UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DCD.C. 20549

FORM 10-Q

(Mark One)

☑     þQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 20172021

OR

o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ______ to ______

Commission file number:File Number: 001-34810

Picture 17

Aspira Women’s Health Inc.

(Exact name of registrant as specified in its charter)

Vermillion, Inc.Delaware

33-0595156

(Exact Name of Registrant as Specified in Its Charter)

Delaware

33-0595156

(State or Other Jurisdictionother jurisdiction of Incorporationincorporation or Organization)organization)

(I.R.S. Employer Identification No.)

12117 Bee Caves Road, Building Three, Suite 100, Austin, Texas

78738

(Address of Principal Executive Offices)principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (512) 519-0400

(Registrant’s Telephone Number, Including Area Code)Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.001 per share

AWH

The NASDAQ Stock Market

1


Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes þNo ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes þNo ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.  (Check one):

Large accelerated filer ¨

Accelerated filer ¨

Non-accelerated filer þ

Non-accelerated filer  ☐

Smaller reporting company þ

Emerging growth company

¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No þ

Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court.  Yes ☑ No ☐

As of October 31,  2017,November 8, 2021, the registrant had 59,998,748112,126,549 shares of common stock, par value $0.001 per share, outstanding.

2

1


VERMILLION,ASPIRA WOMEN’S HEALTH INC.

FORM 10-Q

For the Quarter Ended September 30, 2021

Table of Contents

Page

PART I

Financial Information

4Page

PART I

Financial Information

3

Item 1

Financial Statements

43

Condensed Consolidated Balance Sheets as of September 30, 20172021 and December 31, 20162020 (unaudited)

43

Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 20172021 and 20162020 (unaudited)

64

Condensed Consolidated Statements of Changes in Stockholders’ Equity for the three and nine months ended September 30, 2021 and 2020 (unaudited)

5

Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 20172021 and 20162020 (unaudited)

76

Notes to Condensed Consolidated Financial Statements (unaudited)

7

Item 2

8

Item 2

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

15

Item 3

15

Item 3

Quantitative and Qualitative Disclosures About Market Risk

30

Item 4

26Controls and Procedures

30

Item 4PART II

Controls and ProceduresOther Information

30

Item 1

26Legal Proceedings

30

PART IIItem 1A

Other InformationRisk Factors

30

Item 6

27Exhibits

31

Item 1SIGNATURES

Legal Proceedings

27

Item 1A

Risk Factors

27

Item 6

Exhibits

28

SIGNATURES

2932

Vermillion, OVA1 and OveraThe following are registered and unregistered trademarksand service marksof Vermillion, Aspira Women’s HealthInc.:VERMILLION®,ASPIRA WOMEN’S HEALTH™, OVA1®, OVERA®,ASPIRA LABS®,ASPIRAIVD®,OVACALC®,ASPIRA GENETIXSM,  OVA1PLUS™,OVAWATCH™,  ENDOCHECK™,OVAINHERIT™,ASPIRA SYNERGYSM,, and OVA360™.

3

2


PART I - FINANCIAL INFORMATION

ITEM 1.FINANCIAL STATEMENTS

Vermillion,Aspira Women’s Health Inc.

Condensed Consolidated Balance Sheets

(Amounts in Thousands, Except Share and Par Value Amounts)

(Unaudited)

 

 

 

 

 

September 30,

 

December 31,

September 30,

December 31,

2017

 

2016

2021

2020

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

$

7,752 

 

$

5,242 

$

44,870

$

16,631

Restricted cash

250

-

Accounts receivable

 

221 

 

 

275 

1,103

865

Prepaid expenses and other current assets

 

175 

 

 

498 

828

1,077

Inventories

 

155 

 

 

93 

137

30

Total current assets

 

8,303 

 

 

6,108 

47,188

18,603

Property and equipment, net

 

1,364 

 

 

1,911 

498

583

Right-of-use assets

361

406

Other assets

 

11 

 

 

 -

-

13

Total assets

$

9,678 

 

$

8,019 

$

48,047

$

19,605

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

$

514 

 

$

881 

$

1,155

$

1,103

Accrued liabilities

 

1,430 

 

 

1,464 

4,998

3,618

Deferred Revenue

 

62 

 

 

 -

Current portion of long-term debt

200

645

Short-term debt

 

191 

 

 

182 

-

611

Other current liabilities

 

32 

 

 

34 

Lease liability

56

23

Total current liabilities

 

2,229 

 

 

2,561 

6,409

6,000

Non-current liabilities:

 

 

 

 

 

Long-term debt

 

1,528 

 

 

1,667 

2,768

3,477

Other non-current liabilities

 

 -

 

 

29 

Lease liability

366

409

Total liabilities

 

3,757 

 

 

4,257 

9,543

9,886

Commitments and contingencies (Note 3)

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Common stock, par value $0.001 per share, 150,000,000 shares authorized at

 

 

 

 

 

September 30, 2017 and December 31, 2016; 59,998,748 and 52,328,492 shares

 

 

 

 

 

issued and outstanding at September 30, 2017 and December 31, 2016,

 

 

 

 

 

respectively

 

60 

 

 

52 

Common stock, par value $0.001 per share, 150,000,000 shares authorized at September 30, 2021 and December 31, 2020; 112,100,049 and 104,619,876 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively

112

105

Additional paid-in capital

 

398,959 

 

 

389,266 

501,159

449,680

Accumulated deficit

 

(393,098)

 

 

(385,556)

(462,767)

(440,066)

Total stockholders’ equity

 

5,921 

 

 

3,762 

38,504

9,719

Total liabilities and stockholders’ equity

$

9,678 

 

$

8,019 

$

48,047

$

19,605

4


See accompanying notes to the unaudited condensed consolidated financial statements.

5

3


Aspira Women’s Health Inc.

Vermillion, Inc.

Condensed Consolidated Statements of Operations

(Amounts in Thousands, Except Share and Per Share Amounts)

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

Nine Months Ended

Three Months Ended September 30,

 

Nine Months Ended September 30,

September 30,

September 30,

2017

 

2016

 

2017

 

2016

2021

2020

2021

2020

Revenue:

 

 

 

 

 

 

 

 

 

 

 

Product

$

657 

 

$

581 

 

$

2,195 

 

$

1,640 

$

1,614

$

1,217

$

4,748

$

3,128

Genetics

49

22

208

64

Service

 

42 

 

 

42 

 

 

128 

 

 

197 

3

-

5

13

Total revenue

 

699 

 

 

623 

 

 

2,323 

 

 

1,837 

1,666

1,239

4,961

3,205

Cost of revenue:(1)

 

 

 

 

 

 

 

 

 

 

 

Cost of revenue(1):

Product

 

495 

 

 

461 

 

 

1,345 

 

 

1,516 

694

670

2,167

1,793

Genetics

223

133

746

394

Service

 

284 

 

 

356 

 

 

855 

 

 

416 

-

4

-

13

Total cost of revenue

 

779 

 

 

817 

 

 

2,200 

 

 

1,932 

917

807

2,913

2,200

Gross profit (loss)

 

(80)

 

 

(194)

 

 

123 

 

 

(95)

Gross profit

749

432

2,048

1,005

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Research and development(2)

 

192 

 

 

370 

 

 

685 

 

 

1,868 

1,518

595

3,861

1,370

Sales and marketing(3)

 

1,050 

 

 

1,606 

 

 

3,114 

 

 

5,514 

5,083

2,152

12,209

6,000

General and administrative(4)

 

1,177 

 

 

1,295 

 

 

3,825 

 

 

4,645 

3,839

1,966

9,627

5,542

Total operating expenses

 

2,419 

 

 

3,271 

 

 

7,624 

 

 

12,027 

10,440

4,713

25,697

12,912

Loss from operations

 

(2,499)

 

 

(3,465)

 

 

(7,501)

 

 

(12,122)

(9,691)

(4,281)

(23,649)

(11,907)

Interest income (expense), net

 

(10)

 

 

(11)

 

 

(32)

 

 

(16)

(14)

5

(35)

14

Other income (expense), net

 

 -

 

 

 -

 

 

(9)

 

 

16 

(2)

(11)

983

69

Net loss

$

(2,509)

 

$

(3,476)

 

$

(7,542)

 

$

(12,122)

$

(9,707)

$

(4,287)

$

(22,701)

$

(11,824)

Deemed dividend on warrant repricing

 

(942)

 

 

 -

 

 

(942)

 

 

 -

Net loss attributable to common stockholders

$

(3,451)

 

$

(3,476)

 

$

(8,484)

 

$

(12,122)

Net loss per share attributable to common stockholders - basic and diluted

$

(0.06)

 

$

(0.07)

 

$

(0.15)

 

$

(0.23)

Net loss per share - basic and diluted

$

(0.09)

$

(0.04)

$

(0.20)

$

(0.12)

Weighted average common shares used to compute basic and diluted net loss per common share

 

57,455,786 

 

 

52,237,287 

 

 

55,909,788 

 

 

52,167,543 

112,077,133

103,200,612

110,904,824

99,555,194

Non-cash stock-based compensation expense included in cost of revenue and operating expenses:

 

 

 

 

 

 

 

 

 

 

 

(1) Cost of revenue

$

29 

 

$

27 

 

$

108 

 

$

73 

$

50

$

20

$

137

$

73

(2) Research and development

 

 

 

10 

 

 

 

 

63 

115

16

235

17

(3) Sales and marketing

 

38 

 

 

14 

 

 

115 

 

 

70 

367

31

843

116

(4) General and administrative

 

257 

 

 

210 

 

 

767 

 

 

655 

646

343

1,734

915

See accompanying notes to the unaudited condensed consolidated financial statements.

6

4


Vermillion,Aspira Women’s Health Inc.

Consolidated Statements of Changes in Stockholders’ Equity

(Amounts in Thousands, Except Share Amounts)

(Unaudited)

Common Stock

Shares

Amount

Additional Paid-In Capital

Accumulated Deficit

Total Stockholders’ Equity

Balance at December 31, 2020

104,619,876 

$

105 

$

449,680 

$

(440,066)

$

9,719 

Net loss

-

-

-

(5,920)

(5,920)

Common stock issued in conjunction with exercise of stock options

196,976 

-

317 

-

317 

Common stock issued in conjunction with public offering, net of issuance costs of $0.5 million

6,900,000 

47,713 

-

47,720 

Stock-based compensation expense

-

-

489 

-

489 

Balance at March 31, 2021

111,716,852 

$

112 

$

498,199 

$

(445,986)

$

52,325 

Net loss

-

-

-

(7,074)

(7,074)

Common stock issued in conjunction with exercise of stock options

305,090 

-

304 

-

304 

Common stock issued for restricted stock awards

36,092 

-

267 

-

267 

Common stock issued in conjunction with public offering, net of issuance costs

-

-

-

Stock-based compensation expense

-

-

1,015 

-

1,015 

Balance at June 30, 2021

112,058,034 

$

112 

$

499,786 

$

(453,060)

$

46,838 

Net loss

-

-

-

(9,707)

(9,707)

Common stock issued in conjunction with exercise of stock options

14,515 

-

58 

-

58 

Common stock issued for restricted stock awards

27,500 

-

108 

-

108 

Offering cost adjustment

-

-

137 

-

137 

Stock-based compensation expense

-

-

1,070 

-

1,070 

Balance at September 30, 2021

112,100,049 

$

112 

$

501,159 

$

(462,767)

$

38,504 

Common Stock

Shares

Amount

Additional Paid-In Capital

Accumulated Deficit

Total Stockholders’ Equity

Balance at December 31, 2019

97,286,157

$

97

$

430,802

$

(422,161)

$

8,738

Net loss

-

-

-

(3,706)

(3,706)

Common stock issued in conjunction with exercise of stock options

2,500

-

1

-

1

Stock-based compensation expense

-

-

269

-

269

Balance at March 31, 2020

97,288,657

$

97

$

431,072

$

(425,867)

$

5,302

Net loss

-

-

-

(3,831)

(3,831)

Common stock issued in conjunction with exercise of stock options

247,625

-

295

-

295

Common stock issued for restricted stock awards

178,470

-

122

-

122

Common stock issued in conjunction with warrant exercises

2,810,338

4

5,055

-

5,059

Stock-based compensation expense

-

-

320

-

320

Balance at June 30, 2020

100,525,090

$

101

$

436,864

$

(429,698)

$

7,267

Net loss

-

-

-

(4,287)

(4,287)

Common stock issued in conjunction with exercise of stock options

277,167

-

508

-

508

Common stock issued for restricted stock awards

89,236

-

61

-

61

Common stock issued in conjunction with private placement, net of $373 in issuance costs

3,150,000

3

10,649

-

10,652

Stock-based compensation expense

-

-

349

-

349

Balance at September 30, 2020

104,041,493

$

104

$

448,431

$

(433,985)

$

14,550

See accompanying notes to the unaudited condensed consolidated financial statements.

5


Aspira Women’s Health Inc.

Condensed Consolidated Statements of Cash Flows

(Amounts in Thousands)

(Unaudited)

 

 

 

 

 

Nine Months Ended

Nine Months Ended

September 30,

September 30,

2017

 

2016

2021

2020

Cash flows from operating activities:

 

 

 

 

 

Net loss

$

(7,542)

 

$

(12,122)

$

(22,701)

$

(11,824)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

Non-cash lease expense

35

10

Depreciation and amortization

 

599 

 

 

523 

238

178

Stock-based compensation expense

 

997 

 

 

861 

2,949

1,121

Loss on sale and disposal of property and equipment

 

 

 

1

3

Forgiveness of PPP loan

(1,006)

-

Changes in operating assets and liabilities:

 

 

 

 

 

Accounts receivable

 

54 

 

 

(44)

(238)

76

Prepaid expenses and other assets

 

312 

 

 

354 

262

248

Inventories

 

(62)

 

 

(5)

(107)

(20)

Accounts payable, accrued liabilities and other liabilities

 

(401)

 

 

(769)

821

230

Deferred revenue

 

62 

 

 

 -

Net cash used in operating activities

 

(5,977)

 

 

(11,199)

(19,746)

(9,978)

Cash flows from investing activities:

 

 

 

 

 

Purchase of property and equipment

 

(56)

 

 

(1,240)

(154)

(267)

Net cash used in investing activities

 

(56)

 

 

(1,240)

(154)

(267)

Cash flows from financing activities:

 

 

 

 

 

Proceeds from private placement offering of common stock, net of issuance costs

 

5,127 

 

 

 -

Proceeds from exercise of common stock warrants, net of issuance costs

 

3,577 

 

 

 -

Proceeds from issuance of DECD loan, net of issuance costs

 

 -

 

 

1,967 

Principal repayment of DECD loan

 

(136)

 

 

(73)

(148)

(143)

Repayment of capital lease obligations

 

(25)

 

 

(22)

Proceeds from issuance of common stock from exercise of stock options

 

 -

 

 

679

804

Proceeds from PPP loan

-

1,006

Proceeds from exercise of warrants

-

5,059

Proceeds from private placement, net of issuance costs

-

10,652

Proceeds from public offering

48,236

-

Payment of offering costs for public offering

(378)

-

Net cash provided by financing activities

 

8,543 

 

 

1,877 

48,389

17,378

Net increase (decrease) in cash and cash equivalents

 

2,510 

 

 

(10,562)

Cash and cash equivalents, beginning of period

 

5,242 

 

 

18,642 

Cash and cash equivalents, end of period

$

7,752 

 

$

8,080 

Net increase in cash, cash equivalents and restricted cash

28,489

7,133

Cash, cash equivalents and restricted cash, beginning of period

16,631

11,703

Cash, cash equivalents and restricted cash, end of period

$

45,120

$

18,836

Supplemental disclosure of cash flow information:

 

 

 

 

 

Cash paid during the period for interest

 

36 

 

 

24 

57

27

Supplemental disclosure of non-cash investing and financing activities:

 

 

 

 

 

Deemed dividend on warrant repricing

 

942 

 

 

 -

Supplemental disclosure of noncash investing and financing activities:

Net (decrease) increase in right-of-use assets

(45)

369

Net changes in accounts payable related to capital expenditures

-

154

See accompanying notes to the unaudited condensed consolidated financial statements.


7

6


Aspira Women’s Health Inc.

Vermillion, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

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

Organization

Aspira Women’s Health Inc., formerly known as Vermillion, Inc. (“Vermillion”; VermillionAspira” and its wholly-owned subsidiaries are collectively referred to as the “Company, “we” or “our”) 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 OVA1™the following products and Overa™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 reflex 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 hereditary 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 wet-lab testing platform and cloud service technology. Through September 30, 2021, the Company’s product and related services revenue was limited to revenue generated by sales of malignancy tests for ovarian cancer (“OVA1”OVA1, OVA1plus and “Overa,” respectively)Aspira GenetiX.  The Company sells OVA1 and OVA1plus through Vermillion’sAspira’s wholly-owned Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) certified clinical laboratory, ASPiRA LABS,Aspira Labs, Inc. (“ASPiRA LABS”).

In 2021, the Company began to enter into decentralized arrangements with large healthcare networks and large practices for its Aspira Synergy product. The Company also offers in-vitro diagnostic (“IVD”) trialhas entered into 4 technology transfer agreements since the launch of Aspira Synergy. NaN of the agreements are with two of the nation’s largest and leading independent women’s healthcare groups.  The other 2 agreements are with two independent laboratories providing services to third-party customers through its wholly-owned subsidiary, ASPiRA IVD, Inc. (“ASPiRA IVD”), which commenced operations in June 2016. ASPiRA IVD is a specialized, CLIA certified, laboratory provider dedicated to meeting the unique testing needs of IVD manufacturers seeking to commercialize high-complexity assays.across five states.

Going Concern

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 $393,098,000 at September 30, 2017.$462,767,000. The Company also expects to incur a net loss and negative cash flows from operations for the remainder of 20172021. 

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 foreseeable future. The Company’s management believes that successful achievementUnited 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 Company’s business objectives will require additional financing. Given these conditions, there is substantial doubt aboutCOVID-19 pandemic and actions taken to contain it, the Company’s ability to continuetest 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 going concern. The condensed consolidated financial statements have been prepared on a going concern basis and do not include any adjustments that might result from these uncertainties.

of closures. The Company expectssaw 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 raise capitalpre-COVID-19 levels during the late third quarter 2020 through a varietythe first quarter 2021. We began exceeding pre-COVID-19 levels starting in the first half of sources, which may include the exercisesecond quarter of common stock warrants,  equity offerings, debt financing, collaborations, licensing arrangements, grants2021 but began trending down in the latter half of the second quarter of 2021 as physician offices had fewer patient visits. In addition, during the third quarter of 2021, the Company experienced additional restrictions to doctor offices in key states such as Michigan, Florida, New York and government funding and strategic alliances. However, additional funding may not be availableKentucky when needed or on terms acceptablecompared to the Company. Ifsecond quarter 2021. 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, Key Opinion Leader

7


presentations, and increased digital sales and marketing. Enrollment for clinical research studies has been slower than originally planned due to the impact of clinic closures and patients not seeking medical care in 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 obtain additional capital, it may not be able to continue sales and marketing, research and development,estimate the extent of the impact of the COVID-19 pandemic on its operations or other operations on the scope or scale of current activity and that could have a material adverse effect on the Company’s business, results of operations and financial condition.liquidity.

As discussed in Note 4, on August 31, 2017, certain investors exercised outstanding warrants for common stock for net proceeds of approximately $3,577,000 after deducting offering expenses.

As discussed in Note 4, on February 17, 2017, the Company completed a private placement pursuant to which certain investors purchased Vermillion common stock and warrants to purchase shares of Vermillion common stock for net proceeds of approximately $5,127,000 after deducting offering expenses.

As discussed in Note 3, in March 2016, the Company entered into ana loan agreement (the “Loan(as amended on March 7, 2018 and April 3, 2020, the “DECD Loan Agreement”) pursuant to which it may borrow up to $4,000,000 fromwith 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 inon April 15, 2016 under the DECD Loan Agreement. The Loan Agreement provides thatOn December 3, 2020, the Company received a disbursement of the remaining $2,000,000 will be disbursed if and whenunder the DECD Loan Agreement, as the Company achieves certain future milestones. 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”).

8


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 $10,600,000, 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 $47,900,000, after deducting underwriting discounts and offering expenses. 

As discussed in Note 3, in March 2021, the Company applied for forgiveness of the PPP Loan, and, effective May 27, 2021, the SBA confirmed the waiver of the Company’s repayment of the PPP Loan. The Company remains subject to an audit of the PPP loan. The Company recognized a gain on forgiveness of debt of $1,005,767, which is included in other income in the condensed consolidated statements of operations, and reduced long- and short-term indebtedness by the same amount. 

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

8


have access to the audited consolidated financial statements for the preceding fiscal year. The condensed consolidated balance sheet at December 31, 20162020 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, 20162020 included in Vermillion’sAspira’s Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on March 31, 20172021 (the “2016“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.

Reclassification

Certain prior period amounts have been reclassified to conform to the current period presentation with no material effect on the consolidated financial statements.

Significant Accounting and Reporting Policies

Revenue Recognition

Product Revenue

– OVA1, OVERA and OVA1plus: The Company has adopted ASC 954-605,Health Care Entities—Revenue Recognition, as revenue from laboratory services has become significant to the Company.The Company'srecognizes product revenue in accordance with the provisions of ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). Product revenue is generated by performing diagnostic services using itsrecognized upon completion of the OVA1, OVERA or OVA1plus test and Overa tests, and the service is completed upon the delivery of test results to the prescribing physician. The Company recognizes revenue related to billings for Medicare and commercial payersphysician based on an accrual basis, netestimates of contractual and other adjustments, when amounts that will ultimately be realized canrealized. In determining the amount of revenue to be estimated. Untilrecognized for a contract has been negotiated with a commercial payer or governmental program, the OVA1 and Overa tests may or may not be covered by these entities' existing reimbursement policies. In addition, patients do not enter into direct agreements withdelivered test result, the Company that commit them to pay any portion ofconsiders factors such as payment history and amount, payer coverage, whether there is a reimbursement contract between the cost of the tests in the event that their insurance declines to reimburse the Company. In the absence of an agreement with the patient or other clearly enforceable legal right to demand payment from the patient, the related revenue is only recognized upon cash receipt.

Estimates of amounts thatpayer and the Company, will ultimately realizeand any developments or changes that could impact reimbursement. These estimates require significant judgment by management. Some patients have out-of-pocket costs for amounts not covered by their insurance carrier, andmanagement as the Company may bill the patient directly for these amounts in the form of co-payments and co-insurance in accordance with the patient’s health plan. Some payers may not cover the OVA1 and Overa testscollection cycle on some accounts can be as ordered by the prescribing physician under their reimbursement policies. long as one year.

The Company pursues reimbursement from such patients on a case-by-case basis. In the absence of contracted reimbursement coverage or the ability to estimate the amount that will ultimately be realized for the Company's services, revenue is recognized when cash is received.

 See discussion of ASU No. 2014-09 (defined below) included in Recent Accounting Pronouncements below.  

9


Service Revenue

The Company’s service revenue is generated by performing IVD trial services for third-party customers. In accordance with SAB Topic 13, service revenue is recognized when the following revenue recognition criteria are met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the fee is fixed or determinable; and (4) collectability is reasonably assured. 

See discussion of ASU No. 2014-09 included in Recent Accounting Pronouncements below.

The Company has made no other significant changes in its critical accounting policies and estimates from those disclosed in the 2016 Annual Report. 

Recent Accounting Pronouncements

In March 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-09, Improvements to Employee Share-Based Payment Accounting (Topic 718), Compensation - Stock Compensation (“ASU 2016-09”). The new guidance simplifies several aspects of the accounting for share-based payments, including immediate recognition of all excess tax benefits and deficiencies in the income statement, changing the threshold to qualify for equity classification up to the employees' maximum statutory tax rates, allowing an entity-wide accounting policy election to either estimate the number of awards that are expected to vest or account for forfeitures as they occur, and clarifying the classification on the statement of cash flows for the excess tax benefit and employee taxes paid when an employer withholds shares for tax-withholding purposes. ASU 2016-09 is effective for annual reporting periods beginning after December 15, 2016 and interim periods within that reporting period. The adoption of this standard is not expected to have a material effect on our financial statements.

In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”), which removes inconsistencies and weaknesses in revenue requirements, provides a more robust framework for addressing revenue issues, improves comparability of revenue recognition practices across entities, industries, jurisdictions and capital markets, provides more useful information to users of financial statements through improved disclosure requirements and simplifies the preparation of financial statements by reducing the number of requirements to which an entity must refer. This guidance requires that an entity depict the consideration by applying a five-step analysis in determining when and how revenue is recognized. The new model will require revenue recognition to depict the transfer of promised goods or services to customers in an amount that reflects the consideration a company expects to receive in exchange for those goods or services. On April 1, 2015, the FASB voted for a one-year deferral of the effective date of the new revenue recognition standard, ASU No. 2014-09. On July 15, 2015, the FASB affirmed these changes, which requires public entities to apply the amendments in ASU 2014-09 for annual reporting beginning after December 15, 2017. Early adoption is permitted beginning after December 31, 2016, the original effective date in ASU 2014-09.

The Company is in the early stages of its analysis of the effect ASU 2014-09 will have on its Service Revenue, but expects to complete its analysis during the fourth quarter of 2017.

The Company is also continuing its analysis of the effect ASU 2014-09 will have on its Product Revenue and also expects to complete this analysis in the fourth quarter of 2017. Revenue that is recognized upon the ultimate receipt of cash under the Company’s existing revenue recognition policy will have to be reassessed under the new standard. The Company’s implementation process is to reviewreviews its patient account population to determine theand determines an appropriate distribution of patient accounts by payer  (i.e. (i.e., Medicare, patient pay, other third-party payer, etc.etc.) into portfolios with similar collection experienceexperience. The Company has elected this practical expedient that, when evaluated for collectability, will resultresults in a materially

10


consistent revenue amount for such portfolios as if each patient account were evaluated on an individual contract basis. During the period ended September 30, 2021, there were no adjustments to estimates of variable consideration to derecognize revenue for services provided in a contract-by-contract basis.prior period. There were 0 impairment losses on accounts receivable recorded during the periods ended September 30, 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 hasdoes not yet determined ifexpect to have any significant service revenue going forward, as it plans to utilizelargely wound down performing the full retrospective or modified retrospective method of adoption, but anticipates adopting the new standardASPiRA IVD, Inc. (“ASPiRA IVD”) trial services in the firstfourth quarter of 2018.2019.  During 2020 and 2021, the Company’s service revenue was limited to the fulfillment of one legacy IVD contract.  

9


Recent Accounting Pronouncements

In June 2016, the Financial Accounting Standards Board issued Accounting Standard Update 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.

2.    AGREEMENTS WITH QUEST DIAGNOSTICS INCORPORATED

In March 2015, the Company entered into a commercialreached an agreement with Quest Diagnostics, IncorporatedInc. (“Quest Diagnostics”). Pursuant to this agreement, all OVA1 U.S. testing services for Quest Diagnostics customers were transferred toVermillion’s Aspira’s wholly-owned subsidiary, ASPiRA LABS,as of August 2015. Pursuant to this agreement, as amended as of March 11, 2017,2020, Quest Diagnostics has agreedcontinued to provide blood draw and logistics support by transporting specimens from its clients to ASPiRA LABS for testing through at least March 11, 2018 in exchange for a market value fee. PerThe 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.

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 this agreement,the CARES Act and the PPP Loan, all or a portion of the principal amount of the PPP Loan was 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 will not offerused those proceeds for payroll costs, rent, utility costs or the maintenance of employee and compensation levels. The PPP Loan, which was granted pursuant to existing or future Quest Diagnostics customers tests that Quest Diagnostics offers.a promissory note, was set to mature on May 1, 2022. The Company applied for forgiveness of the PPP Loan in March 2021, and, effective May 27, 2021, the SBA confirmed the waiver of the Company’s repayment of the PPP Loan. The Company recognized a gain on forgiveness of debt of $1,005,767, which is included in other income in the condensed consolidated statements of operations, and reduced long- and short-term indebtedness by the same amount. The Company remains subject to an audit of the PPP loan.

3.COMMITMENTS AND CONTINGENCIES

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. Proceeds from the $2,000,000 April 2016 initial disbursement under the Loan Agreement were utilized primarily to fund the build-out, information technology infrastructure and other costs related to the Company’s Trumbull, Connecticut facility and operations. 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.

10


Under the terms of the DECD Loan Agreement, the Company may be eligible for forgiveness of up to $2,000,000$1,500,000 of the principal amount of the loan if the Company achieves certain job creation and retention milestones by March 1, 2018.December 31, 2022. Conversely, if the Company is either unable to meet these job creation milestones, namely, hiring 40retain 25 full-time employees with a specified average annual salary within the allotted timeframe and retaining those employees for a two-yearconsecutive two year period or does not maintain the Company’s Connecticut operations for a period of 10 years,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:

September 30,

December 31,

2021

2020

(in thousands)

DECD loan, net of issuance costs

$

2,968

$

3,116

PPP loan

-

1,006

Total debt

2,968

4,122

Less: Current portion, net of issuance costs

(200)

(645)

Total long-term debt, net of issuance costs

$

2,768

$

3,477

As discussed above, an initial disbursement of $2,000,000 was made toSeptember 30, 2021, the annual amounts of future minimum principal payments due under the Company’s contractual obligation are shown in the table below. Unamortized debt issuance costs for the DECD loan were $16,000. 

Payments Due by Period

(in thousands)

Total

2021

2022

2023

2024

2025

Thereafter

DECD Loan

$

2,984

$

51

$

204

$

406

$

452

$

461

$

1,410

Total

$

2,984

$

51

$

204

$

406

$

452

$

461

$

1,410

Insurance Notes

During 2020 and 2019, the Company on April 15, 2016 underentered into insurance promissory notes for the Loan Agreement. The Loan Agreement provides that the remaining $2,000,000 will be disbursed ifpayment of insurance premiums at an interest rate of 3.88% and when the Company achieves certain future milestones. The loan may be prepaid at any time without premium or penalty.4.49% respectively, with an aggregate principal amount outstanding of approximately $0 and $611,000 as of September 30, 2021 and December 31, 2020, respectively. These notes were payable in 10 monthly installments with a maturity date of October 1, 2021.

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 by ASPiRA IVDfor research and development services is located in Trumbull, Connecticut.  TheIn October 2020, the Company renewed the Austin, Texas lease includesfor an aggregate annual base rent of $85,000 and annual estimated common area charges, taxes and insurance of $46,000 andadditional one year.  The Company’s renewed lease expires on January 31, 2019.    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 term ofCompany’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 lease is five yearsyear renewal option beginning after the initial date of occupancy in January on July 1, 2026.

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2016 and a rent abatement period of five months. The lease includes an aggregate annual base rent of $32,000 and annual estimated common area charges, taxes and insurance of $95,000.  

Building rentexpense associated with these operating leases for the three months ended September 30, 2017 and 2016 totaled $66,000 and $71,000, respectively. Building rent for the nine months ended September 30, 20172021 and 2016 totaled $189,000 and $175,000, respectively.2020 is shown in the table below (in thousands).

Capital Lease

Three Months Ended September, 30

Lease Cost

Classification

2021

2020

Operating rent expense

Cost of revenue

$

14

$

13

Research and development

13

9

Sales and marketing

8

8

General and administrative

16

15

Variable rent expense

Cost of revenue

$

8

$

8

Research and development

12

4

Sales and marketing

11

12

General and administrative

16

17

Nine Months Ended September, 30

Lease Cost

Classification

2021

2020

Operating rent expense

Cost of revenue

$

42

$

41

Research and development

35

29

Sales and marketing

25

16

General and administrative

51

39

Variable rent expense

Cost of revenue

$

23

$

19

Research and development

25

11

Sales and marketing

30

34

General and administrative

46

45

In April 2015,Based on the Company leased a laboratory instrument for a total initial payment of $125,000 and ongoing payments of approximately $3,500 per month for 36 months after delivery. The agreement also requires minimum annual purchases of reagents from the manufacturer of the equipment. The laboratory instrument was placed into service on July 1, 2015.

The accumulated amortization of assets under capital lease obligations was $174,000 and $97,000Company’s leases as of September 30, 20172021, 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

$

22

2022

95

2023

106

2024

116

2025

124

2026

64

Total Operating Lease Payments

527

Less: Interest

(105)

Present Value of Lease Liabilities

$

422

Weighted-average lease term and 2016, respectively. The net book value of assets under capital lease obligations was $58,000 and $135,000discount rate were as ofSeptember 30, 2017 and 2016, respectively.  follows:

Weighted-average remaining lease term (in years)

4.7

Weighted-average discount rate

9.34%

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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, VermillionAspira 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 three months ended September 30, 20172021 and 2016 totalled $30,0002020 totaled $65,000 and $24,000, respectively. Royalty$48,000, respectively, and royalty expense for the nine months ended September 30, 20172021 and 2016 totalled $94,0002020 totaled $190,000 and $66,000, respectively.$124,000, respectively, as recorded in cost of revenue in the condensed consolidated statements of operations.

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.

4.    STOCKHOLDERS’ EQUITY

2017 Warrant Repricing and Exercise

2020Exercise of Warrants

In December 2014,

On February 17, 2017, the Company issued certain warrants to purchase up to an aggregate of 4,166,659 2,810,338 shares of VermillionAspira common stock at an exercise price of $2.00$1.80 per share in conjunctionconnection with a December 2014February 2017 private placement of VermillionAspira common stock. The warrants expire by their original terms on December 23, 2017.

On August 31, 2017, certain holders exercised warrants to purchase 3,796,818 shareswere initially sold at a price of Vermillion$0.125 per share of common stock in considerationunderlying the warrants. 

On June 1, 2020, following the 20th consecutive trading day for which the Company agreeing to reduceclosing price per share of Aspira common stock, as reported on the Nasdaq stock market, exceeded the exercise price, the Company sent notice to $1.00 per sharethe investors holding such warrants accelerating the expiration date of Vermillion common stock.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 3,796,8182,810,338 shares of Vermillion Aspira common stock and received $3,796,818$5,060,000 in aggregate gross proceeds (approximately $3,577,000 net of transaction costs). The incremental non-cash fair value of approximately $942,000 from the modificationexercise of the warrants.  As of the date of the issuance of these financial statements, there are no outstanding warrants was calculated usingfor the Black-Scholes model and recorded as a deemed dividend to the warrant holders within stockholders’ equity.purchase of Aspira common stock.

20172020 Private Placement

On February 17, 2017,July 20, 2020, the Company completed a private placement pursuant to which certain investors purchased 3,747,1253,150,000 shares of VermillionAspira common stock at a price of $1.40$3.50 per share. Vermillion also issued warrants to purchase shares of Vermillion common stock at a price of $0.125 per warrant share in the private placement.  Net proceeds of the private placement were approximately $5,127,000 $10.6 million, after deducting offering expenses. The warrants are exercisable for 2,810,338 sharesexpenses related to the private placement of Vermillion common stock at $1.80 per share. The warrants expire on the fifth anniversary of the date of issuance or, if earlier, five business days after Vermillion delivers notice that the closing price per share of its common stock exceeded the exercise price for 20 consecutive trading days during the exercise period.

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$384,000.  The sale of common stock and issuance of warrants 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 respective values2021 Underwriters purchased these 6,000,000 shares at the public offering price per share, less the underwriting discount of $0.4875 per share.

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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 warrants and2021 Offering. The 2021 Offering, including the additional 900,000 shares of Aspira common stock, were calculated using their relative fair valuesclosed on February 8, 2021 and classified under common stock and additional paid-in capital. The value ascribedresulted in net proceeds to the warrants is $804,000Company of approximately $47.9 million, after deducting underwriting discounts and to the common stock is approximately $4,296,000.offering expenses.

20102019 Stock Incentive Plan

TheAt the Company’s employees, directors, and consultants are eligible to receive awards under2019 annual meeting of stockholders, the Company’s stockholders approved the Vermillion, Inc. Second Amended and Restated 20102019 Stock Incentive Plan (the “2010“2019 Plan”). The 2010purposes of the 2019 Plan permitsare (i) to align the grantinginterests of a varietythe Company’s stockholders and recipients of awards includingunder 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, sharestock 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 restricted share units, unrestricted shares, deferred share units, performance and cash-settled awards, and dividend equivalent rights. The 2010authorized for grants under the 2019 Plan provides for issuance of up to 8,122,983is 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 Vermillion common stock subject to adjustment as provided insuch award will become available for future grant under the 20102019 Plan. As of September 30, 2021, 10,514,967 shares of Aspira common stock were subject to outstanding stock options, and 14,374 shares of Aspira common stock were subject to unvested restricted stock awards and a total of 3,501,145 shares of Aspira common stock were reserved for issuance under the 2019 Plan.

Stock-Based Compensation

During the ninethree months ended September 30, 2017,March 31, 2021, the Company awarded to Vermillion’s non-employee directors 131,250 shares of restricted stockgranted the following awards under the 2010 Plan having a fair value of approximately $281,000 as payment for services to be rendered in 2017. These shares of restricted stock vested 50% on2019 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

During the three months ended June 1, 2017 and 25% on September 1, 2017, and30, 2021, the remaining 25% will vest on December 1, 2017. The Company also issued to certain consultants 27,878 shares of restricted stockgranted the following awards under the 2010 Plan having a fair value of approximately $48,000.2019 Plan:

Grant Date

Number of Shares

Type of Award

Exercise Price

Fair Value / Share

5/6/2021

210,720 

Options

$            4.92

$         3.13

5/6/2021

423 

Restricted Stock Units

$                 -

$              -

6/24/2021

313,502 

Options

$            5.90

$         3.73

6/24/2021

330 

Restricted Stock Units

$                 -

$              -

524,975 


14


During the three months ended September 30, 2017, the Company issued to certain consultants 5,037 shares of restricted stock under the 2010 Plan having a fair value of approximately $9,000. The Company did not make any awards of restricted stock to non-employee directors during the three months ended September 30, 2017. 

During the nine months ended September 30, 2017, the Company also granted certain consultants options to purchase 70,000 shares of Vermillion common stock with an exercise price of $2.14 per share.  The Company also granted certain officers and employees options to purchase approximately 916,000 shares of Vermillion common stock with an exercise price of $2.14 per share. In addition,2021, the Company granted certain officers and employees options to purchase 14,500 shares of Vermillion common stock with an exercise price of $1.83 per share.  These stock options generally vest 25% on each of the four anniversaries offollowing awards under the grant date.  2019 Plan:

Grant Date

Number of Shares

Type of Award

Exercise Price

Fair Value / Share

8/19/2021

48,000 

Options

$            3.52

$         2.22

9/30/2021

389,000 

Options

$            3.25

$         2.05

437,000 

During the nine months ended September 30, 2017, the Company also granted certain officers and employees options to purchase 250,000 shares of Vermillion common stock with an exercise price of approximately $2.14 per share with performance-based vesting based on certain metrics through December 31, 2017. These options vest 25% on each of the four anniversaries of the grant date if the performance-based metrics are met.

During the three months ended September 30, 2017, the Company granted certain officers and employees options to purchase 22,500 shares of Vermillion common stock with an exercise price of $1.32 per share. These stock options vest 25% on each of the four anniversaries of the vesting commencement date for each such stock option. 

During the three months ended September 30, 2017, the Company granted certain consultants of the Company options to purchase 120,000 shares of Vermillion common stock with an exercise price of $1.32 per share. These stock options vest in 24 equal monthly installments beginning on the vesting commencement date for each such stock option.

The allocation of employee stock-based compensation expense by functional area for the three and nine months ended September 30, 20172021 and 20162020 was as follows:

Three Months Ended

Nine Months Ended

September 30,

September 30,

(in thousands)

2021

2020

2021

2020

Cost of revenue

$

44

$

18

$

122

$

66

Research and development

113

15

231

16

Sales and marketing

350

31

815

111

General and administrative

445

228

1,236

722

Total

$

952

$

292

$

2,404

$

915

13




 

 

 

 

 

 

 

 

 

 

 

 



 

Three Months Ended September 30,

 

Nine Months Ended September 30,

(in thousands)

 

2017

 

2016

 

2017

 

2016

Cost of revenue

 

$

21 

 

$

24 

 

$

61 

 

$

70 

Research and development

 

 

 —

 

 

10 

 

 

 

 

63 

Sales and marketing

 

 

38 

 

 

10 

 

 

108 

 

 

66 

General and administrative

 

 

216 

 

 

198 

 

 

630 

 

 

623 

Total

 

$

275 

 

$

242 

 

$

804 

 

$

822 



 

 

 

 

 

 

 

 

 

 

 

 

5.    LOSS PER SHARE

The Company calculates basic loss per share using the weighted average number of shares of VermillionAspira 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 VermillionAspira common stock outstanding and excludes the effects of 7,971,86010,529,341 and 7,485,6328,451,788 potential shares of VermillionAspira common stock as of September 30, 20172021 and 2016,2020, respectively, that are anti-dilutive. Potential shares of VermillionAspira common stock include incremental shares of VermillionAspira common stock issuable upon the exercise of outstanding warrants, stock options and unvested restricted stock units.

14


ITEM 2.    MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995.

These statements involve a number of risks and uncertainties.  Words such as “may,” “expects,” “intends,” “anticipates,” “believes,” “estimates,” “plans,” “seeks,” “could,” “should,” “continue,” “will,” “potential,” “projects” and similar expressions are intended to identify such forward-looking statements.  Readers are cautioned that these forward-looking statements speak only as of the date on which this Quarterly Report on Form 10-Q is filed with the Securities and Exchange Commission (“SEC”(the “SEC”), and, except as required by law, Vermillion,Aspira Women’s Health Inc. (“Vermillion”Aspira” and, together with its subsidiaries, the “Company,” “we,” “our,” or “us”) does not assume any obligation to update, amend or clarify them to reflect events, new information or circumstances occurring after such date.

Examples of forward-looking statements include, without limitation:

projections or expectations regarding our business include the following:future test volumes, revenue, cost of revenue, operating expenses, research and development expenses, gross profit margin, cash flow, results of operations and financial condition;

our plan to broaden our commercial focus from ovarian cancer to differential diagnosis of women with a range of gynecological disorders, including additional pelvic disease conditions such as endometriosis, in addition to genetics risk assessment, including breast and ovarian cancer hereditary risk assessment and carrier screening;

·

projections or expectations regarding our future test volumes, revenue, cost of revenue, operating expenses, cash flow, results of operations and financial condition;

·

our plan to broaden our commercial focus from ovarian cancer to differential diagnosis of women with a range of gynecological disorders;

·

our planned business strategy and the anticipated timing of the implementation thereof;

·

plans with respect to our market expansion and growth, including plans to market Overa outside the United States;

·

plans to develop new algorithms and molecular diagnostic tests; 

·

plans to develop a product or tool combining an OVA1 with results of a symptom index;

·

plans to establish our own payer coverage for OVA1 and Overa;

·

intentions to address clinical questions related to early disease detection, treatment response, monitoring of disease progression, prognosis and other issues in the fields of oncology and women’s health;

·

plans to leverage infrastructure and enhance our pipeline of future technologies by fostering relationships with in vitro diagnostic (“IVD”) companies;

·

plans with respect to ASPiRA IVD, Inc. (“ASPiRA IVD”);

·

expected service revenue growth based on ASPiRA IVD;

·

expected license revenue in future periods;

·

our planned focus on the execution of five core strategic business drivers in ovarian cancer diagnostics and specialized laboratory services to address unmet medical needs for women faced with gynecologic disease and other conditions and the continued development of our business;

·

anticipated efficacy of our products, product development activities and product innovations;

·

expected competition in the markets in which we compete;

·

plans with respect to ASPiRA LABS, Inc. (“ASPiRA LABS”);

·

expectations regarding future services provided by Quest Diagnostics Incorporated (“Quest Diagnostics”);

·

plans to expand our ovarian cancer franchise beyond OVA1, including with respect to Overa and OvaX;

15


·

plans regarding the commercialization of Overa;

our planned business strategy and strategic business drivers and the anticipated effects thereof;

plans to commercialize OVA1, OVERA, OVA1plus, Aspira GenetiX, OVASight (now known as OVAWatch), EndoCheck, OVAInherit and Aspira Synergy on a global level;

plans to develop new algorithms, molecular diagnostic tests, products and tools and otherwise expand our product offerings, including plans to develop a product using genetics, proteins and other modalities to assess the risk of developing cancer when carrying a pathogenic variant associated with hereditary breast and ovarian cancer that is difficult to detect through a diagnostic test;

plans and timeline to establish payer coverage for OVERA, Aspira GenetiX, OVAWatch, EndoCheck and OVAInherit separately and expand coverage for OVA1;

intentions to address clinical questions related to early disease detection, treatment response, monitoring of disease progression, prognosis and other issues in the fields of oncology and women’s health;

anticipated efficacy of our products, product development activities and product innovations, including our ability to improve sensitivity and specificity over traditional diagnostic biomarkers;

expected competition in the markets in which we compete;

plans with respect to ASPiRA LABS, including plans to expand ASPiRA LABS’ testing capabilities;

expectations regarding future services provided by Quest Diagnostics Incorporated;

plans to develop informatics products and develop and perform laboratory developed tests (“LDTs”);

FDA oversight changes of LDT’s;

plans to develop a race and / or ethnicity-specific pelvic mass risk assessment;

expectations regarding existing and future collaborations and partnerships for our products, including plans to enter into decentralized arrangements for our Aspira Synergy product;

plans regarding future publications;

our ability to continue to comply with applicable governmental regulations, expectations regarding pending regulatory submissions and plans to seek regulatory approvals for our tests within the United States and internationally, as applicable;

our continued ability to expand and protect our intellectual property portfolio;

anticipated liquidity, capital requirements and future losses;

expectations regarding raising capital and the amount of financing anticipated to be required to fund our planned operations;

expectations regarding the results of our clinical research studies and our ability to recruit patients to participate in such studies;

our ability to use our net operating loss carryforwards and anticipated future tax liability under U.S. federal and state income tax legislation;

expected market adoption of our diagnostic tests, including OVA1, OVERA, OVA1plus, Aspira GenetiX and Aspira Synergy platform;

expectations regarding our ability to launch new products we develop, or license, co-market or acquire new products;

expectations regarding the size of the markets for our products;

expectations regarding reimbursement for our products, and our ability to obtain such reimbursement, from third-party payers such as private insurance companies and government insurance plans;

plans to use each of AbbVie Inc. serum samples and ObsEva S.A. plasma samples in EndoCheck product validation studies;

expectations regarding the wind down of our ASPiRA IVD, Inc. subsidiary and future service revenue;

expectations in leveraging telehealth, including for the development of a process for patients to access Aspira GenetiX testing directly;

plans with respect to EndoCheck whether or not the FDA designates it a Breakthrough Device;

expected target launch date for OVAWatch and Endocheck;

·

plans to develop and perform laboratory developed tests (“LDTs”);

·

plans with respect to the Company’s pelvic mass registry, including anticipated sources of funding;  

16


·

anticipated effects on reimbursement for OVA1 from changes to Novitas Solutions’ administrative requirements;

·

expectations regarding the Company’s monitoring and combining multiple protein biomarkers to create diagnostic tests to aid physicians considering treatment options for patients with complex diseases, and the Company’s future development of new In Vitro Diagnostic Multivariate Index Assays (IVDMIA);

·

expectations regarding existing and future collaborations and partnerships, including OVA1 and Overa distribution agreements;

·

plans regarding future publications;

·

our continued ability to comply with applicable governmental regulations,  expectations regarding pending regulatory submissions and plans to seek regulatory approvals for our tests outside the United States;

·

our ability to obtain and maintain the regulatory approvals required to market Overa in other countries;

·

our continued ability to expand and protect our intellectual property portfolio;

·

anticipated liquidity and capital requirements;

·

anticipated future losses and our ability to continue as a going concern; 

·

expectations regarding the second disbursement from our financing arrangement with the State of Connecticut Department of Economic and Community Development (the “DECD”);

·

expected expenditures, including the expected decrease in expenses related to research and development in 2017;

·

our ability to use our net operating loss carryforwards;

·

expected market adoption of our diagnostic tests, including OVA1 and Overa;

·

expectations regarding our ability to launch new products developed, licensed, co-marketed or acquired;

·

expectations regarding raising capital and the amount of financing anticipated to be required to fund our planned operations; and

·

expectations regarding reimbursement for our products, and our ability to obtain such reimbursement, from third-party payers such as private insurance companies and government insurance plans.

compliance with federal and state laws and regulations relating to billing arrangements conducted in coordination with physician owned laboratories;

effectiveness of our efforts to advocate for legislation and professional society guidelines to broaden access to our products and services; and

expectations regarding the impacts resulting from or attributable to the COVID-19 pandemic and actions taken to contain it.

Forward-looking statements are subject to significant risks and uncertainties, including those discussed in Part I Item 1A, “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2016 (our “2016 Annual Report”) and Part II, Item 1A.2020, as supplemented by the section entitled “Risk Factors” ofin our Quarterly Report on Form 10-Q for the three monthsquarter ended March 31, 2017 (our “2017 First Quarterly Report”June 30, 2021 (“Second Quarter 2021 Form 10-Q”), that could cause actual results to differ materially from those projected in such forward-looking statements due to various factors, including impacts resulting from or relating to the COVID-19 pandemic and actions taken to contain it; anticipated use of capital and its effects; our ability to increase the volume of OVA1 or Overaour product sales; our ability to market our test through sales channels other than Quest Diagnostics including ASPiRA LABS; failures by third-party payers to reimburse OVA1 or Overafor our products and services or changes or variances into reimbursement rates; our ability to secure additional capital on acceptable termscontinue developing existing technologies and to executedevelop, protect and promote our business plan;proprietary technologies; plans to develop and perform LDTs; our ability to comply with Food and Drug Administration (“FDA”) regulations that relate to our products and to obtain any FDA clearance or approval required to develop and commercialize OVA1 and/or Overa both within and outside the United States; in the event that we succeed in commercializing OVA1 and/or Overa outside the United States, the political, economic and other conditions affecting other countries (including foreign exchange rates);medical devices; our ability to develop and commercialize additional diagnostic products and achieve market acceptance with respect to these products; our ability to compete successfully; our ability to obtain any regulatory approval required for our future diagnostic products; our or our

16


suppliers’ ability to comply with United States Food and Drug Administration (“FDA”)FDA requirements for production, marketing and post-market monitoring of our products; additional costs that may be required to make further improvements to our manufacturing operations; our ability to maintain sufficient or acceptable supplies of immunoassay kits from our suppliers; in the event that we succeed in commercializing our ability to continue to develop, protectproducts outside the United States, the political, economic and promote our proprietary technologies; future litigation against us, including infringement of intellectual property and product liability exposure; our ability to retain key employees; business interruptions; legislative actions resulting in higher compliance costs;other conditions affecting other countries; changes in healthcare policy; our ability to comply with environmental laws; our ability to generate sufficient demand for ASPiRA LABS’ services to cover its operating costs; our ability to comply with the additional laws and regulations that apply to us in connection with the operation of ASPiRA LABS; our ability to comply with FDA regulations that relate touse our products and to obtain any FDA clearance or approval required to develop and perform LDTs; ASPiRA IVD’s lack ofnet operating history; ASPiRA IVD’s ability to generate and maintain business; fluctuations over time with respect to ASPiRA IVD’s operating results; ASPiRA IVD’s ability to enter into profitable contracts; ASPiRA IVD’s ability to maintain effective information systems without significant interruption; ASPiRA IVD’s ability to perform its services in compliance with contractual requirements, regulatory standards and ethical considerations; andloss carry forwards; our ability to continue asuse intellectual property directed to diagnose biomarkers; our ability to successfully defend our proprietary technology against third parties; our ability to obtain licenses in the event a going concern.   third party successfully asserts proprietary rights; the liquidity and trading volume of our common stock; the concentration of ownership of our common stock; our ability to retain key employees; our ability to secure additional capital on acceptable terms to execute our business plan; business interruptions; the effectiveness and availability of our information systems; our ability to integrate and achieve anticipated results from any acquisitions or strategic alliances; future litigation against us, including infringement of intellectual property and product liability exposure; and additional costs that may be required to make further improvements to our manufacturing operations.

Overview

Our visioncore mission is to drivetransform the advancementstate of women’s health, by providing innovative methodsglobally, starting with ovarian cancer. We aim to detect, monitoreradicate late-stage detection of ovarian cancer and manageto ensure that all our solutions will meet the treatmentneeds of both benignwomen of all ages, races, ethnicities and malignant gynecologic disease, with our primary focus being diseasesstages of the female pelvic cavity.disease. Our core patient goal is to develop a lifelong relationship with each patient, ensuring each woman has access to the best-in-class diagnostics.

We have expanded our corporate strategy with the goal of transforming Vermillion from a technology license company to a diagnostic service and bio-analytic solutions provider. 

Our plan is to broaden our commercial focus from ovarian cancer to differential diagnosis of women with a range of gynecological disorders. Our strategy is being deployed in three phases. The three phases are a rebuild phase, which was completed in the third quarter of 2015, a transformation phase, which is now virtually complete except for continuing expansion of payer coverage, and a market expansion and growth phase, which we began in 2017.  

During the first phase, we expanded our leadership team by hiring several new senior leaders including a chief executive officer.  In addition, we expanded our commercial strategy, reestablished medical and advisory support, rebuilt our patient advocacy strategy and established a billing system and a payer strategy outside of our relationship with Quest Diagnostics.  During the second phase, we completed the process of obtaining licensure of ASPiRA LABS in all of the states that require licenses, and are in the process of establishing our own payer coverage for OVA1, Multivariate Index Assay (MIA), and our second-generation OVA1 test, trademarked Overa, Multivariate Index Assay, 2nd Generation (MIA2G). Overa has been launched on a targeted basis.  In the third phase, we We plan to fully commercializecontinue commercializing our new generation of technology as well as our decentralized technology transfer service platform. We also intend to raise public awareness regarding the diagnostic superiority of OVA1 and Overa by utilizingas compared to cancer antigen 125 (“CA125”) for Black women with adnexal masses, as well as the full national licensureimportance of ASPiRA LABS, select laboratories for distribution, managed care coveragemachine learning algorithm development in select markets, our sales force and existing customer base.  Unlike OVA1, Overa uses a global testing platform, which will allow Overa to be deployed internationally.  We initiated the targeted launch of Overa in October 2016 with two key accounts converting from OVA1 to Overa. In October 2015, we announced registration of the CE mark for and clearance to market Overa in the European Union.enriched ethic populations. We also plan to develop an LDT product series, which we referadvocate for legislation and professional society guidelines that provide broad access to internally as OvaX.  our products and services.

We anticipate that OvaX will include not only biomarkers, but also clinical risk factors, other diagnosticscurrently market and patient history data in order to boost predictive value. 

We are dedicated tosell the discovery, developmentfollowing products and commercialization of novel high-value diagnostic and bio-analytical solutions that help physicians diagnose, treat and improve outcomes for women. Our tests are intended to detect, characterize and stage disease, and to help guide decisions regarding patient treatment, which may include decisions to refer patients to specialists, to perform additional testing, or to assist in monitoring response to therapy. A distinctive feature of our approach is to combine multiple biomarkers, other modalities and diagnostics, clinical risk factors and patient data into a single, reportable index score that has higher diagnostic accuracy than its constituents. We concentrate on our development of novel diagnostic tests for gynecologic disease, with an initial focus on ovarian cancer. We also intend to address clinical questions related to early disease detection, treatment response, monitoring of disease progression, prognosis and others through collaborations with leading academic and research institutions.

Our initial product,services: (1) OVA1, is an FDA cleareda 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 riskhigh-risk of having a malignant ovarian

17


tumor prior to planned surgery. We have launched on a targeted basissurgery; (2) OVERA, a second-generation biomarker panel known as Overa, which isreflex intended to maintain our product’sOVA1’s high sensitivity while improving specificity.specificity; (3) OVA1plus,

17


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 hereditary gynecologic cancer risk, with a core focus on hereditary female reproductive cancers, including breast, ovarian, endometrial, uterine and cervical cancers; and (5) Aspira Synergy, our new decentralized wet-lab testing platform and cloud service technology, which we plan to house our algorithms for decentralized global access of both protein biomarker and hereditary genetic testing. We plan to make OVA1, OVERA, OVA1plus and Aspira GenetiX available through Aspira Synergy. Our OVA1 algorithm received FDA de novo classification in September 2009, and our OVERA algorithm received FDA 501(k) clearance for Overa in March 2016. Overa usesOVA1 and OVERA each use the Roche cobas 4000, 6000 platform.  and 8000 platforms for analysis of proteins. Through September 30, 2021, our product and related services revenue has been limited to revenue generated by sales of OVA1, OVA1plus and Aspira GenetiX. In 2021, we began to enter into decentralized arrangements with large healthcare networks and large practices for our Aspira Synergy product. The Company has entered into four technology transfer agreements since the launch of Aspira Synergy. Two of the agreements are with two of the nation’s largest and leading independent women’s healthcare groups incorporating more than 750 providers and more than 950,000 patients annually.  The other two agreements are with two independent laboratories providing services across five states.

We are developing three additional products and related services, including two diagnostic algorithms, OVAWatch (previously OVASight) and EndoCheck, and a high-risk diagnostic algorithm, OVAInherit, for patients with or without a pelvic mass who are genetically predisposed to ovarian cancer. These products may be launched as LDTs or FDA-cleared tests.

OVAWatch is validated for use as a non-invasive risk assessment test used in conjunction with clinical assessment and imaging to determine ovarian cancer risk for patients with an adnexal mass. We plan to offer a future revision of this test to women in this same cohort who have a low risk of ovarian cancer and who may benefit from serially monitoring their ovarian cancer risk over time. As such, OVAWatch would be applicable to a larger population than OVA1 based on its FDA cleared indication of use. OVAWatch is currently under market and scientific review. The launch date is pending this review.

EndoCheck, a blood test to be used in conjunction with other non-surgical modalities, will be designed to address the patient population of women who are experiencing moderate to severe pelvic pain and provide non-invasive surgical confirmation that their symptoms are indicative of endometriosis. The goal of this test is to support an early diagnosis and direct appropriate medical management that potentially reduces the progression of disease. Current detection methods for endometriosis require surgery and a surgical biopsy diagnosis and/or visualization diagnosis. EndoCheck is intended to address this large patient population using a non-invasive solution with both the sensitivity and specificity equal to or greater than surgical biopsy and/or visualization.

OVAInherit will be designed as a high-risk diagnostic tool, intended for those patients with or without a pelvic mass who are genetically predisposed to gynecologic cancer. It will use genetics, proteins and other modalities to assess the risk of gynecologic cancers early without visible presence of cancer via traditional ultrasound methodologies. Our OVAInherit related clinical studies for each of OVANex and OVA360, launched in late 2019 and early 2020, respectively, are focused on developing a diagnostic test for the early detection of ovarian cancer.

We ultimately plan to commercialize each of OVA1, OVERA, OVA1plus, Aspira GenetiX, OVAWatch, EndoCheck, OVAInherit and Aspira Synergy on a global level. We currently hold CE marks for OVA1 and OVERA. In June 2014, Vermillion launched addition, each of OVA1 and OVERA, and the reflex offering, OVA1plus, will be offered on our global testing platform, which allows both tests to be deployed worldwide.

Outside of the United States, we have studies in process to validate OVERA and OVA1 in specific populations. This includes active international distribution agreements for OVERA with Pro-Genetics LTD in Israel and MacroHealth, Inc. in the Philippines. The MacroHealth, Inc. agreement was our first agreement regarding our decentralized technology, Aspira Synergy, for OVERA specimen testing.

18


We own and operate Aspira Labs, Inc. (“ASPiRA LABS, a Clinical Laboratory Improvements Amendments of 1988 (“CLIA”LABS”) certified national laboratory, based in Austin, Texas, a Clinical Chemistry and Endocrinology Laboratory accredited by the College of American Pathologists, which specializes in applying biomarker-based technologies to address critical needs in the management of gynecologic cancers and disease. ASPiRA LABS provides expert diagnostic services using a state-of-the-art biomarker-based diagnostic algorithmrisk assessment to aid in clinical decision making and advance personalized treatment plans. The lab currently processes our OVA1 and OveraOVERA tests, and we plan to expand the testing to other gynecologic conditions with high unmet need. We also plan to develop and perform LDTs at ASPiRA LABS in the future.LABS. ASPiRA LABS holds a CLIAClinical Laboratory Improvements Amendments of 1988 (“CLIA”) Certificate of RegistrationAccreditation and a state laboratory license in California, Florida, Maryland, New York, Pennsylvania and Rhode Island. This allows the lab test OVA1 and OVERA to be performed on a national basis. The Centers for Medicare & Medicaid Services (“CMS”) issued a providersupplier number to ASPiRA LABS in March 2015.

Recent Developments

Business, Product and Coverage Developments

Our collaboration work with Dana Farber Cancer Institute/Harvard University andUniversity of Lutdz. Phase 1 Proof of Concept is succeeding. The Phase 1 evaluation surpassed all required metrics and based on the outcome data, the Aspira Innovation Team along with the collaborators from the aforementioned institutions have begun implementing Phase 2 of the study. In 2016,Phase 2, the team is proceeding to evaluate the combined potential impact of our protein biomarker algorithms and the investigators miRNA technology in the development of this assay and platform which we createdbelieve may be a new service withinhigh risk screen, which we refer to as OVAInherit.

On October 7, 2021, we announced a partnership with Genoox Ltd., the ASPiRA channel strategy, “an ASPiRA IVD Services Program”world’s largest community-driven genomic data platform, to develop solutions to advance women’s health with rapid results, diagnosis, and insights. Currently, the majority of genetic sequencing information can be found across multiple databases which can limit the ability for medical professionals to access and analyze this important data. Without advanced data aggregation and analytics that inform machine learning and artificial intelligence algorithms, it is more difficult to detect early-stage diseases as well as monitor and treat patients effectively. Genoox’s global platform brings together onto a single platform information available in the public domain, allowing for the complete analysis of the data and better patient care. We plan to leverage this knowledge base to expand on our proprietary algorithm development across multiple product lines.

On July 8, 2021, the Company announced that AIM Specialty Health, which represents 50 million lives in the United States, one of the nation’s largest Laboratory Benefits Management firms owned by Anthem Blue Cross Blue Shield, published guidelines indicating that OVA1 is considered medically necessary per the test’s FDA-cleared label. This allows all Anthem and other BCBS plans to modify their own OVA1 coverage policies to reflect this coverage.

The FDA’s Breakthrough Devices Program provides patients and health care providers with timely access to medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions by speeding up their development, assessment and review. In the first quarter of 2021, we submitted to the FDA a Breakthrough Device designation request with respect to EndoCheck. We have been in communications with the FDA regarding our request, and we plan to update the request based on the guidance we have received thus far regarding the need to show Endometriosis is an irreversible debilitating disease. The FDA has demonstrated interest in continuing to work with us on EndoCheck, and we plan to continue our discussions with the agency on Breakthrough Device Program designation. There is no assurance that the FDA will grant our request for EndoCheck to be designated as a Breakthrough Device. If our device is granted a Breakthrough Device designation, we plan to move forward with interacting with the FDA through a variety of options including sprint discussions, a request for a discussion on a data development plan, and a request for clinical protocol agreement, and any final submission will be a de novo submission. If the FDA denies our request for a Breakthrough Device designation by the end of 2021, we plan to proceed with a LDT. In April 2016,late October, the FDA’s Center for Devices and Radiological Health issued an updated guidance for the content of Premarket Submission for Software Contained in Medical Devices, specific to “Artificial Intelligence/Machine Learnings-Based Software as a Medical Device Action Plan” which will provide

19


a much-needed framework for our future EndoCheck devices. We are currently working to ensure our EndoCheck development process is aligned to the proposed framework.

COVID-19 Pandemic

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. On March 11, 2020, the World Health Organization declared COVID-19, the disease caused by the novel coronavirus, a pandemic, and on March 13, 2020, 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. Patient enrollment for our planned research studies has been lower due to the impact of closures and restricted travel, which has led to delays in the completion of such studies. Our commercial efforts to enter into decentralized arrangements with large healthcare networks and supergroups have continued to move forward. However, finalization of such arrangements has been slowed by the pandemic. In addition, many conventions and industry conferences have been cancelled.

As a result of the COVID-19 pandemic and actions taken to contain it, the majority of our non-laboratory employees had been working remotely since March 2020. In the third quarter of 2021, non-laboratory employees returned to the office a few days a week. We expect that they will continue to do so until the number of daily COVID-19/variant cases in the areas surrounding our offices consistently levels off or declines.  In terms of business continuity, our lab operations require on site essential employees. As previously disclosed, we formed ASPiRA IVDhave put in place staffing and reagent contingency plans to offer IVD trial servicesensure there is no down time at our lab. We believe the lab could continue to third-party customers. ASPiRA IVD isoperate in the event any isolated infection were to impact a specialized laboratory provider dedicatedportion of the workforce. In addition, as of the date of the filing of this Form 10-Q, we have approximately four months of reagents, one of our key testing supplies, in stock, depending on volume of tests performed, and we are working with the manufacturer to meetingensure a consistent supply over the unique testing needsnext six months. 

We are committed to following recommended physical and social distancing guidelines in order to reduce the risk of IVD manufacturers seekinginfection for our employees. We have also decreased our travel and convention-related expenses. We have taken several measures to commercialize high-complexity assays. ASPiRA IVD was built aroundreduce the impact of the COVID-19 related closures and quarantines. For example, because our salespeople have experienced limitations on their ability to physically visit physician offices, we have implemented other means of coverage such as virtual sales representative meetings and increased digital sales and marketing. In March 2020, our sales team began making in-person calls to customers as determined on a corestate-by-state basis, in accordance with local guidelines. We have developed protocols and training for our team where physical visits are allowed to help ensure employee, customer and patient safety.

In the third quarter of laboratory expertise and an FDA-compliant quality system,  and strives2021, our test volume decreased 7% compared to deliver accurate and reliable results to its third-party customers suitable for FDA submission.  ASPiRA IVD received  a CLIA laboratory license in June 2016 and commenced operations in the second quarter of 2016.2021, which we believe was caused by physician offices having lower level of patient visits. In addition, we experienced significant COVID-19 related access restrictions in July and August 2021 in key states such as Michigan, Florida, New York and Kentucky. In these areas, our team had a 18% reduction in test volume and a 19% reduction in physician events as a result of COVID-19 as compared to the second quarter of 2021. Given the potential for future resurgences of COVID-19 cases and the variety of federal and state actions taken to contain them, we are unable to estimate the potential future impact of the COVID-19 pandemic on our business, results of operations or cash flows as of the date of the filing of this Form 10-Q.

In this program, we also plan

On March 27, 2020, the U.S federal government enacted the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”). The CARES Act is an emergency economic stimulus package in response to leverage our existing infrastructurethe coronavirus outbreak which, among other things, provided loans, guarantees and enhance our pipelinesubsidies to qualifying businesses and contained numerous income tax provisions. Some of future technologies by fostering relationships with IVD companies whothese tax provisions are developing new diagnostics including companion diagnostics platforms. We believe this plan will allow us to continueexpected to be innovativeeffective retroactively for years ending before the date of enactment. We do not expect these tax provisions to have a material impact on our financial statements.

On April 10, 2020, we received a stimulus check of approximately $89,000 from the U.S. Department of Health and Human Services pursuant to the CARES Act.

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On May 1, 2020, we were granted a loan (the “PPP Loan”) from BBVA USA in evaluating potential diagnostics. Our goal with the additionaggregate amount of this line$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 (“SBA”). In March 2021, we applied for forgiveness of business isthe PPP Loan, and, effective May 27, 2021, the SBA confirmed the waiver of our repayment of the PPP Loan. The Company recognized a gain on forgiveness of debt of $1,005,767 and reduced long- and short-term indebtedness by the same amount.  The Company remains subject to invest in our short-terman audit of the PPP loan. See “Liquidity and long-term enterprise value while leveraging our specimen bank, database, FDA experience, laboratory informatics and operating efficiency.Capital Resources” for more information.

Strategy:Strategy

We are focused on the execution of fivethe following core strategic business drivers in women’s pelvic mass assessment, starting with ovarian cancer diagnostics, and specialized laboratory services to build long-term value for our investors:

·

Maximizing the existing OVA1 opportunity in the United States by taking the lead in payer coverage and commercialization of OVA1. This strategy included the launch of a CLIA certified clinical laboratory, ASPiRA LABS, in June 2014;

·

Expanding the distribution platform beyond the U.S. by launching Overa, a next generation biomarker panel, while building the clinical utility and health economics foundation of both OVA1 and Overa, which we believe may allow for better domestic market penetration and international expansion (FDA clearance for Overa was received in March 2016);

·

Leveraging our existing database and specimen bank while building the largest specimen and data repository of gynecologic pelvic mass patients worldwide;

·

Expanding our product offerings to additional pelvic disease conditions such as endometriosis and polycystic ovarian syndrome by adding additional gynecologic bio-analytic solutions involving biomarkers, other modalities (e.g., imaging), clinical risk factors and patient data to aid diagnosis and risk stratification of women presenting with a pelvic mass disease; and

·

Expanding our customer offerings with the launch of our ASPiRA IVD laboratory services.

Maximizing the existing OVA1plus (OVERA, a next generation biomarker reflex, and OVA1 on the same platform) opportunity in the United States by actively pursuing payer coverage and commercialization of OVA1plus;

Expanding the distribution platform beyond the U.S. by launching OVA1plus, while building the clinical utility and health economics foundation of both OVA1 and OVERA, which we believe may allow for better domestic market penetration and international expansion;

Finalizing clinical utility studies for OVA1 to further enhance payer coverage and reimbursement and launch clinical utility study for OVAWatch;

Considering business development and M&A opportunities that represent synergistic offerings in women’s health;

Leveraging our existing database and specimen bank while building the largest specimen and data repository of gynecologic pelvic mass patients worldwide;

Expanding our product offerings to additional women’s health diseases with a focus on pelvic disease conditions such as pelvic mass monitoring and endometriosis by adding additional gynecologic bio-analytic solutions involving biomarkers, genetics, other modalities (e.g., imaging), clinical risk factors and patient data to aid diagnosis and risk stratification of women presenting with a pelvic mass;

Coupling our OVA1 products with an individual’s hereditary genetic risk to refine ovarian cancer risk assessment for high-risk populations;

Establishing a proprietary decentralization platform, Aspira Synergy, to allow large healthcare networks and gynecologic practices to access OVA1plus technology algorithms and genetics algorithms as a technology transfer service; and

Working with governments, legislative bodies and advocacy groups to enhance awareness and drive policies that provide broader access to the Company’s tests.

We believe that these business drivers will contribute significantly to addressing unmet medical needs for women faced with gynecologic disease and other conditions and the continued development of our business.

OVA1 addresses a clear clinical need, namely the pre-surgical identification of women who are at risk of having a malignant ovarian tumor. Numerous studies

We have documented the benefit of referral of these women to gynecologic oncologistsactive international distribution agreements for their initial surgery. Prior to the clearance of OVA1, no blood test had been cleared by

18


the FDA for physicians to useOVERA with Pro-Genetics LTD in Israel and MacroHealth, Inc. in the pre-surgical management of ovarian adnexal masses. OVA1 is a qualitative serum test that utilizes five well-established biomarkersPhilippines. The MacroHealth, Inc. agreement was our first agreement regarding decentralized technology transfer for OVERA specimen testing.

In the United States, revenue for diagnostic tests comes from several sources, including third-party payers such as insurance companies, government healthcare programs, such as Medicare and proprietary software cleared as part of the OVA1 510(k) to determine the likelihood of malignancy in women over age 18, with a pelvic mass for whom surgery is planned. OVA1 should not be used without an independent clinical/radiological evaluationMedicaid, client bill accounts and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of OVA1 carries the risk of unnecessary testing, surgery and delayed diagnosis.  OVA1 was developed through large pre-clinical studies in collaboration with numerous academic medical centers encompassing over 2,500 clinical samples. OVA1 was fully validated in a prospective multi-center clinical trial encompassing 27 sites reflective of the diverse nature of the clinical centers at which ovarian adnexal masses are evaluated.

patients. Novitas Solutions, thea Medicare contractor, covers and reimburses for OVA1.  ThisOVA1 tests performed in certain states, including Texas. Due to OVA1 tests being performed exclusively at ASPiRA LABS in Texas, the local coverage determination from Novitas Solutions essentially provides national coverage for patients enrolled in Medicare as well as Medicare Advantage health plans. However, ASPiRA LABS initially experienced difficulty in obtaining payment from Novitas Solutionsalso bills third-party commercial and other government payers as well as client bill accounts and patients for most claims submitted due to Novitas Solutions’ administrative requirements. In October 2016, Novitas Solutions updated its administrative requirements for OVA1 reimbursement which has improved our ability to obtain reimbursement for OVA1 from Novitas Solutions.OVA1.

In October 2016, we launched our pelvic mass specimen and data repository and began the collection of Institutional Review Board patient consents for collection and cataloguing of serum samples for future research purposes.

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In November 2016, Thethe American College of Obstetricians and Gynecologists ("(“ACOG”) issued Practice Bulletin Number 174 which included OVA1, defined as athe “Multivariate Index Assay”. This bulletin outlines ACOG's “new”, outlining ACOG’s clinical management guidelines for adnexal mass management.

These new clinical management guidelines replace the July 2007 version, Practice Bulletin 83. Practice Bulletins summarize current information on techniques and clinical management issues for the practice of obstetrics and gynecology. Practice Bulletins are evidence-based documents, and recommendations are based on the evidence. This is also the only clinical management tool used for adnexal masses. Guidelines do not exist for adnexal masses, only Practice Bulletins. Guidelines do exist, however, for ovarian cancer management.  

The Practice BulletinNumber 174 recommends that obstetricians and gynecologists evaluating women with adnexal masses who do not meet Level A criteria of a low risk transvaginal ultrasound should proceed with Level B clinical guidelines. Level B guidelines state that the physician may use risk assessment tools such as existing CA125 technology or OVA1 (“Multivariate Index Assay”) as listed in the bulletin. Based on this, OVA1 has now achieved parity with CA125 as a Level B clinical recommendation for the management of adnexal masses.

Practice Bulletins summarize current information on techniques and clinical management issues for the practice of obstetrics and gynecology. Practice Bulletins are evidence-based documents, and recommendations are based on the evidence. This is also the only clinical management tool used for adnexal masses. Although there are Practice Bulletins, guidelines do not exist for adnexal masses. ACOG guidelines do exist, however, for ovarian cancer management.

In December 2016, we received an FDA Clarification Letter regardingOctober 2018, ASPiRA LABS launched OVA1plus, a clinical pathway which combines the strengths of OVA1 and Overa.OVERA. This letteroffering helps drive earlier ovarian cancer risk detection, which in turn lowers overall healthcare costs and reduces inefficiencies in the care pathway.

In July 2021, we announced coverage for OVA1 in the AIM Specialty Health Laboratory Medicine Clinical Guidelines. Our OVA1 risk assessment test for ovarian cancer in women with pelvic masses is considered medically necessary according to AIM Specialty Health’s Clinical Appropriateness Guidelines. AIM is a member of the Anthem Blue Cross Blue Shield family of companies, which promotes optimal care through use of evidence-based clinical guidelines and real-time decision support for both providers and their patients. AIM is a wholly owned subsidiary of Anthem, Inc., serving more than 50 million members across 50 states, D.C. and U.S. territories.

Recent Publications

In parallel to building our OVA platform offering and our commercial deployment, we have been working on several key publications and product extensions.

The OVA1plus paper was in referenceaccepted to the September 7, 2016 FDA Safety Communication advisingInternational Journal of Biological Markers, titled “A Two-Step Multivariate Index Assay Improves the Accuracy of Ovarian Cancer Risk Assessment for Women with an Adnexal Mass.” It is expected to be published at a future date.

On August 10, 2021, in a special ovarian cancer edition, Diagnostics published a paper entitled “Salvaging Detection of Early-Stage Ovarian Malignancies When CA125 is Not Informative.” The paper reports that in a retrospective study of 2,305 patients, OVA1 detected over 50% of ovarian malignancies in premenopausal women that CA125 would have missed. OVA1 also correctly identified 63% of early-stage cancers missed by CA125. This paper further validates and their physicians against the usesupports OVA1’s superior early-stage detection of ovarian cancer screening tests for asymptomatic women.versus the current standard of care in a large population.

In order to avoid any confusion, as well as to document the FDA position on OVA1 and Overa, Jeffrey Shuren, M.D., J.D., Director for the Center for Devices and Radiological Health at the FDA, sent a letter to Vermillion, dated December 21, 2016. In the letter, Dr. Shuren stated:

We agree that this safety communication does not apply to Vermillion’s FDA-cleared tests, OVA1 (MIA) and Overa (MIA2G), which are not screening tests for ovarian cancer.

FDA cleared OVA1 (MIA) and Overa (MIA2G) as aids to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The intended uses of the two assays are the same—to help physicians more reliably identify which patients would benefit from consultation with or referral to a gynecologic oncologist. OVA1 (MIA) and Overa (MIA2G) are indicated for women who present with an adnexal mass.

In March 2015, we entered into a new commercial agreement with Quest Diagnostics.  Pursuant to this agreement, all OVA1 U.S. testing services for Quest Diagnostics customers were transferred to Vermillion’s wholly-owned subsidiary, ASPiRA LABS, as of August 10, 2015.  Pursuant to this agreement, as amended as of March 11, 2017, Quest Diagnostics has agreed to provide blood draw and logistics support by transporting specimens from its clients to ASPiRA LABS for testing through at least March 11, 2018 in exchange for a market value fee.   Per the

19


terms of this agreement, we will not offer to existing or future Quest Diagnostics customers CA 125-II or other tests that Quest Diagnostics offers.

In 2016, we continued to make progress with increased payer positive medical polices and in network agreements for a total of over 80 million covered lives.

In the first half of 2017, ASPiRA IVD services landed two top pharmaceutical trial service agreements including one enrollment study.

In July 2017 ASPiRA LABS expanded its patient advocacy program nationally to assist patients with proactive benefit checks, with over 90% resulting in OVA1 utilization.

In September 2017, the preliminary Protecting Access to Medicare Act of 2014 (PAMA) price for OVA1 and Overa was published by the Center for Medicare and Medicaid Service (CMS). The preliminary OVA1 rate is based on the median of private payer payments submitted by Vermillion as part of the market-based payment reforms mandated through PAMA. The Overa price was benchmarked to the only proteomic test currently on the fee schedule, which uses biomarkers and an algorithm to produce a prognostic score. The new rates, once finalized, are scheduled to become effective January 1, 2018.

In 2017, we continued to make progress with increased payer positive medical polices and in network agreements for a total of over 123 million covered lives, expected effective by February 2018.

Critical Accounting Policies and Estimates

There have been no materialOur product revenue is generated by performing diagnostic services using our OVA1, OVERA, OVA1plus or ASPiRA GenetiX tests, and the service is completed upon the delivery of the test result to the prescribing physician.The entire transaction price is allocated to the single performance obligation contained in a contract with a patient. Under ASC Topic 606, Revenue from Contracts with Customers, all revenue is recognized upon completion of the OVA1, OVERA, OVA1plus or ASPiRA GenetiX test and delivery of test 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, we consider factors such as payment history and amount, payer coverage, whether there is a reimbursement contract between the payer and us, and any developments or changes tothat could impact reimbursement. These estimates require significant judgment by management. For OVA1, OVERA, OVA1plus and ASPiRA GenetiX tests, we also review our critical accounting policiespatient account population and estimates from those disclosed in Item 7determine an appropriate distribution of our 2016 Annual Report.patient accounts by payer (i.e., Medicare, patient pay, other third-party payer, etc.) into

20

22


portfolios with similar collection experience. When evaluated for collectability, this results in a materially consistent revenue amount for such portfolios as if each patient account were evaluated on an individual contract basis.

Results of Operations - Three Months Ended September 30, 20172021 Compared to Three Months Ended September 30, 20162020

The selected summary financial and operating data of the Company for the three months ended September 30, 20172021 and 20162020 were as follows:

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Three Months Ended September 30,

 

Increase (Decrease)

September 30,

Increase (Decrease)

(dollars in thousands)

 

2017

 

2016

 

Amount

 

%  

2021

2020

Amount

%

Revenue:

 

 

 

 

 

 

 

 

 

 

 

Product

 

$

657 

 

$

581 

 

$

76 

 

13 

$

1,614

$

1,217

$

397

33

Genetics

49

22

27

123

Service

 

 

42 

 

 

42 

 

 

 -

 

 -

3

-

3

-

Total revenue

 

 

699 

 

 

623 

 

 

76 

 

12 

1,666

1,239

427

34

Cost of revenue:

 

 

 

 

 

 

 

 

 

 

 

Product

 

 

495 

 

 

461 

 

 

34 

 

694

670

24

4

Genetics

223

133

90

68

Service

 

 

284 

 

 

356 

 

 

(72)

 

(20)

-

4

(4)

-

Total cost of revenue

 

 

779 

 

 

817 

 

 

(38)

 

(5)

917

807

110

14

Gross profit

 

 

(80)

 

 

(194)

 

 

114 

 

(59)

749

432

317

73

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

192 

 

 

370 

 

 

(178)

 

(48)

1,518

595

923

155

Sales and marketing

 

 

1,050 

 

 

1,606 

 

 

(556)

 

(35)

5,083

2,152

2,931

136

General and administrative

 

 

1,177 

 

 

1,295 

 

 

(118)

 

(9)

3,839

1,966

1,873

95

Total operating expenses

 

 

2,419 

 

 

3,271 

 

 

(852)

 

(26)

10,440

4,713

5,727

122

Loss from operations

 

 

(2,499)

 

 

(3,465)

 

 

966 

 

(28)

(9,691)

(4,281)

(5,410)

126

Interest income (expense), net

 

 

(10)

 

 

(11)

 

 

 

(9)

(14)

5

(19)

380

Other income (expense), net

 

 

 -

 

 

 -

 

 

 -

 

 -

Other expense, net

(2)

(11)

9

82

Net loss

 

 

(2,509)

 

 

(3,476)

 

 

967 

 

(28)

$

(9,707)

$

(4,287)

$

(5,420)

126

Product Revenue. Product revenue was $657,000$1,614,000 for the three months ended September 30, 20172021, compared to $581,000$1,217,000 for the same period in 2016.2020. Revenue for ASPiRA LABS is being recognized when the OVA1, OVERA, or OVA1plus test is being performed or when amounts that willcompleted based on estimates of what we expect to ultimately be realized can be estimated. All other ASPiRA LABS revenue is being recognized on a cash basis and thus recognition of revenue lags the performance of some OVA1 tests.realize. The 13%33% product revenue growthincrease is primarily due to improvementthe lower number of tests performed in the2020 due to COVID-19, as well as an increase in OVA1 average unit price receivedrevenue per test in 2021 compared to the same quarter in the prior year. The increase in average unit price was driven by an increase in client bill contracts, expansionPartially as a result of positive medical policy and contracting with payers, and improved billing and collection practices.

The number of OVA1 tests performed decreased 13% to approximately 1,954 OVA1 testsCOVID-related access restrictions during the three months ended September 30, 20172021, product revenue decreased 6% sequentially during the third quarter 2021 as compared to approximately 2,257 OVA1the second quarter 2021.

The number of OVA1plus tests performed increased 19% to 4,281 during the three months ended September 30, 2021, compared to 3,596 OVA1plus tests for the same period in 2016. 2020. Revenue increased due to increased access to provider offices, patients’ return to physician visits, and increased investment in our current commercial channel. Partially as a result of COVID-related access restrictions during the three months ended September 30, 2021, the number of OVA1plus tests performed decreased 6% sequentially during the third quarter 2021 as compared to the second quarter 2021.

The volume decreaserevenue per OVA1plus test performed increased to approximately $377 compared to $338 for the same period in 2020, an increase of 11%. This increase was primarily due to the previously announced loss of a client bill customer in July 2017,  which was concentrated in uncovered territories (territories not covereddriven by an ASPiRA sales representative)increase in payments by contracted payers and to a lesser extent, the impactdecrease in volume of hurricanes in two key areas (Texas and Florida).  Partially affecting the volume decrease was modest year-over-year growth in covered territories (territories covered by an ASPiRA sales representative).We expect the test volume to improve in the fourth quarter relative topatient payers, which have a lower reimbursement rate. Medicaid represents approximately 12% of volume in the third quarterthree months ended September 30, 2021, at an average unit price (“AUP”) of 2017. 

Service Revenue.  Service revenue$94. Our OVA1plus AUP without Medicaid was $42,000$410 for the three months ended September 30, 20172021, compared to $42,000 for the same period in 2016.  Service revenue will vary from quarter to quarter based on the size of ongoing customer projects. Revenue for ASPiRA IVD is being recognized once certain revenue recognition criteria has been met (see Note 1 to the financial statements included in Part I, Item I of this Form 10-Q). We expect service revenue to increase in the fourth quarter of 2017 relative to service revenue in the third quarter of 2017 due to the performance of certain anticipated projects.

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Cost of Revenue - Product.  Cost of product revenue was $495,000$362 for the three months ended September 30, 2017 compared to $461,000 for the same period in 2016, representing an increase of 7% due primarily to some equipment maintenance costs and increased consultant fees incurred in the third quarter. We expect the cost of product revenue to decrease modestly in the fourth quarter of 2017 compared to the third quarter of 2017 as one-time costs incurred in the third quarter of 2017 are not expected to be repeated.2020.

23


Cost of

Genetics Revenue - Service.    Cost of service.Genetics revenue was $284,000$49,000 for the three months ended September 30, 20172021, compared to $356,000$22,000 for the same period in 2016.2020. Revenue for Aspira GenetiX is recognized when the Aspira GenetiX test is completed based on estimates of what we expect to ultimately realize. The 20% decrease related123% genetics revenue increase is primarily due to an increase in Aspira GenetiX test volume as we continued to market this product in 2021, as well as a higher revenue per test. The revenue per test performed increased to approximately $462 compared to $348, an increase of 33%, from the same period in 2020. This increase was primarily driven by an increase in payments by contracted payers. The duration of the pandemic and efforts to contain it remains uncertain.

Service Revenue. Service revenue was $3,000 for the three months ended September 30, 2021, compared to $0 for the same period in 2020. Substantially all projects with ASPiRA IVD were finalized during 2019 and the subsidiary’s operations were largely completed. Revenue for ASPiRA IVD was recognized once certain revenue recognition criteria had been met. We do not expect to have any significant service revenue in 2021 as the IVD trial services were largely wound down in 2019. However, the Company may continue to have some future legacy IVD activity in the fourth quarter of 2021.

Cost of Revenue – Product. Cost of product revenue was $694,000 for the three months ended September 30, 2021, compared to $670,000 for the same period in 2020, representing an increase of $24,000, or 4%, due primarily to increased test volume.

Cost of Revenue - Genetics.Cost of genetics revenue, which consisted primarily of personnel costs and consulting expense after the launch of Aspira GenetiX, was $223,000 for the three months ended September 30, 2021, compared to $133,000 for the same period in 2020. The increase in cost was due to an increase of $68,000 in personnel costs, as well as an increase in volume as compared to the same period in 2020.

Gross Profit Margin.  Gross profit margin for OVA1plus was 57.0% for the three months ended September 30, 2021, compared to 44.9% for the same period in 2020, an increase of 12.1%, and 52% for the three months ended June 30, 2021, an increase of 5.0%. The year-on-year increase was driven by volume improvement, while the decrease from the second quarter of 2021 was due to one-time costs related to the opening of the laba switch in kit vendors that did not recur in the third quarter of 2016, which were not repeated2021. Overall gross profit margin was 45.0% for the three months ended September 30, 2021, compared to 34.9% for the same period in 2017. We expect the cost2020, an increase of service revenue10.1%, due primarily to an increase in the fourth quarter of 2017 compared to the third quarter of 2017 due to expected variable costs relating to performance of certain projects.     volume covering our fixed costs.

Research and Development Expenses.Expenses.  Research and development expenses represent costs incurred to develop our technology and carry out clinical studies, and include personnel-related expenses, regulatory costs, reagents and supplies used in research and development laboratory work, infrastructure expenses, contract services and other outside costs. Research and development expenses for the three months ended September 30, 2017 decreased $178,000,2021 increased by $923,000, or 48%155%, compared to the same period in 2016.2020. This decreaseincrease was primarily due to a reductionclinical utility and product development costs related to OVAWatch, our third-generation product, as well as investments in personnelbioinformatics, investments in Aspira Synergy and personnel related expenses.consulting expenses associated with EndoCheck regulatory clearance. We expect research and development expenses to remain consistent with third quarter 2017 levelsincrease in the fourth quarter2021, as a result of 2017.increased projects and clinical studies.

Sales and Marketing Expenses.Expenses.  Our sales and marketing expenses consist primarily of personnel-related expenses, education and promotional expenses, and infrastructure expenses. These expenses include the costs of educating physicians laboratory personnel and other healthcare professionals regarding OVA1, OVERA, OVA1plus and Overa.Aspira GenetiX. Sales and marketing expenses also include the costs of sponsoring continuing medical education, medical meeting participation, and dissemination of scientific and health economic publications. Sales and marketing expenses for the three months ended September 30, 2017 decreased $556,000,2021 increased by $2,931,000, or 35%136%, compared to the same period in 2016.2020. This decreaseincrease was primarily due to a reduction inincreased personnel, recruiting costs, consulting costs, travel and entertainment expense and promotional marketing services and lower health economic study costs in the third quarter of 2017 compared to 2016.expense. We expect sales and marketing expenses to increase modestly overfurther in the remainderfourth quarter of 2017 as we focus efforts on the commercialization of OVA12021, due to investing in key strategic hires and Overa.product portfolio expansion.

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General and Administrative Expenses.Expenses.  General and administrative expenses consist primarily of personnel-related expenses, professional fees and other costs, including legal, finance and accounting expenses and other infrastructure expenses. General and administrative expenses for the three months ended September 30, 2017 decreased 2021 increased by $118,000, $1,873,000, or 9%95%, compared to the same period in 2016.  The decrease2020. This increase was primarily due to a  reduction inincreased personnel expenses, consulting services.expenses, as well as non cash stock compensation expenses. We expect general and administrative expenses to remain consistent with third quarter 2017 levelslevel off in the fourth quarter of 2017.2021.

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Results of Operations – Nine Months Ended September 30, 20172021 Compared to Nine Months Ended September 30, 20162020

The selected summary financial and operating data of the Company for the nine months ended September30, 20172021 and 20162020 were as follows:

Nine Months Ended

June 30,

Increase (Decrease)

(dollars in thousands)

2021

2020

Amount

%

Revenue:

Product

$

4,748

$

3,128

$

1,620

52

Genetics

208

64

144

225

Service

5

13

(8)

(62)

Total revenue

4,961

3,205

1,756

55

Cost of revenue:

Product

2,167

1,793

374

21

Genetics

746

394

352

89

Service

-

13

(13)

-

Total cost of revenue

2,913

2,200

713

32

Gross profit

2,048

1,005

1,043

104

Operating expenses:

Research and development

3,861

1,370

2,491

182

Sales and marketing

12,209

6,000

6,209

103

General and administrative

9,627

5,542

4,085

74

Total operating expenses

25,697

12,912

12,785

99

Loss from operations

(23,649)

(11,907)

(11,742)

99

Interest income (expense), net

(35)

14

(49)

(350)

Other income, net

983

69

914

1,325

Net loss

$

(22,701)

$

(11,824)

$

(10,877)

92



 

 

 

 

 

 

 

 

 

 

 



 

Nine Months Ended September 30,

 

Increase (Decrease)

(dollars in thousands)

 

2017

 

2016

 

Amount

 

%  

Revenue:

 

 

 

 

 

 

 

 

 

 

 

Product

 

$

2,195 

 

$

1,640 

 

$

555 

 

34 

Service

 

 

128 

 

 

197 

 

 

(69)

 

(35)

Total revenue

 

 

2,323 

 

 

1,837 

 

 

486 

 

26 

Cost of revenue:

 

 

 

 

 

 

 

 

 

 

 

Product

 

 

1,345 

 

 

1,516 

 

 

(171)

 

(11)

Service

 

 

855 

 

 

416 

 

 

439 

 

106 

Total cost of revenue

 

 

2,200 

 

 

1,932 

 

 

268 

 

14 

Gross profit

 

 

123 

 

 

(95)

 

 

218 

 

(229)

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

685 

 

 

1,868 

 

 

(1,183)

 

(63)

Sales and marketing

 

 

3,114 

 

 

5,514 

 

 

(2,400)

 

(44)

General and administrative

 

 

3,825 

 

 

4,645 

 

 

(820)

 

(18)

Total operating expenses

 

 

7,624 

 

 

12,027 

 

 

(4,403)

 

(37)

Loss from operations

 

 

(7,501)

 

 

(12,122)

 

 

4,621 

 

(38)

Interest income (expense), net

 

 

(32)

 

 

(16)

 

 

(16)

 

100 

Other income (expense), net

 

 

(9)

 

 

16 

 

 

(25)

 

(156)

Net loss

 

 

(7,542)

 

 

(12,122)

 

 

4,580 

 

(38)

Product Revenue. Product revenue was $2,195,000$4,748,000 for the nine months ended September 30, 20172021 compared to $1,640,000$3,128,000 for the same period in 2016.2020. Revenue for ASPiRA LABS is being recognized when the OVA1, OVERA, or OVA1plus test is being performed or when amounts that willcompleted based on estimates of what we expect to ultimately be realized can be estimated. All other ASPiRA LABS revenue is being recognized on a cash basis and thus recognition of revenue lags the performance of some OVA1 tests.realize. The $555,000, or 34%,52% product revenue growthincrease is primarily due to improvementthe lower number of tests performed in the2020 due to COVID-19 closures, as well as an increase in OVA1 average unit price receivedrevenue per test in 2021 compared to the same period in the prior year. The increase in average unit price was driven by an increase in client bill contracts, expansion of positive medical policy and contracting with payers, and improved billing and collection practices.

The number of OVA1OVA1plus tests performed decreased 3%increased 30% to approximately 6,665 OVA1 tests12,609 during the nine months ended September 30, 20172021, compared to approximately 6,867 OVA19,708 OVA1plus tests for the same period in 2016.  2020. Revenue increased due to increased access to offices, patients’ return to physician visits, and increased investment in our current commercial channel.

The volume decreaserevenue per OVA1plus test performed increased to approximately $377 compared to $322 for the same period in 2020, an increase of 17%. This increase was primarily due to the previously announced loss of a client bill customer in July 2017,  which was concentrated in uncovered territories (territories not covereddriven by an ASPiRA sales representative)increase in payments by contracted payers and to a lesser extent, the impactdecrease in volume of hurricanes in two key areas (Texas and Florida).patient payers, which have a lower reimbursement rate.

Service

Genetics Revenue.  ServiceGenetics revenue was $128,000$208,000 for the nine months ended September 30, 20172021, compared to $197,000$64,000 for the same period in 2016,2020. Revenue for Aspira GenetiX is recognized when the Aspira

25


GenetiX test is completed based on estimates of what we expect to ultimately realize. The 225% genetics revenue increase is primarily due to an increase in Aspira GenetiX test volume as we continued to market this product in 2021, as well as a decreasehigher revenue per test. The revenue per test performed increased to approximately $478 compared to $293, an increase of $69,000, or 35%63%, for the same period in 2020. This increase was primarily driven by an increase in payments by contracted payers. The duration of the pandemic and efforts to contain it remains uncertain.

Service Revenue. Service revenue will vary from quarter to quarter based on the size of ongoing customer projects. Revenue for ASPiRA IVD is being recognized once certain revenue recognition criteria has been met (see Note 1 to the financial statements included in Part I, Item I of this Form 10-Q). 

Cost of Revenue - Product.  Cost of product revenue was $1,345,000$5,000 for the nine months ended September 30, 20172021 compared to $1,516,000$13,000 for the same period in 2016, representing a decrease of $171,000, or 11%, due2020. Substantially all projects with ASPiRA IVD were finalized during 2019 and the subsidiary’s operations were largely completed. Revenue for ASPiRA IVD was recognized once certain revenue recognition criteria had been met. We do not expect to operating efficiencies comparedhave any significant service revenue in 2021 as the IVD trial services were largely wound down in 2019. However, the Company may continue to the prior year. have some future legacy IVD activity in 2021.

23


Cost of Revenue - Service.– Product. Cost of serviceproduct revenue was $855,000$2,167,000 for the nine months ended September 30, 20172021, compared to $416,000$1,793,000 for the same period in 2016.  ASPiRA IVD did not commence operations until June 20162020, representing an increase of $374,000, or 21%, due primarily to increased test volume.

Cost of Revenue - Genetics.Cost of genetics revenue, which consisted primarily of personnel costs and thus included only fourconsulting expense after the launch of Aspira GenetiX, was $746,000 for the nine months of expenseended September 30, 2021 compared to three full quarters$394,000 for the same period in 2020. The increase in cost was due to $197,000 increase in personnel costs, as well as an increase in volume as compared to the same period in 2020.

Gross Profit Margin.  Gross profit margin for OVA1plus was 54.4% for the nine months ended September 30, 2021 compared to 42.7% for the same period in 2020, an increase of expense11.7%. Overall gross profit margin was 41.3% for the nine months ended September 30, 2021 compared to 31.4% for the same period in 2017.2020, an increase of 9.9%, due primarily to an increase in volume covering our fixed costs.

Research and Development Expenses.Expenses.  Research and development expenses represent costs incurred to develop our technology and carry out clinical studies, and include personnel-related expenses, regulatory costs, reagents and supplies used in research and development laboratory work, infrastructure expenses, contract services and other outside costs. Research and development expenses through March 2016 also included costs related to activities performed under contracts with our collaborators and strategic partners. Research and development expenses for the nine months ended September 30, 2017 decreased $1,183,000,2021 increased by $2,491,000, or 63%182%, compared to the same period in 2016.2020. This decreaseincrease was primarily due to the expiration ofclinical utility and product development costs related to OVAWatch, our collaboration agreement with The Johns Hopkins University School of Medicine in March 2016third-generation product, as well as lower personnelinvestments in bioinformatics, investments in Aspira Synergy and personnel relatedconsulting expenses dueassociated with EndoCheck regulatory clearance. We expect research and development expenses to the clearanceincrease in 2021, as a result of Overa in March 2016.increased projects and clinical studies.

Sales and Marketing Expenses.Expenses.  Our sales and marketing expenses consist primarily of personnel-related expenses, education and promotional expenses, and infrastructure expenses. These expenses include the costs of educating physicians laboratory personnel and other healthcare professionals regarding OVA1, OVERA, OVA1plus and Overa.Aspira GenetiX. Sales and marketing expenses also include the costs of sponsoring continuing medical education, medical meeting participation, and dissemination of scientific and health economic publications. Sales and marketing expenses for the nine months ended September 30, 2017 decreased $2,400,000,2021 increased by $6,209,000, or 44%103%, compared to the same period in 2016.2020. This decreaseincrease was primarily due to a reduction inincreased personnel related costs, travel and personnel expensesentertainment expense and decreases in consultingpromotional marketing expense. We expect sales and marketing services comparedexpenses to increase further in the prior year period.fourth quarter of 2021, due to investing in key strategic hires and product portfolio expansion.

General and Administrative Expenses.Expenses.  General and administrative expenses consist primarily of personnel-related expenses, professional fees and other costs, including legal, finance and accounting expenses and other infrastructure expenses. General and administrative expenses for the nine months ended September 30, 2017 decreased 2021 increased by $820,000, $4,085,000, or 18%74%, compared to the same period in 2016. The decrease2020. This increase was primarily due to increased personnel expenses of $1.6 million, consulting expenses of $562,000, recruiting expenses of $340,000, stock compensation expenses of $813,000, as well as director and officer insurance expenses of $241,000. We expect general and administrative expenses to level off in the reductionfourth quarter of consulting services2021.

26


Net Interest Expense and ASPiRA IVD start-up expensesOther Income.  Net interest expense and other income for the nine months ended September 30, 2021 increased by $865,000 compared to the same period in 2016 not being repeated2020.  Other income in 2017. the first nine months of 2021 consisted primarily of forgiveness of the PPP Loan in the second quarter.

Liquidity and Capital Resources

We plan to continue to expend resources selling and marketing OVA1, OVERA, OVA1plus and Overa, operating our IVD trial services businessAspira GenetiX and developing additional diagnostic tests and service capabilities.

We have incurred significant net losses and negative cash flows from operations since inception. At September 30, 2017, we had an accumulated deficit of $393,098,000 and stockholders’ equity of $5,921,000. As of September 30, 2017, we had $7,752,000 of cash and cash equivalents and $2,229,000 of current liabilities. Working capital was $6,074,000 and $3,547,000 at September 30, 2017 and December 31, 2016, respectively.

In December 2014,On February 8, 2021, the Company issued warrantscompleted a public offering (the “2021 Offering”), resulting in net proceeds to purchase up to an aggregate of 4,166,659 shares of Vermillion common stock at an exercise price of $2.00 per share in conjunction with a December 2014 private placement of Vermillion common stock.  The warrants expire by their original terms on December 23, 2017.

On August 31, 2017, certain holders exercised warrants to purchase 3,796,818 shares of Vermillion common stock in consideration for the Company agreeing to reduce the exercise price to $1.00 per share of Vermillion common stock.approximately $47.9 million, after deducting underwriting discounts and offering expenses.

The Company issued 3,796,818 shares of Vermillion common stock and received  $3,796,818 in aggregate gross proceeds (approximately $3,577,000 net of transaction costs).

On February 17, 2017,July 20, 2020, the Company completed a private placement pursuant to which certain investors purchased Vermillion3,150,000 shares of Aspira common stock at a per share price of $3.50.  Net proceeds of the private placement were approximately $10.6 million, after deducting underwriting discounts and warrants to purchaseoffering expenses.

In June 2020, we issued 2,810,338 shares of VermillionAspira common stock upon the exercise of all of our outstanding warrants and received approximately $5.1 million in aggregate proceeds therefrom.

On May 1, 2020, the Company obtained the PPP Loan from BBVA USA in the aggregate amount of $1,005,767. The application for netthese 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 was subject to forgiveness so long as, over the 24-week period following the Company’s receipt of the proceeds of approximately $5,127,000 after deducting offering expenses.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, was set to mature on May 1, 2022. The Company applied for forgiveness of the PPP Loan in March 2021, and, effective May 27, 2021, the SBA confirmed the waiver of the Company’s repayment of the PPP Loan. The Company recognized a gain on forgiveness of debt of $1,005,767 and reduced long- and short-term indebtedness by the same amount. The Company remains subject to an audit of the PPP loan. There is no assurance that the Company will not be required to repay all or a portion of the PPP Loan as a result of the audit.

In

On March 22, 2016, we entered into ana 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 “Loan Agreement”“DECD”), pursuant to which we may borrow up to $4,000,000 from the DECD. We received anThe 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, we have granted the DECD a blanket security interest in our personal and intellectual property. The DECD’s security interest in our 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 inwas made to us on April 15, 2016 under this

24


agreement. Thethe DECD Loan Agreement. On December 3, 2020, the Company received a disbursement of the remaining $2,000,000 will be disbursed ifunder the DECD Loan Agreement, as we achieved the target employment milestone necessary to receive an additional $1,000,000 under the DECD Loan Agreement and when we achieve certain future milestones. 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 Companywe may be eligible for forgiveness of up to $2,000,000$1,500,000 of the principal amount of the loan if the Company achieveswe achieve certain job creation and retention milestones by March 1, 2018 (the “Measurement Date”).December 31, 2022. Conversely, if the Company iswe are either unable to meet these job creation milestones, namely, hiring 40retain 25 full-time employees with a specified average annual salary within the allotted timeframe and retaining those employees

27


for a consecutive two-year period or does not maintain the Company’sour Connecticut operations for a period of 10 years,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.  For additional information, see Note 3 of our consolidated financial statements.

The Company has incurred significant net losses and negative cash flows from operations since inception. On September 30, 2021 we had an accumulated deficit of $462,767,000 and liabilities and stockholders’ equity of $48,047,000. As of September 30, 2021, we had $44,870,000 of cash, cash equivalents and restricted cash and $6,409,000 of current liabilities. Working capital was $40,779,000 and $12,603,000 at September 30, 2021 and December 31, 2020, respectively. There can be no assurance that we will achieve or sustain profitability or positive cash flow from operations. In addition, while we expect to grow revenue through ASPiRA LABS, there is continuingno assurance of our ability to monitor progress towards achievinggenerate substantial revenues and cash flows from ASPiRA LABS’ operations. We expect revenue from our products to be our only material, recurring source of cash in 2021.

Net cash used in operating activities was $19,746,000 for the employment milestone noted above. See also Note 3  nine months ended September 30, 2021, resulting primarily from the net loss reported of $22,701,000, which includes non-cash items such as stock compensation expense of $2,949,000, PPP loan forgiveness of $1,005,767 and depreciation and amortization of $238,000, offset by changes in accounts payable, accrued and other liabilities of $821,000 and prepaid expenses and other assets of $262,000, partially offset by changes in accounts receivable of $238,000, and changes in inventory of $107,000.

Net cash used in operating activities was $9,978,000 for the nine months ended September 30, 2020, resulting primarily from the net loss reported of $11,824,000, which includes non-cash stock compensation expense of $1,121,000 and changes in depreciation and amortization of $178,000, offset by changes in prepaid expenses and other assets of $248,000, changes in accounts payable, accrued and other liabilities of $230,000, and changes in accounts receivable of $76,000.

Net cash used in investing activities was $154,000 and $267,000 for the nine months ended September 30, 2021 and 2020, respectively, which consisted of property and equipment purchases.

Net cash provided by financing activities was $48.4 million for the nine months ended September 30, 2021, which resulted primarily from the February 2021 public offering, resulting in net proceeds to the financial statements includedCompany of approximately $47.9 million, after deducting underwriting discounts and offering expenses.

Net cash provided by financing activities was $17.4 million for the nine months ended September 30, 2020, which resulted primarily from the July 2020 private placement of $10.7 million, after deducting expense related to the private placement, the June 2020 exercise of the warrants generating approximately $5.1 million and the PPP Loan of $1.0 million in Part I, Item I of this Form 10-Q for further information regarding the Loan Agreement.2020.

We expect to incur a net loss and negative cash flows from operations in 2021. The impact of the remainderCOVID-19 pandemic and actions taken to contain it on our liquidity for 2021 and 2022 cannot be estimated as of 2017the date of this filing.

However, we believe that our cash and the foreseeable future.  Our management believes that successful achievement ofcash equivalents will be sufficient to fund our business objectives will require additional financing. Given these conditions, there is substantial doubt about our ability to continue as a going concern. The condensed consolidated financial statements have been prepared on a going concern basis and do not include any adjustments that might result from these uncertainties.

The Company expects to raise capital through a variety of sources, which may include the exercise of common stock warrants, equity offerings, debt financing, collaborations, licensing arrangements, grants and government funding and strategic alliances.  However, additional funding may not be available when needed or on terms acceptable to the Company. If the Company is unable to obtain additional capital, it may not be able to continue sales and marketing, research and development, or other operations on the scope or scale of current activity and that could have a material adverse effect on the Company’s business, results of operations and financial condition.

Net cash used in operating activities was $5,977,000 for the nine months ended September 30,  2017, resulting primarily from the net loss reported of $7,542,000 and changes in accounts payable, accrued and other liabilities of $401,000, partially offset by stock compensation expense of $997,000, depreciation and amortization of $599,000 and changes in prepaid expenses of $312,000.next twelve months.

Net cash used in operating activities was $11,199,000 for the nine months ended September 30, 2016 resulting primarily from the net loss reported of $12,122,000 and changes in accounts payable, accrued and other liabilities of $769,000, partially offset by stock compensation expense of $861,000, depreciation and amortization of $523,000 and changes in prepaid expenses of $354,000.

Net cash used in investing activities was $56,000 and $1,240,000 for the nine months ended September 30, 2017 and 2016, respectively. The higher costs in 2016 resulted from purchases of property and equipment for the ASPiRA IVD laboratory.

Net cash provided by financing activities was $8,543,000 for the nine months ended September 30, 2017, which consisted primarily of proceeds from the sale of Vermillion common stock in our February 2017 private placement, net of issuance costs, as well proceeds from the exercise of common stock warrants, net of issuance costs. 

Net cash provided by financing activities of $1,877,000 for the nine months ended September 30, 2016 consisted primarily of proceeds from the DECD loan.      

Our future liquidity and capital requirements will depend upon many factors, including, among others:  

resources devoted to sales, marketing and distribution capabilities;

the rate of OVA1, OVERA, OVA1plus and Aspira GenetiX product adoption by physicians and patients;

the rate of product adoption by healthcare systems and large physician practices of the decentralized distribution agreements for OVA1, OVERA and OVA1plus;

the insurance payer community’s acceptance of and reimbursement for our products;

our plans to acquire or invest in other products, technologies and businesses;

the market price of our common stock;

·

resources devoted to sales, marketing and distribution capabilities;

·

the rate of OVA1 and Overa product adoption by physicians and patients;

·

the insurance payer community’s acceptance of and reimbursement for OVA1 and Overa;

·

the successful targeted launch of Overa;

·

resources devoted to our IVD trials laboratory and services;

25

28


·

the revenue generated by our IVD trial services business;

·

our plans to acquire or invest in other products, technologies and businesses; and

·

the market price of our common stock.

the potential need to add study sites to access additional patients to maintain clinical timelines; and

the impact of the COVID-19 pandemic and the actions taken to contain it.

We have significant net operating loss (“NOL”) carryforwards as of September 30, 20172021 for which a full valuation allowance has been provided due to our history of operating losses. Section 382 of the Internal Revenue Code of 1986, as amended (“Section 382”), as well as similar state provisions may restrict our ability to use our NOL credit carryforwards due to ownership change limitations occurring in the past or that could occur in the future. These ownership changes may also limit the amount of NOL credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively.

Legislation commonly referred to as the Tax Cuts and Jobs Act (H.R. 1) was enacted on December 22, 2017. As a result of the Tax Cuts and Jobs Act of 2017, federal NOLs arising before January 1, 2018, and federal NOLs arising after January 1, 2018, are subject to different rules. The Company's pre- 2018 federal NOLs will expire in varying amounts from 2021 through 2037, if not utilized; and can offset 100% of future taxable income for regular tax purposes. Any federal NOLs arising after January 1, 2018, can generally be carried forward indefinitely and can offset up to 80% of future taxable income. State NOLs will expire in varying amounts from 2021 through 2037 if not utilized. The Company's ability to use its NOLs during this period will be dependent on the Company's ability to generate taxable income, and the NOLs could expire before the Company generates sufficient taxable income.  

The Company believes that Section 382 ownership changes occurred as a result of the Company's follow-on public offerings in 2011, 2013, and 2015. Any limitation may result in the expiration of a portion of the net operating loss and tax credit carryforwards before utilization and any net operating loss and tax credit carryforwards that expire prior to utilization as a result of such limitations will be removed from deferred tax assets with a corresponding reduction of the Company's valuation allowance. Due to the existence of a valuation allowance, it is not expected that such limitations, if any, will have an impact on the Company's results of operations or financial position. The Company is still assessing whether the 2021 Offering resulted in a Section 382 ownership change.

Off-Balance Sheet Arrangements

As of September 30, 2017,2021, we had no off-balance sheet arrangements that are reasonably likely to have a current or future material effect on our condensed consolidated financial condition, results of operations, liquidity, capital expenditures or capital resources.


29

ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK


ITEM 3.    QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Per Item 305(e) of Regulation S-K, the information called for by this Item 3 is not required.

ITEM 4.

CONTROLS AND PROCEDURES

ITEM 4.    CONTROLS AND PROCEDURES

Evaluation of disclosure controls and procedures.

Our senior management is responsible for establishing and maintaining a system of disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange Act is accumulated and communicated to the issuer’s management, including its principal executive officer and principal financial officer, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Management, including our Chief Executive Officer and Chief AccountingFinancial Officer, performed an evaluation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of September 30, 2017.2021. Based on this evaluation, our Chief Executive Officer and Chief AccountingFinancial Officer have concluded that as of September 30, 2017,2021, our disclosure controls and procedures were effective.

Changes in internal controls over financial reporting.

There was no change in our internal control over financial reporting that occurred during the period covered by this Quarterly Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

26


PART II - OTHER INFORMATION

ITEM 1.

LEGAL PROCEEDINGS

ITEM 1.    LEGAL PROCEEDINGS

In the ordinary course of business, we may periodically become subject to legal proceedings and claims arising in connection with ongoing business activities. The results of litigation and claims cannot be predicted with certainty, and unfavorable resolutions are possible and could materially and adversely affect our results of operations, cash flows and financial position. In addition, regardless of the outcome, litigation could have an adverse impact on us because of defense costs, diversion of management resources and other factors. While the outcome of these proceedings and claims cannot be predicted with certainty, there are no matters, as of September 30, 2017,2021, that, in the opinion of management, will have a material adverse effect on our financial position, results of operations or cash flows.

ITEM 1A.    RISK FACTORS

There have been no material changes to our risk factors from those disclosed under “Risk Factors” in Part I, Item 1A of our 20162020 Annual Report, and Part II, Item 1A of our 2017 First Quarterly Report.filed with the SEC on March 31, 2021, as supplemented by the risk factor disclosed under “Risk Factors” in the Second Quarter 2021 Form 10-Q. The risks and uncertainties described in our 20162020 Annual Report and 2017 First Quarterly Reportthe Second Quarter 2021 Form 10-Q are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also materially adversely affect our business, financial condition or results of operations.


27

30


ITEM 6.    EXHIBITS

(a) The following exhibits are filed or incorporated by reference with this report as indicated below:



 

 

 

 

 

 

 

 

 

 

 

 

Exhibit

 

 

 

Incorporated by Reference

 

Filed

Number

 

Exhibit Description

 

Form

 

File No.

 

Exhibit

 

Filing Date

 

Herewith



 

 

 

 

 

 

 

 

 

 

 

 

3.1

 

Fourth Amended and Restated Certificate of Incorporation of Vermillion, Inc. dated January 22, 2010

 

8-K

 

000-31617

 

3.1 

 

January 25, 2010

 

 

3.2

 

Certificate of Amendment of Fourth Amended and Restated Certificate of Incorporation, effective June 19, 2014

 

10-Q

 

001-34810

 

3.2 

 

August 14, 2014

 

 

3.3

 

Fifth Amended and Restated Bylaws of Vermillion, Inc., effective June 19, 2014

 

 

 

 

10-Q

 

001-34810

 

3.3 

 

August 14, 2014

 

 

4.1

 

Form of Letter Agreement, by and between Vermillion, Inc. and certain warrant holders

 

8-K

 

001-34810

 

4.1

 

August 28, 2017

 

 

31.1

 

Certification of the Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

 

 

 

 

 

 

 

 

 √ 

31.2

 

Certification of the Chief Accounting Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

 

 

 

 

 

 

 

 

 √

32.1

 

Certification of the Chief Executive Officer and Chief Accounting Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

 

 

 

 

 

 

 

 

(1)

101

 

Interactive Data Files

 

 

 

 

 

 

 

 

 

 

Exhibit

Incorporated by Reference

Filed

Number

Exhibit Description

Form

File No.

Exhibit

Filing Date

Herewith

3.1

Fourth Amended and Restated Certificate of Incorporation of Vermillion, Inc. dated January 22, 2010

8-K

000-31617

3.1

January 25, 2010

3.2

Certificate of Amendment of Fourth Amended and Restated Certificate of Incorporation, effective June 19, 2014

10-Q

001-34810

3.2

August 14, 2014

3.3

Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation of Vermillion, Inc. dated June 11, 2020

8-K

001-34810

3.1

June 11, 2020

3.4

Certificate of Designations, Preferences and Rights of Series B Convertible Preferred Stock

8-K

001-34810

4.1

April 17, 2018

3.5

Amended and Restated Bylaws of Aspira Women's Health Inc., effective May 6, 2021

8-K

001-34810

3.2

May 10, 2021

31.1

Certification of the Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

31.2

Certification of the Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

32.1

Certification of the Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

√√

101

Interactive Data Files pursuant to Rule 405 of Regulation S-T formatted in Inline Extensible Business Reporting Language ("Inline XBRL")

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

Filed herewith

√√

Furnished herewith

(1)

Furnished herewith


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SIGNATURES

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

Vermillion,Aspira Women’s Health Inc.

Date: November 8, 201710, 2021

/s/ Valerie B. Palmieri

Valerie B. Palmieri

President and Chief Executive Officer

(Duly Authorized Officer and

Principal Executive Officer)

Date: November 8, 201710, 2021

/s/ Eric J. SchoenRobert Beechey

Eric J. SchoenRobert Beechey

Senior Vice President, Finance and Chief AccountingFinancial Officer

(Duly Authorized Officer, Principal Financial Officer

and Principal Accounting Officer)

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