AccuStem Sciences, Inc. is an early-stage diagnostics company developing genomic tests for cancer detection and prognosis, with a focus on lung and breast cancers.

# Company Overview: AccuStem Sciences, Inc.

## Business Focus
- **Type:** Clinical stage diagnostics company.
- **Mission:** Improve quality of life and outcomes for cancer patients by developing and commercializing genomic diagnostic tests.

## Core Products
1. **MSC (MicroRNA Signature Classifier)**
   - Purpose: To distinguish benign from malignant lung nodules detected by low dose computed tomography (LDCT).
   - Technology: A 24-microRNA (miRNA) assay using blood samples analyzed via qRT-PCR platform.
   - Clinical Validation: Validated in over 5,000 patients across multiple prospective randomized cohorts.
   - Market Opportunity: >$5.5 billion globally in the U.S. alone.
   - Status: Plans to launch after establishing a CLIA-certified laboratory, with milestones including transferring the assay to a partner lab and obtaining necessary certifications.

2. **StemPrintER**
   - Purpose: To predict distant recurrence risk in early-stage luminal (ER+/HER2-negative) breast cancer patients.
   - Technology: A 20-gene prognostic assay based on tumor “stemness”.
   - Clinical Validation: Validated in over 3,000 patients, including data from the TransATAC study.
   - Market Opportunity: US population of 214,000 patients, with an annual revenue potential over $800 million.
   - Status: Similar development and commercialization plans as MSC, including validation for other tumor types and ancillary testing options.

## Market and Industry
- **Initial Focus:** Lung cancer (via MSC) and breast cancer (via StemPrintER).
- **Estimated Total Market:** Over $6.3 billion in annual revenue in the U.S.
- **Potential Expansion:** To other tumors and ancillary testing services like hereditary and somatic mutation testing.

## Company Size and Financials
- **Employees:** 2 full-time employees (as of December 31, 2024).
- **Customer Base:** Not specified; the company is still pre-revenue, with no products yet commercially launched.
- **Revenue:** Currently none.
- **Financial Performance (2024):**
  - Net Loss: $1,505,102.
  - Total Assets: Primarily in the U.S.
  - Capital: Received approximately $5,046 in cash as of December 31, 2024.
- **Funding:** 
  - Initial transfer of ~$1.35 million from Tiziana in January 2022.
  - Additional investment of ~$2.68 million in March 2022.
  - Cash likely insufficient to fund operations beyond April 2025.
- **Operational Status:** Developing and validating tests, preparing for commercial launch, no revenue yet.

## Intellectual Property
- Holds exclusive licenses and patents related to MSC and StemPrintER.
- Licensing agreements with institutions like IEO/University of Milan.
- The company expects to expand its patent portfolio.

## Regulatory & Development Milestones
- Working towards CLIA certification for laboratory testing.
- Plans to transfer assays to certified labs and obtain reimbursement approvals.
- Following FDA and EU regulations for medical devices and diagnostics.

## Summary
AccuStem Sciences is a small, early-stage diagnostics company focusing on genomic assays for cancer detection and prognostication. It is in the development and validation phase of its two main tests—MSC for lung nodules and StemPrintER for breast cancer—aiming for commercialization shortly after obtaining necessary certifications. The company has no current revenue, limited staff, and is primarily funded by initial investments from its parent and external sources expected to be secured through future financings.

AccuStem Sciences, Inc. is a clinical-stage diagnostics company developing genomic tests to enhance cancer treatment outcomes.

# Summary of AccuStem Sciences, Inc.

## Company Overview
AccuStem Sciences, Inc. is a clinical-stage diagnostics company focused on developing and commercializing genomic tests aimed at improving the quality of life and health outcomes for patients diagnosed with cancer. The company specializes in creating proprietary genomic assays that aid decision-making throughout the continuum of oncology care.

## Key Product
- **StemPrintER:** 
  - A 20-gene prognostic assay designed to predict the risk of distant recurrence in luminal (ER+/HER2-negative) breast cancer patients.
  - Developed to measure the "stemness" of tumors to indicate the likelihood of cancer recurrence or resistance to treatments.
  - The product is backed by extensive clinical validation, including studies involving approximately 2,400 patients from the European Institute of Oncology and 800 patients from the TransATAC clinical trial.

## Market Opportunity
- Estimated annual market for StemPrintER in breast cancer exceeds **$1.3 billion**, given the high prevalence of early-stage breast cancer, with over **2 million cases** diagnosed worldwide each year, and approximately **75%** classified as ER-positive.

## Financials
- **Number of Employees:** As of December 31, 2023, the company has **three full-time employees**.
- **Customers:** The company primarily caters to healthcare professionals and institutions involved in oncology. As of March 22, 2024, they had approximately **510 holders of record** of their common stock, indicating stakeholder diversity.
- **Revenue:** AccuStem has **no products approved for commercial sale** and thus has not yet generated significant revenue.
- **Net Loss:** The company incurred a net loss of **$2,050,664** for the year ended December 31, 2023, a decrease from a net loss of **$3,746,419** for the prior year.

## Business Model and Future Directions
- AccuStem aims to establish a CLIA-certified laboratory to process test results, which is anticipated to take around **18 months**, with an initial launch planned for the U.S. market followed by potential expansion to other markets.
- Plans include offering ancillary testing services alongside StemPrintER to augment diagnostic value and patient care.

## Summary of Financial Health
- **Accumulated Deficit:** As of December 31, 2023, AccuStem reported an accumulated deficit of **$6,521,945**, highlighting the financial challenges faced since inception.
- **Funding Needs:** The company anticipates needing substantial additional funding to support ongoing and future research and development activities.

Overall, AccuStem Sciences, Inc. is positioned in the diagnostic sector, producing innovative genomic products aimed at enhancing cancer treatment outcomes amid significant market potential, although it currently struggles with profitability and capital acquisition.

Accustem Sciences Inc.

10-K / April 3, 2025

10-K / March 22, 2024

10-K / April 3, 2025

Company Overview: AccuStem Sciences, Inc.

Business Focus

Core Products

Market and Industry

Company Size and Financials

Intellectual Property

Regulatory & Development Milestones

Summary