Q1 2024 OvaSuiteSM revenue of
Q1 2024 cash utilization of
Conference Call and Webcast scheduled for today at
“Our continued focus on growth, innovation and operational excellence has positioned us for an exciting year,” said
“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 inCalifornia for reimbursement coverage of the Company’s OvaSuite portfolio of risk assessment tests effectiveJune 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 inCalifornia . 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 endedMarch 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 endedMarch 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 endedMarch 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
Conference Call and Webcast Details
Aspira’s management team will host a conference call beginning at
About Aspira Women’s
Aspira Women’s
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
Investor Relations Contact:
Chief Financial Officer
Aspira Women’s Health
Investors@aspirawh.com
Condensed Consolidated Balance Sheets (unaudited) | |||||||
(Amounts in Thousands, Except Share and Par Value Amounts) | |||||||
2024 | 2023 | ||||||
Assets | (Unaudited) | ||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 3,413 | $ | 2,597 | |||
Accounts receivable, net of reserves of | 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 | 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 | |||||||
Condensed Consolidated Statements of Operations (unaudited) | |||||||
(Amounts in Thousands, Except Share and Per Share Amounts) | |||||||
Three Months Ended | |||||||
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 | |||||
Source:
2024 GlobeNewswire, Inc., source