ASPIRA WOMEN'S HEALTH INC., 10-Q filed on 14 May 21
v3.21.1
Document and Entity Information - shares
3 Months Ended
Mar. 31, 2021
Apr. 30, 2021
Document And Entity Information [Abstract]    
Document Type 10-Q  
Document Quarterly Report true  
Document Period End Date Mar. 31, 2021  
Document Transition Report false  
Current Fiscal Year End Date --12-31  
Entity File Number 001-34810  
Entity Registrant Name Aspira Women's Health Inc.  
Entity Incorporation, State or Country Code DE  
Entity Tax Identification Number 33-0595156  
Entity Address, Address Line One 12117 Bee Caves Road  
Entity Address, Address Line Two Building Three  
Entity Address, Address Line Three Suite 100  
Entity Address, City or Town Austin  
Entity Address, State or Province TX  
Entity Address, Postal Zip Code 78738  
City Area Code 512  
Local Phone Number 519-0400  
Title of 12(b) Security Common Stock, par value $0.001 per share  
Trading Symbol AWH  
Security Exchange Name NASDAQ  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Non-accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   111,946,449
Document Fiscal Year Focus 2021  
Document Fiscal Period Focus Q1  
Entity Central Index Key 0000926617  
Amendment Flag false  
v3.21.1
Condensed Consolidated Balance Sheets - USD ($)
$ in Thousands
Mar. 31, 2021
Dec. 31, 2020
Current assets:    
Cash and cash equivalents $ 59,369 $ 16,631
Accounts receivable 952 865
Prepaid expenses and other current assets 981 1,077
Inventories 71 30
Total current assets 61,373 18,603
Property and equipment, net 533 583
Right-of-use assets 391 406
Other assets   13
Total assets 62,297 19,605
Current liabilities:    
Accounts payable 1,587 1,103
Accrued liabilities 3,471 3,618
Current portion long-term debt 645 645
Short-term debt 408 611
Lease liability 37 23
Total current liabilities 6,148 6,000
Non-current liabilities:    
Long-term debt 3,428 3,477
Lease liability 396 409
Total liabilities 9,972 9,886
Commitments and contingencies (Note 3)
Stockholders' equity:    
Common stock, par value $0.001 per share, 150,000,000 shares authorized at March 31, 2021 and December 31, 2020; 111,716,852 and 104,619,876 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively 112 105
Additional paid-in capital 498,199 449,680
Accumulated deficit (445,986) (440,066)
Total stockholders' equity 52,325 9,719
Total liabilities and stockholders' equity $ 62,297 $ 19,605
v3.21.1
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
Mar. 31, 2021
Dec. 31, 2020
Condensed Consolidated Balance Sheets [Abstract]    
Common stock, par value $ 0.001 $ 0.001
Common stock, shares authorized 150,000,000 150,000,000
Common stock, shares issued 111,716,852 104,619,876
Common stock, shares outstanding 111,716,852 104,619,876
v3.21.1
Condensed Consolidated Statements Of Operations - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2021
Mar. 31, 2020
Revenue:    
Revenue $ 1,496 $ 1,220
Cost of revenue:    
Cost of revenue [1] 893 800
Gross profit 603 420
Operating expenses:    
Research and development [1] 872 395
Sales and marketing [1] 3,108 2,115
General and administrative [1] 2,509 1,710
Total operating expenses 6,489 4,220
Loss from operations (5,886) (3,800)
Interest income (expense), net (24) 8
Other income (expense), net (10) 86
Net loss $ (5,920) $ (3,706)
Net loss per share - basic and diluted $ (0.05) $ (0.04)
Weighted average common shares used to compute basic and diluted net loss per common share 108,661,712 97,287,461
Product [Member]    
Revenue:    
Revenue $ 1,416 $ 1,185
Cost of revenue:    
Cost of revenue [1] 648 665
Genetics [Member]    
Revenue:    
Revenue 80 25
Cost of revenue:    
Cost of revenue [1] 245 130
Service [Member]    
Revenue:    
Revenue   10
Cost of revenue:    
Cost of revenue [1]   5
Cost Of Revenue [Member]    
Operating expenses:    
Stock-based compensation expense 34 25
Research And Development [Member]    
Operating expenses:    
Stock-based compensation expense 26  
Sales And Marketing [Member]    
Operating expenses:    
Stock-based compensation expense 139 42
General And Administrative [Member]    
Operating expenses:    
Stock-based compensation expense $ 290 $ 202
[1] Non-cash stock-based compensation expense included in cost of revenue and operating expenses
v3.21.1
Consolidated Statements Of Changes In Stockholders' Equity - USD ($)
$ in Thousands
Common Stock [Member]
Additional Paid-In Capital [Member]
Accumulated Deficit [Member]
Total
Balance (in shares) at Dec. 31, 2019 97,286,157      
Balance at Dec. 31, 2019 $ 97 $ 430,802 $ (422,161) $ 8,738
Net loss     (3,706) (3,706)
Common stock issued in conjunction with exercise of stock options (in shares) 2,500      
Common stock issued in conjunction with exercise of stock options   1   1
Stock compensation charge   269   269
Balance (in shares) at Mar. 31, 2020 97,288,657      
Balance at Mar. 31, 2020 $ 97 431,072 (425,867) 5,302
Balance (in shares) at Dec. 31, 2020 104,619,876      
Balance at Dec. 31, 2020 $ 105 449,680 (440,066) 9,719
Net loss     (5,920) (5,920)
Common stock issued in conjunction with exercise of stock options (in shares) 196,976      
Common stock issued in conjunction with exercise of stock options   317   317
Common stock issued in conjunction with public offering, net of issuance costs (in shares) 6,900,000      
Common stock issued in conjunction with public offering, net of issuance costs $ 7 47,713   47,720
Stock compensation charge   489   489
Balance (in shares) at Mar. 31, 2021 111,716,852      
Balance at Mar. 31, 2021 $ 112 $ 498,199 $ (445,986) $ 52,325
v3.21.1
Consolidated Statements Of Changes In Stockholders' Equity (Parenthetical)
$ in Millions
3 Months Ended
Mar. 31, 2021
USD ($)
Public Offering Of Common Stock [Member]  
Stock issued, issuance costs $ 0.5
v3.21.1
Condensed Consolidated Statements Of Cash Flows - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2021
Mar. 31, 2020
Cash flows from operating activities:    
Net loss $ (5,920) $ (3,706)
Adjustments to reconcile net loss to net cash used in operating activities:    
Non-cash lease expense 16  
Depreciation and amortization 90 56
Stock-based compensation expense 489 269
Loss on sale and disposal of property and equipment 1 2
Changes in operating assets and liabilities:    
Accounts receivable (87) (111)
Prepaid expenses and other assets (94) 14
Inventories (41) (38)
Accounts payable, accrued liabilities and other liabilities 291 13
Net cash used in operating activities (5,255) (3,501)
Cash flows from investing activities:    
Purchase of property and equipment (41) (23)
Net cash used in investing activities (41) (23)
Cash flows from financing activities:    
Principal repayment of DECD loan (3) (48)
Proceeds from issuance of common stock from exercise of stock options 317 1
Proceeds from public offering 48,236  
Payment of issuance costs for public offering (516)  
Net cash provided by (used in) financing activities 48,034 (47)
Net increase (decrease) in cash and cash equivalents 42,738 (3,571)
Cash and cash equivalents, beginning of period 16,631 11,703
Cash and cash equivalents, end of period 59,369 8,132
Supplemental disclosure of cash flow information:    
Cash paid during the period for interest 29 9
Supplemental disclosure of noncash investing and financing activities:    
Net (decrease) increase in right-of-use assets $ (15) $ 1
v3.21.1
Organization, Basis Of Presentation And Significant Accounting And Reporting Policies
3 Months Ended
Mar. 31, 2021
Organization, Basis Of Presentation And Significant Accounting And Reporting Policies [Abstract]  
Organization, Basis Of Presentation And Significant Accounting And Reporting Policies

1.   ORGANIZATION, BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING AND REPORTING POLICIES

Organization

Aspira Women’s Health Inc., formerly known as Vermillion, Inc. (“Aspira” and its wholly-owned subsidiaries are collectively referred to as the “Company”) is incorporated in the state of Delaware, and is engaged in the business of developing and commercializing diagnostic tests for gynecologic disease. The Company currently markets and sells the following products and related services: (1) OVA1, a blood test designed to, in addition to a physician’s clinical assessment of a woman with a pelvic mass, identify women who are at high-risk of having a malignant ovarian tumor prior to planned surgery; (2) OVERA, a second-generation biomarker panel intended to maintain OVA1’s high sensitivity while improving specificity; (3) OVA1plus, a reflex offering, which uses OVA1 and OVERA as a confirmation for OVA1 intermediate range results and leverages the strengths of OVA1’s Multivariate Index Assay (“MIA”) sensitivity and OVERA’s (MIA2G) specificity and as a result reduces false elevations by over 40%;; (4) Aspira GenetiX, a genetic test for gynecological cancer risk, with a core focus on female cancers, including breast, ovarian, endometrial, uterine and cervical cancers; and (5) Aspira Synergy, the Company’s new decentralized platform and cloud service technology. Through March 31, 2021, the Company’s product and related services revenue was limited to revenue generated by sales of OVA1, OVA1plus and Aspira GenetiX.  The Company sells OVA1 and OVA1plus through Aspira’s wholly-owned Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) certified clinical laboratory, Aspira Labs, Inc. (“ASPiRA LABS”).



Liquidity

The Company has incurred significant net losses and negative cash flows from operations since inception, and as a result has an accumulated deficit of approximately $445,986,000. The Company also expects to incur a net loss and negative cash flows from operations for 2021. 

 

In December 2019, a novel strain of coronavirus was reported to have surfaced in Wuhan, China. The novel coronavirus has since spread to over 100 countries, including every state in the United States. In March 2020, the World Health Organization declared COVID-19, the disease caused by the novel coronavirus, a pandemic, and the United States declared a national emergency with respect to the coronavirus outbreak. This outbreak has severely impacted global economic activity, and many countries and many states in the United States have reacted to the outbreak by instituting quarantines, mandating business and school closures and restricting travel. In addition, many conventions and industry conferences have been canceled.

 

As a result of the COVID-19 pandemic and actions taken to contain it, the Company’s test volume, and resulting revenue, decreased significantly in late March and the full month of April 2020 as fewer patients visited their physicians and elective surgeries were postponed as a result of closures. The Company saw some increases in its test volume towards the latter half of the second quarter and in the third quarter of 2020, and test volume trended back to pre-COVID-19 levels during the late third quarter 2020. In order to reduce the impact of limitations on visiting physician offices due to closures and quarantines, the Company implemented other mechanisms for reaching physicians such as virtual sales representative meetings and increased digital sales and marketing. Enrollment for future studies has been slower than originally planned due to the impact of current closures for some states. The full impact of the COVID-19 pandemic continues to evolve as of the date of this filing. As a result, the Company is unable to estimate the extent of the impact of the COVID-19 pandemic on its operations or liquidity.

 

As discussed in Note 3, in March 2016, the Company entered into a loan agreement (as amended on March 7, 2018 and April 3, 2020, the “DECD Loan Agreement”) with the State of Connecticut Department of Economic and Community Development (the “DECD”), pursuant to which it may borrow up to $4,000,000 from the DECD.  

 

The loan may be prepaid at any time without premium or penalty. An initial disbursement of $2,000,000 was made to the Company on April 15, 2016 under the DECD Loan Agreement. On December 3, 2020, the Company received a disbursement of the remaining $2,000,000 under the DECD Loan Agreement, as the Company had achieved the target employment milestone necessary to receive an additional $1,000,000 under the DECD Loan Agreement and the DECD determined to fund the remaining $1,000,000 under the DECD Loan Agreement after concluding that the required revenue target would likely have been achieved in the first quarter of 2020 in the absence of the impacts of COVID-19.

 

On April 10, 2020, the Company received a stimulus check of approximately $89,000 from the U.S. Department of Health and Human Services pursuant to the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”).

 

As discussed in Note 3, on May 1, 2020, the Company obtained a loan (the “PPP Loan”) from BBVA USA in the aggregate amount of $1,005,767, pursuant to the Paycheck Protection Program (the “PPP”), which was established under the CARES Act, as administered by the U.S. Small Business Administration (the “SBA”).

 

As discussed in Note 4, during June 2020, all of the warrants from the Company’s 2017 private placement were exercised.  The Company received $5,058,608 in aggregate proceeds from the exercise of the warrants.

 

As discussed in Note 4, on July 20, 2020, the Company completed a private placement of Aspira common stock, par value $0.001 per share, for net proceeds of $10.6 million, after deducting expenses related to the private placement.

 

As discussed in Note 4, on February 8, 2021, the Company completed a public offering (the “2021 Offering”) resulting in net proceeds of approximately $47.7 million, after deducting underwriting discounts and offering expenses. 

 

As discussed in Note 3, in March 2021, the Company applied for forgiveness of the PPP Loan, but there is no assurance that all or a portion of the PPP Loan will be forgiven. 



Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8-03 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management of the Company, all adjustments, consisting of normal recurring adjustments necessary for the fair statement of results for the periods presented, have been included. The results of operations of any interim period are not necessarily indicative of the results of operations for the full year or any other interim period.



The unaudited condensed consolidated financial statements and related disclosures have been prepared with the presumption that users of the interim unaudited condensed consolidated financial statements have read or have access to the audited consolidated financial statements for the preceding fiscal year. The condensed consolidated balance sheet at December 31, 2020 included in this report has been derived from the audited consolidated financial statements at that date but does not include all the information and footnotes required by GAAP. Accordingly, these unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2020 included in Aspira’s Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on March 31, 2021 (the “2020 Annual Report”).



The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimated results.



Significant Accounting and Reporting Policies

Revenue Recognition

Product Revenue – OVA1, OVERA and OVA1plus: The Company recognizes product revenue in accordance with the provisions of ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). Product revenue is recognized upon completion of the OVA1, OVERA or OVA1plus test and delivery of results to the physician based on estimates of amounts that will ultimately be realized. In determining the amount of revenue to be recognized for a delivered test result, the Company considers factors such as payment history and amount, payer coverage, whether there is a reimbursement contract between the payer and the Company, and any developments or changes that could impact reimbursement. These estimates require significant judgment by management as the collection cycle on some accounts can be as long as one year.   



The Company also reviews its patient account population and determines an appropriate distribution of patient accounts by payer (i.e., Medicare, patient pay, other third-party payer, etc.) into portfolios with similar collection experience. The Company has elected this practical expedient that, when evaluated for collectability, results in a materially consistent revenue amount for such portfolios as if each patient account were evaluated on an individual contract basis. During the period ended March 31, 2021, there were no adjustments to estimates of variable consideration to derecognize revenue for services provided in a prior period. There were no impairment losses on accounts receivable recorded during the periods ended March 31, 2021 and 2020.



Genetics Revenue – Aspira GenetiX: Under ASC 606, the Company’s genetics revenue is recognized upon completion of the Aspira GenetiX test and delivery of results to the physician based on estimates of amounts that will ultimately be realized. In determining the amount of revenue to be recognized for a delivered test result, the Company considers factors such as payment history and amount, payer coverage, whether there is a reimbursement contract between the payer and the Company, and any developments or changes that could impact reimbursement. These estimates require significant judgment by management as the Company has limited experience with such factors relating to Aspira GenetiX.  

 

Service Revenue - The Company’s service revenue was generated by performing in vitro diagnostic (“IVD”) trial services for third-party customers. Measurement of progress on contracts with customers was generally based on the input measurement of cost incurred relative to the total expected costs to satisfy the performance obligation. The Company does not expect to have any significant service revenue going forward, as it largely wound down performing the ASPiRA IVD, Inc. (“ASPiRA IVD”) trial services in the fourth quarter of 2019.  During 2020, the Company’s service revenue was limited to the fulfillment of one legacy IVD contract.  



Recent Accounting Pronouncements

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). This update changes the impairment model from the currently used incurred loss methodology to an expected loss methodology, which will result in the more timely recognition of losses. The ASU 2016-13 is scheduled to be effective in 2023 for smaller reporting companies. The Company is currently assessing the impact of this standard on its consolidated financial statements.

v3.21.1
Agreements With Quest Diagnostics Incorporated
3 Months Ended
Mar. 31, 2021
Agreements With Quest Diagnostics Incorporated [Abstract]  
Agreements With Quest Diagnostics Incorporated



2.   AGREEMENTS WITH QUEST DIAGNOSTICS INCORPORATED



In March 2015, the Company reached an agreement with Quest Diagnostics, Inc. (“Quest Diagnostics”). Pursuant to this agreement, all OVA1 U.S. testing services for Quest Diagnostics customers were transferred to Aspira’s wholly-owned subsidiary, ASPiRA LABS, as of August 2015. Pursuant to this agreement, as amended as of March 11, 2020, Quest Diagnostics has continued to provide blood draw and logistics support by transporting specimens to ASPiRA LABS for testing in exchange for a market value fee. The purpose of the 2020 amendment was to extend the term of the Testing and Services Agreement from March 11, 2019 to March 11, 2023 and for the Company to pay an annual fee of $75,000 for the services of a part-time Quest Diagnostics project manager.  

v3.21.1
Commitments And Contingencies
3 Months Ended
Mar. 31, 2021
Commitments And Contingencies [Abstract]  
Commitments And Contingencies

3.   COMMITMENTS AND CONTINGENCIES

Coronavirus Aid, Relief, and Economic Security (CARES) Act and PPP Loan



On May 1, 2020, the Company obtained the PPP Loan from BBVA USA in the aggregate amount of $1,005,767. The application for these funds required the Company to, in good faith, certify that the described economic uncertainty at the time made the loan request necessary to support the ongoing operations of the Company. This certification further required the Company to consider its current business activity and its ability to access other sources of liquidity sufficient to support ongoing operations in a manner that was not significantly detrimental to the business. Under the terms of the CARES Act and the PPP Loan, all or a portion of the principal amount of the PPP Loan is subject to forgiveness so long as, over the 24-week period following the Company’s receipt of the proceeds of the PPP Loan, the Company used those proceeds for payroll costs, rent, utility costs or the maintenance of employee and compensation levels. The PPP Loan, which was granted pursuant to a promissory note, matures on May 1, 2022. Any unforgiven portion of the PPP Loan bears interest at a rate of 1.000% per annum, payable monthly in equal installments commencing in August 2021. The Company applied for forgiveness of the PPP Loan in March 2021, but there is no assurance that all or a portion of the PPP Loan will be forgiven. The PPP Loan is subject to any new guidance and new requirements released by the Department of the Treasury.



Development Loan 

 

On March 22, 2016, the Company entered into the DECD Loan Agreement, pursuant to which the Company may borrow up to $4,000,000 from the DECD. The loan bears interest at a fixed rate of 2.0% per annum and requires equal monthly payments of principal and interest until maturity, which occurs on April 15, 2026. As security for the loan, the Company has granted the DECD a blanket security interest in the Company’s personal and intellectual property. The DECD’s security interest in the Company’s intellectual property may be subordinated to a qualified institutional lender. 

 

The loan may be prepaid at any time without premium or penalty. An initial disbursement of $2,000,000 was made to the Company on April 15, 2016 under the DECD Loan Agreement. On December 3, 2020, the Company received a disbursement of the remaining $2,000,000 under the DECD Loan Agreement, as the Company had achieved the target employment milestone necessary to receive an additional $1,000,000 under the DECD Loan Agreement and the DECD determined to fund the remaining $1,000,000 under the DECD Loan Agreement after concluding that the required revenue target would likely have been achieved in the first quarter of 2020 in the absence of the impacts of COVID-19.



Under the terms of the DECD Loan Agreement, the Company may be eligible for forgiveness of up to $1,500,000 of the principal amount of the loan if the Company achieves certain job creation and retention milestones by December 31, 2022. Conversely, if the Company is either unable to retain 25 full-time employees with a specified average annual salary for a consecutive two-year period or does not maintain the Company’s Connecticut operations through March 22, 2026, the DECD may require early repayment of a portion or all of the loan plus a penalty of 5% of the total funded loan.



Long-term debt consisted of the following:





 

 

 

 

 



 

 

 

 

 



 

March 31,

 

 

December 31,



2021

 

2020

(in thousands)

 

 

 

 

 

DECD loan

$

3,067 

 

$

3,116 

PPP loan

 

1,006 

 

 

1,006 

Total debt

 

4,073 

 

 

4,122 

Less:  Current portion

 

(645)

 

 

(645)

Total long-term debt

 

3,428 

 

 

3,477 



As of March 31, 2021, the annual amounts of future minimum principal payments due under certain of the Company’s contractual obligations are shown in the table below.  Debt issuance costs for the DECD loan were $18,000.  Debt related to the PPP Loan of $1,006,000 and that certain insurance promissory note of $408,000, as described below, are not included in the table below, as the PPP Loan’s forgiveness is pending a decision by the SBA as of the date of this filing, and the $408,000 insurance promissory note is cancellable.







 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



 

 

Payments Due by Period

(in thousands)

 

 

Total

 

 

2021

 

 

2022

 

 

2023

 

 

2024

 

 

2025

 

 

Thereafter

DECD Loan

 

 

3,084 

 

 

151 

 

 

204 

 

 

406 

 

 

452 

 

 

461 

 

 

1,410 

Total

 

$

3,084 

 

$

151 

 

$

204 

 

$

406 

 

$

452 

 

$

461 

 

$

1,410 



Insurance Notes

 

During 2020 and 2019, the Company entered into insurance promissory notes for the payment of insurance premiums at an interest rate of 3.88% and 4.49% respectively, with an aggregate principal amount outstanding of approximately $408,000 and $611,000 as of March 31, 2021 and December 31, 2020, respectively. The amount outstanding could be substantially offset by the cancellation of the related insurance coverage which is classified in prepaid insurance. These notes are payable in ten monthly installments with maturity dates of October 1, 2021 and October 1, 2020, respectively.



Operating Leases 

The Company leases facilities to support its business of discovering, developing and commercializing diagnostic tests in the fields of gynecologic disease. The Company’s principal facility, including the CLIA laboratory used by ASPiRA LABS, is located in Austin, Texas, and the CLIA laboratory used for ASPiRA IVD services is located in Trumbull, Connecticut.  In October 2020, the Company renewed the Austin, Texas lease for one additional year.  The Company’s renewed lease expires on January 31, 2022, with no automatic renewal or renewal option.

 

In October 2015, the Company entered into a lease agreement for a facility in Trumbull, Connecticut. The lease required initial payments for the buildout of leasehold improvements to the office space, which were approximately $596,000. In September 2020, the Company exercised the renewal option for its Trumbull, Connecticut lease. The Company’s renewed lease expires on June 30, 2026, with a five year renewal option.  The Company is not reasonably certain that it will exercise the five year renewal option beginning on July 1, 2026.



The expense associated with these operating leases for the three months ended March 31, 2021 and 2020 is shown in the table below (in thousands).



 

 

 

 

 

 



 

 

 

 

 

 



 

Three Months Ended March, 31

Lease Cost

Classification

2021

 

2020

Operating rent expense

 

 

 

 

 

 



Cost of revenue

$

19 

 

$

15 



Research and development

 

13 

 

 

11 



Sales and marketing

 

11 

 

 



General and administrative

 

21 

 

 

14 

Variable rent expense

 

 

 

 

 

 



Cost of revenue

$

 

$



Research and development

 

 

 



Sales and marketing

 

12 

 

 

11 



General and administrative

 

13 

 

 

14 





Based on the Company’s leases as of March 31, 2021, the table below sets forth the approximate future lease payments related to operating leases with initial terms of one year or more (in thousands).





 

 



 

 

2021

$

54 

2022

 

95 

2023

 

106 

2024

 

116 

2025

 

123 

2026

 

64 

Total Operating Lease Payments

 

558 

Less: Interest

 

(125)

Present Value of Lease Liabilities

$

433 



Weighted-average lease term and discount rate were as follows:



 

 

Weighted-average remaining lease term (in years)

 

5.2 

Weighted-average discount rate

 

9.36% 



Non-cancelable Royalty Obligations

The Company is a party to an amended research collaboration agreement with The Johns Hopkins University School of Medicine under which the Company licenses certain of its intellectual property directed at the discovery and validation of biomarkers in human subjects, including but not limited to clinical application of biomarkers in the understanding, diagnosis and management of human disease. Under the terms of the amended research collaboration agreement, Aspira is required to pay the greater of 4% royalties on net sales of diagnostic tests using the assigned patents or annual minimum royalties of $57,500. Royalty expense for the periods ended March 31, 2021 and 2020 totaled $57,000 and $46,000, respectively.



Contingent Liabilities



From time to time, the Company is involved in legal proceedings and regulatory proceedings arising from operations. The Company establishes reserves for specific liabilities in connection with legal actions that management deems to be probable and estimable. The Company is not currently a party to any proceeding, the adverse outcome of which would have a material adverse effect on the Company’s financial position or results of operations.

  

v3.21.1
Stockholders' Equity
3 Months Ended
Mar. 31, 2021
Stockholders' Equity:  
Stockholders' Equity

4.   STOCKHOLDERS’ EQUITY



2020 Exercise of Warrants



On February 17, 2017, the Company issued certain warrants to purchase up to an aggregate of 2,810,338 shares of Aspira common stock at an exercise price of $1.80 per share in connection with a February 2017 private placement of Aspira common stock. The warrants were initially sold at a price of $0.125 per share of common stock underlying the warrants. 



On June 1, 2020, following the 20th consecutive trading day for which the closing price per share of Aspira common stock, as reported on the Nasdaq stock market, exceeded the exercise price, the Company sent notice to the investors holding such warrants accelerating the expiration date of the warrants, in accordance with the terms thereof.  Pursuant to the terms of the warrants, any portion of the warrants not exercised prior to such accelerated expiration date would become void and of no value.



As of June 9, 2020, all of the warrants were exercised.  The Company issued 2,810,338 shares of Aspira common stock and received $5,060,000 in aggregate proceeds from the exercise of the warrants.  As of the date of the issuance of these financial statements, there are no outstanding warrants for the purchase of Aspira common stock.



2020 Private Placement



On July 20, 2020, the Company completed a private placement pursuant to which certain investors purchased 3,150,000 shares of Aspira common stock at a price of $3.50 per share.  Net proceeds of the private placement were $10.6 million, after deducting expenses related to the private placement of $384,000.  The sale of common stock qualified for equity treatment under GAAP.



2021 Public Offering



On February 4, 2021, the Company entered into an underwriting agreement (the “2021 Underwriting Agreement”) with William Blair & Company, L.L.C. and Truist Securities, Inc., as representatives of several underwriters (the “2021 Underwriters”), in connection with the underwritten public offering of 6,000,000 shares of Aspira common stock at a price to the public of $7.50 per share. The 2021 Underwriters purchased these 6,000,000 shares at the public offering price per share, less the underwriting discount of $0.4875 per share.



Under the 2021 Underwriting Agreement, the Company granted the 2021 Underwriters an option to purchase up to an additional 900,000 shares of Aspira common stock at the public offering price, less the underwriting discount of $0.4875 per share.  On February 5, 2021, the 2021 Underwriters notified the Company that they were exercising this option in connection with the closing of the 2021 Offering. The 2021 Offering, including the additional 900,000 shares of Aspira common stock, closed on February 8, 2021 and resulted in net proceeds to the Company of approximately $47.7 million, after deducting underwriting discounts and offering expenses.



2019 Stock Incentive Plan

At the Company’s 2019 annual meeting of stockholders, the Company’s stockholders approved the Vermillion, Inc. 2019 Stock Incentive Plan (the “2019 Plan”). The purposes of the 2019 Plan are (i) to align the interests of the Company’s stockholders and recipients of awards under the 2019 Plan by increasing the proprietary interest of such recipients in the Company’s growth and success; (ii) to advance the interests of the Company by attracting and retaining non-employee directors, officers, other employees, consultants, independent contractors and agents; and (iii) to motivate such persons to act in the long-term best interests of the Company and its stockholders. The 2019 Plan allows the Company to grant stock options, stock appreciation rights, restricted stock, restricted stock units and performance awards to participants.



Subject to the terms and conditions of the 2019 Plan, the initial number of shares authorized for grants under the 2019 Plan is 10,492,283. To the extent an equity award granted under the 2019 Plan expires or otherwise terminates without having been exercised or paid in full, or is settled in cash, the shares of common stock subject to such award will become available for future grant under the 2019 Plan. As of March 31, 2021, 10,438,081 shares of Aspira common stock were subject to outstanding stock options, and 75,988 shares of Aspira common stock were subject to unvested restricted stock awards and a total of 3,946,874 shares of Aspira common stock were reserved for issuance under the 2019 Plan. 



Stock-Based Compensation

During the three months ended March 31, 2021, the Company granted the following awards under the 2019 Plan:



 

 

 

 

 

 

 

 

 

Grant Date

 

Number of Shares

 

Type of Award

 

Exercise Price / Share

 

Fair Value / Share

 

1/28/2021

 

262,000

 

Options

 

$            7.79

 

$         4.95

 

3/19/2021

 

1,971,912

 

Options

 

$            7.40

 

$         4.71

 

3/19/2021

 

350,000

 

Performance Options

 

$            7.40

 

$         4.71

 

3/19/2021

 

75,988

 

Restricted Stock Units

 

$                 -

 

$              -

 



 

2,659,900

 

 

 

 

 

 

 



The allocation of employee stock-based compensation expense by functional area for the three months ended March 31, 2021 and 2020 was as follows:

 



 

 

 

 

 

 



 

Three Months Ended



 

March 31,

(in thousands)

 

2021

 

2020

Cost of revenue

 

$

31 

 

$

23 

Research and development

 

 

25 

 

 

 —

Sales and marketing

 

 

139 

 

 

37 

General and administrative

 

 

190 

 

 

201 

Total

 

$

385 

 

$

261 



v3.21.1
Loss Per Share
3 Months Ended
Mar. 31, 2021
Loss Per Share [Abstract]  
Loss Per Share

5.   LOSS PER SHARE

The Company calculates basic loss per share using the weighted average number of shares of Aspira common stock outstanding during the period. Because the Company is in a net loss position, diluted loss per share is calculated using the weighted average number of shares of Aspira common stock outstanding and excludes the effects of 10,514,070 and 12,543,364 potential shares of Aspira common stock as of March 31, 2021 and 2020, respectively, that are anti-dilutive. Potential shares of Aspira common stock include incremental shares of Aspira common stock issuable upon the exercise of outstanding warrants, stock options and unvested restricted stock units.

v3.21.1
Commitments And Contingencies (Tables)
3 Months Ended
Mar. 31, 2021
Commitments And Contingencies [Abstract]  
Schedule of Long-term Debt



 

 

 

 

 



 

 

 

 

 



 

March 31,

 

 

December 31,



2021

 

2020

(in thousands)

 

 

 

 

 

DECD loan

$

3,067 

 

$

3,116 

PPP loan

 

1,006 

 

 

1,006 

Total debt

 

4,073 

 

 

4,122 

Less:  Current portion

 

(645)

 

 

(645)

Total long-term debt

 

3,428 

 

 

3,477 



Annual Amounts of Future Minimum Principal Payments Due Under Certain Contractual Obligations



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



 

 

Payments Due by Period

(in thousands)

 

 

Total

 

 

2021

 

 

2022

 

 

2023

 

 

2024

 

 

2025

 

 

Thereafter

DECD Loan

 

 

3,084 

 

 

151 

 

 

204 

 

 

406 

 

 

452 

 

 

461 

 

 

1,410 

Total

 

$

3,084 

 

$

151 

 

$

204 

 

$

406 

 

$

452 

 

$

461 

 

$

1,410 



Expense Associated with Operating Leases



 

 

 

 

 

 



 

 

 

 

 

 



 

Three Months Ended March, 31

Lease Cost

Classification

2021

 

2020

Operating rent expense

 

 

 

 

 

 



Cost of revenue

$

19 

 

$

15 



Research and development

 

13 

 

 

11 



Sales and marketing

 

11 

 

 



General and administrative

 

21 

 

 

14 

Variable rent expense

 

 

 

 

 

 



Cost of revenue

$

 

$



Research and development

 

 

 



Sales and marketing

 

12 

 

 

11 



General and administrative

 

13 

 

 

14 



Future Lease Payments Related to Operating Leases



 

 



 

 

2021

$

54 

2022

 

95 

2023

 

106 

2024

 

116 

2025

 

123 

2026

 

64 

Total Operating Lease Payments

 

558 

Less: Interest

 

(125)

Present Value of Lease Liabilities

$

433 



Weighted-Average Lease Term and Discount Rate



 

 

Weighted-average remaining lease term (in years)

 

5.2 

Weighted-average discount rate

 

9.36% 



v3.21.1
Stockholders' Equity (Tables)
3 Months Ended
Mar. 31, 2021
Stockholders' Equity:  
Schedule of Awards Granted



 

 

 

 

 

 

 

 

 

Grant Date

 

Number of Shares

 

Type of Award

 

Exercise Price / Share

 

Fair Value / Share

 

1/28/2021

 

262,000

 

Options

 

$            7.79

 

$         4.95

 

3/19/2021

 

1,971,912

 

Options

 

$            7.40

 

$         4.71

 

3/19/2021

 

350,000

 

Performance Options

 

$            7.40

 

$         4.71

 

3/19/2021

 

75,988

 

Restricted Stock Units

 

$                 -

 

$              -

 



 

2,659,900

 

 

 

 

 

 

 



Allocation of Employee and Director Stock-Based Compensation Expense by Functional Area



 

 

 

 

 

 



 

Three Months Ended



 

March 31,

(in thousands)

 

2021

 

2020

Cost of revenue

 

$

31 

 

$

23 

Research and development

 

 

25 

 

 

 —

Sales and marketing

 

 

139 

 

 

37 

General and administrative

 

 

190 

 

 

201 

Total

 

$

385 

 

$

261 



v3.21.1
Organization, Basis Of Presentation And Significant Accounting And Reporting Policies (Details) - USD ($)
1 Months Ended 3 Months Ended
Feb. 08, 2021
Dec. 03, 2020
Jul. 20, 2020
Jun. 09, 2020
Apr. 15, 2016
Jun. 30, 2020
Mar. 31, 2021
Mar. 31, 2020
Dec. 31, 2020
May 01, 2020
Apr. 10, 2020
Mar. 22, 2016
Organization Consolidation And Summary Of Significant Accounting Policies [Line Items]                        
Minimum percentage reduction of false elevations by OVAL1plus             40.00%          
Accumulated deficit             $ (445,986,000)   $ (440,066,000)      
Net proceeds after deducting underwriting discounts and offering expenses             $ 48,236,000          
Common stock, par value             $ 0.001   $ 0.001      
2017 Private Placement [Member]                        
Organization Consolidation And Summary Of Significant Accounting Policies [Line Items]                        
Proceeds from exercise of warrants           $ 5,058,608            
2020 Exercise of Warrants [Member]                        
Organization Consolidation And Summary Of Significant Accounting Policies [Line Items]                        
Proceeds from exercise of warrants       $ 5,060,000                
2020 Private Placement [Member]                        
Organization Consolidation And Summary Of Significant Accounting Policies [Line Items]                        
Proceeds from private placement, net of issuance costs     $ 10,600,000                  
Common stock, par value     $ 0.001                  
Accounts Receivable [Member]                        
Organization Consolidation And Summary Of Significant Accounting Policies [Line Items]                        
Impairment losses             $ 0 $ 0        
Common Stock [Member] | 2021 Underwriters Agreement [Member] | 2021 Public Offering [Member]                        
Organization Consolidation And Summary Of Significant Accounting Policies [Line Items]                        
Net proceeds after deducting underwriting discounts and offering expenses $ 47,700,000                      
CARES Act [Member]                        
Organization Consolidation And Summary Of Significant Accounting Policies [Line Items]                        
Proceeds from stimulus check received pursuant to the CARES Act                     $ 89,000  
DECD [Member] | DECD Loan Agrement [Member]                        
Organization Consolidation And Summary Of Significant Accounting Policies [Line Items]                        
DECD maximum borrowing capacity                       $ 4,000,000
Proceeds from development loan   $ 2,000,000     $ 2,000,000              
DECD [Member] | DECD Loan Agrement [Member] | Loan Agreement Target Employment Milestone [Member]                        
Organization Consolidation And Summary Of Significant Accounting Policies [Line Items]                        
Proceeds from development loan   1,000,000                    
DECD [Member] | DECD Loan Agrement [Member] | Loan Agreement Required Revenue Target [Member]                        
Organization Consolidation And Summary Of Significant Accounting Policies [Line Items]                        
Proceeds from development loan   $ 1,000,000                    
BBVA USA [Member] | CARES Act [Member] | PPP Loan [Member]                        
Organization Consolidation And Summary Of Significant Accounting Policies [Line Items]                        
Aggregate amount of loan                   $ 1,005,767    
v3.21.1
Agreements With Quest Diagnostics Incorporated (Details)
$ in Thousands
Mar. 11, 2020
USD ($)
Quest Diagnostics [Member]  
Line of Credit Facility [Line Items]  
Annual fee to services of Part-time Quest Diagnostics project manager $ 75
v3.21.1
Commitments And Contingencies (Narrative) (Details)
3 Months Ended
Dec. 03, 2020
USD ($)
employee
Apr. 15, 2016
USD ($)
Mar. 22, 2016
USD ($)
Mar. 31, 2021
USD ($)
item
Mar. 31, 2020
USD ($)
Dec. 31, 2020
USD ($)
May 01, 2020
USD ($)
Dec. 31, 2019
Oct. 31, 2015
USD ($)
Austin, Texas Facility [Member]                  
Commitments And Contingencies [Line Items]                  
Lease expiration date       Jan. 31, 2022          
Lease renewal term       1 year          
Trumbull, Connecticut Facility [Member]                  
Commitments And Contingencies [Line Items]                  
Leasehold improvements                 $ 596,000
Lease expiration date       Jun. 30, 2026          
Lease renewal term       5 years          
Insurance Promissory Notes [Member]                  
Commitments And Contingencies [Line Items]                  
Debt instrument interest rate           3.88%   4.49%  
Aggregate principal amount outstanding       $ 408,000   $ 611,000      
Cancelable insurance promissory note       $ 408,000          
Notes payable number of monthly payment installment | item       10          
CARES Act [Member] | PPP Loan [Member]                  
Commitments And Contingencies [Line Items]                  
Debt instrument carrying amount       $ 1,006,000          
Johns Hopkins University School Of Medicine [Member]                  
Commitments And Contingencies [Line Items]                  
Percent of royalty paid       4.00%          
Minimum royalty payment       $ 57,500          
Royalty expense       $ 57,000 $ 46,000        
BBVA USA [Member] | CARES Act [Member] | PPP Loan [Member]                  
Commitments And Contingencies [Line Items]                  
Aggregate amount of loan             $ 1,005,767    
Maturity date       May 01, 2022          
BBVA USA [Member] | CARES Act [Member] | PPP Loan [Member] | Unforgiven Portion Of PPP Loan [Member]                  
Commitments And Contingencies [Line Items]                  
Debt instrument interest rate       1.00%          
DECD [Member]                  
Commitments And Contingencies [Line Items]                  
Debt issuance costs       $ 18,000          
DECD [Member] | DECD Loan Agrement [Member]                  
Commitments And Contingencies [Line Items]                  
DECD maximum borrowing capacity     $ 4,000,000            
Line of credit fixed interest rate     2.00%            
Proceeds from development loan $ 2,000,000 $ 2,000,000              
Maximum loan forgiveness amount under loan agreement $ 1,500,000                
Number of full time employees expected to be retained under loan agreement | employee 25                
Consecutive period full times employees with specified average annual salary under loan agreement 2 years                
Percentage of penality on total loan fund included in loan agreement 5.00%                
Maturity date       Apr. 15, 2026          
DECD [Member] | DECD Loan Agrement [Member] | Loan Agreement Target Employment Milestone [Member]                  
Commitments And Contingencies [Line Items]                  
Proceeds from development loan $ 1,000,000                
DECD [Member] | DECD Loan Agrement [Member] | Loan Agreement Required Revenue Target [Member]                  
Commitments And Contingencies [Line Items]                  
Proceeds from development loan $ 1,000,000                
v3.21.1
Commitments And Contingencies (Schedule of Long-term Debt) (Details) - USD ($)
$ in Thousands
Mar. 31, 2021
Dec. 31, 2020
Debt Instrument [Line Items]    
Total debt $ 4,073 $ 4,122
Less: Current portion (645) (645)
Total long-term debt 3,428 3,477
DECD Loan [Member]    
Debt Instrument [Line Items]    
Total debt 3,067 3,116
PPP Loan [Member]    
Debt Instrument [Line Items]    
Total debt $ 1,006 $ 1,006
v3.21.1
Commitments, Contingencies And Debt (Annual Amounts of Future Minimum Principal Payments Due Under Certain Contractual Obligations) (Details) - USD ($)
$ in Thousands
Mar. 31, 2021
Dec. 31, 2020
Other Commitments [Line Items]    
Total debt $ 4,073 $ 4,122
Contractual obligation, 2021 151  
Contractual obligation, 2022 204  
Contractual obligation, 2023 406  
Contractual obligation, 2024 452  
Contractual obligation, 2025 461  
Contractual obligation, Thereafter 1,410  
Total 3,084  
DECD Loan [Member]    
Other Commitments [Line Items]    
Total debt 3,067 $ 3,116
Contractual obligation, 2021 151  
Contractual obligation, 2022 204  
Contractual obligation, 2023 406  
Contractual obligation, 2024 452  
Contractual obligation, 2025 461  
Contractual obligation, Thereafter 1,410  
Total $ 3,084  
v3.21.1
Commitments And Contingencies (Expense Associated with Operating Leases) (Details) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2021
Mar. 31, 2020
Cost Of Revenue [Member]    
Operating rent expense $ 19 $ 15
Variable rent expense 1 3
Research And Development [Member]    
Operating rent expense 13 11
Variable rent expense 0 1
Sales And Marketing [Member]    
Operating rent expense 11 6
Variable rent expense 12 11
General And Administrative [Member]    
Operating rent expense 21 14
Variable rent expense $ 13 $ 14
v3.21.1
Commitments And Contingencies (Future Lease Payments Related to Operating Leases) (Details)
$ in Thousands
Mar. 31, 2021
USD ($)
Lessee, Operating Lease, Liability, Payment, Due [Abstract]  
2021 $ 54
2022 95
2023 106
2024 116
2025 123
2026 64
Total Operating Lease Payments 558
Less: Interest (125)
Present Value of Lease Liabilities $ 433
v3.21.1
Commitments And Contingencies (Weighted-Average Lease Term and Discount Rate) (Details)
Mar. 31, 2021
Leases [Abstract]  
Weighted-average remaining lease term (in years) 5 years 2 months 12 days
Weighted-average discount rate 9.36%
v3.21.1
Stockholders' Equity (Narrative) (Details) - USD ($)
1 Months Ended 3 Months Ended
Feb. 08, 2021
Feb. 04, 2021
Jul. 20, 2020
Jun. 09, 2020
Feb. 17, 2017
Jun. 30, 2020
Mar. 31, 2021
Dec. 31, 2020
Dec. 31, 2019
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                  
Common stock, par value             $ 0.001 $ 0.001  
Net proceeds after deducting underwriting discounts and offering expenses             $ 48,236,000    
2019 Stock Incentive Plan [Member]                  
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                  
Share based compensation shares authorized for grants                 10,492,283
Share based compensation shares reserved for issuance             3,946,874    
Common Stock [Member]                  
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                  
Common stock shares issued             6,900,000    
2020 Exercise of Warrants [Member]                  
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                  
Warrants issued to purchase common stock         2,810,338        
Exercise price of warrants         $ 1.80        
Proceeds from exercise of warrants       $ 5,060,000          
Stock price per share         $ 0.125        
Common stock shares issued       2,810,338          
2017 Private Placement [Member]                  
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                  
Proceeds from exercise of warrants           $ 5,058,608      
2020 Private Placement [Member]                  
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                  
Stock price per share     $ 3.50            
Proceeds from private placement, net of issuance costs     $ 10,600,000            
Expenses related to stock issuance     $ 384,000            
Common stock, par value     $ 0.001            
Common stock shares issued     3,150,000            
2021 Public Offering [Member] | Common Stock [Member] | 2021 Underwriters Agreement [Member]                  
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                  
Stock price per share   $ 0.4875              
Underwriting agreement, shares   6,000,000              
Underwriting agreement, per share   $ 7.50              
Common stock shares issued 900,000 6,000,000              
Underwriting commitments additional shares offered   900,000              
Net proceeds after deducting underwriting discounts and offering expenses $ 47,700,000                
Common Stock Subject to Outstanding Stock Options [Member]                  
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                  
Share based compensation shares reserved for issuance             10,438,081    
Common Stock Subject to Unvested Restricted Stock Awards [Member] | 2019 Stock Incentive Plan [Member]                  
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                  
Share based compensation shares reserved for issuance             75,988    
v3.21.1
Stockholders' Equity (Schedule of Awards Granted) (Details) - 2019 Stock Incentive Plan [Member]
3 Months Ended
Mar. 31, 2021
$ / shares
shares
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]  
Number of Shares | shares 2,659,900
1/28/2021 [Member] | Options [Member]  
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]  
Number of Shares | shares 262,000
Exercise Price / Share $ 7.79
Fair Value / Share $ 4.95
3/19/2021 [Member] | Options [Member]  
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]  
Number of Shares | shares 1,971,912
Exercise Price / Share $ 7.40
Fair Value / Share $ 4.71
3/19/2021 [Member] | Performance Options [Member]  
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]  
Number of Shares | shares 350,000
Exercise Price / Share $ 7.40
Fair Value / Share $ 4.71
3/19/2021 [Member] | Restricted Stock Units (RSUs)  
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]  
Number of Shares | shares 75,988