What changed in this filing

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Item 1A. Risk Factors

2021-05-05 compared with 2020-11-10 · 156 added, 244 removed, 6 unchanged (99% of the section changed)

RISK FACTORS.

The following information updates, and

should be read in conjunction with, the information disclosed in Part I, Item 1A, “Risk Factors,” contained

in our 2019 Form 10-K.

Except as disclosed below, there have been no material changes from the risk factors disclosed in our 2019

The following information updates, and should

be read in conjunction with, the information disclosed in Part I, Item 1A, “Risk Factors,” contained in our

2020 Form 10-K.

Except as disclosed below, there have been no material changes from the risk factors disclosed in our 2020 Form 10-K.

RISKS RELATING TO OUR BUSINESS

Our auditor’s report on our

consolidated financial statements for the years ended December 31, 2019 and 2018 contains an explanatory paragraph regarding our

ability to continue as a going concern and the notes to our financial statements for the quarter ended September 30, 2020 mention

there being substantial doubt about our ability to continue as a going concern.

Our consolidated financial statements as

of December 31, 2019 have been prepared under the assumption that we will continue as a going concern for the next twelve

In addition, our independent registered public accounting firm has issued a report that includes an explanatory paragraph

referring to our recurring losses from operations (anticipated continued losses in the future) and net capital deficiency that

raise substantial doubt about our ability to continue as a going concern without additional capital becoming available.

Our consolidated

financial statements as of December 31, 2019 did not include any adjustments that might result from the outcome of this uncertainty.

The consolidated financial statements for

the quarter ended September 30, 2020 have been prepared assuming we will continue as a going concern.

We continue to incur losses

and, as of September 30, 2020, we had an accumulated deficit of approximately $245 million.

Our consolidated financial statements

as of September 30, 2020 do not include any adjustments that might result from the outcome of this uncertainty.

Our ability to continue as a going concern

is dependent upon our ability to raise additional debt and equity capital.

There can be no assurance that such capital will be

available in sufficient amounts or on terms acceptable to us.

These factors raise substantial doubt about our ability to continue

as a going concern.

We will need to raise additional

capital to operate our business and our failure to obtain funding when needed may force us to delay, reduce or eliminate our development

programs or commercialization efforts.

During the nine months ended September

30, 2020, our operating activities used net cash of approximately $9.0 million and our cash and cash equivalents were $6.0 million

as of September 30, 2020.

With the exception of the three months ended June 30, 2010 and the three months ended December 31, 2017,

we have experienced significant losses since inception and have a significant accumulated deficit.

As of September 30, 2020, our

accumulated deficit totaled approximately $245 million on a consolidated basis.

We do not have sufficient capital to fund our operations

beyond twelve months following the issuance date of this Quarterly Report on Form 10-Q.

We expect to incur additional operating

losses in the future and therefore expect our cumulative losses to increase.

With the exception of the quarter ended September

30, 2010, and limited laboratory revenues from Adeona Clinical Laboratory, which we sold in March 2012, we have generated very

minimal revenues.

We do not expect to derive revenue from any source in the near future until we or our potential partners successfully

commercialize our products.

We expect our expenses to increase in connection with our anticipated activities, particularly as we

continue research and development, initiate and conduct clinical trials, recommence clinical trials that have been postponed and

seek marketing approval for our product candidates.

Until such time as we receive approval from the FDA and other regulatory authorities

for our product candidates, we will not be permitted to sell our products and therefore we will not have product revenues from

the sale of products.

For the foreseeable future we will have to fund all of our operations and capital expenditures from equity

and debt offerings, cash on hand, licensing and collaboration fees and grants, if any.

We will need to raise additional capital

to fund our operations and meet our current timelines and we cannot be certain that funding will be available on acceptable terms

on a timely basis, or at all.

Based on our current plans, our cash and cash equivalents will not be sufficient to complete our

planned Phase 3 clinical trial for SYN-004 or post-Phase 1 future clinical programs for SYN-020, which are expected to require

to operate our business and our failure to obtain funding when needed may force us to delay, reduce or eliminate our development programs

or commercialization efforts.

In addition, potential capital raises and strategic opportunities may require the issuance of additional

During the three months ended March 31, 2021,

our operating activities used net cash of approximately $3.3 million and our cash and cash equivalents were approximately $76.9 million

as of March 31, 2021.

With the exception of the three months ended June 30, 2010 and the three months ended December 31, 2017, we have

experienced significant losses since inception and have a significant accumulated deficit.

As of March 31, 2021, our accumulated deficit

totaled approximately $259.6 million on a consolidated basis.

We expect to incur additional operating losses in the future and therefore

expect our cumulative losses to increase.

With the exception of the quarter ended September 30, 2010, and limited laboratory revenues

from Adeona Clinical Laboratory, which we sold in March 2012, we have generated very minimal revenues.

We do not expect to derive revenue

from any source in the near future until we or our potential partners successfully commercialize our products, if ever.

We expect our

expenses to increase in connection with our anticipated activities, particularly as we continue research and development, initiate and

conduct later stage clinical trials, and seek marketing approval for our product candidates.

Until such time as we receive approval from

the FDA and other regulatory authorities for our product candidates, we will not be permitted to sell our products and therefore will

not have product revenues from the sale of products.

For the foreseeable future we will have to fund all of our operations and capital

expenditures from equity and debt offerings, cash on hand, licensing and collaboration fees and grants, if any.

We will need to raise additional capital to fund

our operations and meet our current timelines and we cannot be certain that funding will be available on acceptable terms on a timely

basis, or at all.

Any failure to raise additional capital as and when needed, as a result of insufficient authorized shares or otherwise,

could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies.

Based on our current

plans, our cash and cash equivalents will be sufficient to complete our planned Phase 1a/2a clinical trial of SYN-004, our planned Phase

1 single-ascending and multiple-ascending dose clinical trials of SYN-020, and a potential Phase 2a clinical trial of SYN-020 but, may

not be sufficient for post-Phase 2a future clinical programs for SYN-020 or additional trials of SYN-004, which are expected to require

significant cash expenditures.

In addition, based on the anticipated significant cost of a Phase 3 clinical program in a broad

indication for SYN-004, we expect it will not be feasible for us to initiate and complete this trial at this time without a partner

given the capital constraints tied to our current market cap and share price.

To the extent that we raise additional funds by issuing

equity securities, our stockholders may experience significant dilution.

Any debt financing, if available, may involve restrictive

covenants that may impact our ability to conduct our business and also have a dilutive effect on our stockholders.

A failure otherwise

to secure additional funds when needed in the future whether through an equity or debt financing or a sufficient amount of capital

without a strategic partnership could result in us being unable to complete planned preclinical and clinical trials or obtain approval

of our product candidates from the FDA and other regulatory authorities.

In addition, based on the significant anticipated cost of a Phase 3 clinical program in a broad indication

for SYN-004, we expect it will not be feasible for us to initiate and complete this trial at this time without a partner given the capital

constraints tied to our current market cap and share price.

To the extent that we raise additional funds by issuing equity securities,

our stockholders may experience significant dilution.

We may also issue shares of our common stock in connection with strategic opportunities.

However, our remaining authorized and unissued shares of common stock available may be insufficient to complete potential future equity

financing transactions and/or strategic transactions we may seek to undertake.

Accordingly, we anticipate taking steps, when appropriate,

to increase our number of available shares which may have the effect of facilitating such transactions.

Any debt financing, if available,

may involve restrictive covenants that may impact our ability to conduct our business and also have a dilutive effect on our stockholders.

A failure otherwise to secure additional funds when needed in the future whether through an equity or debt financing or a sufficient amount

of capital without a strategic partnership could result in us being unable to complete planned preclinical and clinical trials or obtain

approval of our product candidates from the FDA and other regulatory authorities.

In addition, we could be forced to delay, discontinue

or curtail product development, forego sales and marketing efforts, and forego licensing in attractive business opportunities.

Our ability to raise capital through the sale of securities is currently limited by the rules of the SEC and NYSE American that

place limits on the number and dollar amount of securities that may be sold.

There can be no assurances that we will be able to

raise the funds needed, especially in light of the fact that our ability to sell securities registered on registration statement

Form S-3 will be limited until such time the market value of our voting securities held by non-affiliates is $75 million or more.

We also may be required to seek collaborators for our product candidates at an earlier stage than otherwise would be desirable

and on terms that are less favorable than might otherwise be available.

The COVID-19 global health crisis has impacted our planned

operations, including our clinical studies

In January 2020, the World Health Organization

declared a global pandemic for the novel strain of coronavirus, COVID-19.

Since then, the COVID-19 coronavirus has spread to multiple

countries, including throughout the United States.

We have experienced disruptions that have impacted our business and clinical

trials and expect to experience additional disruptions as the pandemic continues, including:

unwillingness of potential study participants to enroll in new clinical trials and/or visit healthcare facilities;

postponement in clinical site initiation for our SYN-004 clinical study;

postponement of the initiation of our SYN-020 single ascending dose (SAD) study

diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials;

interruption of key clinical trial activities, such as clinical site visits by study participants and clinical trial site monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others;

limitations in employee resources that would otherwise be focused on the conduct of our clinical trials, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people;

delays in receiving approval from local regulatory authorities to initiate our planned clinical trials;

delays in clinical sites receiving the supplies and materials needed to conduct our clinical trials;

interruption in global shipping that may affect the transport of clinical trial materials, such as investigational drug product used in our clinical trials;

changes in local regulations as part of a response to the COVID-19 coronavirus outbreak 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;

delays in necessary interactions with local regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees;

delay in the timing of interactions with the FDA due to absenteeism by federal employees or by the diversion of their efforts and attention to approval of other therapeutics or other activities related to COVID-19.

Our business and

the business of the suppliers of our clinical product candidates has been and is expected to continue to be materially and adversely

affected by the pandemic.

Such events could result in the complete or partial closure of clinical trial sites or one or more manufacturing

facilities which could impact our supply of our clinical product candidates.

In addition, it could impact economies and financial

markets, resulting in an economic downturn that could impact our ability to raise capital or slow down potential partnering relationships.

In response to the spread of COVID-19 as

well as public health directives and orders, we have implemented a number of measures designed to ensure employee safety and business

We have limited access to our offices and are allowing our administrative employees to continue their work outside

of our offices in order to support the community efforts to reduce the transmission of COVID-19 and protect employees, complying

with guidance from federal, state and local government and health authorities.

The effects of the governmental orders and our work-from-home

policies may negatively impact productivity, disrupt our business and delay our clinical programs and timelines, the magnitude

of which will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct our

business in the ordinary course.

the COVID-19 outbreak could

disrupt our operations due to absenteeism by infected or ill members of management or other employees, or absenteeism by members

of management and other employees who elect not to come to work due to the illness affecting others in our office, or due to quarantines.

The COVID-19 illness could also impact members of our Board of Directors resulting in absenteeism from meetings of the directors

or committees of directors, and making it more difficult to convene the quorums of the full Board of Directors or its committees

needed to conduct meetings for the management of our affairs.

The global outbreak

of the virus continues to rapidly evolve.

The extent to which the virus may impact our business and clinical trials will depend

on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread

of the disease, the duration of the outbreak, travel restrictions and social distancing in the United States, business closures

or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the

We do not yet know the full extent of potential delays or impacts on our business, operations, or the global economy as

While the spread of COVID-19 may eventually be contained or mitigated, there is no guarantee that a future outbreak of

this or any other widespread epidemics will not occur, or that the global economy will recover, either of which could seriously

harm our business.

Difficulties enrolling patients in

our clinical trials or delays in enrollment are expected to result in our clinical development activities being delayed or otherwise

adversely affected.

Delays in patient enrollment may result

in increased cost or may adversely affect timing or outcome of planned clinical trials, which could prevent completion of these

trials and adversely affect our ability to advance the development of our product candidates.

In some cases, generating meaningful

clinical data may require rigorous screening criteria which may result in unintended and higher than anticipated patient-related

screen-fail rates, as had occurred with our current investigator-sponsored Phase 2b clinical study conducted by CSMC.

lead to delays in completion of clinical trials as well as additional expense for recruitment of patients.

In addition, the COVID-19

pandemic may result in fewer technicians being available to conduct clinical testing for patients currently enrolled in our clinical

Delays in clinical testing could

result in increased costs to us and delay our ability to generate revenue.

We recently have experienced delays

in clinical testing of our product candidates due to COVID-19 and may in the future experience other delays.

We do not know when

the planned SYN-004 clinical trial or planned SYN-020 SAD study will initiate.

These delays may result in the need for trials

to be redesigned and will impact whether they will be completed on schedule, if at all.

Clinical trials can be delayed for a variety

of reasons, including the COVID-19 pandemic, delays in obtaining regulatory approval to commence a clinical trial, in securing

clinical trial agreements with prospective sites with acceptable terms, in obtaining institutional review board approval to conduct

a clinical trial at a prospective site, in recruiting patients to participate in a clinical trial or in obtaining sufficient supplies

of clinical trial materials.

Manufacturing considerations for clinical development candidates may include an expected several

month lead time following a decision to commence any clinical trial(s) and capacity considerations of our third-party contract

manufacturers to provide clinical supply of our product candidates could cause delays in clinical trials.

Many factors affect

patient enrollment, including the size of the patient population, the proximity of patients to clinical sites, the eligibility

criteria for the clinical trial, competing clinical trials and new drugs approved for the conditions we are investigating.

investigators will need to decide whether to offer their patients enrollment in clinical trials of our product candidates versus

treating these patients with commercially available drugs that have established safety and efficacy profiles.

Any delays in completing

our clinical trials will increase our costs, slow down our product development and timeliness and approval process and delay our

ability to generate revenue.

RISKS RELATING TO OUR SECURITIES

We cannot assure you that our Common

Stock will be liquid or that it will remain listed on the NYSE American.

A failure to regain compliance with the NYSE American

stockholders’ equity listing requirements or failure to continue to meet the other listing requirements could result in a

de-listing of our Common Stock.

Our Common Stock is listed on the NYSE

The NYSE American’s listing standards generally mandate that we meet certain requirements relating to stockholders’

equity, stock price, market capitalization, aggregate market value of publicly held shares and distribution requirements.

assure you that we will be able to maintain the continued listing standards of the NYSE American.

More specifically, the NYSE American

requires companies to meet certain continued listing criteria including a minimum stockholders’ equity of $6.0 million if

an issuer has sustained losses from continuing operations and/or net losses in its five most recent years, as outlined in the NYSE

American Company Guide.

At September 30, 2020, we had a stockholders’ deficit of $8.8 million.

The NYSE American Company

Guide also states that the NYSE normally will not consider removing from listing securities of an issuer with total value of market

capitalization of at least $50.0 million and 1,100,000 shares publicly held, a market value of publicly held shares of at least

$15.0 million and 400 round lot shareholders.

Although we have more than 1,100,000 shares publicly held and 400 round lot shareholders,

our stock price is volatile and, during the first two quarters of 2018, the price of our Common Stock experienced a sustained decrease

resulting in a period where our market capitalization fell below $50.0 million.

Our market capitalization is currently below $50.0

On November 25, 2019, we announced that

we received written communication from the NYSE American stating we were no longer in compliance with certain continued listing

standards as set forth in the NYSE American Company Guide relating to stockholders’ equity as of September 30, 2019.

Specifically,

the Deficiency Letter stated that we were not in compliance with Section 1003(a)(iii) (requiring stockholders’ equity of

$6.0 million or more if the Company has reported losses from continuing operations and/or net losses in its five most recent fiscal

The Deficiency Letter noted that the Company had stockholders’ equity of $4.9 million as of September 30, 2019 and

had reported net losses in its five most recent fiscal years.

On December 20, 2019, we submitted a plan of compliance to the NYSE

American outlining our plan to regain compliance with certain continued listing standards as set forth in Part 10, Section 1003(iii)

of the NYSE American Company Guide by November 25, 2020, the conclusion of the compliance plan period.

On February 7, 2020, we

received notice from the NYSE American that it had accepted our plan and granted a plan period through November 25, 2020 to regain

On July 30, 2020 we received written communication from NYSE American stating that in addition to Section 1003(iii),

we were also not in compliance with Section 1003(i) and Section 1003(ii) of the NYSE American Company Guide since we reported a

stockholders’ deficit of ($4.0) million as of March 31, 2020 and losses from continuing operations and/or net losses in its

five most recent fiscal years ended December 31, 2019.

As a result, the Company is now subject to the procedures and requirements

set forth in Section 1009 of the Company Guide.

The Company remains subject to the conditions set forth in the Exchange’s

letter dated November 25, 2019 for the initial equity noncompliance.

The NYSE Regulation staff will review our company periodically

for compliance with the initiatives outlined in the plan.

If we are not in compliance with the continued listing standards by November

25, 2020 or if we do not make progress consistent with the plan during the plan period, NYSE Regulation staff may initiate a delisting

proceeding as appropriate.

There can be no assurance that we can regain

compliance with the listing standards of the NYSE American, or that the NYSE American will continue to list our Common Stock if

we regain compliance, or if we should continue to fail to maintain the minimum stockholders’ equity.

In addition, in the

future we may not be able to maintain such minimum stockholders’ equity and/or issue additional equity securities in exchange

for cash or other assets, if available, to maintain certain minimum stockholders’ equity required by the NYSE American.

we are delisted from the NYSE American then our Common Stock will trade, if at all, only on the over-the-counter market, such as

the OTC Bulletin Board securities market, and then only if one or more registered broker-dealer market makers comply with quotation

requirements.

If our Common Stock is delisted from the NYSE American due to our failure to regain compliance with the listing standards

by the end of the compliance period or for any other reason, and the market value of our shares of Common Stock held by non-affiliates

remains below $75 million, we will likely no longer be eligible to sell Common Stock pursuant to the B.

Riley FBR Sales Agreement

or otherwise utilize our shelf registration statement.

In addition, delisting of our Common Stock could depress our stock price,

substantially limit liquidity of our Common Stock and materially adversely affect our ability to raise capital on terms acceptable

to us, or at all.

Delisting from the NYSE American could also have other negative results, including the potential loss of confidence

by suppliers and employees, the loss of institutional investor interest and fewer business development opportunities.

assure you that our Common Stock will be liquid or that it will remain listed on the NYSE American.

A failure to regain compliance

with the NYSE American stockholders’ equity requirements or failure to continue to meet the other listing requirements could

result in a de-listing of our Common Stock.

UNREGISTERED SALES OF EQUITY

SECURITIES AND USE OF PROCEEDS.

We did not sell any equity securities during

the three and nine months ended September 30, 2020 in transactions that were not registered under the Securities Act.

DEFAULTS UPON SENIOR SECURITIES.

Not applicable.

MINE SAFETY DISCLOSURES.

Not applicable.

may be required to seek collaborators for our product candidates at an earlier stage than otherwise would be desirable and on terms that

are less favorable than might otherwise be available.

The market price of our common stock has

been and may continue to be volatile and adversely affected by various factors.

Our stock price has fluctuated in the past,

has recently been volatile and may be volatile in the future.

By way of example, on February 8, 2021, the price of our common stock

closed at $1.17 per share while on April 19, 2021, our stock price closed at $0.52 per share with no discernable announcements or

developments by the company or third parties.

On February 9, 2021, the intra-day sales price of our common stock fluctuated between

a reported low sale price of $0.91 and a reported high sales price of $1.19.

We may incur rapid and substantial decreases in our

stock price in the foreseeable future that are unrelated to our operating performance or prospects.

In addition, the recent outbreak

of the novel strain of coronavirus (COVID-19) has caused broad stock market and industry fluctuations.

The stock market in general

and the market for biotechnology and pharmaceutical companies in particular have experienced extreme volatility that has often been

unrelated to the operating performance of particular companies.

As a result of this volatility, investors may experience losses on

their investment in our common stock.

The market price of our common stock could fluctuate significantly in response to various

factors and events, including:

investor reaction to our business strategy;

the success of competitive products or technologies;

our continued compliance with the listing standards of the NYSE American;

regulatory or legal developments in the United States and other countries, especially changes in laws or regulations applicable to our products;

results of our clinical trials;

actions taken by regulatory agencies with respect to our products, clinical studies, manufacturing process or sales and marketing terms;

variations in our financial results or those of companies that are perceived to be similar to us;

the success of our efforts to acquire or in-license additional products or product candidates;

developments concerning our collaborations or partners;

developments or disputes concerning patents or other proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our products;

our ability or inability to raise additional capital and the terms on which we raise it;

declines in the market prices of stocks generally;

trading volume of our common stock;

sales of our common stock by us or our stockholders;

general economic, industry and market conditions;

other events or factors, including those resulting from such events, or the prospect of such events, including war, terrorism and other international conflicts, public health issues including health epidemics or pandemics, such as the recent outbreak of the novel coronavirus (COVID-19), and natural disasters such as fire, hurricanes, earthquakes, tornados or other adverse weather and climate conditions, whether occurring in the United States or elsewhere, could disrupt our operations, disrupt the operations of our suppliers or result in political or economic instability.

These broad market and industry factors may seriously

harm the market price of our common stock, regardless of our operating performance.

Further, recent increases are significantly inconsistent

with any improvements in actual or expected operating performance, financial condition or other indicators of value.

Since the stock price

of our common stock has fluctuated in the past, has been recently volatile and may be volatile in the future, investors in our common

stock could incur substantial losses.

In the past, following periods of volatility in the market, securities class-action litigation has

often been instituted against companies.

Such litigation, if instituted against us, could result in substantial costs and diversion of

management’s attention and resources, which could materially and adversely affect our business, financial condition, results of

operations and growth prospects.

There can be no guarantee that our stock price will remain at current prices or that future sales

of our common stock will not be at prices lower than those sold to investors.

Additionally, recently, securities of certain

companies have experienced significant and extreme volatility in stock price due short to sellers of shares of common stock, known

as a “short squeeze.”

These short squeezes have caused extreme volatility in those companies and in the market and have

led to the price per share of those companies to trade at a significantly inflated rate that is disconnected from the underlying value

of the company.

Many investors who have purchased shares in those companies at an inflated price face the risk of losing a significant

portion of their original investment as the price per share has declined steadily as interest in those stocks has abated.

While we have

no reason to believe our shares would be the target of a short squeeze, there can be no assurance that we won’t be in the future,

and you may lose a significant portion or all of your investment if you purchase our shares at a price that is significantly disconnected

from our underlying value.

We expect to seek to raise additional capital

in the future, which may be dilutive to stockholders or impose operational restrictions.

We expect to seek to raise additional capital

in the future to help fund development of our proposed products.

If we raise additional capital through the issuance of equity or of debt

securities, the percentage ownership of our current stockholders will be reduced.

We may also enter into strategic transactions, issue

equity as consideration for acquisitions or part of license issue fees to our licensors, compensate consultants or settle outstanding

payables using equity that may be dilutive.

We are authorized to issue 200,000,000 shares of common stock, of which 132,042,548 shares

of common stock were issued and outstanding as of May 3, 2021.

At May 3, 2021, we had reserved 10,342,384 shares of common stock for issuance

upon exercise of our outstanding options and warrants.

In addition, at such date, we had 2,460,000 shares of our common stock reserved

for future issuance under our equity incentive plans.

If all of these securities were to be exercised, the total number of shares of our

common stock that we would be required to issue is 12,802,384, which in addition to the 132,042,548 shares issued and outstanding, would

leave 55,155,068 authorized but unissued shares of common stock.

As a result of our limited number of authorized and unissued shares of

common stock, we may have insufficient shares of common stock available to issue in connection with any future equity financing transactions

or strategic transactions we may seek to undertake.

Accordingly, we anticipate taking steps, when appropriate, to increase our number

of available shares which may have the effect of facilitating such transactions.

Our stockholders may experience additional dilution

in net book value per share and any additional equity securities may have rights, preferences and privileges senior to those of the holders

of our common stock.

In order to raise additional capital, we may in the future offer additional

shares of our common stock or other securities convertible into or exchangeable for our common stock at prices that may not be the same

as the price per share paid by existing stockholders, thereby subjecting such stockholders to dilution.

We may sell shares or other securities

in any other offering at a price per share that is less than the price per share paid by existing stockholders, and investors purchasing

shares or other securities in the future could have rights superior to existing stockholders.

In the event that we sell shares or other

securities at prices below the exercise price of the warrants that we issued in our October 2018 offering, the price protection anti-dilution

provisions of the warrant provide that the exercise price of the warrants sold in our October 2018 offering is to be reduced which may

result in additional warrant exercises and additional dilution to stockholders as was the case in 2020 and during the first quarter of

2021 when we utilized our at-the-market facility and the warrant exercise price was reduced.

The price per share at which we sell additional

shares of our common stock, or securities convertible or exchangeable into common stock, in future transactions may be higher or lower

than the price per share paid by existing stockholders.

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-Q

Item 1A. Risk Factors