BioSig Technologies(BSGM) - 2019 Q4 - Annual Report

Part I Business BioSig Technologies is a commercial-stage medical device company focused on its PURE EP™ System for cardiac procedures, expanding into neurology Business Overview and Product BioSig is a commercial-stage medical device company focused on its FDA-cleared PURE EP™ System for cardiac signal processing - BioSig is a commercial-stage medical device company commercializing its proprietary PURE EP™ System, a biomedical signal processing technology platform, which received FDA 510(k) clearance in August 2018[18] - The PURE EP™ System is designed to acquire, process, and display high-fidelity intracardiac signals during electrophysiology (EP) procedures, aiming to improve accuracy for treating arrhythmias like Atrial Fibrillation (AF) and Ventricular Tachycardia (VT)[20][21] - The company has conducted 24 pre-clinical studies, primarily at the Mayo Clinic, and commenced its first clinical trial in November 2019, enrolling 53 patients as of March 13, 2020[23][28] - While the company has no paying customers yet, it plans a commercial launch in 2020, targeting medical centers of excellence for initial system placements on a trial basis[26][66] Corporate Structure and Recent Developments BioSig formed NeuroClear Technologies, a majority-owned subsidiary, and secured financing for new product development - In November 2018, BioSig formed NeuroClear Technologies, Inc., a majority-owned subsidiary (87.8% owned as of March 13, 2020), to apply its PURE EP™ technology outside of electrophysiology[17] - In November 2019, BioSig and NeuroClear entered into three new patent and know-how license agreements with the Mayo Foundation to develop a new product pipeline, including solutions for autonomic nervous system diseases[31][32][33] - NeuroClear raised approximately $5.0 million through private placements in 2019 to fund its initial operations, with shares including a provision to be exchanged for BioSig common stock under certain conditions[36][37] - The company closed a registered direct offering on December 31, 2019, raising gross proceeds of approximately $1.39 million, and a "best efforts" underwritten offering in February 2020, raising approximately $10 million[29][39] Industry and Competition The company operates in a competitive, growing electrophysiology market and is expanding into neurostimulation - The global electrophysiology (EP) device market is forecasted to grow at a 10.4% CAGR, from $4.54 billion in 2017 to $7.45 billion in 2022, with the U.S. EP recording device market estimated at approximately $548 million[41] - The market is highly competitive, dominated by four large companies: GE Healthcare (CardioLab), Boston Scientific (LabSystem PRO), Siemens AG (Axiom Sensis XP), and Abbott Laboratories (EP-WorkMate), which BioSig believes are built on older technologies that can sacrifice signal fidelity[77][78][81] - The global neurostimulation devices market, relevant to the NeuroClear subsidiary, is projected to reach $12.2 billion by 2024, with North America being the largest market[95] Intellectual Property and Regulation The company protects its PURE EP™ System with patents and has secured FDA 510(k) clearance for U.S. market entry - The company's owned patent portfolio includes 5 allowed/issued patents and 13 pending worldwide utility patent applications covering the PURE EP™ System, along with 21 allowed/issued worldwide design patents for its GUI[110] - The PURE EP™ System is a Class II medical device and received FDA 510(k) clearance in August 2018, allowing it to be marketed in the U.S[18][122] - The company plans to seek ISO 13485:2016 certification and CE Mark approval in 2021 to commercialize its products in the European Union[25][75] Risk Factors The company faces significant risks including operating losses, product commercialization dependency, regulatory hurdles, competition, and internal control weaknesses - As an early commercialization stage company with one product, BioSig expects to incur substantial additional operating losses and may not achieve profitability[139][140] - The company's success is highly dependent on the successful commercialization of the PURE EP System, and failure to generate revenue from this product would materially harm the business[143][144] - The medical device industry is subject to stringent FDA regulation, and while the PURE EP System has 510(k) clearance, any modifications or new indications may require new, expensive, and lengthy regulatory processes[155][156][158] - A material weakness in internal control over financial reporting was identified related to inadequate segregation of duties, which could prevent the accurate or timely reporting of financial results[255][256] - The company depends on its collaboration with the Mayo Clinic for R&D, and termination of these agreements or issues with the licensed intellectual property could delay or halt the development of advanced product features[229][230] Unresolved Staff Comments The company reports no unresolved staff comments - Not applicable[274] Properties The company leases its principal executive and engineering offices, with future minimum lease payments totaling $776,510 - Principal executive office is located at 54 Wilton Road, Westport, CT, under a sublease for approximately 4,343 sq. ft. expiring in October 2021[275] - Engineering offices are located at 12424 Wilshire Boulevard, Los Angeles, CA, leasing approximately 4,000 sq. ft. expiring in June 2021[276] Future Minimum Lease Payments | Year Ending December 31, | Future Minimum Lease Payments | | :--- | :--- | | 2020 | $455,124 | | 2021 | $321,386 | | Total | $776,510 | Legal Proceedings The company is not currently aware of any material legal proceedings or claims - The company is not currently aware of any material legal proceedings[279] Mine Safety Disclosures This item is not applicable to the company - Not applicable[281] Part II Market for Common Equity and Stockholder Matters The company's common stock trades on Nasdaq, with 332 holders of record, and no cash dividends have been paid or are anticipated - The company's common stock began trading on the Nasdaq Capital Market on September 21, 2018, under the symbol "BSGM"[284] - As of March 13, 2020, there were approximately 332 holders of record for the company's common stock[285] - The company has never paid cash dividends on its common stock and intends to retain capital for reinvestment[286] Selected Financial Data This item is not applicable - Not applicable[286] Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A) The company reported a $34.1 million net loss in 2019 due to increased R&D and G&A expenses, with no revenue, but maintains sufficient liquidity Consolidated Statement of Operations Data (in US Dollars) | Description | 2019 | 2018 | Change (%) | | :--- | :--- | :--- | :--- | | Revenues | $0 | $0 | N/A | | Research and Development Expenses | $9,738,819 | $4,368,784 | 123% | | General and Administrative Expenses | $24,810,712 | $12,881,027 | 93% | | Loss from Operations | ($34,603,880) | ($17,262,214) | 100% | | Net Loss Available to BioSig | ($34,079,991) | ($18,136,053) | 88% | - The increase in R&D expenses was primarily due to higher payroll from staff increases, accelerated design work, and $3.3 million in acquired research and development related to warrants issued to the Mayo Foundation[304][306][308] - The increase in G&A expenses was driven by a rise in payroll and stock-based compensation to $17.9 million (from $8.2 million in 2018) and increased professional, consulting, and travel costs related to commercialization and fundraising[309][310][312] - As of December 31, 2019, the company had cash of $12.1 million and working capital of $10.8 million, and management believes existing cash, supplemented by a February 2020 offering, is sufficient to fund operations for at least one year[321][332][338] Quantitative and Qualitative Disclosures about Market Risk This item is not applicable - Not applicable[343] Financial Statements and Supplementary Data This section presents audited financial statements for 2019 and 2018, including balance sheets, income statements, and cash flows, with an auditor's adverse opinion on internal controls Consolidated Balance Sheet Data (as of Dec 31, in US Dollars) | Metric | 2019 | 2018 | | :--- | :--- | :--- | | Total Assets | $14,217,113 | $4,996,832 | | Cash | $12,108,582 | $4,450,160 | | Total Liabilities | $2,340,673 | $1,197,563 | | Total Stockholders' Equity | $11,661,440 | $3,324,269 | Consolidated Statement of Operations Data (for the year ended Dec 31, in US Dollars) | Metric | 2019 | 2018 | | :--- | :--- | :--- | | Loss from Operations | ($34,603,880) | ($17,262,214) | | Net Loss | ($34,470,677) | ($17,251,317) | | Net Loss per Share (Basic & Diluted) | ($1.65) | ($1.25) | Consolidated Statement of Cash Flows Data (for the year ended Dec 31, in US Dollars) | Metric | 2019 | 2018 | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | ($15,482,982) | ($10,255,427) | | Net Cash Used in Investing Activities | ($285,934) | ($307,679) | | Net Cash Provided by Financing Activities | $23,427,338 | $13,465,687 | Changes in and Disagreements with Accountants The company reports no disagreements with its accountants on accounting and financial disclosure - None[673] Controls and Procedures Management concluded disclosure controls were ineffective due to a material weakness in internal control over financial reporting, resulting in an adverse auditor opinion - Management concluded that disclosure controls and procedures were not effective as of December 31, 2019[674] - A material weakness was identified in internal control over financial reporting related to inadequate segregation of duties in business processes and financial systems[677][690] - The independent auditor, Liggett & Webb, P.A., issued an adverse opinion on the company's internal control over financial reporting as of December 31, 2019[683] - The company has initiated a remediation plan in 2020, which includes adding personnel and third-party service providers to address the segregation of duties deficiencies[678] Other Information The company reports no other information - None[692] Part III Directors, Executive Compensation, and Corporate Governance Information for Items 10-14 is incorporated by reference from the company's 2020 Definitive Proxy Statement - Information for Item 10 (Directors, Executive Officers and Corporate Governance), Item 11 (Executive Compensation), Item 12 (Security Ownership), Item 13 (Certain Relationships and Related Transactions), and Item 14 (Principal Accounting Fees and Services) is incorporated by reference from the 2020 Proxy Statement[695][696][697] Part IV Exhibits, Financial Statement Schedules This section lists all documents filed as part of the Form 10-K, including consolidated financial statements and various exhibits - The filing includes the Consolidated Financial Statements and Notes to Consolidated Financial Statements[702] - A list of exhibits is provided, including the Amended and Restated Certificate of Incorporation, Bylaws, various material agreements, and certifications by the CEO and CFO[703][704][705] Form 10-K Summary No Form 10-K summary is provided - None[708]