What changed in this filing

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Item 1A. Risk Factors

2021-03-04 compared with 2020-02-20 · 684 added, 861 removed, 491 unchanged (76% of the section changed)

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RISKS RELATING TO OUR BUSINESS

Our auditor’s report on our

consolidated financial statements contains an explanatory paragraph regarding 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 months.

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 in our ability to continue as a going concern without additional capital

becoming available.

Our ability to continue as a going concern is dependent upon our ability to obtain additional equity or

debt financing, attain further operating efficiencies, reduce expenditures, and, ultimately, to generate revenue.

consolidated financial statements as of December 31, 2019 did not include any adjustments that might result from the

outcome of this uncertainty.

We will need to raise additional

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During the year ended December 31,

our operating activities used net cash of approximately $13.9 million and as of December 31, 2019 our cash and cash equivalents

were $15.0 million.

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

losses since inception and have a significant accumulated deficit.

As of December 31, 2019, our accumulated deficit totaled approximately

$235.5 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 June 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, 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.

2020, our operating activities used net cash of approximately $12.2 million and as of December 31, 2020 our cash and cash

equivalents were $6.2 million.

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

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

As of December 31, 2020, our accumulated

deficit totaled approximately $248.1 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 June 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, 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 in order to 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 FDA-agreed Phase 3 clinical program for the prevention of CDI or pursue the prevention of aGVHD in allogeneic HCT recipients

for SYN-004 beyond the planned Phase 1b/2a clinical study with Washington University, pursue SYN-010 beyond our ongoing Phase 2b

investigator-sponsored clinical study with CSMC, or pursue SYN-020 following the planned IND filing.

Any additional sources of

financing will likely involve the issuance of our equity or debt securities, which will have a dilutive effect on our stockholders.

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 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 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.

Any debt financing, if available, may involve restrictive covenants that may impact our ability to conduct our business.

we continued preparation for our clinical trials, our previously planned Phase 3 (SYN-004) and Phase 2b/3 (SYN-010) clinical trials

have been delayed until such time as we obtain adequate financing.

A failure otherwise to raise additional funds when needed in

the future 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 may be 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 our registration statement on 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.

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

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.

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 of enrollment in our SYN-004 Phase 1b/2a clinical study;

postponement of the initiation of our SYN-020 single ascending and multiple ascending dose studies;

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 continued delay or 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.

outbreak of the virus continues to rapidly evolve.

The extent to which the virus may continue to 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 disease.

We do not yet know the full extent of potential delays or impacts on our

business, operations, or the global economy as a whole.

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.

We recently have experienced delays in

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

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.

Furthermore, due to the COVID-19 pandemic, many manufacturers

have been prioritizing the manufacture of COVD-19 related products, increasing the manufacturing lead times for non-COVID-19 related

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.

Clinical 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.

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.

We expect to continue to incur significant

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Other than with respect to the three months

ended December 31, 2017 and June 30, 2010, we have a history of losses and we have incurred, and will continue to incur, substantial

losses and negative operating cash flow.

Even if we succeed in developing and commercializing one or more of our product candidates,

we may still incur substantial losses for the foreseeable future and may not sustain profitability.

We expect that the Phase 3

clinical program of SYN-004 (ribaxamase) for the prevention of CDI, and potential future Phase 3 clinical trials for SYN-010 will

enroll a greater number of patients than our prior clinical trials and will be more costly than our prior clinical trials.

ended December 31, 2017 and June 30, 2010, we have a history of losses and we have incurred, and will continue to incur,

substantial losses and negative operating cash flow.

Even if we succeed in developing and commercializing one or more of our product

candidates, we may still incur substantial losses for the foreseeable future and may not sustain profitability.

We expect that

later stage clinical trials, including a Phase 3 clinical program of SYN-004 (ribaxamase) for the prevention of CDI will enroll

a greater number of patients than our prior clinical trials and will be more costly than our prior clinical trials.

we anticipate a need for additional employees as we undertake later stage clinical trials.

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future as we do the following:

continue to undertake preclinical development and mid and late-stage clinical trials for our product candidates, including SYN-004 (ribaxamase), SYN-010 and SYN-020;

continue to undertake preclinical development and mid and late-stage clinical trials for our product candidates, including SYN-004 (ribaxamase), and SYN-020;

seek regulatory approvals for our product candidates;

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the costs associated with manufacturing-related services to produce materials for use in our clinical trials;

the costs involved in prosecuting and enforcing patent claims

and other intellectual property rights;

the costs involved in prosecuting and enforcing patent claims and other intellectual property rights;

the costs incurred to screen and enroll patients;

The costs and timing of regulatory approvals.

We have based our estimate on

assumptions that may prove to be wrong.

We may need to obtain additional funds sooner or in greater amounts than we currently

Potential sources of financing include strategic relationships, public or private sales of our shares or debt and

other sources.

Additionally, we may seek to access the public or private equity markets when conditions are favorable due to

our long-term capital requirements.

We do not have any committed sources of financing at this time, and it is uncertain

whether additional funding will be available when we need it on terms that will be acceptable to us, or at all.

We currently have no significant

source of revenue and may never generate significant revenue.

Currently, we have no products approved for commercial sale.

We have based our estimate on assumptions

that may prove to be wrong.

We may need to obtain additional funds sooner or in greater amounts than we currently anticipate.

sources of financing include strategic relationships, public or private sales of our shares or debt and other sources.

Additionally,

we may seek to access the public or private equity markets when conditions are favorable due to our long-term capital requirements.

We do not have any committed sources of financing at this time, and it is uncertain whether additional funding will be available

when we need it on terms that will be acceptable to us, or at all.

We currently have no products approved

for commercial sale, have no significant source of revenue and may never generate significant revenue.

Our ability to generate revenue depends

our ability to raise additional capital on a timely basis to continue to fund our clinical trials;

demonstration in current and future clinical trials that our lead product candidates, SYN-010 for the treatment of IBS-C and SYN-004 (ribaxamase) for the prevention C.

difficile infection and aGVHD, are safe and effective;

demonstration in current and future clinical trials that our lead product candidates, SYN-004 (ribaxamase) for the prevention C.

difficile infection and aGVHD and SYN-020, are safe and effective;

our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking;

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may not succeed in developing commercially successful products and technologies, which may limit our ability to achieve profitability.

We are largely dependent on the success of our lead product candidates, SYN-004 and SYN-010 (ribaxamase), which require significant

additional clinical testing before we can seek regulatory approval and we cannot be certain that these product candidates will

receive regulatory approval or be successfully commercialized.

We are largely dependent on the success of our lead product candidates, SYN-004 and SYN-020, which require significant additional

clinical testing before we can seek regulatory approval and we cannot be certain that these product candidates will receive regulatory

approval or be successfully commercialized.

We must continue to explore opportunities

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any point in the process, including after significant funds have been invested.

The success of our business currently

depends on our development, approval and commercialization of our lead product candidates, SYN-004 (ribaxamase) and SYN-010,

which are our only two product candidates for which we have conducted clinical trials.

Our current ongoing investigator

sponsored clinical trial of SYN-010 for IBS-C and our planned Phase 1b/2a clinical trial of SYN-004 for aGVHD are not

designed as registrational clinical trials and we currently do not have the necessary funding to complete any registrational

clinical trials.

There are many uncertainties known and unknown that may affect the outcome of future clinical trials.

our product candidates, including SYN-004 (ribaxamase), SYN-010 and SYN-020, will require additional clinical and

non-clinical development, regulatory review and approval in multiple jurisdictions, substantial investment, access to

sufficient commercial manufacturing capacity and significant marketing efforts before we can generate any revenue from

The success of our business currently depends

on our development, approval and commercialization of our lead product candidates, SYN-004 (ribaxamase) and SYN-020.

Phase 1b/2a clinical trial of SYN-004 for the prevention of aGVHD in allogeneic HCT recipients and planned Phase 1 single ascending

and multiple ascending dose studies of SYN-020 are not designed as registrational clinical trials and we currently do not have

the necessary funding to complete any registrational clinical trials.

There are many uncertainties known and unknown that may affect

the outcome of future clinical trials.

All of our product candidates, including SYN-004 (ribaxamase) and SYN-020, will require

additional clinical and non-clinical development, regulatory review and approval in multiple jurisdictions, substantial investment,

access to sufficient commercial manufacturing capacity and significant marketing efforts before we can generate any revenue from

product sales.

Regardless of whether our clinical trials are deemed to be successful, promising new product candidates may

fail to reach the market or may only have limited commercial success because of efficacy or safety concerns, failure to

achieve positive clinical outcomes, inability to obtain necessary regulatory approvals or satisfy regulatory criteria,

limited scope of approved uses, excessive costs to manufacture, the failure to establish or maintain intellectual property

rights, or infringement of the intellectual property rights of others.

Failure to obtain regulatory approvals of SYN-004

(ribaxamase) or SYN-010 in a timely manner would have a material adverse impact on our business.

Even if we successfully

develop SYN-004 (ribaxamase) or SYN-010 or other new products or enhancements, they may be quickly rendered obsolete by

changing customer preferences, changing industry standards, or competitors’ innovations.

Innovations may not be quickly

accepted in the marketplace because of, among other things, entrenched patterns of clinical practice or uncertainty over

third-party reimbursement.

We cannot state with certainty when or whether any of our products under development will be

launched, whether we will be able to develop, license, or otherwise acquire drug candidates or products, or whether any

products will be commercially successful.

Failure to launch successful new products or new indications for existing products

may cause our products to become obsolete, which may limit our ability to achieve profitability.

Regardless of whether our clinical trials are deemed to be successful, promising new product candidates may fail

to reach the market or may only have limited commercial success because of efficacy or safety concerns, failure to achieve positive

clinical outcomes, inability to obtain necessary regulatory approvals or satisfy regulatory criteria, limited scope of approved

uses, excessive costs to manufacture, the failure to establish or maintain intellectual property rights, or infringement of the

intellectual property rights of others.

Failure to obtain regulatory approvals of SYN-004 (ribaxamase) or SYN-020 in a timely

manner would have a material adverse impact on our business.

Even if we successfully develop SYN-004 (ribaxamase) or SYN-020 or

other new products or enhancements, they may be quickly rendered obsolete by changing customer preferences, changing industry standards,

or competitors’

Innovations may not be quickly accepted in the marketplace because of, among other things, entrenched

patterns of clinical practice or uncertainty over third-party reimbursement.

We cannot state with certainty when or whether any

of our products under development will be launched, whether we will be able to develop, license, or otherwise acquire drug candidates

or products, or whether any products will be commercially successful.

Failure to launch successful new products or new indications

for existing products may cause our products to become obsolete, which may limit our ability to achieve profitability.

We are actively seeking and may form

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we also currently rely on licensing agreements with third party patent holders/licensors for our products.

We have an exclusive

license agreement with CSMC relating to our IBS-C program.

This agreement requires us or our sublicensee to use our best efforts

to commercialize each of the technologies as well as meet certain diligence requirements and timelines in order to keep the license

agreement in effect.

In the event we or our sublicensee are not able to meet our diligence requirements, we may not be able to

retain the rights granted under our agreement or renegotiate with our arrangement institution on reasonable terms, or at all.

the license were to terminate and we were to lose the right to commercialize our products, our business opportunity would be adversely

Furthermore, we currently have very limited product development capabilities, and limited marketing or sales capabilities.

For us to research, develop, and test our product candidates, we would need to contract with outside researchers, in most cases

those parties that did the original research and from whom we have licensed the technologies.

Our ECC agreement with Intrexon provides

that Intrexon may terminate an agreement if we do not perform certain specified requirements, including developing therapies considered

Our agreement with UT Austin allows UT Austin to terminate its agreement if we fail to comply with the terms of the agreement.

Our agreement with CSMC allows CSMC to terminate its agreement if we fail to comply with the terms of the agreement.

We entered into an option

agreement with MGH to enter into an exclusive license to intellectual property and technology related to the use of IAP to maintain

GI and microbiome health, diminish systemic inflammation, and treat age-related diseases.

There can be no assurance that we will

be able to reach agreement on license terms or that the terms will be favorable to us.

This license agreement is expected to require

us to meet certain diligence requirements and timelines in order to keep the license agreement in effect.

In addition, certain

license agreements, including the one that may potentially be entered into with MGH, typically contain provisions requiring royalty

free non-exclusive licenses to the U.S government if any federal funding was used to invent any of the patents being licensed.

In the event we or our sublicensee are not able to meet our diligence requirements contained in the license agreement with MGH

or any other license agreement, we may not be able to retain the rights granted under our agreement or renegotiate with our arrangement

institution on reasonable terms, or at all.

If any license were to terminate and we were to lose the right to commercialize our

products, our business opportunity would be adversely affected.

Furthermore, we currently have very limited product development

capabilities, and limited marketing or sales capabilities.

For us to research, develop, and test our product candidates, we would

need to contract with outside researchers, in most cases those parties that did the original research and from whom we have licensed

the technologies.

Our ECC agreement with Intrexon provides that Intrexon may terminate an agreement if we do not perform certain

specified requirements, including developing therapies considered superior.

Our agreement with UT Austin allows UT Austin to terminate

its agreement if we fail to comply with the terms of the agreement.

We can give no assurances that any of our

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does the issuance of a patent provide the patent holder with freedom to operate without infringing the patent rights of others.

We will incur additional expenses

We may incur additional expenses

in connection with our licenses and collaboration arrangements and our development of our product candidates.

Our agreements with CSMC requires that

we initiate certain studies and file or have accepted an NDA within a certain amount of time, each of which are costly and will

require additional expenditures.

Although all manufacturing, preclinical studies and human clinical trials are expensive and difficult

to design and implement, costs associated with the manufacturing, research and development of biologic product candidates are generally

greater in comparison to small molecule product candidates.

Due to our corporate restructuring plan to reduce cost that was implemented

in 2018, we have a reduced work force and expect in future years to require additional personnel to support our later stage research

and development efforts.

In addition, we have commenced or intend to commence manufacturing of SYN-004 (ribaxamase), SYN-010 and

SYN-020 materials to support our planned preclinical and clinical studies which will require us to incur additional expenses.

to our ECC agreement with Intrexon, we are responsible for future research and development expenses of product candidates developed

under our collaboration, the effect of which has and will continue to increase the level of our overall research and development

expenses going forward.

Because development

activities in our collaborations are sometimes determined pursuant to joint steering committees and we have limited product development

experience, future development costs associated with these programs may be difficult to anticipate and exceed our expectations.

Our actual cash requirements may vary materially from our current expectations for a number of other factors that may include,

but are not limited to, unanticipated technical challenges, enrollment challenges, changes in the focus and direction of our development

activities or adjustments necessitated by changes in the competitive landscape in which we operate.

If we are unable to continue

to financially support such collaborations due to our own working capital constraints, we may be forced to delay our activities.

If we are unable to obtain additional financing on terms acceptable to us or at all, we may be forced to seek licensing partners

or discontinue development.

by competitors may render our products or technologies obsolete or non-competitive.

Companies that currently sell or are

developing proprietary products for the prevention and treatment of C.

difficile infection include:

Pharmaceutical Ltd., Assembly Biosciences, Inc., AzurRx, Inc., Da Volterra, Merck & Co.

Inc., Pfizer Inc., Rebiotix,

Inc., Seres Therapeutics, Inc., Summit Therapeutics plc., and Vedanta Biosciences, Inc.

Companies that sell or are developing

products for the treatment or prevention of acute graft-versus-host-disease (aGVHD) include:

Amgen, Inc., Astellas Pharma,

Janssen Biotech, Inc., Mallinckrodt plc, Novartis International AG, Pfizer, Inc.

Companies that currently sell or

are developing proprietary products for IBS-C include:

Ardelyx, Inc., Allergan plc, Bausch Health Companies, Inc., Ironwood

Pharmaceuticals, Inc., and Takeda Pharmaceutical Company Limited.

Companies that currently sell or are developing proprietary

products for pertussis include:

GlaxoSmithKline plc, MitsubishiTanabe Pharma Corporation and Sanofi S.A.

AG The infectious

disease market is highly competitive with many generic and proprietary intravenous and oral formulations available to

physicians and their patients.

For our monoclonal antibodies, we currently do not expect to be able to deliver our infectious

disease candidates via the oral route and may thus be limited to the in-patient and/or acute treatment setting.

academic research centers may develop technologies that compete with our SYN-004, SYN-010, SYN-020, and SYN-005 products and

our other technologies.

Should clinicians or regulatory authorities view alternative therapeutic regiments as more effective

than our products, this might delay or prevent us from obtaining regulatory approval for our products, or it might prevent us

from obtaining favorable reimbursement rates from payers, such as Medicare, Medicaid, hospitals and private insurers.

We operate in a highly competitive

The pharmaceutical and biotechnology industries,

including the monoclonal antibody industry, are characterized by rapidly evolving technology and intense competition.

Our competitors

include major multi-national pharmaceutical companies and biotechnology companies developing both generic and proprietary therapies

to treat serious diseases.

Many of our competitors have drugs that have already been commercialized and therefore benefit from

being first to market their products.

Our agreements with Washington University

and MGH may require that we initiate certain studies and file or have accepted an NDA within a certain amount of time, each of

which are costly and will require additional expenditures.

Although all manufacturing, preclinical studies and human clinical trials

are expensive and difficult to design and implement, costs associated with the manufacturing, research and development of biologic

product candidates are generally greater in comparison to small molecule product candidates.

Due to our corporate restructuring

plan to reduce cost that was implemented in 2018, we have a reduced work force and expect in future years to require additional

personnel to support our later stage research and development efforts.

In addition, we intend to commence manufacturing of SYN-004

(ribaxamase) and SYN-020 materials to support potential future clinical studies which will require us to incur additional expenses.

Because development activities in our collaborations

are sometimes determined pursuant to joint steering committees, future development costs associated with these programs may be

difficult to anticipate and may exceed our expectations.

Our actual cash requirements may vary materially from our current expectations

for a number of other factors that may include, but are not limited to, unanticipated technical challenges, enrollment challenges,

changes in the focus and direction of our development activities or adjustments necessitated by changes in the competitive landscape

in which we operate.

If we are unable to continue to financially support such collaborations due to our own working capital constraints,

we may be forced to delay our activities.

If we are unable to obtain additional financing on terms acceptable to us or at all,

we may be forced to seek licensing partners or discontinue development.

Developments by competitors may

render our products or technologies obsolete or non-competitive.

The pharmaceutical and biotechnology industries, including the

monoclonal antibody industry, are characterized by rapidly evolving technology and intense competition.

Our competitors include

major multi-national pharmaceutical companies and biotechnology companies developing both generic and proprietary therapies to

treat serious diseases.

Many of our competitors have drugs that have already been commercialized and therefore benefit from being

first to market their products.

Many of these companies are well-established and possess technical, human, research and development,

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currently pursuing.

Academic research centers, governmental

agencies and other public and private research organizations are also conducting and financing research activities which may produce

products directly competitive to those being developed by us.

In addition, many of these competitors may be able to obtain patent

protection, obtain FDA and other regulatory approvals and begin commercial sales of their products before us.

These competitors

will compete with us in product sales as well as recruitment and retention of qualified scientific and management personnel, establishment

of clinical trial sites and patient enrollment for clinical trials, as well as in the acquisition of technologies and technology

licenses complementary to our programs or advantageous to our business.

Competitors could develop and/or

gain FDA approval of our product candidates for a different indication.

Many of our competitors may have more resources

We cannot provide any assurances that our products will be FDA approved prior to those of our competitors.

We are subject

to the risk that products containing our active ingredients that are already marketed to treat other indications, or future FDA

approved products containing our active ingredients that are marketed to treat other indications, may be prescribed by physicians,

or that physicians may substitute a competitor’s products, to treat the diseases for which we are intending to commercialize;

this is commonly referred to as “off-label” use.

While under FDA regulations a competitor is not allowed to promote

off-label uses of its product, the FDA does not regulate the practice of medicine and, as a result, cannot direct physicians to

select certain products for their patients.

Consequently, we might be limited in our ability to prevent off-label use of a competitor’s

product to treat the diseases we are intending to commercialize, even if we have issued method of use patents for that indication.

If we are not able to obtain and enforce our patents, if any, or otherwise receive orphan drug protection, a competitor could develop

and commercialize similar products for the same indications that we are pursuing.

We cannot provide any assurances that a competitor

will not obtain FDA approval for a product that contains the same active ingredients as our products.

may seek to selectively establish collaborations, and, if we are unable to establish them on commercially reasonable terms, we

may have to alter our development and commercialization plans.

Our product development

programs and the potential commercialization of our clinical product candidate will require substantial additional cash to fund

For some of our product candidates we may decide to collaborate with governmental entities or additional pharmaceutical

and biotechnology companies for the development and potential commercialization of our product candidates.

Academic research centers, governmental agencies and other public and private research organizations are also

conducting and financing research activities which may produce products directly competitive to those being developed by us.

addition, many of these competitors may be able to obtain patent protection, obtain FDA and other regulatory approvals and begin

commercial sales of their products before us, including for different indications of the same active ingredients that comprise

our pipeline products.

These competitors will compete with us in product sales as well as recruitment and retention of qualified

scientific and management personnel, establishment of clinical trial sites and patient enrollment for clinical trials, as well

as in the acquisition of technologies and technology licenses complementary to our programs or advantageous to our business.

that currently sell or are developing proprietary products for the prevention and treatment of C.

difficile infection include:

Actelion Pharmaceutical Ltd., Artugen Therapeutics, Inc., AzurRx, Inc., Da Volterra, Deinove, Merck & Co.

Merus B.V., Pfizer Inc., Rebiotix, Inc., Seres Therapeutics, Inc., Summit Therapeutics plc., and Vedanta Biosciences, Inc.

Companies that sell or are developing products for the treatment or prevention of acute graft-versus-host-disease (aGVHD) include:

Amgen, Inc., Astellas Pharma, Janssen Biotech, Inc., Mallinckrodt plc, Novartis International AG, Pfizer, Inc.,

Roche AG and Takeda Pharmaceutical Company Ltd.

Companies that currently sell or are developing proprietary products for pertussis

GlaxoSmithKline plc, Mitsubishi Tanabe Pharma Corporation and Sanofi S.A.

The infectious disease market is highly

competitive with many generic and proprietary intravenous and oral formulations available to physicians and their patients.

our monoclonal antibodies, we currently do not expect to be able to deliver our infectious disease candidates via the oral route

and may thus be limited to the in-patient and/or acute treatment setting.

In addition, academic research centers may develop technologies

that compete with our SYN-004, SYN-020, and SYN-005 products and our other technologies.

Should clinicians or regulatory authorities

view alternative therapeutic regiments as more effective than our products, this might delay or prevent us from obtaining regulatory

approval for our products, or it might prevent us from obtaining favorable reimbursement rates from payers, such as Medicare, Medicaid,

hospitals and private insurers.

to selectively establish collaborations, and, if we are unable to establish them on commercially reasonable terms, we may have

to alter our development and commercialization plans.

development programs and the potential commercialization of our clinical product candidates will require substantial

additional cash to fund expenses.

For some of our product candidates (such as our planned phase 3 clinical trial of SYN-004)

we may decide to collaborate with governmental entities or additional pharmaceutical and biotechnology companies for the

development and potential commercialization of our product candidates.

We face significant

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Whether we reach a definitive agreement for a collaboration will depend, among

other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed

collaboration and the proposed collaborator’s evaluation of a number of factors.

other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed

collaboration and the proposed collaborator’s evaluation of a number of factors.

Those factors may include the design or

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and services in sufficient quality or quantity, it may delay or impair our ability to develop, manufacture and market our product

We rely on suppliers for the

substance raw materials of our product candidates and third parties for manufacturing-related services to produce material

that meets appropriate content, quality and stability standards and use in clinical trials of our products and, after

approval, for commercial distribution.

To succeed, clinical trials require adequate supplies of study material, which may be

difficult or uneconomical to procure or manufacture and there can be no assurance that we will successfully procure such

study material or even if procured, that we can do so in quantities and in a timely manner to allow our clinical trials to

proceed as planned.

We and our suppliers and vendors may not be able to (i) produce our study material to appropriate

standards for use in clinical studies, (ii) perform under any definitive manufacturing, supply or service agreements with us,

or (iii) remain in business for a sufficient time to successfully produce and market our product candidates.

maintain important manufacturing and service relationships, we may fail to find a replacement supplier or required vendor or

manufacturer which could delay or impair our ability to obtain regulatory approval for our products and substantially

increase our costs or deplete profit margins, if any.

If we do find replacement manufacturers and vendors, we may not be able

to enter into agreements with them on terms and conditions favorable to us and there could be a substantial delay before a

new facility could be qualified and registered with the FDA and foreign regulatory authorities.

The third-party manufacturers of the active

pharmaceutical ingredient (API) and drug product for our lead product candidates, SYN-004 (ribaxamase), SYN-010 and SYN-020, are

established cGMP manufacturers.

For all other therapeutic areas, we have not yet established cGMP manufacturers for our biologic

and drug candidates.

We currently have only one manufacturer for each of our lead product candidates as well as our SYN-020 program.

Although we believe additional manufacturers are available, if either of our manufacturers were to limit or terminate production

or otherwise fail to meet the quality or delivery requirements needed to satisfy the supply commitments, the process of locating

and qualifying alternate sources could require up to several months, during which time our production could be delayed.

Any curtailment

in the availability of SYN-004 (ribaxamase), SYN-010 or SYN-020 could have a material adverse effect on our business, financial

position and results of operations.

In addition, because regulatory authorities must generally approve raw material sources for

pharmaceutical products, changes in raw material suppliers may result in production delays or higher raw material costs.

We rely on suppliers for the substance

raw materials of our product candidates and third parties for manufacturing-related services to produce material that meets appropriate

content, quality and stability standards and use in clinical trials of our products and, after approval, for commercial distribution.

To succeed, clinical trials require adequate supplies of study material, which may be difficult or uneconomical to procure or manufacture

and there can be no assurance that we will successfully procure such study material or even if procured, that we can do so in quantities

and in a timely manner to allow our clinical trials to proceed as planned.

We and our suppliers and vendors may not be able to

(i) produce our study material to appropriate standards for use in clinical studies, (ii) perform under any definitive

manufacturing, supply or service agreements with us, or (iii) remain in business for a sufficient time to successfully produce

and market our product candidates.

If we do not maintain important manufacturing and service relationships, we may fail to find

a replacement supplier or required vendor or manufacturer which could delay or impair our ability to obtain regulatory approval

for our products and substantially increase our costs or deplete profit margins, if any.

If we do find replacement manufacturers

and vendors, we may not be able to enter into agreements with them on terms and conditions favorable to us and there could be a

substantial delay before a new facility could be qualified and registered with the FDA and foreign regulatory authorities.

The third-party manufacturers of the

active pharmaceutical ingredient (API) and drug product for our lead product candidates, SYN-004 (ribaxamase) and SYN-020,

are established cGMP manufacturers.

For all other therapeutic areas, we have not yet established cGMP manufacturers for our

biologic and drug candidates.

We do not currently have a definitive agreement with any third-party vendors for the

manufacture of additional quantities of SYN-004 or SYN-020 and we currently have only one manufacturer for each of our lead

product candidates.

Although we believe additional manufacturers are available, if either of our manufacturers were to limit

or terminate production or otherwise fail to meet the quality or delivery requirements needed to satisfy the supply

commitments, the process of locating and qualifying alternate sources could require up to several months, during which time

our production could be delayed.

Any curtailment in the availability of SYN-004 (ribaxamase) or SYN-020 could have a material

adverse effect on our business, financial position and results of operations.

In addition, because regulatory authorities

must generally approve raw material sources for pharmaceutical products, changes in raw material suppliers may result in

production delays or higher raw material costs.

The manufacture of our product candidates

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experience longer than expected lead times with respect to the manufacture of clinical drug supply, which may result from the increase

in manufacturing scale necessary to conduct our anticipated Phase 3 clinical trial(s) and result in trial delays.

in manufacturing scale necessary to conduct our anticipated late stage clinical trials and result in trial delays.

Furthermore, due to the COVID-19 pandemic, many manufacturers

have been prioritizing the manufacture of COVID-19 related products, increasing the manufacturing lead times for non-COVID-19 related

any delay or interruption in the supply of clinical trial supplies could delay the completion of our clinical trials, increase

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of records and documentation.

The approval process for NDAs includes a review of the manufacturer’s compliance with cGMP

requirements.

We are responsible for regularly assessing a contract manufacturer’s compliance with cGMP requirements through

record reviews and periodic audits and for ensuring that the contract manufacturer takes responsibility and corrective action for

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potential revenues.

We may not be able to manufacture

our product candidates in commercial quantities, which would prevent us from commercializing our product candidates.

To date, our product candidates have

been manufactured in small quantities for preclinical studies and clinical trials.

If any of our product candidates is

approved by the FDA or comparable regulatory authorities in other countries for commercial sale, we will need to manufacture

such product candidate in larger quantities.

We may not be able to increase successfully the manufacturing capacity for any

of our product candidates in a timely or economic manner, or at all.

Significant scale-up of manufacturing may require

additional validation studies, which the FDA must review and approve.

If we are unable to increase successfully the

manufacturing capacity for a product candidate, the clinical trials as well as the regulatory approval or commercial launch

of that product candidate may be delayed or there may be a shortage in supply.

Our product candidates require precise, high

quality manufacturing.

Our failure to achieve and maintain these high quality manufacturing standards in collaboration with

our third-party manufacturers, including the incidence of manufacturing errors, could result in patient injury or death,

product recalls or withdrawals, delays or failures in product testing or delivery, cost overruns or other problems that could

harm our business, financial condition and results of operations.

We may fail to retain or recruit

necessary personnel, and we may be unable to secure the services of consultants.

As of March 3, 2021, we employed 10 full-time

We have also engaged clinical consultants to advise us on our clinical programs and regulatory consultants to advise

us on our dealings with the FDA and other foreign regulatory authorities.

Due to our corporate restructuring plan to reduce cost

that was implemented in 2018, we have reduced our work force and expect in future years to require additional personnel to support

our later stage research and development efforts.

We have been and may be required to retain additional consultants and employees

in order to fulfill our obligations under our licenses and collaborations for our development of SYN-004, SYN-020 and our agreements

with Washington University and other collaborators.

Our future performance will depend in part on our ability to successfully integrate

newly hired officers into our management team and our ability to develop an effective working relationship among senior management.

Certain of our directors, scientific advisors,

and consultants serve as officers, directors, scientific advisors, or consultants of other biopharmaceutical or biotechnology companies

that might be developing competitive products to ours.

Other than corporate opportunities, none of our directors are obligated

under any agreement or understanding with us to make any additional products or technologies available to us.

Similarly, we can

give no assurances, and we do not expect and stockholders should not expect, that any biomedical or pharmaceutical product or technology

identified by any of our directors or affiliates in the future would be made available to us other than corporate opportunities.

We can give no assurances that any such other companies will not have interests that are in conflict with our interests.

Losing key personnel or failing to recruit

necessary additional personnel would impede our ability to attain our development objectives.

There is intense competition for

qualified personnel in the drug and biologic development areas, and we may not be able to attract and retain the qualified personnel

we would need to develop our business.

We rely on independent organizations, advisors,

and consultants to perform certain services for us, including handling substantially all aspects of regulatory approval, clinical

management, manufacturing, marketing, and sales.

We expect that this will continue to be the case.

Such services may not always

be available to us on a timely basis when we need them.

We rely extensively on our information

technology systems and are vulnerable to damage and interruption.

We rely on our information technology systems

and infrastructure to process transactions, summarize results and manage our business, including maintaining client and supplier

Additionally, we utilize third parties, including cloud providers, to store, transfer and process data.

Our information

technology systems, as well as the systems of our suppliers and other partners, whose systems we do not control, are vulnerable

to outages and an increasing risk of continually evolving deliberate intrusions to gain access to company sensitive information.

Likewise, data security incidents and breaches by employees and others with or without permitted access to our systems pose a risk

that sensitive data may be exposed to unauthorized persons or to the public.

A cyber-attack or other significant disruption involving

our information technology systems, or those of our vendors, suppliers and other partners, could also result in disruptions in

critical systems, corruption or loss of data and theft of data, funds or intellectual property.

We may be unable to

prevent outages or security breaches in our systems.

We remain potentially vulnerable to additional known or yet unknown

threats as, in some instances, we, our suppliers and our other partners may be unaware of an incident or its magnitude and effects.

also face the risk that we expose our vendors or partners to cybersecurity attacks.

Any or all of the foregoing could

adversely affect our results of operations and our business reputation.

Any failure to maintain the security

of information relating to our customers, employees and suppliers, whether as a result of cybersecurity attacks or otherwise, could

expose us to litigation, government enforcement actions and costly response measures, and could disrupt our operations and harm

our reputation.

In connection with the pre-clinical and

clinical development, sales and marketing of our products and services, we may from time to time transmit confidential information.

We also have access to, collect or maintain private or confidential information regarding our clinical trials and the patients

enrolled therein, employees, and suppliers, as well as our business.

Cyberattacks are rapidly evolving and becoming increasingly

sophisticated.

It is possible that computer hackers and others might compromise our security measures, or security measures of

those parties that we do business with now or in the future, and obtain the personal information of patients in our clinical trials,

vendors, employees and suppliers or our business information.

A security breach of any kind, including physical or electronic break-ins,

computer viruses and attacks by hackers, employees or others, could expose us to risks of data loss, litigation, government enforcement

actions, regulatory penalties and costly response measures, and could seriously disrupt our operations.

Any resulting negative

publicity could significantly harm our reputation, which could cause us to lose market share and have an adverse effect on our

results of operations.

REGULATORY RISKS

If we do not obtain the necessary

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and compliance with FDA-approved risk evaluation and mitigation strategies.

The FDA’s exercise of its authority has in some

cases resulted, and in the future could result, in delays or increased costs during product development, clinical trials and regulatory

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time-consuming, and difficult to design and implement.

Human clinical trials are very

expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements.

clinical trial process is also time-consuming.

We estimate that clinical trials for our product candidates would take at

least several years to complete.

Furthermore, failure can occur at any stage of the trials, and we could encounter problems

that cause us to abandon or repeat clinical trials.

Commencement and completion of clinical trials may be delayed by several

factors, including:

Human clinical trials are very expensive

and difficult to design and implement, in part because they are subject to rigorous regulatory requirements.

The clinical trial

process is also time-consuming.

We estimate that clinical trials for our product candidates would take at least several years to

Furthermore, failure can occur at any stage of the trials, and we could encounter problems that cause us to abandon or

repeat clinical trials.

Commencement and completion of clinical trials may be delayed by several factors, including:

obtaining an IND application with the FDA to commence clinical trials;

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unwillingness of the FDA or IRBs to permit the clinical trials to be initiated.

In addition, we, IRBs or the FDA may suspend

our clinical trials at any time if it appears that we are exposing participants to unacceptable health risks or if IRBs or the

FDA finds deficiencies in our submissions or conduct of our trials.

In addition, we, IRBs or the FDA may

suspend our clinical trials at any time if it appears that we are exposing participants to unacceptable health risks or if IRBs

or the FDA finds deficiencies in our submissions or conduct of our trials.

The results of our clinical trials

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Favorable results in our early studies or

trials may not be repeated in later studies or trials.

Even if our clinical trials are initiated and completed as planned, we cannot

be certain that the results will support our product candidate claims.

Success in preclinical testing and early clinical trials

does not ensure that later clinical trials will be successful.

Success of our predecessor P1A clinical product or positive topline

data from our previous SYN-004 (ribaxamase) Phase 1 and Phase 2 clinical trials, does not ensure success of SYN-004 (ribaxamase),

and positive topline data for our SYN-010 Phase 2 clinical trials does not ensure success of SYN-010.

Furthermore, the FDA could

determine that SYN-004 (ribaxamase) has not demonstrated safety and require additional clinical trials and safety data, despite

positive results from our SYN-004 (ribaxamase) Phase 2b clinical trial and the determination by clinical sites investigators and

an independent third party that the adverse events that occurred in the group that received SYN-004 in our Phase 2b clinical trial

were not drug related.

We cannot be sure that the results of later clinical trials would replicate the results of prior clinical

trials and preclinical testing nor that they would satisfy the requirements of the FDA or other regulatory agencies.

Clinical trials

may fail to demonstrate that our product candidates are safe for humans and effective for indicated uses.

A number of companies

in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or unacceptable

safety issues, notwithstanding promising results in earlier trials.

Most product candidates that commence clinical trials are never

approved as products.

Any such failure could cause us or our sublicensee to abandon a product candidate and might delay development

of other product candidates.

Preclinical and clinical results are frequently susceptible to varying interpretations that may delay,

limit or prevent regulatory approvals or commercialization.

Any delay in, or termination of, our clinical trials would delay our

obtaining FDA approval for the affected product candidate and, ultimately, our ability to commercialize that product candidate.

If we encounter difficulties enrolling

patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

trials may not be repeated in later studies or trials as was the case with SYN-010.

Even if our clinical trials are initiated and

completed as planned, we cannot be certain that the results will support our product candidate claims.

Success in preclinical testing

and early clinical trials does not ensure that later clinical trials will be successful.

Success of our predecessor P1A clinical

product or positive topline data from our previous SYN-004 (ribaxamase) Phase 1 and Phase 2 clinical trials, does not ensure success

of SYN-004 (ribaxamase),.

Furthermore, the FDA could determine that SYN-004 (ribaxamase) has not demonstrated safety and require

additional clinical trials and safety data, despite positive results from our SYN-004 (ribaxamase) Phase 2b clinical trial and

the determination by clinical sites investigators and an independent third party that the serious adverse events that occurred

in the group that received SYN-004 in our Phase 2b clinical trial were not drug related.

We cannot be sure that the results of

later clinical trials would replicate the results of prior clinical trials and preclinical testing nor that they would satisfy

the requirements of the FDA or other regulatory agencies.

Clinical trials may fail to demonstrate that our product candidates are

safe for humans and effective for indicated uses.

A number of companies in the biopharmaceutical industry have suffered significant

setbacks in advanced clinical trials due to lack of efficacy or unacceptable safety issues, notwithstanding promising results in

earlier trials.

Most product candidates that commence clinical trials are never approved as products.

Any such failure could cause

us or our sublicensee to abandon a product candidate and might delay development of other product candidates.

Preclinical and clinical

results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals or commercialization.

Any delay in, or termination of, our clinical trials would delay our obtaining FDA approval for the affected product candidate

and, ultimately, our ability to commercialize that product candidate.

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

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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 has 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.

Delays in clinical testing

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

We may experience delays in clinical testing

of our product candidates.

We do not know whether planned clinical trials will begin on time, will need to be redesigned or will

be completed on schedule, if at all.

Clinical trials can be delayed for a variety of reasons, including 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.

Clinical 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

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.

This can 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 trial.

Patients who are administered our

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acceptance of our product candidates and could substantially increase commercialization costs.

An NDA submitted under Section 505(b)(2)

subjects us to the risk that we may be subject to a patent infringement lawsuit that would delay or prevent the review or approval

of our product candidate.

We plan to submit SYN-010 to the FDA

for approval under Section 505(b)(2) of the FDCA.

Section 505(b)(2) permits the submission of an NDA where at least some of

the information required for approval comes from studies that were not conducted by, or for, the applicant and on which the

applicant has not obtained a right of reference.

The 505(b)(2) application would enable us to reference published literature

and/or the FDA’s previous findings of safety and effectiveness for the branded reference drug.

For NDAs submitted under

Section 505(b)(2) of the FDCA, the patent certification and related provisions of the Hatch-Waxman Act apply.

In accordance

with the Hatch-Waxman Act, such NDAs may be required to include certifications, known as paragraph IV certifications, that

certify that any patents listed in the Patent and Exclusivity Information Addendum of the FDA’s publication, Approved

Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, with respect to any product

referenced in the 505(b)(2) application, are invalid, unenforceable or will not be infringed by the manufacture, use or sale

of the product that is the subject of the 505(b)(2) NDA.

Under the Hatch-Waxman Act, the holder

of patents that the 505(b)(2) application references may file a patent infringement lawsuit after receiving notice of the paragraph

IV certification.

Filing of a patent infringement lawsuit against the filer of the 505(b)(2) applicant within 45 days of the patent

owner’s receipt of notice triggers a one-time, automatic, 30-month stay of the FDA’s ability to approve the 505(b)(2)

NDA, unless patent litigation is resolved in the favor of the paragraph IV filer or the patent expires before that time.

we may invest a significant amount of time and expense in the development of one or more product candidates only to be subject

to significant delay and patent litigation before such product candidates may be commercialized, if at all.

In addition, a 505(b)(2)

application will not be approved until any non-patent exclusivity, such as exclusivity for obtaining approval of a new chemical

entity, listed in the Orange Book for the referenced product has expired.

The FDA may also require us to perform one or more additional

clinical studies or measurements to support the change from the branded reference drug, which could be time consuming and could

substantially delay our achievement of regulatory approvals for such product candidates.

The FDA may also reject our future 505(b)(2)

submissions and require us to file such submissions under Section 505(b)(1) of the FDCA, which would require us to provide extensive

data to establish safety and effectiveness of the drug for the proposed use and could cause delay and be considerably more expensive

and time consuming.

These factors, among others, may limit our ability to successfully commercialize our product candidates.

Our product candidates, if approved

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pricing, reimbursement and cost effectiveness, which may be subject to regulatory control;

effectiveness of our or any of our partners’ sales and marketing strategies;

effectiveness of our or any of our partners’

sales and marketing strategies;

the product labeling or product insert required by the FDA or regulatory authority in other countries;

the availability of adequate third-party insurance coverage or reimbursement.

If any product candidate that we

develop does not provide a treatment regimen that is as beneficial as, or is perceived as being as beneficial as, the current

standard of care or otherwise does not provide patient benefit, that product candidate, if approved for commercial sale by

the FDA or other regulatory authorities, likely will not achieve market acceptance.

Our ability to effectively promote and

sell any approved products will also depend on pricing and cost-effectiveness, including our ability to produce a product at

a competitive price and our ability to obtain sufficient third-party coverage or reimbursement.

If any product candidate is

approved but does not achieve an adequate level of acceptance by physicians, patients and third-party payors, our ability to

generate revenues from that product would be substantially reduced.

In addition, our efforts to educate the medical community

and third-party payors on the benefits of our product candidates may require significant resources, may be constrained by FDA

rules and policies on product promotion, and may never be successful.

If any product candidate that we develop

does not provide a treatment regimen that is as beneficial as, or is perceived as being as beneficial as, the current standard

of care or otherwise does not provide patient benefit, that product candidate, if approved for commercial sale by the FDA or other

regulatory authorities, likely will not achieve market acceptance.

Our ability to effectively promote and sell any approved products

will also depend on pricing and cost-effectiveness, including our ability to produce a product at a competitive price and our ability

to obtain sufficient third-party coverage or reimbursement.

If any product candidate is approved but does not achieve an adequate

level of acceptance by physicians, patients and third-party payors, our ability to generate revenues from that product would be

substantially reduced.

In addition, our efforts to educate the medical community and third-party payors on the benefits of our

product candidates may require significant resources, may be constrained by FDA rules and policies on product promotion, and

may never be successful.

We depend on third parties, including

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duties or meet expected deadlines, we may not be able to seek or obtain regulatory approval for or commercialize our product candidates.

Since we have in-licensed some of our product

candidates, have sublicensed a product candidate and have collaboration agreements for the development of other product candidates,

we depend upon our sublicensee and independent investigators and scientific collaborators, such as universities and medical institutions

or private physician scientists, to advise us and to conduct our preclinical and clinical trials under agreements with us.

collaborators are not our employees and we cannot control the amount or timing of resources that they devote to our programs or

the timing of their procurement of clinical-trial data or their compliance with applicable regulatory guidelines.

Should any of

these scientific inventors/advisors or those of our sublicensee become disabled or die unexpectedly, or should they fail to comply

with applicable regulatory guidelines, we or our sublicensee may be forced to scale back or terminate development of that program.

They may not assign as great a priority to our programs or pursue them as diligently as we would if we were undertaking those programs

Failing to devote sufficient time and resources to our drug-development programs, or substandard performance and failure

to comply with regulatory guidelines, could result in delay of any FDA applications and our commercialization of the drug candidate

We have in-licensed some of our

product candidates, have sublicensed a product candidate, and have collaboration agreements for the development of other

product candidates.

As a result, we depend upon our sublicensee and independent investigators and scientific collaborators,

such as universities and medical institutions or private physician scientists, to advise us and to conduct our preclinical

and clinical trials under agreements with us.

These collaborators are not our employees and we cannot control the amount or

timing of resources that they devote to our programs or the timing of their procurement of clinical-trial data or their

compliance with applicable regulatory guidelines.

Should any of these scientific inventors/advisors or those of our

sublicensee become disabled or die unexpectedly, or should they fail to comply with applicable regulatory guidelines, we or

our sublicensee may be forced to scale back or terminate development of that program.

They may not assign as great a priority

to our programs or pursue them as diligently as we would if we were undertaking those programs ourselves.

Failing to devote

sufficient time and resources to our drug-development programs, or substandard performance and failure to comply with

regulatory guidelines, could result in delay of any FDA applications and our commercialization of the drug candidate

These collaborators may also have relationships

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Our collaborators assisting our competitors could harm our competitive

For example, we are highly dependent on scientific collaborators for our IBS-C development program, each of whom are

employed by third parties.

With respect to our product candidate for

pertussis in collaboration with University of Texas at Austin, we are dependent on its research laboratories as we have no such

facilities or capabilities of our own.

If any of the foregoing were to become inaccessible or terminated, it would be difficult

for us to develop and commercialize our synthetic biologic product candidates.

We have in the past and expect to

have in the future agreements with third-party contract research organizations (CROs), under which we have delegated to the

CROs the responsibility to coordinate and monitor the conduct of our SYN-004 and SYN-010 clinical trials and to manage data

for our clinical programs.

Our current investigator sponsored clinical trial of SYN-010, and our planned Phase 1b/2a clinical

trial of SYN-004 will be conducted by the clinical sites over which we have little control.

We, our CROs and our clinical

sites are required to comply with current Good Clinical Practices, or cGCPs, regulations and guidelines issued by the FDA and

by similar governmental authorities in other countries where we are conducting clinical trials.

We have an ongoing obligation

to monitor the activities conducted by our CROs and at our clinical sites to confirm compliance with these requirements.

the future, if we, our CROs or our clinical sites fail to comply with applicable GCPs, the clinical data generated in our

clinical trials may be deemed unreliable and the FDA may require us to perform additional clinical trials before approving

our marketing applications.

In addition, our clinical trials must be conducted with product produced under cGMP regulations,

and will require a large number of test subjects.

Our failure to comply with these regulations may require us to repeat

clinical trials, which would delay the regulatory approval process.

If our CROs or investigator-sponsored clinical sites do

not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced,

or if the quality or accuracy of the clinical data they obtain is compromised due to their failure to adhere to our clinical

protocols, regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated, and we

may not be able to obtain regulatory approval for or successfully commercialize our product candidates.

As a result, our

financial results and the commercial prospects for our product candidates would be harmed, our costs could increase, and our

ability to generate revenue could be delayed.

We currently have no marketing,

sales or distribution organization and have no experience in marketing products as a company.

pertussis in collaboration with UT Austin, we are dependent on its research laboratories as we have no such facilities or capabilities

If any of the foregoing were to become inaccessible or terminated, it would be difficult for us to develop and commercialize

our synthetic biologic product candidates.

We have in the past and expect to have

in the future agreements with third-party contract research organizations (CROs) under which we have delegated to the CROs the

responsibility to coordinate and monitor the conduct of our SYN-004 and SYN-020 clinical trials and to manage data for our clinical

Our planned Phase 1b/2a clinical trial of SYN-004 and planned Phase 1 clinical trials of SYN-020 will be conducted by

clinical sites over which we have little direct control.

We, our CROs and our clinical sites are required to comply with current

Good Clinical Practices, or cGCPs, regulations and guidelines issued by the FDA and by similar governmental authorities in other

countries where we are conducting clinical trials.

We have an ongoing obligation to monitor the activities conducted by our CROs

and at our clinical sites to confirm compliance with these requirements.

In the future, if we, our CROs or our clinical sites fail

to comply with applicable GCPs, the clinical data generated in our clinical trials may be deemed unreliable and the FDA may require

us to perform additional clinical trials before approving our marketing applications.

In addition, our clinical trials must be

conducted with product produced under cGMP regulations and will require a large number of test subjects.

Our failure to comply

with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process.

or investigator-sponsored clinical sites do not successfully carry out their contractual duties or obligations or meet expected

deadlines, if they need to be replaced, or if the quality or accuracy of the clinical data they obtain is compromised due to their

failure to adhere to our clinical protocols, regulatory requirements or for other reasons, our clinical trials may be extended,

delayed or terminated, and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates.

As a result, our financial results and the commercial prospects for our product candidates would be harmed, our costs could increase,

and our ability to generate revenue could be delayed.

We currently have no marketing, sales

or distribution organization and have no experience in marketing products as a company.

If we are unable to establish marketing

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to commercialize any product in the United States or overseas.

Even if our products are approved,

if doctors decide not to prescribe SYN-010 or hospitals decide not to prescribe SYN-004, we may be unable to generate sufficient

revenue to sustain our business.

To increase awareness and adoption of our

products once approved, we and our collaborators will need to educate doctors and hospitals on the benefits and value of our products

through published papers, presentations at scientific conferences and one-on-one education sessions.

In addition, we and our collaborators

will need to assure doctors of our ability to obtain and maintain adequate reimbursement coverage from third-party payors.

our collaborators may need to hire additional commercial, scientific, technical, sales and marketing and other personnel to support

this process.

If our educational efforts fail and medical practitioners do not decide to prescribe our products in sufficient volume,

we may be unable to generate sufficient revenue to sustain our business.

In addition, factors outside of our control, such as insurance

reimbursement are expected to influence market acceptance of our products.

Accordingly, even if we receive regulatory approval

for the use of our products, we may not be successful in generating revenue from the sale of our products.

Reimbursement may not be available

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our products to governmental control, we may not be able to generate revenue, attain profitability or commercialize our products.

As a result of legislative proposals

and the trend towards managed health care in the United States, third-party payors are increasingly attempting to contain

health care costs by limiting both coverage and the level of reimbursement of new drugs.

They may also impose strict prior

authorization requirements and/or refuse to provide any coverage of uses of approved products for medical indications other

than those for which the FDA has granted market approvals.

As a result, significant uncertainty exists as to whether and how

much third-party payors will reimburse patients for their use of newly-approved drugs, which in turn will put pressure on the

pricing of drugs.

As a result of legislative proposals and

the trend towards managed health care in the United States, third-party payors are increasingly attempting to contain health care

costs by limiting both coverage and the level of reimbursement of new drugs.

They may also impose strict prior authorization requirements

and/or refuse to provide any coverage of uses of approved products for medical indications other than those for which the FDA has

granted market approvals.

As a result, significant uncertainty exists as to whether and how much third-party payors will reimburse

patients for their use of newly-approved drugs, which in turn will put pressure on the pricing of drugs.

Healthcare reform measures could

hinder or prevent our product candidates’ commercial success.

hinder or prevent our product candidates’

commercial success.

government and other governments

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substantial monetary awards to patients or other claimants;

distraction of management’s attention from our primary business;

product recalls;

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the inability to commercialize our product candidates.

We have clinical trial liability

We intend to expand our insurance coverage to include the sale of commercial products if marketing approval is

obtained for our product candidates.

Our current insurance coverage may prove insufficient to cover any liability claims

brought against us.

In addition, because of the increasing costs of insurance coverage, we may not be able to maintain

insurance coverage at a reasonable cost or obtain insurance coverage that will be adequate to satisfy liabilities that may

We have clinical trial liability insurance.

We intend to expand our insurance coverage to include the sale of commercial products if marketing approval is obtained for our

product candidates.

Our current insurance coverage may prove insufficient to cover any liability claims brought against us.

addition, because of the increasing costs of insurance coverage, we may not be able to maintain insurance coverage at a reasonable

cost or obtain insurance coverage that will be adequate to satisfy liabilities that may arise.

INTELLECTUAL PROPERTY RISKS

We rely on patent applications and

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if we are not able to protect our products.

The patent positions of pharmaceutical

companies are uncertain and may involve complex legal and factual questions.

We may incur significant expenses in protecting our

intellectual property and defending or assessing claims with respect to intellectual property owned by others.

Any patent or other

infringement litigation by or against us could cause us to incur significant expenses and divert the attention of our management.

The patent positions of

pharmaceutical companies are uncertain and may involve complex legal and factual questions.

We may incur significant expenses

in protecting our intellectual property and defending or assessing claims with respect to intellectual property owned by

Any patent or other infringement litigation by or against us could cause us to incur significant expenses and divert

the attention of our management.

Even for our issued patents, we do not have a guarantee of patent term restoration and marketing exclusivity of the ingredients for our

drugs under the Hatch-Waxman Amendments, even if we are granted FDA approval of our products.

Others may file patent applications or

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In some foreign jurisdictions, we could become involved in opposition

proceedings, either by opposing the validity of another’s foreign patent or by persons opposing the validity of our foreign

We may also face frivolous litigation or

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to offer us a license on commercially acceptable terms.

We do not have a guarantee of patent

term restoration and marketing exclusivity of the ingredients for our drugs even if we are granted FDA approval of our products.

Drug Price Competition and Patent

Term Restoration Act of 1984 (Hatch-Waxman) permits the FDA to approve Abbreviated New Drug Applications (ANDAs) for generic versions

of innovator drugs, as well as NDAs with less original clinical data, and provides patent restoration and exclusivity protections

to innovator drug manufacturers.

The ANDA process permits competitor companies to obtain marketing approval for drugs with the

same active ingredient and for the same uses as innovator drugs, but does not require the conduct and submission of clinical studies

demonstrating safety and efficacy.

As a result, a competitor could copy any of our drugs and only need to submit data demonstrating

that the copy is bioequivalent to gain marketing approval from the FDA.

Hatch-Waxman requires a competitor that submits an ANDA,

or otherwise relies on safety and efficacy data for one of our drugs, to notify us and/or our business partners of potential infringement

of our patent rights.

We and/or our business partners may sue the company for patent infringement, which would result in a 30-month

stay of approval of the competitor’s application.

The discovery, trial and appeals process in such suits can take several

If the litigation is resolved in favor of the generic applicant or the challenged patent expires during the 30-month period,

the stay is lifted and the FDA may approve the application.

Hatch-Waxman also allows competitors to market copies of innovator

products by submitting significantly less clinical data outside the ANDA context.

Such applications, known as Section 505(b)(2)

NDAs may rely on clinical investigations not conducted by or for the applicant and for which the applicant has not obtained a right

of reference or use and are subject to the ANDA notification procedures described above.

The law also permits restoration of a

portion of a product’s patent term that is lost during clinical development and NDA review, and provides statutory

protection, known as exclusivity, against FDA approval or acceptance of certain competitor applications.

Restoration can

return up to five years of patent term for a patent covering a new product or its use to compensate for time lost during

product development and regulatory review.

The restoration period is generally one-half the time between the effective date

of an IND and submission of an NDA, plus the time between NDA submission and its approval (subject to the five-year limit),

and no extension can extend total patent life beyond 14 years after the drug approval date.

Applications for patent term

extension are subject to U.S.

Patent and Trademark Office (USPTO) approval, in conjunction with FDA.

Approval of these

applications takes at least nine months, and there can be no guarantee that it will be given at all.

Hatch-Waxman also provides for differing

periods of statutory protection for new drugs approved under an NDA.

Among the types of exclusivity are those for a “new

chemical entity” and those for a new formulation or indication for a previously-approved drug.

If granted, marketing exclusivity

for the types of products that we are developing, which include only drugs with innovative changes to previously-approved products

using the same active ingredient, would prohibit the FDA from approving an ANDA or 505(b)(2) NDA relying on our safety and efficacy

data for three years.

This three-year exclusivity, however, covers only the innovation associated with the original NDA.

not prohibit the FDA from approving applications for drugs with the same active ingredient but without our new innovative change.

These marketing exclusivity protections do not prohibit the FDA from approving a full NDA, even if it contains the innovative change.

We may fail to retain or recruit

necessary personnel, and we may be unable to secure the services of consultants.

As of February 20, 2020, we employed approximately

11 full-time employees.

We have also engaged clinical consultants to advise us on our clinical programs and regulatory consultants

to advise us on our dealings with the FDA and other foreign regulatory authorities.

Due to our corporate restructuring plan to

reduce cost that was implemented in 2018, we have reduced our work force and expect in future years to require additional personnel

to support our later stage research and development efforts.

We have been and may be required to retain additional consultants

and employees in order to fulfill our obligations under our licenses and collaborations for our development of SYN-004, SYN-010,

SYN-020 and our agreements with CSMC and Washington University.

Our future performance will depend in part on our ability to successfully

integrate newly hired officers into our management team and our ability to develop an effective working relationship among senior

Certain of our directors, scientific advisors,

and consultants serve as officers, directors, scientific advisors, or consultants of other biopharmaceutical or biotechnology companies

that might be developing competitive products to ours.

Other than corporate opportunities, none of our directors are obligated

under any agreement or understanding with us to make any additional products or technologies available to us.

Similarly, we can

give no assurances, and we do not expect and stockholders should not expect, that any biomedical or pharmaceutical product or technology

identified by any of our directors or affiliates in the future would be made available to us other than corporate opportunities.

We can give no assurances that any such other companies will not have interests that are in conflict with our interests.

Losing key personnel or failing to recruit

necessary additional personnel would impede our ability to attain our development objectives.

There is intense competition for

qualified personnel in the drug and biologic development areas, and we may not be able to attract and retain the qualified personnel

we would need to develop our business.

We rely on independent organizations, advisors,

and consultants to perform certain services for us, including handling substantially all aspects of regulatory approval, clinical

management, manufacturing, marketing, and sales.

We expect that this will continue to be the case.

Such services may not always

be available to us on a timely basis when we need them.

We rely extensively on our information

technology systems and are vulnerable to damage and interruption.

We rely on our information technology

systems and infrastructure to process transactions, summarize results and manage our business, including maintaining client

and supplier information.

Additionally, we utilize third parties, including cloud providers, to store, transfer and process

Our information technology systems, as well as the systems of our suppliers and other partners, whose systems we do not

control, are vulnerable to outages and an increasing risk of continually evolving deliberate intrusions to gain access to

company sensitive information.

Likewise, data security incidents and breaches by employees and others with or without

permitted access to our systems pose a risk that sensitive data may be exposed to unauthorized persons or to the public.

cyber-attack or other significant disruption involving our information technology systems, or those of our vendors, suppliers

and other partners, could also result in disruptions in critical systems, corruption or loss of data and theft of data, funds

or intellectual property.

We may be unable to prevent outages or security breaches in our systems.

remain potentially vulnerable to additional known or yet unknown threats as, in some instances, we, our suppliers and our

other partners may be unaware of an incident or its magnitude and effects.

We also face the risk that we expose

our vendors or partners to cybersecurity attacks.

Any or all of the foregoing could adversely affect our results

of operations and our business reputation.

Any failure to maintain the security

of information relating to our customers, employees and suppliers, whether as a result of cybersecurity attacks or otherwise, could

expose us to litigation, government enforcement actions and costly response measures, and could disrupt our operations and harm

our reputation.

In connection with the pre-clinical and

clinical development, sales and marketing of our products and services, we may from time to time transmit confidential information.

We also have access to, collect or maintain private or confidential information regarding our clinical trials and the patients

enrolled therein, employees, and suppliers, as well as our business.

Cyberattacks are rapidly evolving and becoming increasingly

sophisticated.

It is possible that computer hackers and others might compromise our security measures, or security measures of

those parties that we do business with now or in the future, and obtain the personal information of patients in our clinical trials,

vendors, employees and suppliers or our business information.

A security breach of any kind, including physical or electronic break-ins,

computer viruses and attacks by hackers, employees or others, could expose us to risks of data loss, litigation, government enforcement

actions, regulatory penalties and costly response measures, and could seriously disrupt our operations.

Any resulting negative

publicity could significantly harm our reputation, which could cause us to lose market share and have an adverse effect on our

results of operations.

RISKS RELATING TO OUR SECURITIES

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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

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 American.

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.

We cannot assure you that we will be able to maintain the continued listing standards of the NYSE

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 December 31, 2019, we had a

stockholders’ deficit of $1.1 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

If our common stock falls below $0.20

per share on a 30-trading-day average it will become subject to the continued listing evaluation and follow-up procedures set

forth in Section 1009 of the NYSE American Company Guide which could, among other things, result in initiation of immediate

delisting procedures.

In the event that we were to fail to meet the requirements of NYSE American per share price requirement

or stockholders’ equity requirement and we could not timely cure such deficiency, our listing could become subject to

NYSE American continued listing evaluation and follow-up procedures, which could result in delisting procedures.

low stock price on July 28, 2018, our Board of Directors approved a one-for-thirty-five proportionate reverse stock

split of our authorized number of shares of common stock and our outstanding number of shares of common stock that we

effected on August 10, 2018.

However, there can be no assurance that the reverse stock split will result in a sustained

higher stock price that will allow us to meet the NYSE American stock price listing requirements or that the reverse stock

split will not inhibit our ability to seek equity financing as a remedy to regain compliance with NYSE American

stockholders’ equity requirements.

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 it has reported losses from continuing operations and/or net losses in its five most recent fiscal years).

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

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 compliance.

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 delisting proceeding as appropriate.

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.

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 December 31, 2020, we had a stockholders’

deficit of $7.5 million.

The NYSE American Company Guide also states that

the NYSE normally will not consider removing from listing securities of an issuer if it is in compliance with all of the following:a

total value of market capitalization of at least $50.0 million;

1,100,000 publicly-held shares;

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 2019 and 2020, 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 above $50.0 million.

If our common stock falls below $0.20 per

share on a 30-trading-day average it will become subject to the continued listing evaluation and follow-up procedures set forth

in Section 1009 of the NYSE American Company Guide which could, among other things, result in initiation of immediate delisting

In the event that we were to fail to meet the requirements of NYSE American per share price requirement or stockholders’

equity requirement and we could not timely cure such deficiency, our listing could become subject to NYSE American continued listing

evaluation and follow-up procedures, which could result in delisting procedures.

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 it has reported losses from continuing operations and/or net losses in its five most recent fiscal

The Deficiency Letter noted that the Company had a 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

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 compliance.

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.

the Company is now subject to the procedures and requirements set forth in Section 1009 of the Company Guide.

We remain subject

to the conditions set forth in the Exchange’s letter dated November 25, 2019 for the initial equity noncompliance.

NYSE Regulation staff will review our company periodically for compliance with the initiatives outlined in the plan.

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 delisting proceeding as appropriate.

On November 23, 2020

we received written communication from NYSE American notifying us that we have had been granted an extension until May 25,

2021 to regain compliance with certain continued listing standards as set forth in Sections 1003(a)(i), (ii) and (iii) of

the NYSE American Company Guide.

We will remain subject to periodic review by NYSE American staff during the extension period.

Failure to make progress consistent with the plan or regain compliance with the continued listing standards by the end of the extension

period could result in the Company being delisted from the NYSE American.

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 continue to fail to maintain the minimum stockholders’ equity.

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

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 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.

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

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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 $15 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 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 requirements or failure to continue to meet the other listing requirements

could result in a de-listing of our common stock.

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 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 requirements or failure to continue to meet the other listing requirements could result in a de-listing of our common stock.

We expect to seek to raise additional

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issue equity as part of license issue fees to our licensors, compensate consultants or settle outstanding payables using equity

that may be dilutive.

In addition, the right of CSMC to exchange its equity in our subsidiary for shares of our common stock could,

if effected, be dilutive.

Our stockholders may experience additional dilution in net book value per share and any additional equity

that may be dilutive 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.

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.

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

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.

Holders of our warrants issued in

our October 2014 offering, our November 2016 offering, and our October 2018 offering and our Series A Preferred Stock and our Series

B Preferred Stock have no rights as common stockholders until they exercise their warrants or convert their Series A Preferred

Stock or Series B Preferred Stock and acquire our common stock.

Until the holders of the warrants we issued

in our November 2016 offering and our October 2018 offering and the holders of our Series A Preferred Stock and Series B Preferred

Stock acquire shares of our common stock by exercising their warrants or converting their Series A Preferred Stock or Series B

Preferred Stock, respectively, the holders have no rights as a stockholder with respect to the shares of common stock underlying

their securities.

Upon exercise of the warrants or conversion of the Series A Preferred Stock or Series B Preferred Stock, the

holders will be entitled to exercise the rights of a common stockholder only as to matters for which the record date occurs after

the exercise date.

Because there is no established public

trading market for November 2016 or October 2018 warrants or the Series A Preferred Stock and Series B Preferred Stock we issued,

the liquidity of each such security is limited.

We do not expect a market to develop, nor do we intend to apply to list the warrants

or the Series A Preferred Stock or the Series B Preferred Stock on any securities exchange.

Upon exercise of the warrants and conversion

of the Series A Preferred Stock and Series B Preferred Stock, our stockholders will experience dilution.

The fundamental change purchase feature

of the warrants we issued in our November 2016 offering may delay or prevent an otherwise beneficial attempt to take over our company.

The terms of the November 2016 warrants

require us to offer to purchase the warrants for cash in the event of a fundamental change, as defined.

This feature may have the

effect of delaying or preventing a takeover of our company that would otherwise be beneficial to investors.

The warrants are a risky investment.

Holders of our warrants may not be able to recover the investment in the warrants, and the warrants may expire worthless.

Whether the outstanding warrants will have

any value will depend on the market conditions for, and the price of, our common stock, which conditions will depend on factors

related and unrelated to the success of our clinical development program, and cannot be predicted at this time.

If our common stock price does not increase

to an amount sufficiently above the exercise prices of the warrants during the periods the warrants are exercisable, holders of

warrants will be unable to recover any of their investment in the warrants.

In fact, the warrants issued in November 2016 that

had an exercise price of $60.20 expired unexercised because their exercise price was above the common stock trading price.

can be no assurance that any of the factors that could impact the trading price of our common stock will result in the trading

price increasing to an amount that will exceed the exercise price or the price required for holders of warrants to achieve a positive

return on their investment in the warrants.

We may not have the funds necessary

to fulfill our obligation to repurchase the warrants.

Under certain circumstances, if an extraordinary

transaction (as defined in the warrant agreement) occurs, holders of the warrants issued in November 2016 may require us to repurchase

the remaining unexercised portion of such warrants for an amount of cash equal to the value of the warrant as determined in accordance

with the Black Scholes option pricing model and the terms of the warrants.

Our ability to repurchase the warrants depends on our

ability to generate cash flow in the future.

To some extent, this is subject to general economic, financial, competitive, legislative

and regulatory factors and other factors that are beyond our control.

We cannot assure you that we will maintain sufficient cash

reserves or that our business will generate cash flow from operations at levels sufficient to permit us to repurchase the warrants.

The issuance of shares of

common stock upon conversion of the Series A Preferred Stock and/or Series B Preferred Stock would reduce the relative voting

power of holders of our common stock, would dilute the ownership of such holders and may adversely affect the market price of

our common stock.

In addition, if CSMC were to exchange its shares of common stock in SYN Biomics for shares of our common

stock, the relative voting power of holders of our common stock would be reduced, the ownership of such holders would be

diluted and the market price of our common stock may be adversely affected.

The conversion of the Series A Preferred

Stock and/or Series B Preferred Stock to common stock would dilute the ownership interest of existing holders of our common stock,

and any sales in the public market of the common stock issuable upon conversion of the Series A Preferred Stock and/or Series B

Preferred Stock could adversely affect prevailing market prices of our common stock.

Sales by such holders of a substantial number

of shares of our common stock in the public market, or the perception that such sales might occur, could have a material adverse

effect on the price of our common stock.

The agreement with CSMC provides CSMC with

a right, commencing on the six month anniversary of issuance of the stock under certain circumstances in the event that the shares

of stock of SYN Biomics are not then freely tradeable, and subject to NYSE American, LLC approval, to exchange its SYN Biomics

shares for unregistered shares of our common stock, with the rate of exchange based upon the relative contribution of the valuation

of SYN Biomics to the public market valuation of our company at the time of each exchange all subject to approval of the NYSE

American, LLC.

The exchange of such shares could, depending on the value of SYN Biomics result in a significant number of shares

of our common stock being issued to CSMC and dilution to holders of our common stock, and any sales in the public market of the

common stock issuable upon such exchange could adversely affect prevailing market prices of our common stock.

The holders of shares of the Series A Preferred Stock

may exercise significant influence over us.

Under the terms of the Certificate of Designation

that governs the Series A Preferred Stock, the Series A Preferred Stock generally ranks, with respect to liquidation, dividends

and redemption, senior to other securities and, so long as any shares of Series A Preferred Stock remain outstanding, the approval

of the holders of a majority of the Series A Preferred Stock outstanding at the time of approval is required in order for us to,

among other things, (i) alter or change adversely the powers, preferences or rights given to the Series A Preferred Stock or alter

or amend the Certificate of Designation;

(ii) amend our Articles of Incorporation or bylaws in any manner that adversely affects

any powers, preferences or rights of the Series A Preferred Stock;

(iii) authorize or create any series or class of stock ranking

as to redemption, distribution of assets upon a Liquidation Event (as defined in the Certificate of Designation) or dividends senior

to, or otherwise pari passu with, the Series A Preferred Stock;

(iv) declare or make any dividends other than dividend payments

on the Series A Preferred Stock or other distributions payable solely in common stock;

(v) authorize any increase in the number

of shares of Series A Preferred Stock or issue any additional shares of Series A Preferred Stock;

or (vi) enter into any agreement

with respect to any of the foregoing.

The holders of Series A Preferred

Stock will have rights, preferences and privileges that are not held by, and are preferential to, the rights of our common stockholders

and holders of our Series B Preferred Stock.

Upon our liquidation, dissolution or

winding up, the holders of the Series A Preferred Stock will be entitled to receive out of our assets, in preference to the

holders of the common stock and any junior preferred stock (including the Series B Preferred stock issued in October 2018),

an amount per share equal to the greater of (i) the sum of the Accreted Value (as defined in the Certificate of Designation)

plus an amount equal to all accrued or declared and unpaid dividends on the Series A Preferred Stock that have not previously

been added to the Accrued Value, or (ii) the amount that such shares would have been entitled to receive if they had

converted into common stock immediately prior to such liquidation, dissolution or winding up.

In addition, upon consummation

of a specified change of control transaction, each holder of Series A Preferred Stock will be entitled to have us redeem the

Series A Preferred Stock at a price specified in the Certificate of Designation.

These provisions may make it more costly for

a potential acquirer to engage in a business combination transaction with us.

Provisions that have the effect of

discouraging, delaying or preventing a change in control could limit the opportunity for our stockholders to receive a

premium for their shares of our common stock and could also affect the price that some investors are willing to pay for our

common stock.

If there are insufficient assets to pay in full such amounts, then the available assets will be ratably

distributed to the holders of the Series A Preferred Stock in accordance with the respective amounts that would be payable on

such shares if all amounts payable thereon were paid in full.

This will reduce the remaining amount of our assets, if any,

available to distribute to holders of our common stock.

The holders of Series A Preferred Stock also have a preferential

right to receive cumulative dividends on the Accreted Value of each share of Series A Preferred Stock at an initial rate of

2% per annum, compounded quarterly.

In addition, the holders of the Series

A Preferred Stock also have certain redemption and conversion rights.

Our obligations to the holders of Series

A Preferred Stock could limit our ability to obtain additional financing or increase our borrowing costs, which could have an adverse

effect on our financial condition.

These preferential rights could also result in divergent interests between the holders of shares

of the Series A Preferred Stock and holders of our common stock.

The redemption right of the holders

of the Series A Preferred Stock may delay or prevent an otherwise beneficial change of control transaction or result in a depletion

of our cash in order to satisfy the redemption right of the holders Series A Preferred Stock.

The terms of the Series A Preferred Stock

provide the holders with the right to require us to redeem the stock upon a change of control for cash in the event of a fundamental

change, as defined.

This feature may have the effect of delaying or preventing a change of control that would otherwise be beneficial

to investors or depleting our cash.

our October 2018 offering have no rights as common

stockholders until they exercise their warrants and acquire our common stock.

Until the holders of the warrants we issued in our October 2018

offering acquire shares of our common stock by exercising their warrants, the holders of the warrants have no rights as a stockholder

with respect to the shares of common stock underlying their securities.

Upon exercise of the warrants they will be entitled to

the rights of a common stockholder only as to matters for which the record date occurs after the exercise date.

Whether the outstanding warrants will have any value will depend on the market conditions for, and the price of, our common stock, which

conditions will depend on factors related and unrelated to the success of our clinical development program, and cannot be predicted at

If our common stock price does not increase to an amount sufficiently above the exercise price of the warrants during the periods

the warrants are exercisable, holders of warrants will be unable to recover any of their investment in the warrants

Because there is no established public trading market for the October 2018 warrants we issued, the liquidity of each such security is

We do not expect a market to develop, nor do we intend to apply to list the warrants on any securities exchange.

Upon exercise

of the warrants, our stockholders will experience dilution.

The market price of our common stock

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

The market price of our common stock could

fluctuate significantly in response to various factors and events, including:

our ability to execute our business plan;

operating results below expectations;

announcements concerning product development results, including clinical trial results, or intellectual property rights of others;

litigation or public concern about the safety of our potential products;

our issuance of additional securities, including debt or equity or a combination thereof, necessary to fund our operating expenses;

announcements of technological innovations or new products by us or our competitors;

loss of any strategic relationship;

industry developments, including, without limitation, changes in healthcare policies or practices or third-party reimbursement policies;

economic and other external factors affecting U.S.

or Global equity markets;

period-to-period fluctuations in our financial results;

whether an active trading market in our common stock develops and is maintained.

In addition, the securities markets have

from time to time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular

These market fluctuations may also materially and adversely affect the market price of our common stock.

Our stock price has fluctuated in the past, has recently been volatile and may be volatile in the future.

By way of example, on October

2, 2020, the price of our common stock closed at $0.32 per share while on February 9, 2021, our stock price closed at $1.10 per share

with no discernable announcements or developments by the company or third parties.

On January 5, 2021, the intra-day sales price of our

common stock fluctuated between a reported low sale price of $0.93 and a reported high sales price of $1.70.

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

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

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 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 rate 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 have 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 rate that is significantly disconnected from our underlying value.

Our articles of incorporation and

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of any registration statement, and therefore there can be no assurance that we will not incur damages with respect to such agreements.

Pursuant to the terms of the registration

rights agreement that we entered into with holders of our Series A Preferred Stock, we are required to file a registration statement

with respect to the securities issued to them upon their request within certain time periods and are required to maintain the effectiveness

of such registration statement.

The failure to do so could result in the payment of damages by us.

There can be no assurance that

we will be able to meet the required filing deadlines or maintain the effectiveness of any registration statement, and therefore

there can be no assurance that we will not incur damages with respect to such agreements.

We do not intend to pay dividends

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In turn, these resales could have the effect of depressing the market price for our common

The shares of common stock offered

under the FBR Sales Agreement may be sold in “at the market” offerings, and investors who buy shares at different times

will likely pay different prices.

Investors who purchase shares that are

sold under the FBR Sales Agreement at different times will likely pay different prices, and so may experience different outcomes

in their investment results.

We will have discretion, subject to market demand, to vary the timing, prices, and numbers of shares

sold, and there is no minimum or maximum sales price.

The shares of common stock

offered under our current Amended and Restated At Market Issuance Sales Agreement may be

sold in “at the market”

offerings, and investors who buy shares at different times will likely pay different

Investors who purchase shares that

are sold under our current Amended and Restated At Market Issuance Sales Agreement at different times will likely pay

different prices, and so may experience different outcomes in their investment results.

We will have discretion, subject to

market demand, to vary the timing, prices, and numbers of shares sold, and there is no minimum or maximum sales price.

Investors may experience declines in the

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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