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xFEFF; Aspira Women's Health Reports Second Quarter 2021 Financial Results   Total Revenue Increased 141% to $1.8 million; OVA1 Volume Grew 85% to 4,553 Accessions  New Publication Demonstrates OV

Key Takeaway: Aspira Women's Health Reports Second Quarter 2021 Financial Results Total Revenue Increased 141% to $1.8 million; OVA1 Volume Grew 85% to 4,553 Accessions New Publication Demonstrates OVA1 Superiority to Standard of Care Expanded Access of OVA1 Through AIM Specialty Health Co

Full Press Release Details

Aspira Women's Health Reports Second Quarter 2021 Financial Results
Total Revenue Increased 141% to $1.8 million; OVA1 Volume Grew 85% to 4,553 Accessions
New Publication Demonstrates OVA1 Superiority to Standard of Care
Expanded Access of OVA1 Through AIM Specialty Health
Conference Call and Webcast Today at 4:30 p.m. ET
AUSTIN, Texas August 12, 2021 Aspira Women's Health Inc. ( Aspira ) (Nasdaq: AWH), a bio-analytical based women's health company focused on gynecologic disease, today reported its financial results for the second quarter ended, June 30, 2021.
We are pleased with the volume growth in our products as the economy has somewhat emerged from COVID-19 restriction as well as with the advancement of our preparations for our fourth quarter 2021 launch of OVASight indicated Valerie Palmieri, Chief Executive Officer. We are making positive progress on our product collaboration with the Dana Farber Cancer Institute as we disclosed in the first quarter of 2021. We have also continued to have a positive dialogue with the FDA regarding our planned EndoCheck product.
Recent Corporate Highlights
A paper has been published in a special ovarian cancer edition of Diagnostics entitled Salvaging detection of early-stage ovarian malignancies when CA125 is not informative. 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 supports the superior early-stage detection of ovarian cancer versus the current standard of care in a large population.
OVASight (MIA3G) is the Company's third-generation OVA technology and is a laboratory-developed, blood-based pelvic mass risk assessment test for ovarian cancer in a low prevalence population. It was developed to increase specificity, maintain high sensitivity with early-stage disease, and allow for conservative management of suspected benign masses in women. A total of 596 samples collected from real-world patients were used to validate the OVASight diagnostic algorithm. Validation data demonstrated 89% specificity, 91% sensitivity and
a negative predictive value of 99.6% in a low prevalence population (3.8%). In addition, overall sensitivity as well as sensitivity in early-stage disease were significantly better than assessing risk with CA-125 alone.
In May 2021, Laura McPadden joined the Company as Head of People and Culture. Laura joined us with over 25 years of experience leading human resources and talent engines and providing strategic guidance for employee relations, performance management, talent acquisition and organizational design.
Financial Highlights
Highlights Second Quarter 2021 vs. Second Quarter 2020:
Highlights of Second Quarter 2021 vs. First Quarter 2021:
Conference Call and Webcast
Aspira will host a call today at 4:30 p.m. Eastern Time to discuss results followed by a question-and-answer period.
Domestic: 877-407-4018
International: 201-689-8471
Conference ID: 1372054
Webcast: http://public.viavid.com/index.php?id=145272
About Aspira Women's Health Inc.
Aspira Women's Health Inc. (formerly known as Vermillion, Inc., Nasdaq: VRML) is transforming women's health with the discovery, development, and commercialization of innovative testing options and bio-analytical solutions that help physicians assess risk, optimize patient management, and improve gynecologic health outcomes for women. Aspira Women's Health is particularly focused on closing the ethnic disparity gap in ovarian cancer risk assessment and developing solutions for pelvic diseases such as pelvic mass risk assessment and endometriosis. OVA1plusTM combines our FDA-cleared products, OVA1 and OVERA , to detect risk of ovarian malignancy in women with adnexal masses. Aspira GenetiXTM testing offers both targeted and more comprehensive genetic testing options with a gynecologic focus. With over 10 years of expertise in ovarian cancer risk assessment, Aspira Women's Health is delivering a portfolio of pelvic mass products over a patient's lifetime with our cutting-edge research. The next generation of products in development are OVASightTM and EndoCheckTM. Visit our website for more information at www.aspirawh.com.
Forward-Looking Statements
This press release contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995, including statements regarding anticipated expenses. These statements involve a number of risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements. Words such as may, expects, intends, anticipates, believes, estimates, plans, seeks, could, should, continue, will, potential, projects and similar expressions are intended to identify forward-looking statements. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including those described in the section entitled Risk Factors in Aspira's Annual Report on Form 10-K for the year ended December 31, 2020. The events and circumstances reflected in Aspira's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Aspira expressly disclaims any obligation to update, amend or clarify any forward-looking statements to reflect events, new information or circumstances occurring after the date of this press release, except as required by law.
Investor Relations Contact:
LifeSci Advisors, LLC
Aspira Women's Health Inc.
Condensed Consolidated Balance Sheets
(Amounts in Thousands, Except Share and Par Value Amounts)
June 30, December 31,
2021 2020
Assets
Current assets:
Cash and cash equivalents $ 52,993 $ 16,631
Accounts receivable 1,073 865
Prepaid expenses and other current assets 740 1,077
Inventories 101 30
Total current assets 54,907 18,603
Property and equipment, net 546 583
Right-of-use assets 376 406
Other assets - 13
Total assets $ 55,829 $ 19,605
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $ 1,436 $ 1,103
Accrued liabilities 3,900 3,618
Current portion long-term debt 199 645
Short-term debt 204 611
Lease liability 52 23
Total current liabilities 5,791 6,000
Non-current liabilities:
Long-term debt 2,818 3,477
Lease liability 382 409
Total liabilities 8,991 9,886
Commitments and contingencies
Stockholders' equity:
Common stock, par value $0.001 per share, 150,000,000 shares authorized at June 30, 2021 and December 31, 2020; 112,058,034 and 104,619,876 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively 112 105
Additional paid-in capital 499,786 449,680
Accumulated deficit (453,060) (440,066)
Total stockholders' equity 46,838 9,719
Total liabilities and stockholders' equity $ 55,829 $ 19,605
Aspira Women's Health Inc.
Condensed Consolidated Statements of Operations
(Amounts in Thousands, Except Share and Per Share Amounts)
Three Months Ended Six Months Ended
June 30, June 30,
2021 2020 2021 2020
Revenue:
Product $ 1,718 $ 726 $ 3,134 $ 1,911
Genetics 79 17 159 42
Service 2 3 2 13
Total revenue 1,799 746 3,295 1,966
Cost of revenue (1) :
Product 825 458 1,473 1,123
Genetics 278 131 523 261
Service - 4 - 9
Total cost of revenue 1,103 593 1,996 1,393
Gross profit 696 153 1,299 573
Operating expenses:
Research and development (2) 1,471 380 2,343 775
Sales and marketing (3) 4,018 1,733 7,126 3,848
General and administrative (4) 3,279 1,866 5,788 3,576
Total operating expenses 8,768 3,979 15,257 8,199
Loss from operations (8,072) (3,826) (13,958) (7,626)
Interest income (expense), net 3 1 (21) 9
Other income (expense), net 995 (6) 985 80
Net loss $ (7,074) $ (3,831) $ (12,994) $ (7,537)
Net loss per share - basic and diluted $ (0.06) $ (0.04) $ (0.12) $ (0.08)
Weighted average common shares used to compute basic and diluted net loss per common share 111,958,928 98,123,789 110,311,666 97,707,904
Non-cash stock-based compensation expense included in cost of revenue and operating expenses:
(1) Cost of revenue $ 53 $ 28 $ 87 $ 53
(2) Research and development 94 1 120 1
(3) Sales and marketing 337 43 476 85
(4) General and administrative 798 369 1,088 571
Last updated: Aug 12, 2021