Business context and reporting period
Filing identity mismatch: The request identifies Streamex Corp., but the supplied Form 10-K is for BioSig Technologies, Inc. This summary covers the filing supplied, for the fiscal year ended December 31, 2018; it is not a standalone fourth-quarter report.
BioSig is a development-stage medical-device company developing the PURE EP System for acquiring and displaying cardiac signals during electrophysiology procedures. The system received FDA 510(k) clearance in August 2018. The company had no customers and had generated no revenue through the reporting date.
Financial and operating highlights
| Metric | 2018 | 2017 |
|---|---|---|
| Revenue and cost of goods sold | $0 | $0 |
| Research and development expense | $4.37 million | $4.76 million |
| General and administrative expense | $12.88 million | $8.14 million |
| Net loss | $17.25 million | $12.70 million |
| Net loss available to common stockholders | $18.14 million | $12.82 million |
| Cash used in operating activities | $10.26 million | $7.47 million |
| Cash at year-end | $4.45 million | $1.55 million |
Gross and operating margins are not meaningful because the company had no revenue. At December 31, 2018, working capital was $3.43 million, total assets were $5.00 million, and stockholders’ equity was $3.32 million. Current liabilities were $1.20 million. The balance sheet reported no convertible debentures; the filing does not identify conventional debt outstanding at year-end.
Material changes versus the prior year
- Net loss available to common stockholders increased 42% to $18.14 million, primarily as general and administrative expense and preferred-stock dividends rose.
- General and administrative expense increased 58%, reflecting higher compensation and stock-based compensation, professional services, consulting, travel, and operating costs.
- Research and development expense declined 8%, mainly because 2017 included $543,927 of warrant-based acquired R&D expense; personnel and consulting costs increased in 2018.
- Operating cash use increased by $2.79 million. Financing activities provided $13.47 million in 2018, and year-end cash rose by $2.90 million.
- Adoption of ASU 2017-11 reclassified $3.04 million of embedded reset-feature liabilities to equity. This accounting change reduced reported liabilities but did not itself provide cash.
Outlook, risks and unusual items
- Funding and going concern: The auditor stated that recurring losses and operating cash outflows raise substantial doubt about the company’s ability to continue as a going concern. Management said year-end funds were expected to cover at least nine months, but also stated it expected to need approximately $10 million beyond available cash for the next 12 months.
- Subsequent financing: After year-end and through the filing’s disclosure, the company reported raising $8.62 million from common-stock sales and $418,718 from warrant exercises. These proceeds do not remove the disclosed execution, liquidity, or future financing risks.
- Commercialization: First-in-human use occurred in February 2019, with initial results described by management as showing improved signal detection and fidelity. Further evaluations were planned. The filing gives no clear timetable for commercial launch or quantified revenue, profit, or cash-flow guidance.
- Development and market risks: Commercial success depends on manufacturing, clinical and user evaluation, adoption by hospitals and physicians, competition, and potential foreign regulatory approvals. The company planned to seek CE Mark approval and expected to submit an initial application in the second half of 2019.
- Preferred-stock and dilution risks: Series C preferred stock carries a 9% dividend that may rise to 18% in specified circumstances, restrictive covenants, and potential redemption obligations. Outstanding options and warrants, future fundraising, and anti-dilution provisions could materially dilute common stockholders.
- Controls: Management found disclosure controls ineffective and reported a material weakness in segregation of duties. The auditor did not provide an opinion on internal-control effectiveness.
- Other items: The company reported no material litigation or off-balance-sheet arrangements. Adoption of lease accounting in 2019 was expected to add approximately $419,000 each in operating lease liabilities and right-of-use assets.
Important facts for investors to verify
- Confirm the issuer: the supplied filing is BioSig Technologies, Inc., not Streamex Corp.
- Review subsequent cash balances, spending, and financing needs, given the going-concern warning and management’s differing nine-month and 12-month funding statements.
- Track evidence of commercial launch, customer orders, manufacturing readiness, clinical evaluation results, and any CE Mark progress; the filing reports no customers or commercial revenue.
- Assess the full potential dilution and cash obligations from preferred stock, warrants, options, and future equity financing.
- Monitor remediation of the material weakness and whether disclosure controls become effective.