8-K
Aspira Women's Health Inc. (AWHL)
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
Dateof Report (Date of earliest event reported): March 27, 2025
AspiraWomen’s Health Inc.
(Exactname of registrant as specified in its charter)
| Delaware | 001-34810 | 33-0595156 |
|---|---|---|
| (State<br> or other jurisdiction | (Commission | (IRS<br> Employer |
| of<br> incorporation) | File<br> Number) | Identification<br> No.) |
| 12117 Bee Caves Road, Building III, Suite 100, Austin, Texas | 78738 |
|---|---|
| (Address<br> of principal executive offices) | (Zip<br> Code) |
Registrant’stelephone 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<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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| ☐ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ☐ | Pre-commencement<br> communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Securitiesregistered pursuant to Section 12(b) of the Act:
| Title<br> of each class | Trading<br> Symbol(s) | Name<br> of each exchange on which registered |
|---|---|---|
| Common<br> Stock, par value $0.001 per share | AWH | Nasdaq<br> 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. ☐
Item2.02 Results of Operations and Financial Conditions.
On March 27, 2025, Aspira Women’s Health Inc. (the “Company”) issued a press release reporting financial results for the three and twelve months ended December 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.
Item9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit<br> No. | Description |
|---|---|
| 99.1 | Press Release issued by Aspira Women’s Health on March 27, 2025 |
| 104 | Cover<br> 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<br> WOMEN’S HEALTH INC. | |
|---|---|---|
| | ||
| Date:<br> March 27, 2025 | By: | /s/ James Crawford |
| | James<br> Crawford | |
| | Vice<br> President of Finance |
Exhibit99.1
AspiraWomen’s Health Reports Fourth Quarter and Full Year 2024 Financial Results
Record2024 OvaSuite revenue of $9.2 million and volume of 24,305 units sold
AUSTIN, Texas, Mar. 27, 2025 (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 fourth quarter and year ended December 31, 2024. Select financial results are as follows:
FourthQuarter 2024 and Recent Financial Highlights
| ● | Product<br> revenue increased 9.5% to $2.3 million for the three months ended December 31, 2024, compared to $2.1 million for the same period<br> in 2023. |
|---|---|
| ● | The<br> number of OvaSuite tests performed increased 6.1% to approximately 6,004 during the three months ended December 31, 2024, compared<br> to the approximately 5,659 OvaSuite tests for the same period in 2023. |
| ● | The<br> average unit price (AUP) increased 4.3% to $391 for the three months ended December 31, 2024, compared to $376 for the same period<br> in 2023. |
| ● | Gross<br> profit margin improved 6.2 percentage points to 63.4% for the three months ended December 31, 2024, compared to 57.2% for the same<br> period in 2023. |
| ● | Total<br> operating expenses were $4.9 million for the three months ended December 31, 2024, a decrease of $0.4 million, or 8%, compared to<br> the same period in 2023. |
| ● | Cash<br> balance as of March 27, 2024, of approximately $3.7 million, excluding the pending $1.5 million ARPA-H milestone payment currently<br> in process of payment. |
| ● | Company<br> successfully completed a $1.36 million convertible note raise and raised $4.39 million under its At-The-Market (ATM) facility in<br> the 4th quarter and subsequent to year end, bringing the total funds raised to $5.75 million. |
Forthe Full Year 2024:
| ● | Product<br> revenue was unchanged at $9.2 million for the year ended December 31, 2024, compared to $9.2 million for the same period in 2023. |
|---|---|
| ● | The<br> number of OvaSuite tests performed increased 1.3% to approximately 24,305 during the year ended December 31, 2024, compared to the<br> approximately 23,990 OvaSuite tests for the same period in 2023. |
| ● | The<br> average unit price (AUP) decreased 1.0% to $378 for the year ended December 31, 2024, compared to $382 for the same period in 2023. |
| ● | Gross<br> profit margin improved 2.2 percentage points to 59.7% for the year ended December 31, 2024, compared to 57.5% for the year ended<br> December 31, 2023. |
| ● | Total<br> operating expenses were $21.8 million for the year ended December 31, 2024, a decrease of $2.4 million, or 10%, compared to the same<br> period in 2023. |
Newly appointed CEO Mike Buhle stated, “The Aspira team generated record test volume and revenue in a challenging environment in 2024. During a period of transition and change, our sales and operational team remained focused on markets and the medical community we serve. We are deeply committed to meeting the medical needs of millions of women that benefit from the life-saving capabilities of our early detection OvaSuite product.”
Mr. Buhle continued, “Looking ahead, our strategic focus in 2025 and beyond is to rapidly accelerate top-line revenue growth through our improved go-to-market strategy. This is our highest priority for the team at this time, and we believe this is how we will quickly improve top line financial performance in 2025.”
“Additionally, we have identified clear opportunities to run a leaner cost model, dedicating more of our financial resources to sales growth, improved profitability, while will continue to look at new in-licensing opportunities, channel partners, and other strategic collaborations that enable efficient revenue streams and digital integrations.”
“Lastly, our research and development pipeline will not only increase our total addressable market but will also enhance our current portfolio of treatment pathway solutions, making us more attractive for long-term partnerships. In addition, we were honored by the $10 million Federal Government investment in ENDOinform, which is a strong validation of our mission to empower patients and healthcare providers with facts, not fear,” continued Mr. Buhle. “This funding will accelerate our near-term pipeline, fuel meaningful growth, and drive new strategic partnerships to make a lasting impact on women’s health.”
RecentCorporate Highlights
| ● | Announced<br> the appointment of Mike Buhle as Chief Executive Officer |
|---|---|
| ● | Successfully<br> reached the first milestone of the ARPA-H $10 million award |
| ● | Appointed<br> Ellen Beausang, former Chief Commercial Officer of BioReference Health, to the Board of Directors |
| ● | Closed<br> $1.36 million private placement of convertible notes in March 2025 |
| ● | Generated<br> $3.48 million in gross proceeds through our 2024 At the Market Offering Agreement so far in Q1 2025 |
AboutAspira Women’s Health Inc.
Aspira Women’s Health Inc. is dedicated to the discovery, development, and commercialization of noninvasive, AI-enabled tests to aid in the diagnosis of gynecologic diseases.
OvaWatch^®^and Ova1Plus^®^ are offered to clinicians as OvaSuite^SM^. Together, they provide the only comprehensive portfolio of blood tests to aid in the detection of ovarian cancer risk for the more than 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 a reflex process of two FDA-cleared tests, Ova1^®^ and Overa^®^, to assess the risk of ovarian malignancy in women with an adnexal mass planned for surgery.
Our in-development test pipeline will expand our ovarian cancer portfolio and address the need for non-invasive diagnostics for endometriosis, a debilitating disease that impacts millions of women worldwide. In ovarian cancer, we intend to combine microRNA and protein biomarkers with patient data to further enhance the sensitivity and specificity of our current tests and expand the indicated population to screen women with a family history of ovarian cancer or a germline mutation. Through our ongoing endometriosis development program, we are combining microRNA and protein biomarkers with patient data, with the intent of identifying endometriosis independent of disease location or severity.
Forward-LookingStatements
This press release contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve a number of risks and uncertainties. Such forward-looking statements include statements regarding, among other things, the timing and completion of any products in the development pipeline and other statements that are predictive in nature, and whether the marketing of the OvaSuite portfolio will prove successful. 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,” and other words of similar meaning and the use of future dates. These and additional risks and uncertainties are described more fully in the Company’s filings with the Securities and Exchange Commission (SEC), including those factors identified as “Risk Factors” in our most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and subsequent Quarterly Reports on Form 10-Q. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Aspira presently does not know, or that Aspira currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Aspira’s expectations, plans, or forecasts of future events and views as of the date of this press release. Subsequent events and developments may cause the Company’s assessments to change. However, while Aspira may elect to update these forward-looking statements at some point in the future, Aspira expressly disclaims any obligation to do so, except as required by law. These forward-looking statements should not be relied upon as representing Aspira’s assessments of any date after the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.
InvestorRelations Contact :
investors@aspirawh.com
AspiraWomen’s Health Inc.
CondensedConsolidated Balance Sheets
(Amounts in Thousands, Except Share and Par Value Amounts)
| December 31, | |||||
|---|---|---|---|---|---|
| 2023 | |||||
| Assets | |||||
| Current assets: | |||||
| Cash and cash equivalents | 1,769 | $ | 2,597 | ||
| Accounts receivable, net of reserves of 0 and 15, as of December 31, 2024 and December 31, 2023, respectively | 990 | 1,459 | |||
| Prepaid expenses and other current assets | 1,098 | 997 | |||
| Inventories | 326 | 227 | |||
| Total current assets | 4,183 | 5,280 | |||
| Property and equipment, net | 69 | 165 | |||
| Right-of-use assets | 1,194 | 528 | |||
| Restricted cash | - | 258 | |||
| Other assets | 45 | 31 | |||
| Total assets | 5,491 | $ | 6,262 | ||
| Liabilities and Stockholders’ (Deficit) Equity | |||||
| Current liabilities: | |||||
| Accounts payable | 2,173 | $ | 1,261 | ||
| Accrued liabilities | 2,445 | 2,863 | |||
| Current portion of long-term debt | 229 | 166 | |||
| Short-term debt | 614 | 670 | |||
| Current maturities of lease liabilities | 7 | 159 | |||
| Total current liabilities | 5,468 | 5,119 | |||
| Non-current liabilities: | |||||
| Long-term debt | 1,278 | 1,430 | |||
| Non-current maturities of lease liabilities | 1,248 | 427 | |||
| Warrant liabilities | 60 | 1,651 | |||
| Total liabilities | 8,054 | 8,627 | |||
| Commitments and contingencies | |||||
| Stockholders’ (deficit) equity: | |||||
| Common stock, par value 0.001 per share, 200,000,000 and 200,000,000 shares authorized at December 31, 2024 and December 31, 2023, respectively; 17,407,120 and 10,645,049 shares issued and outstanding at December 31, 2024 and December 31, 2023, respectively | 17 | 11 | |||
| Additional paid-in capital | 528,817 | 515,927 | |||
| Accumulated deficit | (531,397 | ) | (518,303 | ) | |
| Total stockholders’ deficit | (2,563 | ) | (2,365 | ) | |
| Total liabilities and stockholders’ deficit | 5,491 | $ | 6,262 |
All values are in US Dollars.
AspiraWomen’s Health Inc.
CondensedConsolidated Statements of Operations
(Amounts in Thousands, Except Share and Par Value Amounts)
| Three Months Ended | Year Ended | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| December 31, | December 31, | |||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||
| Revenue: | ||||||||||||
| Product | $ | 2,349 | $ | 2,130 | $ | 9,182 | $ | 9,153 | ||||
| Genetics | - | - | - | 1 | ||||||||
| Total revenue | 2,349 | 2,130 | 9,182 | 9,154 | ||||||||
| Cost of revenue: | ||||||||||||
| Product | 860 | 911 | 3,703 | 3,892 | ||||||||
| Genetics | - | - | - | - | ||||||||
| Total cost of revenue | 860 | 911 | 3,703 | 3,892 | ||||||||
| Gross profit | 1,489 | 1,219 | 5,479 | 5,262 | ||||||||
| Operating expenses: | ||||||||||||
| Research and development | 500 | 1,077 | 3,266 | 4,035 | ||||||||
| Sales and marketing | 1,977 | 1,743 | 8,146 | 7,812 | ||||||||
| General and administrative | 2,443 | 2,534 | 10,345 | 12,267 | ||||||||
| Total operating expenses | 4,920 | 5,354 | 21,757 | 24,114 | ||||||||
| Loss from operations | (3,431 | ) | (4,135 | ) | (16,278 | ) | (18,852 | ) | ||||
| Other income, net: | ||||||||||||
| Change in fair value of warrant liabilities | 32 | 862 | 1,346 | 629 | ||||||||
| Interest income (expense), net | (13 | ) | 2 | (33 | ) | 48 | ||||||
| Forgiveness of DECD loan | - | - | - | 1,000 | ||||||||
| Other income, net | 2,024 | 182 | 1,871 | 485 | ||||||||
| Total other income, net | 2,043 | 1,046 | 3,184 | 2,162 | ||||||||
| Net loss | $ | (1,388 | ) | $ | (3,089 | ) | $ | (13,094 | ) | $ | (16,690 | ) |
| Net loss per share - basic and diluted | $ | (0.08 | ) | $ | (0.30 | ) | $ | (0.93 | ) | $ | (1.81 | ) |
| Weighted average common shares used to compute basic and diluted net loss per common share | 16,715,342 | 10,408,132 | 14,134,626 | 9,233,306 |