AccuStem Sciences, Inc.

Overview

AccuStem Sciences is a clinical-stage diagnostics company developing genomic tests to guide oncology care. The company is pursuing commercial launch through a U.S. CLIA-certified laboratory and partnerships to process samples, report results, and pursue payer reimbursement.

Core planned products:

• MSC (MicroRNA Signature Classifier): a 24‑miRNA blood test intended to triage lung nodules identified by LDCT and distinguish benign from malignant nodules.
• StemPrintER: a 20‑gene prognostic assay intended to predict distant recurrence risk in luminal (ER+/HER2-) breast cancer to inform treatment planning.

The company plans to offer ancillary testing (for example, hereditary genetic and somatic mutation testing) to complement the core assays and expand revenue opportunities. EmeritusDx is the initial U.S. commercial testing partner for MSC and StemPrintER.

Market opportunity

• Lung nodules (MSC): the U.S. serviceable addressable market is cited as more than 1.6 million nodules diagnosed per year; the U.S. market opportunity for MSC in its target setting is estimated at over $5.5 billion.
• Breast cancer (StemPrintER): the initial U.S. target population is approximately 214,000 patients with early-stage ER+/HER2- breast cancer; the U.S. market opportunity is estimated at more than $800 million annually.
• The StemPrint platform is positioned for potential expansion into additional tumor types, and ancillary testing is intended to broaden clinical and commercial utility.

Product development and validation

• MSC: a blood-based 24‑miRNA assay using qRT‑PCR, validated in prospective cohorts totaling more than 5,000 patients; results have been published in major journals including the Journal of Clinical Oncology.
• StemPrintER: a 20‑gene stemness signature validated in a retrospective IEO cohort (~2,400 patients) and an independent prospective TransATAC cohort (~800 ER+/HER2- patients).
• The company intends to establish a CLIA-certified lab and use EmeritusDx as a testing partner during commercialization. A CMS coverage policy submission for MSC was filed in November 2025.

Intellectual property and licensing

• Three patent families are licensed from third parties:
  • StemPrintER algorithm and breast cancer stratification patents (U.S. and Europe; expiration 2037; additional filings pending).
  • SPARE algorithm and breast cancer recurrence risk (U.S., Europe, Canada; expiration around 2041).
  • MSC (miRNA-based lung nodule stratification) with an issued European patent expiring 2034 and pending U.S./China applications.
• StemPrintER, SPARE and MSC-related technology are licensed under agreements with IEO/University of Milan and related parties. The IEO/University of Milan license was amended in 2022 to extend regulatory timelines and to allow CLIA-based commercialization pathways, subject to development payments and ongoing royalties.

Regulatory and compliance

• U.S.: the tests are regulated as in vitro diagnostics and can be offered as laboratory-developed tests (LDTs) under current policy; CLIA certification and state laboratory licensing are required to bill Medicare/Medicaid. Proposed legislative or regulatory changes to the LDT/IVCT framework (for example, the VALID Act) and agency actions could alter oversight and timelines.
• European Union: the IVDR applies; CE marking and conformity assessment are required for EU marketing, with Notified Bodies involved for higher-risk devices.
• Reimbursement and approvals: payer coverage and reimbursement are expected to be important for commercial success.
• Privacy and security: U.S. and international data protection laws (HIPAA, GDPR/UK GDPR, CPRA, etc.) govern handling of patient data and test results.

Financial position and key operating metrics (as of and for the year ended December 31, 2025)

• Corporate status: public, OTCQB‑listed under the symbol ACUT; Emerging Growth Company under the JOBS Act.
• Employees: four full-time employees as of December 31, 2025.
• Revenue and profitability: no products approved for commercial sale; no revenue to date. Net loss for 2025: $1,756,096. Net loss for 2024: $1,505,102. Accumulated deficit as of December 31, 2025: $9,783,143.
• Cash and liquidity: cash balance of $13,929 as of December 31, 2025. Net cash used in operating activities for 2025: $850,389. Net cash provided by financing activities for 2025: $859,271 (primarily advances from a related party), partially offset by note payable payments.
• Financing and capitalization: following a demerger, related-party funding in 2022 included cash contributions totaling approximately $2.7 million over two transactions. As of April 14, 2026, approximately 16,072,267 shares of common stock were outstanding.
• Going concern: auditors and management disclosed substantial doubt about the company’s ability to continue as a going concern without additional financing.

Strategic outlook and risks

• Strategy centers on commercializing MSC for lung nodule triage and StemPrintER for breast cancer recurrence risk, supported by validated clinical data and a licensing framework with IEO/University of Milan.
• The company depends on establishing CLIA testing capability, obtaining payer coverage and reimbursement, and securing additional financing through equity, debt, collaborations, or strategic arrangements.
• Limited cash, ongoing operating losses, and the need for external funding represent material risks to continued operations and near-term commercialization plans.