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Aspira Women's Health Inc. (Nasdaq: AWH) is a pioneering company focused on the development and commercialization of noninvasive diagnostic tests for gynecologic diseases. The company is at the forefront of women's health, offering innovative solutions that leverage bio-analytical techniques and artificial intelligence.
One of Aspira's flagship products is OvaSuite, a comprehensive portfolio of blood tests designed to assess the risk of ovarian cancer. This suite includes the well-known OvaWatch and Ova1Plus tests. OvaWatch, with a negative predictive value of 99%, is instrumental in evaluating ovarian cancer risk in women with adnexal masses that appear indeterminate or benign, potentially allowing them to avoid unnecessary surgeries. Ova1Plus combines two FDA-cleared tests, Ova1® and Overa®, providing a robust assessment for women scheduled for surgery due to pelvic masses.
In addition to ovarian cancer diagnostics, Aspira is expanding its test pipeline to address other pressing women's health issues. The company is developing EndoCheck, the first-ever noninvasive test for identifying endometriomas, a common form of endometriosis. Another promising test in development is OvaMDx, which combines microRNA and protein biomarkers with patient data to enhance the accuracy of ovarian cancer risk assessments.
The company's commitment to innovation is reflected in its recent achievements. Aspira has published significant clinical studies demonstrating the efficacy of OvaWatch in longitudinal monitoring of ovarian cancer risk, which could significantly reduce surgical backlogs and unnecessary referrals. Furthermore, Aspira has made strides in market access, securing payer coverage from Anthem Blue Cross and expanding its reach to millions of lives across various health plans.
Financially, Aspira has shown remarkable progress. In 2023, the company significantly reduced its operational cash use while increasing revenues and test volumes. These accomplishments were accompanied by important enhancements to their commercial organization and the achievement of key market access milestones. As of December 31, 2023, Aspira had $2.9 million in cash and raised an additional $5.5 million through a registered direct offering and private placement.
The management team, led by CEO Nicole Sandford, has positioned Aspira for substantial growth in 2024 and beyond. The company's forward-looking strategies and robust test pipeline are set to meet the growing demand for noninvasive diagnostics in women's health, offering new hope and improved outcomes for millions of women worldwide.
Aspira Women's Health (NASDAQ: AWH) announced that CEO Nicole Sandford will step down immediately for personal reasons, with Dr. Sandra Milligan, the company's President, appointed as interim CEO. During Sandford's tenure, the company launched the OvaWatch multivariate assay for ovarian cancer detection and received a $10 million award from the Advanced Research Projects Agency for Health to complete their endometriosis detection product. Sandford will remain as a consultant to ensure a smooth transition while the company conducts a nationwide search for a permanent CEO. The Board praised Sandford's contributions in stabilizing the business and building a strong team for future growth.
Aspira Women's Health (AWH) has achieved the first milestone of its ARPA-H Sprint for Women's Health Award, receiving a $2 million payment from the total $10 million grant. The funding supports the development of a multi-marker blood test for endometriosis detection, utilizing AI-enabled algorithms combining protein and microRNA biomarkers. The first milestone included project execution plans, risk mitigation strategies, and laboratory expansion activities. The company expects to complete the second milestone in Q1 2025, which focuses on R&D capabilities expansion and will result in a $1.5 million payment upon completion.
Aspira Women's Health reported Q3 2024 financial results with OvaSuite revenue of $2.3 million, representing a 2% increase year-over-year. Test volume grew 4% to 6,001 units, driven by OvaWatch's 27% growth. The company maintained a 60% gross profit margin and reduced cash utilization to $2.9 million, down 12% from Q2. Notably, Aspira secured a $10 million ARPA-H contract for ENDOinform development. The company reaffirmed its full-year 2024 cash utilization guidance of $13.0-$14.5 million.
Aspira Women's Health has expanded its co-marketing and distribution collaboration with BioReference to include OvaWatch® in their portfolio. The partnership, which has included Ova1Plus® since 2022, will now market Aspira's complete OvaSuite portfolio to BioReference's healthcare provider clients. This expansion follows OvaWatch's approval by the New York State Department of Health's Clinical Laboratory Evaluation Program, making it available to over 15 million women in New York and New Jersey.
Aspira Women's Health (Nasdaq: AWH) has scheduled its Q3 2024 earnings release for Thursday, November 14, 2024. The company will discuss financial results for the three and nine months ended September 30, 2024. Management will host a conference call at 8:30 am ET to present financial results and provide a corporate update. The call will be accessible via toll-free number (877-545-0320) and international number (973-528-0002) with access code 436613. A webcast replay will be available on the company's Investor Relations website.
Aspira Women's Health (Nasdaq: AWH) announced it has been awarded $10 million over two years from the Advanced Research Projects Agency for Health (ARPA-H) as part of the Sprint for Women's Health initiative. The funding will support the development of ENDOinform™, a multi-marker blood test for endometriosis detection using AI-enabled algorithms combining protein and microRNA biomarkers. Selected as one of 23 awardees from over 1,700 submissions, Aspira received one of only six Launchpad awards for advanced-stage projects. The company expects to meet its first milestone in Q4 2024, triggering a $2 million payment. The company will host a virtual R&D Day on October 29, 2024, to discuss the development pipeline.
Aspira Women's Health (Nasdaq: AWH) has been selected to receive a $10 million award from ARPA-H's Sprint for Women's Health program. The funding, distributed over two years through milestone-based payments, will support the development of EndoMDx, a multi-marker miRNA blood test for endometriosis detection. Selected from over 1,700 submissions, Aspira will collaborate with ARPA-H Program Manager and Investor Catalyst Hub for test development and commercial launch. The project addresses a critical need, as endometriosis affects up to six million women in the US, currently requiring invasive laparoscopic surgery for diagnosis, with patients typically facing 7-10 years delay in diagnosis.
Aspira Women's Health Inc. (Nasdaq: AWH) has received approval from the New York State Department of Health's (NYSDOH) Clinical Laboratory Evaluation Program (CLEP) for OvaWatch®. This non-invasive blood test assesses ovarian cancer risk in women with adnexal masses initially determined as indeterminate or benign. The CLEP approval, required for all lab-developed tests in New York, ensures compliance with state regulatory standards and includes a comprehensive review of Quality Management Systems.
CEO Nicole Sandford highlighted the significance of this approval, stating it opens doors to one of the nation's largest healthcare markets with over 10 million women in New York state. The CLEP approval is viewed as a validation of the test's rigorous science, potentially strengthening Aspira's credibility in other markets and positioning the company well for future regulatory pathways.
Aspira Women's Health (Nasdaq: AWH) has published data in Gynecologic Oncology demonstrating improved performance of its in-development blood test for assessing malignancy risk in adnexal masses. The study shows that combining miRNA with protein biomarkers, age, and menopausal status offers the most accurate classification for identifying early-stage ovarian cancer.
Key findings include:
- 92% sensitivity at 80% specificity overall
- 80% sensitivity for early-stage cancers
- 100% sensitivity for later-stage cancers
- 78% sensitivity for early-stage, serous ovarian cancers
- 82% sensitivity for early-stage, non-serous cancers
The combined model improved ROC AUC on internal (0.9) and external (0.95) validation sets compared to miRNA alone or proteins plus metadata without miRNA.
Aspira Women's Health (Nasdaq: AWH), a bio-analytical women's health company, announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event will take place from September 9-11, 2024 at the Lotte New York Palace Hotel. CEO Nicole Sandford will deliver a presentation, available on-demand from September 9 at 7:00 am ET for registered attendees.
Company management will be available for in-person one-on-one meetings on September 10 and 11. Interested investors should contact H.C. Wainwright representatives. A replay of the presentation will be posted on the Events page of Aspira's Investors section on their website when available.
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