What changed in this filing

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Item 1A. Risk Factors

2022-03-29 compared with 2021-02-16 · 1033 added, 1587 removed, 2 unchanged (100% of the section changed)

investment in our securities involves a high degree of risk.

Careful consideration should be given to all of the risks described

below, together with the other information contained in this Annual Report on Form 10-K, before making a decision to invest in

our securities.

If any of the following events occur, our business, financial condition and operating results may be materially

adversely affected.

In that event, the trading price of our securities could decline, and our stockholders could lose all or part

of their investment.

are a newly formed company with no operating history and no revenues, and stockholders have no basis on which to evaluate our

ability to achieve our business objective.

are a newly formed company with no operating results.

Because we lack an operating history, stockholders have no basis upon which

to evaluate our ability to achieve our business objective of completing our initial business combination with one or more target

We may be unable to complete our initial business combination within the time period required.

If we fail to complete

our initial business combination, we will never generate any operating revenues.

search for a business combination, and any target business with which we ultimately consummate a business combination, may be

materially adversely affected by the recent coronavirus (COVID-19) pandemic.

COVID-19 pandemic has resulted in a widespread health crisis that has adversely affected the economies and financial markets

worldwide, and the business of any potential target business with which we consummate a business combination could be materially

and adversely affected.

Furthermore, we may be unable to complete a business combination if continued concerns relating to COVID-19 restrict

travel, limit the ability to have meetings with potential investors or the target company’s personnel, vendors and services

providers are unavailable to negotiate and consummate a transaction in a timely manner.

The extent to which COVID-19 impacts

our search for a business combination will depend on future developments, which are highly uncertain and cannot be predicted,

including new information which may emerge concerning the severity of COVID-19 and the actions to contain COVID-19 or

treat its impact, among others.

If the disruptions posed by COVID-19 or other matters of global concern continue for an extensive

period of time, our ability to consummate a business combination, or the operations of a target business with which we ultimately

consummate a business combination, may be materially adversely affected.

public stockholders may not be afforded an opportunity to vote on our proposed initial business combination, which means we may

complete our initial business combination even though a majority of our public stockholders do not support such a combination.

may choose not to hold a stockholder vote to approve our initial business combination unless the initial business combination

would require stockholder approval under applicable law or stock exchange listing requirements or if we decide to hold a stockholder

vote for business or other legal reasons.

Except as required by applicable law or stock exchange requirements, the decision as

to whether we will seek stockholder approval of a proposed initial business combination or will allow stockholders to sell their

shares to us in a tender offer will be made by us, solely in our discretion, and will be based on a variety of factors, such as

the timing of the transaction and whether the terms of the transaction would otherwise require us to seek stockholder approval.

Accordingly, we may complete our initial business combination even if holders of a majority of our public shares do not approve

of the initial business combination we complete.

we seek stockholder approval of our initial business combination, our initial stockholders have agreed to vote in favor of such

initial business combination, regardless of how our public stockholders vote.

to the letter agreement, our sponsor, officers and directors have agreed to vote any founder shares and placement shares held

by them, as well as any public shares they may have acquired during or after our initial public offering (including in open market

and privately negotiated transactions), in favor of our initial business combination.

As a result, in addition to our initial

stockholders’

founder shares and placement shares, we would need only 3,572,501, or 35.7%, of the 10,000,000 public shares

sold in our initial public offering to be voted in favor of an initial business combination (assuming all outstanding shares are

voted and the placement shares issued to the underwriters are voted in favor of the transaction) in order to have our initial

business combination approved.

Our initial stockholders own shares representing approximately 21.8% of our outstanding shares

of common stock.

Accordingly, if we seek stockholder approval of our initial business combination, the agreement by our initial

stockholders to vote in favor of our initial business combination will increase the likelihood that we will receive the requisite

stockholder approval for such initial business combination.

stockholders’

only opportunity to affect the investment decision regarding a potential business combination will be limited

to the exercise of their right to redeem their shares from us for cash, unless we seek stockholder approval of the initial business

our board of directors may complete an initial business combination without seeking stockholder approval, public stockholders

may not have the right or opportunity to vote on the initial business combination, unless we seek such stockholder vote.

if we do not seek stockholder approval, our stockholders’

only opportunity to affect the investment decision regarding a

potential business combination may be limited to exercising their redemption rights within the period of time (which will be at

least 20 business days) set forth in our tender offer documents mailed to our public stockholders in which we describe our initial

business combination.

ability of our public stockholders to redeem their shares for cash may make our financial condition unattractive to potential

business combination targets, which may make it difficult for us to enter into an initial business combination with a target.

may seek to enter into an initial business combination agreement with a prospective target that requires as a closing condition

that we have a minimum net worth or a certain amount of cash.

If too many public stockholders exercise their redemption rights,

we would not be able to meet such closing condition and, as a result, would not be able to proceed with the initial business combination.

Furthermore, in no event will we redeem our public shares unless our net tangible assets are at least $5,000,001 either immediately

prior to or upon consummation of our initial business combination and after payment of underwriters’

fees and commissions

(so that we are not subject to the SEC’s “penny stock”

rules) or any greater net tangible asset or cash requirement

which may be contained in the agreement relating to our initial business combination.

Consequently, if accepting all properly

submitted redemption requests would cause our net tangible assets to be less than $5,000,001 upon consummation of our initial

business combination and after payment of underwriters’

fees and commissions or such greater amount necessary to satisfy

a closing condition, each as described above, we would not proceed with such redemption and the related business combination and

may instead search for an alternate business combination.

Prospective targets will be aware of these risks and, thus, may be reluctant

to enter into an initial business combination with us.

ability of our public stockholders to exercise redemption rights with respect to a large number of our shares may not allow us

to complete the most desirable business combination or optimize our capital structure.

the time we enter into an agreement for our initial business combination, we will not know how many stockholders may exercise

their redemption rights, and therefore will need to structure the transaction based on our expectations as to the number of shares

that will be submitted for redemption.

If our initial business combination agreement requires us to use a portion of the cash

in the trust account to pay the purchase price, or requires us to have a minimum amount of cash at closing, we will need to reserve

a portion of the cash in the trust account to meet such requirements, or arrange for third party financing.

In addition, if a

larger number of shares are submitted for redemption than we initially expected, we may need to restructure the transaction to

reserve a greater portion of the cash in the trust account or arrange for third party financing.

Raising additional third-party financing

may involve dilutive equity issuances or the incurrence of indebtedness at higher than desirable levels.

Furthermore, this dilution

would increase to the extent that the anti-dilution provision of the Class B common stock result in the issuance of

Class A shares on a greater than one-to-one basis upon conversion of the Class B common stock at the time of the

consummation of our business combination.

The above considerations may limit our ability to complete the most desirable business

combination available to us or optimize our capital structure.

The amount of the deferred underwriting commissions payable to

the underwriters will not be adjusted for any shares that are redeemed in connection with an initial business combination.

per-share amount we will distribute to stockholders who properly exercise their redemption rights will not be reduced by

the deferred underwriting commission and after such redemptions, the per-share value of shares held by non-redeeming stockholders

will reflect our obligation to pay the deferred underwriting commissions.

ability of our public stockholders to exercise redemption rights with respect to a large number of our shares could increase the

probability that our initial business combination would be unsuccessful and that stockholders would have to wait for liquidation

in order to redeem their stock.

our initial business combination agreement requires us to use a portion of the cash in the trust account to pay the purchase price,

or requires us to have a minimum amount of cash at closing, the probability that our initial business combination would be unsuccessful

is increased.

If our initial business combination is unsuccessful, stockholders would not receive their pro rata portion of the

trust account until we liquidate the trust account.

If stockholders are in need of immediate liquidity, they could attempt to

sell their stock in the open market;

however, at such time our stock may trade at a discount to the pro rata amount per share

in the trust account.

In either situation, stockholders may suffer a material loss on their investment or lose the benefit of

funds expected in connection with our redemption until we liquidate or such stockholders are able to sell their stock in the open

requirement that we complete our initial business combination within the prescribed time frame may give potential target businesses

leverage over us in negotiating an initial business combination and may decrease our ability to conduct due diligence on potential

business combination targets as we approach our dissolution deadline, which could undermine our ability to complete our initial

business combination on terms that would produce value for our stockholders.

potential target business with which we enter into negotiations concerning an initial business combination will be aware that

we must complete our initial business combination within 24 months from the closing of our initial public offering.

Consequently,

such target business may obtain leverage over us in negotiating an initial business combination, knowing that if we do not complete

our initial business combination with that particular target business, we may be unable to complete our initial business combination

with any target business.

This risk will increase as we get closer to the timeframe described above.

In addition, we may have

limited time to conduct due diligence and may enter into our initial business combination on terms that we would have rejected

upon a more comprehensive investigation.

may not be able to complete our initial business combination within the prescribed time frame, in which case we would cease all

operations except for the purpose of winding up and we would redeem our public shares and liquidate, in which case our public

stockholders may only receive $10.00 per share, or less than such amount in certain circumstances, and our warrants will expire

amended and restated certificate of incorporation provides that we must complete our initial business combination within 24 months

from the closing of our initial public offering.

We may not be able to find a suitable target business and complete our initial

business combination within such time period.

Our ability to complete our initial business combination may be negatively impacted

by general market conditions, volatility in the capital and debt markets and the other risks described herein.

For example, if

the outbreak of COVID-19 continues to grow both in the U.S.

and globally and, while the extent of the impact of the outbreak

on us will depend on future developments, it could limit our ability to complete our initial business combination, including as

a result of increased market volatility, decreased market liquidity and third-party financing being unavailable on terms

acceptable to us or at all.

Additionally, the outbreak of COVID-19 may negatively impact businesses we may seek to acquire.

we have not completed our initial business combination within such time period, we will:

(i) cease all operations except

for the purpose of winding up, (ii) as promptly as reasonably possible but not more than ten business days thereafter, redeem

the public shares, at a per-share price, payable in cash, equal to the aggregate amount then on deposit in the trust account

including interest earned on the funds held in the trust account and not previously released to us to pay our taxes (less up to

$100,000 of interest to pay dissolution expenses), divided by the number of then outstanding public shares, which redemption will

completely extinguish public stockholders’

rights as stockholders (including the right to receive further liquidating distributions,

if any), subject to applicable law, and (iii) as promptly as reasonably possible following such redemption, subject to the

approval of our remaining stockholders and our board of directors, dissolve and liquidate, subject in the case of clauses (ii) and

(iii) above to our obligations under Delaware law to provide for claims of creditors and the requirements of other applicable

In such case, our public stockholders may only receive $10.00 per share, and our warrants will expire worthless.

circumstances, our public stockholders may receive less than $10.00 per share on the redemption of their shares.

we seek stockholder approval of our initial business combination, our sponsor, directors, officers and their affiliates may elect

to purchase shares or warrants from public stockholders, which may influence a vote on a proposed initial business combination

and reduce the public “float”

of our Class A common stock.

we seek stockholder approval of our initial business combination and we do not conduct redemptions in connection with our initial

business combination pursuant to the tender offer rules, our sponsor, directors, officers or their affiliates may purchase public

shares or public warrants or a combination thereof in privately negotiated transactions or in the open market either prior to

or following the completion of our initial business combination, although they are under no obligation to do so.

However, they

have no current commitments, plans or intentions to engage in such transactions and have not formulated any terms or conditions

for any such transactions.

None of the funds in the trust account will be used to purchase shares or public warrants in such transactions.

a purchase may include a contractual acknowledgement that such stockholder, although still the record holder of our shares is

no longer the beneficial owner thereof and therefore agrees not to exercise its redemption rights.

In the event that our sponsor,

directors, officers or their affiliates purchase shares in privately negotiated transactions from public stockholders who have

already elected to exercise their redemption rights or submitted a proxy to vote against our initial business combination, such

selling stockholders would be required to revoke their prior elections to redeem their shares and any proxy to vote against our

initial business combination.

The price per share paid in any such transaction may be different than the amount per share a public

stockholder would receive if it elected to redeem its shares in connection with our initial business combination.

of such purchases could be to vote such shares in favor of the initial business combination and thereby increase the likelihood

of obtaining stockholder approval of the initial business combination, or to satisfy a closing condition in an agreement with

a target that requires us to have a minimum net worth or a certain amount of cash at the closing of our initial business combination,

where it appears that such requirement would otherwise not be met.

The purpose of any such purchases of public warrants could

be to reduce the number of public warrants outstanding or to vote such warrants on any matters submitted to the warrantholders

for approval in connection with our initial business combination.

Any such purchases of our securities may result in the completion

of our initial business combination that may not otherwise have been possible.

We expect that any such purchases will be reported

pursuant to Section 13 and Section 16 of the Exchange Act to the extent such purchasers are subject to such reporting

requirements.

addition, if such purchases are made, the public “float”

of our Class A common stock or public warrants and the

number of beneficial holders of our securities may be reduced, possibly making it difficult to obtain or maintain the quotation,

listing or trading of our securities on a national securities exchange.

a stockholder fails to receive notice of our offer to redeem our public shares in connection with our initial business combination,

or fails to comply with the procedures for tendering its shares, such shares may not be redeemed.

will comply with the tender offer rules or proxy rules, as applicable, when conducting redemptions in connection with our initial

business combination.

Despite our compliance with these rules, if a stockholder fails to receive our tender offer or proxy materials,

as applicable, such stockholder may not become aware of the opportunity to redeem its shares.

In addition, proxy materials or

tender offer documents, as applicable, that we will furnish to holders of our public shares in connection with our initial business

combination will describe the various procedures that must be complied with in order to validly tender or redeem public shares.

For example, we may require our public stockholders seeking to exercise their redemption rights, whether they are record holders

or hold their shares in “street name,”

to either deliver their stock certificates to our transfer agent prior to the

date set forth in the tender offer documents mailed to such holders, or up to two business days prior to the vote on the proposal

to approve the initial business combination in the event we distribute proxy materials, or to deliver their shares to the transfer

agent electronically.

In the event that a stockholder fails to comply with these or any other procedures disclosed in the proxy

or tender offer materials, as applicable, its shares may not be redeemed.

will not have any rights or interests in funds from the trust account, except under certain limited circumstances.

an investment in our securities, therefore, stockholders may be forced to sell their public shares or warrants, potentially at

public stockholders will be entitled to receive funds from the trust account only upon the earliest to occur of:

completion of an initial business combination, and then only in connection with those shares of Class A common stock that

such stockholder properly elected to redeem, subject to the limitations described herein, (ii) the redemption of any public

shares properly submitted in connection with a stockholder vote to amend our amended and restated certificate of incorporation

(A) to modify the substance or timing of our obligation to allow redemption in connection with our initial business combination

or certain amendments to our charter prior thereto or to redeem 100% of our public shares if we do not complete our initial business

combination within 24 months from the closing of our initial public offering or (B) with respect to any other provision

relating to stockholders’

rights or pre-initial business combination activity and (iii) the redemption of our

public shares if we are unable to complete an initial business combination within 24 months from the closing of our initial

public offering, subject to applicable law.

In no other circumstances will a public stockholder have any right or interest of

any kind in the trust account.

Holders of warrants will not have any right to the proceeds held in the trust account with respect

to the warrants.

Accordingly, to liquidate an investment in our securities, our stockholders may be forced to sell their public

shares or warrants, potentially at a loss.

may delist our securities from trading on its exchange, which could limit investors’

ability to make transactions in our

securities and subject us to additional trading restrictions.

cannot make any assurances that our securities will continue to be listed on Nasdaq in the future or prior to our initial business

In order to continue listing our securities on Nasdaq prior to our initial business combination, we must maintain

certain financial, distribution and stock price levels.

Generally, we must maintain a minimum amount in stockholders’

(generally $2,500,000) and a minimum number of holders of our securities (generally 300 public holders).

Additionally, in connection

with our initial business combination, we will be required to demonstrate compliance with Nasdaq’s initial listing requirements,

which are more rigorous than Nasdaq’s continued listing requirements, in order to continue to maintain the listing of our

securities on Nasdaq.

For instance, our stock price would generally be required to be at least $4.00 per share, our stockholders’

equity would generally be required to be at least $5.0 million and we would be required to have a minimum of 300 round lot

holders (with at least 50% of such round lot holders holding securities with a market value of at least $2,500) of our securities.

We cannot make any assurances that we will be able to meet those initial listing requirements at that time.

Nasdaq delists our securities from trading on its exchange and we are not able to list our securities on another national securities

exchange, we expect our securities could be quoted on an over-the-counter market.

If this were to occur, we could face significant

material adverse consequences, including:

limited availability of market quotations for our securities;

liquidity for our securities;

determination that our Class A common stock is a “penny stock”

which will require brokers trading in our Class A

common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading

market for our securities;

limited amount of news and analyst coverage;

decreased ability to issue additional securities or obtain additional financing in the future.

National Securities Markets Improvement Act of 1996, which is a federal statute, prevents or preempts the states from regulating

the sale of certain securities, which are referred to as “covered securities.”

Because our units, Class A common

stock and warrants are listed on Nasdaq, our units, Class A common stock and warrants are covered securities.

states are preempted from regulating the sale of our securities, the federal statute does allow the states to investigate companies

if there is a suspicion of fraud, and, if there is a finding of fraudulent activity, then the states can regulate or bar the sale

of covered securities in a particular case.

While we are not aware of a state having used these powers to prohibit or restrict

the sale of securities issued by blank check companies, other than the State of Idaho, certain state securities regulators view

blank check companies unfavorably and might use these powers, or threaten to use these powers, to hinder the sale of securities

of blank check companies in their states.

Further, if we were no longer listed on Nasdaq, our securities would not be covered

securities and we would be subject to regulation in each state in which we offer our securities, including in connection with

our initial business combination.

we seek stockholder approval of our initial business combination and we do not conduct redemptions pursuant to the tender offer

rules, and if stockholders or a “group”

of stockholders are deemed to hold in excess of 15% of our Class A common

stock, stockholders will lose the ability to redeem all such shares in excess of 15% of our Class A common stock.

we seek stockholder approval of our initial business combination and we do not conduct redemptions in connection with our initial

business combination pursuant to the tender offer rules, our amended and restated certificate of incorporation provides that a

public stockholder, together with any affiliate of such stockholder or any other person with whom such stockholder is acting in

concert or as a “group”

(as defined under Section 13 of the Exchange Act), will be restricted from seeking redemption

rights with respect to more than an aggregate of 15% of the shares sold in our initial public offering without our prior consent,

which we refer to as the “Excess Shares.”

However, we would not be restricting our stockholders’

vote all of their shares (including Excess Shares) for or against our initial business combination.

The inability to redeem the

Excess Shares will reduce our stockholders’

influence over our ability to complete our initial business combination and

our stockholders could suffer a material loss on their investment in us if they sell Excess Shares in open market transactions.

Additionally, our stockholders will not receive redemption distributions with respect to the Excess Shares if we complete our

initial business combination.

And as a result, our stockholders will continue to hold that number of shares exceeding 15% and,

in order to dispose of such shares, would be required to sell stock in open market transactions, potentially at a loss.

of our limited resources and the significant competition for business combination opportunities, it may be more difficult for

us to complete our initial business combination.

If we are unable to complete our initial business combination, our public stockholders

may receive only approximately $10.00 per share on our redemption of our public shares, or less than such amount in certain circumstances,

and our warrants will expire worthless.

expect to encounter intense competition from other entities having a business objective similar to ours, including private investors

(which may be individuals or investment partnerships), other blank check companies and other entities competing for the types

of businesses we intend to acquire.

Many of these individuals and entities are well-established and have extensive experience

in identifying and effecting, directly or indirectly, acquisitions of companies operating in or providing services to various

Many of these competitors possess greater technical, human and other resources or more industry knowledge than we

do, and our financial resources will be relatively limited when contrasted with those of many of these competitors.

While we believe

there are numerous target businesses we could potentially acquire, our ability to compete with respect to the acquisition of certain

target businesses that are sizable will be limited by our available financial resources.

This inherent competitive limitation

gives others an advantage in pursuing the acquisition of certain target businesses.

Furthermore, because we are obligated to pay

cash for the shares of Class A common stock which our public stockholders redeem in connection with our initial business

combination, target companies will be aware that this may reduce the resources available to us for our initial business combination.

This may place us at a competitive disadvantage in successfully negotiating and completing an initial business combination.

we are unable to complete our initial business combination, our public stockholders may receive only approximately $10.00 per

share on the liquidation of our trust account and our warrants will expire worthless.

In certain circumstances, our public stockholders

may receive less than $10.00 per share upon our liquidation.

the net proceeds of our initial public offering and the sale of the placement units not being held in the trust account are insufficient

to allow us to operate for at least the 24 months following the closing of our initial public offering, we may be unable to complete

our initial business combination, in which case our public stockholders may only receive $10.00 per share, or less than such amount

in certain circumstances, and our warrants will expire worthless.

funds available to us outside of the trust account to fund our working capital requirements may not be sufficient to allow us

to operate for at least the 24 months following the closing of our initial public offering, assuming that our initial business

combination is not completed during that time.

We believe that the funds available to us outside of the trust account will be

sufficient to allow us to operate for at least the 24 months following the closing of our initial public offering;

we cannot provide any assurance that our estimate is accurate.

the funds available to us, we could use a portion of the funds available to us to pay fees to consultants to assist us with our

search for a target business.

We could also use a portion of the funds as a down payment or to fund a “no-shop”

(a provision in letters of intent or merger agreements designed to keep target businesses from “shopping”

transactions with other companies or investors on terms more favorable to such target businesses) with respect to a particular

proposed initial business combination, although we do not have any current intention to do so.

If we entered into a letter of

intent or merger agreement where we paid for the right to receive exclusivity from a target business and were subsequently required

to forfeit such funds (whether as a result of our breach or otherwise), we might not have sufficient funds to continue searching

for, or conduct due diligence with respect to, a target business.

If we are unable to complete our initial business combination,

our public stockholders may receive only approximately $10.00 per share on the liquidation of our trust account and our warrants

will expire worthless.

In certain circumstances, our public stockholders may receive less than $10.00 per share upon our liquidation.

the net proceeds of our initial public offering and the sale of the placement units not being held in the trust account are insufficient,

it could limit the amount available to fund our search for a target business or businesses and complete our initial business combination

and we will depend on loans from our sponsor or management team to fund our search for an initial business combination, to pay

our taxes and to complete our initial business combination.

If we are unable to obtain these loans, we may be unable to complete

our initial business combination.

we are required to seek additional capital, we would need to borrow funds from our sponsor, management team or other third parties

to operate or may be forced to liquidate.

None of our sponsor, members of our management team nor any of their affiliates is under

any obligation to advance funds to us in such circumstances.

Any such advances would be repaid only from funds held outside the

trust account or from funds released to us upon completion of our initial business combination.

Up to $1,500,000 of such loans

may be convertible into units, at a price of $10.00 per unit at the option of the lender, upon consummation of our initial business

The units would be identical to the placement units.

Prior to the completion of our initial business combination,

we do not expect to seek loans from parties other than our sponsor or an affiliate of our sponsor as we do not believe third parties

will be willing to loan such funds and provide a waiver against any and all rights to seek access to funds in our trust account.

If we are unable to obtain these loans, we may be unable to complete our initial business combination.

If we are unable to complete

our initial business combination because we do not have sufficient funds available to us, we will be forced to cease operations

and liquidate the trust account.

Consequently, our public stockholders may only receive approximately $10.00 per share on our

redemption of our public shares, and our warrants will expire worthless.

In certain circumstances, our public stockholders may

receive less than $10.00 per share on the redemption of their shares.

to the completion of our initial business combination, we may be required to take write-downs or write-offs, restructuring and

impairment or other charges that could have a significant negative effect on our financial condition, results of operations and

our stock price.

if we conduct extensive due diligence on a target business with which we combine, we cannot assure our stockholders that this

diligence will surface all material issues that may be present inside a particular target business, that it would be possible

to uncover all material issues through a customary amount of due diligence, or that factors outside of the target business and

outside of our control will not later arise.

As a result of these factors, we may be forced to later write-down or write-off assets,

restructure our operations, or incur impairment or other charges that could result in our reporting losses.

Even if our due diligence

successfully identifies certain risks, unexpected risks may arise and previously known risks may materialize in a manner not consistent

with our preliminary risk analysis.

Even though these charges may be non-cash items and not have an immediate impact on our

liquidity, the fact that we report charges of this nature could contribute to negative market perceptions about us or our securities.

In addition, charges of this nature may cause us to violate net worth or other covenants to which we may be subject as a result

of assuming pre-existing debt held by a target business or by virtue of our obtaining debt financing to partially finance

the initial business combination.

Accordingly, any stockholders who choose to remain stockholders following the initial business

combination could suffer a reduction in the value of their shares.

Such stockholders are unlikely to have a remedy for such reduction

in value unless they are able to successfully claim that the reduction was due to the breach by our officers or directors of a

duty of care or other fiduciary duty owed to them, or if they are able to successfully bring a private claim under securities

laws that the proxy solicitation or tender offer materials, as applicable, relating to the initial business combination constituted

an actionable material misstatement or omission.

third parties bring claims against us, the proceeds held in the trust account could be reduced and the per-share redemption amount

received by stockholders may be less than $10.00 per share.

placing of funds in the trust account may not protect those funds from third-party claims against us.

Although we will seek

to have all vendors, service providers, prospective target businesses and other entities with which we do business execute agreements

with us waiving any right, title, interest or claim of any kind in or to any monies held in the trust account for the benefit

of our public stockholders, such parties may not execute such agreements, or even if they execute such agreements they may not

be prevented from bringing claims against the trust account, including, but not limited to, fraudulent inducement, breach of fiduciary

responsibility or other similar claims, as well as claims challenging the enforceability of the waiver, in each case in order

to gain advantage with respect to a claim against our assets, including the funds held in the trust account.

If any third party

refuses to execute an agreement waiving such claims to the monies held in the trust account, our management will perform an analysis

of the alternatives available to it and will only enter into an agreement with a third party that has not executed a waiver if

management believes that such third party’s engagement would be significantly more beneficial to us than any alternative.

Marcum LLP, our independent registered public accounting firm, and the underwriters of our initial public offering, have not executed

agreements with us waiving such claims to the monies held in the trust account.

of possible instances where we may engage a third party that refuses to execute a waiver include the engagement of a third party

consultant whose particular expertise or skills are believed by management to be significantly superior to those of other consultants

that would agree to execute a waiver or in cases where management is unable to find a service provider willing to execute a waiver.

In addition, there is no guarantee that such entities will agree to waive any claims they may have in the future as a result of,

or arising out of, any negotiations, contracts or agreements with us and will not seek recourse against the trust account for

Upon redemption of our public shares, if we are unable to complete our initial business combination within the prescribed

timeframe, or upon the exercise of a redemption right in connection with our initial business combination, we will be required

to provide for payment of claims of creditors that were not waived that may be brought against us within the 10 years following

Accordingly, the per-share redemption amount received by public stockholders could be less than the $10.00 per

share initially held in the trust account, due to claims of such creditors.

Pursuant to the letter agreement, our sponsor has

agreed that it will be liable to us if and to the extent any claims by a third party for services rendered or products sold to

us, or a prospective target business with which we have entered into a written letter of intent, confidentiality or similar agreement

or business combination agreement, reduce the amount of funds in the trust account to below the lesser of (i) $10.00 per public

share and (ii) the actual amount per public share held in the trust account as of the date of the liquidation of the trust

account, if less than $10.00 per share due to reductions in the value of the trust assets, less taxes payable, provided that such

liability will not apply to any claims by a third party or prospective target business who executed a waiver of any and all rights

to the monies held in the trust account (whether or not such waiver is enforceable) nor will it apply to any claims under our

indemnity of the underwriters of our initial public offering against certain liabilities, including liabilities under the Securities

However, we have not asked our sponsor to reserve for such indemnification obligations, nor have we independently verified

whether our sponsor has sufficient funds to satisfy its indemnity obligations and believe that our sponsor’s only assets

are securities of our company.

Therefore, we cannot provide any assurance that our sponsor would be able to satisfy those obligations.

None of our officers or directors will indemnify us for claims by third parties including, without limitation, claims by vendors

and prospective target businesses.

directors may decide not to enforce the indemnification obligations of our sponsor, resulting in a reduction in the amount of

funds in the trust account available for distribution to our public stockholders.

the event that the proceeds in the trust account are reduced below the lesser of (i) $10.00 per share and (ii) the actual

amount per share held in the trust account as of the date of the liquidation of the trust account if less than $10.00 per share

due to reductions in the value of the trust assets, in each case net of the interest which may be withdrawn to pay taxes, and

our sponsor asserts that it is unable to satisfy its obligations or that it has no indemnification obligations related to a particular

claim, our independent directors would determine whether to take legal action against our sponsor to enforce its indemnification

we currently expect that our independent directors would take legal action on our behalf against our sponsor to enforce its indemnification

obligations to us, it is possible that our independent directors in exercising their business judgment and subject to their fiduciary

duties may choose not to do so in any particular instance if, for example, the cost of such legal action is deemed by the independent

directors to be too high relative to the amount recoverable or if the independent directors determine that a favorable outcome

is not likely.

If our independent directors choose not to enforce these indemnification obligations, the amount of funds in the

trust account available for distribution to our public stockholders may be reduced below $10.00 per share.

may not have sufficient funds to satisfy indemnification claims of our directors and executive officers.

have agreed to indemnify our officers and directors to the fullest extent permitted by law.

However, our officers and directors

have agreed to waive any right, title, interest or claim of any kind in or to any monies in the trust account and to not seek

recourse against the trust account for any reason whatsoever.

Accordingly, any indemnification provided will be able to be satisfied

by us only if (i) we have sufficient funds outside of the trust account or (ii) we consummate an initial business combination.

Our obligation to indemnify our officers and directors may discourage stockholders from bringing a lawsuit against our officers

or directors for breach of their fiduciary duty.

These provisions also may have the effect of reducing the likelihood of derivative

litigation against our officers and directors, even though such an action, if successful, might otherwise benefit us and our stockholders.

Furthermore, a stockholder’s investment may be adversely affected to the extent we pay the costs of settlement and damage

awards against our officers and directors pursuant to these indemnification provisions.

after we distribute the proceeds in the trust account to our public stockholders, we file a bankruptcy petition or an involuntary

bankruptcy petition is filed against us that is not dismissed, a bankruptcy court may seek to recover such proceeds, and we and

our board may be exposed to claims of punitive damages.

after we distribute the proceeds in the trust account to our public stockholders, we file a bankruptcy petition or an involuntary

bankruptcy petition is filed against us that is not dismissed, any distributions received by stockholders could be viewed under

applicable debtor/creditor and/or bankruptcy laws as either a “preferential transfer”

or a “fraudulent conveyance.”

As a result, a bankruptcy court could seek to recover some or all amounts received by our stockholders.

In addition, our board

of directors may be viewed as having breached its fiduciary duty to our creditors and/or having acted in bad faith, thereby exposing

itself and us to claims of punitive damages, by paying public stockholders from the trust account prior to addressing the claims

of creditors.

before distributing the proceeds in the trust account to our public stockholders, we file a bankruptcy petition or an involuntary

bankruptcy petition is filed against us that is not dismissed, the claims of creditors in such proceeding may have priority over

the claims of our stockholders and the per-share amount that would otherwise be received by our stockholders in connection with

our liquidation may be reduced.

before distributing the proceeds in the trust account to our public stockholders, we file a bankruptcy petition or an involuntary

bankruptcy petition is filed against us that is not dismissed, the proceeds held in the trust account could be subject to applicable

bankruptcy law, and may be included in our bankruptcy estate and subject to the claims of third parties with priority over the

claims of our stockholders.

To the extent any bankruptcy claims deplete the trust account, the per-share amount that would

otherwise be received by our stockholders in connection with our liquidation may be reduced.

we are deemed to be an investment company under the Investment Company Act, we may be required to institute burdensome compliance

requirements and our activities may be restricted, which may make it difficult for us to complete our initial business combination.

we are deemed to be an investment company under the Investment Company Act, our activities may be restricted, including:

● restrictions

on the nature of our investments;

● restrictions

on the issuance of securities, each of which may make it difficult for us to complete our initial business combination.

addition, we may have imposed upon us burdensome requirements, including:

● registration

as an investment company with the SEC;

of a specific form of corporate structure;

record keeping, voting, proxy and disclosure requirements and other rules and regulations that we are currently not subject to.

order not to be regulated as an investment company under the Investment Company Act, unless we can qualify for an exclusion, we

must ensure that we are engaged primarily in a business other than investing, reinvesting or trading in securities and that our

activities do not include investing, reinvesting, owning, holding or trading “investment securities”

more than 40% of our total assets (exclusive of U.S.

government securities and cash items) on an unconsolidated basis.

will be to identify and complete an initial business combination and thereafter to operate the post-transaction business

or assets for the long term.

We do not plan to buy businesses or assets with a view to resale or profit from their resale.

do not plan to buy unrelated businesses or assets or to be a passive investor.

do not believe that our anticipated principal activities will subject us to the Investment Company Act.

To this end, the proceeds

held in the trust account may only be invested in United States “government securities”

within the meaning of

Section 2(a)(16) of the Investment Company Act having a maturity of 185 days or less or in money market funds meeting

certain conditions under Rule 2a-7 promulgated under the Investment Company Act which invest only in direct U.S.

treasury obligations.

Pursuant to the trust agreement, the trustee is not permitted to invest in other securities or assets.

restricting the investment of the proceeds to these instruments, and by having a business plan targeted at acquiring and growing

businesses for the long term (rather than on buying and selling businesses in the manner of a merchant bank or private equity

fund), we intend to avoid being deemed an “investment company”

within the meaning of the Investment Company Act.

trust account is intended as a holding place for funds pending the earliest to occur of:

(i) the completion of our initial

business combination;

(ii) the redemption of any public shares properly submitted in connection with a stockholder vote to

amend our amended and restated certificate of incorporation (A) to modify the substance or timing of our obligation to allow

redemption in connection with our initial business combination or certain amendments to our charter prior thereto or to redeem

100% of our public shares if we do not complete our initial business combination within 24 months from the closing of our

initial public offering or (B) with respect to any other provision relating to stockholders’

rights or pre-initial business

combination activity;

or (iii) absent an initial business combination within 24 months from the closing of our initial

public offering, our return of the funds held in the trust account to our public stockholders as part of our redemption of the

public shares.

If we do not invest the proceeds as discussed above, we may be deemed to be subject to the Investment Company Act.

If we were deemed to be subject to the Investment Company Act, compliance with these additional regulatory burdens would require

additional expenses for which we have not allotted funds and may hinder our ability to complete an initial business combination

or may result in our liquidation.

If we are unable to complete our initial business combination, our public stockholders may receive

only approximately $10.00 per share on the liquidation of our trust account and our warrants will expire worthless.

in laws or regulations, or a failure to comply with any laws and regulations, may adversely affect our business, including our

ability to negotiate and complete our initial business combination and results of operations.

are subject to laws and regulations enacted by national, regional and local governments.

In particular, we will be required to

comply with certain SEC and other legal requirements.

Compliance with, and monitoring of, applicable laws and regulations may

be difficult, time consuming and costly.

laws and regulations and their interpretation and application may also change from time to time and those changes could have a

material adverse effect on our business, investments and results of operations.

In addition, a failure to comply with applicable

laws or regulations, as interpreted and applied, could have a material adverse effect on our business, including our ability to

negotiate and complete our initial business combination and results of operations.

stockholders may be held liable for claims by third parties against us to the extent of distributions received by them upon redemption

of their shares.

the DGCL, stockholders may be held liable for claims by third parties against a corporation to the extent of distributions received

by them in a dissolution.

The pro rata portion of our trust account distributed to our public stockholders upon the redemption

of our public shares in the event we do not complete our initial business combination within 24 months from the closing of

our initial public offering may be considered a liquidating distribution under Delaware law.

If a corporation complies with certain

procedures set forth in Section 280 of the DGCL intended to ensure that it makes reasonable provision for all claims against

it, including a 60-day notice period during which any third-party claims can be brought against the corporation, a 90-day period

during which the corporation may reject any claims brought, and an additional 150-day waiting period before any liquidating

distributions are made to stockholders, any liability of stockholders with respect to a liquidating distribution is limited to

the lesser of such stockholder’s pro rata share of the claim or the amount distributed to the stockholder, and any liability

of the stockholder would be barred after the third anniversary of the dissolution.

However, it is our intention to redeem our

public shares as soon as reasonably possible following the 24 th month from the closing of our initial public offering

in the event we do not complete our initial business combination and, therefore, we do not intend to comply with the foregoing

we will not be complying with Section 280, Section 281(b) of the DGCL requires us to adopt a plan, based on facts known

to us at such time that will provide for our payment of all existing and pending claims or claims that may be potentially brought

against us within the 10 years following our dissolution.

However, because we are a blank check company, rather than an operating

company, and our operations will be limited to searching for prospective target businesses to acquire, the only likely claims

to arise would be from our vendors (such as lawyers, investment bankers, etc.) or prospective target businesses.

If our plan of

distribution complies with Section 281(b) of the DGCL, any liability of stockholders with respect to a liquidating distribution

is limited to the lesser of such stockholder’s pro rata share of the claim or the amount distributed to the stockholder,

and any liability of the stockholder would likely be barred after the third anniversary of the dissolution.

We cannot assure our

stockholders that we will properly assess all claims that may be potentially brought against us.

As such, our stockholders could

potentially be liable for any claims to the extent of distributions received by them (but no more) and any liability of our stockholders

may extend beyond the third anniversary of such date.

Furthermore, if the pro rata portion of our trust account distributed to

our public stockholders upon the redemption of our public shares in the event we do not complete our initial business combination

within 24 months from the closing of our initial public offering is not considered a liquidating distribution under Delaware

law and such redemption distribution is deemed to be unlawful (potentially due to the imposition of legal proceedings that a party

may bring or due to other circumstances that are currently unknown), then pursuant to Section 174 of the DGCL, the statute

of limitations for claims of creditors could then be six years after the unlawful redemption distribution, instead of three years,

as in the case of a liquidating distribution.

may not hold an annual meeting of stockholders until after the consummation of our initial business combination, which could delay

the opportunity for our stockholders to elect directors.

accordance with Nasdaq corporate governance requirements, we are not required to hold an annual meeting until no later than one

year after our first fiscal year end following our listing on Nasdaq.

Under Section 211(b) of the DGCL, we are, however,

required to hold an annual meeting of stockholders for the purposes of electing directors in accordance with our bylaws unless

such election is made by written consent in lieu of such a meeting.

We may not hold an annual meeting of stockholders to elect

new directors prior to the consummation of our initial business combination, and thus we may not be in compliance with Section 211(b)

of the DGCL, which requires an annual meeting.

Therefore, if our stockholders want us to hold an annual meeting prior to the consummation

of our initial business combination, they may attempt to force us to hold one by submitting an application to the Delaware Court

of Chancery in accordance with Section 211(c) of the DGCL.

have not registered the shares of Class A common stock issuable upon exercise of the warrants under the Securities Act or

any state securities laws, and such registration may not be in place when a warrant holder desires to exercise warrants, thus

precluding such warrant holder from being able to exercise its warrants except on a cashless basis.

If the issuance of the shares

upon exercise of warrants is not registered, qualified or exempt from registration or qualification, the holder of such warrant

will not be entitled to exercise such warrant and such warrant may have no value and expire worthless.

have not registered the shares of Class A common stock issuable upon exercise of the warrants under the Securities Act or

any state securities laws.

However, under the terms of the warrant agreement, we have agreed that as soon as practicable, but

in no event later than 15 business days after the closing of our initial business combination, we will use our best efforts to

file with the SEC a registration statement for the registration under the Securities Act of the issuance of the shares of Class A

common stock issuable upon exercise of the warrants and thereafter will use our best efforts to cause the same to become effective

within 60 business days following our initial business combination and to maintain a current prospectus relating to the Class A

common stock issuable upon exercise of the warrants, until the expiration of the warrants in accordance with the provisions of

the warrant agreement.

We cannot provide any assurance that we will be able to do so if, for example, any facts or events arise

which represent a fundamental change in the information set forth in the registration statement or prospectus, the financial statements

contained or incorporated by reference therein are not current, complete or correct or the SEC issues a stop order.

If the shares

of Class A common stock issuable upon exercise of the warrants are not registered under the Securities Act, we will be required

to permit holders to exercise their warrants on a cashless basis.

However, no warrant will be exercisable for cash or on a cashless

basis, and we will not be obligated to issue any shares to holders seeking to exercise their warrants, unless the issuance of

the shares upon such exercise is registered or qualified under the securities laws of the state of the exercising holder, or an

exemption from registration is available.

Notwithstanding the foregoing, if a registration statement covering the issuance of

the Class A common stock issuable upon exercise of the warrants is not effective within a specified period following the

consummation of our initial business combination, warrant holders may, until such time as there is an effective registration statement

and during any period when we shall have failed to maintain an effective registration statement, exercise warrants on a cashless

basis pursuant to the exemption provided by Section 3(a)(9) of the Securities Act, provided that such exemption is available.

If that exemption, or another exemption, is not available, holders will not be able to exercise their warrants on a cashless basis.

We will use our best efforts to register or qualify the shares under applicable blue sky laws to the extent an exemption is not

In no event will we be required to net cash settle any warrant, or issue securities or other compensation in exchange

for the warrants in the event that we are unable to register or qualify the shares underlying the warrants under applicable state

securities laws and there is no exemption available.

If the issuance of the shares upon exercise of the warrants is not so registered

or qualified or exempt from registration or qualification, the holder of such warrant will not be entitled to exercise such warrant

and such warrant may have no value and expire worthless.

In such event, holders who acquired their warrants as part of a purchase

of units will have paid the full unit purchase price solely for the shares of Class A common stock included in the units.

If and when the warrants become redeemable by us, we may not exercise our redemption right if the issuance of shares of common

stock upon exercise of the warrants is not exempt from registration or qualification under applicable state blue sky laws or we

are unable to effect such registration or qualification.

We will use our best efforts to register or qualify such shares of common

stock under the blue sky laws of the state of residence in those states in which the warrants were offered by us.

However, there

may be instances in which holders of our public warrants may be unable to exercise such public warrants but holders of our placement

warrants may be able to exercise such placement warrants.

our warrant holders exercise their public warrants on a “cashless basis,”

they will receive fewer shares of Class A

common stock from such exercise than if they were to exercise such warrants for cash.

are circumstances in which the exercise of the public warrants may be required or permitted to be made on a cashless basis.

if a registration statement covering the issuance of the shares of Class A common stock issuable upon exercise of the warrants

is not effective by the 60 th business day after the closing of our initial business combination, warrantholders

may, until such time as there is an effective registration statement, exercise warrants on a cashless basis in accordance with

Section 3(a)(9) of the Securities Act or another exemption.

Second, if a registration statement covering the Class A

common stock issuable upon exercise of the warrants is not effective within a specified period following the consummation of our

initial business combination, warrant holders may, until such time as there is an effective registration statement and during

any period when we shall have failed to maintain an effective registration statement, exercise warrants on a cashless basis pursuant

to the exemption provided by Section 3(a)(9) of the Securities Act, provided that such exemption is available;

if that exemption,

or another exemption, is not available, holders will not be able to exercise their warrants on a cashless basis.

call the public warrants for redemption, our management will have the option to require all holders that wish to exercise warrants

to do so on a cashless basis.

In the event of an exercise on a cashless basis, a holder would pay the warrant exercise price by

surrendering the warrants for that number of shares of Class A common stock equal to the quotient obtained by dividing (x) the

product of the number of shares of Class A common stock underlying the warrants, multiplied by the difference between the

exercise price of the warrants and the “fair market value”

(as defined in the next sentence) by (y) the fair

market value.

The “fair market value”

for this purpose shall mean the average reported last sale price of the Class A

common stock for the 10 trading days ending on the third trading day prior to the date on which the notice of exercise is received

by the warrant agent or on which the notice of redemption is sent to the holders of warrants, as applicable.

As a result, they

would receive fewer shares of Class A common stock from such exercise than if they were to exercise such warrants for cash.

grant of registration rights to our initial stockholders and the underwriters may make it more difficult to complete our initial

business combination, and the future exercise of such rights may adversely affect the market price of our Class A common

to an agreement entered into concurrently with the issuance and sale of the securities in our initial public offering, our initial

stockholders, the underwriters and their permitted transferees can demand that we register the resale of the placement units,

the placement shares, the placement warrants, the shares of Class A common stock issuable upon exercise of the placement

warrants, the shares of Class A common stock issuable upon conversion of the founder shares, the shares of Class A common

stock included in the placement units and holders of units that may be issued upon conversion of working capital loans may demand

that we register the resale of such shares of Class A common stock, warrants or the Class A common stock issuable upon

exercise of such units and warrants.

We will bear the cost of registering these securities.

The registration and availability

of such a significant number of securities for trading in the public market may have an adverse effect on the market price of

our Class A common stock.

In addition, the existence of the registration rights may make our initial business combination

more costly or difficult to complete.

This is because the stockholders of the target business may increase the equity stake they

seek in the combined entity or ask for more cash consideration to offset the negative impact on the market price of our Class A

common stock that is expected when the securities owned by our initial stockholders or holders of working capital loans or their

respective permitted transferees are registered.

we are not limited to evaluating a target business in a particular industry sector, our stockholders will be unable to ascertain

the merits or risks of any particular target business’s operations.

will seek to complete an initial business combination with companies in the healthcare industry but may also pursue other business

combination opportunities, except that we will not, under our amended and restated certificate of incorporation, be permitted

to effectuate our initial business combination with another blank check company or similar company with nominal operations.

the extent we complete our initial business combination, we may be affected by numerous risks inherent in the business operations

with which we combine.

For example, if we combine with a financially unstable business or an entity lacking an established record

of sales or earnings, we may be affected by the risks inherent in the business and operations of a financially unstable or a development

stage entity.

Although our officers and directors will endeavor to evaluate the risks inherent in a particular target business,

we cannot provide any assurance that we will properly ascertain or assess all of the significant risk factors or that we will

have adequate time to complete due diligence.

Furthermore, some of these risks may be outside of our control and leave us with

no ability to control or reduce the chances that those risks will adversely impact a target business.

We also cannot provide any

assurance that an investment in our securities will ultimately prove to be more favorable to investors than a direct investment,

if such opportunity were available, in a business combination target.

Accordingly, any stockholders who choose to remain stockholders

following our initial business combination could suffer a reduction in the value of their securities.

Such stockholders are unlikely

to have a remedy for such reduction in value unless they are able to successfully claim that the reduction was due to the breach

by our officers or directors of a duty of care or other fiduciary duty owed to them, or if they are able to successfully bring

a private claim under securities laws that the proxy solicitation or tender offer materials, as applicable, relating to the business

combination contained an actionable material misstatement or material omission.

performance by our management team may not be indicative of future performance of an investment in us.

performance by our management team is not a guarantee either (i) of success with respect to any business combination we may

consummate or (ii) that we will be able to locate a suitable candidate for our initial business combination.

The historical

record of our management team’s performance should not be relied upon as indicative of our future performance of an investment

in the company or the returns the company will, or is likely to, generate going forward.

Other than Rajiv Shukla, our Chief Executive

Officer, and Patrick A.

Sturgeon, our Chief Financial Officer, none of our directors has experience with blank check companies

or special purpose acquisition companies.

Additionally, in the course of their respective careers, members of our management team

have been involved in businesses and deals that were unsuccessful.

may seek business combination opportunities in industries or sectors which may or may not be outside of our management’s

area of expertise.

we intend to focus on identifying healthcare companies, we will consider an initial business combination outside of our management’s

area of expertise if an initial business combination candidate is presented to us and we determine that such candidate offers

an attractive business combination opportunity for our company or we are unable to identify a suitable candidate in this sector

after having expanded a reasonable amount of time and effort in an attempt to do so.

Although our management will endeavor to

evaluate the risks inherent in any particular business combination candidate, we cannot provide any assurance that we will adequately

ascertain or assess all of the significant risk factors.

We also cannot provide any assurance that an investment in our securities

will not ultimately prove to be less favorable to our stockholders than a direct investment, if an opportunity were available,

in an initial business combination candidate.

In the event we elect to pursue a business combination outside of the areas of our

management’s expertise, our management’s expertise may not be directly applicable to its evaluation or operation,

and the information contained in this Form 10-K regarding the areas of our management’s expertise would not be relevant

to an understanding of the business that we elect to acquire.

As a result, our management may not be able to adequately ascertain

or assess all of the significant risk factors.

Accordingly, any stockholders who choose to remain stockholders following our initial

business combination could suffer a reduction in the value of their shares.

Such stockholders are unlikely to have a remedy for

such reduction in value.

we have identified general criteria and guidelines that we believe are important in evaluating prospective target businesses,

we may enter into our initial business combination with a target that does not meet such criteria and guidelines, and as a result,

the target business with which we enter into our initial business combination may not have attributes entirely consistent with

our general criteria and guidelines.

we have identified general criteria and guidelines for evaluating prospective target businesses, it is possible that a target

business with which we enter into our initial business combination will not have all of these positive attributes.

If we complete

our initial business combination with a target that does not meet some or all of these guidelines, such combination may not be

as successful as a combination with a business that does meet all of our general criteria and guidelines.

In addition, if we announce

a prospective business combination with a target that does not meet our general criteria and guidelines, a greater number of stockholders

may exercise their redemption rights, which may make it difficult for us to meet any closing condition with a target business

that requires us to have a minimum net worth or a certain amount of cash.

In addition, if stockholder approval of the transaction

is required by applicable law or stock exchange requirements, or we decide to obtain stockholder approval for business or other

legal reasons, it may be more difficult for us to attain stockholder approval of our initial business combination if the target

business does not meet our general criteria and guidelines.

If we are unable to complete our initial business combination, our

public stockholders may receive only approximately $10.00 per share on the liquidation of our trust account and our warrants will

expire worthless.

In certain circumstances, our public stockholders may receive less than $10.00 per share on the redemption of

their shares.

may seek business combination opportunities with a financially unstable business or an entity lacking an established record of

revenue, cash flow or earnings, which could subject us to volatile revenues, cash flows or earnings or difficulty in retaining

key personnel.

the extent we complete our initial business combination with a financially unstable business or an entity lacking an established

record of revenues or earnings, we may be affected by numerous risks inherent in the operations of the business with which we

These risks include volatile revenues or earnings and difficulties in obtaining and retaining key personnel.

our officers and directors will endeavor to evaluate the risks inherent in a particular target business, we may not be able to

properly ascertain or assess all of the significant risk factors and we may not have adequate time to complete due diligence.

Furthermore, some of these risks may be outside of our control and leave us with no ability to control or reduce the chances that

those risks will adversely impact a target business.

are not required to obtain a fairness opinion and consequently, our stockholders may have no assurance from an independent source

that the price we are paying for the business is fair to our company from a financial point of view.

we complete our initial business combination with an affiliated entity or our board cannot independently determine the fair market

value of the target business or businesses, we are not required to obtain an opinion from an independent investment banking firm

or another independent entity that commonly renders valuation opinions that the price we are paying is fair to our company from

a financial point of view.

If no opinion is obtained, our stockholders will be relying on the judgment of our board of directors,

who will determine fair market value based on standards generally accepted by the financial community.

Such standards used will

be disclosed in our proxy materials or tender offer documents, as applicable, related to our initial business combination.

may issue additional common stock or preferred stock to complete our initial business combination or under an employee incentive

plan after completion of our initial business combination.

We may also issue shares of Class A common stock upon the conversion

of the Class B common stock at a ratio greater than one-to-one at the time of the consummation of our initial business combination

as a result of the anti-dilution provisions contained in our amended and restated certificate of incorporation.

Any such issuances

would dilute the interest of our stockholders and likely present other risks.

amended and restated certificate of incorporation authorizes the issuance of up to 100,000,000 shares of Class A common

stock, par value $0.0001 per share, 10,000,000 shares of Class B common stock, par value $0.0001 per share, and 1,000,000 shares

of preferred stock, par value $0.0001 per share.

There are 89,645,000 and 7,500,000 authorized but unissued shares of Class A

common stock and Class B common stock, respectively, available for issuance, which amount does not take into account the

shares of Class A common stock reserved for issuance upon exercise of outstanding warrants or the shares of Class A

common stock issuable upon conversion of Class B common stock.

There are no shares of preferred stock issued and outstanding.

Shares of Class B common stock are convertible into shares of our Class A common stock initially at a one-for-one ratio

but subject to adjustment, including in certain circumstances in which we issue Class A common stock or equity-linked securities

related to our initial business combination.

may issue a substantial number of additional shares of common or preferred stock to complete our initial business combination

or under an employee incentive plan after completion of our initial business combination (although our amended and restated certificate

of incorporation provides that we may not issue securities that can vote with common stockholders on matters related to our pre-initial business

combination activity).

We may also issue shares of Class A common stock upon conversion of the Class B common stock

at a ratio greater than one-to-one at the time of the consummation of our initial business combination as a result of the

anti-dilution provisions contained in our amended and restated certificate of incorporation.

However, our amended and restated

certificate of incorporation provides, among other things, that prior to our initial business combination, we may not issue additional

shares of capital stock that would entitle the holders thereof to (i) receive funds from the trust account or (ii) vote

on any initial business combination.

These provisions of our amended and restated certificate of incorporation, like all provisions

of our amended and restated certificate of incorporation, may be amended with the approval of our stockholders.

However, our executive

officers and directors have agreed, pursuant to a written agreement with us, that they will not propose any amendment to our amended

and restated certificate of incorporation (A) to modify the substance or timing of our obligation to allow redemption in

connection with our initial business combination or certain amendments to our charter prior thereto or to redeem 100% of our public

shares if we do not complete our initial business combination within 24 months from the closing of our initial public offering

or (B) with respect to any other provision relating to stockholders’

rights or pre-initial business combination

activity, unless we provide our public stockholders with the opportunity to redeem their shares of common stock upon approval

of any such amendment at a per-share price, payable in cash, equal to the aggregate amount then on deposit in the trust account,

including interest (which interest shall be net of taxes payable), divided by the number of then outstanding public shares.

issuance of additional shares of common or preferred stock:

significantly dilute the equity interest of our public stockholders, which dilution would increase if the anti-dilution provisions

in the Class B common stock resulted in the issuance of Class A shares on a greater than one-to-one basis upon

conversion of the Class B common stock;

subordinate the rights of holders of our common stock if preferred stock is issued with rights senior to those afforded our common

cause a change of control if a substantial number of shares of our common stock are issued, which may affect, among other things,

our ability to use our net operating loss carry forwards, if any, and could result in the resignation or removal of our present

officers and directors;

have the effect of delaying or preventing a change of control of us by diluting the stock ownership or voting rights of a person

seeking to obtain control of us;

adversely affect prevailing market prices for our units, Class A common stock and/or warrants.

could be wasted in researching business combinations that are not completed, which could materially adversely affect subsequent

attempts to locate and acquire or merge with another business.

If we are unable to complete our initial business combination,

our public stockholders may receive only approximately $10.00 per share, or less than such amount in certain circumstances, on

the liquidation of our trust account and our warrants will expire worthless.

anticipate that the investigation of each specific target business and the negotiation, drafting and execution of relevant agreements,

disclosure documents and other instruments will require substantial management time and attention and substantial costs for accountants,

attorneys, consultants and others.

If we decide not to complete a specific initial business combination, the costs incurred up

to that point for the proposed transaction likely would not be recoverable.

Furthermore, if we reach an agreement relating to

a specific target business, we may fail to complete our initial business combination for any number of reasons including those

beyond our control.

Any such event will result in a loss to us of the related costs incurred which could materially adversely

affect subsequent attempts to locate and acquire or merge with another business.

If we are unable to complete our initial business

combination, our public stockholders may receive only approximately $10.00 per share on the liquidation of our trust account and

our warrants will expire worthless.

In certain circumstances, our public stockholders may receive less than $10.00 per share on

the redemption of their shares.

ability to successfully effect our initial business combination and to be successful thereafter will be totally dependent upon

the efforts of our key personnel, some of whom may join us following our initial business combination.

The loss of key personnel

could negatively impact the operations and profitability of our post-combination business.

ability to successfully effect our initial business combination is dependent upon the efforts of our key personnel.

our key personnel in the target business, however, cannot presently be ascertained.

Although some of our key personnel may remain

with the target business in senior management or advisory positions following our initial business combination, it is likely that

some or all of the management of the target business will remain in place.

While we intend to closely scrutinize any individuals

we employ after our initial business combination, we cannot provide any assurance that our assessment of these individuals will

prove to be correct.

These individuals may be unfamiliar with the requirements of operating a company regulated by the SEC, which

could cause us to have to expend time and resources helping them become familiar with such requirements.

In addition, the officers

and directors of an initial business combination candidate may resign upon completion of our initial business combination.

departure of an initial business combination target’s key personnel could negatively impact the operations and profitability

of our post-combination business.

The role of an initial business combination candidate’s key personnel upon the completion

of our initial business combination cannot be ascertained at this time.

Although we contemplate that certain members of an initial

business combination candidate’s management team will remain associated with the initial business combination candidate

following our initial business combination, it is possible that members of the management of an initial business combination candidate

will not wish to remain in place.

The loss of key personnel could negatively impact the operations and profitability of our post-combination business.

are dependent upon our executive officers and directors and their departure could adversely affect our ability to operate.

operations are dependent upon a relatively small group of individuals and, in particular, our executive officers and directors.

We believe that our success depends on the continued service of our executive officers and directors, at least until we have completed

our initial business combination.

We do not have an employment agreement with, or key-man insurance on the life of, any of

our directors or executive officers.

The unexpected loss of the services of one or more of our directors or executive officers

could have a detrimental effect on us.

key personnel may negotiate employment or consulting agreements with a target business in connection with a particular business

These agreements may provide for them to receive compensation following our initial business combination and as a

result, may cause them to have conflicts of interest in determining whether a particular business combination is the most advantageous.

key personnel may be able to remain with the company after the completion of our initial business combination only if they are

able to negotiate employment or consulting agreements in connection with the initial business combination.

Such negotiations would

take place simultaneously with the negotiation of the initial business combination and could provide for such individuals to receive

compensation in the form of cash payments and/or our securities for services they would render to us after the completion of the

initial business combination.

The personal and financial interests of such individuals may influence their motivation in identifying

and selecting a target business.

However, we believe the ability of such individuals to remain with us after the completion of

our initial business combination will not be the determining factor in our decision as to whether or not we will proceed with

any potential business combination.

There is no certainty, however, that any of our key personnel will remain with us after the

completion of our initial business combination.

We cannot provide any assurance that any of our key personnel will remain in senior

management or advisory positions with us.

The determination as to whether any of our key personnel will remain with us will be

made at the time of the consummation of our initial business combination.

may have a limited ability to assess the management of a prospective target business and, as a result, may effect our initial

business combination with a target business whose management may not have the skills, qualifications or abilities to manage a

public company, which could, in turn, negatively impact the value of our stockholders’

investment in us.

evaluating the desirability of effecting our initial business combination with a prospective target business, our ability to assess

the target business’s management may be limited due to a lack of time, resources or information.

Our assessment of the capabilities

of the target’s management, therefore, may prove to be incorrect and such management may lack the skills, qualifications

or abilities we suspected.

Should the target’s management not possess the skills, qualifications or abilities necessary

to manage a public company, the operations and profitability of the post-combination business may be negatively impacted.

Accordingly, any stockholders who choose to remain stockholders following the initial business combination could suffer a reduction

in the value of their shares.

Such stockholders are unlikely to have a remedy for such reduction in value.

officers and directors will allocate their time to other businesses thereby causing conflicts of interest in their determination

as to how much time to devote to our affairs.

This conflict of interest could have a negative impact on our ability to complete

our initial business combination.

officers and directors are not required to, and will not, commit their full time to our affairs, which may result in a conflict

of interest in allocating their time between our operations and our search for an initial business combination and their other

We do not intend to have any full-time employees prior to the completion of our initial business combination.

Each of our officers is engaged in other business endeavors for which he may be entitled to substantial compensation and our officers

are not obligated to contribute any specific number of hours per week to our affairs.

Our independent directors may also serve

as officers or board members for other entities.

If our officers’

and directors’

other business affairs require them

to devote substantial amounts of time to such affairs in excess of their current commitment levels, it could limit their ability

to devote time to our affairs which may have a negative impact on our ability to complete our initial business combination.

of our officers and directors are now, and all of them may in the future become, affiliated with entities engaged in business

activities similar to those intended to be conducted by us and, accordingly, may have conflicts of interest in allocating their

time and determining to which entity a particular business opportunity should be presented.

we consummate our initial business combination, we intend to engage in the business of identifying and combining with one or more

Our sponsor and officers and directors are, and may in the future become, affiliated with entities (such as operating

companies or investment vehicles) that are engaged in a similar business and our officers and directors may become officers or

directors of another special purpose acquisition company with a class of securities intended to be registered under the Exchange

Act, even prior to us entering into a definitive agreement for our initial business combination.

Our officers and directors also

may become aware of business opportunities which may be appropriate for presentation to us and the other entities to which they

owe certain fiduciary or contractual duties.

they may have conflicts of interest in determining to which entity a particular business opportunity should be presented.

conflicts may not be resolved in our favor and a potential target business may be presented to another entity prior to its presentation

Our amended and restated certificate of incorporation provides that we renounce our interest in any corporate opportunity

offered to any director or officer unless such opportunity is expressly offered to such person solely in his or her capacity as

a director or officer of our company and such opportunity is one we are legally and contractually permitted to undertake and would

otherwise be reasonable for us to pursue, and to the extent the director or officer is permitted to refer that opportunity to

us without violating another legal obligation.

officers, directors, security holders and their respective affiliates may have competitive pecuniary interests that conflict with

our interests.

have not adopted a policy that expressly prohibits our directors, officers, security holders or affiliates from having a direct

or indirect pecuniary or financial interest in any investment to be acquired or disposed of by us or in any transaction to which

we are a party or have an interest.

In fact, we may enter into an initial business combination with a target business that is

affiliated with our sponsor, our directors or officers, although we do not intend to do so.

We do not have a policy that expressly

prohibits any such persons from engaging for their own account in business activities of the types conducted by us.

such persons or entities may have a conflict between their interests and ours.

may engage in an initial business combination with one or more target businesses that have relationships with entities that may

be affiliated with our sponsor, officers, directors or existing holders which may raise potential conflicts of interest.

light of the involvement of our sponsor, officers and directors with other entities, we may decide to acquire one or more businesses

affiliated with our sponsor, officers or directors.

Our directors and officers also serve as officers and board members for other

Such entities may compete with us for business combination opportunities.

Our sponsor, officers and directors are not

currently aware of any specific opportunities for us to complete our initial business combination with any entities with which

they are affiliated, and there have been no preliminary discussions concerning an initial business combination with any such entity

Although we will not be specifically focusing on, or targeting, any transaction with any affiliated entities, we

would pursue such a transaction if we determined that such affiliated entity met our criteria for an initial business combination

and such transaction was approved by a majority of our disinterested directors.

Despite our agreement to obtain an opinion from

an independent investment banking firm or another independent entity that commonly renders valuation opinions, regarding the fairness

to our stockholders from a financial point of view of an initial business combination with one or more businesses affiliated with

our sponsor, officers, directors or existing holders, potential conflicts of interest still may exist and, as a result, the terms

of the initial business combination may not be as advantageous to our public stockholders as they would be absent any conflicts

our sponsor, officers and directors will lose their entire investment in us if our initial business combination is not completed,

a conflict of interest may arise in determining whether a particular business combination target is appropriate for our initial

business combination.

securities held by our founders will be worthless if we do not complete an initial business combination.

Holders of founder shares

have agreed (A) to vote any shares owned by them in favor of any proposed initial business combination and (B) not to

redeem any founder shares or placement shares held by them in connection with a stockholder vote to approve a proposed initial

business combination.

In addition, we may obtain loans from our sponsor, affiliates of our sponsor or an officer or director.

The personal and financial interests of our officers and directors may influence their motivation in identifying and selecting

a target business combination, completing an initial business combination and influencing the operation of the business following

the initial business combination.

may issue notes or other debt securities, or otherwise incur substantial debt, to complete an initial business combination, which

may adversely affect our leverage and financial condition and thus negatively impact the value of our stockholders’

we have no commitments to issue any notes or other debt securities, or to otherwise incur outstanding debt, we may choose to incur

substantial debt to complete our initial business combination.

We have agreed that we will not incur any indebtedness unless we

have obtained from the lender a waiver of any right, title, interest or claim of any kind in or to the monies held in the trust

As such, no issuance of debt will affect the per-share amount available for redemption from the trust account.

Nevertheless,

the incurrence of debt could have a variety of negative effects, including:

and foreclosure on our assets if our operating revenues after an initial business combination are insufficient to repay our debt

● acceleration

of our obligations to repay the indebtedness even if we make all principal and interest payments when due if we breach certain

covenants that require the maintenance of certain financial ratios or reserves without a waiver or renegotiation of that covenant;

immediate payment of all principal and accrued interest, if any, if the debt security is payable on demand;

inability to obtain necessary additional financing if the debt security contains covenants restricting our ability to obtain such

financing while the debt security is outstanding;

inability to pay dividends on our common stock;

a substantial portion of our cash flow to pay principal and interest on our debt, which will reduce the funds available for dividends

on our common stock if declared, our ability to pay expenses, make capital expenditures and acquisitions, and fund other general

corporate purposes;

● limitations

on our flexibility in planning for and reacting to changes in our business and in the industry in which we operate;

vulnerability to adverse changes in general economic, industry and competitive conditions and adverse changes in government regulation;

● limitations

on our ability to borrow additional amounts for expenses, capital expenditures, acquisitions, debt service requirements, and execution

of our strategy;

disadvantages compared to our competitors who have less debt.

may only be able to complete one business combination with the proceeds of our initial public offering and concurrent private

placement, which will cause us to be solely dependent on a single business which may have a limited number of services and limited

operating activities.

This lack of diversification may negatively impact our operating results and profitability.

the net proceeds from our initial public offering and the sale of the placement units, $100,000,000 is available to complete our

initial business combination and pay related fees and expenses (which includes up to $3,500,000 for the payment of deferred underwriting

commissions).

may effectuate our initial business combination with a single target business or multiple target businesses simultaneously or

within a short period of time.

However, we may not be able to effectuate our initial business combination with more than one target

business because of various factors, including the existence of complex accounting issues and the requirement that we prepare

and file pro forma financial statements with the SEC that present operating results and the financial condition of several target

businesses as if they had been operated on a combined basis.

By completing our initial business combination with only a single

entity, our lack of diversification may subject us to numerous economic, competitive and regulatory developments.

would not be able to diversify our operations or benefit from the possible spreading of risks or offsetting of losses, unlike

other entities which may have the resources to complete several business combinations in different industries or different areas

of a single industry.

In addition, we intend to focus our search for an initial business combination in a single industry.

the prospects for our success may be:

dependent upon the performance of a single business, property or asset, or

upon the development or market acceptance of a single or limited number of products, processes or services.

lack of diversification may subject us to numerous economic, competitive and regulatory risks, any or all of which may have a

substantial adverse impact upon the particular industry in which we may operate subsequent to our initial business combination.

may attempt to simultaneously complete business combinations with multiple prospective targets, which may hinder our ability to

complete our initial business combination and give rise to increased costs and risks that could negatively impact our operations

and profitability.

we determine to simultaneously acquire several businesses that are owned by different sellers, we will need for each of such sellers

to agree that our purchase of its business is contingent on the simultaneous closings of the other business combinations, which

may make it more difficult for us, and delay our ability, to complete our initial business combination.

We do not, however, intend

to purchase multiple businesses in unrelated industries in conjunction with our initial business combination.

With multiple business

combinations, we could also face additional risks, including additional burdens and costs with respect to possible multiple negotiations

and due diligence investigations (if there are multiple sellers) and the additional risks associated with the subsequent assimilation

of the operations and services or products of the acquired companies in a single operating business.

If we are unable to adequately

address these risks, it could negatively impact our profitability and results of operations.

may attempt to complete our initial business combination with a private company about which little information is available, which

may result in an initial business combination with a company that is not as profitable as we suspected, if at all.

pursuing our initial business combination strategy, we may seek to effectuate our initial business combination with a privately

held company.

Very little public information generally exists about private companies, and we could be required to make our decision

on whether to pursue a potential initial business combination on the basis of limited information, which may result in an initial

business combination with a company that is not as profitable as we suspected, if at all.

management may not be able to maintain control of a target business after our initial business combination.

may structure an initial business combination so that the post-transaction company in which our public stockholders own shares

will own less than 100% of the equity interests or assets of a target business, but we will only complete such business combination

if the post-transaction company owns or acquires 50% or more of the outstanding voting securities of the target or otherwise

acquires a controlling interest in the target sufficient for us not to be required to register as an investment company under

the Investment Company Act.

We will not consider any transaction that does not meet such criteria.

Even if the post-transaction company

owns 50% or more of the voting securities of the target, our stockholders prior to the initial business combination may collectively

own a minority interest in the post business combination company, depending on valuations ascribed to the target and us in the

initial business combination.

For example, we could pursue a transaction in which we issue a substantial number of new shares

of Class A common stock in exchange for all of the outstanding capital stock of a target.

In this case, we would acquire

a 100% interest in the target.

However, as a result of the issuance of a substantial number of new shares of common stock, our

stockholders immediately prior to such transaction could own less than a majority of our outstanding shares of common stock subsequent

to such transaction.

In addition, other minority stockholders may subsequently combine their holdings resulting in a single person

or group obtaining a larger share of the company’s stock than we initially acquired.

Accordingly, this may make it more

likely that our management will not be able to maintain our control of the target business.

We cannot provide assurance that,

upon loss of control of a target business, new management will possess the skills, qualifications or abilities necessary to profitably

operate such business.

do not have a specified maximum redemption threshold.

The absence of such a redemption threshold may make it possible for us to

complete an initial business combination with which a substantial majority of our stockholders do not agree.

amended and restated certificate of incorporation does not provide a specified maximum redemption threshold, except that in no

event will we redeem our public shares unless our net tangible assets are at least $5,000,001 either immediately prior to or upon

consummation of our initial business combination and after payment of underwriters’

fees and commissions (such that we are

not subject to the SEC’s “penny stock”

rules) or any greater net tangible asset or cash requirement which may

be contained in the agreement relating to our initial business combination.

As a result, we may be able to complete our initial

business combination even though a substantial majority of our public stockholders do not agree with the transaction and have

redeemed their shares or, if we seek stockholder approval of our initial business combination and do not conduct redemptions in

connection with our initial business combination pursuant to the tender offer rules, have entered into privately negotiated agreements

to sell their shares to our sponsor, officers, directors or their affiliates.

In the event the aggregate cash consideration we

would be required to pay for all shares of Class A common stock that are validly submitted for redemption plus any amount

required to satisfy cash conditions pursuant to the terms of the proposed initial business combination exceed the aggregate amount

of cash available to us, we will not complete the initial business combination or redeem any shares, all shares of Class A

common stock submitted for redemption will be returned to the holders thereof, and we instead may search for an alternate business

order to effectuate an initial business combination, blank check companies have, in the recent past, amended various provisions

of their charters and other governing instruments, including their warrant agreements.

We cannot provide any assurance that we

will not seek to amend our amended and restated certificate of incorporation or governing instruments in a manner that will make

it easier for us to complete our initial business combination that our stockholders may not support.

order to effectuate an initial business combination, blank check companies have, in the recent past, amended various provisions

of their charters and modified governing instruments, including their warrant agreements.

For example, blank check companies have

amended the definition of business combination, increased redemption thresholds and extended the time to consummate an initial

business combination and, with respect to their warrants, amended their warrant agreements to require the warrants to be exchanged

for cash and/or other securities.

Amending our amended and restated certificate of incorporation will require the approval of

holders of 65% of our common stock, and amending our warrant agreement will require a vote of holders of at least a majority of

the public warrants (which may include public warrants acquired by our sponsor or its affiliates in our initial public offering

or thereafter in the open market).

In addition, our amended and restated certificate of incorporation requires us to provide our

public stockholders with the opportunity to redeem their public shares for cash if we propose an amendment to our amended and

restated certificate of incorporation (A) to modify the substance or timing of our obligation to allow redemption in connection

with our initial business combination or certain amendments to our charter prior thereto or to redeem 100% of our public shares

if we do not complete our initial business combination within 24 months from the closing of our initial public offering or

(B) with respect to any other provision relating to stockholders’

rights or pre-initial business combination activity.

the extent any such amendments would be deemed to fundamentally change the nature of any securities offered through this registration

statement, we would register, or seek an exemption from registration for, the affected securities.

We cannot assure our stockholders

that we will not seek to amend our charter or governing instruments or extend the time to consummate an initial business combination

in order to effectuate our initial business combination.

provisions of our amended and restated certificate of incorporation that relate to our pre-business combination activity (and

corresponding provisions of the agreement governing the release of funds from our trust account), including an amendment to permit

us to withdraw funds from the trust account such that the per share amount investors will receive upon any redemption or liquidation

is substantially reduced or eliminated, may be amended with the approval of holders of at least 65% of our common stock, which

is a lower amendment threshold than that of some other blank check companies.

It may be easier for us, therefore, to amend our

amended and restated certificate of incorporation and the trust agreement to facilitate the completion of an initial business

combination that some of our stockholders may not support.

amended and restated certificate of incorporation provides that any of its provisions related to pre-initial business combination

activity (including the requirement to deposit proceeds of our initial public offering and concurrent private placement into the

trust account and not release such amounts except in specified circumstances, and to provide redemption rights to public stockholders

and including to permit us to withdraw funds from the trust account such that the per share amount investors will receive upon

any redemption or liquidation is substantially reduced or eliminated) may be amended if approved by holders of at least 65% of

our common stock entitled to vote thereon, and corresponding provisions of the trust agreement governing the release of funds

from our trust account may be amended if approved by holders of at least 65% of our common stock entitled to vote thereon.

all other instances, our amended and restated certificate of incorporation may be amended by holders of a majority of our outstanding

common stock entitled to vote thereon, subject to applicable provisions of the DGCL or applicable stock exchange rules.

not issue additional securities that can vote on amendments to our amended and restated certificate of incorporation.

stockholders, who will collectively beneficially own approximately 21.8% of our common stock, will participate in any vote to

amend our amended and restated certificate of incorporation and/or trust agreement and will have the discretion to vote in any

manner they choose.

As a result, we may be able to amend the provisions of our amended and restated certificate of incorporation

which govern our pre-initial business combination behavior more easily than some other blank check companies, and this may

increase our ability to complete an initial business combination with which stockholders do not agree.

Our stockholders may pursue

remedies against us for any breach of our amended and restated certificate of incorporation.

sponsor, officers and directors have agreed, pursuant to a written agreement with us, that they will not propose any amendment

to our amended and restated certificate of incorporation (i) to modify the substance or timing of our obligation to allow

redemption in connection with our initial business combination or certain amendments to our charter prior thereto or to redeem

100% of our public shares if we do not complete our initial business combination within 24 months from the closing of our

initial public offering or (ii) with respect to any other provision relating to stockholders’

rights or pre-initial business

combination activity, unless we provide our public stockholders with the opportunity to redeem their shares of Class A common

stock upon approval of any such amendment at a per-share price, payable in cash, equal to the aggregate amount then on deposit

in the trust account, divided by the number of then outstanding public shares.

These agreements are contained in a letter agreement

that we have entered into with our sponsor, officers and directors.

Our stockholders are not parties to, or third-party beneficiaries

of, these agreements and, as a result, will not have the ability to pursue remedies against our sponsor, officers or directors

for any breach of these agreements.

As a result, in the event of a breach, our stockholders would need to pursue a stockholder

derivative action, subject to applicable law.

may be unable to obtain additional financing to complete our initial business combination or to fund the operations and growth

of a target business, which could compel us to restructure or abandon a particular business combination.

intend to target businesses larger than we could acquire with the net proceeds of our initial public offering and the concurrent

private placement.

As a result, we may be required to seek additional financing to complete such proposed initial business combination.

We cannot assure our stockholders that such financing will be available on acceptable terms, if at all.

To the extent that additional

financing proves to be unavailable when needed to complete our initial business combination, we would be compelled to either restructure

the transaction or abandon that particular business combination and seek an alternative target business candidate.

amount of additional financing we may be required to obtain could increase as a result of future growth capital needs for any

particular transaction, the depletion of the available net proceeds in search of a target business, the obligation to repurchase

for cash a significant number of shares from stockholders who elect redemption in connection with our initial business combination

and/or the terms of negotiated transactions to purchase shares in connection with our initial business combination.

unable to complete our initial business combination, our public stockholders may receive only approximately $10.00 per share plus

any pro rata interest earned on the funds held in the trust account and not previously released to us to pay our taxes on the

liquidation of our trust account and our warrants will expire worthless.

In addition, even if we do not need additional financing

to complete our initial business combination, we may require such financing to fund the operations or growth of the target business.

The failure to secure additional financing could have a material adverse effect on the continued development or growth of the

target business.

None of our officers, directors or stockholders is required to provide any financing to us in connection with

or after our initial business combination.

If we are unable to complete our initial business combination, our public stockholders

may only receive approximately $10.00 per share on the liquidation of our trust account, and our warrants will expire worthless.

Furthermore, under certain circumstances our public stockholders may receive less than $10.00 per share upon the liquidation of

the trust account.

initial stockholders may exert a substantial influence on actions requiring a stockholder vote, potentially in a manner that our

public stockholders do not support.

initial stockholders own shares representing approximately 21.8% of our issued and outstanding shares of common stock.

they may exert a substantial influence on actions requiring a stockholder vote, potentially in a manner that public stockholders

do not support, including amendments to our amended and restated certificate of incorporation and approval of major corporate

transactions.

If our initial stockholders purchase any additional shares of common stock in the open market or in privately negotiated

transactions, this would increase their control.

Factors that would be considered in making such additional purchases would include

consideration of the current trading price of our Class A common stock.

In addition, our board of directors, whose members

were elected by our initial stockholders, is and will be divided into three classes, each of which will generally serve for a

term of three years with only one class of directors being elected in each year.

We may not hold an annual meeting of stockholders

to elect new directors prior to the completion of our initial business combination, in which case all of the current directors

will continue in office until at least the completion of the initial business combination.

If there is an annual meeting, as a

consequence of our “staggered”

board of directors, only a minority of the board of directors will be considered for

election and our initial stockholders, because of their ownership position, will have considerable influence regarding the outcome.

Accordingly, our initial stockholders will continue to exert control at least until the completion of our initial business combination.

sponsor paid an aggregate of $25,000 for the founder shares, or approximately $0.009 per founder share.

As a result of this low

initial price, our sponsor, its affiliates and our management team stand to make a substantial profit even if an initial business

combination subsequently declines in value or is unprofitable for our public stockholders.

a result of the low acquisition cost of our founder shares, our sponsor, its affiliates and our management team could make a substantial

profit even if we select and consummate an initial business combination with an acquisition target that subsequently declines

in value or is unprofitable for our public stockholders.

Thus, such parties may have more of an economic incentive for us to enter

into an initial business combination with a riskier, weaker-performing or financially unstable business, or an entity lacking

an established record of revenues or earnings, than would be the case if such parties had paid the full offering price for their

founder shares.

many other similarly structured special purpose acquisition companies, our initial stockholders will receive additional shares

of Class A common stock if we issue shares to consummate an initial business combination.

founder shares will automatically convert into Class A common stock at the time of the consummation of our initial business

combination, on a one-for-one basis, subject to adjustment.

In the case that additional shares of Class A common stock,

or equity-linked securities convertible or exercisable for Class A common stock, are issued or deemed issued in excess

of the amounts issued in our initial public offering and related to the closing of the initial business combination, the ratio

at which founder shares shall convert into Class A common stock will be adjusted so that the number of Class A common

stock issuable upon conversion of all founder shares will equal, in the aggregate, on an as-converted basis, 20% of the total

number of all outstanding shares of common stock upon completion of the initial business combination, excluding the placement

shares and any shares or equity-linked securities issued, or to be issued, to any seller in the business combination and

any private placement-equivalent units and their underlying securities issued to our sponsor or its affiliates upon conversion

of loans made to us.

This is different from most other similarly structured blank check companies in which the initial stockholder

will only be issued an aggregate of 20% of the total number of shares to be outstanding prior to the initial business combination.

Additionally, the aforementioned adjustment will not take into account any shares of Class A common stock redeemed in connection

with the business combination.

Accordingly, the holders of the founder shares could receive additional shares of Class A

common stock even if the additional shares of Class A common stock, or equity-linked securities convertible or exercisable

for Class A common stock, are issued or deemed issued solely to replace those shares that were redeemed in connection with

the business combination.

The foregoing may make it more difficult and expensive for us to consummate an initial business combination.

may amend the terms of the warrants in a manner that may be adverse to holders of public warrants with the approval by the holders

of at least a majority of the then outstanding public warrants.

As a result, the exercise price of the warrants could be increased,

the exercise period could be shortened and the number of shares of our Class A common stock purchasable upon exercise of

a warrant could be decreased.

warrants were issued in registered form under a warrant agreement between Continental Stock Transfer & Trust Company,

as warrant agent, and us.

The warrant agreement provides that the terms of the warrants may be amended without the consent of

any holder to cure any ambiguity or correct any mistake, including to conform the provisions of the warrant agreement to the description

of the terms of the warrants and the warrant agreement, or defective provision, but requires the approval by the holders of at

least a majority of the then outstanding public warrants to make any change that adversely affects the interests of the registered

holders of public warrants (which may include public warrants acquired by our sponsor or its affiliates in the initial public

offering or thereafter in the open market).

Accordingly, we may amend the terms of the public warrants in a manner adverse to

a holder if holders of at least a majority of the then outstanding public warrants approve of such amendment.

Although our ability

to amend the terms of the public warrants with the consent of at least a majority of the then outstanding public warrants is unlimited,

examples of such amendments could be amendments to, among other things, increase the exercise price of the warrants, convert the

warrants into cash or stock, shorten the exercise period or decrease the number of shares of our Class A common stock purchasable

upon exercise of a warrant.

warrant agreement designates the courts of the State of New York or the United States District Court for the Southern District

of New York as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by holders of our

warrants, which could limit the ability of warrant holders to obtain a favorable judicial forum for disputes with our company.

warrant agreement provides that, subject to applicable law, (i) any action, proceeding or claim against us arising out of or relating

in any way to the warrant agreement, including under the Securities Act, will be brought and enforced in the courts of the State

of New York or the United States District Court for the Southern District of New York, and (ii) that we irrevocably submit to

such jurisdiction, which jurisdiction shall be the exclusive forum for any such action, proceeding or claim.

We will waive any

objection to such exclusive jurisdiction and that such courts represent an inconvenient forum.

Notwithstanding

the foregoing, these provisions of the warrant agreement will not apply to suits brought to enforce any liability or duty created

by the Exchange Act or any other claim for which the federal district courts of the United States of America are the sole and

exclusive forum.

Any person or entity purchasing or otherwise acquiring any interest in any of our warrants shall be deemed to

have notice of and to have consented to the forum provisions in our warrant agreement.

If any action, the subject matter of which

is within the scope the forum provisions of the warrant agreement, is filed in a court other than a court of the State of New

York or the United States District Court for the Southern District of New York (a “foreign action”) in the name of

any holder of our warrants, such holder shall be deemed to have consented to:

(x) the personal jurisdiction of the state and federal

courts located in the State of New York in connection with any action brought in any such court to enforce the forum provisions

(an “enforcement action”), and (y) having service of process made upon such warrant holder in any such enforcement

action by service upon such warrant holder’s counsel in the foreign action as agent for such warrant holder.

choice-of-forum provision may limit a warrant holder’s ability to bring a claim in a judicial forum that it finds favorable

for disputes with our company, which may discourage such lawsuits.

Alternatively, if a court were to find this provision of our

warrant agreement inapplicable or unenforceable with respect to one or more of the specified types of actions or proceedings,

we may incur additional costs associated with resolving such matters in other jurisdictions, which could materially and adversely

affect our business, financial condition and results of operations and result in a diversion of the time and resources of our

management and board of directors

may redeem unexpired warrants prior to their exercise at a time that is disadvantageous to the warrant holders, thereby making

the warrants worthless.

have the ability to redeem outstanding warrants at any time after they become exercisable and prior to their expiration, at a

price of $0.01 per warrant, provided that the reported last sale price of our Class A common stock equals or exceeds $18.00

per share (as adjusted for stock splits, stock dividends, reorganizations, recapitalizations and the like) for any 20 trading

days within a 30 trading-day period commencing once the warrants become exercisable and ending on the third trading day prior

to the date on which we give proper notice of such redemption and provided certain other conditions are met.

If and when the warrants

become redeemable by us, we may not exercise our redemption right if the issuance of shares of common stock upon exercise of the

warrants is not exempt from registration or qualification under applicable state blue sky laws or we are unable to effect such

registration or qualification.

Redemption of the outstanding warrants could force warrant holders (i) to exercise their warrants

and pay the exercise price therefor at a time when it may be disadvantageous for them to do so, (ii) to sell their warrants

at the then-current market price when they might otherwise wish to hold the warrants or (iii) to accept the nominal

redemption price which, at the time the outstanding warrants are called for redemption, is likely to be substantially less than

the market value of the warrants.

None of the placement warrants will be redeemable by us so long as they are held by the sponsor,

the underwriters or their permitted transferees.

warrants and founder shares may have an adverse effect on the market price of our Class A common stock and make it more difficult

to effectuate our initial business combination.

issued warrants to purchase 5,000,000 shares of our Class A common stock as part of the units sold in our initial public

offering and, simultaneously with the closing of our initial public offering, issued placement units, in a private placement,

consisting of an aggregate of 177,500 placement warrants.

Our initial stockholders currently own an aggregate of 2,500,000 founder

The founder shares are convertible into shares of Class A common stock on a one-for-one basis, subject to adjustment.

In addition, if our sponsor makes any working capital loans, up to $1,500,000 of such loans may be converted into units, at a

price of $10.00 per unit at the option of the lender, upon consummation of our initial business combination.

The units would be

identical to the placement units.

To the extent we issue shares of Class A common stock to effectuate an initial business

combination, the potential for the issuance of a substantial number of additional shares of Class A common stock upon exercise

of these warrants and conversion rights could make us a less attractive business combination vehicle to a target business.

such issuance will increase the number of issued and outstanding shares of our Class A common stock and reduce the value

of the shares of Class A common stock issued to complete the initial business combination.

Therefore, our warrants and founder

shares may make it more difficult to effectuate an initial business combination or increase the cost of acquiring the target business.

placement warrants included in the placement units are identical to the warrants sold as part of the units in our initial public

offering except that, so long as they are held by our sponsor, the underwriters or their permitted transferees, (i) they

will not be redeemable by us, (ii) they (including the Class A common stock issuable upon exercise of these warrants)

may not, subject to certain limited exceptions, be transferred, assigned or sold by the holders until 30 days after the completion

of our initial business combination, (iii) they may be exercised by the holders on a cashless basis, (iv) will be entitled

to registration rights and (v) for so long as they are held by the underwriters, will not be exercisable more than five years

from the effective date of the registration statement in connection with our initial public offering in accordance with FINRA

Rule 5110(f)(2)(G)(i).

each unit contains one-half of one redeemable warrant and only a whole warrant may be exercised, the units may be worth less than

units of other special purpose acquisition companies.

unit contains one-half of one redeemable warrant.

No fractional warrants will be issued upon separation of the units and

only whole warrants will trade.

Accordingly, unless a public stockholder holds at least two units, such stockholder will not be

able to receive or trade a whole warrant.

We have established the components of the units in this way in order to reduce the dilutive

effect of the warrants upon completion of an initial business combination since the warrants will be exercisable in the aggregate

for one-half of the number of shares compared to units that each contain a warrant to purchase one whole share, thus making

us, we believe, a more attractive merger partner for target businesses.

Nevertheless, this unit structure may cause our units

to be worth less than if they included a warrant to purchase one whole share.

provision of our warrant agreement may make it more difficult for us to consummate an initial business combination.

most blank check companies, if

issue additional shares of Class A common stock or equity-linked securities for capital raising purposes in connection

with the closing of our initial business combination at a newly issued price of less than $9.20 per share;

aggregate gross proceeds from such issuances represent more than 60% of the total equity proceeds, and interest thereon, available

for the funding of our initial business combination on the date of the consummation of our initial business combination (net of

redemptions), and

market value is below $9.20 per share,

the exercise price of the warrants will be adjusted to be equal to 115% of the greater of the market value and the newly issued

price, and the $18.00 per share redemption trigger price will be adjusted (to the nearest cent) to be equal to 180% of the greater

of the market value and the newly issued price.

This may make it more difficult for us to consummate an initial business combination

with a target business.

we must furnish our stockholders with target business financial statements, we may lose the ability to complete an otherwise advantageous

initial business combination with some prospective target businesses.

federal proxy rules require that a proxy statement with respect to a vote on an initial business combination meeting certain financial

significance tests include historical and/or pro forma financial statement disclosure in periodic reports.

We will include the

same financial statement disclosure in connection with our tender offer documents, whether or not they are required under the

tender offer rules.

These financial statements may be required to be prepared in accordance with, or be reconciled to, accounting

principles generally accepted in the United States of America, or GAAP, or international financial reporting standards as

issued by the International Accounting Standards Board, or IFRS, depending on the circumstances and the historical financial statements

may be required to be audited in accordance with the standards of the Public Company Accounting Oversight Board (United States),

These financial statement requirements may limit the pool of potential target businesses we may acquire because some

targets may be unable to provide such financial statements in time for us to disclose such statements in accordance with federal

proxy rules and complete our initial business combination within the prescribed time frame.

are an emerging growth company and a smaller reporting company within the meaning of the rules adopted by the Securities and Exchange

Commission, and if we take advantage of certain exemptions from disclosure requirements available to emerging growth companies

and smaller reporting companies, this could make our securities less attractive to investors and may make it more difficult to

compare our performance with other public companies.

are an “emerging growth company”

within the meaning of the rules adopted by the Securities and Exchange Commission,

as modified by the JOBS Act, and we may take advantage of certain exemptions from various reporting requirements that are applicable

to other public companies that are not emerging growth companies including, but not limited to, not being required to comply with

the auditor internal controls 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.

Our operations and financial results are subject to a high degree of risk.

These risks include, but are not limited to, those described below, each of which may have a material and adverse effect on our business, prospects, operating results, financial condition and the trading price of our common stock.

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

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.

In that event, the trading price of our common stock could decline and you could lose all or part of your investment.

Summary of Risk Factors

The following is a summary of the principal risks to which our business, operations and financial performance are subject.

Each of these risks is more fully described in the individual risk factors immediately following this summary.

• We have never generated product revenue and have incurred significant losses to date.

We expect to continue to incur losses for the foreseeable future and may never generate product revenue or be profitable.

We will need to raise additional capital to finance our operations, which we may not be able to do on acceptable terms or at all.

• If our clinical trials fail to demonstrate safety and efficacy to the satisfaction of the FDA or similar regulatory authorities outside the United States or do not otherwise produce favorable results, we may incur significant additional costs or experience significant delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.

• Our near-term prospects are dependent on the success of our 6 millimeter HAV, and if we are unable to successfully develop and commercialize it, our business, operating results and financial condition will be materially harmed.

• We may experience delays or difficulties in the enrollment of patients in our clinical trials, which may delay or prevent additional clinical trials and our receipt of necessary marketing approvals.

• Lack of experience by investigators and surgeons with our HAVs can lead to incorrect implantation or follow-up procedures which could harm the results of our clinical trials and market acceptance of our HAVs, if approved.

• We may not be successful in our efforts to use our proprietary scientific technology platform to build a pipeline of additional product candidates.

• Even if our HAVs receive marketing approval in the future for one or more of our product candidates, they may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.

• The sizes of the market opportunities for our product candidates have not been established with precision and are estimates that management believes to be reasonable.

If these market opportunities are smaller than we estimate or if any approval that we obtain is based on a narrower definition of the relevant patient population, our revenue and ability to achieve profitability might be materially and adversely affected.

• Our distribution agreement with Fresenius Medical Care imposes obligations on us that may restrict our ability to operate our business in ways we believe to be in our long-term best interest.

• If we receive approval for a product candidate that is not subject to our distribution agreement with Fresenius Medical Care, and we are unable to establish our own marketing, sales and distribution capabilities or are unable to enter into agreements with third parties do so, we may not be able to generate product revenue and will have to alter our development and commercialization plans.

• The outbreak of COVID-19 may continue to adversely impact our business, including our manufacturing efforts, and our preclinical studies and clinical trials.

• The manufacture of our product candidates is complex, we have not manufactured commercial product, and we may encounter difficulties in production.

If we or any third-party manufacturer encounter such difficulties, our ability to supply our product candidates for clinical trials or, if approved, for commercial sale could be delayed or halted entirely.

• The terms of our existing indebtedness may limit our ability to incur future debt.

• We rely on third parties to conduct and support our clinical trials, and those third parties may not perform satisfactorily, including by failing to adhere to regulatory requirements or our stated protocols or to meet deadlines for the completion of such trials.

• We rely on third-party suppliers, including sole source suppliers, to provide certain components for our product candidates.

Any failure by a third-party supplier to supply these components for manufacture may delay or impair our ability to complete our clinical trials and to commercialize our product candidates.

• We intend to rely on our strategic, global partnership with Fresenius Medical Care to undertake, or assist with, the marketing, sale and distribution of certain of our product candidates in certain markets if we receive marketing approval from relevant regulatory authorities.

Disruption of this arrangement could materially adversely affect our business, prospects, operating results and financial condition.

• Our ability to successfully commercialize our products may be impaired if we are unable to obtain and maintain effective intellectual property rights for our proprietary scientific technology platform and product candidates.

• We may be required to take write-downs or write-offs, restructuring and impairment or other charges that could have a significant negative effect on our financial condition, results of operations and stock price, which could cause you to lose some or all of your investment.

Risks Related to the Development and Commercialization of Our Product Candidates

If our clinical trials fail to demonstrate safety and efficacy to the satisfaction of the FDA or similar regulatory authorities outside the United States or do not otherwise produce favorable results, we may incur significant additional costs or experience significant delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.

If we experience significant delays or significant additional costs, our business will be materially harmed.

Before obtaining marketing approval for any of our product candidates, we must conduct extensive clinical trials to demonstrate the safety and efficacy of our product candidates in humans.

Clinical testing is expensive and time-consuming, and its outcomes are uncertain.

We believe the novelty of our research and development efforts, which are focused on the development of bioengineered human, acellular, tissue-based vessels for use across a wide spectrum of applications in vascular surgery, augments this uncertainty.

The scientific discoveries that form the basis for our efforts to develop our product candidates are relatively new, and the scientific evidence to support the feasibility of developing product candidates based on these discoveries is both preliminary and limited.

At this time, no products based on HAVs have been approved in the United States or in Europe.

The clinical trial requirements of the FDA and other regulatory agencies and the criteria these regulators use to determine the safety and efficacy of a product candidate vary substantially according to

the type, complexity, novelty and intended use and market of the potential product, and we may not succeed in obtaining marketing approval even if we view our clinical trials as successful.

Data obtained from preclinical and clinical activities, and manufacturing comparability studies, are also subject to varying interpretations, which may delay, limit or prevent marketing approval.

In such circumstances, we could experience significant delays, or be prevented from, developing or commercializing our HAVs, and our business, prospects, operating results and financial condition could be materially harmed.

Our V006 trial did not meet its primary endpoint, and if we fail to achieve the primary endpoint of our other ongoing or future clinical trials, or if safety issues arise, our comparability demonstration between our former and new manufacturing process fails or is not accepted by the FDA, or the results from our clinical trials are otherwise inadequate to support regulatory approval of our product candidates, we may incur significant additional costs or experience significant delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.

Even if we receive FDA approval for our HAVs, we may face a number of difficulties if the results of our clinical trials are unfavorable, inconclusive, or only modestly favorable or if there are safety concerns, such as adverse events (“AEs”) or serious adverse events (“SAEs”), which could include clotting, mechanical failure, immunological rejection or infection, that could outweigh potential benefits associated with such product candidates.

This could result in:

• obtaining approval for indications or patient populations that are not as broad as intended or desired;

• obtaining approval with, or later becoming subject to, labelling that includes significant use or distribution restrictions or significant safety warnings;

• being subject to a REMS or equivalent requirement from a comparable foreign regulatory agency, to ensure that the benefits of a biological product outweigh its risks or to change the way the product is used;

• being required to perform additional clinical trials to support approval or comparability or being subject to additional post-marketing testing requirements;

• having regulatory authorities withdraw their approval of the product;

• being sued;

• suffering damage to our reputation.

Any of these events could cause us to incur significant additional costs, significant delays and prevent us from achieving or maintaining market acceptance of or commercializing one or more of our product candidates.

If we experience failures or delays in our preclinical and clinical programs, we would be prevented from developing and commercializing our product candidates in a timely matter, if at all.

A number of factors impact the timing of our preclinical and clinical programs and the development and commercialization of our product candidates.

We cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all.

Events that prevent successful or timely completion of the development of our product candidates beyond unfavorable or inconclusive clinical trial results include, among others, the following:

• delays in the testing, validation, manufacturing or delivery of our product candidates to the clinical sites;

• delays in reaching — or inability to reach — agreement with the FDA or other regulatory agencies on trial design, including with respect to our ongoing discussions with the FDA as to whether trial size must be increased in our ongoing V005 trial;

• delays in reaching agreement on acceptable terms with prospective clinical research organizations (“CROs”) and clinical trial sites;

• delays in obtaining required IRB approval at each clinical trial site;

• delays in recruiting suitable patients in sufficient volume to participate in our clinical trials and in having those patients complete participation in our clinical trials or return for follow-up, including delays related to the ongoing COVID-19 pandemic;

• the occurrence of SAEs associated with any of our product candidates that are viewed to outweigh their potential benefits;

• imposition of a clinical hold by regulatory agencies, including after an inspection of our clinical trial sites;

• failure by CROs, other third parties or us to adhere to clinical trial requirements;

• failure to perform in accordance with the FDA’s good clinical practices (“GCP”) or current good tissue practices (“cGTP”), or applicable regulatory guidelines in other countries;

• clinical trial sites dropping out of, or being removed from, a trial;

• changes in regulatory requirements and guidance that require amending or submitting new clinical protocols or data.

Any inability to successfully complete development of our product candidates would likely result in significant additional costs to us, create delays in filing a BLA for regulatory approval of our product candidates and impair our ability to generate revenue.

Clinical trial delays could also allow our competitors to bring products to market before we do, which could materially impair our ability to successfully commercialize our product candidates and may harm our business and prospects.

Our progress in early stage clinical trials may not be indicative of long-term efficacy in late stage clinical trials, and our progress in trials for one product candidate may not be indicative of progress in trials for another product candidate.

The product candidates in our pipeline are at various stages of development.

Trial designs and results from previous studies are not necessarily predictive of our future clinical trial designs or results, and initial results of ongoing trials may not be confirmed upon full analysis of the complete trial data.

A number of companies in the biotechnology industry have suffered significant setbacks in late-stage clinical trials even after achieving promising results in earlier stage clinical trials, and we may experience similar setbacks.

Favorable results in clinical trials for one of our product candidates also do not necessarily indicate that we will obtain positive results in clinical trials related to other product candidates.

The novelty of our proprietary scientific technology platform adds another layer of risk that early-stage clinical trials may not be indicative of long-term efficacy in our late-stage clinical trials.

If we are unable to demonstrate favorable results in future clinical trials for our various product candidates, we expect that our business, prospects, operating results and financial condition will be materially adversely affected.

Additionally, several of our past, planned and ongoing clinical trials utilize an “open-label” trial design.

An “open-label” clinical trial is one where both the patient and investigator know whether the patient is receiving the investigational product candidate.

Some open-label clinical trials test only the investigational product candidate without a comparator.

Open-label clinical trials are subject to various limitations that may exaggerate any therapeutic effect as patients in open-label clinical trials are aware when they are receiving treatment.

Open-label clinical trials may be subject to a “patient bias” where patients perceive their symptoms to have improved merely due to their awareness of receiving an experimental treatment.

In addition, open-label clinical trials may be subject to an “investigator bias” where those assessing and reviewing the physiological outcomes of the clinical trials are aware of which patients have received treatment and may interpret the information of the treated group more favorably given this knowledge.

The results from an open-label trial may not be predictive of future clinical trial results with any of our product candidates when studied in an environment with an active control.

Interim, “topline,” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.

From time to time, we may publicly disclose preliminary or topline data from our clinical trials, which is based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial.

We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, although we may not have received or had the opportunity to fully and carefully evaluate all data at the time such preliminary or topline results are released.

As a result, the topline or preliminary results that we report may differ from future results of the same studies, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated.

Topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published.

As a result, topline data should be viewed with caution until the final data are

From time to time, we may also disclose interim data from our clinical trials.

Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available, or as patients from our clinical trials continue other treatments for their disease.

Adverse differences between preliminary or interim data and final data could significantly harm our business prospects.

If the interim, topline, or preliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which could harm our business, operating results, prospects or financial condition.

In addition, the information we choose to publicly disclose regarding a particular clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is material or otherwise appropriate information to include in our disclosure.

If SAEs occur at an unacceptable rate or other unacceptable side effects are identified in our HAVs we may need to delay, abandon or limit development and marketing of our product candidates.

Our HAVs may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude us from obtaining marketing approval.

The reported SAEs related to the HAV for hemodialysis access, a patient population which typically has a high prevalence of existing medical conditions, are detailed in the table below which summarizes results from our V006 HUMANITY Phase III study in which subjects were randomized to receive either a HAV or a commercially available expanded polytetrafluoroethylene (“ePTFE”) graft.

SAEs Reported in V006 Phase III Clinical Study in AV Access

Number of SAEs

(% of total subjects)

Description of SAE HAV ePTFE

Number of subjects in V006 study 177 178

General disorders and administration conditions:

Implant site extravasation 0(0.0)% 1(0.6)%

Infections and infestations

Vascular access site infection 0(0.0)% 5(2.8)%

Injury, poisoning and procedural complications:

Anastomotic stenosis 1(0.6)% (0.0)%

Description of SAE Number of SAEs

(% of total subjects)

Vascular access site hematomas 1(0.6)% (0.0)%

Vascular access site hemorrhage 0(0.0)% 3(1.7)%

Vascular access site pain 1(0.6)% 0(0.0)%

Vascular access site pseudoaneurysm 10(5.6)% 0(0.0)%

Vascular access site rupture 2(1.1)% 0(0.0)%

Vascular access site thrombosis 41(23.2)% 28(15.7)%

Skin and subcutaneous tissue disorders:

Skin necrosis 0(0.0)% 1(0.6)%

Vascular disorders:

Steal syndrome 2(1.1)% 2(1.1)%

Subclavian vein occlusion 0(0.0)% 1(0.6)%

Vascular stenosis 34(19.2)% 27(15.2)%

Venous stenosis 3(1.7)% 9(0.0)%

In our V002 and V004 Phase II clinical studies in peripheral arterial disease (“PAD”) in 35 subjects, another patient population which typically has a high prevalence of existing medical conditions, the SAEs reported for the HAV are detailed in the table below.

SAEs Reported in V002 and V004 Phase II Clinical Studies in PAD

Description of SAE Number of SAEs

(% of total subjects)

Number of subjects in V002 and V004 studies

Arterial bypass thrombosis

Anastomotic stenosis

Graft thrombosis

Vascular graft complication

If our HAVs are associated with undesirable side effects in clinical trials or have negative characteristics that are unexpected, we may need to perform additional clinical trials, abandon their development or limit development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective.

Even if one of our product candidates is approved, the FDA and other regulatory authorities may take action to withdraw it from the market if serious safety concerns emerge.

Any of these events could cause us to delay, abandon or limit the development and, if approved, marketing of our product candidates.

We may experience delays or difficulties in the enrollment of patients in our clinical trials, which may delay or prevent additional clinical trials and our receipt of necessary marketing approvals.

We are currently enrolling patients in several clinical trials, including in our V005 trial, which is a Phase II/III clinical trial of our 6 millimeter HAV in traumatic vascular repair and our V007 trial, which is a Phase III clinical trial comparing the safety and efficacy of our 6 millimeter HAV to AV fistula for hemodialysis access.

Identifying and qualifying patients to participate in clinical trials of our product candidates is critical to our success.

The timing of our clinical trials depends in part on the rate at which we can recruit patients to participate in such trials.

Additionally, the COVID-19 pandemic has had and may continue to have a sustained impact on our ability to recruit and follow up with patients.

We may not be able to initiate or continue clinical trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA and other regulatory authorities, and as such our product candidates could be delayed or otherwise adversely affected.

Patient enrollment and trial completion is affected by many factors including the:

• size of the patient population and process for identifying subjects;

• availability of clinical trial research resources at clinical sites in the era of the COVID-19 pandemic;

• availability of persons to provide or obtain patient consent for trial participation due to COVID-19 restrictions;

• design of the trial protocol;

• inclusion and exclusion criteria;

• safety profile to date of the product candidate under study;

• perceived risks and benefits of the product candidate under study;

• availability of competing therapies and clinical trials;

• severity of the disease under investigation;

• degree of progression of the subject’s disease at the time of enrollment;

• proximity and availability of clinical trial sites for prospective subjects;

• the impact of the COVID-19 pandemic or future pandemics or similar events on patients’ willingness and ability to participate in clinical trials or on study site policies;

• ability to obtain and maintain subject consent;

• risk that enrolled subjects will drop out before completion of the trial;

• patient referral practices of physicians;

• ability to monitor subjects adequately during and after treatment.

If we have difficulty enrolling a sufficient number of patients to conduct our clinical trials as planned, we may need to delay, limit or terminate ongoing or planned clinical trials, any of which would have an adverse effect on our business, financial condition, results of operations and prospects.

Lack of experience by investigators and surgeons with our HAVs can lead to incorrect implantation or follow-up procedures which could harm the results of our clinical trials and market acceptance of our HAVs, if approved.

Our HAVs are currently in various stages of preclinical and clinical testing and have not been widely used.

We do not have the personnel capacity to directly conduct or manage all of the clinical trials that are necessary for the development of our HAVs.

Therefore, we rely, and will continue to rely, on third parties to assist us in managing, monitoring and conducting our clinical trials.

Some of the investigators in our clinical trials have not been, and, if our HAVs receive marketing approval, surgeons may not be, previously exposed to the implantation and follow-up procedures related to their use.

As a result, our HAVs may be, and have been in the past, incorrectly implanted and follow-up procedures may be performed incorrectly, resulting in violations of our trial protocols, increased interventions or failure of the HAV.

Our efforts to educate investigators, surgeons and interventionalists regarding the proper techniques for use of our HAVs both during clinical trials and following potential commercialization may be costly, prove unsuccessful and could materially harm our ability to continue the clinical trials or marketing of our HAVs.

Regulatory authorities may also seek to impose restrictive labeling or proactive communication obligations on any marketing approval granted for use of our HAVs as a result, which could reduce market acceptance of any of our HAVs that receive marketing approval.

Our near-term prospects are dependent on the success of our 6 millimeter HAV, and if we are unable to successfully develop and commercialize it, our business, operating results and financial condition will be materially harmed.

We currently have no products approved for sale and, while we are developing a number of product candidates, we have invested and continue to invest a substantial portion of our efforts and financial resources in the development of our 6 millimeter HAV.

None of our remaining product geometries and modifications have advanced beyond preclinical development.

As a result, in the near term we are dependent on the success of our 6 millimeter HAV, and if we are unable to successfully develop, obtain marketing approval for, and commercialize it, our business, along with our operating results and financial condition, will be materially harmed.

Even if we succeed with the development of our 6 millimeter HAV, our ability to generate product revenue and become profitable from our 6 millimeter HAV depends on our assumptions regarding the relevant market opportunity, for which our estimates may prove inaccurate, and market acceptance in any approved indication, which may never occur.

We may not be successful in our efforts to use our proprietary scientific technology platform to build a pipeline of additional product candidates.

A key element of our strategy is to use our proprietary scientific technology platform to expand our pipeline of HAVs and to progress other product candidates into and through clinical development.

We may not be able to identify or develop future product candidates that are safe and effective.

Even if we are successful in building our pipeline, the potential product candidates that we identify may not be suitable for clinical development, including if they have harmful side effects or other characteristics that render them unlikely to receive marketing approval or achieve market acceptance.

Research programs to identify new product candidates require substantial technical, financial and human resources, and we may focus our efforts and resources on potential programs or product candidates that ultimately prove to be unsuccessful.

If we do not successfully develop and commercialize additional product candidates based upon our technology, we may have difficulty generating product revenue in the future, which could result in significant harm to our business, prospects, operating results and financial condition and adversely affect our stock price.

Even if our HAVs receive marketing approval in the future for one or more of our product candidates, they may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.

Even with the requisite approvals from the FDA in the United States, the European Commission in the EU and other regulatory authorities internationally, the commercial success of our HAVs will depend, in part, on the acceptance of physicians, patients and health care payors, as medically necessary, cost-effective and safe.

Any product that we commercialize may not gain acceptance by physicians, patients, health care payors and others in the medical community due to ethical, social, medical and legal concerns.

If these products do not achieve an adequate level of acceptance, we may not generate significant product revenue and may not become profitable.

The degree of market acceptance of any of our product candidates that receives marketing approval will depend on a number of factors, including:

• the efficacy and potential advantages of our product candidates compared with alternative products or methods, including convenience and ease of administration;

• the prices we charge for our products, if approved;

• the availability of third-party coverage and adequate reimbursement;

• the willingness of the target patient population to try new products and methods and of physicians to use these products and methods;

• the quality of our relationships with patient advocacy groups;

• the strength of marketing and distribution support;

• the availability of the product and our ability to meet market demand;

• the prevalence and severity of any side effects;

• any restrictions on the use of our products, if approved.

The sizes of the market opportunities for our product candidates have not been established with precision and are estimates that management believes to be reasonable.

Our estimates of the market opportunity for certain of our product candidates are based on a number of internal and third-party estimates.

While we believe our assumptions and the data underlying these estimates are reasonable, they may be inaccurate or based on imprecise data.

In addition, the assumptions and conditions underlying the estimates may change at any time.

For example, the number of patients who ultimately use our product candidates, if approved by regulatory authorities, and our total market opportunities for such product candidates, will depend on, among other things, pricing and reimbursement, market acceptance of those product candidates and patient access, and may be lower than we estimate.

Additionally, any approval we receive for our product candidates may be based on a narrower definition of the relevant patient population than we have estimated.

Either of these circumstances could materially harm our business, financial condition, results of operations and prospects.

We face and will continue to face substantial competition, which may result in others discovering, developing or commercializing competing products before or more successfully than we do, which may adversely affect our ability to successfully market or commercialize our HAVs.

The development and commercialization of new biological products is highly competitive and subject to rapid change and technological advancements.

If approved, we expect our HAVs would compete with the use of a patient’s own blood vessels, as well as a variety of marketed products, such as conventional synthetic grafts, xenografts, and allografts, as well as developing technologies.

We expect to face competition with respect to any additional product candidates that we may seek to develop or commercialize in the future from a variety of sources, including major pharmaceutical companies, specialty pharmaceutical

companies and biotechnology companies, hospital product-focused companies, as well as public and private universities and research organizations.

Many of our existing or potential competitors, either alone or with their strategic partners, have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining marketing approvals and marketing approved products than we do.

Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors.

Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.

Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than the products that we develop.

Our competitors also may obtain FDA or other marketing approval for their products more rapidly than we may obtain the same approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market.

We plan to seek marketing approval for our HAVs in the United States as a biologic and in the EU as a medicinal product.

In both the United States and the EU, our competitors may try to market vascular conduits similar to our product candidates as medical devices.

Such competitive products could have comparable characteristics and could function similarly in the body (and could even be protein-based like our product candidates).

Companies may be able to obtain marketing approval for such products on the basis of less data than the data required for a BLA and marketing similar products as devices could permit our competitors to circumvent regulatory exclusivity for biologics in the United States and medicinal products in the EU.

Our distribution agreement with Fresenius Medical Care imposes obligations on us that may restrict our ability to operate our business in ways we believe to be in our long-term best interest.

We expect to rely on our strategic, global relationship with Fresenius Medical Care for the development and commercialization of certain of our product candidates.

As discussed in more detail in the section of this Annual Report on Form 10-K titled “Business — Distribution — Distribution Agreement with Fresenius Medical Care,” Fresenius Medical Care will have the exclusive right to develop outside of the United States and EU and commercialize outside of the United States, among other things, our 6 millimeter x 42 centimeter HAV and all improvements thereto, and modifications and derivatives thereof (including any changes to the length, diameter, or configuration of the foregoing), which we refer to as the distribution product, for use in vascular creation, repair, replacement or construction (including renal replacement therapy for dialysis access, the treatment of vascular trauma, and the treatment of PAD, but excluding coronary artery bypass graft, pediatric heart surgery, or adhering pancreatic islet cells onto the outer surface of the distribution product for use in diabetic patients).

We refer to these indications wherein Fresenius Medical Care has rights to develop and commercialize Humacyte’s products as the field.

The distribution agreement also imposes a number of restrictions on our business.

For instance, outside the United States, the distribution agreement restricts our ability to engage a distributor for the distribution product outside the field or for HAV products other than the distribution product:

we have granted Fresenius Medical Care (i) an exclusive right of first negotiation for exclusive distribution rights outside the United States for the distribution product for use outside the field, and (ii) an exclusive right of first negotiation for exclusive distribution rights outside the United States for our other HAV products, if any, subject, in each case, to certain conditions.

These and other obligations may restrict our ability to operate our business in ways we believe are in our long-term best interest, which could harm our business and our prospects.

If we receive approval for a product candidate that is not subject to our distribution agreement with Fresenius Medical Care, and we are unable to establish our own marketing, sales and distribution capabilities or are unable to enter into agreements with third parties do so, we may not be able to generate product revenue and will have to alter our development and commercialization plans.

We currently have limited internal marketing, sales or distribution capabilities, and our management team has limited experience commercializing products following marketing approval.

If one of our product candidates that is not subject to the distribution agreement with Fresenius Medical Care receives marketing approval, we will be required either to develop these capabilities internally or to make arrangements with third parties for the marketing, sales and distribution of the relevant product candidate.

The establishment and development of our own marketing, sales and distribution functions will be expensive and time-consuming and may delay any product launch, and we may ultimately be unable to successfully develop the product candidate.

In addition, or in the alternative, we could seek one or more partners to handle some or all

of the marketing, sales and distribution activities associated with any such product candidate.

However, we may face significant competition in seeking appropriate strategic partners, and the negotiation process is time consuming and complex.

Therefore, we may not be able to enter into arrangements with third parties to do so on favorable terms or at all.

In the event we are unable to develop our own marketing, sales and distribution functions or collaborate with a third-party organization for this purpose, we may not be able to successfully commercialize a product candidate that is not subject to the distribution agreement with Fresenius Medical Care, which would adversely affect our ability to generate revenue.

Further, whether we commercialize any such product candidate on our own or rely on a third party to do so, our ability to generate revenue will be dependent on the effectiveness of the organization performing these functions.

Even if we receive marketing approval for our HAVs, there is uncertainty with respect to third-party coverage and reimbursement of our HAVs.

They may also be subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, any of which could harm our business, prospects, operating results and financial condition.

There is uncertainty around third-party coverage and reimbursement of newly approved regenerative medicine type products, even those with the RMAT designation from FDA, such as our 6 millimeter HAV for AV access for performing hemodialysis, which received the RMAT designation in 2017.

In the United States, third-party payors, including government payors such as the Medicare and Medicaid programs, play an important role in determining the extent to which medical products and biologics will be covered and reimbursed.

The Medicare and Medicaid programs increasingly are used as models for how private payors and government payors develop their coverage and reimbursement policies.

Currently, no RMAT tissue engineered product has established coverage and reimbursement by the CMS.

Even if our HAVs receive approval from regulatory authorities, it is difficult to predict what CMS or any comparable foreign regulatory agency will decide with respect to coverage and reimbursement for novel products such as ours, as there is no body of established practices and precedents for these types of products.

The healthcare industry is acutely focused on cost containment, both in the United States and elsewhere.

Government authorities and third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement.

These payors may not view our products, if any, as cost-effective, and coverage and reimbursement may not be available to our customers or may not be sufficient to allow our products, if any, to be marketed on a competitive basis.

Cost-control initiatives could also cause us to decrease any price we might establish for products, which could result in lower than anticipated product revenue.

Moreover, eligibility for reimbursement does not imply that any product will be paid for in all cases or at a rate that covers our costs, including our costs related to research, development, manufacture, sale and distribution.

Reimbursement rates may vary, by way of example, according to the use of the product and the clinical setting in which it is used.

If the prices for our products, if any, decrease or if governmental and other third-party payors do not provide adequate coverage or reimbursement, our business, prospects, operating results and financial condition will suffer, perhaps materially.

In some countries, particularly in Europe, the pricing of our product may be subject to governmental control.

In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product.

To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidate to other available therapies.

If reimbursement of our products, if approved, is unavailable or more limited in scope or amount than we anticipate, or if pricing is set at even lower levels than we anticipate, our business could be harmed, possibly materially.

Product liability lawsuits against us could cause us to incur substantial liabilities that may not be covered by our limited product liability insurance and may limit development, approval and commercialization of our HAVs and any other product candidates that we develop in the future.

We face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials and will face an even greater risk, if and when we commercially sell our HAVs and any other product candidates that we may develop.

If we cannot successfully defend ourselves against claims that our product candidates or products caused injuries, we will incur substantial liabilities.

Regardless of merit or eventual outcome, product liability claims may result in:

• decreased demand for any product candidates or products that we develop or sell, leading to loss of revenue;

• injury to our reputation and significant negative media attention;

• withdrawal, or slower enrollment, of clinical trial participants;

• significant costs to defend the related litigation and reduced resources of our management to pursue our business strategy;

• substantial monetary awards to trial participants or patients;

• inability to further develop or commercialize our product candidates.

We currently hold limited product liability insurance coverage, and it may not be adequate to cover all liabilities that we may incur.

We also may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.

The outbreak of COVID-19 may continue to adversely impact our business, including our manufacturing efforts, and our preclinical studies and clinical trials.

The ongoing COVID-19 pandemic has impacted our business and we expect it to continue to do so.

In response to the spread of COVID-19, we limited entry into our facilities for non-essential personnel, and instituted daily health checks and weekly COVID-19 screenings for employees who entered the facility.

In addition, we have experienced delays in the ongoing enrollment of our clinical trials as a result of COVID-19.

If COVID-19 continues to spread in the United States and elsewhere, we may experience disruptions that could severely impact our business, preclinical studies and clinical trials, including:

• further delays or difficulties in enrolling patients in our clinical trials;

• delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;

• delays in clinical sites receiving the supplies and materials needed to conduct our clinical trials, including interruption in global shipping that may affect the transport of clinical trial materials;

• changes in hospital or research institution policies or local regulations as part of a response to the COVID-19 pandemic which may require us to change the ways in which our clinical trials are conducted, which may result in unexpected costs, or to discontinue the clinical trials altogether;

• diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals and clinics serving as our clinical trial sites and hospital and clinic staff supporting the conduct of our clinical trials;

• interruption of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others, or interruption of clinical trial subject visits and study procedures, or the closing of clinical trial sites due to the virus, the occurrence of which could affect the integrity of clinical trial data;

• interruption in global shipping affecting the transport of clinical trial materials, such as our HAVs and other supplies used in our clinical trials;

• interruption in supply of raw materials required to manufacture our product candidates, or increased costs due to supply chain disruptions or inflation in the cost of goods, services or other operating inputs;

• risk that participants enrolled in our clinical trials will acquire COVID-19 while the clinical trial is ongoing, or will withdraw from the clinical trial due to concerns over COVID-19, which could impact the results of the clinical trial, including by increasing the number of observed adverse events, or reducing the statistical power of the clinical trials;

• interruptions or delays in preclinical studies, including delays in obtaining and housing experimental animals and in performing surgical interventions on animals to test our products;

• delays in necessary interactions with regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees;

• delays in receiving feedback or responses from the FDA regarding regulatory submissions;

• delays in obtaining meetings with FDA reviewers regarding manufacturing and clinical trials;

• limitations in employee resources that would otherwise be focused on the conduct of our clinical trials or the manufacture of our product candidates, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people;

• changes to the clinical endpoints, statistical analysis plan, or enrollment plans for ongoing clinical trials due to limitations in patients, resources, or sites, including due to COVID-19;

• unanticipated deaths of clinical trial patients due to COVID-19 or due to lack of healthcare resources and follow-up as a consequence of COVID-19;

• interruption or delays to our sourced discovery and clinical activities;

• impacts from prolonged remote work arrangements, such as increased cybersecurity risks and strains on our business continuity plans.

The demand for COVID-19 vaccines and potential for manufacturing facilities and materials to be commandeered under the Defense Production Act of 1950, or equivalent foreign legislation, may make it more difficult to obtain materials for the products needed for our clinical trials, which could lead to delays in these trials.

In addition, the competition for bioprocessing, quality control, manufacturing and logistics personnel due to COVID-19 vaccine production in the North Carolina region may make it difficult to recruit and retain necessary employees.

The extent to which the COVID-19 pandemic impacts our business, preclinical studies and clinical trials will depend on future developments, which are highly uncertain and cannot be predicted with confidence.

Risks Related to Manufacturing Our Product Candidates

The manufacture of our product candidates is complex, we have not manufactured commercial product, and we may encounter difficulties in production.

The process of manufacturing our HAVs is complex, highly regulated and subject to multiple risks.

The manufacture of biologics such as our HAVs is susceptible to product loss due to contamination, equipment failure, improper installation or operation of equipment, vendor or operator error, inconsistency in yields, variability in product characteristics and difficulties in scaling the production process.

Even minor deviations from normal manufacturing processes could result in reduced production yields, product defects and other supply disruptions.

If microbial, viral or other contaminations are discovered in our product candidates or in the manufacturing facilities in which our product candidates are made, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination, which would harm our business, operating results and financial condition as well as our reputation.

We currently manufacturing the 6 millimeter HAVs for our clinical trials at our manufacturing facility in Durham, North Carolina, where we have created a scalable modular manufacturing process, which we refer to as the LUNA200 system, that we believe will enable us to manufacture our HAVs, if approved, in commercial quantities in compliance with current good manufacturing practices (“cGMPs”).

Our efforts to scale out our manufacturing operations may not succeed.

Scaling out a biologic manufacturing process is a difficult task, as there are risks including, among others, cost overruns, process reproducibility, stability issues, lot consistency and timely availability of raw materials.

Prior to the establishment of our internal manufacturing facility, we employed a contract manufacturer who produced our HAVs using a smaller-production system known as the AURA system.

We have limited experience manufacturing our HAVs in-house with the LUNA200 system, and no experience manufacturing the volume that we anticipate will be required to supply all of our clinical trials or to achieve planned levels of commercial sales following marketing approval, if received.

Additionally, our manufacturing process has evolved over time and we may not have the experience, resources, or facility capacity to handle adoption of future changes or expansion of capacity.

The forecasts of demand we plan to use to determine order quantities and lead times for components from outside suppliers may be incorrect, and we may be unable to obtain such components when needed and at a reasonable cost.

In addition, we may not be able to develop and implement efficient manufacturing capabilities and processes to manufacture our HAVs in sufficient volumes that also satisfy the legal, regulatory, quality, price, durability, engineering, design and production standards required to commercialize our HAVs successfully.

If we are unable to produce sufficient quantities of our HAVs for our clinical trial needs or commercialization due to production system limitations, we may need to make additional changes to our manufacturing processes and procedures.

Such changes to our manufacturing platform could trigger the need to conduct additional bridging studies between our prior clinical supply and that of any new manufacturing processes and procedures.

Should we experience delays or be unable to produce sufficient quantities of our HAVs utilizing our current or a modified version of our manufacturing

system, we expect that our development and commercialization efforts would be impaired as a result, which would likely materially adversely affect our business, prospects, operating results and financial condition.

Manufacturing facilities are subject to significant government regulations and approvals, which are often costly and could result in adverse consequences to our business if we fail to comply with the regulations or maintain the approvals.

Our manufacturing facility is subject to ongoing regulation and periodic inspection by the FDA and other regulatory authorities to ensure compliance with cGMPs.

Failure to follow and document adherence to such regulations or other regulatory requirements may (i) lead to significant delays in the availability of product for our clinical trials, (ii) result in the termination of or a hold being placed on one or more of our clinical trials, or (iii) delay or prevent filing or approval of marketing applications for our HAVs.

To monitor compliance with applicable regulations, the FDA routinely conducts inspections of facilities and may identify potential deficiencies.

For example, the FDA issues what are referred to as “Form 483s” that set forth observations and concerns that are identified during its inspections.

Failure to satisfactorily address the concerns or potential deficiencies identified in a Form 483 could result in the issuance of a warning letter, which is a notice of the issues that the FDA believes to be significant regulatory violations requiring prompt corrective actions.

Failure to respond adequately to a warning letter, or to otherwise fail to comply with applicable regulatory requirements could result in enforcement, remedial or punitive actions by the FDA or other regulatory authorities.

Risks Related to Our Reliance on Third Parties

We rely on third parties to conduct and support our clinical trials, and those third parties may not perform satisfactorily, including by failing to adhere to regulatory requirements or our stated protocols or to meet deadlines for the completion of such trials.

We do not independently conduct clinical trials for our product candidates and instead rely on third parties, such as CROs, clinical data management organizations, medical institutions and clinical investigators, to perform various functions, including implanting our HAVs and monitoring patients.

The FDA and other regulatory authorities require us and these third parties to comply with GCP and, where applicable, cGTPs for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of patients in clinical trials are protected;

ultimately, we remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and trial protocol.

Failure by us or these third parties to do so could require us to enroll additional trial subjects beyond those we anticipate, could require us to modify our protocol, which may cause us to lose previously established Special Protocol Assessment (“SPA”) agreements with the FDA or similar agreements with other regulatory authorities concerning whether the design and size of our clinical trial adequately addresses scientific and regulatory requirements to support marketing approval, or could materially harm our ability to complete our clinical trials, including as a result of the need to remove trial sites and participants from the trial.

We have in the past and may in the future need to terminate trial sites due to failure to conduct a trial in accordance with its protocol, applicable regulations, and generally accepted research standards.

The performance of the sites for our clinical trials may also be adversely affected by various other issues, including familiarity with the properties of our HAVs, intervention rates, insufficient training of personnel, variances in medical infrastructure, lack of familiarity with conducting clinical trials in accordance with international regulatory standards, communication difficulties or changes in local regulations.

If these third parties do not successfully conduct our clinical trials in accordance with regulatory requirements or our stated protocols, carry out their contractual duties, or meet expected deadlines, we may not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates and may not be able to, or may be delayed in our efforts to, successfully commercialize our products if approved by regulatory authorities.

We rely on third-party suppliers, including sole source suppliers, to provide certain components for our product candidates.

Any failure by a third-party supplier to supply these components for manufacture may delay or impair our ability to complete our clinical trials and to commercialize our product candidates.

We currently rely, and expect to continue to rely, on third parties for the supply of certain components necessary for our product candidates, such as donor tissue, other biologically derived substances, the PGA polymer mesh and the bioreactor bags in which our HAVs are grown.

Our suppliers for certain of these materials, including SeraCare for the supply of human plasma and Confluent for the supply of polymer mesh, are sole source suppliers.

Failure of one or more of our suppliers, including these sole source suppliers, to deliver components necessary for the production of our HAVs in a timely and sufficient manner, whether due to shortages of such materials, difficulties in scaling up supply to satisfy our

clinical trial and commercial needs, contamination, recall, the COVID-19 pandemic or otherwise, or to source or manufacture such components in accordance with cGMPs and cGTPs, as applicable, could delay our ability to complete our clinical trials, obtain marketing approval and commercialize our product candidates.

Establishing additional or replacement suppliers for these components could take a substantial amount of time and it may be difficult to establish replacement suppliers who meet regulatory requirements.

In addition, as part of the FDA’s approval of our product candidates, the FDA must review and approve the individual components of our production process, which includes raw materials, the manufacturing processes and facilities of our suppliers.

Some of our current suppliers have not undergone this process nor have they had any components included in any product approved by the FDA.

If our suppliers fail to comply with applicable regulations, and if we do not qualify alternate suppliers, the clinical development, marketing approval or commercialization of our product candidates could be delayed, thereby increasing our costs to complete clinical development and to obtain marketing approval and depriving us of potential product revenue.

We intend to rely on our strategic, global relationship with Fresenius Medical Care to undertake, or assist with, the development and commercialization of certain of our product candidates if we receive marketing approval from relevant regulatory authorities.

Disruption of this arrangement could materially adversely affect our business, prospects, operating results and financial condition.

Under the distribution agreement, Fresenius Medical Care has the exclusive right to sell and distribute the distribution product in the field outside of the United States.

In addition, under the terms of the distribution agreement, Fresenius Medical Care will collaborate with Humacyte in its commercialization of the distribution product in the field in the United States, including adoption of the distribution product as a standard of care in patients for which such use is supported by clinical results and health economic analyses.

As a result of our arrangement with Fresenius Medical Care, we expect to be reliant on Fresenius Medical Care to undertake or assist with the development and commercialization, as well as, in some cases, obtaining and maintaining regulatory approval, of the distribution product in the field and for Fresenius Medical Care to do so in a manner consistent with applicable law and regulatory requirements outside of the United States.

If Fresenius Medical Care otherwise fails to undertake or assist with the development or commercialization, or obtaining or maintaining regulatory approvals, of the distribution product in accordance with the terms of the distribution agreement, our business, prospects, operating results and financial condition would be adversely affected, perhaps materially.

Fresenius Medical Care also maintains certain discretionary termination rights on a country-by-country basis with respect to any country outside of the United States under the distribution agreement, as discussed in more detail in the section of this Annual Report on Form 10-K titled “Business — Distribution — Distribution Agreement with Fresenius Medical Care.” If the distribution agreement is terminated, we may not be able to secure an alternative distributor in the applicable country on a timely basis or at all, in which case our ability to generate revenues from the distribution product in such country would be harmed.

In addition, if Fresenius Medical Care fails to undertake or assist with the development or commercialization, or obtaining or maintaining regulatory approval, as applicable, of the distribution product in a manner consistent with applicable law and regulatory requirements, patient access to, and demand for, the distribution product could be reduced, our reputation could be damaged, and, under certain circumstances, we could be exposed to potential liability.

Furthermore, while Fresenius Medical Care has certain commercialization diligence obligations, Fresenius Medical Care is not restricted from offering its own products and services or the products and services of other companies that compete with the distribution product, and may not undertake or assist with the development or commercialization of the distribution product effectively.

Risks Related to Our Financial Position and Need for Additional Funding

We have never generated product revenue and have incurred significant losses to date.

We expect to continue to incur losses for the foreseeable future and may never generate product revenue or be profitable.

Since inception, we have generated no product revenue, and prior to receipt of marketing approval from regulatory authorities, we will be unable to do so.

We incurred net losses of $26.5 million and $66.5 million for the years ended December 31, 2021 and 2020, respectively.

As of December 31, 2021 and 2020, we had an accumulated deficit of $414.6 million and $388.1 million, respectively.

Up to the date of the consummation of the Merger, we financed our operations primarily through the sale of equity securities and convertible debt and, to a lesser extent, through grants from governmental agencies.

We have devoted substantially all of our financial resources and efforts to research and development, including preclinical studies and clinical trials and development of manufacturing technology, and we anticipate that our expenses will continue to increase over the next several years as we continue these activities.

Our V005 and V007 trials are currently enrolling, and we currently intend to submit a BLA to the FDA relating to vascular trauma in

2022 or 2023 and submit a BLA for AV access for hemodialysis in 2023.

We also intend to continue scaling out our manufacturing facility to satisfy potential demand if the FDA approves our BLA, advancing preclinical and clinical development of additional clinical applications for our HAVs and funding our operations.

Accordingly, we expect to continue to incur substantial operating losses for the foreseeable future, which may fluctuate significantly from quarter-to-quarter and year-to-year.

To become and remain profitable, we must succeed in obtaining marketing approval for our HAVs in the United States, in commercializing our HAVs, and in developing and commercializing additional product candidates that generate significant revenue.

We may never succeed in these activities and, even if we do, may never generate revenue that is sufficient to achieve profitability.

Even if we do achieve profitability, we may not be able to sustain or increase profitability.

Our failure to become and remain profitable would depress the value of our company and could impair our ability to maintain our research and development efforts, expand our business, diversify our product offerings or even continue our operations.

A decline in the value of Humacyte could also cause you to lose all or part of your investment in our securities.

Our ability to use our net operating loss and tax credit carryforwards to offset future taxable income may be subject to certain limitations.

As of December 31, 2021, we had net operating loss carryforwards for federal and state tax purposes of approximately $278.5 million and $278.9 million, respectively, which begin to expire in 2025.

In addition, we had tax credit carryforwards for federal and state tax purposes of approximately $17.0 million, as of December 31, 2021, which begin to expire in 2025 and will expire completely in 2041.

The future utilization of net operating loss and tax credit carryforwards may be limited due to changes in ownership.

In general, if we experience a greater than 50% aggregate change in ownership of certain significant stockholders or groups over a three-year period (which constitutes an ownership change under Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”)), utilization of our pre-change net operating loss carryforwards is subject to an annual limitation under Section 382 of the Code (and similar state laws).

The annual limitation generally is determined by multiplying the value of our stock at the time of such ownership change (subject to certain adjustments) by the applicable long-term tax-exempt rate.

Such limitations may result in expiration of a portion of the pre-change net operating loss carryforwards before utilization and may be substantial.

In the past we may have experienced, and in the future may experience, ownership changes as a result of subsequent shifts in our stock ownership.

As a result, if we earn net taxable income, our ability to use our pre-change net operating loss carryforwards to offset United States federal taxable income may be subject to limitations, which could potentially result in increased future tax liability to us.

We expect to need to raise additional funding, which may not be available on acceptable terms, or at all, and any failure to obtain capital when needed may force us to delay, limit or terminate our product development or commercialization efforts.

We expect to incur significant expenses in connection with our ongoing activities as we seek to (i) scale out our manufacturing facility to satisfy potential demand if our HAVs receive marketing approval in the United States, (ii) continue our preclinical and clinical development efforts, including the ongoing clinical trials, and (iii) obtain marketing approval for our 6 millimeter HAV, and, if marketing approval is obtained, to commercialize our HAVs for one or more approved indications.

We will need additional funding in connection with these activities.

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

• the progress and results of our clinical trials and interpretation of those results by the FDA and other regulatory authorities;

• the cost, timing and outcome of regulatory review of our product candidates, particularly for approval of our HAVs in the United States;

• the scope, progress, results and costs of preclinical development, laboratory testing and clinical trials for our additional product candidates;

• the cost and timing of our future commercialization activities, including product manufacturing, marketing and distribution for our HAVs if approved by the FDA, and any other product candidate for which we receive marketing approval in the future;

• the amount and timing of revenues, if any, that we receive from commercial sales of any product candidates for which we receive marketing approval;

• the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims.

Adequate capital may not be available to us when needed or on acceptable terms.

If we are unable to raise capital, we could be forced to delay, reduce, suspend or cease our research and development programs or any future commercialization efforts, which would have a negative impact on our business, prospects, operating results and financial condition.

As of December 31, 2021 and 2020, we had $225.5 million and $39.9 million, respectively, in cash and cash equivalents and short-term investments.

Based upon our current operating plan, we believe that our cash and cash equivalents and short-term investments will be sufficient to fund our operations, including clinical trial expenses and capital expenditure requirements, for at least 12 months from the date of this Annual Report on Form 10-K.

Pursuant to the terms of our outstanding indebtedness, we may be limited in our ability to incur future debt.

In March 2021, Humacyte Global, Inc., or Legacy Humacyte, entered into a Loan and Security Agreement (as amended, the “Loan Agreement”) with Silicon Valley Bank and SVB Innovation Credit Fund VIII, L.P., which provides a term loan facility of up to $50.0 million with a maturity date of March 1, 2025.

We became a co-borrower under the Loan Agreement in connection with the Merger.

The obligations of Humacyte and Legacy Humacyte under the Loan Agreement are secured by substantially all of their assets, except for their intellectual property.

Pursuant to the terms of the Loan Agreement, we are limited in our ability to incur additional indebtedness.

In addition, a failure to comply with the covenants under the Loan Agreement could result in an event of default and an acceleration of amounts due.

If an event of default occurs that is not waived by the lenders, and the lenders accelerate any amounts due, we may not be able to make accelerated payments, and the lenders could seek to enforce their security interests in the collateral securing such indebtedness, which could have a material adverse effect on our business and results of operations.

Our payment obligations under the Loan Agreement reduce cash available to fund working capital, capital expenditures, research and development and other corporate purposes, and limit our ability to obtain additional financing for working capital, capital expenditures, expansion plans and other investments, which may in turn limit our ability to implement our business strategy, heighten our vulnerability to downturns in our business, the industry, or in the general economy, limit our flexibility in planning for, or reacting to, changes in our business and the industry and prevent us from taking advantage of business opportunities as they arise.

If market rates increase, we will have to pay additional interest on this indebtedness, which would further reduce cash available for our other business needs.

We cannot assure you that our business will generate sufficient cash flow from operations or that future financing will be available to us in amounts sufficient to enable us to make required and timely payments on our indebtedness, or to fund our operations.

To date, we have not requested or obtained marketing approval for, or commercialized, any of our product candidates, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability.

We are a development-stage company.

Our operations to date, with respect to the development of our product candidates, have been limited to organizing and staffing our company, business planning, raising capital, identifying markets for our product candidates, undertaking preclinical studies and clinical trials of our product candidates for various potential indications and establishing research and development, manufacturing and distributing collaborations.

We have not yet demonstrated the ability to obtain marketing approval for a product, to manufacture an approved product at commercial scale or to successfully commercialize an approved product.

Consequently, any predictions you make about our financial prospects may not be as accurate as they could be if we had received marketing approval and begun commercializing a product.

Risks Related to Government Regulation

We may not obtain marketing approval from the FDA for any of our product candidates even if we successfully complete our clinical trials, which failure would materially harm our business, prospects, operating results and financial condition.

Prior to commercialization, biologics, like our HAVs, require the submission of a BLA to, and approval of the BLA by, the FDA.

A BLA must be supported by extensive preclinical and clinical data, as well as extensive information regarding chemistry, manufacturing and controls (“CMC”), sufficient to demonstrate the safety, purity, potency and

effectiveness of the applicable product candidate to the satisfaction of the FDA.

We have never submitted a BLA for approval or otherwise obtained FDA approval for any of our product candidates.

The BLA approval process is expensive and uncertain, it may take several years to complete, and we may not be successful in obtaining such approval.

The FDA has substantial discretion in the approval process.

The number and types of preclinical studies and clinical trials that will be required for BLA approval varies depending on the product candidate, the disease or the condition that the product candidate is designed to target and the regulations applicable to any particular product candidate.

The FDA could delay, limit or deny approval of our product candidates for many reasons, including because it:

• may not deem the product candidate to be adequately safe or effective;

• may not find the data from preclinical studies, clinical trials or CMC data sufficient to support approval;

• may not approve the manufacturing processes or facilities associated with the product candidate;

• may conclude that the long-term integrity of the product candidate for which approval is being sought has not been sufficiently demonstrated;

• may change approval policies or adopt new regulations;

• may not accept a submission due to, among other reasons, the content or formatting of the submission.

In some cases, the FDA may agree to an SPA for a clinical trial, when it determines that the trial is adequately designed to provide necessary data to support a license application.

Even in such cases, however, the FDA may subsequently abandon the SPA if a substantial scientific issue essential to determining the safety or effectiveness of the product candidate has been identified after the testing has begun.

In addition, if a company alters the protocol for a trial, the SPA may no longer apply.

Further, the results of pivotal clinical trials are always subject to thorough FDA review.

Even highly significant clinical trial results are no guarantee of approval.

We currently intend to submit a BLA to the FDA relating to vascular trauma in 2022 or 2023, and submit a BLA for AV access in hemodialysis in 2023, based on the results and trial design of our V005 and V007 trials.

The FDA may decline to approve our 6 millimeter HAV on the basis of these or other trial results, or for other reasons.

Even if we obtain and maintain approval for our HAVs from the FDA, we may never obtain approval for our HAVs outside of the United States, where the regulatory process is also complex and subject to significant uncertainty.

Failure to do so would limit our market opportunities and adversely affect our business.

Even if we receive FDA approval to market any biologic in the United States, we must comply with the numerous and varying regulatory and compliance related requirements of other countries, including the submission of extensive preclinical and clinical data, manufacturing and quality information regarding the process and facility, scientific data characterizing the relevant product candidate and other supporting data in order to establish safety and effectiveness.

Approval procedures vary among countries and can involve additional product testing and additional administrative review periods, including obtaining reimbursement and pricing approval in select markets.

The time required to obtain approval in other countries might differ from that required to obtain FDA approval.

The marketing approval process in other countries may include all of the risks associated with FDA approval as well as additional, presently unanticipated, risks.

Marketing approval in one country does not ensure marketing approval in another, but a failure or delay in obtaining marketing approval in one country may negatively impact the regulatory process in others, including the risk that our product candidates may not be approved for all indications requested and that such approval may be subject to limitations on the indicated uses for which the product candidate may be marketed.

Even if we seek “rolling review” or priority review, the review time for BLAs for our product candidates may be longer and more expensive than for other products because of the novelty and complexity of our product candidates, which would delay our ability to begin commercialization and earn product revenues.

The marketing approval process for novel product candidates such as ours may take longer to complete and be more expensive than the process for other, better known or extensively studied pharmaceutical or other product candidates.

We may be eligible for a “rolling review” of a BLA, which means we may submit completed modules of a BLA rather than waiting until every module of the BLA is completed before submitting the full BLA for FDA review.

Such “rolling review” is common for indications that are part of one of FDA’s expedited programs, such as our 6 millimeter HAV, which

has received Fast Track and RMAT designations for AV access in hemodialysis.

The FDA may also designate one or more of our product candidates for priority review after we submit a BLA.

Under priority review, the FDA’s goal is to review an application within six months of the 60-day filing date, compared to ten months for a standard review.

Even if we are able to utilize a “rolling review” and/or the FDA designates one or more of our product candidates for priority review, it may not lead to a shorter review period.

The FDA could also decide to consult an advisory committee as part of our BLA review process, which often leads to a longer review time.

We are not permitted to commercialize our product candidates in the United States until they have been approved by the FDA, and if we experience a lengthier review period than expected, our ability to generate product revenues would be materially harmed.

We may in the future seek orphan drug designation for the use of our HAVs to treat congenital pediatric heart defects.

We may be unable to obtain such designation or to maintain the benefits associated with orphan drug designation, including market exclusivity, which may cause our revenue, if any, to be reduced.

Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition, defined as a disease or condition with a patient population of fewer than 200,000 in the United States, or a patient population of 200,000 or more in the United States when there is no reasonable expectation that the cost of developing and making available the drug or biologic in the United States will be recovered from sales in the United States for that drug or biologic.

Orphan drug designation must be requested before submitting a BLA.

In the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers.

After the FDA grants orphan drug designation, the generic identity of the drug or biologic and its potential orphan use are disclosed publicly by the FDA.

Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.

Even if one of our product candidates receives orphan exclusivity, the FDA can still approve other drugs that have a different active ingredient for use in treating the same indication or disease, as well as the same drug or biologic for a different indication or disease.

The FDA can also approve the same drug or biologic for the same indication or disease if the subsequent drug or biologic demonstrates clinical superiority.

Furthermore, the FDA can waive orphan exclusivity if we are unable to manufacture sufficient supply of our product.

Inadequate funding for the FDA and other government agencies, including from government shut downs, global health concerns or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, policy changes, and the risk of slowdowns and shutdowns due to the COVID-19 pandemic.

Average review times at the FDA have fluctuated in recent years as a result.

Disruptions at the FDA and other agencies may also slow the time necessary for new product candidates to be reviewed and/or approved by necessary government agencies, which could adversely affect our business.

In addition, government funding of other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.

We may experience delays or rejections based upon additional government regulation from future legislation or administrative action, or changes in regulatory agency policy during the period of product development, clinical trials and the review process.

In addition, disruptions at the FDA and other agencies may also slow the time necessary for new product candidates to be reviewed and/or approved by necessary government agencies, which would adversely affect our business.

For example, over the last several years the U.S.

government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA and other government employees and stop critical activities.

If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

On March 18, 2020, the FDA temporarily postponed routine surveillance inspections of domestic manufacturing facilities as a result of the COVID-19 pandemic.

In July 2021, the FDA resumed standard inspectional operations of domestic facilities.

However, the FDA may not be able to maintain this pace and delays or setbacks are possible in the future, including where a pre-approval inspection or an inspection of clinical sites is required, and due to the COVID-19

pandemic and travel restrictions, the FDA is unable to complete such required inspections during the review period.

The FDA has continued to monitor and implement changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates as it adapts to the evolving COVID-19 pandemic.

Additionally, regulatory authorities outside the U.S.

may adopt similar restrictions or other policy measures in response to the COVID-19 pandemic and may experience delays in their regulatory activities.

If a prolonged government shutdown or other disruption occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

Future shutdowns or other disruptions could also affect other government agencies such as the SEC, which may also impact our business by delaying review of our public filings, to the extent such review is necessary, and our ability to access the public markets.

Even if we receive marketing approval for a product candidate, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and subject us to significant penalties if we fail to comply with applicable regulatory requirements.

If we obtain marketing approval for any of our product candidates, the approved product will be subject to ongoing regulatory requirements from the FDA and, if applicable, non-U.S.

regulatory authorities.

Any marketing approval that we receive for our product candidates may be subject to limitations on the indicated uses for which the product may be marketed or contain requirements for potentially costly post-marketing follow-up trials to monitor the safety and efficacy of the product.

The FDA could also approve our product candidates with a REMS, which could include significant restrictions on distribution and/or use of our products.

In addition, if the FDA and non-U.S.

regulatory authorities approve any of our product candidates, we will be subject to extensive and ongoing regulatory requirements by the FDA and other regulatory authorities with regard to the manufacturing, labelling, packaging, AE reporting, storage, advertising, distribution, promotion and recordkeeping for our products.

If we, our product candidates or the manufacturing facilities for our product candidates fail to comply with regulatory requirements of the FDA and, if relevant, other non-U.S.

regulatory authorities, we could be subject to administrative or judicially imposed sanctions, including the following:

• issuance of warning letters or untitled letters by regulatory authorities asserting that we are in violation of the law;

• imposition of injunctions or significant civil monetary penalties or pursuit by regulatory authorities of civil or criminal prosecutions and fines against us or our responsible officers;

• suspension or withdrawal of marketing approval;

• suspension of any ongoing clinical trials or refusal by regulatory authorities to approve pending marketing applications or supplements to approved applications;

• seizure of products or refusal to allow us to enter into supply contracts, including government contracts, or to import or export products;

• voluntary or mandatory product recalls and publicity requirements;

• restrictions on operations, including marketing efforts, or restrictions that mandate costly new manufacturing requirements.

Any of these events could reduce market acceptance of any or our product candidates that had received marketing approval, substantially reduce our revenue, increase the costs of operating our business, and cause us significant reputational damage, among other consequences.

If we ultimately receive approval for any product candidates in jurisdictions outside the U.S., we expect to be subject to similar ongoing regulatory oversight by the relevant foreign regulatory authorities.

Our products may be subject to product recalls that could harm our reputation and could materially and adversely affect our business, financial condition, operating results, cash flows and prospects.

The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription products, if approved.

In particular, while the FDA permits the dissemination of truthful and non-misleading information about an approved product, the FDA restricts our ability to promote a product for uses that are not approved by the FDA.

The misuse or off-label use of our product may harm our reputation in the marketplace, result in injuries that lead to product liability suits or result in costly investigations, fines or sanctions by regulatory authorities if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.

We may also face risks in other non-U.S.

jurisdictions from product recalls and advertising/promotion rules.

We could also face product liability suits or regulatory delays due to defects in our products, which could be expensive and time-consuming and result in substantial damages payable by us and increases in our insurance rates.

Designation of our product candidates for expedited programs, such as Fast Track designation, Breakthrough Therapy Designation, or RMAT designation, or accelerated approval by the FDA, or priority designation by the Department of Defense, may not lead to a faster development or regulatory review or approval process, and even if granted, will not increase the likelihood that our product candidates will receive marketing approval.

In 2014, the FDA granted Fast Track designation for our 6 millimeter HAV for use in the creation of AV access for hemodialysis, and, in 2017, the FDA granted RMAT designation for our 6 millimeter HAV for the creation of vascular access for performing hemodialysis.

We have not received designations pursuant to any of the FDA’s expedited programs for vascular trauma, peripheral arterial disease or our other indications, although we may in the future seek such designations if such product candidates meet the criteria for that designation.

As a result, even if we submit a BLA for vascular repair, reconstruction and replacement, including in AV access in hemodialysis, our Fast Track and RMAT designations, and their attendant benefits, may not apply to this broader requested indication.

In addition, even with one or more of these designations, we may not experience a faster development process, or faster review or approval, for our product candidates compared to product candidates that are not part of the expedited programs.

Further, the FDA may withdraw a designation if it believes that the designation is no longer supported by data from our clinical development program.

In addition, a product candidate may no longer demonstrate a potential to address unmet medical need if, for example, a new product is approved that addresses the same need, which could lead to loss of a designation.

The loss of a designation under an expedited program, including a Fast Track designation, Breakthrough Therapy Designation, or RMAT designation, could significantly increase the costs of development and length of time required before we could seek marketing approval of such a product candidate.

We may seek accelerated approval for our HAV relating to vascular trauma.

A product candidate may be eligible for accelerated approval if it treats a serious or life-threatening condition, generally provides a meaningful advantage over available therapies, and demonstrates an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit.

As a condition of accelerated approval, the FDA may require that a sponsor of a product receiving accelerated approval perform adequate and well-controlled confirmatory clinical trials post-approval.

These confirmatory trials must be completed with due diligence.

In addition, the FDA currently requires as a condition for accelerated approval pre-approval of promotional materials, which could adversely impact the timing of the commercial launch of the product.

Even if we do receive accelerated approval, we may not experience a faster development or regulatory review or approval process, and receiving accelerated approval does not provide assurance of ultimate full FDA approval.

Accelerated approval may also be withdrawn if, among other things, a confirmatory trial required to verify the predicted clinical benefit of the product fails to verify such benefit or if such trial is not conducted with due diligence.

In addition, in 2018, our HAV product candidate was assigned a priority designation by the Secretary of Defense under Public Law 115-92.

Similar to the designations described above that FDA may grant, a priority designation by the Department of Defense does not change the standards for approval but may expedite the development or approval process.

Healthcare reform measures could hinder or prevent our product candidates’ commercial success.

Our industry is highly regulated, and changes in or revisions to laws and regulations that make gaining coverage of and adequate reimbursement for our product candidates more difficult or subject to different criteria and standards may adversely impact our business, prospects, operating results and financial condition.

In the United States, there have been and we expect there will continue to be a number of legislative, regulatory and other changes to the healthcare system to contain or reduce healthcare costs that may adversely affect our ability to set a price we believe is fair for our product candidates, our ability to generate revenues and achieve or maintain profitability, and the availability of capital.

Federal and state lawmakers regularly propose and, at times, enact legislation that would result in significant changes to the healthcare system, some of which are intended to contain or reduce the costs of medical products and services.

For example, ACA, enacted in 2010 and amended by the Health Care and Education Reconciliation Act, contains a number of provisions that were intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies for fraud and abuse, add transparency requirements for the healthcare and health insurance industries, impose new taxes and fees on the health industry, and impose additional health policy reforms.

The Bipartisan Budget Act of 2018, among other things, amended the ACA to close the coverage gap in most Medicare drug plans, commonly referred to as the “donut hole,” in part by requiring greater discounts from manufacturers.

Various members of Congress have expressed a desire to repeal all or portions of the ACA, and in December 2017, portions of the ACA dealing with the individual mandate insurance requirement were effectively repealed by the Tax Cuts and Jobs Act of 2017.

10, 2021, the Biden administration withdrew the federal government’s support for overturning the ACA.

Further, on January 28, 2021, President Biden issued an executive order to initiate a special enrollment period for purposes of obtaining health insurance coverage through the ACA marketplace, which ran until August 15, 2021.

The executive order also instructs certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA.

In June 2021, the United States Supreme Court held that the individual plaintiffs and states lacked standing to challenge the constitutionality of the ACA.

Additionally, in December 2018, CMS published a final rule permitting further collections and payments to and from certain ACA qualified health plans and health insurance issuers under the ACA risk adjustment program in response to the outcome of federal district court litigation regarding the method CMS uses to determine this risk adjustment.

Since then, the ACA risk adjustment program payment parameters have been updated annually.

In addition, CMS published a final rule that gave states greater flexibility, starting in 2020, in setting benchmarks for insurers in the individual and small group marketplaces, which may have the effect of relaxing the essential health benefits required under the ACA for plans sold through such marketplaces.

At this time, it remains unclear whether there will be further changes made to the ACA.

The ACA, as currently enacted or as amended in the future, may adversely affect our business and operating results, and we do not know how future federal or state legislative or administrative changes relating to healthcare reform will affect our business.

Other legislative changes that have been adopted since enactment of the ACA could also affect potential pricing and utilization of our product candidates.

In addition, the Secretary of Health and Human Services, various members of Congress and CMS have made statements and issued proposals regarding containment of drug prices through various means, including enabling CMS to negotiate U.S.

drug pricing to align with foreign drug pricing, pricing transparency measures, reform of drug rebate programs, and conditioning coverage and reimbursement of certain drugs upon the prior failure or inadequacy of less expensive therapies, sometimes referred to as “step therapy.” Additionally, there has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices.

Specifically, there have been several recent U.S.

Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies.

At the federal level, on March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law, which eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single source and innovator multiple source drugs, beginning January 1, 2024.

In addition, at the state level, individual states have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

Beginning in fiscal year 2018, CMS altered the reimbursement formula on specified covered outpatient drugs (“SCODs”).

A SCOD drug product may also be a covered outpatient drug under the 340B program, which allows 340B-participating hospitals to purchase the drug product at the 340B discounted rate and, when prescribing it to a Medicare patient, be reimbursed at the Medicare rate.

Under the prior Medicare reimbursement rate, this created a significant, positive gap for 340B-participating health care facilities.

CMS’s change in the Medicare reimbursement rate for SCODs significantly impacted, or eliminated, the positive gap for 340B-participating health care facilities.

The District Court for the District of Columbia invalidated the formula change, but the U.S.

Court of Appeals for the District of Columbia Circuit reversed the district court’s decision and found that the changes were within the Secretary’s authority.

The case is currently under review by the U.S.

Supreme Court, and a decision is expected by summer of 2022.

It is unlikely the Medicare rate litigation will impact 340B pricing for our approved products in the future, but it possible it could affect covered hospitals who might purchase our products.

The FDA also released a final rule on September 24, 2020, which went into effect on November 30, 2020, providing guidance for states to build and submit importation plans for drugs from Canada.

Additionally, on November 20, 2020, HHS finalized a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law.

The 2020 rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers.

Pursuant to a court order, HHS subsequently delayed the effective date for aspects of the rule, including those relating to pharmacy benefit managers, until

The rule was then effectively delayed until January 1, 2026, as part of the Infrastructure Investment and Jobs Act, which was signed into law on November 15, 2021.

In addition, on November 19, 2021, the House of Representatives passed a version of the Build Back Better Act that includes a provision prohibiting the implementation, administration, or enforcement of the rule.

Although a number of these, and other proposed measures may require authorization through additional legislation to become effective, and the Biden administration may reverse or otherwise change these measures, Congress has indicated that it will continue to seek new legislative measures to control drug costs.

The ultimate content, timing, or effect of any healthcare reform legislation or executive order or the impact that the resulting changes may have on us is uncertain, but we expect there will continue to be legislative and regulatory proposals at the federal and state levels directed at containing or lowering the cost of health care.

If we fail to comply with healthcare regulations, we could face substantial penalties and our business, prospects, operating results and financial condition could be adversely affected.

Certain federal and state healthcare laws and regulations pertaining to fraud and abuse and patients’ rights are and will be applicable to our business even though we do not and will not control referrals of healthcare services.

We could also be subject to patient privacy regulation by both the U.S.

Government and the states in which we conduct our business.

Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.

The regulations that may affect our ability to operate include, without limitation:

• the federal Anti-Kickback Statute, which prohibits, among other things, any person from knowingly and willfully offering, soliciting, receiving or providing remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs, such as the Medicare and Medicaid programs, even if the person does not have actual knowledge of the statute or specific intent to violate it;

• the federal False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, false claims, or knowingly using false statements, to obtain payment from the U.S.

• federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;

• the anti-inducement law, which prohibits, among other things, the offering or giving of remuneration, which includes, without limitation, any transfer of items or services for free or for less than fair market value (with limited exceptions), to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of items or services reimbursable by a federal or state governmental program;

• the federal transparency requirements under the ACA, including the provision commonly referred to as the Physician Payments Sunshine Act and its implementing regulations, which require applicable manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid, or the State Children’s Health Insurance Program to report annually to CMS information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held by the physicians described above and their immediate family members.

Effective January 1, 2022, these reporting obligations were extended to include transfers of value made to certain non-physician providers such as physician assistants and nurse practitioners;

• federal government price reporting laws, which require us to calculate and report complex pricing metrics in an accurate and timely manner to government programs;

• federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers;

• HIPAA, which governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information;

• state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers.

If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from participating in federal health care programs and the curtailment or restructuring of our operations.

Any penalties, damages, fines, curtailment, exclusion, or restructuring of our operations could adversely affect our ability to operate our business, prospects, operating results and financial condition.

Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business.

Moreover, achieving and sustaining compliance with applicable federal and state privacy and fraud and abuse laws may prove costly.

Our business and operations, including our development programs, could be materially disrupted in the event of system failures, security breaches, violations of data protection laws or data loss or damage by us or third parties on which we rely, including our CROs or other contractors or consultants.

Our internal computer systems (including our LUNA200 manufacturing system) and those of third parties on which we rely, including our CROs and other contractors and consultants, are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures.

If such an event were to occur and cause interruptions in our operations, it could have a material adverse effect on our business operations, including a material disruption of our development program.

Unauthorized disclosure of sensitive or confidential patient or employee data, including personally identifiable information, whether through breach of computer systems, systems failure, employee negligence, fraud or misappropriation, or otherwise, or unauthorized access to or through our information systems and networks, whether by our employees or third parties, could result in negative publicity, legal liability and damage to our reputation.

Unauthorized disclosure of personally identifiable information could also expose us to sanctions for violations of data privacy laws and regulations around the world.

To the extent that any disruption or security breach resulted in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development of our product candidates could be delayed.

For example, the loss of or damage to clinical trial data, such as from completed or ongoing clinical trials, for any of our product candidates would likely result in delays in our marketing approval efforts and significantly increased costs in an effort to recover or reproduce the data.

We have previously been, and expect to remain, the target of cyber-attacks.

As we become more dependent on information technologies to conduct our operations, cyber incidents, including deliberate attacks, such as ransomware attacks, and attempts to gain unauthorized access to computer systems (including our LUNA200 manufacturing system) and networks, may increase in frequency and sophistication.

These incidents pose a risk to the security of our systems and networks, the confidentiality and the availability and integrity of our data and these risks apply both to us, and to third parties on whose systems we rely for the conduct of our business.

While the effect of these incidents has not historically been material to our results of operations, financial condition or prospects, cyber threats are persistent and constantly evolving.

Such threats have increased in frequency, scope and potential impact in recent years, which increase the difficulty of detecting and successfully defending against them.

As cyber threats continue to evolve, we may be required to incur additional expenses in order to enhance our protective measures or to remediate any information security vulnerability.

There can be no assurance that we or our third-party providers will be successful in preventing cyber-attacks or successfully mitigating their effects.

Similarly, there can be no assurance that our collaborators, CROs, third-party logistics providers, distributors and other contractors and consultants will be successful in protecting our clinical and other data that is stored on their systems.

Any cyber-attack or destruction or loss of data could have a material adverse effect on our business and prospects.

In addition, we may suffer reputational harm or face litigation or adverse regulatory action as a result of cyber-attacks or destruction or loss of data and may incur significant additional expense to implement further data protection measures.

It is also possible that unauthorized access to data may be obtained through inadequate use of security controls by our suppliers or other vendors.

In 2021, a remote code execution vulnerability in Apache Log4j was identified as affecting large amounts of systems worldwide.

We were not impacted by the Log4j vulnerability, however we cannot provide assurance that these and other attacks will not have an impact in the future.

Although we have general liability insurance coverage, our insurance may not cover all claims, continue to be available on reasonable terms or be sufficient in amount to cover one or more large claims.

Additionally, the insurer may disclaim coverage as to any claim.

The successful assertion of one or more large claims against us that exceed or are not covered by our insurance coverage or changes in our insurance policies, including premium increases or the imposition of large deductible or co-insurance requirements, could have a material adverse effect on our business, prospects, operating results and financial condition.

If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines and penalties or incur costs that could harm our business.

We are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes.

Our operations involve the use of hazardous and flammable materials, including chemicals and biological materials and produce hazardous waste products.

We generally contract with third parties for the disposal of these materials and wastes.

In the event of contamination or injury resulting from our use or production of hazardous materials, we could be held liable for any resulting damages even if we contract with a third party for their disposal, and any liability could exceed our resources.

We also could incur significant costs associated with civil or criminal fines and penalties resulting from contamination or injury from our use or production of hazardous materials.

Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use or production of hazardous materials, this insurance may not provide adequate coverage against potential liabilities.

We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological, hazardous materials.

In addition, we may be required to incur substantial costs to comply with future environmental, health and safety laws and regulations.

Compliance with such laws and regulations may divert resources away from our research, development and manufacturing efforts.

Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.

Failure to comply with health and data protection laws and regulations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation and adverse publicity and could negatively affect our operating results and business.

We and any potential collaborators may be subject to federal, state and foreign data protection laws and regulations ( i.e.

, laws and regulations that address privacy and data security).

In the United States, numerous federal and state laws and regulations, including federal health information privacy laws, state data breach notification laws, state privacy and health information privacy laws and federal and state consumer protection laws ( e.g.

, Section 5 of the Federal Trade Commission Act), that govern the collection, use, disclosure and protection of health-related and other personal information could apply to our operations or the operations of our collaborators.

In addition, we may obtain health information from third parties (including research institutions from which we obtain clinical trial data) that are subject to privacy and security requirements under HIPAA.

Depending on the facts and circumstances, we could be subject to civil or criminal penalties if we obtain, use, or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA.

International data protection laws, including Regulation 2016/679, known as the General Data Protection Regulation (“GDPR”), may also apply to health-related and other personal information obtained outside of the United States.

The GDPR will increase our responsibility and liability in relation to personal data that we process, and we may be required to put in place additional mechanisms to ensure compliance with the new EU (which also includes the European Economic Area, or “EEA”) data protection rules.

Further, the United Kingdom’s vote in favor of exiting the EU, often referred to as Brexit, has created more uncertainty with regard to data protection regulation in the United Kingdom (the “UK”).

The UK retained the GDPR in UK law, which sits alongside the amended version of the Data Protection Act 2018.

The EU adopted an adequacy decision so data can be transferred from the EU to the UK.

Additionally, there are no new requirements for transfer from the UK to the EU.

However, going forward, the EU and UK’s data protection rules could diverge and data transfers may not be possible and/or new arrangements may need to be put in place.

In particular, it is unclear to what extent the UK regime will begin diverging from the GDPR and how data transfers to and from the UK will be regulated.

In addition, California recently enacted the California Consumer Privacy Act (“CCPA”), which creates new individual privacy rights for California consumers (as defined in the law) and places increased privacy and security obligations on entities handling personal data of consumers or households.

The CCPA became effective on January 1, 2020, but the California Consumer Rights Act (“CPRA”) was recently enacted to strengthen elements of the CCPA effective January 1, 2023.

In addition, there are a number of other states that have considered similar privacy proposals, with states like Virginia and Colorado enacting their own privacy laws (also scheduled to come into effect in January 1, 2023 and July 1, 2023, respectively).

These privacy laws may impact our business activities and exemplify the vulnerability of our business to the evolving regulatory environment related to personal data.

Compliance with U.S.

and international data protection laws and regulations could require us to take on more onerous obligations in our contracts, restrict our ability to collect, use and disclose data, or in some cases, impact our ability to

operate in certain jurisdictions.

Failure to comply with U.S.

and international data protection laws and regulations could result in government enforcement actions (which could include civil or criminal penalties), private litigation and adverse publicity and could negatively affect our operating results and business.

Moreover, clinical trial subjects about whom we or our potential collaborators obtain information, as well as the providers who share this information with us, may contractually limit our ability to use and disclose the information.

Claims that we have violated individuals’ privacy rights, failed to comply with data protection laws, or breached our contractual obligations, even if we are not found liable, could be expensive and time-consuming to defend and could result in adverse publicity that could harm our business.

We or the third parties upon which we depend may be adversely affected by natural disasters, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.

Natural disasters such as hurricanes could severely disrupt our operations and have a material adverse effect on our business, prospects, operating results and financial condition.

In addition, flooding, lightning strikes, meteor strikes, and polar vortices could affect our building operations.

If a natural disaster, power outage or other unforeseen event occurred that prevented us from using all or a significant portion of our headquarters, that damaged critical infrastructure, such as our in-house manufacturing facility, or that otherwise significantly disrupted our operations, it may be difficult or, in certain cases, impossible for us to continue our business for a substantial period of time.

The disaster recovery and business continuity plans we have in place currently may prove inadequate in the event of a natural disaster or similar event.

We may incur substantial expenses as a result of any natural disaster, which could have a material adverse effect on our business.

We are subject to anti-corruption and a variety of other laws governing our international operations.

If we fail to comply with these laws, we could be subject to, among other things, civil or criminal penalties, other sanctions and remedial measures, and reputational damage, which could adversely affect our business, prospects, operating results and financial condition.

Our operations are subject to anti-corruption laws, including the U.S.

Foreign Corrupt Practices Act (“FCPA”), the U.K.

Bribery Act and other anti-corruption laws.

Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, contractors, and partners from authorizing, promising, offering, or providing, directly or indirectly, improper payments or anything else of value to recipients in the public or private sector.

We are conducting certain of our trials at a number of trial sites around the world.

Certain of these jurisdictions pose a risk of potential FCPA violations, and we have relationships with third parties, including government-affiliated hospitals and universities, whose actions could potentially subject us to liability under the FCPA or local anti-corruption laws.

We are also subject to other laws and regulations governing our international operations, including regulations administered by the U.S.

Department of Commerce’s Bureau of Industry and Security, the U.S.

Department of the Treasury’s Office of Foreign Assets Control, and various non-U.S.

government entities, including applicable economic sanctions on countries and persons, customs requirements, currency exchange regulations and transfer pricing regulations.

If we fail to comply with applicable anti-corruption laws and other legal requirements, we may become subject to criminal and civil penalties, disgorgement and other sanctions and remedial measures, including the loss of export or import privileges and debarment, and face substantial legal expenses.

Likewise, even an investigation by U.S.

or foreign authorities of potential violations of such laws could damage our reputation.

In either case, our business, prospects, operating results and financial condition could be adversely affected.

Under certain circumstances, we could also be held liable for the activities of our employees, contractors, and partners that violate anti-corruption laws, even if we do not explicitly authorize or have actual knowledge of such activities.

Even allegations of such violations could potentially damage our reputation and harm our business.

Risks Related to Our Intellectual Property

Our ability to successfully commercialize our products may be impaired if we are unable to obtain and maintain effective intellectual property rights for our proprietary scientific technology platform and product candidates.

Our success depends in large part on our and our licensors’ ability to obtain and maintain patent and other intellectual property protection in the United States and in other countries with respect to our proprietary scientific technology platform and products.

We have sought to protect our proprietary position by filing patent applications in the United States and abroad related to our novel technologies and product candidates that we and/or our licensors view as important to our business.

This process is expensive and time-consuming, and we and our licensors may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner.

It is also possible that we and/or our licensors will fail to identify patentable aspects of our research and development output before it is too late to obtain patent

In some circumstances, we may not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the patents or enforce the patents, covering technology or products that we license from third parties.

Our existing patents and any future patents and the existing and any future licenses to third-party patents we obtain may not be sufficiently broad to prevent others from using our technologies or from developing competing products and technologies.

The patent position of biotechnology companies generally is highly uncertain and involves complex legal and factual questions for which legal principles remain unresolved.

In recent years, patent rights have been the subject of significant litigation.

As a result, the issuance, scope, validity, enforceability and commercial value of our and our licensors’ patent rights are highly uncertain.

Additionally, changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our owned or licensed patents or narrow the scope of our patent protection.

The laws of foreign countries may not protect our rights to the same extent as the laws of the United States.

Even if our owned and licensed patent applications issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage.

We, or our licensors, may fail to identify patentable aspects of inventions made in the course of development and commercialization activities before it is too late to obtain patent protection on them.

Therefore, we may miss potential opportunities to strengthen our patent position.

Our competitors may be able to circumvent our owned or licensed patents by developing similar or alternative technologies or products in a non-infringing manner.

The issuance of a patent is not conclusive as to its scope, validity or enforceability, and our owned and licensed patents may be challenged in the courts or patent offices in the United States and abroad.

Such challenges may result in patent claims being narrowed, invalidated or held unenforceable, which could limit our ability to stop or prevent us from stopping others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology and products.

Given the amount of time required for the development, testing and regulatory review of future product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized.

As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours or otherwise provide us with a competitive advantage.

The patent protection we obtain for our product candidates may not be sufficient enough to provide us with any competitive advantage or our owned or licensed patents may be challenged.

In some instances, agreements through which we license patent rights may not give us control over patent prosecution or maintenance, so that we may not be able to control which claims or arguments are presented, how claims are amended, and may not be able to secure, maintain, or successfully enforce necessary or desirable patent protection from those patent rights.

We have not had and do not have primary control over patent prosecution and maintenance for certain of the patents and patent applications we license and therefore cannot guarantee that these patents and applications will be prosecuted or maintained in a manner consistent with the best interests of our business.

We cannot be certain that patent prosecution and maintenance activities by our licensors have been or will be conducted in compliance with applicable laws and regulations or will result in valid and enforceable patents.

Moreover, some of our in-licensed patents and patent applications are, and our future owned and licensed patents may be, co-owned with third parties.

If we are unable to obtain an exclusive license to any such third-party co-owners’ interest in any future patents or patent applications, such co-owners may be able to license their rights to other third parties, including our competitors, and our competitors could market competing products and technology.

In addition, we may need the cooperation of any such co-owners of our patents in order to enforce such patents against third parties, and such cooperation may not be provided to us.

It is possible that defects of form in the preparation or filing of our owned or licensed patents or patent applications may exist, or may arise in the future, for example with respect to proper priority claims, inventorship, claim scope, or requests for patent term adjustments or extensions.

If we or our partners, collaborators, licensees, or licensors, whether current or future, fail to establish, maintain or protect such patents and other intellectual property rights, such rights may be reduced or eliminated.

If our partners, collaborators, licensees, or licensors, are not fully cooperative or disagree with us as to the prosecution, maintenance or enforcement of any patent rights, such patent rights could be compromised.

If there are material defects in the form, preparation, prosecution, or enforcement of our owned or licensed patents or patent applications, such patents may be invalid and/or unenforceable, and such applications may never result in valid, enforceable patents.

Any of these outcomes could impair our ability to prevent competition from third parties, which may have an adverse impact on our business.

Pending patent applications cannot be enforced against third parties practicing the technology claimed in such applications unless and until a patent issues from such applications.

Assuming the other requirements for patentability are met, currently, the first to file a patent application is generally entitled to the patent.

However, prior to March 16, 2013, in the United States, the first to invent was entitled to the patent.

Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are not published until 18 months after filing, or in some cases not at all.

Therefore, we cannot be certain that we were the first to make the inventions claimed in our patents or pending patent applications, or that we were the first to file for patent protection of such inventions.

Similarly, we cannot be certain that parties from whom we do or may license or purchase patent rights were the first to make relevant claimed inventions, or were the first to file for patent protection for them.

If third parties have filed prior patent applications on inventions claimed in our owned or licensed patents or applications that were filed on or before March 15, 2013, an interference proceeding in the United States can be initiated by such third parties to determine who was the first to invent any of the subject matter covered by the patent claims of such owned or licensed patent applications.

If third parties have filed such prior applications after March 15, 2013, a derivation proceeding in the United States can be initiated by such third parties to determine whether our owned or licensed invention was derived from theirs.

Moreover, because the issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, our owned and licensed patents or pending patent applications may be challenged in the courts or patent offices in the United States and abroad.

There is no assurance that all of the potentially relevant prior art relating to our owned or licensed patents and patent applications has been found.

If such prior art exists, it may be used to invalidate a patent, or may prevent a patent from issuing from a pending patent application.

For example, such patent filings may be subject to a third-party submission of prior art to the U.S.

Patent and Trademark Office (“USPTO”), or to other patent offices around the world.

Alternately or additionally, we may become involved in post-grant review procedures, oppositions, derivation proceedings, ex parte reexaminations, inter partes review, supplemental examinations, or interference proceedings or challenges in district court, in the United States or in various foreign patent offices, including both national and regional, challenging patents or patent applications in which we have rights, including patents on which we rely to protect our business.

An adverse determination in any such challenges may result in loss of the patent or in patent or patent application claims being narrowed, invalidated or held unenforceable, in whole or in part, or in denial of the patent application or loss or reduction in the scope of one or more claims of the patent or patent application, any of which could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology and products.

In addition, given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized.

Pending and future patent applications may not result in patents being issued that protect our business, in whole or in part, or which effectively prevent others from commercializing competitive products.

Competitors may also be able to design around our owned or licensed patents.

Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our owned or licensed patents or narrow the scope of our patent protection.

In addition, the laws of foreign countries may not protect our rights to the same extent or in the same manner as the laws of the United States.

For example, patent laws in various jurisdictions, including significant commercial markets such as Europe, restrict the patentability of methods of treatment of the human body more than United States law does.

If these developments were to occur, they could have a material adverse effect on our ability to generate revenue.

Issued patents that we have or may obtain or license may not provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage.

Our competitors may be able to circumvent our owned or licensed patents by developing similar or alternative technologies or products in a non-infringing manner.

Our competitors may also seek approval to market their own products similar to or otherwise competitive with our products.

In these circumstances, we may need to defend or assert our owned or licensed patents, or both, including by filing lawsuits alleging patent infringement.

In any of these types of proceedings, a court or other agency with jurisdiction may find our owned or licensed patents invalid or unenforceable, or that our competitors are competing in a non-infringing manner.

Thus, even if we have valid and enforceable patents, these patents still may not provide protection against competing products or processes sufficient to achieve our business objectives.

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

We may become involved in lawsuits to protect or enforce our patents, which could be expensive, time-consuming and unsuccessful.

Competitors may infringe, misappropriate or violate our owned or licensed patents or other intellectual property.

To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming.

In addition, in an infringement proceeding, a court may decide that a patent of ours is invalid or

unenforceable, in whole or in part.

There is also a risk that, even if the validity of such patents is upheld, the court will construe the patent’s claims narrowly and refuse to stop the other party from using the technology at issue on the grounds that our owned or licensed patents do not cover such technology.

The standards that courts use to interpret patents are not always applied predictably or uniformly and can change, particularly as new technologies develop.

As a result, we do not know how much protection, if any, will be given to our owned or licensed patents if we attempt to enforce them and they are challenged in court.

An adverse result in any litigation proceeding could put one or more of our owned or licensed patents at risk of being invalidated or interpreted narrowly.

Inequitable conduct is frequently raised as a defense during intellectual property litigation.

It is believed that all parties involved in the prosecution of our patent applications have complied with their duties of disclosure in the course of prosecuting our patent applications;

however, it is possible that legal claims to the contrary could be asserted if we were engaged in intellectual property litigation, and the results of any such legal claims are uncertain due to the inherent uncertainty of litigation.

If a court determines that any party involved in the prosecution of our owned or licensed patents failed to comply with its duty of candor, the subject patent could be held to be unenforceable.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation.

Intellectual property litigation or other legal proceedings may cause us to incur significant expenses and may also absorb significant management time.

Uncertainties resulting from our participation in patent litigation or other proceedings could have a material adverse effect on our business.

Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could harm our business, prospects, operating results and financial condition.

Third parties may assert infringement, misappropriation or other claims against us, or other parties we have agreed to indemnify, based on existing third-party patents or patents that may be granted in the future as well as other intellectual property rights.

There may be existing third-party patents or patent applications covering aspects of our technology.

Furthermore, because patent applications are published sometime after filing, and because applications can take several years to issue, there may be additional currently pending third-party patent applications that are unknown to us, which may later result in issued patents.

Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business.

We may not have sufficient resources to bring these actions to a successful conclusion.

There could also be public announcements of the results of hearings, motions or other interim proceedings or developments.

If securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of shares of our common stock.

Because of the inevitable uncertainty in intellectual property litigation, we could lose a patent infringement or other action asserted against us regardless of our perception of the merits of the case.

If we are found to infringe upon, misappropriate or otherwise violate a third party’s intellectual property rights, we could be required to obtain a license from such third party to continue developing and commercializing our products and technology.

However, we may not be able to obtain any required license on commercially reasonable terms or at all.

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

We could be forced, including by court order, to cease commercializing the implicated technology or product.

In addition, in any such proceeding or litigation, we could be found liable for monetary damages, which could be significant, including treble damages and attorneys’ fees, if we are found to have willfully infringed a patent.

A finding of infringement, misappropriation or that we otherwise violated intellectual property rights could prevent us from commercializing our product candidates or force us to cease some or all of our business operations.

If we fail to comply with our obligations in our intellectual property licenses with third parties, we could lose license rights that are important to our business.

We are a party to intellectual property license agreements with third parties.

For example, we have licenses with each of Duke University and Yale University for patents associated with our proprietary technology, and may enter into additional license agreements in the future.

Our existing license agreements impose, and we expect that our future license agreements will impose, various diligence, royalty payment, milestone payment, insurance and other obligations on us.

If we fail to comply with these obligations or other obligations in our license agreements, our licensors may have the right to terminate these agreements, in which event we may not be able to develop and market any product or use any platform technology that is covered by these agreements.

If our license agreements terminate, or we experience a reduction or elimination of licensed rights under these agreements, we may have to negotiate new or reinstated licenses with less

favorable terms or we may not have sufficient intellectual property rights to operate our business.

The occurrence of such events could materially harm our business.

Further, the agreements under which we currently license intellectual property or technology from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations.

Accordingly, disputes may arise between us and our licensor, our licensor and its licensors, regarding intellectual property subject to a license agreement, including those relating to:

• the scope of rights, if any, granted under the license agreement and other interpretation-related issues;

• whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the license agreement;

• whether our licensor or its licensor had the right to grant the license agreement;

• whether third parties are entitled to compensation or equitable relief, such as an injunction, for our use of the intellectual property without their authorization;

• our right to sublicense patent and other rights to third parties under collaborative development relationships;

• whether we are complying with our obligations with respect to the use of the licensed technology in relation to our development and commercialization of product candidates;

• our involvement in the prosecution of the licensed patents and our licensors’ overall patent enforcement strategy;

• the allocation of ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and by us and our partners;

• the amounts of royalties, milestones or other payments due under the license agreement.

The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other obligations under the relevant 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 commercialize the affected product candidates.

If we or any such licensors fail to adequately protect this intellectual property, our ability to commercialize our products could suffer.

Any disputes with our licensors or any termination of the licenses on which we depend could have a material adverse effect on our business, financial condition, results of operations and prospects.

We may not be successful in obtaining necessary intellectual property rights to product candidates for our development pipeline through acquisitions and in-licenses.

Although we intend to develop product candidates through our own internal research, we may need to obtain additional licenses from others to advance our research or allow commercialization of our product candidates.

However, we may be unable to acquire or in-license intellectual property rights relating to, or necessary for, any such product candidates from third parties on commercially reasonable terms or at all.

In that event, we may be unable to develop or commercialize such product candidates.

We may also be unable to identify additional, future product candidates that we believe are an appropriate strategic fit for our company and intellectual property relating to, or necessary for, such product candidates.

The in-licensing and acquisition of third-party intellectual property is a competitive area, and a number of more established companies are also pursuing strategies to in-license or acquire third-party intellectual property rights that we may consider attractive or necessary.

These established companies may have a competitive advantage over us due to their size, cash resources and greater clinical development and commercialization capabilities.

Furthermore, companies that perceive us to be a competitor may be unwilling to assign or license rights to us.

In addition, we expect that competition for the in-licensing or acquisition of third-party intellectual property rights for product candidates that are attractive to us may increase in the future, which may mean fewer suitable opportunities for us as well as higher acquisition or licensing costs.

We may be unable to in-license or acquire the third-party intellectual property rights for product candidates on terms that would allow us to make an appropriate return on our investment.

If we are unable to successfully obtain rights to suitable product candidates, our business, financial condition, results of operations and prospects for growth could suffer.

We may be unable to protect the confidentiality of our trade secrets, particularly in light of our reliance on third parties, which increases the possibility that such trade secrets will be disclosed or misappropriated, thus harming our business and competitive position.

In addition to our patented technology and products, we rely upon trade secrets, including unpatented know-how, technology and other proprietary information to develop and maintain our competitive position, particularly with respect to our manufacturing process.

We seek to protect our trade secrets, in part, through confidentiality agreements with our employees, collaborators and consultants.

We seek to have agreements with our employees and selected consultants that obligate them to assign any inventions created during their tenure with us.

However, we may not obtain these agreements in all circumstances and the assignment of intellectual property under such agreements may not be self-executing.

If the employees, collaborators or consultants that are parties to these agreements breach or violate their respective terms, we may not have adequate remedies for any such breach or violation.

Our trade secrets could also be misappropriated by our competitors.

Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive, time-consuming and potentially distracting, and the outcome is unpredictable.

In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets.

If any of our trade secrets were to be lawfully obtained or independently developed by a competitor or other third party, we would have no right to prevent such a party from using that technology or information to compete with us.

If our trade secrets are disclosed to or misappropriated or independently developed by a third party, it would harm our ability to protect our rights and could materially harm our business and competitive position.

Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.

We may employ individuals or engage consultants that previously worked with other organizations, including our competitors or potential competitors.

Although we seek to ensure that such persons do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or they, or both, have inadvertently or otherwise used or disclosed intellectual property, including trade secrets or other proprietary information, of a former employer or other third party.

Litigation may be necessary to defend against these claims.

If we fail in defending any such claims or settling those claims, we may lose valuable intellectual property rights or personnel in addition to paying monetary damages or a settlement.

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

Patent terms may be inadequate to protect our competitive position on our HAVs or our other product candidates for an adequate amount of time.

Patents have a limited lifespan.

In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S.

non-provisional filing date.

Various extensions may be available, but the life of a patent, and the protection it affords, is limited.

Even if patents covering our HAVs are obtained, once the patent life has expired, we may face competition, including from other competing technologies.

As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

We may not be able to protect our intellectual property rights throughout the world.

Filing, prosecuting, maintaining, defending and enforcing patents on our product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can be less extensive than those in the United States.

In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States.

Consequently, we may not be able to prevent third parties from practicing our inventions in countries outside the United States, or from selling or importing products made using our inventions in and into or other jurisdictions.

Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and may also export infringing products to territories where we have patent protection, but enforcement rights are not as strong as those in the United States.

These products may compete with our products, to the extent approved, and our owned or licensed patents or other intellectual property rights may not be effective or sufficient to prevent them from doing so.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions.

The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets, and other intellectual property protection, particularly those relating to biotechnology products, which could make it difficult for us to stop the infringement of our owned or licensed patents or marketing of competing products in violation of our proprietary rights generally.

Proceedings to enforce our patent rights in foreign

jurisdictions, whether or not successful, could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our owned or licensed patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us.

We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded to us, if any, may not be commercially meaningful.

Many countries have compulsory licensing laws under which a patent owner may be compelled under specified circumstances to grant licenses to third parties.

In addition, many countries limit the enforceability of patents against government agencies or government contractors.

In those countries, we may have limited remedies if patents are infringed or if we are compelled to grant a license to a third party, which could materially diminish the value of those patents.

This could limit our potential revenue opportunities.

Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license, which could adversely affect our business, financial condition, results of operations, and prospects.

Some of our internal intellectual property and most of our in-licensed intellectual property has been generated under U.S.

Government grants and contracts that trigger certain obligations and U.S.

Government rights and thus is subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies.

Compliance with such regulations may limit our exclusive rights and limit our ability to contract with non-U.S.

manufacturers.

Some of our internal intellectual property and most of our in-licensed intellectual property has been generated under U.S.

Government grants and contracts that trigger certain obligations and U.S.

Government rights under federal statutes and regulations, including the Bayh-Dole Act of 1980 and the Federal Technology Transfer Act of 1986.

For example, the U.S.

Government has a non-exclusive, non-transferable, irrevocable worldwide license to inventions conceived or first actually reduced to practice in the performance of a U.S.

Government agreement.

In addition, the U.S.

Government has certain “march-in” rights to require us to grant exclusive, partially exclusive, or non-exclusive licenses to such inventions for the benefit of a third party if the U.S.

Government determines that:

(i) action is necessary to alleviate health or safety needs not reasonably met by us, our assignees, our licensees, or, in some cases, our licensors, (ii) action is necessary due to noncompliance with a U.S.-based manufacturing requirement applicable to exclusive licenses, (iii) action is necessary to meet requirements for public use specified by federal regulations and such requirements are not reasonably satisfied by us, our assignees, our licensees, and, in some cases, our licensors, and (iv) with respect to inventions made under funding agreements, adequate steps have not been taken to achieve practical application of the invention.

Government also has the right to take title to these inventions if we, or the applicable licensor, fails to disclose, elect title to, file or prosecute a patent application for, or defend or obtain a patent covering such inventions within time limits specified in particular funding agreements.

Government also has varying rights to use and disclose information, including copyrighted works, generated or delivered under a U.S.

Government agreement depending on the terms of the agreement and the nature of the information.

Intellectual property generated under a U.S.

Government agreement is also subject to certain reporting requirements, compliance with which may require us or the applicable licensor to expend substantial resources.

In addition, when inventions that are conceived or first actually reduced to practice under a U.S.

Government funding agreement are exclusively licensed, products embodying or produced through the use of such inventions must be manufactured substantially in the United States.

This U.S.-based manufacturing requirement may limit our ability to contract with non-U.S.

companies to produce a covered product, although this requirement can be waived in certain circumstances.

To the extent that any of our licensors’ current or future intellectual property is generated in the performance of U.S.

Government grants or contracts, these requirements may apply to such intellectual property.

If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our marks of interest and our business may be adversely affected.

Our trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks.

We may not be able to protect our rights to these trademarks and trade names or may be forced to stop using these names, which we need for name recognition by potential partners or customers in our markets of interest.

During trademark registration proceedings, we may receive rejections.

Although we would be given an opportunity to respond to those rejections, we may be unable to overcome such rejections.

In addition, in the USPTO and in comparable agencies in many foreign jurisdictions, third parties are given an opportunity to oppose pending trademark applications and to seek to cancel registered trademarks.

Opposition or cancellation proceedings may be filed against our trademarks, and our trademarks may not survive such proceedings.

If we are unable to establish name recognition based on our trademarks and trade names, we may not be able to compete effectively and our business may be adversely affected.

Intellectual property rights do not necessarily address all potential threats.

The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage.

• others may be able to make products that are similar to any product candidates we may develop or utilize similar technology but that are not covered by the claims of the patents that we own or license or may own or license in the future;

• we, or our current or future licensors might not have been the first to make the inventions covered by the issued patent or pending patent application that we own or license or may own or license in the future;

• we, or our current or future licensors might not have been the first to file patent applications covering certain of our or their inventions;

• others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our owned or licensed intellectual property rights;

• it is possible that our and our licensors’ pending owned or licensed patent applications or those that we may own or license in the future will not lead to issued patents;

• issued patents that we hold rights to may be held invalid or unenforceable, including as a result of legal challenges by our competitors;

• our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;

• we may not develop additional proprietary technologies that are patentable;

• the patents of others may harm our business;

• we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.

Should any of these events occur, they could harm our business, financial condition, results of operations, and prospects.

Risks Related to Business Matters and Our Ability to Manage Growth

Our future success depends on our ability to retain our key employees, consultants and advisors and to attract, retain and motivate qualified personnel.

We are highly dependent on the research and development, clinical, regulatory, financial, commercial, and manufacturing expertise of the principal members of our management, scientific and clinical teams.

The loss of the services of our executive officers or other key employees could impede the achievement of our research, development and commercialization objectives and seriously harm our ability to successfully implement our business strategy.

Furthermore, losing or replacing executive officers and key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to successfully develop, gain marketing approval of and commercialize our product candidates.

Competition to hire from this limited pool is intense.

We also experience competition for the hiring of scientific and clinical personnel from public and private universities and research institutions.

In addition, we rely on consultants and advisors, including scientific, commercial and clinical advisors, to assist us in formulating our research and development and commercialization strategy.

Our consultants and advisors may have commitments under employment, consulting or advisory contracts with other entities that may limit their availability to us.

If we are unable to continue to attract and retain high quality personnel, our ability to pursue our growth strategy will be limited.

We expect to increase the size of our workforce in the future, and we may encounter difficulties in managing this growth, which could harm our operations.

As of December 31, 2021, we had 146 employees.

As we move forward in our efforts to commercialize our HAVs, if approved, we expect to continue to experience significant growth in the number of our employees and the scope of our operations, particularly in the areas of development, regulatory affairs, manufacturing and quality and compliance and support functions.

Due to our limited financial resources, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel.

The expansion of our operations may lead to significant costs and may divert our management and business development resources.

Any inability to manage this growth effectively could delay the execution of our business plans or harm our operations.

Risks Related to Ownership of Our Securities

The price of our common stock may be volatile.

The price of our common stock may fluctuate due to a variety of factors, including:

• actual or anticipated fluctuations in our quarterly and annual results and those of other public companies in our industry;

• mergers and strategic alliances in the industry in which we operate;

• market prices and conditions in the industry in which we operate;

• changes in government regulation;

• the impact of the COVID-19 pandemic on our business and operations;

• potential or actual military conflicts or acts of terrorism;

• announcements concerning Humacyte or our competitors;

• the general state of the securities markets.

These market and industry factors may materially reduce the market price of our common stock, regardless of our operating performance.

Reports published by analysts, including projections in those reports that differ from our actual results, could adversely affect the price and trading volume of our common stock.

We expect that securities research analysts will establish and publish their own periodic projections for the business of Humacyte.

These projections may vary widely and may not accurately predict the results we actually achieve.

Our stock price may decline if our actual results do not match the projections of these securities research analysts.

Similarly, if one or more of the analysts who write reports on Humacyte downgrades our stock or publishes inaccurate or unfavorable research about our business, our stock price could decline.

If one or more of these analysts ceases coverage of Humacyte or fails to publish reports on Humacyte regularly, our stock price or trading volume could decline.

We may issue additional shares of common stock or other equity securities without your approval, which would dilute your ownership interests and may depress the market price of our common stock.

As of December 31, 2021, we had Warrants outstanding to purchase up to an aggregate of 5,177,500 shares of our common stock and options and warrants outstanding to purchase up to an aggregate of 7,122,198 shares of our common stock.

Under the Humacyte, Inc.

2021 Long-Term Incentive Plan (the “2021 Plan”) and the Humacyte, Inc.

2021 Employee Stock Purchase Plan (the “ESPP”), we also have the ability to issue 7,725,253 shares and 1,030,033 shares, respectively.

In addition, such aggregate number of shares under the 2021 Plan and the ESPP will automatically increase on January 1 of each year commencing January 1, 2022, in an amount equal to 5% and 1%, respectively, of the number of shares of our capital stock outstanding on December 31 of the preceding year, unless our board of directors (the “Board”) acts prior to January 1 of a given year to provide that the increase for such year will be a lesser number.

At the end of 2021, our Board elected not to increase the number of shares under the 2021 Plan and the ESPP.

We may also issue additional shares of common stock or other equity securities of equal or senior rank in the future in connection with, among other things, future acquisitions or repayment of outstanding indebtedness, without stockholder approval, in a number of circumstances.

Our issuance of additional shares of common stock or other equity securities of equal or senior rank would have the following effects:

• our existing stockholders’ proportionate ownership interest in Humacyte will decrease;

• the amount of cash available per share, including for payment of dividends in the future, may decrease;

• the relative voting strength of each previously outstanding share of common stock may be diminished;

• the market price of shares of our common stock may decline.

Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be your sole source of gains and you may never receive a return on your investment.

We may retain future earnings, if any, for future operations, expansion and debt repayment and have no current plans to pay any cash dividends for the foreseeable future.

Any decision to declare and pay dividends as a public company in the future will be made at the discretion of the Board and will depend on, among other things, our results of operations, financial condition, cash requirements, contractual restrictions and other factors that the Board may deem relevant.

In addition, our ability to pay dividends may be limited by covenants of any existing and future outstanding indebtedness we or our subsidiaries incur.

As a result, you may not receive any return on an investment in our securities unless you sell your securities for a price greater than that which you paid for it.

The Public Warrants may not be in the money in the future, and they may expire worthless, and the terms of the Public Warrants may be amended in a manner adverse to a holder if holders of at least 50% of the then outstanding Public Warrants approve of such amendment.

In connection with the Merger, the Company assumed 5,000,000 publicly-traded warrants (“Public Warrants”) and 177,500 private placement warrants issued to AHAC Sponsor LLC (the “Sponsor”), Oppenheimer & Co.

and Northland Securities, Inc, in connection with AHAC’s initial public offering (“Private Placement Warrants” and, together with the Public Warrants, the “Warrants”).

The Warrants were issued in registered form under a warrant agreement between Continental Stock Transfer & Trust Company, as warrant agent, and AHAC.

The warrant agreement provides that the terms of the Warrants may be amended without the consent of any holder to cure any ambiguity or correct any defective provision or correct any mistake, but requires the approval by the holders of at least 50% of the then-outstanding Public Warrants to make any change that adversely affects the interests of the registered holders of Public Warrants.

Accordingly, we may amend the terms of the Public Warrants in a manner adverse to a holder if holders of at least 50% of the then-outstanding Public Warrants approve of such amendment and, solely with respect to any amendment to the terms of the Private Placement Warrants or any provision of the warrant agreement with respect to the Private Placement Warrants, holders of at least 50% of the number of the then outstanding Private Placement Warrants.

Although our ability to amend the terms of the Public Warrants with the consent of at least 50% of the then-outstanding Public Warrants is unlimited, examples of such amendments could be amendments to, among other things, increase the exercise price of the Warrants, convert the Warrants into cash, shorten the exercise period or decrease the number of shares of common stock purchasable upon exercise of a Warrant.

We may redeem your unexpired Public Warrants prior to their exercise at a time that is disadvantageous to you, thereby making your Public Warrants worth less than they would be if you held and exercised them at a later time.

We have the ability to redeem outstanding Public Warrants prior to their expiration, at a price of $0.01 per Warrant, provided that the last reported sales price of our common stock equals or exceeds $18.00 per share (as adjusted for share subdivisions, share dividends, rights issuances, subdivisions, reorganizations, recapitalizations and the like) for any 20 trading days within a 30 trading-day period ending on the third trading day prior to the date we send the notice of redemption to the holders thereof.

If and when the Public Warrants become redeemable by us, we may exercise our redemption right even if we are unable to register or qualify the underlying securities for sale under all applicable state securities laws.

Redemption of the outstanding Public Warrants could force you to:

(i) exercise your Public Warrants and pay the exercise price therefor at a time when it may be disadvantageous for you to do so;

(ii) sell your Public Warrants at the then-current market price when you might otherwise wish to hold your Public Warrants;

or (iii) accept the nominal

redemption price which, at the time the outstanding Public Warrants are called for redemption, is likely to be substantially less than the market value of your Public Warrants.

The value received upon exercise of the Public Warrants (i) may be less than the value the holders would have received if they had exercised their Public Warrants at a later time where the underlying share price is higher and (ii) may not compensate the holders for the value of the Public Warrants.

The Private Placement Warrants are not subject to the same risk of redemption as the Public Warrants as the Private Placement Warrants are not redeemable so long as they are held by the Sponsor, the underwriters of AHAC’s initial public offering or their permitted transferees.

If the Private Placement Warrants are held by holders other than the Sponsor, the underwriters or their permitted transferees, the Private Placement Warrants will be redeemable by us.

We have derivative securities that are accounted for as liabilities and the changes in value of such derivative securities could have a material effect on our financial results.

Included on the Company’s consolidated balance sheets as of December 31, 2021 are derivative liabilities related to the Contingent Consideration and the Private Placement Warrants.

Accounting Standards Codification 815, Derivatives and Hedging (“ASC 815”), provides for the remeasurement of the fair value of such derivatives at each balance sheet date, with a resulting non-cash gain or loss related to the change in the fair value being recognized in earnings in the statement of operations.

As a result of the recurring fair value measurement, our financial statements and results of operations may fluctuate quarterly, based on factors which are outside of our control.

Due to the recurring fair value measurement, we expect that we will recognize non-cash gains or losses on the Contingent Consideration and the Private Placement Warrants each reporting period and that the amount of such gains or losses could be material.

Prior to the Merger, on April 12, 2021, the Acting Director of the Division of Corporation Finance and Acting Chief Accountant of the SEC together issued a statement regarding the accounting and reporting considerations for warrants issued by special purpose acquisition companies entitled “Staff Statement on Accounting and Reporting Considerations for Warrants Issued by Special Purpose Acquisition Companies (“SPACs”)” (the “SEC Statement”).

Specifically, the SEC Statement focused on certain settlement terms and provisions related to certain tender offers following a business combination, which terms are similar to those contained in the Public Warrants.

As a result of the SEC Statement, prior to the Merger, AHAC reevaluated the accounting treatment of the Public Warrants and determined to classify the Public Warrants as derivative liabilities measured at fair value, with changes in fair value each period reported in earnings.

As a result, included on AHAC’s balance sheet as of December 31, 2020 are derivative liabilities related to embedded features contained within the Public Warrants.

In connection with its Amended Annual Report on Form 10-K/A for the year ended December 31, 2020, AHAC reached a determination to restate certain previously issued financial statements and related disclosures for the periods disclosed in order to correct the accounting treatment for the Warrants following the publication of the SEC Statement.

As a result, prior to the Merger, AHAC incurred unanticipated costs for accounting and legal fees in connection with or related to the restatement, and we may become subject to additional risks and uncertainties related to the restatement.

AHAC restated certain previously issued financial statements and related disclosures for the periods disclosed, and as of September 30, 2021, our management concluded that the conditions causing the material weakness that led to these restatements did not exist.

However, in the future, we may determine that we have additional material weaknesses.

Our failure to remediate any material weaknesses or failure to identify and address any material weaknesses or control deficiencies could result in inaccuracies in our financial statements and could also impair our ability to comply with applicable financial reporting requirements and related regulatory filings on a timely basis, which could cause investors to lose confidence in our reported financial information, which may result in volatility in and a decline in the market price of our common stock.

Our business could be adversely impacted by inflation.

Increases in inflation may have an adverse effect on our business.

Current and future inflationary effects may be driven by, among other things, supply chain disruptions and governmental stimulus or fiscal policies.

Continuing increases in inflation could impact the overall demand for our products, our costs for labor, material and services, and the margins we are able to realize on our products, all of which could have an adverse impact on our business, financial position, results of operations and cash flows.

Inflation may also result in higher interest rates, which in turn would result in higher interest

expense related to our variable rate indebtedness and any borrowings we undertake to refinance existing fixed rate indebtedness.

We may be required to take write-downs or write-offs, restructuring and impairment or other charges that could have a significant negative effect on our financial condition, results of operations and stock price, which could cause you to lose some or all of your investment.

We may be forced to write-down or write-off assets, restructure our operations, or incur impairment or other charges that could result in losses.

Even though these charges may be non-cash items and may not have an immediate impact on our liquidity, the fact that we may report charges of this nature could contribute to negative market perceptions about our securities.

In addition, charges of this nature may cause us to be unable to obtain future financing on favorable terms or at all.

Accordingly, a stockholder could suffer a reduction in the value of their shares.

The obligations associated with being a public company involve significant expenses and will require significant resources and management attention, which may divert from our business operations.

As a public company, we are subject to the reporting requirements of the Exchange Act and the Sarbanes-Oxley Act.

The Exchange Act requires the filing of annual, quarterly and current reports with respect to a public company’s business and financial condition.

The Sarbanes-Oxley Act requires, among other things, that a public company establish and maintain effective internal control over financial reporting.

As a result, we will incur significant legal, accounting and other expenses that we did not incur as a private company.

Our entire management team and many of its other employees will need to devote substantial time to compliance, and may not effectively or efficiently manage our transition into a public company.

These rules and regulations will result in our incurring substantial legal and financial compliance costs and will make some activities more time-consuming and costly.

For example, these rules and regulations have made it more difficult and more expensive for Humacyte to obtain director and officer liability insurance, and it has accepted reduced coverage.

As a result, it may be difficult for us to attract and retain qualified people to serve on the Board or committees of the Board or as executive officers.

We are an “emerging growth company” and a “smaller reporting company” within the meaning of the rules adopted by the SEC, and if we take advantage of certain exemptions from disclosure requirements available to emerging growth companies and smaller reporting companies, this could make our securities less attractive to investors and may make it more difficult to compare our performance with other public companies.

We are an emerging growth company as defined in the JOBS Act, and we may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in 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.

As a result, our stockholders may not have access to certain information they may deem important.

be an emerging growth company for up to five years, although circumstances could cause us to lose that status earlier, including

if the market value of our Class A common stock held by non-affiliates exceeds $700 million as of any June 30 before

that time, in which case we would no longer be an emerging growth company as of the following December 31.

We cannot predict whether

investors will find our securities less attractive because we will rely on these exemptions.

If some investors find our securities

less attractive as a result of our reliance on these exemptions, the trading prices of our securities may be lower than they otherwise

would be, there may be a less active trading market for our securities and the trading prices of our securities may be more volatile.

Section 102(b)(1) of the JOBS Act exempts emerging growth companies from being required to comply with new or revised financial

accounting standards until private companies (that is, those that have not had a Securities Act registration statement declared

effective or do not have a class of securities registered under the Exchange Act) are required to comply with the new or revised

financial accounting standards.

The JOBS Act provides that a company can elect to opt out of the extended transition period and

comply with the requirements that apply to non-emerging growth companies but any such an election to opt out is irrevocable.

We have elected not to opt out of such extended transition period, which means that when a standard is issued or revised and it

has different application dates for public or private companies, we, as an emerging growth company, can adopt the new or revised

standard at the time private companies adopt the new or revised standard.

This may make comparison of our financial statements

with another public company which is neither an emerging growth company nor an emerging growth company which has opted out of

using the extended transition period difficult or impossible because of the potential differences in accounting standards used.

Additionally,

we are a “smaller reporting company”

as defined in Rule 10(f)(1) of Regulation S-K.

Smaller reporting companies

may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited

financial statements.

We will remain a smaller reporting company until the last day of the fiscal year in which (1) the market

value of our common stock held by non-affiliates equals or exceeds $250 million as of the end of the prior June 30 th ,

or (2) our annual revenues equaled or exceeded $100 million during such completed fiscal year and the market value of

our common stock held by non-affiliates exceeds $700 million as of the prior June 30 th .

To the extent we

take advantage of such reduced disclosure obligations, it may also make comparison of our financial statements with other public

companies difficult or impossible.

obligations under the Sarbanes-Oxley Act may make it more difficult for us to effectuate our initial business combination, require

substantial financial and management resources, and increase the time and costs of completing an initial business combination.

of the Sarbanes-Oxley Act requires that we evaluate and report on our system of internal controls beginning with our Annual

Report on Form 10-K for the year ending December 31, 2021.

Only in the event we are deemed to be a large accelerated

filer or an accelerated filer, and no longer qualify as an emerging growth company, will we be required to comply with the independent

registered public accounting firm attestation requirement on our internal control over financial reporting.

Further, for as long

as we remain an emerging growth company, we will not be required to comply with the independent registered public accounting firm

attestation requirement on our internal control over financial reporting.

The fact that we are a blank check company makes compliance

with the requirements of the Sarbanes-Oxley Act particularly burdensome on us as compared to other public companies because

a target company with which we seek to complete our initial business combination may not be in compliance with the provisions

of the Sarbanes-Oxley Act regarding adequacy of its internal controls.

The development of the internal control of any such

entity to achieve compliance with the Sarbanes-Oxley Act may increase the time and costs necessary to complete any such business

in our amended and restated certificate of incorporation and Delaware law may inhibit a takeover of us, which could limit the

price investors might be willing to pay in the future for our Class A common stock and could entrench management.

amended and restated certificate of incorporation contains provisions that may discourage unsolicited takeover proposals that

stockholders may consider to be in their best interests.

These provisions include a staggered board of directors and the ability

of the board of directors to designate the terms of and issue new series of preferred shares, which may make the removal of management

more difficult and may discourage transactions that otherwise could involve payment of a premium over prevailing market prices

for our securities.

are also subject to anti-takeover provisions under Delaware law, which could delay or prevent a change of control.

these provisions may make the removal of management more difficult and may discourage transactions that otherwise could involve

payment of a premium over prevailing market prices for our securities.

amended and restated certificate of incorporation requires, to the fullest extent permitted by law, that derivative actions brought

in our name, actions against our directors, officers, other employees or stockholders for breach of fiduciary duty and certain

other actions may be brought only in the Court of Chancery in the State of Delaware and, if brought outside of Delaware, the stockholder

bringing the suit will, subject to certain exceptions, be deemed to have consented to service of process on such stockholder’s

counsel, which may have the effect of discouraging lawsuits against our directors, officers, other employees or stockholders.

amended and restated certificate of incorporation requires, to the fullest extent permitted by law, that derivative actions brought

in our name, actions against our directors, officers, other employees or stockholders for breach of fiduciary duty and certain

other actions may be brought only in the Court of Chancery in the State of Delaware and, if brought outside of Delaware, the stockholder

bringing the suit will be deemed to have consented to service of process on such stockholder’s counsel except any action

(A) as to which the Court of Chancery in the State of Delaware determines that there is an indispensable party not subject

to the jurisdiction of the Court of Chancery (and the indispensable party does not consent to the personal jurisdiction of the

Court of Chancery within ten days following such determination), (B) which is vested in the exclusive jurisdiction of a court

or forum other than the Court of Chancery or (C) for which the Court of Chancery does not have subject matter jurisdiction.

Any person or entity purchasing or otherwise acquiring any interest in shares of our capital stock shall be deemed to have notice

of and consented to the forum provisions in our amended and restated certificate of incorporation.

This choice of forum provision

may limit or make more costly a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes

with us or any of our directors, officers, other employees or stockholders, which may discourage lawsuits with respect to such

Alternatively, if a court were to find the choice of forum provision contained in our amended and restated certificate

of incorporation to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such

action in other jurisdictions, which could harm our business, operating results and financial condition.

amended and restated certificate of incorporation provides that the exclusive forum provision will be applicable to the fullest

extent permitted by applicable law, subject to certain exceptions.

Section 27 of the Exchange Act creates exclusive federal

jurisdiction over all suits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations

As a result, the exclusive forum provision will not apply to suits brought to enforce any duty or liability created

by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction.

In addition, the exclusive forum

provision will not apply to actions brought under the Securities Act, or the rules and regulations thereunder.

incidents or attacks directed at us could result in information theft, data corruption, operational disruption and/or financial

depend on digital technologies, including information systems, infrastructure and cloud applications and services, including those

of third parties with which we may deal.

Sophisticated and deliberate attacks on, or security breaches in, our systems or infrastructure,

or the systems or infrastructure of third parties or the cloud, could lead to corruption or misappropriation of our assets, proprietary

information and sensitive or confidential data.

As an early stage company without significant investments in data security protection,

we may not be sufficiently protected against such occurrences.

We may not have sufficient resources to adequately protect against,

or to investigate and remediate any vulnerability to, cyber incidents.

It is possible that any of these occurrences, or a combination

of them, could have adverse consequences on our ability to consummate a business combination and lead to financial loss.

we effect our initial business combination with a company with operations or opportunities outside of the United States,

we would be subject to a variety of additional risks that may negatively impact our operations.

we effect our initial business combination with a company with operations or opportunities outside of the United States,

we would be subject to any special considerations or risks associated with companies operating in an international setting, including

any of the following:

costs and difficulties inherent in managing cross-border business operations and complying with different commercial and

legal requirements of overseas markets;

and regulations regarding currency redemption;

corporate withholding taxes on individuals;

governing the manner in which future business combinations may be effected;

and trade barriers;

● regulations

related to customs and import/export matters;

payment cycles and challenges in collecting accounts receivable;

issues, including but not limited to tax law changes and variations in tax laws as compared to the United States;

fluctuations and exchange controls;

of inflation;

and language differences;

strikes, riots, civil disturbances, terrorist attacks, natural disasters and wars;

● deterioration

of political relations with the United States;

appropriations of assets.

may not be able to adequately address these additional risks.

If we were unable to do so, our operations might suffer, which may

adversely impact our results of operations and financial condition.

are risks related to the healthcare industry to which we may be subject.

combinations with companies with operations in the healthcare industry entail special considerations and risks.

If we are successful

in completing a business combination with a target business with operations in the healthcare industry, we will be subject to,

and possibly adversely affected by, the following risks, including but not limited to:

● Competition

could reduce profit margins.

inability to comply with governmental regulations affecting the healthcare industry could negatively affect our operations.

inability to license or enforce intellectual property rights on which our business may depend.

success of our planned business following consummation of our initial business combination may depend on maintaining a well-secured business

and technology infrastructure.

we are required to obtain governmental approval of our products, the production of our products could be delayed and we could

be required to engage in a lengthy and expensive approval process that may not ultimately be successful.

government and private efforts to contain healthcare costs, including through the implementation of legal and regulatory changes,

may reduce our future revenue and our profitability following such business combination.

in the healthcare related wellness industry and markets for such products affecting our customers or retailing practices could

negatively impact customer relationships and our results of operations.

healthcare industry is susceptible to significant liability exposure.

If liability claims are brought against us following a business

combination, it could materially adversely affect our operations.

of our operations upon third-party suppliers, manufacturers or contractors whose failure to perform adequately could disrupt

our business.

Affordable Care Act, possible changes to it or its repeal, and how it is implemented could negatively impact our business.

disruption in supply could adversely impact our business.

of the foregoing could have an adverse impact on our operations following a business combination.

However, our efforts in identifying

prospective target businesses will not be limited to the healthcare industry.

Accordingly, if we acquire a target business in

another industry, these risks will likely not affect us and we will be subject to other risks attendant with the specific industry

in which we operate or target business which we acquire, none of which can be presently ascertained.

We could be an emerging growth company for up to five years from the closing of AHAC’s initial public offering, although circumstances could cause us to lose that status earlier, including if the market value of our common stock held by non-affiliates exceeds $700 million as of any June 30 before that time, in which case we would no longer be an emerging growth company as of the following December 31.

We cannot predict whether investors will find our securities less attractive because we will rely on these exemptions.

If some investors find our securities less attractive as a result of our reliance on these exemptions, the trading prices of our securities may be lower than they otherwise would be, there may be a less active trading market for our securities and the trading prices of our securities may be more volatile.

Further, Section 102(b)(1) of the JOBS Act exempts emerging growth companies from being required to comply with new or revised financial accounting standards until private companies (that is, those that have not had a Securities Act registration statement declared effective or do not have a class of securities registered under the Exchange Act) are required to comply with the new or revised financial accounting standards.

The JOBS Act provides that an emerging growth company can elect to opt out of the extended transition period and comply with the requirements that apply to non-emerging growth companies, but any such an election to opt out is irrevocable.

We have elected not to opt out of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, we, as an emerging growth company, can adopt the new or revised standard at the time private companies adopt the new or revised standard.

This may make comparison of our financial statements with another public

company which is neither an emerging growth company nor an emerging growth company which has opted out of using the extended transition period difficult or impossible because of the potential differences in accounting standards used.

Additionally, we are a “smaller reporting company” as defined under the Exchange Act.

Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements.

We will remain a smaller reporting company for so long as (1) the market value of our common stock held by non-affiliates is less than $250 million as of the last business day of the second fiscal quarter, or (2) our annual revenues in our most recent fiscal year completed before the last business day of our second fiscal quarter are less than $100 million and the market value of our common stock held by non-affiliates is less than $700 million as of the last business day of the second fiscal quarter.

To the extent we take advantage of such reduced disclosure obligations, it may also make comparison of our financial statements with other public companies difficult or impossible.

If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results.

As a result, stockholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our common stock.

Effective internal control over financial reporting is necessary for us to provide reliable financial reports.

Any failure to implement new or improved controls necessary to maintain effective internal control over financial reporting, or difficulties encountered in their implementation, could cause us to fail to meet our reporting obligations.

In addition, any testing by us conducted in connection with Section 404 of the Sarbanes-Oxley Act, or our independent registered public accounting firm, may identify deficiencies in our internal control over financial reporting that are deemed to be material weaknesses.

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the company’s annual or interim financial statements will not be prevented or detected on a timely basis.

Ineffective internal control over financial reporting could also cause investors to lose confidence in our reported financial information, which could have a negative effect on the trading price of our common stock.

Our assessment is that, after the Merger, we have a sufficiently staffed and technically experienced finance and accounting team to address the financial reporting requirements of a public company.

Because the conditions causing the material weakness no longer existed, and are not expected to exist in the foreseeable future, we determined the material weakness did not exist in internal control over financial reporting as of September 30, 2021.

Prior to the Merger, AHAC’s management concluded that its disclosure controls and procedures were not effective as of December 31, 2020, and that its internal control over financial reporting was not effective as of December 31, 2020, as a result of a material weakness in controls related to the accounting for the Warrants.

As a result, AHAC incurred unanticipated costs for accounting and legal fees in connection with or related to the restatement, and we may become subject to additional risks and uncertainties related to the restatement, such as a negative impact on investor confidence in the accuracy of our financial disclosures, and may face reputational risks for our business.

Effective as of the closing of the Merger, our management is responsible for internal control over financial reporting and the former management of AHAC no longer participates in financial reporting.

As long as we are an emerging growth company under the JOBS Act or a non-accelerated filer and a “smaller reporting company” as defined in Rule 12b-2 of the Exchange Act, our independent registered public accounting firm will not be required to attest to the effectiveness of our internal control over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act.

An independent assessment of the effectiveness of our internal control over financial reporting could detect deficiencies that our management’s assessment might not.

Undetected material weaknesses in our internal control over financial reporting could lead to financial statement restatements and require us to incur the expense of remediation.

Anti-takeover provisions in our Second Amended and Restated Certificate of Incorporation and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult, and may prevent attempts by our stockholders to replace or remove our current management.

Our Second Amended and Restated Certificate of Incorporation (the “Charter”) contains provisions that may delay or prevent an acquisition of the company or change in our management.

These provisions may make it more difficult for stockholders to replace or remove members of the Board.

Because the Board is responsible for appointing the members of the management team, these provisions could in turn frustrate or prevent any attempt by our stockholders to replace or

remove our current management.

In addition, these provisions could limit the price that investors might be willing to pay in the future for shares of our common stock.

Among other things, these provisions include:

• the limitation of the liability of, and the indemnification of, our directors and officers;

• provisions that permit only (i) the chairperson of the Board, (ii) our chief executive officer or (iii) a majority of our Board to call special meetings of stockholders and therefore do not permit our stockholders to call stockholder meetings;

• a prohibition on actions by our stockholders by written consent;

• the ability of the Board to issue preferred stock without stockholder approval.

Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law (the “DGCL”), which prohibits a person who owns 15% or more of our outstanding voting stock from merging or combining with us for a period of three years after the date of the transaction in which the person acquired 15% or more of our outstanding voting stock, unless the merger or combination is approved in a prescribed manner.

This could discourage, delay or prevent a third party from acquiring or merging with us, whether or not it is desired by, or beneficial to, our stockholders.

This could also have the effect of discouraging others from making tender offers for our common stock, including transactions that may be in our stockholders’ best interests.

Finally, these provisions establish advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder meetings.

These provisions would apply even if the offer may be considered beneficial by some stockholders.

Our Charter provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware and the federal district courts of the United States of America are the exclusive forums for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.

Our Charter provides that the Court of Chancery of the State of Delaware will be the exclusive forum for the following types of actions or proceedings under Delaware statutory or common law:

• any derivative action or proceeding brought on our behalf;

• any action asserting a breach of fiduciary duty;

• any action asserting a claim against us arising under the DGCL, our Charter or our amended and restated bylaws (the “Bylaws”);

• any action or proceeding asserting a claim as to which the DGCL confers jurisdiction upon the Court of Chancery of the State of Delaware;

• any action asserting a claim against us that is governed by the internal affairs doctrine or otherwise related to our internal affairs.

This exclusive forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or any of our directors, officers, other employees or stockholders, which may discourage lawsuits with respect to such claims.

We cannot be certain that a court will decide that this provision is either applicable or enforceable, and if a court were to find the choice of forum provision contained in our Charter to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business, operating results and financial condition.

This exclusive forum provision will not apply to suits brought to enforce any liability or duty created by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction.

In addition, unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States of America shall, to the fullest extent permitted by law, be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act or the rules and regulations promulgated thereunder.

Unresolved Staff Comments.

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