AWH Aspira Womans Health Inc

 

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): August 12, 2024

 

 

Aspira Women's Health Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			001-34810	33-0595156
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer 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

 

(Former Name or Former Address, if Changed Since Last Report)

 

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:

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

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. ☐

 

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Item 2.02 Results of Operations and Financial Condition.

On August 12, 2024, Aspira Women’s Health Inc. (the “Company”) issued a press release reporting financial results for the three and six months ended June 30, 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 August 12, 2024
104	Cover Page Interactive Data File (the cover page XBRL tags are embedded within the Inline XBRL document)

 

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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:	August 12, 2024	By:	/s/ Nicole Sandford
			Nicole Sandford, Chief Executive Officer

 

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Aspira Women’s Health Reports Second Quarter 2024 Financial Results

 

Q2 2024 OvaSuiteSM revenue of $2.4 million and volume of 6,471 units

 

Q2 2024 cash utilization decreased by 16% compared to Q1 2024

 

Full year 2024 cash guidance decreased to $13-$14.5 million

 

Conference Call and Webcast scheduled for today at 4:30 pm ET

 

 

AUSTIN, Texas, August 12, 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 second quarter ended June 30, 2024.

 

“OvaWatch product volume grew an impressive 48% in the second quarter when compared to last year, which we believe is the most important indicator of future growth,” said Nicole Sandford, Chief Executive Officer of Aspira. “We expanded the addressable market of our commercial portfolio to between 2 and 4 million tests per year when we launched the longitudinal mass monitoring application of the OvaWatch test based on powerful new data published in May. This is ten times the addressable market of the Ova1Plus test, which currently enjoys a 5-10% market share. With the hard work of rebuilding the commercial team and tools from the ground up, I believe we are uniquely positioned to take full advantage of the opportunity in front of us. We are now fully focused on making our OvaSuite test portfolio the universal standard of care for every woman diagnosed with an adnexal mass.”

Ms. Sandford added, “We continue to aggressively pursue nondilutive sources of cash. However, our recent financing brought in the cash we needed to stay focused on our goals based on our lower cash projections for the year. Each person in the company sees it as their personal responsibility to continue forward progress while minimizing costs.”

 

Dr. Sandy Milligan, President of Aspira said, “Our in-development molecular tests for ovarian cancer and endometriosis have the potential to be truly ground-breaking for women’s health. Our focus on prudent, properly paced R&D spending has not materially impacted our progress towards our near-term milestones. I am excited to continue leading the design and development of cutting-edge diagnostic tools for gynecologic diseases that have plagued women for far too long.”

 

Recent Corporate Highlights

 

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Second Quarter 2024 Financial Highlights

 

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Balance Sheet Highlights

As of June 30, 2024, Aspira had $1.0 million in cash, compared to $2.9 million in cash as of December 31, 2023. Subsequent to the end of the quarter, Aspira raised $1.9 million in gross proceeds in a registered direct offering and $2.1 million in a warrant inducement offering. Adjusting for this, the cash balance as of June 30, 2024, would have been $5.0 million. Additionally, the Company entered into a $4.5 million at-the-market facility with H.C. Wainwright.

 

Cash used in operating activities was $3.7 million for the three months ended June 30, 2024. The Company is updating its expected operating cash utilization target for the balance of 2024 to be between $4.8 million and $6.3 million, or $13 million and $14.5 million for the full year 2024, down from its original 2024 target of between $15 million and $18 million.

 

Conference Call and Webcast Details

Aspira’s management team will host a conference call beginning at 4:30 pm ET today, August 12, 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

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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:
Nicole Sandford

Chief Executive Officer

Investors@aspirawh.com

 

 

 

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Aspira Women’s Health Inc.

Condensed Consolidated Balance Sheets (unaudited)

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

 

	June 30,					December 31,
	2024					2023
Assets	(Unaudited)
Current assets:
Cash and cash equivalents	$		962			$		2,597
Accounts receivable, net of reserves of $0 and $15, as of June 30, 2024 and December 31, 2023, respectively			1,445					1,459
Prepaid expenses and other current assets			618					997
Inventories		226					227
Total current assets			3,251					5,280
Property and equipment, net		120					165
Right-of-use assets		559					528
Restricted cash		-					258
Other assets			31				31
Total assets	$		3,961			$		6,262
Liabilities and Stockholders’ Deficit
Current liabilities:
Accounts payable	$		1,943			$		1,261
Accrued liabilities			2,856					2,863
Current portion of long-term debt		316					166
Short-term debt			166				670
Current maturities of lease liabilities		177					159
Total current liabilities			5,458					5,119
Non-current liabilities:
Long-term debt			1,264					1,430
Non-current maturities of lease liabilities		437					427
Warrant liabilities			511					1,651
Total liabilities			7,670					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 June 30, 2024 and December 31, 2023, respectively; 12,825,090 and 10,645,049 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively			13				11
Additional paid-in capital			522,740					515,927
Accumulated deficit			(526,462	)				(518,303	)
Total stockholders’ deficit			(3,709	)				(2,365	)
Total liabilities and stockholders’ deficit	$		3,961			$		6,262

 

 

 

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Aspira Women’s Health Inc.

Condensed Consolidated Statements of Operations (unaudited)

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

 

	Three Months Ended										Six Months Ended
	June 30,										June 30,
	2024					2023					2024					2023
Revenue:
Product	$		2,423			$		2,491			$		4,576			$		4,806
Genetics			-					-					-					1
Total revenue			2,423					2,491					4,576					4,807
Cost of revenue:
Product			1,002					941					1,941					2,071
Total cost of revenue			1,002					941					1,941					2,071
Gross profit			1,421					1,550					2,635					2,736
Operating expenses:
Research and development			952					693					1,858					1,960
Sales and marketing			2,137					1,772					4,026					4,367
General and administrative			2,725					3,406					5,854					7,010
Total operating expenses			5,814					5,871					11,738					13,337
Loss from operations			(4,393	)				(4,321	)				(9,103	)				(10,601	)
Other income (expense), net:
Change in fair value of warrant liabilities			889					992					1,140					968
Interest (expense) income, net			(10	)				8					(15	)				34
Forgiveness of DECD loan			-					1,000					-					1,000
Other expense, net			(16	)				4					(181	)				(296	)
Total other income (expense), net			863					2,004					944					1,706
Net loss	$		(3,530	)		$		(2,317	)		$		(8,159	)		$		(8,895	)
Net loss per share - basic and diluted	$		(0.28	)		$		(0.28	)		$		(0.67	)		$		(1.06	)
Weighted average common shares used to compute basic and diluted net loss per common share			12,518,725					8,400,157					12,181,481					8,357,013

 

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v3.24.2.u1

Document And Entity Information	Aug. 12, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 12, 2024
Entity Registrant Name	Aspira Women's Health Inc.
Entity Central Index Key	0000926617
Entity Emerging Growth Company	false
Entity File Number	001-34810
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	33-0595156
Entity Address, Address Line One	12117 Bee Caves Road
Entity Address, Address Line Two	Building III
Entity Address, Address Line Three	Suite 100
Entity Address, City or Town	Austin
Entity Address, State or Province	TX
Entity Address, Postal Zip Code	78738
City Area Code	512
Local Phone Number	519-0400
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	AWH
Security Exchange Name	NASDAQ

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