What changed in this filing

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Item 5. Market for Registrant’s Common Equity

2021-03-04 compared with 2020-02-20 · 395 added, 12 removed, 30 unchanged (93% of the section changed)

Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

Market Information

5 unchanged sentences

since October 16, 2008.

The last price of our common stock as reported on the NYSE American on February

The last price of our common stock as reported on the NYSE American on March

3, 2021 was $0.6445 per share.

4 unchanged sentences

imposed under Nevada corporate law.

The timing, amount and form of dividends, if any, will depend on, among other things, our results

of operations, financial condition, cash requirements and other factors deemed relevant by our Board of Directors.

The Series A Preferred Stock ranks senior

to the shares of our common stock and shares of our Series B Preferred Stock with respect to dividend rights and holders of Series

A Preferred Stock are entitled to a cumulative dividend at the rate of 2.0% per annum, payable quarterly in arrears, as set

forth in the Certificate of Designation of Series A Convertible Preferred Stock.

As of February 18, 2020, we had approximately

The timing, amount and form of dividends, if any, will depend on, among other things, our

results of operations, financial condition, cash requirements and other factors deemed relevant by our Board of Directors.

The Series A Preferred Stock, none of which remains outstanding, ranked senior to the shares of our common stock and shares of our Series

B Preferred Stock with respect to dividend rights and holders of Series A Preferred Stock were entitled to a cumulative dividend at the

rate of 2.0% per annum, payable quarterly in arrears, as set forth in the Certificate of Designation of Series A Convertible Preferred

As of March 3, 2021, we had approximately

343 stockholders of record of our common stock.

5 unchanged sentences

Equity Compensation Plan Information

See Part II–Item 12 under the heading

“Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters—Equity Compensation

Plan Information” of this Annual Report on Form 10-K for equity compensation plan information.

See Part II–Item 12 under the

heading “Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters—Equity Compensation

Plan Information”

of this Annual Report on Form 10-K for equity compensation plan information.

Recent Sales of Unregistered Securities

8 unchanged sentences

as defined by Rule 12b-2 of the Exchange Act and is not required to provide the information required under this item.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion of our financial

condition and results of operations should be read in conjunction with our audited financial statements and notes thereto for the

years ended December 31, 2020 and 2019 included elsewhere in this Annual Report.

In addition to historical information, the

following discussion contains certain forward-looking statements that involve risks, uncertainties and assumptions.

Where possible,

we have tried to identify these forward-looking statements by using words such as “anticipate,”

“believe,”

“intends,”

or similar expressions.

Our actual results could differ materially from those expressed or implied by the

forward-looking statements due to important factors and risks including, but not limited to, those set forth under “Risk

Factors”

in Part I, Item 1A of this Annual Report.

We are a diversified clinical-stage company

developing therapeutics designed to treat gastrointestinal (GI) diseases in areas of high unmet need.

Our lead clinical development

candidates are:

(1) SYN-004 (ribaxamase) which is designed to degrade certain commonly used intravenous (IV) beta-lactam

antibiotics within the GI tract to prevent microbiome damage, Clostridioides difficile infection (CDI), overgrowth of pathogenic

organisms, the emergence of antimicrobial resistance (AMR), and acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic

cell transplant (HCT) recipients, and (2) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase

(IAP) produced under cGMP conditions and intended to treat both local GI and systemic diseases.

We plan to explore and evaluate a range

of strategic options, which may include:

in-licensing opportunities;

evaluation of potential acquisitions;

or other potential strategic

transactions.

In the meantime, we remain focused on working with our clinical development partners to advance the planned Phase

1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) patients, and advancing the clinical

development program for SYN-020 intestinal alkaline phosphatase (IAP) in multiple potential indications.

We are continuing to assess the potential

impact of the COVID-19 pandemic.

We are in close contact with our clinical development partners in order to assess the impact

of COVID-19 on our studies and current timelines and costs.

While we currently do not anticipate any interruptions in our

operations due to COVID-19, it is possible that if the COVID-19 pandemic persists, for an extended period of time, we could experience

significant disruptions to our clinical development timelines due to the COVID-19 pandemic, which would adversely affect our business,

financial condition, results of operations and growth prospects.

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 full extent to which the COVID-19 outbreak will

directly or indirectly impact our business, results of operations and financial condition will depend on future developments that

are highly uncertain and cannot be accurately predicted.

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.

Our Product Pipeline

aGVHD acute graft-vs-host disease;

allogeneic-HCT

allogeneic hematopoietic cell transplant patients;

AMR antimicrobial resistance;

CDI Clostridioides difficile infection.

SAD single ascending dose

¹Additional products with preclinical

proof-of-concept include SYN-006 (carbapenemase) designed to prevent aGVHD and infection by vancomycin resistant enterococci and

SYN-007 (ribaxamase) DR designed to prevent antibiotic associated diarrhea with oral β-lactam antibiotics.

²Dependent on funding/partnership.

³Announced option-license agreement

with Massachusetts General Hospital to develop SYN-020 in several potential indications related to inflammation and gut barrier

*Based on management’s current beliefs

and expectations.

Summary of Clinical and Preclinical

Therapeutic Area

Current Status

Prevention of microbiome damage, CDI, overgrowth of pathogenic organisms, AMR, and aGVHD in allogeneic HCT recipients (Degrade IV beta-lactam antibiotics)

(oral enzyme)

outcomes from End of Phase 2 meeting, including Food and Drug Administration (FDA)-proposed criteria for Phase 3 clinical efficacy

and safety which, if achieved, may support submission for marketing approval on the basis of a single Phase 3 clinical trial (Q4

Clarified market/potential partner needs and identified potential additional indications in specialty patient

populations such as allogeneic hematopoietic cell transplant (HCT) patients

clinical trial agreement (CTA) with Washington University School of Medicine to conduct a Phase 1b/2a clinical trial to evaluate

safety, tolerability and pharmacokinetics in up to 36 evaluable adult allogeneic HCT recipients (Q3 2019)

Received official meeting minutes from FDA Type-C meeting held on December 2, 2019 to discuss development in allogeneic HCT

recipients who are administered IV beta-lactam antibiotics in response to fever (Q1 2020)

written notification from the FDA informing the Company that the FDA determined the Phase 1b/2a clinical program in adult allogeneic

hematopoietic cell transplant (HCT) recipients may proceed per the submitted clinical program protocol (Q3 2020)

University has begun screening patients for enrollment of the first of three antibiotic cohorts for the Phase 1b/2a

clinical trial of SYN-004 in adult HCT recipients (Q1 2021)

Preserve gut barrier, treat local GI inflammation, and restore gut microbiome

(oral IAP enzyme)

high expressing manufacturing cell lines for intestinal alkaline phosphatase (IAP) (1H 2017)

basic Drug Supply manufacturing process and potential tablet formulation (2H 2017)

potential clinical indications with unmet medical need including enterocolitis associated with radiation therapy for cancer (Q1

pre-IND (Investigational New Drug) meeting with the FDA to clarify requirements for IND-enabling toxicology studies and manufacturing

requirements (Q2 2019)

into an agreement with Massachusetts General Hospital (“MGH”) granting the Company an option for 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 (Q2 2020)

IND application with U.S.

FDA supporting an initial indication for the treatment of radiation enteropathy secondary to pelvic cancer

therapy (Q2 2020)

study-may-proceed letter from U.S.

FDA to conduct a Phase 1 single ascending dose study in healthy volunteers, designed to evaluate

SYN-020 for safety, tolerability, and pharmacokinetic parameters (Q3 2020)

Phase 1 single-ascending-dose (SAD) study is expected to commence during the second quarter of 2021.

A topline data readout is

anticipated during the third quarter of 2021, pandemic conditions permitting.

Prevention of CDI, overgrowth of pathogenic organisms and AMR (Degrade IV carbapenem antibiotics)

(oral enzyme)

P2A as a potent carbapenemase that is stable in the GI tract

a formulated research lot for oral delivery (2017)

microbiome protection in a pig model of ertapenem administration (Q1 2018)

supporting data demonstrating SYN-006 attenuated emergence of antibiotic resistance in a pig model, including encoded beta-lactamases

and genes conferring resistance to a broad range of antibiotics such as aminoglycosides and macrolides (Q1 2019)

Prevention of CDI, overgrowth of pathogenic organisms and AMR (Degrade oral beta-lactam antibiotics)

(oral enzyme)

work ongoing to expand the utility of SYN-004 (ribaxamase) for use with oral beta-lactam antibiotics

supportive data from a second canine animal model demonstrating that when co-administered with oral Amoxicillin and oral Augmentin,

oral SYN-007 did not interfere with systemic absorption of antibiotics but did diminish microbiome damage associated with these

antibiotics (Q2 2018)

supportive data demonstrating SYN-007 mitigated antibiotic-mediated gut microbiome alterations and maintained gut microbiome integrity

when co-administered with oral amoxicillin in a dose-response canine study (Q2 2019)

supportive data demonstrating SYN-007 protected the gut microbiome of dogs from amoxicillin and the beta-lactam/beta-lactamase

inhibitor combination amoxicillin/clavulanate and also reduced the emergence of antibiotic resistance in a canine study (Q1 2020)

Prevention and treatment of pertussis

(monoclonal antibody

supportive preclinical data demonstrating that an extended half-life version of hu1B7, a component of SYN-005, provided protection

from pertussis for five weeks in a neonatal non-human primate study (Q4 2017)

Collaboration

with UT Austin

Financial Developments

B Riley and AGP Securities Sales Agreement

During the year ended

December 31, 2020, we sold an aggregate of 9.2 million shares of our common stock and received net proceeds of

approximately $3.4 million before deducting issuance expenses pursuant to that certain At

Market Issuance Sales Agreement, dated August 5, 2016, with B.

Riley Securities, Inc.

(formerly known as B.

Riley FBR, Inc.),

as amended by amendment no.

1 thereto, dated May 7, 2018 (the “Original ATM Sales Agreement”).

entered into an Amended and Restated At Market Issuance Sales Agreement, dated February 9, 2021, with B.

Riley Securities, Inc.,

Riley, and A.G.P./Alliance Global Partners, or AGP and together with B.

Riley, the sales agents (the “Amended and Restated

ATM Sales Agreement”), which replaced the Original ATM Sales Agreement.

Subsequent to year end through March 3,

2021 , we have sold approximately 76.3 million shares of our common stock and received net

proceeds of approximately $63.8 million, pursuant to the Original ATM Sales Agreement and the Amended and Restated ATM Sales Agreement.

Stock Warrants

On November 16, 2020, the exercise

price of warrants issued by us in October 2018 (the “2018 Warrants”) was reduced from $1.38 per Warrant per full

share of the Company’s common stock, $0.001 par value per share (the “Common Stock”), to $0.69 per 2018 Warrant

per full share of Common Stock pursuant to the terms of the Warrants.

The reduction was the result of the issuance of shares of

common stock by the us through its “at the market offering”

An entry to reduce the income available to common

shareholders was recorded for $880,000 to recognize the value of the effect of the change in exercise price.

During January and

February 2021, 11,655,747 2018 Warrants were exercised for cash proceeds of $ 8.

Critical Accounting Policies and Estimates

The preparation of our consolidated financial

statements in accordance with accounting principles generally accepted in the United States of America (U.S.

GAAP) requires management

to make estimates and assumptions that affect the reported amounts of assets, liabilities, net revenues and expenses, and related

We believe our estimates and assumptions are reasonable;

however, actual results and the timing of the recognition

of such amounts could differ from these estimates.

There are accounting policies that we believe

are significant to the presentation of our consolidated financial statements.

The most significant accounting policies relate to

stock-based compensation, warrants, grants and research and development costs.

Stock-Based Compensation

We recognize stock-based compensation expense

under the provisions of ASC 718, Compensation—Stock Compensation (“ASC 718”) .

The fair value of stock

options granted is the fair market value on the grant date.

We apply the Black-Scholes option pricing model to determine the fair

value of our stock options.

Inherent in this model are assumptions related to expected stock-price volatility, option life, risk-free

interest rate and dividend yield.

We estimate the volatility of our common stock at the date of grant based on historical volatility.

We estimate the expected life of our stock options using the weighted average life between the dates that options become fully

vested and the maximum life of options granted.

The risk-free interest rate is based on the U.S.

Treasury zero-coupon yield curve

on the grant date for a maturity similar to the expected life of the options.

The dividend rate is based on our historical rate,

which we anticipate to remain at zero.

The assumptions used in calculating the fair value of stock options represent our best estimates,

however these estimates involve inherent uncertainties and the application of management judgment.

As a result, if factors change

and different assumptions are used, the stock-based compensation expense could be materially different in the future.

we only recognize expense for those stock options expected to vest over the service period.

We have issued common stock warrants in

connection with the execution of certain equity financings.

The fair value of certain warrants, deemed to be derivative instruments,

is recorded as a derivative liability under the provisions of Financial Accounting Standards Board (FASB) Accounting Standards

Codification (ASC) 815, Derivatives and Hedging (“ASC 815”), upon issuance.

Subsequently, the liability is adjusted

to fair value as of each reporting period and the changes in fair value of derivative liabilities are recorded in the consolidated

statement of operations under the caption “Change in fair value of warrant liability.”

The fair value of warrants deemed to be

derivative instruments is determined using Monte Carlo simulations using varying assumptions regarding volatility of our common

share price, remaining life of the warrant and risk-free interest rates at each period end.

We thus use model-derived valuations

where significant value drivers are unobservable to third parties to determine the fair value and accordingly classify such warrants

as Level 3 per ASC 820, Fair Value Measurement (Topic 820).

In 2020 and 2019, the Monte Carlo simulations were not used

as the value of the warrants were deemed to be minimal based on the historical fair value of the warrants and the Company’s

current stock price.

Research and Development Costs

We expense research and development costs

associated with developmental products not yet approved by the FDA to research and development expense as incurred.

development costs consist primarily of license fees (including upfront payments), milestone payments, manufacturing costs,

salaries, stock-based compensation and related employee costs, fees paid to consultants and outside service providers for laboratory

development, legal expenses resulting from intellectual property prosecution and other expenses relating to the design, development,

testing and enhancement of our product candidates.

Research and development expenses include external contract research organization

(“CRO”) services.

We make payments to the CROs based on agreed upon terms and may include payments in advance of study

We review and accrue CRO expenses based on services performed and rely on estimates of those costs applicable to the

stage of completion of study as provided by the CRO.

Accrued CRO costs are subject to revisions as such studies progress to completion.

At December 31, 2020 and 2019, we have accrued CRO expenses of $0.7 million that are included in accrued expenses.

As of December 31,

2020, and 2019, we have prepaid CRO costs of $470,000 and $48,000, respectively.

Results of Operations

Years Ended December 31, 2020

General and Administrative Expenses

General and administrative expenses increased

to $5.0 million for the year ended December 31, 2020, from $4.6 million for the year ended December 31, 2019.

This increase

of 8.7% is due to increased legal costs related to business development, patent execution, employee contract matters, vacation

expense, insurance costs and registration fees.

The charge relating to stock-based compensation expense was $0.3 million for the

year ended December 31, 2020, compared to $0.3 million for the year ended December 31, 2019.

Research and Development Expenses

Research and development expenses

decreased to $5.1 million for the year ended December 31, 2020, from $11.1 million for the year ended December 31,

This decrease of 54.1% is primarily due to a reduction in preclinical and manufacturing activity of SYN-020 IAP and

the result of the response to the global COVID-19 pandemic by our clinical development partners which led to the

postponement of the Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients and the SYN-010 clinical

trial and to a lesser extent the discontinuation of the Phase 2b investigator sponsored clinical trial of SYN-010.

development expenses also include a charge relating to non-cash stock-based compensation expense of $66,000 for the year

ended December 31, 2020, compared to $75,000 for the year ended December 31, 2019.

The following table sets forth our research

and development expenses directly related to our therapeutic areas for the years ended December 31, 2020 and 2019.

expenses were external costs associated with preclinical studies and clinical trials.

Indirect research and development costs related

to employee costs, facilities, manufacturing, stock-based compensation and research and development support services are not directly

allocated to specific drug candidates.

Therapeutic Areas

(in thousands)

Other therapeutic areas

Total direct costs

Total indirect costs

Total Research and development

Total Other Income

Total other income was $44,000 for the

year ended December 31, 2020, compared to other income of $283,000 for the year ended December 31, 2019.

income for the year ended December 31, 2020 and 2019 is primarily comprised of interest income from investments.

Our net loss for the year ended December 31,

2020 was $10.1 million, or $0.66 per common share, compared to $15.4 million, or $0.98 per common share for the year ended December 31,

Net loss attributable to common stockholders for the year ended December 31, 2020 excludes net loss attributable to

non-controlling interest of $73,000 and includes the accretion of the Series B preferred stock deemed dividends of $1.4 million

on converted shares and Series A preferred stock accrued dividends of $254,000.

Net loss attributable to common stockholders

for the year ended December 31, 2019 excludes net loss attributable to non-controlling interest of $77,000 and includes the

accretion of the Series B preferred stock deemed dividends of $524,000 on converted shares and Series A preferred stock

accrued dividends of $248,000.

Liquidity and Capital Resources

With the exception of the three months

ended June 30, 2010 and the three months ended December 31, 2017, we have experienced significant losses since inception,

incurred negative cash flows from operations, and have a significant accumulated deficit.

We have incurred an accumulated deficit

of $248.1 million as of December 31, 2020 and expect to continue to incur losses in the foreseeable future.

Our cash and cash equivalents totaled $6.2

million as of December 31, 2020, a decrease of $8.8 million from December 31, 2019.

During the year ended December 31,

2020, the primary use of cash was for working capital requirements and operating activities which resulted in a net loss of $10.1

million for the year ended December 31, 2020.

Subsequent to year end through March 3, 2021, we have raised approximately $71.8

million from cash received via the exercise of the 2018 Warrants and sales of our common stock through the Original ATM Sales Agreement

and the Amended and Restated ATM Sales Agreement.

With the cash available in early March 2021 of $72.6 million, we believe these

resources will be sufficient to fund our operations through at least the end of the first quarter of 2023.

As a result of the global COVID-19

pandemic, management was able to extend the Company’s cash runway in 2020 since our clinical development partners (CSMC

and Washington University) reduced their operating capacity to include only essential activities as part of their response to

the pandemic.

These delays impacted the timelines for our clinical programs, which included delaying commencement of the

Phase 1b/2a clinical trial of SYN-004, as well as a temporary halting of enrollment for the since discontinued clinical trial

If enrollment in our ongoing Phase 1b/2a clinical trial being conducted by Washington University is further

postponed due to COVID-19 developments, we expect to continue to experience reduced expenses until such time as enrollment

On September 30, 2020, CSMC agreed to discontinue the ongoing Phase 2b investigator-sponsored clinical study of

SYN-010 following the results of a planned interim futility analysis.

Although it was concluded that SYN-010 was well

tolerated, it was also concluded that SYN-010 is unlikely to meet its primary endpoint by the time enrollment is

Although we are experiencing limited, if

any, adverse impact to our financial stability stemming from the global economic slowdown, the overall disruption of global healthcare

systems and other risks and uncertainties associated with the COVID-19 pandemic, including uncertainty regarding our clinical timelines,

our business, financial condition, results of operations and growth prospects could be materially adversely affected.

Historically, we have financed our operations

primarily through public and private sales of our securities, and we expect to continue to seek and obtain additional capital in

a similar manner.

During the year ended December 31, 2020, our only source of financing other than warrant exercises was from

sales of 9.2 million shares of our common stock utilizing our at-the-market offering program through the Original ATM Sales

Agreement pursuant to which we received net proceeds of approximately $3.4 million.

Subsequent to year end through March 3, 2021,

the Company sold approximately 76.3 million shares of the Company’s common stock for net proceeds of approximately $63.8

million pursuant to the Original ATM Sales Agreement and the Amended and Restated ATM Sales Agreement.

During the year ended

December 31, 2019, we did not engage in financing activities as capital raised via a public offering of our common stock

during the year ended December 31, 2018 was sufficient to satisfy our cash needs in 2019 and 2020.

The Amended and

Restated ATM Sales Agreement enables us to offer and sell shares of our common stock from time to time through B Riley and

AGP as our sales agents.

Sales of common stock under the Amended and Restated ATM Sales Agreement are made in sales deemed to

be an “at the market offering”

as defined in Rule 415 promulgated under the Securities Act.

B Riley and AGP

are entitled to receive a commission rate of up to 3.0% of gross sales in connection with the sale of our common stock sold

on our behalf.

There can be no assurance that we will

be able to continue to raise funds through the sale of shares of common stock through the Amended and Restated ATM Sales Agreement.

If we raise funds by selling additional shares of common stock or other securities convertible into common stock, the ownership

interest of our existing stockholders will be diluted.

If we are not able to obtain funding for future clinical trials when needed,

we will be unable to carry out our business plan and we will be forced to delay the initiation of future clinical trials until

such time as we obtain adequate financing.

We have committed, and expect to continue

to commit, substantial capital in order to implement our business strategy, including our planned product development efforts,

preparation for our planned clinical trials, and performance of clinical trials and our research and discovery efforts.

our cash position of $72.6 million in early March 2021 is sufficient to fund our operations through at least the end of the

first quarter of 2023, including continuation of our ongoing Phase 1b/2a clinical study of SYN-004 (ribaxamase) in allogeneic HCT

recipients for the prevention of aGVHD, as well as our planned Phase 1 and Phase 2s clinical programs for SYN-020.

Following the anticipated completion of

our ongoing Phase 1b/2a clinical study of SYN-004 (ribaxamase) in allogeneic HCT recipients, the planned Phase 1 SAD and MAD studies

and planned Phase 2a clinical trial of SYN-020, we will need to obtain additional funds for future clinical trials.

We anticipate

that our future clinical trials will be much larger in size and require larger cash expenditures than the aforementioned clinical

We do not have any committed sources of financing for future clinical trials 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.

As the COVID-19 coronavirus continues to

spread around the globe, we have experienced disruptions that impacted our business and clinical trials, including halting the

enrollment of new patients in our ongoing Phase 2b investigator-sponsored clinical trial of SYN-010 clinical study and postponement

of clinical site initiation of the Phase 1b/2a clinical trial of SYN-004.

The full impact of the COVID-19 outbreak continues to

evolve as of the date of this report.

As such, it is uncertain as to the full magnitude that the pandemic will have on our financial

condition, liquidity, and future results of operations.

We are actively monitoring the global situation and its potential impact

on our financial condition, liquidity, operations, suppliers, industry, and workforce.

Given the daily evolution of the COVID-19

outbreak and the global responses to curb its spread, we are not able to estimate the future effects of the COVID-19 outbreak on

our results of operations, financial condition, or liquidity.

License and Contractual Agreement Obligations

We have entered into several license and

collaborative agreements for the right to use research, technology and patents.

Some of these license and collaborative agreements

may contain milestones.

The specific timing of such milestones cannot be predicted and are dependent on future developments as

well as regulatory actions which cannot be predicted with certainty (including actions which may never occur).

Further, under the

terms of certain licensing agreements, we may have the obligation to pay certain milestones contingent upon the achievement of

specific levels of sales.

Off-Balance Sheet Arrangements

During the years ended December 31,

2020 and 2019, we did not have, and we do not currently have, any off-balance sheet arrangements, as defined under SEC rules.

Contractual Obligations

We are a smaller reporting company as defined

by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.

Consulting Fees

In November 2017, we engaged a regulatory

consultant to assist in our efforts to prepare, file and obtain FDA approval for ribaxamase.

The term of the engagement was

on a monthly basis, provided that either party may terminate the agreement at any time by providing the other party a six-month

notice period.

We are obligated to pay the consultant a monthly retainer in addition to the success fee payments of up to an aggregate

of $4,500,000 for attainment of certain regulatory milestones.

We do not deem the contingent fee is probable at this time.

and Qualitative Disclosures About Market Risk

The Company is a smaller reporting company

as defined by Rule 12b-2 of the Exchange Act and is not required to provide the information required under this item.

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 5. Market for Registrant’s Common Equity