Aspira Women's Health Inc 8-K, filed Nov 12, 2020
Aspira Women's Health Inc. (AWHL)
About this 8-K
Aspira Women's Health Inc filed this 8-K on November 12, 2020.
Items reported
- Item 2.02: Financial results
- Item 5.02: Director or officer change, or executive pay
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 9, 2020
Aspira Women’s Health Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
001-34810 |
33-0595156 |
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(State or other jurisdiction |
(Commission |
(IRS Employer |
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of incorporation) |
File Number) |
Identification No.) |
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12117 Bee Caves Road, Building Three, Suite 100, Austin, Texas |
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78738 |
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(Address of principal executive offices) |
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(Zip Code) |
Registrant’s telephone number, including area code: (512) 519-0400
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
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Common Stock, par value $0.001 per share |
AWH |
The Nasdaq Stock Exchange |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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. ☐
Item 2.02Results of Operations and Financial Condition.
On November 12, 2020, Aspira Women’s Health Inc. (the “Company”) issued a press release reporting financial results for the three and nine months ended September 30, 2020. A copy of the Company’s press release is attached hereto as Exhibit 99.1.
The information provided in Item 2.02, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. Such information shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended (the “Securities Act”), regardless of any incorporation by reference language in such filing.
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
(d)
On November 9, 2020, the board of directors (the “Board”) of the Company appointed Sandra Brooks, M.D. as a director, effective immediately, filling a vacant seat on the Board. Dr. Brooks will serve as a director until the Company’s 2021 annual meeting of stockholders. Dr. Brooks has not yet been appointed to any committees of the Board. The Board has determined that Dr. Brooks meets the independence requirements of the Nasdaq listing standards and applicable Securities and Exchange Commission regulations.
There are no arrangements or understandings between Dr. Brooks and any other person pursuant to which she was appointed to the Board. Dr. Brooks does not have a direct or indirect material interest in any transaction required to be disclosed pursuant to Item 404(a) of Regulation S‐K.
Dr. Brooks will receive non-employee director compensation as disclosed in the Company’s proxy statement for its 2020 Annual Meeting of Stockholders filed with the SEC on April 27, 2020, pro rated for the portion of the year she will serve on the Board.
Item 7.01Regulation FD Disclosure.
On November 9, 2020, the Company issued a press release to announce Dr. Brooks’ appointment to the Board. A copy of the press release is attached hereto as Exhibit 99.2.
On November 10, 2020, the Company issued a press release to announce the appointment of five new members to its executive leadership team. A copy of the press release is attached hereto as Exhibit 99.3.
The information provided in Item 7.01, including Exhibit 99.2 and Exhibit 99.3 attached hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that Section. Such information shall not be incorporated by reference into any filing under the Securities Act or the Exchange Act, regardless of any incorporation by reference language in such filing.
Item 9.01Financial Statements and Exhibits.
(d) Exhibits
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 hereunto duly authorized.
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ASPIRA WOMEN’S HEALTH INC. |
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Date: November 12, 2020 |
By: |
/s/ Robert Beechey |
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Robert Beechey |
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Chief Financial Officer |
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Exhibit 99.1 |
Aspira Women’s Health Reports Third Quarter 2020 Financial Results
Conference Call scheduled for today, November 12th at 4:30 p.m. ET
AUSTIN, Texas — November 12, 2020 — 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 third quarter ended September 30, 2020.
“Our test volume and revenue have rebounded in Q3 to nearly pre-pandemic levels coupled with price expansion due to the CIGNA contract starting in Q2. We also added a key payer to help further drive adoption and price. We remain on track with our product launches and lastly we are very excited about our board and senior leadership team announcements. Aspira is now a Company majority led by women, for women, and these additions will significantly help to propel our growth.” stated Valerie Palmieri, President and CEO.
Strengthened executive and medical advisory leadership team. Expanded the leadership team with the appointment and promotion of five new corporate executives: Kaile Zagger, Chief Operating Officer; Lesley Northrop M.D., Chief Scientific Officer; Elena Ratner, M.D., Global Chief Medical Advisor, Clinical and Translational Medicine; Gary Altwerger, M.D., BS, Global Deputy Chief Medical Advisor, Clinical and Translational Medicine; and Diane Powis, Chief Spokeswoman
Board Expansion Aspira announced the appointment to our Board of Dr Sandra Brooks M.D., Senior Vice President and Chief Medical Officer of Thomas Jefferson University Hospitals. The majority of our board is now female.
Volume Recovery Aspira ended the third quarter at 95% of pre-covid levels comparing February 2020, the last full calendar month before COVID-19 significantly impacted the United States, to September 2020. Our OVA1 test volume increased 46% sequentially from the second quarter test volume levels and was approximately at the same level as third quarter of 2019. Our average unit price of OVA1 Plus increased sequentially 15% compared with the second quarter of 2020. 2,450 physicians ordered OVA1 with 84 percent of the customers being repeat customers. The number of ordering physicians increased 37% from the second quarter. The number of tests ordered by practice is up 32% compared to the prior year third quarter.
Expanded Payer Coverage Aspira is a participating provider with Anthem BlueCross BlueShield of Georgia, for an estimated additional 3.3 million members across the state. Aspira now has approximately 72% of the covered lives in Georgia. As of November 1, 2020, Aspira has approximately 173 million covered lives in the US.
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State of Connecticut Financing The Company previously announced a $4M loan from the State of Connecticut Department of Economic and Community Development, $2M of which we received in 2016. We expect to receive the additional $2M of funding under the DECD loan in the fourth quarter of 2020.
Publications: In October 2020, we published a paper in Current Medical Research and Opinion, titled “Low-risk Multivariate Index Assay Scores, Physician Referral and Surgical Choices in Women with Adnexal Masses”. A total of 282 independent patient charts were reviewed of which 146 were Low Risk results. Surgery was performed on 56% patients with low risk scores. The other 44% had no surgery and were followed clinically. There were no invasive cancers in the patients who had surgery. Clinicians were comfortable with expectant management of pelvic masses when OVA1 is low risk. These results demonstrated to us that there is an immediate need to assessing the status of a pelvic mass even though surgery is not performed.
Third Quarter Highlights:
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· The number of OVA1plus tests performed was 3596 for the third quarter 2020, compared to 2,458 in the second quarter of 2020 and 3,602 in the third quarter of 2019. Volume increased 46% over the second quarter of 2020 and was relatively flat over the third quarter of 2019. This reflects a strong volume recovery from the second quarter level as a result of the impact of COVID. |
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· Revenue on a per test performed basis for OVA1 revenue was $338 in the third quarter of 2020 compared to $295 in the second quarter of 2020. The sequential increase was driven by realization of a full quarter of our new contract price from CIGNA as of April 1, 2020 as well as the absence of one time items recorded in the second quarter. |
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· Gross profit on OVA1® product revenue was $547 thousand (a 45% profit margin) for the third quarter 2020 compared to $268 thousand for the second quarter of 2020 (a 37% profit margin). |
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· Research and development expenses for the third quarter 2020 were $595 thousand an increase of $255 thousand compared to the same period in 2019. This increase was primarily due to launching clinical studies as well as bioinformatics investments. |
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· Sales and marketing expenses for the third quarter 2020 were $2.1M compared to $2.4M the same period in 2019. This decrease was primarily due to reduced travel due to the COVID-19 pandemic. |
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· General and administrative expenses for the third quarter 2020 were $1.9M compared to $1.4M for the same period in 2019. This increase was primarily due to an increase in headcount and personnel-related expenses as well as legal expenses. |
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.
Thursday, November 12th @ 4:30pmET
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Investors Dial-in: |
877-407-4018 |
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International Dial-in: |
201-689-8471 |
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Conference ID: |
1372253 |
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Webcast: |
http://public.viavid.com/index.php?id=142095 |
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About Aspira Women’s Health Inc.
ASPIRA 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. OVA1®plus combines our FDA-cleared products OVA1® and OVERA® to detect risk of ovarian malignancy in women with adnexal masses. ASPiRA GenetiXSM testing offers both targeted and comprehensive genetic testing options with a gynecologic focus. With over 10 years of expertise in ovarian cancer risk assessment ASPIRA has expertise in cutting-edge research to inform our next generation of products. Our focus is on delivering products that allow healthcare providers to stratify risk, facilitate early detection and optimize treatment plans.
Visit our website for more information about our products 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 expected timing and receipt of proceeds from the State of Connecticut Department of Economic Development loan. 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, 2019, as supplemented by the section entitled “Risk Factors” in ASPIRA’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 and June 30, 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:
Ashley R. Robinson
LifeSci Advisors, LLC
Tel 617-535-7742
Arr@LifeSciAdvisors.com
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September 30, |
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December 31, |
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2020 |
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2019 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
$ |
18,836 |
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$ |
11,703 |
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Accounts receivable |
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848 |
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924 |
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Prepaid expenses and other current assets |
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522 |
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758 |
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Inventories |
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45 |
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25 |
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Total current assets |
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20,251 |
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13,410 |
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Property and equipment, net |
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593 |
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353 |
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Right-of-use asset |
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421 |
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52 |
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Other assets |
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- |
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13 |
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Total assets |
$ |
21,265 |
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$ |
13,828 |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
$ |
1,315 |
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$ |
1,158 |
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Accrued liabilities |
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2,815 |
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2,588 |
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Short-term debt |
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476 |
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193 |
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Lease liability |
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9 |
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39 |
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Total current liabilities |
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4,615 |
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3,978 |
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Non-current liabilities: |
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Long-term debt |
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1,678 |
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1,099 |
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Lease liability |
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422 |
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13 |
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Total liabilities |
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6,715 |
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5,090 |
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Commitments and contingencies |
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Stockholders’ equity: |
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Common stock, par value $0.001 per share, 150,000,000 shares authorized at September 30, 2020 and December 31, 2019; 104,041,493 and 97,286,157 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively |
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104 |
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97 |
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Additional paid-in capital |
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448,431 |
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430,802 |
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Accumulated deficit |
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(433,985) |
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(422,161) |
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Total stockholders’ equity |
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14,550 |
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8,738 |
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Total liabilities and stockholders’ equity |
$ |
21,265 |
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$ |
13,828 |
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2020 |
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2019 |
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2020 |
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2019 |
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Revenue: |
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Product |
$ |
1,239 |
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$ |
1,241 |
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$ |
3,192 |
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$ |
3,120 |
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Service |
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- |
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44 |
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13 |
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110 |
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Total revenue |
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1,239 |
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1,285 |
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3,205 |
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3,230 |
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Cost of revenue(1): |
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Product |
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803 |
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736 |
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2,187 |
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1,950 |
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Service |
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4 |
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213 |
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13 |
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601 |
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Total cost of revenue |
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807 |
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949 |
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2,200 |
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2,551 |
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Gross profit |
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432 |
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336 |
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1,005 |
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679 |
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Operating expenses: |
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Research and development(2) |
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595 |
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340 |
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1,370 |
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774 |
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Sales and marketing(3) |
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2,152 |
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2,425 |
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6,000 |
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7,569 |
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General and administrative(4) |
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1,966 |
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1,421 |
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5,542 |
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4,210 |
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Total operating expenses |
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4,713 |
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4,186 |
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12,912 |
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12,553 |
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Loss from operations |
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(4,281) |
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(3,850) |
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(11,907) |
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(11,874) |
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Interest income, net |
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5 |
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34 |
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14 |
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39 |
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Other income (expense), net |
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(11) |
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(4) |
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69 |
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(15) |
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Net loss |
$ |
(4,287) |
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$ |
(3,820) |
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$ |
(11,824) |
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$ |
(11,850) |
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Net loss per share - basic and diluted |
$ |
(0.04) |
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$ |
(0.04) |
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$ |
(0.12) |
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$ |
(0.14) |
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Weighted average common shares used to compute basic and diluted net loss per common share |
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103,200,612 |
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97,144,586 |
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99,555,194 |
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83,017,019 |
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Non-cash stock-based compensation expense included in cost of revenue and operating expenses: |
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(1) Cost of revenue |
$ |
20 |
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$ |
20 |
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$ |
73 |
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$ |
57 |
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(2) Research and development |
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16 |
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- |
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17 |
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4 |
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(3) Sales and marketing |
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31 |
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32 |
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116 |
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93 |
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(4) General and administrative |
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343 |
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243 |
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915 |
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738 |
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Exhibit 99.2 |
Aspira Women’s Health Strengthens Board of Directors with the Addition of Dr. Sandra E. Brooks
AUSTIN, Texas — November 9, 2020 — Aspira Women’s Health, Inc. (Nasdaq: AWH), a bioanalytical-based women’s health company, today announced the appointment of Sandra E. Brooks, MD, MBA to its Board of Directors. The addition of Dr. Brooks brings the Board composition to seven members with the majority now female.
“It’s a tremendous honor to welcome Dr. Brooks to our Board of Directors at this important phase in the evolution of Aspira Women’s Health. Dr. Brooks brings a wealth of knowledge and experience as a gynecologic oncologist by training as well as an experienced physician executive. Her significant insights will be invaluable as we pursue larger healthcare systems and expand into other gynecologic diseases,” stated Valerie Palmieri, President, and CEO of Aspira Women’s Health.
About Sandra E. Brooks, MD, MBA
Dr. Brooks is Senior Vice President & Chief Medical Officer at Thomas Jefferson University Hospitals, Center City Division, and a Professor in the Department of Obstetrics and Gynecology, Sidney Kimmel Medical College. Dr. Brooks trained in Obstetrics and Gynecology at the Hospital of the University of Pennsylvania and in Gynecologic Oncology at the Brigham and Women’s Hospital, Harvard Medical School, Dr. Brooks also served as Professor and Director of the Division of Gynecology Oncology at the University of Maryland for 10 years where in addition to clinical practice, and teaching trainees, her research focused on health services and cancer disparities. Dr. Brooks received her MBA in Medical Services Management at Johns Hopkins University before transitioning to physician executive roles in multi-site ambulatory and health system settings.
“It is my absolute pleasure to be a board member of a company focused on improving women’s lives, and has the potential to detect ovarian cancer risk in populations of women for whom established assays may less sensitive,” stated Dr. Sandra E. Brooks, Senior Vice President & Chief Medical Officer at Thomas Jefferson University Hospitals, Center City Division. “I believe my skills and perspective will complement the team, and look forward to serving with the other talented Board members.
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 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
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Exhibit 99.2 |
assessment and endometriosis. OVA1® plus includes 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 comprehensive genetic testing options with a gynecologic focus. With over 10 years of expertise in ovarian cancer risk assessment, ASPIRA 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 OVANEXTM and EndoCheckTM. Visit our website for more information at www.aspirawh.com.
Investor Relations Contact:
Ashley R. Robinson
LifeSci Advisors, LLC
Tel 617-430-7577
Arr@lifesciadvisors.com
Media Contact:
Jaime Abrusci
Rx Medical Dynamics
Tel 646-599-8606
jabrusci@rxmedyn.com
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Exhibit 99.3 |
Aspira Women’s Health, Inc. Strengthens
Executive Leadership with New Appointments
Team comprised of distinguished healthcare industry leaders in clinical development, translational medicine, strategy, and operational excellence, joins forces to accelerate innovation and market leadership position
AUSTIN, Texas — November 10, 2020 — Aspira Women’s Health, Inc. (Nasdaq: AWH), a bioanalytical-based women’s health company today announces the appointment of five new members to its executive leadership team. Aspira’s global mission is to transform women’s health, starting with ovarian cancer. These new appointments help the company to further its mission to provide women of all ages, stages, and ethnicities the best solutions to detect their gynecologic cancer risk.
“This is a profound moment in our company and a true inflection point that we are embarking upon. We are thrilled to welcome this distinguished group of executives to our leadership team during this exciting evolution of Aspira Women’s Health. Each of these leaders brings significant experience building successful healthcare pathways, companies and guiding novel products through commercialization,” said Valerie Palmieri, CEO of Aspira Women’s Health. “This team will drive forward our commitment to being a global leader focused solely on women’s health innovation. With the majority of female representation now at the board, executive, and director levels, Aspira is a company led by women for women.”
The appointment and promotion of five new corporate executives:
Elena Ratner, MD, Global Chief Medical Advisor, Clinical and Translational Medicine
Dr. Ratner serves as the Chief Medical Advisor and will formulate and execute Aspira’s clinical and translational medical initiatives. She will be responsible to accelerate the innovation platform, create academic and integrated healthcare system partnerships to propel the company’s growth forward. She is a gynecologic oncologist specializing in ovarian malignancies at the Smilow Cancer Hospital at Yale New Haven. As an associate professor of obstetrics, gynecology, and reproductive sciences at Yale School of Medicine, Dr. Ratner also studies chemotherapy targeted drug development, quality-of-life programs for patients, and early cancer detection. Dr. Ratner is co-founder and director of the Yale Medicine Sexual, Intimacy, and Menopause Program (SIMS), one of the first programs in the country to focus on supporting cancer survivors coping with issues that may not be discussed in the other clinical settings. She is the recipient of multiple awards, including the 2015 Yale Cancer Center Award for Clinical Excellence.
Kaile Zagger, Chief Operating Officer
Kaile joins as Chief Operating officer, combining Commercial and Operations into one role. This position will have oversight over the entire provider and patient experience from landing a new customer through the billing customer experience. The goal is to create a platform for scaling the business for sizable growth and a customer experience that is second to none. Kaile is an accomplished industry executive with 20+ years in the healthcare realm, serving in leadership
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Exhibit 99.3 |
positions at various Fortune 500 healthcare companies including St Jude Medical, Intuitive Surgical, and General Electric Healthcare. She excels at transforming businesses, changing clinical pathways by revolutionizing healthcare systems with disruptive technologies, and conquering white space. In her career, she has originated over $1B in top-line revenue, repeatedly exceeding operating plan expectations by more than 40%, and has sharp expertise in building net new business divisions with accelerated profitability. Kaile comes to Aspira Women’s Health, with a deep passion for the company’s mission and vision and has personally experienced the devastating nature of late-stage Ovarian Cancer, with the diagnosis of her mother at the young age of 40 and her passing from this horrific disease at 46 in 1999. She is fiercely committed to the prevention, early detection, and mitigation of late-stage diagnosis of cancer. In addition to her professional career, and together with Elena Ratner, MD, they co-founded the MAT Organization; a non-profit established to drive early detection for Ovarian Cancer and eradicate late-stage diagnosis through deep education of the provider community, a first of kind approach in the space.
Lesley Northrop, Ph.D., DABMGG, FACMG, Chief Science Officer
Dr. Northrop is promoted into her new role after serving as Global Head of Innovation and Clinical Development at Aspira. She is responsible for providing leadership and setting the overall strategic direction for the clinical and scientific development programs. Dr. Northrop has extensive experience in designing and developing genomic tests for clinical and commercial use and has led laboratory and genetic counseling teams, as well as cross-functional teams for product, marketing, data engineers, bioinformatics, and commercial strategies. She is a Diplomate of the American Board of Medical Genetics and a Fellow of the American College of Medical Genetics, specializing in- Molecular Genetics. In addition, Dr. Northrop holds a certificate qualification of Laboratory Director for the State of New York in Molecular Genetics, California Laboratory Director License, as well as New Jersey Bioanalytical license.
Gary Altwerger, MD, BS, Global Deputy Chief Medical Advisor, Clinical and Translational Medicine
Dr. Altwerger will be responsible for assisting in creating and executing translational and clinical medicine initiatives that will accelerate the company’s innovation and growth. Additionally, he works in New Haven, CT, and four other locations and specializes in gynecologic oncology and obstetrics and gynecology. He is affiliated with Bridgeport Hospital, Yale New Haven Hospital, and Stamford Hospital. Prior to joining Aspira, he served as Assistant Professor of Obstetrics and Gynecology, Wellness committee director, Obstetrics, Gynecology & Reproductive Sciences. Dr. Altwerger graduated from the Jacobs School of Medicine & Biomedical Sciences at The University of Buffalo.
Diane Powis, Ph.D., Chief Spokeswoman
Dr. Powis is an ovarian cancer patient and survivor whose role is to lead how we meet, serve, and educate patients. With her clinical background and journey, she will be responsible for patient advocacy, testimonials/storytelling, and the coordination and management of an ethnically diverse patient advisory board. Her involvement will help to ensure that all women can benefit from Aspira’s lifesaving diagnostics to help ensure improved prevention and early detection of gynecologic cancers. Diane is a Psychologist, Clinical Specialist affiliated with Greenwich Hospital Association, Yale New Haven. She was diagnosed with Stage III Ovarian Cancer in 2013 at which time her prognosis was, at best, five years. She is acutely aware that she is only still alive today because of recent advances in gynecologic oncology and the amazing work of surgeons, oncologists, and countless other health professionals who guided her through multiple surgeries, years of chemotherapy infusions, two clinical trials, and two PARP inhibitor regimens.
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Exhibit 99.3 |
“Our company has truly transformed from a single test to a portfolio of clinical solutions across the entire Gynecologic patient lifecycle. We have coupled this with bringing in several new experts from large healthcare systems, in addition to a top commercial operator and patient spokeswoman. Our current clinical team will be supplemented with Drs. Ratner, Altwerger, as well as input from Dr. Brooks at the board level. We will truly be developing solutions for the “Horizontal Carepathway” and ensuring early risk detection for all women of every socioeconomic background,” stated Valerie Palmieri, President, and CEO.
“I believe in the work the people of Aspira do each day! It’s incredibly humbling to be joining a team and company that allows me to combine both my passion for medicine and advocating for women’s healthcare. I am very much looking forward to working alongside the current clinical team of innovators that are transforming ovarian cancer risk assessment and to leverage their knowledge and expertise in my new role,” stated Dr. Elena Ratner.
Beyond ovarian cancer, Aspira is now tackling other gynecologic diseases through innovations in risk management and early detection solutions. Aspira is looking at gynecologic diseases utilizing a multi-modal approach, with both protein and genetic markers, to be deployed at the local and system level and Aspira is leading the charge in accelerating innovative solutions.
“Aspira Women’s Health is well-positioned to benefit from the dynamic and fast-growing ovarian cancer risk assessment and genetic panel test offerings,” said James T. LaFrance, Aspira Women’s Health Board Chair. “The leadership enhancements align with the company’s long-term strategic focus and expectations of profitable growth.”
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 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. OVA1® plus includes our FDA-cleared products, OVA1®, and OVERA® to detect risk of ovarian malignancy in women with adnexal masses. ASPIRA GenetiXSM testing offers both targeted and comprehensive genetic testing options with a gynecologic focus. With over 10 years of expertise in ovarian cancer risk assessment, ASPIRA 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 OVANEXTM and EndoCheckTM. Visit our website for more information at aspirawh.com.
Forward-Looking Statements
This press release contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995. 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
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Exhibit 99.3 |
and are subject to a number of risks, uncertainties and assumptions, including the risks and uncertainties inherent in c business, including those described in the section entitled “Risk Factors” in ASPIRA’s Annual Report on Form 10-K for the year ended December 31, 2019, as supplemented by the section entitled “Risk Factors” in ASPIRA’s Quarterly Report on Form 10-Q for the quarter ended August 14, 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:
Ashley R. Robinson
LifeSci Advisors, LLC
Tel 617-430-7577
Arr@lifesciadvisors.com
Media Contact:
Jaime Abrusci
Rx Medical Dynamics
Tel 646-599-8606
jabrusci@rxmedyn.com