What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2021-11-03 compared with 2021-08-05 · 68 added, 60 removed, 193 unchanged (40% of the section changed)

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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 HCT patients, and advancing the clinical development program for SYN-020 intestinal alkaline phosphatase (IAP) in multiple potential indications.

In the meantime, we remain focused on working with our clinical development partners to complete the ongoing Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic 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.

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FDA to conduct a Phase 1 single ascending dose (“SAD”) study in healthy volunteers, designed to evaluate SYN-020 for safety, tolerability, and pharmacokinetic parameters (Q3 2020)

Announced enrollment commenced and three out of a total of four cohorts have been dosed in a Phase 1SAD study of SYN-020 (Q2 2021)

Announced that patient enrollment, dosing and observation has been completed in the Phase 1, open label, SAD clinical trial.

Commenced enrollment, dosing and observation in a Phase 1 SAD study of SYN-020 (Q2 2021)

Announced that enrollment, dosing and observation has been completed in the Phase 1, open label, SAD clinical trial.

Analyses of preliminary data demonstrated SYN-020 maintained a favorable safety profile and was well tolerated at all dose levels (Q2 2021)

Commenced enrollment, dosing and observation in a Phase 1, multiple ascending dose (“MAD”) clinical trial of SYN-020 in healthy, adult volunteers (Q3 2021).

A data readout is anticipated during the second quarter of 2022

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

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On April 14, 2021, we announced that enrollment has commenced and the first patient of the first antibiotic cohort of this study had been dosed.

If enrollment proceeds as planned, a data readout for the first cohort is anticipated in Q4 2021.

At this time, enrollment remains ongoing and a data readout for the first antibiotic cohort is anticipated in Q1 2022.

Due to the unique challenges posed by the global COVID-19 pandemic, Washington University continues to evaluate non-essential activities which may have a direct impact on planned and ongoing clinical trials.

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Based on the known mechanisms as well as our own supporting animal model data, we intended to initially develop SYN-020 to mitigate the intestinal damage caused by radiation therapy that is routinely used to treat pelvic cancers.

And, while we believe SYN-020 may play a pivotal role in addressing acute and long-term complications associated with radiation exposure to the GI tract, we have also begun planning to develop SYN-020 in indications that may offer a more accelerated or streamlined pathway to registration while also addressing significant unmet medical needs.

While we believe SYN-020 may play a pivotal role in addressing acute and long-term complications associated with radiation exposure to the GI tract, we have also begun planning to develop SYN-020 in indications that may offer a more accelerated or streamlined pathway to registration while also addressing significant unmet medical needs.

Such indications include celiac disease, non-alcoholic fatty liver disease (“NAFLD”), and indications to treat and prevent metabolic and inflammatory disorders associated with aging which are supported by our collaboration with Massachusetts General Hospital (“MGH”).

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The SAD study enrolled 6 healthy adult volunteers into each of four cohorts with SYN-020 given orally as single doses ranging from 5 mg to 150 mg.

Analyses of preliminary data demonstrated that SYN-020 maintained a favorable safety profile, was well tolerated at all dose levels, and no adverse events were attributed to study drug.

Analyses of preliminary data demonstrated that SYN-020 maintained a favorable safety profile, was well tolerated at all dose levels, and no adverse events were attributed to the study drug.

No serious adverse events were reported.

Additional data from this clinical trial is expected during the third quarter of 2021.

Planning for a second Phase 1 study evaluating multiple-ascending doses (“MAD”) of SYN-020 is also underway and participant screening is anticipated to commence during the third quarter of 2021.

A topline data readout of the Phase 1 MAD clinical study is anticipated during the second quarter of 2022, pandemic conditions permitting.

During the third quarter of 2021 we initiated a Phase 1 clinical study evaluating multiple ascending doses (“MAD”) of SYN-020.

On October 21, 2021 we announced that patient enrollment, dosing and observation commenced in the Phase 1 MAD of SYN-020.

The ongoing Phase 1, placebo-controlled MAD study is intended to evaluate the safety, tolerability and biodistribution of SYN-020 upon repeated dosing and is expected to enroll 8 healthy adult volunteers into each of four cohorts (32 total study participants) with SYN-020 given orally twice daily for fourteen days as multiple ascending doses ranging from 5 mg to 75 mg.

A safety review will be conducted at the end of each cohort to determine whether progression into the next higher dose cohort is permissible.

At this time, the first cohort of 8 study participants is nearing completion and dosing of the second cohort of 8 study participants is expected to begin shortly thereafter, pending a safety review A topline data readout of the Phase 1 MAD clinical study is anticipated during the second quarter of 2022, pandemic conditions permitting.

Both studies are intended to support the development of SYN-020 in multiple potential clinical indications including celiac disease, NAFLD, radiation enteritis, as well as indications supported by our collaboration with Massachusetts General Hospital.

Following the completion of Phase 1 safety studies, we may consider conducting a placebo-controlled Phase 1b/2a gluten challenge study in as many as 40 celiac patients who present with predominantly GI symptoms followed by a Phase 2b proof-of-concept clinical trial in a similar patient population.

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During the second quarter of 2021, we announced an amendment to our option for an exclusive license agreement with MGH to include intellectual property and technology related to the use of SYN-020 to inhibit liver fibrosis in select diseases, including NAFLD.

Research published by a team of investigators led by Richard Hodin, MD, Chief of the Massachusetts General Hospital Division of General and Gastrointestinal Surgery and Professor of Surgery, Harvard Medical School, evaluated long-term oral supplementation of IAP, including SYN-020, in mice.

oral supplementation of IAP, including SYN-020, in mice.

Hodin’s research demonstrated that IAP administration, starting at 10 months of age, slowed the microbiome changes, gut-barrier dysfunction, and gastrointestinal and systemic inflammation that normally accompany aging.

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Results of Operations

Three Months Ended June 30, 2021 and 2020

Three Months Ended September 30, 2021 and 2020

General and Administrative Expenses

General and administrative expenses decreased by 2% to approximately $1.26 million for the three months ended June 30, 2021, from approximately $1.29 million for the three months ended June 30, 2020.

This decrease is primarily due to lower legal costs and vacation expense offset by higher insurance costs, audit fees and registration fees.

The charge related to stock-based compensation expense was $83,000 for the three months ended June 30, 2021, compared to $67,000 for the three months ended June 30, 2020.

General and administrative expenses increased by 9% to approximately $1.3 million for the three months ended September 30, 2021, from approximately $1.2 million for the three months ended September 30, 2020.

This increase is primarily due to higher insurance costs, audit fees and registration fees offset by lower legal costs and vacation expense.

The charge related to stock-based compensation expense was $83,000 for the three months ended September 30, 2021, compared to $67,000 for the three months ended September 30, 2020.

Research and Development Expenses

Research and development expenses increased by 21% to approximately $1.9 million for the three months ended June 30, 2021, from approximately $1.6 million for the three months ended June 30, 2020.

This increase is primarily the result of increased clinical trial expenses as we began dosing patients in the Phase 1b/2a clinical trial of SYN-004 and Phase 1 SAD clinical trial of SYN-020 during the three months ended June 30, 2021, offset by lower indirect program costs for the three months ended June 30, 2021, including salary and related expense reductions, a decrease in manufacturing costs for SYN-020 and market research.

In addition, as a result of the global COVID-19 pandemic, our clinical development partner (Washington University) reduced their operating capacity during 2020 to include only essential activities as part of their pandemic response, which delayed the start of our clinical trial until 2021.

Research and development expenses increased by 116% to approximately $2.0 million for the three months ended September 30, 2021, from approximately $900,000 for the three months ended September 30, 2020.

This increase is primarily the result of increased clinical trial expenses as we continued dosing patients in the Phase 1b/2a clinical trial of SYN-004 and by higher indirect program costs for the three months ended September 30, 2021, including an increase in manufacturing costs for SYN-020.

We anticipate research and development expense to increase as our ongoing clinical trials continue to enroll patients.

The charge related to stock-based compensation expense was $19,000 for the three months ended June 30, 2021, compared to $19,000 related to stock-based compensation expense for the three months ended June 30, 2020.

The following table sets forth our research and development expenses directly related to our therapeutic areas for the three months ended June 30, 2021 and 2020.

The charge related to stock-based compensation expense was $19,000 for the three months ended September 30, 2021, compared to $15,000 related to stock-based compensation expense for the three months ended September 30, 2020.

The following table sets forth our research and development expenses directly related to our therapeutic areas for the three months ended September 30, 2021 and 2020.

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

Indirect research and development expenses related to employee costs, facilities, stock-based compensation and research and development support services that are not directly allocated to specific drug candidates.

September 30,

Therapeutic Areas

Ribaxamase (SYN-004)

Total direct costs

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Other Income/Expense

Other income was $2,000 for the three months ended June 30, 2021, compared to other income of $6,000 for the three months ended June 30, 2020.

Other income for the three months ended June 30, 2021 and 2020 is primarily comprised of interest income.

Other income was $2,000 for the three months ended September 30, 2021, compared to other income of $134 for the three months ended September 30, 2020.

Other income for the three months ended September 30, 2021 and 2020 is primarily comprised of interest income.

Net Loss Attributable to Common Stockholders

Our net loss attributable to common stockholders was approximately $3.2 million, or $0.02 per basic and dilutive common share for the three months ended June 30, 2021, compared to a net loss of approximately $3.3 million, or $0.18 per basic common share and dilutive common share for the three months ended June 30, 2020.

Net loss attributable to common stockholders for the three months ended June 30, 2020 excludes net loss attributable to non-controlling interest of $16,000 and includes the accretion of Series B preferred discount of $392,000 on converted shares and Series A Preferred Stock accrued dividends of $63,000.

Six Months Ended June 30, 2021 and 2020

Our net loss attributable to common stockholders was approximately $3.3 million, or $0.02 per basic and dilutive common share for the three months ended September 30, 2021, compared to a net loss of approximately $2.7 million, or $0.14 per basic common share and dilutive common share for the three months ended September 30, 2020.

Net loss attributable to common stockholders for the three months ended September 30, 2020 excludes net loss attributable to non-controlling interest of $8,000 and includes the accretion of Series B preferred discount of $519,000 on converted shares and Series A Preferred Stock accrued dividends of $64,000.

Nine Months Ended September 30, 2021 and 2020

General and Administrative Expenses

General and administrative expenses for the six months ended June 30, 2021 of $2.69 million were relatively unchanged from six months ended June 30, 2020.

The movement for the period primarily consisted of decreased legal costs related to business development, patent execution and employee contract matters, vacation expense and travel, offset by insurance costs, audit fees and registration fees.

The charge related to stock-based compensation expense was $165,000 for the six months ended June 30, 2021, compared to $132,000 for the six months ended June 30, 2020.

General and administrative expenses increased by 3% to approximately $4.0 million for the nine months ended September 30, 2021, from approximately $3.9 million for the nine months ended September 30, 2020.

The movement for the period primarily consisted of increased insurance costs, audit fees and registration fees offset by lower legal costs related to business development, patent execution and employee contract matters, vacation expense and travel.

The charge related to stock-based compensation expense was $248,000 for the nine months ended September 30, 2021, compared to $193,000 for the nine months ended September 30, 2020.

Research and Development Expenses

Research and development expenses decreased by 6% to $3.0 million for the six months ended June 30, 2021, from $3.2 million for the six months ended June 30, 2020.

This decrease is primarily the result of lower indirect program costs for the six months ended June 30, 2021, including salary and related expense reductions, a decrease in manufacturing costs for SYN-020 and market research offset by increased clinical trial expenses as we began dosing patients in the Phase 1b/2a clinical trial of SYN-004 and Phase 1 SAD clinical trial of SYN-020.

Research and development expenses increased by 21% to $5.0 million for the nine months ended September 30, 2021, from $4.1 million for the nine months ended September 30, 2020.

This increase is primarily the result of the clinical trial expenses as we began dosing patients in the Phase 1b/2a clinical trial of SYN-004 and Phase 1 SAD clinical trial of SYN-020 offset by lower indirect program costs for the nine months ended September 30, 2021, including salary and related expense reductions, a decrease in clinical contract service costs for SYN-004 and market research.

We anticipate research and development expense to increase as our ongoing clinical trials continue to enroll patients.

Research and development expenses also include a charge relating to stock-based compensation expense of $38,000 for the six months ended June 30, 2021, compared to $37,000 for the six months ended June 30, 2020.

The following table sets forth our research and development expenses directly related to our therapeutic areas for the six months ended June 30, 2021 and 2020.

Research and development expenses also include a charge relating to stock-based compensation expense of $57,000 for the nine months ended September 30, 2021, compared to $52,000 for the nine months ended September 30, 2020.

The following table sets forth our research and development expenses directly related to our therapeutic areas for the nine months ended September 30, 2021 and 2020.

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

September 30,

Therapeutic Areas

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Other Income/Expense

Other income was $2,000 for the six months ended June 30, 2021, compared to other income of $44,000 for the six months ended June 30, 2020.

Other income for the six months ended June 30, 2021 and 2020 is primarily comprised of interest income.

Other income was $4,000 for the nine months ended September 30, 2021, compared to other income of $44,000 for the nine months ended September 30, 2020.

Other income for the nine months ended September 30, 2021 and 2020 is primarily comprised of interest income.

Net Loss Attributable to Common Stockholders

Our net loss attributable to common stockholders was approximately $5.7 million, or $0.13 per basic and dilutive common share for the six months ended June 30, 2021, compared to a net loss of approximately $5.8 million, or $0.38 per basic common share and dilutive common share for the six months ended June 30, 2020.

Net loss attributable to common stockholders for the six months ended June 30, 2021 excludes net loss attributable to non-controlling interest of $1,000 and includes the accretion of the Series B preferred discount of $1.5 million on converted shares, Series A Preferred Stock accrued dividends of $24,000 and the deemed dividend for the effect of the Series A preferred shares price adjustment of

$7.4 million.

Net loss attributable to common stockholders for the six months ended June 30, 2020 excludes net loss attributable to non-controlling interest of $42,000 and includes the accretion of Series B preferred discount of $796,000 on converted shares and Series A Preferred Stock accrued dividends of $125,000.

Our net loss attributable to common stockholders was approximately $17.9 million, or $0.15 per basic and dilutive common share for the nine months ended September 30, 2021, compared to a net loss of approximately $9.4 million, or $0.52 per basic common share and dilutive common share for the nine months ended September 30, 2020.

Net loss attributable to common stockholders for the nine months ended September 30, 2021 excludes net loss attributable to non-controlling interest of $1,000 and includes the accretion of the Series B preferred discount of $1.5 million on converted shares, Series A Preferred Stock accrued dividends of $24,000 and the deemed dividend for the effect of the Series A preferred shares price adjustment of $7.4 million.

Net loss attributable to common stockholders for the nine months ended September 30, 2020 excludes net loss attributable to non-controlling interest of $50,000 and includes the accretion of Series B preferred discount of $1.3 million on converted shares and Series A Preferred Stock accrued dividends of $189,000.

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 $262.7 million as of June 30, 2021 and expect to continue to incur losses in the foreseeable future.

During the six months ended June 30, 2021, our operating activities used net cash of approximately $5.9 million.

Our cash and cash equivalents totaled $74.3 million as of June 30, 2021, an increase of $68.1 million from December 31, 2020.

During the three and six months ended June 30, 2021, the primary use of cash was for working capital requirements and operating activities which resulted in a net loss of $3.2 million and 5.7 million for the three and six months ended June 30, 2021, respectively.

During the six months ended June 30, 2021, we raised approximately $74.0 million from cash received via the exercise of approximately 65% of the 2018 Warrants and sales of our common stock in “at the market” offerings pursuant to the Sales Agreement that we had entered into in 2016 with FBR Capital Markets & Co.

We have incurred an accumulated deficit of approximately $266 million as of September 30, 2021 and expect to continue to incur losses in the foreseeable future.

During the nine months ended September 30, 2021, our operating activities used net cash of approximately $8.1 million.

Our cash and cash equivalents totaled approximately $72.1 million as of September 30, 2021, an increase of approximately $65.9 million from December 31, 2020.

During the three and nine months ended September 30, 2021, the primary use of cash was for working capital requirements and operating activities which resulted in a net loss of approximately $3.3 million and approximately $9.0 million for the three and nine months ended September 30, 2021, respectively.

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 was from sales of approximately 9.2 million shares of our common stock utilizing our at-the-market offering program through the Original ATM Sales Agreement (as defined below) pursuant to which we received net proceeds of approximately $3.4 million.

During the nine months ended September 30, 2021, we raised approximately $74.0 million, of which (i) approximately $8.0 million was raised from cash received from the issuance of approximately 11.6 million shares of our common stock upon the exercise of approximately 65% of the 2018 Warrants during the three months ended March 31, 2021 and (ii) approximately $66.0 million of net proceeds was raised from the sale of approximately 78.7 million shares of our common stock during the three months ended March 31, 2021 in “at the market” offerings pursuant to the Sales Agreement that we had entered into in 2016 with FBR Capital Markets & Co.

(now known as B.

Riley Securities) (the “Original ATM Sales Agreement”) and the Amended and Restated ATM Sales Agreement.

During the three months ended June 30, 2021 we did not sell any of our common stock through the Original ATM Sales Agreement and the Amended and Restated ATM Sales Agreement.

We believe that our cash and cash equivalents at June 30, 2021 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, our clinical development partner (Washington University) reduced their operating capacity during 2020 and the first quarter of 2021 to include only essential activities as part of their pandemic response.

These delays impacted the timelines for our clinical programs, which included delaying commencement of the Phase 1b/2a clinical trial of SYN-004 until the second quarter of 2021.

These delays also resulted in a decrease in anticipated expenses as no clinical trials had yet commenced during that period.

If enrollment in our ongoing Phase 1b/2a clinical trial being conducted by Washington University is halted due to COVID-19 developments, we may experience reduced expenses until such time as enrollment resumes.

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 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.

During the six months ended June 30, 2021, we received proceeds of approximately $8.0 million from the cash exercise of approximately 11.6 million of our 2018 warrants and sold approximately 78.7 million shares of our common stock for net proceeds of approximately $66.0 million pursuant to the Original ATM Sales Agreement and the Amended and Restated ATM Sales Agreement, all of which were received during the three months ended March 31, 2021.

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.

During the three months ended September 30, 2021, we did not sell any of our common stock through the Original ATM Sales Agreement and the Amended and Restated ATM Sales Agreement.

We believe that our cash and cash equivalents at September 30, 2021 will be sufficient to fund our operations through at least the end of the first quarter of 2023.

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.

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.

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.

We believe our cash position of $74.3 million as of June 30, 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 ongoing Phase 1 SAD study and planned Phase 1 MAD study and Phase 2 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 ongoing Phase 1 SAD and planned MAD studies and planned Phase 2a clinical trial of SYN-020, we may need to obtain additional funds for future clinical trials, the amount of which will depend upon the trial size and number of clinical sites.

We believe our cash position of $72.1 million as of September 30, 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 ongoing Phase 1 MAD study and Phase 2 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 ongoing Phase 1 MAD study and planned Phase 2a clinical trial of SYN-020, we may need to obtain additional funds for future clinical trials, the amount of which will depend upon the trial size and number of clinical sites.

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

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.

These delays impacted the timelines for our clinical programs, which included delaying commencement of the Phase 1b/2a clinical trial of SYN-004 until the second quarter of 2021.

These delays also resulted in a decrease in anticipated expenses as no clinical trials had yet commenced during that period.

As the COVID-19 coronavirus continues to spread around the globe, we have experienced disruptions that impacted our business and clinical trials, including postponement of commencement of the now ongoing Phase 1b/2a clinical trial of SYN-004.

Although we are currently 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.

The full impact of the COVID-19 outbreak continues to evolve as of the date of this report.

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Off-Balance Sheet Arrangements

During the three and six months ended June 30, 2021, we did not have, and we do not currently have, any off-balance sheet arrangements, as defined under SEC rules.

During the three and nine months ended September 30, 2021, we did not have, and we do not currently have, any off-balance sheet arrangements, as defined under SEC rules.

Contractual Obligations

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ROU assets are included in other noncurrent assets and lease liabilities are included in other current and non-current liabilities in our condensed consolidated balance sheets.

As of June 30, 2021, we did not have any material finance leases.

As of September 30, 2021, we did not have any material finance leases.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis