What changed in this filing

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Item 1A. Risk Factors

2024-03-28 compared with 2023-03-20 · 427 added, 328 removed, 651 unchanged (54% 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.

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.

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.

Additional 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 are subject to the risks associated with

new businesses.

We entered into a License Agreement with Toray

in October 2020 and 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.

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.

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.

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 may not be able to achieve significant revenues or profitability.

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

Since our inception, we have engaged primarily

in development activities.

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

inception, including a net loss of $9.3 million and $3.5 million for the years ended December 31, 2022 and 2021, respectively.

know whether or when we will become profitable.

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 substantial additional funding,

which may not be available to us on acceptable terms, or at all, and, if not so available, may require us to delay, limit, reduce or cease

our operations.

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

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

We anticipate that we will need to raise additional capital

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.

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.

Failure to obtain such additional financing could

result in delay or indefinite postponement of operations or the further development of our business with the possible loss of such properties

If adequate funds are not available or are not available on acceptable terms, we may not be able to fund our business or the

expansion thereof, take advantage of strategic acquisitions or investment opportunities or respond to competitive pressures.

Such inability

to obtain additional financing when needed could have a material adverse effect on our business, results of operations, cash flow, financial

condition and prospects.

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.

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

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

On October 25,

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

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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 April 24, 2023, we may be eligible for an additional 180 calendar days, provided that we meet the continued

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

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than $1.00 per share.

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.

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;

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.

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

The License Agreement with Toray, which

covers the license of the core technology used in our Symphony Cartridges , contains significant risks that may threaten

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

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

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and sale of such products.

We also have a nonexclusive license for the same purposes in Japan.

We have no contractual

rights to the intellectual property covered in the License Agreement other than as expressly set forth therein.

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.

(“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 License Agreement:

● 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.

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

cartridges for a three-year period ending in October 2024.

If we are unable to extend this arrangement or activate a new CMO

to produce cartridges, 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, increasing the time and cost of remediating product defects or impairing our ability

to timely scale up cartridge manufacturing.

● The license is non-assignable

and non-sublicensable (to third parties).

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

● 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 obtain market

approval for the products in the United States and the European Union by October 2023 or the License Agreement could be terminated by

Toray has the right to terminate the License Agreement or make it non-exclusive

if we do not generate commercial sales by October 2025, or by April 2027 if the lack of commercial sales is not directly attributed to

● Except with respect to Toray’s ownership of all intellectual

property rights in respect of the licensed property, 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

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.

the New Toray 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.

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 License Agreement.

You are encouraged

to read the complete text of the License Agreement, which is filed as an exhibit to this Form 10-K.

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

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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.

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

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Our future performance depends to a large

extent on the continued services of members of our current management.

In addition, we will 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.

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.

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 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.

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

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Significant raw material shortages, supplier

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

In connection with effects related to the COVID-19

pandemic, we are operating in a supply-constrained environment and are facing, and may continue to face, supply-chain shortages, inflationary

pressures, logistics challenges and manufacturing disruptions that impact our revenues, profitability, and timeliness in fulfilling customer

In addition, our 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.

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 or test

We intend to market our Symphony platform and test

cartridges following regulatory approval.

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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;

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.

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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.

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.

In addition, the changing landscape related to the

COVID-19 pandemic also could lead to delays in obtaining clinical data.

The declining number of COVID patients with respiratory deterioration

may impact our ability to meet the primary endpoint in our Symphony IL-6 Expanded Clinical Study.

We are currently working with the FDA

to expand this endpoint to better reflect the current standard of care and to make the number of study subjects more realistic in light

of the decreasing number of COVID positive subjects needed in the study.

Any failure or delay in obtaining necessary regulatory clearances

or approvals would materially adversely affect 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

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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

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.

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 LDTs may negatively impact the LDT market and thereby reduce demand for RUO products.

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

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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.

The declining number of COVID patients with respiratory

deterioration may impact our ability to meet the primary endpoint in our Symphony IL-6 Expanded Clinical Study.

We are currently working

with the FDA to expand this endpoint to better reflect the current standard of care and to make the number of study subjects more realistic

in light of the decreasing number of COVID positive subjects needed in the study.

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

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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, and results of operations.

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,

and results of operations.

As a medical device manufacturer, we will need

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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.

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

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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.

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

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licensed from Toray.

Disputes may arise between us and Toray regarding intellectual property subject to the License Agreement.

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 also could suffer.

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.

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 intellectual property relating to our Symphony

platform is owned by Toray.

Under the 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 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 us from continuing to use the licensed

intellectual property that we need to operate 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

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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

● 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.

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.

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 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.”

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

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to claim compensation with respect to our future revenue.

We may receive less revenue from future products if any of employees of Toray

or us successfully claim compensation for their work in developing our intellectual property, which in turn could impact our future profitability.

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

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As an “emerging growth company”

under applicable law, we will be 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.”

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

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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

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

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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.

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

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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

● do not provide stockholders

with the ability to cumulate their votes, which limits the ability of minority stockholders to elect director candidates.

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 incur increased costs as a result of operating as a public

company, and our management will be required to devote substantial time to new compliance initiatives and corporate governance practices.

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 will 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 may 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

This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to

disclosure and governance practices.

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 after we become a public company, including an attestation report on internal control over financial reporting issued by our independent

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 will not be required to include an attestation report on internal

However, while we remain an EGC, we are not be required to include an attestation report on internal

control over financial reporting issued by our independent registered public accounting firm.

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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

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harm our business, operating results and financial condition.

UNRESOLVED STAFF COMMENTS

We have leased two facilities in Acton, Massachusetts which will expire

in 2024 and 2027.

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