0000950170-24-060049.txt : 20240515 0000950170-24-060049.hdr.sgml : 20240515 20240515080011 ACCESSION NUMBER: 0000950170-24-060049 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 12 CONFORMED PERIOD OF REPORT: 20240515 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240515 DATE AS OF CHANGE: 20240515 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Aspira Women's Health Inc. CENTRAL INDEX KEY: 0000926617 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 330595156 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-34810 FILM NUMBER: 24947226 BUSINESS ADDRESS: STREET 1: 12117 BEE CAVES ROAD BUILDING THREE STREET 2: SUITE 100 CITY: AUSTIN STATE: TX ZIP: 78738 BUSINESS PHONE: 512-519-0400 MAIL ADDRESS: STREET 1: 12117 BEE CAVES ROAD BUILDING THREE STREET 2: SUITE 100 CITY: AUSTIN STATE: TX ZIP: 78738 FORMER COMPANY: FORMER CONFORMED NAME: VERMILLION, INC. DATE OF NAME CHANGE: 20070824 FORMER COMPANY: FORMER CONFORMED NAME: CIPHERGEN BIOSYSTEMS INC DATE OF NAME CHANGE: 20000316 FORMER COMPANY: FORMER CONFORMED NAME: ABIOTIC SYSTEMS DATE OF NAME CHANGE: 19950407 8-K 1 awh-20240515.htm 8-K 8-K
0000926617false00009266172024-05-152024-05-15

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): May 15, 2024

 

 

Aspira Women’s Health Inc.

(Exact name of registrant as specified in its charter)

 

 





 

 

Delaware

001-34810

33-0595156

(State or other jurisdiction

(Commission

(IRS Employer

of incorporation)

File Number)

Identification No.)





 

 

 

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

 

78738

(Address of principal executive offices)

 

(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:



 

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)



 

 

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)





 

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))





 

☐

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:





 

 

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.001 per share

AWH

Nasdaq Capital Market



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 2.02 Results of Operations and Financial Conditions.

On May 15, 2024, Aspira Women’s Health Inc. (the “Company”) issued a press release reporting financial results for the three months ended March 31, 2024. A copy of the Company’s press release is attached hereto as Exhibit 99.1.

The information provided in this Current Report, 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, or the Exchange Act, regardless of any incorporation by reference language in such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

 

Exhibit No.

Description

99.1

Press Release issued by Aspira Women’s Health on May 15, 2024

104

Cover Page Interactive Data File (the cover page XBRL tags are embedded within the Inline XBRL document)

 

 



 

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.





 

 

 



 

 



 

ASPIRA WOMEN’S HEALTH INC.



 

 

Date: May 15, 2024

By:

/s/ Torsten Hombeck



 

Torsten Hombeck



 

Chief Financial Officer

 





 

 EX-99.1 2 awh-ex99_1.htm EX-99.1 EX-99.1

 

Aspira Women’s Health Reports First Quarter 2024 Financial Results

Q1 2024 OvaSuiteSM revenue of $2.2 million and volume of 5,829 units

Q1 2024 cash utilization of $4.4 million, a decrease of 22% compared to Q1 2023

Conference Call and Webcast scheduled for today at 8:30 am ET

AUSTIN, Texas, May 15, 2024 (GLOBE NEWSWIRE) -- Aspira Women’s Health Inc. (“Aspira” or the “Company”) (Nasdaq: AWH), a bio-analytical based women’s health company focused on the development of gynecologic disease diagnostic tools, today reported its financial results for the first quarter ended March 31, 2024.

“Our continued focus on growth, innovation and operational excellence has positioned us for an exciting year,” said Nicole Sandford, Chief Executive Officer of Aspira. “We saw OvaWatch®volume grow 114% this quarter when compared to the first quarter of last year, and we continued our two-year trend of cost reductions across the company. Moreover, the price volatility we anticipated following the introduction of OvaWatch in 2022 never materialized, and our gross margin remains strong.”

“OvaWatch offers an incredible opportunity for our growth, especially now that its features have been expanded to allow for repeat testing at provider-prescribed intervals. Moreover, clinical evidence to support the use of OvaWatch is stronger than ever. Recent publications showed that clinicians may have been able to avoid surgery for a majority of women with low- or indeterminate ovarian cancer risk if OvaWatch had been used as part of clinical decision-making. This one-of-a-kind tool offers clear benefits to patients, providers and payers alike, and is poised to improve outcomes for patients that choose to delay or avoid surgery in favor of a watchful waiting approach.”

“Our team is more prepared than ever to take advantage of the expanded commercially available OvaSuite test portfolio. We saw very strong signs of a return to growth now that our commercial strategy has reached the execution phase. March was the strongest month of the first quarter and that momentum carried into April, the second largest volume month in company history.”

Recent Corporate Highlights

•
Published a study that demonstrated OvaWatch significantly improves patient selection for surgery in ovarian cancer management. The study entitled: “Ovarian Cancer Surgical Consideration is Markedly Improved by the Neural Network Powered-MIA3G Multivariate Index Assay,” evaluated 785 surgical results in women with an adnexal mass. Results demonstrated that the use of OvaWatch would have reduced the number of surgeries by 62% overall, and by 77% in pre-menopausal women. Had physicians utilized OvaWatch scores for surgery selection, results demonstrated a 431% improvement in the ability to predict malignancy.

 

 

 

 

•
Published a study of 500 women validating the use of OvaWatch as a tool to monitor adnexal masses over time. The study, entitled “Neural Network-derived Multivariate Index Assay Demonstrates Effective Clinical Performance in Longitudinal Monitoring of Ovarian Cancer Risk,” found serial testing with OvaWatch to be a useful clinical tool in monitoring cancer risk of an adnexal mass.

•
Enhanced the Company’s commercial offering with the formal launch of the longitudinal monitoring feature of OvaWatch. The new feature offers physicians a tool for assessing malignancy risk over time and determining the appropriate personalized treatment path. OvaWatch utilizes an AI-powered algorithm to assess malignancy risk of adnexal masses when initial clinical assessment indicates the mass is indeterminant or low-risk.

•
Announced a new agreement with Anthem Blue Cross in California for reimbursement coverage of the Company’s OvaSuite portfolio of risk assessment tests effective June 1, 2024. Anthem Blue Cross will provide coverage for its commercial and government lines of business, including Medicare Advantage and Medicaid, which represents a total of approximately six million covered lives in California. The Company was credentialed by Anthem during the first quarter of 2024, allowing for its affiliates to partner with Aspira, and more contracts are expected to follow.

First Quarter 2024 Financial Highlights

•
Product revenue was $2.2 million for the three months ended March 31, 2024, compared to $2.3 million for the same period in 2023. The number of OvaSuite tests performed was approximately 5,829 during the three months ended March 31, 2024, a 7% decrease compared to the approximately 6,259 OvaSuite tests for the same period in 2023. The average unit price (AUP) for the Company’s OvaSuite tests was $369 for the three months ended March 31, 2024, compared to $370 for the same period in 2023. Sales efficiency, as measured by volume per full-time sales representative, increased 22% in the first quarter compared to the same period in 2023.

•
Gross profit margin was 56% for the three months ended March 31, 2024, compared to 51% for the same period in 2023.

•
Research and development expenses for the three months ended March 31, 2024, were $0.9 million, a decrease of 28% compared to $1.3 million for the same period in 2023. This decrease was primarily due to decreases in personnel costs.

•
Sales and marketing expenses for the three months ended March 31, 2024, were $1.9 million, a decrease of 27%, compared to $2.6 million for the same period in 2023. This decrease was primarily due to decreased consulting, personnel, and travel costs.

 

 

 

 

•
General and administrative expenses for the three months ended March 31, 2024, were $3.1 million, a decrease of 13%, compared to $3.6 million for the same period in 2023. This decrease was primarily due to a decrease in personnel costs, as well as outside accounting and consulting costs.

Balance Sheet Highlights

As of March 31, 2024, Aspira had $3.7 million in cash, including restricted cash, up from $2.9 million in cash, including restricted cash as of December 31, 2023. Aspira raised $5.6 million in gross proceeds in a registered direct offering during the first quarter 2024. Cash used in operating activities was $4.4 million for the three months ended March 31, 2024, compared to $5.7 million in the same period in 2023, a 22% decrease. The Company’s operating cash utilization target for 2024 remains between $15 million and $18 million.

Conference Call and Webcast Details

Aspira’s management team will host a conference call beginning at 8:30 am ET today, May 15, 2024. Investors and other interested parties may participate in the conference call by dialing 1-877-407-4018. The call will be available via webcast by clicking HERE or on the events page of the Company’s website after the conclusion of the call.

About Aspira Women’s Health Inc.

Aspira Women’s Health Inc. is dedicated to the discovery, development, and commercialization of noninvasive, AI-powered tests to aid in the diagnosis of gynecologic diseases.

OvaWatch® and Ova1Plus® are offered to clinicians as OvaSuiteSM. Together, they provide the only comprehensive portfolio of blood tests to aid in the detection of ovarian cancer for the 1.2+ million American women diagnosed with an adnexal mass each year. OvaWatch provides a negative predictive value of 99% and is used to assess ovarian cancer risk for women where initial clinical assessment indicates the mass is indeterminate or benign, and thus surgery may be premature or unnecessary. Ova1Plus is comprised of two FDA-cleared tests, Ova1®and Overa®, to assess the risk of ovarian malignancy in women planned for surgery.

Our in-development test pipeline is designed to expand our ovarian cancer portfolio and addresses the tremendous need for noninvasive diagnostics for endometriosis, a debilitating disease that impacts millions of women worldwide. In ovarian cancer, our OvaMDxSM risk assessment is designed to combine microRNA and protein biomarkers with patient data to further enhance the sensitivity and specificity of our current tests. In endometriosis, EndoCheckSM is the first-ever noninvasive test designed to identify endometriomas, one of the most commonly occurring forms of endometriosis. The EndoMDxSM test is designed to combine microRNA and protein biomarkers with patient data to identify all endometriosis.

Forward-Looking Statements
This press release may contain forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including those relating to the timing and completion of any products in the pipeline development and other statement that are predictive in nature. Actual results could differ materially from those discussed due to known and unknown risks, uncertainties, and other factors. These forward-looking statements generally can be

 

 

 

 

identified by the use of words such as “designed to,” “expect,” “plan,” “anticipate,” “could,” “may,” “intend,” “will,” “continue,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this press release and other factors that may cause such differences include the satisfaction of customary closing conditions related to the offering and the expected timing of the closing of the offering. These and additional risks and uncertainties are described more fully in the company’s filings with the SEC, including those factors identified as “risk factors” in our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. We are providing this information as of the date of this press release and do not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise, except as required by law.

Investor Relations Contact:
Torsten Hombeck, Ph.D.

Chief Financial Officer

Aspira Women’s Health

Investors@aspirawh.com

 

 

 

 

 

 

Aspira Women’s Health Inc.

Condensed Consolidated Balance Sheets (unaudited)

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

 

 

March 31,

 

 

December 31,

 

 

2024

 

 

2023

 

Assets

(Unaudited)

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

$

 

3,413

 

 

$

 

2,597

 

Accounts receivable, net of reserves of $2 and $15, as of March 31, 2024 and December 31, 2023, respectively

 

 

1,531

 

 

 

 

1,459

 

Prepaid expenses and other current assets

 

 

942

 

 

 

 

997

 

Inventories

 

236

 

 

 

227

 

Total current assets

 

 

6,122

 

 

 

 

5,280

 

Property and equipment, net

 

131

 

 

 

165

 

Right-of-use assets

 

620

 

 

 

528

 

Restricted cash

 

260

 

 

 

258

 

Other assets

 

 

31

 

 

 

31

 

Total assets

$

 

7,164

 

 

$

 

6,262

 

Liabilities and Stockholders’ Deficit

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable

$

 

1,643

 

 

$

 

1,261

 

Accrued liabilities

 

 

2,797

 

 

 

 

2,863

 

Current portion of long-term debt

 

249

 

 

 

166

 

Short-term debt

 

 

416

 

 

 

670

 

Current maturities of lease liabilities

 

188

 

 

 

159

 

Total current liabilities

 

 

5,293

 

 

 

 

5,119

 

Non-current liabilities:

 

 

 

 

 

 

 

Long-term debt

 

 

1,347

 

 

 

 

1,430

 

Non-current maturities of lease liabilities

 

487

 

 

 

427

 

Warrant liabilities

 

 

1,400

 

 

 

 

1,651

 

Total liabilities

 

 

8,527

 

 

 

 

8,627

 

Commitments and contingencies

 

 

 

 

 

 

 

Stockholders’ deficit:

 

 

 

 

 

 

 

Common stock, par value $0.001 per share, 200,000,000 and 150,000,000 shares authorized at March 31, 2024 and December 31, 2023, respectively; 12,344,104 and 10,645,049 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively

 

 

12

 

 

 

11

 

Additional paid-in capital

 

 

521,557

 

 

 

 

515,927

 

Accumulated deficit

 

 

(522,932

)

 

 

 

(518,303

)

Total stockholders’ deficit

 

 

(1,363

)

 

 

 

(2,365

)

Total liabilities and stockholders’ deficit

$

 

7,164

 

 

$

 

6,262

 

 

 

 

 

 

 

Aspira Women’s Health Inc.

Condensed Consolidated Statements of Operations (unaudited)

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

 

Three Months Ended

 

 

March 31,

 

 

2024

 

 

2023

 

Revenue:

 

 

 

 

 

 

 

Product

$

 

2,153

 

 

$

 

2,315

 

Genetics

 

 

-

 

 

 

 

1

 

Total revenue

 

 

2,153

 

 

 

 

2,316

 

Cost of revenue:

 

 

 

 

 

 

 

Product

 

 

939

 

 

 

 

1,130

 

Total cost of revenue

 

 

939

 

 

 

 

1,130

 

Gross profit

 

 

1,214

 

 

 

 

1,186

 

Operating expenses:

 

 

 

 

 

 

 

Research and development

 

 

906

 

 

 

 

1,267

 

Sales and marketing

 

 

1,889

 

 

 

 

2,595

 

General and administrative

 

 

3,129

 

 

 

 

3,604

 

Total operating expenses

 

 

5,924

 

 

 

 

7,466

 

Loss from operations

 

 

(4,710

)

 

 

 

(6,280

)

Other income (expense), net:

 

 

 

 

 

 

 

Change in fair value of warrant liabilities

 

 

251

 

 

 

 

(24

)

Interest (expense) income, net

 

 

(5

)

 

 

 

26

 

Other expense, net

 

 

(165

)

 

 

 

(300

)

Total other income (expense), net

 

 

81

 

 

 

 

(298

)

Net loss

$

 

(4,629

)

 

$

 

(6,578

)

Net loss per share - basic and diluted

$

 

(0.39

)

 

$

 

(0.79

)

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

 

 

11,846,075

 

 

 

 

8,313,091

 

 

 

 

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