Aspira Women's Health (AWH) Investor Day 2024 summary

Strategic updates and funding milestones

• Secured $10 million in non-dilutive ARPA-H Launchpad funding to accelerate development and commercialization of a non-invasive endometriosis diagnostic, with a two-year goal for commercial launch.

• ARPA-H program provides capital, mentorship, regulatory, and commercialization support, with milestone payments over 24 months tied to early deliverables.

• Investment in building an in-house molecular lab and expanding R&D capabilities, including collaborations with Dana Farber Cancer Institute, will support both endometriosis and ovarian cancer test development.

• The company’s infrastructure, experience in commercializing diagnostics, and established reimbursement pathways were key differentiators in winning the largest Launchpad award.

• Prioritizing multi-omic assay development, integrating protein and miRNA biomarkers for enhanced diagnostic accuracy.

Product pipeline and scientific advancements

• OvaWatch and OvaWatch+ are on-market AI-powered blood tests for ovarian cancer risk assessment, with OvaWatch validated in large-scale studies and recently approved in New York State.

• OvaSuite portfolio includes OvaWatch (for indeterminate/benign masses) and Ova1Plus (for surgical cases), with ~200,000 tests ordered since launch.

• OvaInform, the next-generation test, will combine proprietary protein biomarkers and licensed microRNAs, aiming for best-in-class sensitivity and specificity.

• EndoInform, the multi-omic endometriosis diagnostic, will leverage both protein and microRNA biomarkers for early, non-invasive detection and longitudinal monitoring, advancing with ARPA-H support.

• Digital droplet PCR technology is being adopted for more accurate quantification of microRNAs in diagnostics.

Market opportunity and competitive positioning

• The portfolio addresses significant unmet needs in women’s health, with endometriosis affecting up to 15% of women of childbearing age and ovarian cancer impacting hundreds of thousands annually.

• The combined market opportunity for ovarian cancer and endometriosis diagnostics is projected to exceed $1 billion in annual revenue, with OvaSuite tests priced at $897 per test and broad payer coverage.

• Addressable market includes 1.2–1.5 million women with adnexal masses and 6.5 million women affected by endometriosis in the US.

• Only non-invasive, blood-based risk assessment diagnostics in the US market, with rapid commercialization enabled by established sales, lab operations, and payer relationships.

• Exclusive miRNA rights, robust IP, and active clinical studies differentiate the company from early-stage competitors.