What changed in this filing

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Item 1A. Risk Factors

2024-04-10 compared with 2023-03-16 · 203 added, 269 removed, 837 unchanged (36% of the section changed)

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result in our stockholders losing some or all of their investment in us.

We do not have any credit facilities as a source of future funds,

and there can be no assurance that we will be able to raise sufficient additional capital on acceptable terms, or at all.

additional capital through a combination of private and public equity offerings, debt financing and strategic collaborations.

raise additional funds through the issuance of equity or convertible debt securities, the percentage ownership of our stockholders

could be significantly diluted, and these newly issued securities may have rights, preferences or privileges senior to those of existing

stockholders.

Debt financing, if obtained, may involve agreements that include covenants limiting or restricting our ability to take

specific actions, such as incurring additional debt, could increase our expenses and require that our assets secure such debt.

any debt we incur must be repaid regardless of our operating results.

We do not have any credit facilities as a source of future funds, and

there can be no assurance that we will be able to raise sufficient additional capital on acceptable terms, or at all.

We may seek additional

capital through a combination of private and public equity offerings, debt financing and strategic collaborations.

If we raise additional

funds through the issuance of equity or convertible debt securities, the percentage ownership of our stockholders could be significantly

diluted, and these newly issued securities may have rights, preferences or privileges senior to those of existing stockholders.

Debt financing,

if obtained, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring

additional debt, could increase our expenses and require that our assets secure such debt.

Moreover, any debt we incur must be repaid

regardless of our operating results.

We are an early, commercial-stage company with a limited operating

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as well as launching new products, we may not be able to effectively:

adoption of our current and future products and services;

and retain customers for our products and services;

appropriate levels of customer training and support for our products and services;

an effective marketing strategy to promote awareness of our products and services;

manufacture and commercialize new products or achieve an acceptable return on our manufacturing or research and development efforts and

and adapt to changes in our market or predict future performance;

● accommodate

customer expectations and demands with respect to our products and services;

our market share by marketing and selling our products and services to new and additional market segments;

and develop strategic relationships with vendors and manufacturers to acquire necessary materials for the production of our existing

or future products;

or scale our manufacturing activities to meet potential demand at a reasonable cost;

infringement and misappropriation of third-party intellectual property;

any necessary licenses to third-party intellectual property on commercially reasonable terms;

valid and enforceable patents that give us a competitive advantage;

our proprietary technology;

retain and motivate qualified personnel.

drive adoption of our current and future products and services;

attract and retain customers for our products and services;

provide appropriate levels of customer training and support for our products and services;

implement an effective marketing strategy to promote awareness of our products and services;

develop, manufacture and commercialize new products or achieve an acceptable return on our manufacturing or research and development efforts and expenses;

anticipate and adapt to changes in our market or predict future performance;

accommodate customer expectations and demands with respect to our products and services;

grow our market share by marketing and selling our products and services to new and additional market segments;

maintain and develop strategic relationships with vendors and manufacturers to acquire necessary materials for the production of our existing or future products;

adapt or scale our manufacturing activities to meet potential demand at a reasonable cost;

avoid infringement and misappropriation of third-party intellectual property;

obtain any necessary licenses to third-party intellectual property on commercially reasonable terms;

obtain valid and enforceable patents that give us a competitive advantage;

protect our proprietary technology;

attract, retain and motivate qualified personnel.

If our tSMS sequencing instruments or sequencing services fail

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Our research and development efforts are complex and require us to incur substantial expenses.

not be able to develop and commercialize new products, or achieve an acceptable return, if any, on our research and development efforts

and expenses.

be able to develop and commercialize new products, or achieve an acceptable return, if any, on our research and development efforts and

There can also be no assurance that we will be able to develop and manufacture future sequencing instruments and applications

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The introduction of new products may also have a negative impact

on our revenue in the near-term as our current and future customers may delay or cancel orders of existing sequencing instruments or

sequencing services in anticipation of new products and we may also be pressured to decrease prices for our existing products.

we could experience difficulty in managing or forecasting customer reactions, purchasing decisions or transition requirements with respect

to newly-launched sequencing instruments or sequencing services.

We could incur significant costs in completing the transitions, including

costs of inventory write-downs of our products, as current or future customers transition to the new products.

If we do not successfully

manage these product transitions, our business, reputation and financial condition may be materially and adversely affected.

The coronavirus (COVID-19) pandemic has disrupted our business

and could negatively impact our financial condition.

The unprecedented global outbreak of the novel coronavirus ( COVID-19 )

that began in the first quarter of 2020 had a significant impact on certain aspects of our business, including strains on our supply chain

due and the significant reductions of research grants made available during the pandemic, particularly for sequencing research and development

that is not dedicated to COVID-19 related disorders.

The initial target market for our instruments and research services has been the

life sciences research and development market where we provide solutions for a variety of applications, including biomarker discovery

and diagnostic assay developments.

This market, which includes laboratories associated with universities, scientific research centers,

government institutions, and biotechnology and pharmaceutical companies, often depends on research grants and donations for a significant

portion of their funding, and the demand for our products in this customer segment has been affected by a reduction in their non-COVID-19

related research grants and may continue to be so affected in the future.

While our operations have generally stabilized since the peak

of the pandemic, our operations may continue to be impacted by any continuing effects of COVID-19 , including resurgences

and variants of COVID-19 or outbreaks of any new viruses or contagions.

The full extent to which the COVID-19 pandemic impacts

our business and financial condition will largely depend on future developments, which are highly uncertain and cannot be predicted, including

new information which may emerge concerning the severity of the pandemic, emergence of variants and the actions necessary to contain COVID-19

or treat its impact.

on our revenue in the near-term as our current and future customers may delay or cancel orders of existing sequencing instruments or sequencing

services in anticipation of new products and we may also be pressured to decrease prices for our existing products.

Further, we could

experience difficulty in managing or forecasting customer reactions, purchasing decisions or transition requirements with respect to newly-launched

sequencing instruments or sequencing services.

We could incur significant costs in completing the transitions, including costs of inventory

write-downs of our products, as current or future customers transition to the new products.

If we do not successfully manage these product

transitions, our business, reputation and financial condition may be materially and adversely affected.

Our future capital needs are uncertain, and we may need to raise

additional funds to support those needs.

We believe our cash on hand and cash generated from commercial sales

and research activity will enable us to fund our operations for at least 24 months.

However, we expect to seek significant future

financing, namely to:

our sales and marketing efforts to further commercialize our products and services;

additional personnel;

operational, financial and management information systems;

increased costs as a result of operating as a public company;

additional laboratory space to accommodate expanded operations and increased human resources;

our research and development efforts to improve our product offerings and to successfully launch new products;

into collaboration agreements, if any, or in-license other products and technologies;

FDA approval to market our existing products or new products that would be utilized for diagnostic purposes.

To date, we have relied primarily on private debt

and equity financing to carry on our business as well as modest revenues generated from the sales of products and services.

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.

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.

We anticipate that we will need to raise additional

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

We currently do not have any contracts or commitments

for additional financing.

However, we expect to seek significant future financing, namely to:

expand our sales and marketing efforts to further commercialize our products and services;

hire additional personnel;

add operational, financial and management information systems;

expand our research and development efforts to improve our product offerings and to successfully launch new products;

enter into collaboration agreements, if any, or in-license other products and technologies;

seek FDA approval to market our existing products or new products that would be utilized for diagnostic purposes.

Our future funding requirements will depend on many factors, including:

acceptance of our products;

cost and timing of establishing additional sales, marketing and distribution capabilities;

cost of our research and development activities;

success of our existing distribution and marketing arrangements and our ability to enter additional arrangements in the future;

effect of competing technological and market developments.

market acceptance of our products;

the cost and timing of establishing additional sales, marketing and distribution capabilities;

the cost of our research and development activities;

the success of our existing distribution and marketing arrangements and our ability to enter additional arrangements in the future;

the effect of competing technological and market developments.

We cannot assure you that we will be able to obtain additional funds

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resulting from factors beyond our control.

If our suppliers are unable or fail to fulfill their obligations to us for any reason, we

may not be able to manufacture our instruments or reagents and satisfy customer demand or our obligations under sales agreements in a

timely manner, and our business could be harmed as a result.

Our current manufacturing process is characterized by long lead times between

the placement of orders for and delivery of our products.

If we have received insufficient components to manufacture our products on

a timely basis to meet customer demand, our sales and our gross margin may be adversely affected, and our business could be materially

If we are unable to reduce our manufacturing costs and establish and maintain reliable, high-volume manufacturing suppliers as

we scale our operations, our business could be materially harmed.

If our suppliers are unable or fail to fulfill their obligations to us for any reason, we may

not be able to manufacture our instruments or reagents and satisfy customer demand or our obligations under sales agreements in a timely

manner, and our business could be harmed as a result.

Our current manufacturing process is characterized by long lead times between the

placement of orders for and delivery of our products.

If we have received insufficient components to manufacture our products on a timely

basis to meet customer demand, our sales and our gross margin may be adversely affected, and our business could be materially harmed.

If we are unable to reduce our manufacturing costs and establish and maintain reliable, high-volume manufacturing suppliers as we scale

our operations, our business could be materially harmed.

We may be unable to consistently manufacture our instruments

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competing technologies, products and/or services.

Increased competition may result in pricing pressures, which could harm our sales,

profitability or market share.

Our failure to further enhance our existing products and to introduce new products to compete effectively

could materially and adversely affect our business, financial condition or results of operations.

Increased competition may result in pricing pressures, which could harm our sales, profitability

or market share.

Our failure to further enhance our existing products and to introduce new products to compete effectively could materially

and adversely affect our business, financial condition or results of operations.

Single molecule sequencers are highly complex, have recurring

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jurisdiction could be expanded to include our products.

Even where a product is exempted from FDA clearance or approval, the FDA may

impose restrictions as to the types of customers to which we or our partners can market and sell our products.

Even where a product is exempted from FDA clearance or approval, the FDA may impose

restrictions as to the types of customers to which we or our partners can market and sell our products.

Such regulation and restrictions

may materially and adversely affect our business, financial condition and results of operations.

In the event that we fail to obtain

and maintain necessary regulatory clearances or approvals for products that we develop for clinical uses, or if clearances or approvals

for future products and indications are delayed or not issued, our commercial operations may be materially harmed.

Furthermore, even

if we are granted regulatory clearances or approvals, they may include significant limitations on the indicated uses for the product,

which may limit the market for the product.

We do not have experience in obtaining FDA approvals and no assurance can be given that we

will be able to obtain or to maintain such approvals.

Furthermore, any approvals that we may obtain can be revoked if safety or efficacy

problems develop.

In the event that we fail to obtain and

maintain necessary regulatory clearances or approvals for products that we develop for clinical uses, or if clearances or approvals for

future products and indications are delayed or not issued, our commercial operations may be materially harmed.

Furthermore, even if we

are granted regulatory clearances or approvals, they may include significant limitations on the indicated uses for the product, which

may limit the market for the product.

We do not have experience in obtaining FDA approvals and no assurance can be given that we will

be able to obtain or to maintain such approvals.

Furthermore, any approvals that we may obtain can be revoked if safety or efficacy problems

We believe we can produce accurate financial statements on a

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Factors that may cause fluctuations in our quarterly or annual operating results include, without limitation:

acceptance for our products;

ability to attract new customers;

● publications

of studies by us, competitors or third parties;

timing and success of new product introductions by us or our competitors or other changes in the competitive dynamics of our industry,

such as consolidation;

amount and timing of our costs and expenses;

market acceptance for our products;

our ability to attract new customers;

publications of studies by us, competitors or third parties;

the timing and success of new product introductions by us or our competitors or other changes in the competitive dynamics of our industry, such as consolidation;

the amount and timing of our costs and expenses;

general economic, industry and market conditions;

in our pricing policies or those of our competitors;

regulatory environment;

associated with warranty costs or unforeseen product quality issues;

hiring, training and retention of key employees, including our ability to grow our sales organization;

or other claims against us for intellectual property infringement or otherwise;

ability to obtain additional financing as necessary;

or trends in new technologies and industry standards.

changes in our pricing policies or those of our competitors;

the regulatory environment;

expenses associated with warranty costs or unforeseen product quality issues;

the hiring, training and retention of key employees, including our ability to grow our sales organization;

litigation or other claims against us for intellectual property infringement or otherwise;

our ability to obtain additional financing as necessary;

changes or trends in new technologies and industry standards.

Because of these fluctuations, it is likely that in some future quarters

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laws and regulations will be impaired, perhaps materially.

Any such impairment could materially and adversely affect our reputation,

financial condition, results of operations, cash flows and the timeliness with which we report our internal and external operating results.

Any such impairment could materially and adversely affect our reputation, financial

condition, results of operations, cash flows and the timeliness with which we report our internal and external operating results.

Security breaches and other disruptions could compromise our

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over our competitors may be diminished because of these uncertainties.

or our licensors might not have been the first to make the inventions covered by each of our pending patent applications or issued patents;

or our licensors might not have been the first to file patent applications for these inventions;

scope of the patent protection we or our licensors obtain may not be sufficiently broad to prevent others from practicing our technologies,

developing competing products, designing around our patented technologies or independently developing similar or alternative technologies;

and our licensors’ patent applications or patents have been, are and may in the future be, subject to interference, opposition

or similar administrative proceedings, which could result in those patent applications failing to issue as patents, those patents being

held invalid, or the scope of those patents being substantially reduced;

current assignee of our intellectual property may elect to forego paying maintenance fees, placing us at risk to lose the licensed IP,

or the assignee may neglect to enforce the intellectual property we license from them;

or our partners may not adequately protect our trade secrets;

may not develop additional proprietary technologies that are patentable;

patents of others may limit our freedom to operate and prevent us from commercializing our technology in accordance with our plans.

we or our licensors might not have been the first to make the inventions covered by each of our pending patent applications or issued patents;

we or our licensors might not have been the first to file patent applications for these inventions;

the scope of the patent protection we or our licensors obtain may not be sufficiently broad to prevent others from practicing our technologies, developing competing products, designing around our patented technologies or independently developing similar or alternative technologies;

our and our licensors’ patent applications or patents have been, are and may in the future be, subject to interference, opposition or similar administrative proceedings, which could result in those patent applications failing to issue as patents, those patents being held invalid, or the scope of those patents being substantially reduced;

the current assignee of our intellectual property may elect to forego paying maintenance fees, placing us at risk to lose the licensed IP, or the assignee may neglect to enforce the intellectual property we license from them;

we or our partners may not adequately protect our trade secrets;

we may not develop additional proprietary technologies that are patentable;

the patents of others may limit our freedom to operate and prevent us from commercializing our technology in accordance with our plans.

The occurrence of any of these events could impair our ability to operate

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Our ability to stop third parties from making, using, selling, offering

to sell, or importing products that infringe our intellectual property will depend in part on our success in obtaining and enforcing

patent claims that cover our technology, inventions and improvements.

to sell, or importing products that infringe our intellectual property will depend in part on our success in obtaining and enforcing patent

claims that cover our technology, inventions and improvements.

With respect to both licensed and company-owned intellectual property,

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will be commercially useful in protecting our products and the methods used to manufacture those products.

Moreover, even our issued

patents do not guarantee us the right to practice our technology in relation to the commercialization of our products.

The area of patent

and other intellectual property rights in biotechnology is an evolving one with many risks and uncertainties, and third parties may have

blocking patents that could be used to prevent us from commercializing our sequencing instruments and practicing our proprietary technology.

Our issued patent and those that may be issued in the future may be challenged, invalidated, or circumvented, which could limit our ability

Moreover, even our issued patents

do not guarantee us the right to practice our technology in relation to the commercialization of our products.

The area of patent and

other intellectual property rights in biotechnology is an evolving one with many risks and uncertainties, and third parties may have blocking

patents that could be used to prevent us from commercializing our sequencing instruments and practicing our proprietary technology.

issued patent and those that may be issued in the future may be challenged, invalidated, or circumvented, which could limit our ability

to stop competitors from marketing related products or limit the length of the term of patent protection that we may have for our technology.

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Furthermore, our competitors may independently develop similar technologies.

For these reasons, we may have

competition for our products.

Moreover, because of the extensive time required for development and testing of new sequencing instruments,

it is possible that, before any particular product can be commercialized, any related patent may expire or remain in force for only a

short period following commercialization, thereby reducing any advantage of the patent.

For these reasons, we may have competition

for our products.

Moreover, because of the extensive time required for development and testing of new sequencing instruments, it is possible

that, before any particular product can be commercialized, any related patent may expire or remain in force for only a short period following

commercialization, thereby reducing any advantage of the patent.

Moreover, the coverage claimed in a patent application can be significantly

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with whom we do not have a direct relationship.

We could in the future be subject to legal proceedings with

third parties who may claim that our products infringe or misappropriate their intellectual property rights.

We could in the future be subject to legal proceedings with third

parties who may claim that our products infringe or misappropriate their intellectual property rights.

Our products are based on complex, rapidly developing technologies.

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Our future collaborations may be important to our business.

are unable to maintain any of these collaborations, or if these collaborations are not successful, our business could be adversely affected.

we are unable to maintain any of these collaborations, or if these collaborations are not successful, our business could be adversely

We have limited capabilities for technology development, sales, marketing

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Any future collaborations we enter into may pose a number of risks, including the following:

● collaborators

have significant discretion in determining the efforts and resources that they will apply;

● collaborators

may not perform their obligations as expected;

● collaborators

may not pursue development and commercialization of any platform or may elect not to continue or renew development or commercialization

programs or license arrangements based on changes in the collaborators’ strategic focus or available funding, or external factors,

such as a strategic transaction that may divert resources or create competing priorities;

● collaborators

may provide insufficient funding for the research program;

● collaborators

could independently develop, or develop with third parties, products that compete directly or indirectly with our sequencing instruments

and applications if the collaborators believe that the competitive products are more likely to be successfully developed or can be commercialized

under terms that are more economically attractive than ours;

discovered by our collaborators in collaboration with us may be viewed by our collaborators as competitive with their own products, which

may cause collaborators to cease to devote resources to the commercialization of our product;

● disagreements

with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development,

might cause delays or terminations of the research, development or commercialization of new products or platforms, might lead to additional

responsibilities for us with respect to technology development, or might result in litigation or arbitration, any of which would be time-consuming

and expensive;

● collaborators

may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite

litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation;

● collaborators

may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability;

a collaborator of ours is involved in a business combination, the collaborator might deemphasize or terminate the development or commercialization

of any product licensed to it by us;

● collaborations

may be terminated by the collaborator, and, if terminated, we could be required to raise additional capital to pursue further development

or commercialization of the applicable sequencing technology.

collaborators have significant discretion in determining the efforts and resources that they will apply;

collaborators may not perform their obligations as expected;

collaborators may not pursue development and commercialization of any platform or may elect not to continue or renew development or commercialization programs or license arrangements based on changes in the collaborators’ strategic focus or available funding, or external factors, such as a strategic transaction that may divert resources or create competing priorities;

collaborators may provide insufficient funding for the research program;

collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our sequencing instruments and applications if the collaborators believe that the competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;

biomarkers discovered by our collaborators in collaboration with us may be viewed by our collaborators as competitive with their own products, which may cause collaborators to cease to devote resources to the commercialization of our product;

disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or terminations of the research, development or commercialization of new products or platforms, might lead to additional responsibilities for us with respect to technology development, or might result in litigation or arbitration, any of which would be time-consuming and expensive;

collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation;

collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability;

if a collaborator of ours is involved in a business combination, the collaborator might deemphasize or terminate the development or commercialization of any product licensed to it by us;

collaborations may be terminated by the collaborator, and, if terminated, we could be required to raise additional capital to pursue further development or commercialization of the applicable sequencing technology.

If our potential future collaborations do not result in the successful

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announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, capital commitments or achievement of significant milestones;

or departures of key personnel;

● competition

from existing products or new products that may emerge;

● fluctuations

in the valuation of companies perceived by investors to be comparable to us;

or other developments related to proprietary rights, including patents, litigation matters or our ability to obtain intellectual property

protection for our technologies;

● announcement

or expectation of additional financing efforts;

of our common stock or warrants by us or our stockholders;

price and volume fluctuations attributable to inconsistent trading volume levels of our shares;

guidance and ratings issued by securities or industry analysts;

economic and market conditions.

additions or departures of key personnel;

competition from existing products or new products that may emerge;

fluctuations in the valuation of companies perceived by investors to be comparable to us;

disputes or other developments related to proprietary rights, including patents, litigation matters or our ability to obtain intellectual property protection for our technologies;

announcement or expectation of additional financing efforts;

sales of our common stock or warrants by us or our stockholders;

stock price and volume fluctuations attributable to inconsistent trading volume levels of our shares;

reports, guidance and ratings issued by securities or industry analysts;

general economic and market conditions.

If any of the forgoing occurs, it would cause our stock and Warrant

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have substantial control over our company, which could limit your ability to influence the outcome of key transactions, including a change

1, 2023, our executive officers, directors and 10% stockholders owned 5,918,264 shares of our common stock, or approximately 43% of the

outstanding shares of our common stock, based on the number of shares outstanding as of such date.

As a result, these stockholders will

be able to exercise a significant level of control over all matters requiring stockholder approval, including the election of directors

and the approval of mergers, acquisitions or other extraordinary transactions.

They may also have interests that differ from yours and

may vote in a way with which you disagree and which may be adverse to your interests.

This concentration of ownership may have the effect

of delaying, preventing or deterring a change of control of our company, could deprive our stockholders of an opportunity to receive

a premium for their common stock as part of a sale of our company and might ultimately affect the market price of our common stock.

The price of our common stock has not met the requirements for

continued listing on the Nasdaq Capital Market.

If we fail to regain or maintain compliance with the minimum listing requirements, our

common stock will be subject to delisting.

Our ability to publicly or privately sell equity securities and the liquidity of our common

stock could be adversely affected if our common shares are delisted.

On June 21, 2022, we received a notification letter from The Nasdaq

Stock Market LLC (“Nasdaq”) notifying us that we are not in compliance with the minimum bid price requirement,

which requires that the closing bid price for our common stock listed on Nasdaq be maintained at a minimum of $1.00 and failure to maintain

it for 30 consecutive business days constitutes a compliance deficiency.

On December 20, 2022, we

received notice from Nasdaq indicating that, while we have not regained compliance with the Bid Price Requirement, Nasdaq has determined

that we are eligible for an additional 180-day period, or until June 19, 2023, to regain compliance.

According to the notification from

Nasdaq, the Staff’s determination was based on (i) our meeting the continued listing requirement for market value of our publicly-held

shares and all other Nasdaq initial listing standards, with the exception of the minimum bid price requirement, and (ii) our written notice

to Nasdaq of our intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary.

If at any time during this second 180-day compliance period, the closing bid price of our common stock is at least $1 per share for a

minimum of 10 consecutive business days, Nasdaq will provide us with written confirmation of compliance.

If compliance cannot be demonstrated

by June 19, 2023, Nasdaq will provide written notification that our common stock will be delisted.

At that time, we may appeal Nasdaq’s

determination to a Hearings Panel.

If we do not regain compliance within the allotted compliance period(s),

including any extensions that may be granted by Nasdaq, Nasdaq will provide notice that our common stock will be subject to delisting.

Delisting from Nasdaq could adversely affect our ability to consummate a strategic transaction and raise additional financing through

the public or private sale of equity securities, and would significantly affect the ability of investors to trade our securities and negatively

affect the value and liquidity of our common stock.

Delisting could also have other negative results, including the potential loss of

confidence by employees and the loss of institutional investor interest.

If our shares become subject to the penny stock rules, it would

become more difficult to trade our shares.

On April 1, 2024, our executive officers, directors and 10% stockholders

owned 147,960 shares of our common stock, or approximately 39% of the outstanding shares of our common stock, based on the number of shares

outstanding as of such date.

As a result, these stockholders will be able to exercise a significant level of control over all matters

requiring stockholder approval, including the election of directors and the approval of mergers, acquisitions or other extraordinary transactions.

They may also have interests that differ from yours and may vote in a way with which you disagree and which may be adverse to your interests.

This concentration of ownership may have the effect of delaying, preventing or deterring a change of control of our company, could deprive

our stockholders of an opportunity to receive a premium for their common stock as part of a sale of our company and might ultimately affect

the market price of our common stock.

Our shares have become subject to the penny stock rules, which

makes it more difficult to trade our shares.

The SEC has adopted rules that regulate broker-dealer practices in

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that current price and volume information with respect to transactions in such securities is provided by the exchange or system.

price of our common stock is less than $5.00, our common stock will be deemed a penny stock.

The penny stock rules require a broker-dealer,

before a transaction in a penny stock not otherwise exempt from those rules, to deliver a standardized risk disclosure document containing

specified information.

In addition, the penny stock rules require that before effecting any transaction in a penny stock not otherwise

exempt from those rules, a broker-dealer must make a special written determination that the penny stock is a suitable investment for the

purchaser and receive (i) the purchaser’s written acknowledgment of the receipt of a risk disclosure statement;

written agreement to transactions involving penny stocks;

common stock and warrants are no longer registered on a national stock exchange and the price of our common stock is less than $5.00,

our common stock is now deemed a penny stock under the SEC penny stock rules.

The penny stock rules require a broker-dealer, before a

transaction in a penny stock not otherwise exempt from those rules, to deliver a standardized risk disclosure document containing specified

In addition, the penny stock rules require that before effecting any transaction in a penny stock not otherwise exempt from

those rules, a broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser

and receive (i) the purchaser’s written acknowledgment of the receipt of a risk disclosure statement;

(ii) a written agreement

to transactions involving penny stocks;

and (iii) a signed and dated copy of a written suitability statement.

disclosure requirements may have the effect of reducing the trading activity in the secondary market for our common stock, and therefore

stockholders may have difficulty selling their shares.

These disclosure requirements

may have the effect of reducing the trading activity in the secondary market for our common stock, and therefore stockholders may have

difficulty selling their shares.

We are an “emerging growth company” and the reduced

disclosure requirements applicable to emerging growth companies could make our common stock less attractive to investors.

“emerging growth company,” as defined in the JOBS Act.

We may remain an emerging growth company until as late as December 2026

(the fiscal year-end following the fifth anniversary of the completion of our initial public offering), though we may cease to be an emerging

growth company earlier under certain circumstances, including (1) if the market value of our common stock that is held by non-affiliates

exceeds $700 million as of any June 30, in which case we would cease to be an emerging growth company as of the following December 31,

or (2) if our gross revenue exceeds $1.235 billion in

any fiscal year.

Emerging growth companies may take advantage of certain exemptions from various reporting requirements that are applicable

to other public companies, including 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 and 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 are an “emerging growth company,” as defined in the

We may remain an emerging growth company until as late as December 2026 (the fiscal year-end following the fifth anniversary

of the completion of our initial public offering), though we may cease to be an emerging growth company earlier under certain circumstances,

including (1) if the market value of our common stock that is held by non-affiliates exceeds $700 million as of any June 30,

in which case we would cease to be an emerging growth company as of the following December 31, or (2) if our gross revenue exceeds

$1.235 billion in any fiscal year.

Emerging growth companies may take advantage of certain exemptions from various reporting requirements

that are applicable to other public companies, including 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

and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden

parachute payments not previously approved.

Investors could find our common stock less attractive because we may rely on these exemptions.

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 be more volatile.

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 be more volatile.

In addition, Section 102 of the JOBS Act also provides that an

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new or revised accounting standards as other public companies that are not emerging growth companies.

We will incur significant costs as a result of operating as a

public company and our management expects to devote substantial time to public company compliance programs.

As a public company, we will incur significant legal, accounting and

other expenses due to our compliance with regulations and disclosure obligations applicable to us, including compliance with the Sarbanes-Oxley

We incur significant costs as a result of operating as a public

company and our management has devoted substantial time to public company compliance programs.

As a public company, we incur significant legal, accounting and other

expenses due to our compliance with regulations and disclosure obligations applicable to us, including compliance with the Sarbanes-Oxley

Act, as well as rules implemented by the SEC and Nasdaq.

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Our management

and other personnel will devote a substantial amount of time to these compliance programs and monitoring of public company reporting obligations

and other personnel devote a substantial amount of time to these compliance programs and monitoring of public company reporting obligations

and as a result of the new corporate governance and executive compensation related rules, regulations and guidelines prompted by the Dodd-Frank

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in our operating results and the price of our common stock could decline.

In addition, if we are unable to continue to meet these requirements,

we may not be able to remain listed on Nasdaq.

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.

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

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capital appreciation, if any, of our common stock and publicly-traded warrants will be your sole source of gain for the foreseeable future.

UNRESOLVED STAFF COMMENTS

As a Smaller Reporting Company as defined by Rule 12b-2 of the Exchange

Act and in Item 10(f)(1) of Regulation S-K, we are electing scaled disclosure reporting obligations and therefore are not required to

provide the information requested by this Item 1B.

On February 2, 2022, we entered into a new lease agreement for approximately

15,538 square feet of corporate office and laboratory space in Billerica, Massachusetts.

The lease has a term of 92 months with the rent

escalating from $14,317 to $26,453 per month over the lease term.

Risks Relating to Our Proposed Merger with Lyneer

Unless the Merger Agreement has been terminated, you should consider

the risks and uncertainties relating to Lyneer summarized under Item 1.

“Business” above, as well as the more detailed discussion

of such risks and uncertainties included in our registration statement on Form S-1 (Registration No.

333-272908) filed with the SEC, a

copy of which is publicly available through the SEC’s website at http://www.sec.gov .

Additional risks relating to Lyneer

not presently known to us or that we currently deem immaterial may also affect us following consummation of the Merger.

If, following

the Merger, any of these risks occur, our business, financial condition, or results of operations could be materially and adversely affected.

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