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Forward-Looking Statements
This Quarterly Report on Form 10-Q contains “forward-looking statements” that are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. These statements describe the company’s future plans, strategies and expectations, and are based on management’s current beliefs and assumptions. Key factors that could cause actual results to differ materially include the success and timing of the company’s clinical trials, regulatory approvals, ability to compete, sales and marketing capabilities, and the impact of the COVID-19 pandemic.
Overview
AccuStem is a clinical stage diagnostics company focused on developing and commercializing novel genomic tests to support decision-making in oncology care. The company’s two lead product candidates are:
MSC (MicroRNA Signature Classifier): A 24-miRNA blood test designed to help determine whether lung nodules detected by CT scans are benign or malignant. The test has been validated in over 5,000 patients.
StemPrintER: A 20-gene prognostic assay intended to predict the risk of distant recurrence in patients with luminal (ER+/HER2-negative) breast cancer. The test has been validated in over 3,000 patients.
AccuStem plans to launch MSC in early 2027 and commercialize StemPrintER for the ~200,000 ER+/HER2- breast cancer patients diagnosed annually in the US, representing a $800 million market opportunity. The company also sees potential to expand the StemPrint platform to other cancer types.
Financial Operations Overview
AccuStem has not generated any revenue to date and has incurred net losses in each year since inception, totaling $10.5 million in accumulated deficit as of June 30, 2026. The company’s net losses have been driven by research and development expenses as well as general and administrative costs.
As of June 30, 2026, AccuStem had $12,928 in cash, which is inadequate for its current planned level of operations. The company expects to incur substantial additional expenses to support the acceleration of its activities and will need to raise additional capital through equity or debt financing, collaborations, or other strategic transactions to fund its operations.
Results of Operations
| Metric | Q2 2026 | Q2 2025 | $ Change | % Change |
|---|---|---|---|---|
| Other Income | $98,400 | $0 | $98,400 | 100% |
| R&D Expenses | $43,712 | $60,204 | $(16,492) | (27%) |
| G&A Expenses | $307,261 | $341,199 | $(33,938) | (10%) |
| Net Loss | $(252,573) | $(401,403) | $148,830 | 37% |
The increase in other income was due to one-time credits against supplier invoices. R&D expenses decreased due to timing of spend related to technology transfer, while G&A expenses declined primarily from lower payroll-related bonus costs.
Liquidity and Capital Resources
AccuStem had $12,928 in cash as of June 30, 2026, which is insufficient for its current planned level of operations. The company expects to need additional capital to fund its research, development, and commercialization activities. AccuStem may seek to raise funds through equity or debt financing, collaborations, or other strategic transactions, but there is no guarantee it will be able to do so on favorable terms or at all. Without additional funding, the company may be required to delay, limit, or terminate its product development efforts.