Company Overview
Aspira Women's Health Inc. (AWH) is a bio-analytical based women's health company dedicated to the development and commercialization of innovative diagnostic tools for gynecologic diseases. With a steadfast focus on improving health outcomes for women, Aspira has established itself as a trailblazer in the field of women's health diagnostics.
History and Product Development
Founded in 1993 as Vermillion, Inc., the company initially focused on the discovery, development, and commercialization of novel diagnostic and bio-analytical solutions, with a primary emphasis on gynecologic diseases, particularly ovarian cancer. In 2009, Aspira achieved a significant milestone when its flagship product, Ova1, received FDA de novo classification. Ova1, a qualitative serum test designed to aid in the assessment of the likelihood of malignancy in women with an ovarian adnexal mass, became the first FDA-cleared blood test for the assessment of ovarian cancer risk.
Building on this success, Aspira continued to innovate and expand its product portfolio. In 2016, the company received FDA 510(k) clearance for Overa, an updated version of Ova1 that aimed to maintain the test's high sensitivity while improving specificity. The company also introduced the Ova1Plus workflow, which combines Ova1 and Overa to provide improved performance in assessing ovarian cancer risk.
Challenges and Setbacks
Despite these advancements, Aspira has faced its share of challenges. In 2021, the company made the decision to discontinue its Aspira GenetiX product line, including genetics carrier screening on the Aspira Synergy platform, due to lack of commercial traction. Additionally, the company has grappled with consistent profitability issues, reporting net losses in each of the five fiscal years from 2018 to 2022.
Financials
Aspira's financial performance in recent years has reflected these challenges and the company's ongoing efforts to achieve sustainable growth. In the most recent fiscal year (2023), the company reported revenue of $8.18 million, a net loss of $29.89 million, operating cash flow of -$31.07 million, and free cash flow of -$31.30 million.
For the third quarter of 2024, Aspira reported revenue of $2.30 million, a 2% increase from $2.20 million in Q3 2023. This increase was primarily driven by a 27% increase in OvaWatch test volume compared to Q3 2023. However, the company's growth was negatively impacted by severe weather events in its major markets in the southeast. Operating cash flow for Q3 2024 was -$2.90 million, a 12% decrease from -$3.30 million in Q3 2023.
Looking at the first half of 2024, product revenue was $4.58 million, a 5% decrease compared to the same period in 2023. The number of OvaSuite tests performed decreased 2% to 12,300 during the six months ended June 30, 2024, compared to 12,550 tests in the same period in 2023. The average unit price (AUP) per OvaSuite test also decreased from $383 in the first half of 2023 to $372 in the first half of 2024.
Liquidity
The company's liquidity position has experienced volatility in recent years. As of September 30, 2024, Aspira reported cash and cash equivalents of $2.10 million, down from $2.90 million as of December 31, 2023. The company's current ratio stands at 0.60, with a quick ratio of 0.55.
To bolster its financial position, Aspira entered into an at-the-market offering agreement with H.C. Wainwright in September 2024 to sell up to $4.5 million in common stock. This move aims to provide additional liquidity to support the company's ongoing operations and development efforts.
Recent Developments and Future Outlook
Despite financial challenges, Aspira has demonstrated resilience and a commitment to innovation. In the third quarter of 2024, the company delivered over 6,000 OvaSuite tests, a 4% increase compared to approximately 5,783 OvaSuite tests in Q3 2023. The number of tests per sales rep for the 9 months ended September 30, 2024, increased by 21% when compared to the same period in 2023.
Aspira has also made significant strides in expanding its product portfolio and collaborations. In October 2024, the company announced that it had been selected by the Advanced Research Projects Agency for Health (ARPA-H) to receive a $10 million award to fund the development of ENDOinform, a non-invasive multi-marker blood test for the detection of endometriosis. The company expects to receive the first payment of $2 million from this award before the end of 2024 and plans to complete the second milestone in Q1 2025.
Moreover, Aspira has expanded its co-marketing and distribution collaboration with BioReference Health, LLC, adding OvaWatch to its test compendium. This partnership allows Aspira to leverage BioReference's extensive network and reach to further increase the accessibility of its products.
In another significant development, Aspira received approval from the New York State Department of Health for its OvaWatch test in October 2024, allowing the company to market the product in the state of New York. The company continues to focus on expanding access and reimbursement for its OvaSuite products, including recent contract wins with Anthem plans in California and the Northeast.
Future Pipeline
Looking ahead, Aspira remains focused on its mission to improve health outcomes for women through the development of innovative diagnostic tools. The company's pipeline includes the continued advancement of OVAinform, a multi-marker test for the assessment of ovarian cancer risk, as well as the ARPA-H-funded ENDOinform project.
Guidance
Aspira has reiterated its guidance for cash used in operations in 2024 to be less than $14.5 million. The company expects research and development expenses to increase over Q4 2024 as they focus on accelerating the ENDOinform development plan in connection with the $10 million ARPA-H award.
Conclusion
Despite the challenges faced, Aspira has demonstrated a steadfast commitment to innovation, resilience, and a unwavering focus on its core mission. The company's recent developments, including the ARPA-H award, expansion into New York, and increasing test volumes, showcase its potential for growth. However, ongoing financial pressures and the need for sustainable profitability remain key concerns. As Aspira navigates the dynamic women's health diagnostics market, investors will be closely monitoring the company's ability to translate its technological advancements and strategic initiatives into improved financial performance and long-term shareholder value.