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): 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

 





 

---

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

---

First Quarter 2024 Financial Highlights

---

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

 

---

v3.24.1.1.u2

Document and Entity Information	May 15, 2024
Cover [Abstract]
Entity Registrant Name	Aspira Women’s Health Inc.
Security Exchange Name	NASDAQ
Amendment Flag	false
Entity Central Index Key	0000926617
Document Type	8-K
Document Period End Date	May 15, 2024
Entity Incorporation State Country Code	DE
Entity File Number	001-34810
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
Security 12b Title	Common Stock, par value $0.001 per share
Trading Symbol	AWH
Entity Emerging Growth Company	false

---