2019 Q4 Form 10-Q Financial Statement

#000148500319000090 Filed on November 12, 2019

View on sec.gov

Income Statement

Concept 2019 Q4 2019 Q3 2018 Q3
Revenue $0.00 $0.00 $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $3.300M $3.240M $3.830M
YoY Change -5.71% -15.4% 134.97%
% of Gross Profit
Research & Development $5.420M $6.613M $3.372M
YoY Change 16.06% 96.12% -6.83%
% of Gross Profit
Depreciation & Amortization $60.00K $50.00K $60.00K
YoY Change 20.0% -16.67% 20.0%
% of Gross Profit
Operating Expenses $33.74M $13.45M $14.40M
YoY Change 377.47% -6.57% 57.34%
Operating Profit -$33.74M -$13.45M -$14.40M
YoY Change 377.47% -6.57% 57.34%
Interest Expense
YoY Change
% of Operating Profit
Other Income/Expense, Net $190.0K $319.0K $382.0K
YoY Change -38.71% -16.49% 748.89%
Pretax Income -$33.55M -$13.13M -$14.02M
YoY Change 396.3% -6.35% 53.9%
Income Tax $0.00
% Of Pretax Income
Net Earnings -$33.55M -$13.13M -$14.02M
YoY Change 396.57% -6.3% 53.93%
Net Earnings / Revenue
Basic Earnings Per Share
Diluted Earnings Per Share -$322.6K -$129.7K -$182.0K
COMMON SHARES
Basic Shares Outstanding 104.7M shares 101.3M shares 77.01M shares
Diluted Shares Outstanding

Balance Sheet

Concept 2019 Q4 2019 Q3 2018 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $48.10M $57.90M $57.90M
YoY Change -4.56% 0.0% 412.39%
Cash & Equivalents $48.12M $57.90M $57.86M
Short-Term Investments
Other Short-Term Assets $6.300M $1.500M $1.500M
YoY Change 384.62% 0.0% 87.5%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $54.45M $59.41M $59.39M
YoY Change 5.2% 0.05% 390.46%
LONG-TERM ASSETS
Property, Plant & Equipment $238.0K $294.0K $365.0K
YoY Change -25.86% -19.45% -37.61%
Goodwill $13.10M $13.06M $13.06M
YoY Change 0.28% 0.0% 0.0%
Intangibles $46.40M $46.40M $46.40M
YoY Change 0.0% 0.0% 0.0%
Long-Term Investments
YoY Change
Other Assets $196.0K $208.0K $61.00K
YoY Change 240.98% -39.6%
Total Long-Term Assets $59.92M $59.99M $59.91M
YoY Change 0.19% 0.13% -0.42%
TOTAL ASSETS
Total Short-Term Assets $54.45M $59.41M $59.39M
Total Long-Term Assets $59.92M $59.99M $59.91M
Total Assets $114.4M $119.4M $119.3M
YoY Change 2.51% 0.09% 65.07%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $1.902M $2.583M $1.391M
YoY Change 39.14% 85.69% 1.83%
Accrued Expenses $6.169M $6.350M $5.170M
YoY Change 29.98% 22.82% 77.36%
Deferred Revenue $0.00
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $8.517M $9.092M $6.561M
YoY Change 39.33% 38.58% 48.98%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change
Other Long-Term Liabilities $0.00 $311.0K $311.0K
YoY Change -100.0% 0.0% 82.94%
Total Long-Term Liabilities $0.00 $311.0K $311.0K
YoY Change -100.0% 0.0% 82.94%
TOTAL LIABILITIES
Total Short-Term Liabilities $8.517M $9.092M $6.561M
Total Long-Term Liabilities $0.00 $311.0K $311.0K
Total Liabilities $141.1M $116.9M $6.872M
YoY Change 109.44% 1601.56% 50.24%
SHAREHOLDERS EQUITY
Retained Earnings -$293.5M -$260.0M -$179.3M
YoY Change 57.79% 44.99% 22.98%
Common Stock $107.0K $101.0K $77.00K
YoY Change 38.96% 31.17% 208.0%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity -$26.70M $2.467M $50.40M
YoY Change
Total Liabilities & Shareholders Equity $114.4M $119.4M $119.3M
YoY Change 2.51% 0.09% 65.07%

Cashflow Statement

Concept 2019 Q4 2019 Q3 2018 Q3
OPERATING ACTIVITIES
Net Income -$33.55M -$13.13M -$14.02M
YoY Change 396.57% -6.3% 53.93%
Depreciation, Depletion And Amortization $60.00K $50.00K $60.00K
YoY Change 20.0% -16.67% 20.0%
Cash From Operating Activities -$13.80M -$6.980M -$5.200M
YoY Change 80.39% 34.23% 17.38%
INVESTING ACTIVITIES
Capital Expenditures $0.00 -$100.0K
YoY Change
Acquisitions
YoY Change
Other Investing Activities $0.00
YoY Change -100.0%
Cash From Investing Activities $0.00 -$100.0K $0.00
YoY Change -100.0% -100.0%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 4.060M 0.000 90.00K
YoY Change 1745.45% -100.0%
NET CHANGE
Cash From Operating Activities -13.80M -6.980M -5.200M
Cash From Investing Activities 0.000 -100.0K 0.000
Cash From Financing Activities 4.060M 0.000 90.00K
Net Change In Cash -9.740M -7.080M -5.110M
YoY Change 30.91% 38.55% 15.61%
FREE CASH FLOW
Cash From Operating Activities -$13.80M -$6.980M -$5.200M
Capital Expenditures $0.00 -$100.0K
Free Cash Flow -$13.80M -$6.880M
YoY Change 80.39%

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us-gaap Other Nonoperating Income Expense
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us-gaap Proceeds From Warrant Exercises
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CY2018Q3 us-gaap Research And Development Expense
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us-gaap Research And Development Expense
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us-gaap Research And Development Expense
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CY2018Q3 us-gaap Revenues
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CY2019Q3 us-gaap Revenues
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25600000 shares
CY2019Q2 us-gaap Sale Of Stock Number Of Shares Issued In Transaction
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0
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0.021
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1744000 shares
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2.42
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680000 USD
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3942000 shares
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6450000 shares
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2.12
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1.52
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1.50
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1.76
us-gaap Share Based Compensation Arrangements By Share Based Payment Award Options Grants In Period Weighted Average Exercise Price
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1.02
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CY2019Q3 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Exercisable Intrinsic Value1
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84000 USD
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CY2019Q3 us-gaap Short Term Lease Cost
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59000 USD
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188000 USD
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CY2018Q3 us-gaap Stock Issued During Period Value Employee Stock Purchase Plan
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CY2018Q3 us-gaap Stockholders Equity
StockholdersEquity
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us-gaap Weighted Average Number Of Share Outstanding Basic And Diluted
WeightedAverageNumberOfShareOutstandingBasicAndDiluted
56526000 shares
us-gaap Weighted Average Number Of Share Outstanding Basic And Diluted
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us-gaap Basis Of Accounting
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<div style="font-family:Times New Roman;font-size:10pt;"><div style="line-height:120%;padding-top:8px;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-weight:bold;">BASIS OF PRESENTATION</font></div><div style="line-height:120%;padding-top:8px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">The accompanying financial statements have been prepared in accordance with United States generally accepted accounting principles (&#8220;GAAP&#8221;). Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the ASC and Accounting Standards Updates (&#8220;ASUs&#8221;), promulgated by the Financial Accounting Standards Board (&#8220;FASB&#8221;).</font></div><div style="line-height:120%;padding-top:8px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-style:italic;">Interim Financial Statements</font></div><div style="line-height:120%;padding-top:8px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">The accompanying unaudited interim condensed consolidated financial statements have been prepared from the books and records of the Company in accordance with GAAP for interim financial information and Rule 10-01 of Regulation S-X promulgated by the United States Securities and Exchange Commission (&#8220;SEC&#8221;), which permit reduced disclosures for interim periods. All adjustments, consisting only of normal recurring adjustments, necessary for a fair presentation of the accompanying condensed consolidated balance sheets and statements of operations and comprehensive loss, stockholders&#8217; equity and cash flows have been made. Although these interim financial statements do not include all of the information and footnotes required for complete annual financial statements, management believes the disclosures are adequate to make the information presented not misleading. These unaudited interim results of operations and cash flows for the three and </font><font style="font-family:inherit;font-size:10pt;">nine months ended September 30, 2019</font><font style="font-family:inherit;font-size:10pt;"> are not necessarily indicative of the results that may be expected for the full year. These unaudited interim condensed consolidated financial statements and footnotes should be read in conjunction with the Company&#8217;s audited annual consolidated financial statements and footnotes included in its Annual Report on Form 10-K, as filed with the SEC on March 1, 2019, wherein a more complete discussion of significant accounting policies and certain other information can be found.</font></div><div style="line-height:120%;padding-top:8px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-style:italic;">Use of Estimates</font></div><div style="line-height:120%;padding-top:8px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">The preparation of financial statements in accordance with GAAP and the rules and regulations of the SEC requires the use of estimates and assumptions, based on judgments considered reasonable, which affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The Company bases its estimates and assumptions on historical experience, known trends and events and various other factors that management believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Although management believes its estimates and assumptions are reasonable when made, they are based upon information available at the time they are made. Management evaluates the estimates and assumptions on an ongoing basis and, if necessary, makes adjustments. Due to the risks and uncertainties involved in the Company&#8217;s business and evolving market conditions, and given the subjective element of the estimates and assumptions made, actual results may differ from estimated results. The most significant estimates and judgments impact the fair value of intangible assets, goodwill and contingent consideration; income taxes (including the valuation allowance for deferred tax assets); research and development expenses; and going concern considerations.</font></div><div style="line-height:120%;padding-top:8px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-style:italic;">Principles of Consolidation</font></div><div style="line-height:120%;padding-top:8px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">The Company&#8217;s consolidated financial statements include the accounts of the Company, its wholly owned subsidiary, Viventia Bio, Inc. ("Viventia"), and its indirect subsidiaries, Viventia Bio USA&#160;Inc. and Viventia Biotech (EU) Limited. All intercompany transactions and balances have been eliminated in consolidation. </font></div><div style="line-height:120%;padding-top:8px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-style:italic;">Foreign Currency Translation</font></div><div style="line-height:120%;padding-top:8px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">The functional currency of the Company and each of its subsidiaries is the U.S. dollar.</font></div><div style="line-height:120%;padding-top:8px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-style:italic;">Reclassifications</font></div><div style="line-height:120%;padding-top:8px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">On the Company's condensed consolidated statements of cash flows, proceeds from exercises of common stock warrants is now shown separately from proceeds from issuance of common stock and common stock warrants, net of issuance costs.</font></div></div>
us-gaap Nature Of Operations
NatureOfOperations
<div style="font-family:Times New Roman;font-size:10pt;"><div style="line-height:120%;padding-top:8px;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-weight:bold;">DESCRIPTION OF BUSINESS</font></div><div style="line-height:120%;padding-top:8px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">Sesen Bio, Inc. ("Sesen" or the &#8220;Company&#8221;), a Delaware corporation, is a late-stage clinical company developing targeted fusion protein therapeutics ("TFPTs") composed of an anti-cancer antibody fragment tethered to a protein toxin for the treatment of cancer. The Company genetically fuses the cancer-targeting antibody fragment and the cytotoxic protein payload into a single molecule which is produced through the Company's proprietary one-step, microbial manufacturing process. The Company targets tumor cell surface antigens with limited expression on normal cells. Binding of the target antigen by the TFPT allows for rapid internalization into the targeted cancer cell.&#160;The Company has designed its targeted fusion proteins to overcome the fundamental efficacy and safety challenges inherent in existing antibody-drug conjugates ("ADCs"), where a payload is chemically attached to a targeting antibody.</font></div><div style="line-height:120%;padding-top:8px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">The Company&#8217;s most advanced product candidate, VB4-845, also known as Vicinium&#174;, is a locally-administered targeted fusion protein composed of an anti-EpCAM, or epithelial cell adhesion molecule, antibody fragment tethered to a truncated form of Pseudomonas exotoxin A for the treatment of high-risk, non-muscle invasive bladder cancer ("NMIBC"). The Company has an ongoing single-arm, multi-center, open-label Phase 3 clinical trial of Vicinium as a monotherapy in patients with high-risk, bacillus Calmette-Gu&#233;rin ("BCG") unresponsive NMIBC, called the VISTA Trial. The VISTA Trial completed enrollment in April 2018 with a total of 133 patients, and the Company is continuing to collect and assess the trial data.</font></div><div style="line-height:120%;padding-top:12px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-style:italic;">Liquidity and Going Concern</font></div><div style="line-height:120%;padding-top:8px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">As of </font><font style="font-family:inherit;font-size:10pt;">September&#160;30, 2019</font><font style="font-family:inherit;font-size:10pt;">, the Company had cash and cash equivalents of $</font><font style="font-family:inherit;font-size:10pt;">57.9 million</font><font style="font-family:inherit;font-size:10pt;">, net working capital of $</font><font style="font-family:inherit;font-size:10pt;">50.3 million</font><font style="font-family:inherit;font-size:10pt;"> and an accumulated deficit of $</font><font style="font-family:inherit;font-size:10pt;">260.0 million</font><font style="font-family:inherit;font-size:10pt;">. The Company incurred negative cash flows from operating activities of </font><font style="font-family:inherit;font-size:10pt;">$22.8 million</font><font style="font-family:inherit;font-size:10pt;"> for the year ended December 31, 2018 and </font><font style="font-family:inherit;font-size:10pt;">$23.7 million</font><font style="font-family:inherit;font-size:10pt;"> for the </font><font style="font-family:inherit;font-size:10pt;">nine months ended September 30, 2019</font><font style="font-family:inherit;font-size:10pt;">. Since its inception, the Company has received no revenue from sales of its products currently under development, and management anticipates that operating losses will continue for the foreseeable future as the Company continues its ongoing Phase 3 clinical trial for Vicinium and seeks marketing approval from the United States Food and Drug Administration ("FDA"). The Company has financed its operations to date primarily through private placements of its common stock, preferred stock and convertible bridge notes, venture debt borrowings, its initial public offering ("IPO"), follow-on public offerings, sales effected in an "at-the-market" ("ATM") offering and a License Agreement with F. Hoffmann-La Roche Ltd and Hoffman-La Roche Inc. (collectively, "Roche") (the "License Agreement"). See &#8220;Note 8. Stockholders&#8217; Equity&#8221; below for information regarding the Company&#8217;s recently completed equity financings. </font></div><div style="line-height:120%;padding-top:8px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">Under Accounting Standards Codification ("ASC") Topic 205-40, </font><font style="font-family:inherit;font-size:10pt;font-style:italic;">Presentation of Financial Statements - Going Concern</font><font style="font-family:inherit;font-size:10pt;">, management is required at each reporting period to evaluate whether there are conditions and events, considered in the aggregate, that raise substantial doubt about an entity's ability to continue as a going concern within one year after the date that the financial statements are issued. This evaluation initially does not take into consideration the potential mitigating effect of management's plans that have not been fully implemented as of the date the financial statements are issued. When substantial doubt exists, management evaluates whether the mitigating effect of its plans sufficiently alleviates the substantial doubt about the Company's ability to continue as a going concern. The mitigating effect of management's plans, however, is only considered if both (i) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued and (ii) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity's ability to continue as a going concern within one year after the date that the financial statements are issued. Generally, to be considered probable of being effectively implemented, the plans must have been approved by the Company's Board of Directors before the date that the financial statements are issued. </font></div><div style="line-height:120%;padding-top:8px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">The Company's future success is dependent on its ability to develop its product candidates and ultimately upon its ability to attain profitable operations. In order to commercialize its product candidates, the Company needs to complete clinical development and comply with comprehensive regulatory requirements. The Company is subject to a number of risks similar to other late-stage clinical companies, including, but not limited to, successful discovery and development of its product candidates, raising additional capital, development by its competitors of new technological innovations, protection of proprietary technology and market acceptance of its products. The successful discovery and development of product candidates requires substantial working capital, and management expects to seek additional funds through equity or debt financings or through additional collaboration, licensing transactions or other sources. The Company may be unable to obtain equity or debt financings or enter into additional collaboration or licensing transactions at favorable terms, or at all. To the extent that the Company raises additional capital through the sale of equity or convertible debt securities, the ownership interests of existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of existing stockholders. Debt financing, if available, may involve agreements that include liens or other restrictive covenants limiting the Company's ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If the Company raises additional funds through government or other third-party funding, strategic collaborations and alliances or licensing arrangements, it may have to relinquish valuable rights to its technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable. If the Company is unable to raise additional funds when needed, it may be required to implement cost reduction strategies and delay, limit, reduce or terminate its product development or future commercialization efforts or grant rights to develop and market products or product candidates that management would otherwise prefer to develop and market.</font></div><div style="line-height:120%;padding-top:8px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">The Company's management does not believe that its cash and cash equivalents of $</font><font style="font-family:inherit;font-size:10pt;">57.9 million</font><font style="font-family:inherit;font-size:10pt;"> as of </font><font style="font-family:inherit;font-size:10pt;">September&#160;30, 2019</font><font style="font-family:inherit;font-size:10pt;"> is sufficient to fund the Company's current operating plan for at least twelve months after the issuance of these condensed consolidated financial statements. The history of significant losses, the negative cash flows from operations, the limited cash resources currently on hand and the dependence by the Company on its ability - about which there can be no certainty - to obtain additional financing to fund its operations after the current cash resources are exhausted raises substantial doubt about the Company's ability to continue as a going concern. These condensed consolidated financial statements were prepared under the assumption that the Company will continue as a going concern and do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.</font></div></div>
us-gaap Prior Period Reclassification Adjustment Description
PriorPeriodReclassificationAdjustmentDescription
<div style="font-family:Times New Roman;font-size:10pt;"><div style="line-height:120%;padding-top:8px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-style:italic;">Reclassifications</font></div><div style="line-height:120%;padding-top:8px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">On the Company's condensed consolidated statements of cash flows, proceeds from exercises of common stock warrants is now shown separately from proceeds from issuance of common stock and common stock warrants, net of issuance costs.</font></div></div>
us-gaap Use Of Estimates
UseOfEstimates
<div style="font-family:Times New Roman;font-size:10pt;"><div style="line-height:120%;padding-top:8px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-style:italic;">Use of Estimates</font></div><div style="line-height:120%;padding-top:8px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">The preparation of financial statements in accordance with GAAP and the rules and regulations of the SEC requires the use of estimates and assumptions, based on judgments considered reasonable, which affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The Company bases its estimates and assumptions on historical experience, known trends and events and various other factors that management believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Although management believes its estimates and assumptions are reasonable when made, they are based upon information available at the time they are made. Management evaluates the estimates and assumptions on an ongoing basis and, if necessary, makes adjustments. Due to the risks and uncertainties involved in the Company&#8217;s business and evolving market conditions, and given the subjective element of the estimates and assumptions made, actual results may differ from estimated results. The most significant estimates and judgments impact the fair value of intangible assets, goodwill and contingent consideration; income taxes (including the valuation allowance for deferred tax assets); research and development expenses; and going concern considerations.</font></div></div>

Files In Submission

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0001485003-19-000090-index-headers.html Edgar Link pending
0001485003-19-000090-index.html Edgar Link pending
0001485003-19-000090.txt Edgar Link pending
0001485003-19-000090-xbrl.zip Edgar Link pending
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report.css Edgar Link pending
sesn-09302019x10q.htm Edgar Link pending
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sesn-20190930.xml Edgar Link completed
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