a number of laws around the world protecting

the confidentiality of certain patient health information, including patient records, and restricting the use and disclosure of that protected

Privacy rules protect medical records and other personal health information by limiting their use and disclosure, giving

individuals the right to access, amend and seek accounting of their own health information and limiting most use and disclosures of health

information to the minimum amount reasonably necessary to accomplish the intended purpose.

We may face difficulties in holding such information

in compliance with applicable law.

If we are found to be in violation of the privacy rules, we could be subject to civil or criminal penalties,

which could increase our liabilities, harm our reputation and have a material adverse effect on our business, financial condition and

results of operations.

Significant raw material shortages, supplier

capacity constraints, supplier disruptions, and sourcing issues may adversely impact or limit our products sales and or impact our product

Our key suppliers are limited- or sole-source

Disruptions in deliveries, capacity constraints, production disruptions up- or down-stream, price increases, or decreased availability

of raw materials or commodities, including as a result of war, natural disasters (including the effects of climate change such as sea

level rise, drought, flooding, wildfires and more intense weather events), actual or threatened public health emergencies or other business

continuity events, adversely affect our operations and, depending on the length and severity of the disruption, can limit our ability

to meet our commitments to customers or significantly impact our operating profit or cash flows.

Risks Related to Product Development and Regulatory

We adapted our

clinical trial design in 2023 to obtain more patient data to reflect recent FDA feedback, and our regulatory pathway remains subject to

further FDA review and feedback and the results of ongoing and future clinical studies.

Our current regulatory

strategy is designed to support commercialization of Symphony in the United States pending marketing authorization from the FDA.

our regulatory strategy involved clinical studies involving COVID-19 patients.

However, we have shifted our focus away from COVID-19 patients

due to a significant decline in the number of COVID-19 related hospitalizations.

Pursuant to this revised strategy, we are beginning to

conduct a clinical study to support an FDA regulatory submission with an initial indication for risk stratification of hospitalized sepsis

We submitted a pre-submission application to the FDA presenting the new study design in May 2023 and participated in a pre-submission

meeting on August 11, 2023.

At the meeting, the FDA provided feedback on the new study design, determined that the submission of a 510(k)

is the appropriate premarket submission pathway, and requested that certain data be provided in the 510(k).

Based on this feedback, we

determined to proceed on this basis, which considers the FDA’s feedback.

quarter of 2024, we initiated the study at multiple sites, which study is intended to use the Symphony IL-6 test to monitor IL-6

concentrations in patients who are diagnosed with sepsis or septic shock and are admitted or intended to be admitted to the ICU.

objective of this study is to establish IL-6 concentrations in these sepsis patients that best predict 28-day all-cause mortality.

We expect that we will need to bring several additional sites into the study in the future, which we believe will help support

initial commercialization and market penetration.

We believe that this clinical trial expansion could also support additional

indications, but that any such expansion also could delay obtaining marketing authorization for the product.

As a result of our lack

of cash resources, we have recently slowed the timeline of this study to preserve cash resources in the near-term, and we expect

that this will delay our Symphony platform regulatory submission timeline until 2025.

Although we believe that

we have a sound strategy for obtaining FDA regulatory approval and clearance, there can be no assurance that it will ultimately be obtained.

Reasons that approval and clearance might not be obtained, on our expected timeline or at all, include that we are unable to complete

our planned studies (due to lack of funding, delays or interruptions in the manufacturing of quality-sufficient cartridges needed to be

used in the study, or otherwise), that clinical results are not sufficient to demonstrate required efficacy, or that the FDA does not

agree with our study design or aspects of our submission.

In addition, the FDA could also change its clearance and approval policies,

adopt additional regulations, or revise existing regulations, or take other actions which could prevent or delay approval or clearance.

Any of these actions could have a material adverse effect on our business, financial condition, and results of operations.

The regulatory approval process which we

may be required to navigate may be expensive, time-consuming, and uncertain and may prevent us from obtaining clearance for our planned

We intend to market our Symphony platform and test

cartridges following regulatory approval.

To date, we have not received regulatory approval in any jurisdiction.

The research, design,

testing, manufacturing, labeling, selling, marketing, and distribution of medical devices are subject to extensive regulation by country-specific

regulatory authorities, which regulations differ from country to country.

There can be no assurance that, even after such time and expenditures,

we will be able to obtain necessary regulatory approvals for clinical testing or for the manufacturing or marketing of any products.

addition, during the regulatory process, other companies may develop other technologies with the same intended use as our products.

We also will be subject to numerous post-marketing

regulatory requirements, which may include labeling regulations and medical device reporting regulations, which may require us to report

to different regulatory agencies if our device causes or contributes to a death or serious injury, or malfunctions in a way that would

likely cause or contribute to a death or serious injury.

In addition, these regulatory requirements may change in the future in a way

that adversely affects us.

If we fail to comply with present or future regulatory requirements that are applicable to us, we may be subject

to enforcement action by regulatory agencies, which may include, among others, any of the following sanctions:

warning letters, fines, injunctions, consent decrees and civil penalties;

customer notification, or orders for repair, replacement, or refunds;

voluntary or mandatory recall or seizure of our products;

imposing operating restrictions, suspension, or shutdown of production;

refusing our requests for clearance or pre-market approval of new products, new intended uses or modifications to any products;

rescinding clearance or suspending or withdrawing pre-market approvals that have already been granted;

criminal prosecution.

The occurrence of any of these events may have

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

Product clearances and approvals can often

be denied or significantly delayed.

Under FDA regulations, unless exempt, a new medical

device may only be commercially distributed after it has received 510(k) clearance, is authorized through the de novo classification process,

or is the subject of a PMA.

The FDA will clear marketing of a medical device through the 510(k) process if it is demonstrated that the

new product is substantially equivalent to another legally marketed product not subject to a PMA.

Sometimes, a 510(k) clearance must be

supported by preclinical and clinical data.

The PMA process typically is more costly, lengthy,

and stringent than either the 510(k) process or the de novo classification process.

Unlike a 510(k) review, which determines “substantial

equivalence,” a PMA requires that the applicant demonstrate reasonable assurance that the device is safe and effective by producing

valid scientific evidence, including data from preclinical studies and human clinical trials.

Therefore, to obtain regulatory clearance

or approvals, we typically must, among other requirements, provide the FDA and similar foreign regulatory authorities with preclinical

and clinical data that demonstrate to their satisfaction that our products satisfy the criteria for approval.

Preclinical testing and

clinical trials must comply with the regulations of the FDA and other government authorities in the United States and similar agencies

in other countries.

We may be required to obtain PMAs, PMA supplements,

de novo classification, or additional 510(k) pre-market clearances to market modifications to our products once they are approved and

commercialized.

The FDA requires device manufacturers to make and document a determination of whether a device modification requires approval

or clearance;

liability suits, whether or not meritorious, could be brought against us due to an alleged defective product or for the misuse of our

Symphony platform or test cartridges.

These suits could result in expensive and time-consuming litigation, payment of substantial damages,

and an increase in our insurance rates.

our Symphony platform or test cartridges, or any future tests based on our Symphony platform, are defectively designed or manufactured,

contain defective components or are misused, or if someone claims any of the foregoing, whether or not meritorious, we may become subject

to substantial and costly litigation.

Misusing our devices or failing to adhere to the operating guidelines or our devices producing

inaccurate readings could cause significant harm to patients.

In addition, if our operating guidelines are found to be inadequate, we

may be subject to liability.

Product liability claims could divert management’s attention from our core business, be expensive

to defend and result in sizable damage awards against us.

While we expect to maintain product liability insurance, we may not have sufficient

insurance coverage for all future claims.

Any product liability claims brought against us, with or without merit, could increase our

product liability insurance rates or prevent us from securing continuing coverage, could harm our reputation in the industry and could

reduce revenue.

Product liability claims in excess of our insurance coverage would be paid out of cash reserves harming our financial

condition and adversely affecting our results of operations.

we are found to have violated laws protecting the confidentiality of patient health information, we could be subject to civil or criminal

penalties, which could increase our liabilities and harm our reputation or our business.

are a number of laws around the world protecting the confidentiality of certain patient health information, including patient records,

and restricting the use and disclosure of that protected information.

Privacy rules protect medical records and other personal health

information by limiting their use and disclosure, giving individuals the right to access, amend and seek accounting of their own health

information and limiting most use and disclosures of health information to the minimum amount reasonably necessary to accomplish the

intended purpose.

We may face difficulties in holding such information in compliance with applicable law.

If we are found to be in violation

of the privacy rules, we could be subject to civil or criminal penalties, which could increase our liabilities, harm our reputation and

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

raw material shortages, supplier capacity constraints, supplier disruptions, and sourcing issues may adversely impact or limit our products

sales and or impact our product margins.

key suppliers are limited- or sole-source suppliers.

Disruptions in deliveries, capacity constraints, production disruptions up- or down-stream,

price increases, or decreased availability of raw materials or commodities, including as a result of war, natural disasters (including

the effects of climate change such as sea level rise, drought, flooding, wildfires and more intense weather events), actual or threatened

public health emergencies or other business continuity events, adversely affect our operations and, depending on the length and severity

of the disruption, can limit our ability to meet our commitments to customers or significantly impact our operating profit or cash flows.

raw materials used in the production of Symphony IL-6 cartridges are being discontinued or are otherwise limited in supply and the process

of finding a suitable substitute could be expensive, use important resources, reduce the efficacy of the platform, or lead to other delays

and setbacks.

raw materials used in production of Symphony IL-6 cartridges are being discontinued and we will need to validate new materials to use

as substitutes.

These materials include hydrophobic coating solution, side film plastic laminate, and antibody.

Testing new raw materials

at the same time that we are testing to discover the previously discussed instability in the product introduces additional variables

that could make it more difficult for us to discover the source of the instability, adding extra expense and delay.

We cannot currently

predict what substitute materials will be found to work for the discontinued ones, whether they will perform as well, their availability,

or their precise cost.

do not currently have sufficient supply to or know-how from Toray to reproduce the capture antibody in the Symphony IL-6 cartridges.

procedures Toray has provided to us on manufacture of the capture antibody we use in our product are incomplete.

To address this, we

plan to develop manufacturing process for or procure from third-party vendor the immunogen source.

We plan to use industry-standard polyclonal

antibody manufacturing using this immunogen.

If we are unable to do so, we expect that we would need to find a substitute that is different

from Toray’s original design.

We expect that it could currently take over one year for us to complete work on the capture antibody,

and any additional delay would further increase our expected timeline to FDA approval and commercialization further into the future,

and require additional funding beyond the amount that we currently forecast.

might not be able to discover the underlying cause of a Symphony performance reproducibility issue, and if the issues are inherent in

the design of the platform we might have to redesign our approach.

continue to face a performance reproducibility issue with the Symphony cartridges, and we have been unable to discover the cause to date.

Our efforts to redevelop the cartridge might not adequately resolve the issues if they are inherent to the design of the cartridge.

the issue lies in these or similarly difficult-to-address areas, we might need to redesign our approach, which would likely be expensive

and significantly delay the FDA approval process.

there is a shift in customer demand for the type of near-patient diagnostic test that we are working to develop, we would be left without

a commercially marketable product in the pipeline.

only viable product in development at this time is a near-patient diagnostic test.

If there is a shift in consumer demand away from such

tests, for any reason, by or before the time we are ready to reach the market, we might find ourselves without a viable product sales

We cannot be certain that there will be demand for our product by the time it is ready for commercial use or sale, and if there

is not, we could be left without a revenue-generating product, as we do not currently have any other products under development.

Related to Product Development and Regulatory Approval

adapted our clinical trial design in 2023 to obtain more patient data to reflect recent FDA feedback, and our regulatory pathway remains

subject to further FDA review and feedback and the results of ongoing and future clinical studies.

current regulatory strategy is designed to support commercialization of Symphony in the United States pending marketing authorization

from the FDA.

Previously, our regulatory strategy involved clinical studies involving COVID-19 patients.

However, we have shifted our

focus away from COVID-19 patients due to a significant decline in the number of COVID-19 related hospitalizations.

Pursuant to this revised

strategy, we are beginning to conduct a clinical study to support an FDA regulatory submission with an initial indication for risk stratification

of hospitalized sepsis patients.

We submitted a pre-submission application to the FDA presenting the new study design in May 2023 and

participated in a pre-submission meeting on August 11, 2023.

At the meeting, the FDA provided feedback on the new study design, determined

that the submission of a 510(k) is the appropriate premarket submission pathway, and requested that certain data be provided in the 510(k).

Based on this feedback, we determined to proceed on this basis, which considers the FDA’s feedback.

the second quarter of 2024, we completed a multicenter SYmphony IL-6 MONitoring Sepsis (“SYMON”) clinical study investigating

the role of interleukin-6 (IL-6) in patients diagnosed with sepsis and septic shock.

This prospective study assessed the performance

of IL-6 upon initial presentation to the intensive care unit (ICU).

A primary analysis of the SYMON-I pilot clinical study (registered

clinical trial number NCT06181604) highlighted that IL-6 levels within 24 hours of sepsis or septic shock diagnosis and admission to

the ICU may predict patient mortality out to 28 days.

Furthermore, a secondary outcome of the SYMON-I study showed that IL-6 levels within

24 hours of sepsis or septic shock diagnosis and admission to the ICU is a predictor of patient mortality during their hospitalization.

Other secondary outcomes showed that lactate and Sequential Organ Failure Assessment (SOFA), standard clinical tests used for sepsis

and septic shock patients, were not predictors of patient mortality out to 28 days.

We believe that the findings underscore the potential

importance of IL-6 as a predictor and provide new insights into the potential pathways for improving sepsis outcomes.

the data analysis from the SYMON-I pilot clinical study, we initiated the SYMON-II pivotal clinical study in the third quarter of 2024.

The SYMON II clinical study has three components:

(1) collection, freezing, and biobanking of patient samples, (2) measuring IL-6 concentrations

in the biobanked samples near the end of patient enrollment or after the patient enrollment has completed, and (3) analysis of the IL-6

data with the patient outcomes to see if the established IL-6 cutoff value has been validated for 28-day all-cause mortality.

enrollment started during the fourth quarter of 2024.

our Symphony IL-6 cartridges are redeveloped, transferred to a CMO, and pass analytical validation, our goal is to use the Symphony IL-6

test to complete the testing in the SYMON-II clinical trial.

a result of our lack of cash resources and timeline associated with cartridge redevelopment, we have recently slowed the timeline of

this study to preserve cash resources in the near-term, and we expect that these delays will prevent us from submitting an FDA application

for our Symphony platform within the next 30 months.

we believe that we have a sound strategy for obtaining FDA regulatory approval and clearance, there can be no assurance that it will

ultimately be obtained.

Reasons that approval and clearance might not be obtained, on our expected timeline or at all, include that we

are unable to complete our planned studies (due to lack of funding, delays or interruptions in the manufacturing of quality-sufficient

cartridges needed to be used in the study, or otherwise), that clinical results are not sufficient to demonstrate required efficacy,

or that the FDA does not agree with our study design or aspects of our submission.

In addition, the FDA could also change its clearance

and approval policies, adopt additional regulations, or revise existing regulations, or take other actions which could prevent or

delay approval or clearance.

Any of these actions could have a material adverse effect on our business, financial condition, and results

of operations.

in the Symphony cartridge redevelopment and manufacturing transfer to a CMO could negatively affect our timeline for the FDA submission

plan to redevelop the Symphony cartridge to achieve performance requirements.

Delays in the redevelopment or transfer will negatively

affect our timeline for the FDA submission of Symphony.

ability to engage in and complete the activities needed for an FDA submission will be contingent upon us addressing these and other challenges,

including possessing and/or raising sufficient capital, remaining a going concern, and producing product capable of supporting our product

requirements and meeting analytical validation, clinical validation.

The delays described above, coupled with our lack of cash resources,

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

regulatory approval process which we may be required to navigate may be expensive, time-consuming, and uncertain and may prevent us from

obtaining clearance for our planned products.

intend to market our Symphony platform and test cartridges following regulatory approval.

To date, we have not received regulatory approval

in any jurisdiction.

The research, design, testing, manufacturing, labeling, selling, marketing, and distribution of medical devices

are subject to extensive regulation by country-specific regulatory authorities, which regulations differ from country to country.

can be no assurance that, even after such time and expenditures, we will be able to obtain necessary regulatory approvals for clinical

testing or for the manufacturing or marketing of any products.

In addition, during the regulatory process, other companies may develop

other technologies with the same intended use as our products.

also will be subject to numerous post-marketing regulatory requirements, which may include labeling regulations and medical device reporting

regulations, which may require us to report to different regulatory agencies if our device causes or contributes to a death or serious

injury, or malfunctions in a way that would likely cause or contribute to a death or serious injury.

In addition, these regulatory requirements

may change in the future in a way that adversely affects us.

If we fail to comply with present or future regulatory requirements that

are applicable to us, we may be subject to enforcement action by regulatory agencies, which may include, among others, any of the following

letters, fines, injunctions, consent decrees and civil penalties;

notification, or orders for repair, replacement, or refunds;

or mandatory recall or seizure of our products;

operating restrictions, suspension, or shutdown of production;

our requests for clearance or pre-market approval of new products, new intended uses or modifications to any products;

clearance or suspending or withdrawing pre-market approvals that have already been granted;

occurrence of any of these events may have a material adverse effect on our business, financial condition and results of operations.

clearances and approvals can often be denied or significantly delayed.

FDA regulations, unless exempt, a new medical device may only be commercially distributed after it has received 510(k) clearance, is

authorized through the de novo classification process, or is the subject of a PMA.

The FDA will clear marketing of a medical device through

the 510(k) process if it is demonstrated that the new product is substantially equivalent to another legally marketed product not subject

Sometimes, a 510(k) clearance must be supported by preclinical and clinical data.

PMA process typically is more costly, lengthy, and stringent than either the 510(k) process or the de novo classification process.

a 510(k) review, which determines “substantial equivalence,” a PMA requires that the applicant demonstrate reasonable assurance

that the device is safe and effective by producing valid scientific evidence, including data from preclinical studies and human clinical

Therefore, to obtain regulatory clearance or approvals, we typically must, among other requirements, provide the FDA and similar

foreign regulatory authorities with preclinical and clinical data that demonstrate to their satisfaction that our products satisfy the

criteria for approval.

Preclinical testing and clinical trials must comply with the regulations of the FDA and other government authorities

in the United States and similar agencies in other countries.

may be required to obtain PMAs, PMA supplements, de novo classification, or additional 510(k) pre-market clearances to market modifications

to our products once they are approved and commercialized.

The FDA requires device manufacturers to make and document a determination

of whether a device modification requires approval or clearance;

however, the FDA can review a manufacturer’s decision.

The FDA may not agree with our decisions not to seek approvals

or clearances for particular device modifications.

If the FDA requires us to obtain PMAs, PMA supplements or pre-market clearances for

any modification to a previously cleared or approved device, we may be required to cease manufacturing and marketing of the modified device

and perhaps also to recall such modified device until we obtain FDA clearance or approval.

We may also be subject to significant regulatory

fines or penalties.

The FDA may not clear or approve our product submissions

or applications on a timely basis or at all.

Such delays or refusals could have a material adverse effect on our business, financial condition,

and results of operations.

The FDA may also change its clearance and approval

policies, adopt additional regulations, or revise existing regulations, or take other actions which may prevent or delay approval or clearance

of our products under development or impact our ability to modify our currently approved or cleared products on a timely basis.

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

International regulatory approval processes

may take more or less time than the FDA’s clearance or approval process.

If we fail to comply with applicable FDA and

comparable non-U.S.

regulatory requirements, we may not receive regulatory clearances or approvals or may be subject to FDA or

comparable non-U.S.

may not agree with our decisions not to seek approvals or clearances for particular device modifications.

If the FDA requires us to obtain

PMAs, PMA supplements or pre-market clearances for any modification to a previously cleared or approved device, we may be required to

cease manufacturing and marketing of the modified device and perhaps also to recall such modified device until we obtain FDA clearance

We may also be subject to significant regulatory fines or penalties.

FDA may not clear or approve our product submissions or applications on a timely basis or at all.

Such delays or refusals could have

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

FDA may also change its clearance and approval policies, adopt additional regulations, or revise existing regulations, or take other

actions which may prevent or delay approval or clearance of our products under development or impact our ability to modify our currently

approved or cleared products on a timely basis.

Any of these actions could have a material adverse effect on our business, financial

condition, and results of operations.

International

regulatory approval processes may take more or less time than the FDA’s clearance or approval process.

If we fail to comply with

applicable FDA and comparable non-U.S.

regulatory requirements, we may not receive regulatory clearances or approvals or may be subject

to FDA or comparable non-U.S.

enforcement actions.

We may be unable to obtain future regulatory clearance or approval in a timely manner, or

at all, especially if existing regulations are changed or new regulations are adopted.

For example, the FDA’s clearance or

approval process can take longer than anticipated due to requests for additional clinical data and changes in regulatory

requirements.

Any failure or delay in obtaining necessary regulatory clearances or approvals would materially adversely affect our

business, financial condition, and results of operations.

Our Symphony platform may be sold as a research

use only product.

The FDA could disagree with this strategy and subject the product to regulation as a regulated medical device,

which could increase our costs and delay our commercialization efforts, thereby materially and adversely affecting our business and results

of operations.

In the United States, we may decide to label and

sell our Symphony platform for research use only, and not for the diagnosis or treatment of disease.

Our future product candidates

also may follow this same pathway to market.

Because such products are not intended for use in clinical practice in diagnostics, and the

products cannot include clinical or diagnostic claims, they are exempt from many regulatory requirements otherwise applicable to medical

In particular, while FDA regulations require that RUO products be labeled, “For Research Use Only.

Not for use in

diagnostic procedures,” the regulations do not otherwise subject such products to the FDA’s pre- and post-market controls

for medical devices.

A significant change in the laws governing

RUO products or how they are enforced may require us to change our ability to consider generating revenue via this path in order to

maintain compliance.

For instance, in November 2013 the FDA issued a guidance document entitled “Distribution of In Vitro

Diagnostic Products Labeled for Research Use Only or Investigational Use Only” (the “RUO Guidance”)

which highlights the FDA’s interpretation that distribution of RUO products with any labeling, advertising or promotion that

suggests that clinical laboratories can validate the test through their own procedures and subsequently offer it for clinical

diagnostic use as a laboratory developed test is in conflict with RUO status.

The RUO Guidance further articulates the FDA’s

position that any assistance offered in performing clinical validation or verification, or similar specialized technical support, to

clinical laboratories, conflicts with RUO status.

If we engage in any activities that the FDA deems to be in conflict with the RUO

status held by the products that we sell, we may be subject to immediate, severe and broad FDA enforcement action that would

adversely affect our ability to continue operations.

Accordingly, if the FDA finds that we are distributing our RUO products in a

manner that is inconsistent with its regulations or guidance, we may be forced to stop distribution of our RUO tests until we are in

compliance, which would reduce our revenue, increase our costs and adversely affect our business, prospects, results of operations

and financial condition.

In addition, the FDA’s proposed implementation for a new framework for the regulation of laboratory

developed tests (LDTs) may negatively impact the LDT market and thereby reduce demand for RUO products.

Clinical data obtained in the future may

not meet the required objectives, which could delay, limit or prevent any regulatory approval.

There can be no assurance that we will successfully

complete any clinical evaluations necessary to receive regulatory approvals.

While preliminary results have been encouraging and indicative

of the potential performance of our Symphony platform and test cartridges, data already obtained, or in the future obtained, from clinical

studies do not necessarily predict the results that will be obtained from later clinical evaluations.

The failure to adequately demonstrate

the performance characteristics of the device under development could delay or prevent regulatory approval of the device, which could

prevent or result in delays to market launch and could materially harm our business.

There can be no assurance that we will be able to

receive approval for any potential applications of our principal technology, or that we will receive regulatory clearances from targeted

regions or countries.

We may be unable to complete required clinical

evaluations, or we may experience significant delays in completing such clinical evaluations, which could prevent or significantly delay

our targeted product launch timeframe and impair our viability and business plan.

The completion of any future clinical evaluations

of our Symphony platform or test cartridges, or other studies that we may be required to undertake in the future, could be delayed, suspended,

or terminated for several reasons, including:

we may fail to or be unable to conduct the clinical evaluation in accordance with regulatory requirements;

sites participating in the trial may drop out of the trial, which may require us to engage new sites for an expansion of the number of sites that are permitted to be involved in the trial;

patients may not enroll in, remain in or complete, the clinical evaluation at the rates we expect;

clinical investigators may not perform our clinical evaluation on our anticipated schedule or consistent with the clinical evaluation protocol and good clinical practices.

If our clinical evaluations are delayed it will

take us longer to ultimately launch our Symphony platform and test cartridges in the market and generate revenues.

Moreover, our development

costs will increase if we have material delays in our clinical evaluation or if we need to perform more or larger clinical evaluations

than planned.

We and our suppliers may not meet regulatory

quality standards applicable to our manufacturing processes, which could have an adverse effect on our business, financial condition,

We may be unable to obtain future regulatory clearance or approval in a timely manner,

or at all, especially if existing regulations are changed or new regulations are adopted.

For example, the FDA’s clearance or approval

process can take longer than anticipated due to requests for additional clinical data and changes in regulatory requirements.

or delay in obtaining necessary regulatory clearances or approvals would materially adversely affect our business, financial condition,

and results of operations.

As a medical device manufacturer, we will need

to register with the FDA and various non-U.S.

regulatory agencies and will be subject to periodic inspection by the FDA and foreign regulatory

agencies, for compliance with certain Good Manufacturing Practices, including design controls, product validation and verification, in

process testing, quality control and documentation procedures.

Compliance with applicable regulatory requirements is subject to continual

review and is rigorously monitored through periodic inspections by the FDA and foreign regulatory agencies.

Our product and component

suppliers may also be required to meet certain standards applicable to their manufacturing processes.

We cannot assure you that we or our products or

component suppliers will comply with all regulatory requirements.

The failure by us or one of our suppliers to achieve or maintain compliance

with these requirements or quality standards may disrupt our ability to supply products sufficient to meet demand until compliance is

achieved or, until a new supplier has been identified and evaluated.

Our or any product or component supplier’s failure to comply

with applicable regulations could cause sanctions to be imposed on us, including warning letters, fines, injunctions, civil penalties,

failure of regulatory authorities to grant marketing approval of our products, delays, suspension or withdrawal of approvals or clearances,

license revocation, seizures or recalls of products, operating restrictions and criminal prosecutions, which could harm our business.

We cannot assure you that if we need to engage new suppliers to satisfy our business requirements, we can locate new suppliers in compliance

with regulatory requirements at a reasonable cost and in an acceptable timeframe.

Our failure to do so could have a material adverse effect

Symphony platform may be sold as a research use only product.

The FDA could disagree with this strategy and subject the product

to regulation as a regulated medical device, which could increase our costs and delay our commercialization efforts, thereby materially

and adversely affecting our business and results of operations.

the United States, we may decide to label and sell our Symphony platform for research use only, and not for the diagnosis or treatment

Our future product candidates also may follow this same pathway to market.

Because such products are not intended for use

in clinical practice in diagnostics, and the products cannot include clinical or diagnostic claims, they are exempt from many regulatory

requirements otherwise applicable to medical devices.

In particular, while FDA regulations require that RUO products be labeled, “For Research

Not for use in diagnostic procedures,” the regulations do not otherwise subject such products to the FDA’s pre-

and post-market controls for medical devices.

significant change in the laws governing RUO products or how they are enforced may require us to change our ability to consider generating

revenue via this path in order to maintain compliance.

For instance, in November 2013 the FDA issued a guidance document entitled “Distribution

of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only” (the “RUO Guidance”)

which highlights the FDA’s interpretation that distribution of RUO products with any labeling, advertising or promotion that suggests

that clinical laboratories can validate the test through their own procedures and subsequently offer it for clinical diagnostic use as

a laboratory developed test is in conflict with RUO status.

The RUO Guidance further articulates the FDA’s position that any assistance

offered in performing clinical validation or verification, or similar specialized technical support, to clinical laboratories, conflicts

with RUO status.

If we engage in any activities that the FDA deems to be in conflict with the RUO status held by the products that we

sell, we may be subject to immediate, severe and broad FDA enforcement action that would adversely affect our ability to continue operations.

Accordingly, if the FDA finds that we are distributing our RUO products in a manner that is inconsistent with its regulations or guidance,

we may be forced to stop distribution of our RUO tests until we are in compliance, which would reduce our revenue, increase our costs

and adversely affect our business, prospects, results of operations and financial condition.

In addition, the FDA’s proposed implementation

for a new framework for the regulation of laboratory developed tests (LDTs) may negatively impact the LDT market and thereby reduce demand

for RUO products.

data obtained in the future may not meet the required objectives, which could delay, limit or prevent any regulatory approval.

can be no assurance that we will successfully complete any clinical evaluations necessary to receive regulatory approvals.

While preliminary

results have been encouraging and indicative of the potential performance of our Symphony platform and test cartridges, data already

obtained, or in the future obtained, from clinical studies do not necessarily predict the results that will be obtained from later clinical

The failure to adequately demonstrate the performance characteristics of the device under development could delay or prevent

regulatory approval of the device, which could prevent or result in delays to market launch and could materially harm our business.

can be no assurance that we will be able to receive approval for any potential applications of our principal technology, or that we will

receive regulatory clearances from targeted regions or countries.

may be unable to complete required clinical evaluations, or we may experience significant delays in completing such clinical evaluations,

which could prevent or significantly delay our targeted product launch timeframe and impair our viability and business plan.

completion of any future clinical evaluations of our Symphony platform or test cartridges, or other studies that we may be required to

undertake in the future, could be delayed, suspended, or terminated for several reasons, including:

may fail to or be unable to conduct the clinical evaluation in accordance with regulatory requirements;

participating in the trial may drop out of the trial, which may require us to engage new sites for an expansion of the number of

sites that are permitted to be involved in the trial;

may not enroll in, remain in or complete, the clinical evaluation at the rates we expect;

investigators may not perform our clinical evaluation on our anticipated schedule or consistent with the clinical evaluation protocol

and good clinical practices.

our clinical evaluations are delayed it will take us longer to ultimately launch our Symphony platform and test cartridges in the market

and generate revenues.

Moreover, our development costs will increase if we have material delays in our clinical evaluation or if we need

to perform more or larger clinical evaluations than planned.

and our suppliers may not meet regulatory quality standards applicable to our manufacturing processes, which could have an adverse effect

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

We may be liable if the FDA or another regulatory

agency concludes that we have engaged in the off-label promotion of our products.

Our promotional materials and training methods

must comply with FDA and other applicable laws and regulations, including the prohibition of the promotion of the off-label use of our

Once our products are cleared or approved for clinical use, healthcare providers may use our products for off-label uses, as

the FDA does not restrict or regulate a physician’s choice of treatment within the practice of medicine.

However, if the FDA determines

that our promotional, or training materials for sales representatives or physicians constitute promotion of an off-label use, the FDA

could request that we modify our training, promotional materials and/or subject us to regulatory or enforcement actions, including the

issuance of an untitled letter, a warning letter, injunction, seizure, disgorgement of profits, significant penalties, including civil

fines and criminal penalties.

Other federal, state or foreign governmental authorities also might take action if they consider our promotion,

reimbursement or training materials to constitute promotion of an off-label use, which could result in significant fines or penalties

under other statutory authorities, such as laws prohibiting false claims for reimbursement.

In those possible events, our reputation could

be damaged, and adoption of the products would be impaired.

Our products may be subject to recalls after

receiving FDA or foreign approval or clearance or cause or contribute to a death or a serious injury or malfunction in certain ways prompting

voluntary corrective actions or agency enforcement actions, which could divert managerial and financial resources, harm our reputation,

and adversely affect our business.

The FDA and similar foreign governmental authorities

have the authority to require the recall of our products because of any failure to comply with applicable laws and regulations, or defects

in design or manufacture, or if there is a reasonable likelihood our products might cause or contribute to a death or a serious injury

or malfunction.

A government mandated or voluntary product recall by us could occur because of, for example, component failures, device

malfunctions or other adverse events, such as serious injuries or deaths, or quality-related issues, such as manufacturing errors or design

or labeling defects.

Any future recalls of our products could divert managerial and financial resources, harm our reputation, and adversely

affect our business.

If we initiate a correction or removal for one

of our devices to reduce a risk to health posed by the device, we would be required to submit a publicly available Correction and Removal

report to the FDA and, in many cases, similar reports to other regulatory agencies.

This report could be classified by the FDA as a device

recall which could lead to increased scrutiny by the FDA, other international regulatory agencies and our customers regarding the quality

and safety of our devices.

Furthermore, the submission of these reports has been and could be used by competitors against us in competitive

situations and cause customers to delay purchase decisions or cancel orders and would harm our reputation.

In addition, we will be subject to medical device

reporting regulations that will require us to report to the FDA or similar foreign governmental authorities if one of our products may

have caused or contributed to a death or serious injury or if we become aware that it has malfunctioned in a way that would likely cause

or contribute to a death or serious injury if the malfunction recurred.

Failures to properly identify reportable events or to file timely

reports, as well as failure to address each of the observations to the FDA’s satisfaction, can subject us to sanctions and penalties,

including warning letters and recalls.

Physicians, hospitals, and other healthcare providers may make similar reports to regulatory authorities.

Any such reports may trigger an investigation by the FDA or similar foreign regulatory bodies, which could divert managerial and financial

resources, harm our reputation, and have a material adverse effect on our business, financial condition and results of operations.

adverse event involving our products also could result in future voluntary corrective actions, such as recalls or customer notifications,

or agency action, such as inspection or enforcement action.

Any corrective action, whether voluntary or involuntary, as well as defending

ourselves in a lawsuit, would require our time and capital, distract management from operating our business and may harm our reputation

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

Legislative or regulatory reforms may make

it more difficult and costly for us to obtain regulatory clearance or approval of any future products and to manufacture, market and distribute

our products after clearance or approval is obtained.

From time to time, legislation is drafted and

introduced in Congress that could significantly change the statutory provisions governing the regulatory approval, manufacture and marketing

of regulated products or the reimbursement thereof.

In addition, the FDA may change its clearance and approval policies, adopt additional

regulations or revise existing regulations, or take other actions, which may prevent or delay approval or clearance of our future products

under development or impact our ability to modify our currently cleared products on a timely basis.

Any new regulations or revisions or

reinterpretations of existing regulations may impose additional costs or lengthen review times of planned or future products.

It is impossible

to predict whether legislative changes will be enacted, or FDA regulations, guidance or interpretations changed, and what the impact of

such changes, if any, may be.

FDA regulations and guidance are often revised

or reinterpreted by the FDA in ways that may significantly affect our business and our products.

Any new statutes, regulations or revisions

or reinterpretations of existing regulations may impose additional costs or lengthen review times of any future products or make it more

difficult to obtain clearance or approval for, manufacture, market or distribute our products.

We cannot determine what effect changes

in regulations, statutes, legal interpretation or policies, when and if promulgated, enacted or adopted may have on our business in the

Such changes could, among other things, require additional testing prior to obtaining clearance or approval;

changes to manufacturing

a medical device manufacturer, we will need to register with the FDA and various non-U.S.

regulatory agencies and will be subject to

periodic inspection by the FDA and foreign regulatory agencies, for compliance with certain Good Manufacturing Practices, including design

controls, product validation and verification, in process testing, quality control and documentation procedures.

Compliance with applicable

regulatory requirements is subject to continual review and is rigorously monitored through periodic inspections by the FDA and foreign

regulatory agencies.

Our product and component suppliers may also be required to meet certain standards applicable to their manufacturing

cannot assure you that we or our products or component suppliers will comply with all regulatory requirements.

The failure by us or one

of our suppliers to achieve or maintain compliance with these requirements or quality standards may disrupt our ability to supply products

sufficient to meet demand until compliance is achieved or, until a new supplier has been identified and evaluated.

Our or any product

or component supplier’s failure to comply with applicable regulations could cause sanctions to be imposed on us, including warning

letters, fines, injunctions, civil penalties, failure of regulatory authorities to grant marketing approval of our products, delays,

suspension or withdrawal of approvals or clearances, license revocation, seizures or recalls of products, operating restrictions and

criminal prosecutions, which could harm our business.

We cannot assure you that if we need to engage new suppliers to satisfy our business

requirements, we can locate new suppliers in compliance with regulatory requirements at a reasonable cost and in an acceptable timeframe.

Our failure to do so could have a material adverse effect on our business, financial condition and results of operations.

may be liable if the FDA or another regulatory agency concludes that we have engaged in the off-label promotion of our products.

promotional materials and training methods must comply with FDA and other applicable laws and regulations, including the prohibition

of the promotion of the off-label use of our products.

Once our products are cleared or approved for clinical use, healthcare providers

may use our products for off-label uses, as the FDA does not restrict or regulate a physician’s choice of treatment within the

practice of medicine.

However, if the FDA determines that our promotional, or training materials for sales representatives or physicians

constitute promotion of an off-label use, the FDA could request that we modify our training, promotional materials and/or subject us

to regulatory or enforcement actions, including the issuance of an untitled letter, a warning letter, injunction, seizure, disgorgement

of profits, significant penalties, including civil fines and criminal penalties.

Other federal, state or foreign governmental authorities

also might take action if they consider our promotion, reimbursement or training materials to constitute promotion of an off-label use,

which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement.

In those possible events, our reputation could be damaged, and adoption of the products would be impaired.

products may be subject to recalls after receiving FDA or foreign approval or clearance or cause or contribute to a death or a serious

injury or malfunction in certain ways prompting voluntary corrective actions or agency enforcement actions, which could divert managerial

and financial resources, harm our reputation, and adversely affect our business.

FDA and similar foreign governmental authorities have the authority to require the recall of our products because of any failure to comply

with applicable laws and regulations, or defects in design or manufacture, or if there is a reasonable likelihood our products might

cause or contribute to a death or a serious injury or malfunction.

A government mandated or voluntary product recall by us could occur

because of, for example, component failures, device malfunctions or other adverse events, such as serious injuries or deaths, or quality-related

issues, such as manufacturing errors or design or labeling defects.

Any future recalls of our products could divert managerial and financial

resources, harm our reputation, and adversely affect our business.

we initiate a correction or removal for one of our devices to reduce a risk to health posed by the device, we would be required to submit

a publicly available Correction and Removal report to the FDA and, in many cases, similar reports to other regulatory agencies.

report could be classified by the FDA as a device recall which could lead to increased scrutiny by the FDA, other international regulatory

agencies and our customers regarding the quality and safety of our devices.

Furthermore, the submission of these reports has been and

could be used by competitors against us in competitive situations and cause customers to delay purchase decisions or cancel orders and

would harm our reputation.

addition, we will be subject to medical device reporting regulations that will require us to report to the FDA or similar foreign governmental

authorities if one of our products may have caused or contributed to a death or serious injury or if we become aware that it has malfunctioned

in a way that would likely cause or contribute to a death or serious injury if the malfunction recurred.

Failures to properly identify

reportable events or to file timely reports, as well as failure to address each of the observations to the FDA’s satisfaction,

can subject us to sanctions and penalties, including warning letters and recalls.

Physicians, hospitals, and other healthcare providers

may make similar reports to regulatory authorities.

Any such reports may trigger an investigation by the FDA or similar foreign regulatory

bodies, which could divert managerial and financial resources, harm our reputation, and have a material adverse effect on our business,

financial condition and results of operations.

Any adverse event involving our products also could result in future voluntary corrective

actions, such as recalls or customer notifications, or agency action, such as inspection or enforcement action.

Any corrective action,

whether voluntary or involuntary, as well as defending ourselves in a lawsuit, would require our time and capital, distract management

from operating our business and may harm our reputation and have a material adverse effect on our business, financial condition, and

results of operations.

or regulatory reforms may make it more difficult and costly for us to obtain regulatory clearance or approval of any future products

and to manufacture, market and distribute our products after clearance or approval is obtained.

time to time, legislation is drafted and introduced in Congress that could significantly change the statutory provisions governing the

regulatory approval, manufacture and marketing of regulated products or the reimbursement thereof.

In addition, the FDA may change its

clearance and approval policies, adopt additional regulations or revise existing regulations, or take other actions, which may prevent

or delay approval or clearance of our future products under development or impact our ability to modify our currently cleared products

on a timely basis.

Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen

review times of planned or future products.

It is impossible to predict whether legislative changes will be enacted, or FDA regulations,

guidance or interpretations changed, and what the impact of such changes, if any, may be.

regulations and guidance are often revised or reinterpreted by the FDA in ways that may significantly affect our business and our products.

Any new statutes, regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review

times of any future products or make it more difficult to obtain clearance or approval for, manufacture, market or distribute our products.

We cannot determine what effect changes in regulations, statutes, legal interpretation or policies, when and if promulgated, enacted

or adopted may have on our business in the future.

Such changes could, among other things, require additional testing prior to obtaining

clearance or approval;

changes to manufacturing methods;

recall, replacement or discontinuance of our products;

or additional record keeping.

Any change in the laws or regulations that govern

the clearance and approval processes relating to our current, planned and future products could make it more difficult and costly to obtain

clearance or approval for new products or to produce, market and distribute existing products.

Significant delays in receiving clearance

or approval or the failure to receive clearance or approval for any new products would have an adverse effect on our ability to expand

our business.

If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or

if we are not able to maintain regulatory compliance, we may lose any marketing clearance that we may have obtained and we may not achieve

or sustain profitability.

Risks Related to Our Intellectual Property

We depend on intellectual property licensed

from Toray, and any dispute over the license would significantly harm our business.

We are dependent on the intellectual property

licensed from Toray.

Disputes may arise between us and Toray regarding intellectual property subject to the New Toray License Agreement.

If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements

on acceptable terms or are insufficient to provide us the necessary rights to use the intellectual property, we may be unable to successfully

develop and launch our Symphony platform and our other product candidates.

If we or Toray fail to adequately protect this intellectual

property, our ability to launch our products in the market could be limited.

For so long as we are dependent on the intellectual property

covered by the New Toray License Agreement for the pursuit of our business, any such disputes relating to the New Toray License Agreement

or failure to protect the intellectual property could threaten our viability.

We will depend primarily on Toray to file,

prosecute, maintain, defend and enforce intellectual property that we license from it and that is material to our business.

The key underlying intellectual property relating

to our Symphony platform is owned by Toray.

Under the New Toray License Agreement, Toray generally has the right to file, prosecute, maintain

and defend the intellectual property we have licensed from Toray.

If Toray fails to conduct these activities for intellectual property

protection covering any of our product candidates, our ability to develop and launch those product candidates may be adversely affected

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

In addition, pursuant to the terms of

the New Toray License Agreement, Toray generally has the right to control the enforcement of our licensed intellectual property and the

defense of any claims asserting the invalidity of that intellectual property.

We cannot be certain that Toray will allocate sufficient

resources to and otherwise prioritize the enforcement of such intellectual property or the defense of such claims to protect our interests

in the licensed intellectual property.

In the absence of action by Toray, we may be unable to protect and enforce the proprietary rights

on which our business relies.

Even if we are not a party to these legal actions, an adverse outcome could harm our business because it

might prevent or impede us from continuing to use the licensed intellectual property that we need to operate our business or from realizing

the full commercial benefit contemplated by the agreement.

In addition, even if we take control of the prosecution of licensed intellectual

property and related applications, enforcement of licensed intellectual property, or defense of claims asserting the invalidity of that

intellectual property, we may still be adversely affected or prejudiced by actions or inactions of Toray and its counsel that took place

prior to or after our assuming control, and we cannot ensure the cooperation of Toray in any such action.

Furthermore, if we take action

to protect, enforce or defend the licensed intellectual property, we may incur significant costs and the attention of our management may

be diverted from our normal business operations.

As a result, our business, results of operations and financial condition could be materially

and adversely affected.

We and Toray may be unable to protect or

enforce the intellectual property rights licensed to us, which could impair our competitive position.

In order for our business to be viable and to

compete effectively, the proprietary rights with respect to the technologies and intellectual property used in our products must be developed

and maintained.

Toray relies primarily on patent protection and trade secrets to protect its technology and intellectual property rights.

There are significant risks associated with Toray’s ability (or our ability, in the absence of action by Toray) to protect the intellectual

property licensed to us, including:

pending intellectual property applications may not be approved or may take longer than expected to result in approval in one or more of the countries in which we operate;

Toray’s intellectual property rights may not provide meaningful protection;

other companies may challenge the validity or extent of Toray’s patents and other proprietary intellectual property rights through litigation, oppositions and other proceedings.

or additional record

change in the laws or regulations that govern the clearance and approval processes relating to our current, planned and future products

could make it more difficult and costly to obtain clearance or approval for new products or to produce, market and distribute existing

Significant delays in receiving clearance or approval or the failure to receive clearance or approval for any new products

would have an adverse effect on our ability to expand our business.

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

or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing clearance

that we may have obtained and we may not achieve or sustain profitability.

Related to Our Intellectual Property

depend on intellectual property licensed from Toray, and any dispute over the license would significantly harm our business.

are dependent on the intellectual property licensed from Toray.

Disputes may arise between us and Toray regarding intellectual property

subject to our license agreement with Toray.

If disputes over intellectual property that we have licensed prevent or impair our ability

to maintain our current licensing arrangements on acceptable terms or are insufficient to provide us the necessary rights to use the

intellectual property, we may be unable to successfully develop and launch our Symphony platform and our other product candidates.

we or Toray fail to adequately protect this intellectual property, our ability to launch our products in the market could be limited.

For so long as we are dependent on the intellectual property covered by the license agreement for the pursuit of our business, any such

disputes relating to the license agreement or failure to protect the intellectual property could threaten our viability.

will depend primarily on Toray to file, prosecute, maintain, defend and enforce intellectual property that we license from it and that

is material to our business.

key underlying intellectual property relating to our Symphony platform is owned by Toray.

Under our license agreement with Toray, Toray

generally has the right to file, prosecute, maintain and defend the intellectual property we have licensed from Toray.

If Toray fails

to conduct these activities for intellectual property protection covering any of our product candidates, our ability to develop and launch

those product candidates may be adversely affected and we may not be able to prevent competitors from making, using or selling competing

In addition, pursuant to the terms of the license agreement, Toray generally has the right to control the enforcement of our

licensed intellectual property and the defense of any claims asserting the invalidity of that intellectual property.

We cannot be certain

that Toray will allocate sufficient resources to and otherwise prioritize the enforcement of such intellectual property or the defense

of such claims to protect our interests in the licensed intellectual property.

In the absence of action by Toray, we may be unable to

protect and enforce the proprietary rights on which our business relies.

Even if we are not a party to these legal actions, an adverse

outcome could harm our business because it might prevent or impede us from continuing to use the licensed intellectual property that

we need to operate our business or from realizing the full commercial benefit contemplated by the agreement.

In addition, even if we

take control of the prosecution of licensed intellectual property and related applications, enforcement of licensed intellectual property,

or defense of claims asserting the invalidity of that intellectual property, we may still be adversely affected or prejudiced by actions

or inactions of Toray and its counsel that took place prior to or after our assuming control, and we cannot ensure the cooperation of

Toray in any such action.

Furthermore, if we take action to protect, enforce or defend the licensed intellectual property, we may incur

significant costs and the attention of our management may be diverted from our normal business operations.

As a result, our business,

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

and Toray may be unable to protect or enforce the intellectual property rights licensed to us, which could impair our competitive position.

order for our business to be viable and to compete effectively, the proprietary rights with respect to the technologies and intellectual

property used in our products must be developed and maintained.

Toray relies primarily on patent protection and trade secrets to protect

its technology and intellectual property rights.

There are significant risks associated with Toray’s ability (or our ability, in

the absence of action by Toray) to protect the intellectual property licensed to us, including:

intellectual property applications may not be approved or may take longer than expected to result in approval in one or more of the

countries in which we operate;

intellectual property rights may not provide meaningful protection;

companies may challenge the validity or extent of Toray’s patents and other proprietary intellectual property rights through

litigation, oppositions and other proceedings.

These proceedings can be protracted as well as unpredictable;

other companies may have independently developed (or may in the future independently develop) similar or alternative technologies, may duplicate Toray’s technologies or may design their technologies around Toray’s technologies;

enforcement of intellectual property rights is complex, uncertain and expensive, and may be subject to lengthy delays.

In the event we take control of any such action under the New Toray License Agreement, our ability to enforce our intellectual property protection could be limited by our financial resources;

the other risks described in “— Risks Related to Our Intellectual Property.”

If any of Toray’s patents or other intellectual

property rights fail to protect the technology licensed by us, it would make it easier for our competitors to offer similar products.

Any inability on Toray’s part (or on our part, in the absence of action by Toray) to adequately protect its intellectual property

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

We and/or Toray may be subject to claims

alleging the violation of the intellectual property rights of others.

We may face significant expense and liability

as a result of litigation or other proceedings relating to intellectual property rights of others.

In the event that another party has

intellectual property protection relating to an invention or technology licensed by us from Toray, we and/or Toray may be required to

participate in an interference proceeding declared by the regulatory authorities to determine priority of invention, which could result

in substantial uncertainties and costs for us, even if the eventual outcome was favorable to us.

We and/or Toray also could be required

to participate in interference proceedings involving intellectual property of another entity.

An adverse outcome in an interference proceeding

could require us and/or Toray to cease using the technology, to substantially modify it or to license rights from prevailing third parties,

which could delay or prevent the launch of our products in the market or adversely affect our profitability.

The cost to us of any intellectual property litigation

or other proceeding relating the intellectual property licensed by us from Toray, even if resolved in our favor, could be substantial,

especially given our early stage of development.

A third party may claim that we and/or Toray are using inventions claimed by their intellectual

property and may go to court to stop us and/or Toray from engaging in our normal operations and activities, such as research, development

and the sale of any future products.

Such lawsuits are expensive and would consume significant time and other resources.

There is a risk

that a court will decide that we and/or Toray are infringing the third party’s intellectual property and will order us to stop the

activities claimed by the intellectual property.

In addition, there is a risk that a court will order us and/or Toray to pay the other

party damages for having infringed their intellectual property.

Moreover, there is no guarantee that any prevailing intellectual property

owner would offer us a license so that we could continue to engage in activities claimed by the intellectual property, or that such a

license, if made available to us, could be acquired on commercially acceptable terms.

We and Toray may be subject to claims challenging

the invention of the intellectual property that we license from Toray.

We and Toray may be subject to claims that former

employees, collaborators or other third parties have an interest in intellectual property as an inventor or co-inventor.

we and Toray may have inventorship disputes arising from conflicting obligations of consultants or others who are involved in developing

our product candidates.

Litigation may be necessary to defend against these and other claims challenging inventorship.

If we and Toray

fail in defending any such claims, in addition to paying monetary damages, we and Toray may lose valuable intellectual property rights,

such as exclusive ownership of, or right to use, valuable intellectual property.

Such an outcome could have a material adverse effect

on our business.

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

to management and other employees.

As a result, it is unclear whether and, if so, to what extent employees of ours and Toray may be able

to claim compensation with respect to our future revenue.

We may receive less revenue from future products if any of our or Toray’s

employees successfully claim compensation for their work in developing our intellectual property, which in turn could impact our future

profitability.

Risks Related to Our Industry

We face intense competition in the diagnostic

testing market, particularly in the IL-6 space, and as a result we may be unable to effectively compete in our industry.

We expect to compete directly and primarily with

large medical device companies.

These large companies have most of the diagnostic testing business and strong research and development

Their dominant market position and significant control over markets could significantly limit our ability to introduce our Symphony

platform or effectively market and generate sales of our products.

We have not yet entered the revenue stage and

most of our competitors have long histories and strong reputations within the industry.

They have significantly greater brand recognition,

financial and human resources than we do.

They also have more experience and capabilities in researching and developing testing devices,

obtaining and maintaining regulatory clearances and other requirements, manufacturing and marketing those products than we do.

a significant risk that we may be unable to overcome the advantages held by our competition, and our inability to do so could lead to

the failure of our business.

Competition in the diagnostic testing markets

is intense, which can lead to, among other things, price reductions, longer selling cycles, lower product margins, loss of market share

and additional working capital requirements.

To succeed, we must, among other critical matters, gain consumer acceptance for our products,

technical solutions, prices and response time, or a combination of these factors.

If our competitors offer significant discounts on certain

products, we may need to lower our prices or offer other favorable terms in order to compete successfully.

Moreover, any broad-based changes

to our prices and pricing policies could make it difficult to generate revenues or cause our revenues, if established, to decline.

if our competitors develop and commercialize products that are more desirable than the products that we may develop, we may not convince

customers to use our products.

Any such changes would likely reduce our commercial opportunity and revenue potential and could materially

adversely impact our operating results.

If we or Toray fail to respond quickly to

technological developments, our products may become uncompetitive and obsolete.

The diagnostic testing market may experience rapid

technology developments, changes in industry standards, changes in customer requirements and frequent new product introductions and improvements.

If we or Toray are unable to respond to these developments, we may lose competitive position, and our products or technology may become

uncompetitive or obsolete, causing our business and prospects to suffer.

In order to compete, we and Toray may have to develop, license

or acquire new technology on a schedule that keeps pace with technological developments and the requirements for products addressing a

broad spectrum and designers and designer expertise in our industries.

Risks Related to Ownership of Our Common Stock

We could issue “blank check”

preferred stock without stockholder approval with the effect of diluting interests of then-current stockholders and impairing their voting

rights, and provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable.

Our Certificate of Incorporation provides for

the authorization to issue up to 5,000,000 shares of “blank check” preferred stock with designations, rights and preferences

as may be determined from time to time by our Board of Directors.

Our Board of Directors is empowered, without stockholder approval, to

issue one or more series of preferred stock with dividend, liquidation, conversion, voting or other rights which could dilute the interest

of, or impair the voting power of, our common stockholders.

The issuance of a series of preferred stock could be used as a method of discouraging,

delaying or preventing a change in control.

For example, it would be possible for our Board of Directors to issue preferred stock with

voting or other rights or preferences that could impede the success of any attempt to change control of our Company.

In addition, advanced

notice is required prior to stockholder proposals, which might further delay a change of control.

Shares eligible for future sale may adversely

affect the market for our common stock.

The price of our common stock could decline if

there are substantial sales of our common stock, particularly sales by our directors, executive officers, employees, and significant stockholders,

companies may have independently developed (or may in the future independently develop) similar or alternative technologies, may

duplicate Toray’s technologies or may design their technologies around Toray’s technologies;

of intellectual property rights is complex, uncertain and expensive, and may be subject to lengthy delays.

In the event we take control

of any such action under the our license agreement with Toray, our ability to enforce our intellectual property protection could

be limited by our financial resources;

other risks described in “— Risks Related to Our Intellectual Property.”

any of Toray’s patents or other intellectual property rights fail to protect the technology licensed by us, it would make it easier

for our competitors to offer similar products.

Any inability on Toray’s part (or on our part, in the absence of action by Toray)

to adequately protect its intellectual property may have a material adverse effect on our business, financial condition and results of

In addition, the patents we rely on are generally set to expire within the next five years, which could have a material impact

on the future of our products.

and/or Toray may be subject to claims alleging the violation of the intellectual property rights of others.

may face significant expense and liability as a result of litigation or other proceedings relating to intellectual property rights of

In the event that another party has intellectual property protection relating to an invention or technology licensed by us from

Toray, we and/or Toray may be required to participate in an interference proceeding declared by the regulatory authorities to determine

priority of invention, which could result in substantial uncertainties and costs for us, even if the eventual outcome was favorable to

We and/or Toray also could be required to participate in interference proceedings involving intellectual property of another entity.

An adverse outcome in an interference proceeding could require us and/or Toray to cease using the technology, to substantially modify

it or to license rights from prevailing third parties, which could delay or prevent the launch of our products in the market or adversely

affect our profitability.

cost to us of any intellectual property litigation or other proceeding relating the intellectual property licensed by us from Toray,

even if resolved in our favor, could be substantial, especially given our early stage of development.

A third party may claim that we

and/or Toray are using inventions claimed by their intellectual property and may go to court to stop us and/or Toray from engaging in

our normal operations and activities, such as research, development and the sale of any future products.

Such lawsuits are expensive

and would consume significant time and other resources.

There is a risk that a court will decide that we and/or Toray are infringing

the third party’s intellectual property and will order us to stop the activities claimed by the intellectual property.

there is a risk that a court will order us and/or Toray to pay the other party damages for having infringed their intellectual property.

Moreover, there is no guarantee that any prevailing intellectual property owner would offer us a license so that we could continue to

engage in activities claimed by the intellectual property, or that such a license, if made available to us, could be acquired on commercially

acceptable terms.

and Toray may be subject to claims challenging the invention of the intellectual property that we license from Toray.

and Toray may be subject to claims that former employees, collaborators or other third parties have an interest in intellectual property

as an inventor or co-inventor.

For example, we and Toray may have inventorship disputes arising from conflicting obligations of consultants

or others who are involved in developing our product candidates.

Litigation may be necessary to defend against these and other claims

challenging inventorship.

If we and Toray fail in defending any such claims, in addition to paying monetary damages, we and Toray may

lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property.

outcome could have a material adverse effect on our business.

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

could result in substantial costs and be a distraction to management and other employees.

As a result, it is unclear whether and, if

so, to what extent employees of ours and Toray may be able to claim compensation with respect to our future revenue.

We may receive less

revenue from future products if any of our or Toray’s employees successfully claim compensation for their work in developing our

intellectual property, which in turn could impact our future profitability.

Related to Our Industry

face intense competition in the diagnostic testing market, particularly in the IL-6 space, and as a result we may be unable to effectively

compete in our industry.

expect to compete directly and primarily with large medical device companies.

These large companies have most of the diagnostic testing

business and strong research and development capacity.

Their dominant market position and significant control over markets could significantly

limit our ability to introduce our Symphony platform or effectively market and generate sales of our products.

have not yet entered the revenue stage and most of our competitors have long histories and strong reputations within the industry.

have significantly greater brand recognition, financial and human resources than we do.

They also have more experience and capabilities

in researching and developing testing devices, obtaining and maintaining regulatory clearances and other requirements, manufacturing

and marketing those products than we do.

There is a significant risk that we may be unable to overcome the advantages held by our competition,

and our inability to do so could lead to the failure of our business.

in the diagnostic testing markets is intense, which can lead to, among other things, price reductions, longer selling cycles, lower product

margins, loss of market share and additional working capital requirements.

To succeed, we must, among other critical matters, gain consumer

acceptance for our products, technical solutions, prices and response time, or a combination of these factors.

If our competitors offer

significant discounts on certain products, we may need to lower our prices or offer other favorable terms in order to compete successfully.

Moreover, any broad-based changes to our prices and pricing policies could make it difficult to generate revenues or cause our revenues,

if established, to decline.

Moreover, if our competitors develop and commercialize products that are more desirable than the products

that we may develop, we may not convince customers to use our products.

Any such changes would likely reduce our commercial opportunity

and revenue potential and could materially adversely impact our operating results.

we or Toray fail to respond quickly to technological developments, our products may become uncompetitive and obsolete.

diagnostic testing market may experience rapid technology developments, changes in industry standards, changes in customer requirements

and frequent new product introductions and improvements.

If we or Toray are unable to respond to these developments, we may lose competitive

position, and our products or technology may become uncompetitive or obsolete, causing our business and prospects to suffer.

to compete, we and Toray may have to develop, license or acquire new technology on a schedule that keeps pace with technological developments

and the requirements for products addressing a broad spectrum and designers and designer expertise in our industries.

Related to Ownership of Our Common Stock

of substantial amounts of our securities in the public market could depress the market price of our common stock.

common stock is listed for trading on the Nasdaq Capital Market.

If our stockholders sell substantial amounts of our common stock in

the public market, including the shares of common stock issuable upon the exercise of the Class C Warrants and Class D Warrants issued

in the public offering that we consummated in June 2024, or the market perceives that such sales may occur, the market price of our securities

could fall and we may be unable to sell our securities in the future.

could issue “blank check” preferred stock without stockholder approval with the effect of diluting interests of then-current

stockholders and impairing their voting rights, and provisions in our charter documents and under Delaware law could discourage a takeover

that stockholders may consider favorable.

Certificate of Incorporation provides for the authorization to issue up to 5,000,000 shares of “blank check” preferred stock

with designations, rights and preferences as may be determined from time to time by our Board of Directors.

Our Board of Directors is

empowered, without stockholder approval, to issue one or more series of preferred stock with dividend, liquidation, conversion, voting

or other rights which could dilute the interest of, or impair the voting power of, our common stockholders.

The issuance of a series

of preferred stock could be used as a method of discouraging, delaying or preventing a change in control.

For example, it would be possible

for our Board of Directors to issue preferred stock with voting or other rights or preferences that could impede the success of any attempt

to change control of our Company.

In addition, advanced notice is required prior to stockholder proposals, which might further delay

a change of control.

eligible for future sale may adversely affect the market for our common stock.

price of our common stock could decline if there are substantial sales of our common stock, particularly sales by our significant stockholders,

or when there is a large number of shares of our common stock available for sale.

Our existing stockholders (including the holders

of our preferred stock and warrants) may be eligible to sell all or some of their shares of common stock by means of ordinary brokerage

transactions in the open market, subject to the limitations of Rule 144, promulgated under the Securities Act.

In general, under Rule

144 as currently in effect, once we have been subject to public company reporting requirements for at least 90 days, a person who

is not deemed to have been one of our affiliates for purposes of the Securities Act at any time during the 90 days preceding a sale

and who has beneficially owned the shares proposed to be sold for at least six months, including the holding period of any prior owner

other than our affiliates, is entitled to sell those shares without complying with the manner of sale, volume limitation or notice provisions

of Rule 144, subject to compliance with the public information requirements of Rule 144.

If such a person has beneficially owned the shares

proposed to be sold for at least one year, including the holding period of any prior owner other than our affiliates, then that person

is entitled to sell those shares without complying with any of the requirements of Rule 144.

Our affiliates and other persons selling

shares on behalf of our affiliates also are entitled to sell as long as they comply with Rule 144’s manner of sale, volume limitation

and notice provisions, in addition to the provisions applicable to non-affiliates described above.

The market price of the shares of our common stock

could decline as a result of the sale of a substantial number of our shares of common stock in the public market or the perception in

the market that the holders of a large number of shares intend to sell their shares.

We do not currently intend to pay dividends

on our common stock in the foreseeable future, and consequently, your ability to achieve a return on your investment will depend on appreciation

in the price of our common stock.

We do not anticipate paying any cash dividends

to holders of our common stock in the foreseeable future.

Consequently, investors must rely on sales of their common stock after price

appreciation, which may never occur, as the only way to realize any future gains on their investments.

There is no guarantee that shares

of our common stock will appreciate in value or even maintain the price at which our stockholders have purchased their shares.

If securities industry analysts do not publish

research reports on us, or publish unfavorable reports on us, then the market price and market trading volume of our common stock could

be negatively affected.

Any trading market for our common stock will be

influenced in part by any research reports that securities industry analysts publish about us.

We do not currently have and may never

obtain research coverage by securities industry analysts.

If no securities industry analysts commence coverage of us, the market price

and market trading volume of our common stock could be negatively affected.

In the event we are covered by analysts, and one or more of

such analysts downgrade our securities, or otherwise reports on us unfavorably, or discontinues coverage or us, the market price and market

existing stockholders (including the holders of warrants) may be eligible to sell all or some of their shares of common stock by means

of ordinary brokerage transactions in the open market, subject to the limitations of Rule 144, promulgated under the Securities Act.

In general, under Rule 144 as currently in effect, once we have been subject to public company reporting requirements for at least 90 days,

a person who is not deemed to have been one of our affiliates for purposes of the Securities Act at any time during the 90 days

preceding a sale and who has beneficially owned the shares proposed to be sold for at least six months, including the holding period

of any prior owner other than our affiliates, is entitled to sell those shares without complying with the manner of sale, volume limitation

or notice provisions of Rule 144, subject to compliance with the public information requirements of Rule 144.

If such a person has beneficially

owned the shares proposed to be sold for at least one year, including the holding period of any prior owner other than our affiliates,

then that person is entitled to sell those shares without complying with any of the requirements of Rule 144.

Our affiliates and other

persons selling shares on behalf of our affiliates also are entitled to sell as long as they comply with Rule 144’s manner of sale,

volume limitation and notice provisions, in addition to the provisions applicable to non-affiliates described above.

market price of the shares of our common stock could decline as a result of the sale of a substantial number of our shares of common

stock in the public market or the perception in the market that the holders of a large number of shares intend to sell their shares.

do not currently intend to pay dividends on our common stock in the foreseeable future, and consequently, your ability to achieve a return

on your investment will depend on appreciation in the price of our common stock.

do not anticipate paying any cash dividends to holders of our common stock in the foreseeable future.

Consequently, investors must rely

on sales of their common stock after price appreciation, which may never occur, as the only way to realize any future gains on their

There is no guarantee that shares of our common stock will appreciate in value or even maintain the price at which our stockholders

have purchased their shares.

securities industry analysts do not publish research reports on us, or publish unfavorable reports on us, then the market price and market

trading volume of our common stock could be negatively affected.

As an “emerging growth company”

under applicable law, we are subject to lessened disclosure requirements, which could leave our stockholders without information or rights

available to stockholders of other public companies that are not “emerging growth companies.”

For as long as we remain an “emerging growth

company” as defined in the JOBS Act, we have elected to take advantage of certain exemptions from various reporting requirements

that are applicable to other public companies that are not “emerging growth companies” including, but not limited to:

not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act;

reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements;

exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.

We expect to take advantage of these reporting

exemptions until we are no longer an “emerging growth company.” We could be an emerging growth company for up to five years,

although circumstances could cause us to lose that status earlier.

We will remain an emerging growth company until the earlier of:

December 31, 2026, (2) the last day of the fiscal year in which we have total annual gross revenue of at least $1.235 billion, (3) the

date on which we are deemed to be a large accelerated filer, which is the end of the fiscal year in which the market value of our common

stock that is held by non-affiliates exceeds $700.0 million as of the end of our most recent second fiscal quarter, and (4) the date on

which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period.

Because of these lessened regulatory requirements,

our stockholders would be left without information or rights available to stockholders of other public companies that are not “emerging

growth companies.” In addition, we cannot predict if investors will find our common stock less attractive because we rely on these

If some investors find our common stock less attractive as a result, there may be a less active trading market for our common

stock and our stock price may suffer or be more volatile.

Because we have elected to use the extended

transition period for complying with new or revised accounting standards for an “emerging growth company” our financial statements

may not be comparable to companies that comply with public company effective dates.

We have elected to use the extended transition

period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act.

This election allows us to delay

the adoption of new or revised accounting standards that have different effective dates for public and private companies until those

standards apply to private companies.

While we are not currently delaying the implementation of any relevant accounting standards, in

the future we may avail ourselves of these rights, and as a result of this election, our financial statements may not be comparable to

companies that comply with public company effective dates.

Because our financial statements may not be comparable to companies that comply

with public company effective dates, investors may have difficulty evaluating or comparing our business, performance or prospects in

comparison to other public companies, which may have a negative impact on the value and liquidity of our common stock.

Anti-takeover provisions in our charter

documents and Delaware law could discourage, delay or prevent a change in control of our Company and may affect the trading price of our

common stock.

We are a Delaware corporation and the anti-takeover

provisions of the Delaware General Corporation Law may discourage, delay or prevent a change in control by prohibiting us from engaging

in a business combination with an interested stockholder for a period of three years after the person becomes an interested stockholder,

even if a change in control would be beneficial to our existing stockholders.

In addition, our amended and restated certificate of incorporation

and by-laws may discourage, delay or prevent a change in our management or control over us that stockholders may consider favorable.

amended and restated certificate of incorporation and bylaws will:

provide for the issuance of “blank check” preferred stock that could be issued by our Board of Directors to thwart a takeover attempt;

provide that stockholders will not be able to take action by written consent, and special meetings of stockholders may only be called by our Chief Executive Officer, our President, our Board of Directors or a majority of our stockholders;

provide that our stockholders are required to provide advance notice and additional disclosures in order to nominate individuals for election to our Board of Directors or to propose matters that can be acted upon at a stockholders’ meeting, which may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain control of our Company;

do not provide stockholders with the ability to cumulate their votes, which limits the ability of minority stockholders to elect director candidates.

These provisions could also limit the price that

investors might be willing to pay in the future for shares of our common stock, thereby depressing the market price of our common stock.

We will continue incurring increased costs

as a result of operating as a public company, and our management is now required to devote substantial time to new compliance initiatives

and corporate governance practices.

Our common stock began trading on the NASDAQ Global

Select Market in November 2021.

As a public company, and particularly after we are no longer an EGC, we are incurring and will continue

to incur significant legal, accounting and other expenses that we did not incur as a private company.

The Sarbanes-Oxley Act of 2002,

the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of the NASDAQ Global Market and other applicable

securities rules and regulations impose various requirements on public companies, including establishment and maintenance of effective

disclosure and financial controls and corporate governance practices.

These requirements result in significant legal and financial compliance

costs and make some activities more time-consuming and costly.

These rules and regulations are often subject to varying interpretations,

in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is

provided by regulatory and governing bodies.

This results in continuing uncertainty regarding compliance matters and higher costs necessitated

by ongoing revisions to disclosure and governance practices.

Failure to maintain effective internal controls

in accordance with Section 404 of the Sarbanes-Oxley Act could have material adverse effect on our business and stock price, and

our limited internal staffing may enhance the likelihood of such a controls failure.

Pursuant to SOX Section 404 we are required

to furnish a report by our management on our internal control over financial reporting in our Annual Reports on Form 10-K with the

SEC since becoming a public company, including an attestation report on internal control over financial reporting issued by our independent

registered public accounting firm.

However, while we remain an EGC, we are not be required to include an attestation report on internal

trading market for our common stock will be influenced in part by any research reports that securities industry analysts publish about

We do not currently have and may never obtain research coverage by securities industry analysts.

If no securities industry analysts

commence coverage of us, the market price and market trading volume of our common stock could be negatively affected.

In the event we

are covered by analysts, and one or more of such analysts downgrade our securities, or otherwise reports on us unfavorably, or discontinues

coverage or us, the market price and market trading volume of our common stock could be negatively affected.

an “emerging growth company” under applicable law, we are subject to lessened disclosure requirements, which could leave

our stockholders without information or rights available to stockholders of other public companies that are not “emerging growth

as long as we remain an “emerging growth company” as defined in the JOBS Act, we have elected to take advantage of certain

exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies”

including, but not limited to:

being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act;

disclosure obligations regarding executive compensation in our periodic reports and proxy statements;

from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute

payments not previously approved.

expect to take advantage of these reporting exemptions until we are no longer an “emerging growth company.” We could be an

emerging growth company for up to five years, although circumstances could cause us to lose that status earlier.

We will remain an emerging

growth company until the earlier of:

(1) December 31, 2026, (2) the last day of the fiscal year in which we have total annual gross revenue

of at least $1.235 billion, (3) the date on which we are deemed to be a large accelerated filer, which is the end of the fiscal year

in which the market value of our common stock that is held by non-affiliates exceeds $700.0 million as of the end of our most recent

second fiscal quarter, and (4) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the

prior three-year period.

of these lessened regulatory requirements, our stockholders would be left without information or rights available to stockholders of

other public companies that are not “emerging growth companies.” In addition, we cannot predict if investors will find our

common stock less attractive because we rely on these exemptions.

If some investors find our common stock less attractive as a result,

there may be a less active trading market for our common stock and our stock price may suffer or be more volatile.

we have elected to use the extended transition period for complying with new or revised accounting standards for an “emerging growth

company” our financial statements may not be comparable to companies that comply with public company effective dates.

have elected to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of

the JOBS Act.

This election allows us to delay the adoption of new or revised accounting standards that have different effective dates

for public and private companies until those standards apply to private companies.

While we are not currently delaying the implementation

of any relevant accounting standards, in the future we may avail ourselves of these rights, and as a result of this election, our financial

statements may not be comparable to companies that comply with public company effective dates.

Because our financial statements may not

be comparable to companies that comply with public company effective dates, investors may have difficulty evaluating or comparing our

business, performance or prospects in comparison to other public companies, which may have a negative impact on the value and liquidity

of our common stock.

Anti-takeover

provisions in our charter documents and Delaware law could discourage, delay or prevent a change in control of our Company and may affect

the trading price of our common stock.

are a Delaware corporation and the anti-takeover provisions of the Delaware General Corporation Law may discourage, delay or prevent

a change in control by prohibiting us from engaging in a business combination with an interested stockholder for a period of three years

after the person becomes an interested stockholder, even if a change in control would be beneficial to our existing stockholders.

addition, our amended and restated certificate of incorporation and by-laws may discourage, delay or prevent a change in our management

or control over us that stockholders may consider favorable.

Our amended and restated certificate of incorporation and bylaws will:

for the issuance of “blank check” preferred stock that could be issued by our Board of Directors to thwart a takeover

that stockholders will not be able to take action by written consent, and special meetings of stockholders may only be called by

our Chief Executive Officer, our President, our Board of Directors or a majority of our stockholders;

that our stockholders are required to provide advance notice and additional disclosures in order to nominate individuals for election

to our Board of Directors or to propose matters that can be acted upon at a stockholders’ meeting, which may discourage or

deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise

attempting to obtain control of our Company;

not provide stockholders with the ability to cumulate their votes, which limits the ability of minority stockholders to elect director

provisions could also limit the price that investors might be willing to pay in the future for shares of our common stock, thereby depressing

the market price of our common stock.

will continue incurring increased costs as a result of operating as a public company, and our management is now required to devote substantial

time to new compliance initiatives and corporate governance practices.

common stock began trading on the NASDAQ Global Select Market in November 2021.

As a public company, and particularly after we are no

longer an EGC, we are incurring and will continue to incur significant legal, accounting and other expenses that we did not incur as

a private company.

The Sarbanes-Oxley Act of 2002, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements

of the NASDAQ Global Market and other applicable securities rules and regulations impose various requirements on public companies, including

establishment and maintenance of effective disclosure and financial controls and corporate governance practices.

These requirements result

in significant legal and financial compliance costs and make some activities more time-consuming and costly.

These rules and regulations

are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in

practice may evolve over time as new guidance is provided by regulatory and governing bodies.

This results in continuing uncertainty

regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

to maintain effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act could have material adverse effect

on our business and stock price, and our limited internal staffing may enhance the likelihood of such a controls failure.

To reduce expenses,

our President and Chief Executive Officer, in addition to serving as principal executive officer, currently serves as our principal financial

and accounting officer, and we have no employees devoted on a full-time basis to our finance, accounting, legal or compliance functions,

which may substantially increase the likelihood that we will fail to successfully maintain effective internal controls over financial

reporting, or effective disclosure controls and procedures.

to SOX Section 404 we are required to furnish a report by our management on our internal control over financial reporting in

our Annual Reports on Form 10-K with the SEC since becoming a public company, including an attestation report on internal

control over financial reporting issued by our independent registered public accounting firm.

To comply with SOX Section 404, we

document and evaluate our internal control over financial reporting, which is both costly and challenging.

In this regard, we have and

will need to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess

and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate

through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal

control over financial reporting.

Despite our efforts, we may identify one or more material weaknesses, which could result in an adverse

reaction in the financial markets due to a loss of confidence in the reliability of our financial statements.

At present, our Interim

Chief Financial Officer, Frances Scally, is not an employee of ours, but instead provides services to us on a limited basis pursuant to

a scope of work agreement and master services agreement with DLA LLC, where Ms.

Scally is an employee.

We also do not presently employ

an internal legal officer.

Our lack of a directly employed principal financial and accounting officer or principal legal officer may increase

the likelihood that we will fail to successfully maintain effective internal controls over financial reporting, or effective disclosure

controls and procedures.

Our amended and restated certificate of

incorporation will provide, subject to limited exceptions, that the Court of Chancery of the State of Delaware will be the sole and exclusive

forum for certain stockholder litigation matters, which could limit our stockholders’ ability to obtain a favorable judicial forum

for disputes with us or our directors, officers, employees or stockholders.

Our amended and restated certificate of incorporation

will require, to the fullest extent permitted by law, subject to limited exceptions, that derivative actions brought in our name, actions

against directors, officers and employees for breach of fiduciary duty and other similar actions may be brought only in the Court of Chancery

in the State of Delaware and, if brought outside of Delaware, the stockholder bringing the suit will be deemed to have consented to service

of process on such stockholder’s counsel in any action brought to enforce the exclusive forum provision.

Any person or entity purchasing

or otherwise acquiring any interest in shares of our capital stock shall be deemed to have notice of and consented to the forum provisions

in our amended and restated certificate of incorporation.

Notwithstanding the foregoing, Section 27 of the

Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the Exchange Act

or the rules and regulations thereunder.

In addition, Section 22 of the Securities Act creates concurrent jurisdiction for federal and

state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder.

As a result, the exclusive forum provision will provide that the Court of Chancery and the federal district court for the District of

Delaware will have concurrent jurisdiction over any action arising under the Securities Act or the rules and regulations thereunder, and

the exclusive forum provision will not apply to suits brought to enforce any duty or liability created by the Exchange Act or the rules

and regulations thereunder or any other claim for which the federal courts have exclusive jurisdiction.

To the extent the exclusive forum

provision restricts the courts in which our stockholders may bring claims arising under the Securities Act and the rules and regulations

thereunder, there is uncertainty as to whether a court would enforce such provision.

Investors cannot waive compliance with the federal

securities laws and the rules and regulations promulgated thereunder.

This exclusive forum provision may limit a stockholder’s

ability to bring a claim in a judicial forum that it finds favorable for disputes with us or any of our directors, officers, other employees

or stockholders, which may discourage lawsuits with respect to such claims.

By requiring a stockholder to bring such a claim in the Court

of Chancery (or the federal district court for the District of Delaware, in the case of an action under the Securities Act or the rules

and regulations thereunder), the exclusive forum provision also may increase the costs to a stockholder of bringing such a claim.

Alternatively,

if a court were to find the exclusive forum provision contained in our amended and restated certificate of incorporation to be inapplicable

or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could

harm our business, operating results and financial condition.

However, while we remain an EGC, we

are not required to include an attestation report on internal control over financial reporting issued by our independent

registered public accounting firm.

To comply with SOX Section 404, we document and evaluate our internal control over financial

reporting, which is both costly and challenging.

In this regard, we have and will need to continue to dedicate internal resources,

potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over

financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are

functioning as documented and implement a continuous reporting and improvement process for internal control over financial

Despite our efforts, we may identify one or more material weaknesses (as we did in connection with the preparation of this Form 10-K, as described below), which could result in an adverse reaction in the

financial markets due to a loss of confidence in the reliability of our financial statements.

Neil Dey, our President and Chief

Executive Officer, serves as our principal financial and accounting officer, in addition to serving as our principal executive

officer, and Mr.

Dey is not a certified public accountant.

We also do not presently employ an internal legal officer.

Our lack of a

directly employed principal financial and accounting officer or principal legal officer may increase the likelihood that we will

fail to successfully maintain effective internal controls over financial reporting, or effective disclosure controls and

We recently identified a material weakness

in our internal control over financial reporting, and our business and stock price may be adversely affected if our internal control over

financial reporting is not effective.

In connection with the preparation and finalization

of this Form 10-K, our independent registered public accounting firm identified an issue with respect to the Company’s application

of provisions of the Accounting Standards Codification of the FASB related to the accounting and valuation of certain warrants.

In particular,

in June 2024, the Company issued Class C and Class D warrants that contained “reset” features that caused the exercise prices

and number of shares of Company common stock issuable upon exercise to increase following stockholder approval of such warrants in August

2024 and changes in the market price of our common stock that were measured in the period that immediately followed.

Under applicable

accounting guidance, upon reset, the Company should have recorded in its consolidated statement of operations the “deemed dividend

on warrant modification” and “net loss applicable to common stockholders,” in each case, below the presentation of net

In addition, these non-book entry line items were not included in the Company’s consolidated statement of operations for the

three and nine months ended September 30, 2024 in the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended September

As a result of the foregoing, we identified a material weakness in our internal control over financial reporting arising from

a lack of sufficient internal accounting expertise at the Company.

As previously discussed, if we fail to maintain an effective system

of internal controls or if management or our independent registered public accounting firm were to discover additional material weaknesses

in our internal controls, we may be unable to produce reliable financial reports or prevent fraud, which could harm our financial condition

and operating results, and could result in a loss of investor confidence and a decline in our stock price.

amended and restated certificate of incorporation will provide, subject to limited exceptions, that the Court of Chancery of the State

of Delaware will be the sole and exclusive forum for certain stockholder litigation matters, which could limit our stockholders’

ability to obtain a favorable judicial forum for disputes with us or our directors, officers, employees or stockholders.

amended and restated certificate of incorporation will require, to the fullest extent permitted by law, subject to limited exceptions,

that derivative actions brought in our name, actions against directors, officers and employees for breach of fiduciary duty and other

similar actions may be brought only in the Court of Chancery in the State of Delaware and, if brought outside of Delaware, the stockholder

bringing the suit will be deemed to have consented to service of process on such stockholder’s counsel in any action brought to

enforce the exclusive forum provision.

Any person or entity purchasing or otherwise acquiring any interest in shares of our capital stock

shall be deemed to have notice of and consented to the forum provisions in our amended and restated certificate of incorporation.

Notwithstanding

the foregoing, Section 27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability

created by the Exchange Act or the rules and regulations thereunder.

In addition, Section 22 of the Securities Act creates concurrent

jurisdiction for federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the

rules and regulations thereunder.

As a result, the exclusive forum provision will provide that the Court of Chancery and the federal

district court for the District of Delaware will have concurrent jurisdiction over any action arising under the Securities Act or the

rules and regulations thereunder, and the exclusive forum provision will not apply to suits brought to enforce any duty or liability

created by the Exchange Act or the rules and regulations thereunder or any other claim for which the federal courts have exclusive jurisdiction.

To the extent the exclusive forum provision restricts the courts in which our stockholders may bring claims arising under the Securities

Act and the rules and regulations thereunder, there is uncertainty as to whether a court would enforce such provision.

Investors cannot

waive compliance with the federal securities laws and the rules and regulations promulgated thereunder.

exclusive forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes

with us or any of our directors, officers, other employees or stockholders, which may discourage lawsuits with respect to such claims.

By requiring a stockholder to bring such a claim in the Court of Chancery (or the federal district court for the District of Delaware,

in the case of an action under the Securities Act or the rules and regulations thereunder), the exclusive forum provision also may increase

the costs to a stockholder of bringing such a claim.

Alternatively, if a court were to find the exclusive forum provision contained in

our amended and restated certificate of incorporation to be inapplicable or unenforceable in an action, we may incur additional costs

associated with resolving such action in other jurisdictions, which could harm our business, operating results and financial condition.

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