Business context and reporting period
Issuer discrepancy: The request identifies Streamex Corp., but the supplied Form 10-K is for BioSig Technologies, Inc. (NASDAQ: BSGM), for the fiscal year ended December 31, 2021. This summary covers the filing provided, not a Streamex filing.
BioSig is an early-commercialization medical technology company focused on PURE EP, an FDA 510(k)-cleared cardiac electrophysiology signal acquisition and processing system. The company reported its first commercial sales in 2021. Its majority-owned ViralClear subsidiary had discontinued pharmaceutical development and was pursuing nerve-recording technology; NeuroClear was dormant.
Financial performance and liquidity
Amounts below are in U.S. dollars; financial statement figures are in thousands unless noted.
| Metric | 2021 | 2020 |
|---|---|---|
| Revenue | $441 | $0 |
| Gross profit / margin | $242 / 54.9% | $0 |
| Research and development | $5,602 | $18,136 |
| General and administrative | $27,853 | $40,954 |
| Operating loss | $(33,411) | $(59,184) |
| Consolidated net loss | $(32,856) | $(59,140) |
| Net loss attributable to common shareholders | $(31,926) | $(52,232) |
| Basic and diluted loss per share | $(0.95) | $(1.87) |
| Cash used in operating activities | $(26,399) | $(26,601) |
At December 31, 2021, cash was $11.659 million, working capital was $11.318 million, total assets were $15.519 million, and total liabilities were $2.954 million. Cash fell from $28.268 million at year-end 2020. The company reported no convertible debentures outstanding; however, it had Series C preferred stock with a $105,000 stated value and redemption-trigger provisions, as well as lease liabilities. No separate debt balance is clearly presented.
2021 financing activities provided $10.332 million, principally from a $9.004 million public stock offering and $1.300 million from an at-the-market sale. The filing says year-end cash was expected to fund operations through at least July 2022. A March 2022 registered direct offering generated approximately $3.0 million gross, before fees and expenses.
Material changes versus 2020
- Revenue rose from zero to $441,000, including $414,000 of product sales and $27,000 of service revenue. Two customers accounted for approximately 68% and 32% of revenue, respectively.
- Net loss attributable to common shareholders narrowed by 38.9%, mainly as R&D and G&A costs declined. The R&D reduction largely reflected cessation of merimepodib development; BioSig-segment R&D itself increased.
- Operating cash use was broadly unchanged year over year despite lower reported expenses, and year-end cash declined by $16.609 million.
- Inventory increased to $1.881 million from $768,000. The company sold three systems to St. David’s Healthcare and three to Mayo in 2021.
Outlook, commentary, risks, and unusual items
- Going concern: The auditor and management disclosed substantial doubt about BioSig’s ability to continue as a going concern over the next 12 months from issuance of the financial statements. The company expects continuing losses and needs additional financing; further funding is not assured.
- Commercial and product plans: Management planned continued PURE EP commercialization and clinical evaluation, with market development focused on the Northeast, Florida, and Texas. It reported more than 2,160 procedures at 17 U.S. sites. No quantified revenue or profitability guidance is provided.
- Clinical evidence: The PURE EP 2.0 study reported 93% reviewer consensus and 75% overall improvement in signal quality and interpretation confidence versus conventional sources. These are study findings, not evidence of demonstrated patient-outcome or commercial benefits. A repeat-AF ablation study enrolled 20 patients; the filing anticipated results in early 2022.
- Regulatory and manufacturing: Management expected ISO 13485 certification in the first half of 2022 and a CE Mark application in the first half of 2023, subject to the notified body. Plexus was to take over manufacturing; management did not expect significant production delays. These were forward-looking expectations, not completed outcomes at filing.
- Financing and dilution: Future equity or debt funding may dilute shareholders or impose restrictions. Series C preferred stock carries a 9% annual dividend, potentially increasing to 18% under specified covenant failures, and may require redemption following specified triggering events.
- Settlement: BioSig settled Aurigene’s $1.530 million claim for $1.0 million and recorded a $553,000 gain. The filing reports $600,000 remaining at December 31, 2021, and $300,000 due at March 30, 2022; investors should reconcile the timing and payments.
- Other material risks include early-stage market adoption, competition, reimbursement limitations, clinical and regulatory uncertainty, reliance on third parties and Mayo Clinic, COVID-19 disruption, and potential stock-price volatility and dilution.
Important facts for investors to verify
- Confirm the intended issuer: the supplied filing is BioSig Technologies, not Streamex Corp.
- Review the full audited financial statements and cash-flow assumptions, including the going-concern disclosure and expected cash runway.
- Check subsequent financing, cash balances, share count, warrants, and other potential dilution after the March 2022 offering.
- Verify actual PURE EP sales, customer concentration, repeat orders, system economics, and conversion of evaluation sites into paying customers.
- Assess the clinical study design and evidence independently, including whether results support clinical outcomes and adoption.
- Confirm progress on ISO certification, CE Mark application, Plexus manufacturing transition, and the Aurigene settlement balance.