BioSig Technologies(US:BSGM)2024-04-16 21:10Financial Performance - For the twelve months ended December 31, 2023, the net loss available to common stockholders was $29,050, an increase of $1,779 or 6.5% compared to a net loss of $27,271 for the same period in 2022[90]. - The Company has generated minimal revenue to date and has incurred net losses and negative cash flows from operations since inception, indicating a need for additional financing to fund future operations[92]. - Total revenue for 2023 was $18,000, a decrease of 93.7% compared to $286,000 in 2022[187]. - Gross profit for 2023 was $18,000, down from $229,000 in 2022, reflecting a significant decline in product revenue[187]. - Operating expenses increased to $28,530, up 3.8% from $27,494 in 2022, driven by higher general and administrative costs[187]. - Net loss attributable to BioSig Technologies, Inc. for 2023 was $29,041, compared to a net loss of $27,052 in 2022, representing a 7.3% increase in losses[187]. - Net loss per common share, basic and diluted, improved to $(3.95) in 2023 from $(6.33) in 2022[187]. - Cash used in operating activities for 2023 was $17,313, a decrease from $21,705 in 2022, indicating improved cash management[193]. - Research and development expenses for 2023 were $5,092, down from $5,821 in 2022, reflecting a strategic focus on cost management[187]. - The accumulated deficit increased from $215,974,000 in 2022 to $245,015,000 in 2023, reflecting a rise of approximately 13%[182]. Capital and Financing - In 2023, the Company raised a total of $13,140,441 through the sale of 1,613,906 shares of common stock at an average price of $8.7571 per share, along with warrants for 806,981 shares at an average exercise price of $8.1324[98]. - The Company sold 699,693 shares in a registered direct offering on November 8, 2023, at a purchase price of $3.573 per share, generating net proceeds of approximately $2.2 million after fees and expenses[100][103]. - Cash provided by financing activities totaled $17,332, including $15,301 from the sale of common stock, compared to $8,283 in the previous year[114]. - The Company entered into a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald to sell up to $30 million of common stock, but terminated this agreement on September 15, 2023[105][110]. - The Company issued a promissory note for $500,000 on March 7, 2024, with a 12% interest rate due in 2026[111][112]. - The Series C Preferred Stock has an aggregate stated value of $105,000 as of December 31, 2023, with potential triggering events that may require redemption[117]. - The Company sold 28,911 shares through the Ascendiant Sales Agreement for $60,876, after incurring transactional costs of $70,806[109]. - The company raised gross proceeds of $1,040,000 from a securities purchase agreement on January 12, 2024, selling 260,720 shares at $3.989 per share[139]. Operational Challenges - The Company is facing potential delisting from Nasdaq due to non-compliance with minimum bid price and stockholders' equity requirements, with a hearing scheduled for May 7, 2024[76][79]. - The Company has laid off its entire workforce except for the CEO due to a lack of funding, currently operating with only 4 employees and 4 key consultants[83][84]. - The Company had a working capital deficit of $(4,054) as of December 31, 2023, with cash of $190 compared to $357 at the end of 2022[114]. - As of December 31, 2023, the company had cash of $0.2 million and a working capital deficit of $4.1 million, raising substantial doubt about its ability to continue as a going concern[205]. - The company has experienced net losses and negative cash flows from operations since inception and expects these conditions to continue for the foreseeable future[206]. Product Development and Market Potential - The PURE EP™ System, the Company's first product, is designed to enhance clinical decision-making and improve workflow for various arrhythmias, integrating with existing systems in electrophysiology labs[66][67]. - The Company launched PURE EP™ Software Version 7 in late 2023, representing the most advanced iteration of its digital signal processing technology[69]. - The global electrophysiology market is projected to grow from over $8 billion in 2023 to $16 billion by 2028, representing a CAGR of 15%[157]. - The company believes that the PURE EP™ System may improve outcomes during EP studies and ablation procedures for various arrhythmias[159]. - The company anticipates an increasing proportion of diagnosed AF cases being treated via ablation as physician confidence and device efficacy improve[161]. - The PURE EP™ System has been used in over 3,000 procedures across 21 hospitals in the United States[224]. - The company reported a 75% overall improvement in intracardiac signal quality when using the PURE EP System compared to conventional sources[223]. - The method used by conventional recorders may contribute to the need for multiple ablation procedures, impacting patient treatment outcomes[236]. Subsidiary and Partnerships - As of April 15, 2024, the Company retains a 69.08% ownership in its subsidiary ViralClear Pharmaceuticals, which was formed to pursue applications of the PURE EP™ technology outside of cardiac electrophysiology[62]. - ViralClear retains 69.08% ownership and is focusing on developing a novel nerve recording system based on the PURE EP™ signal processing technology[239]. - The company has partnered with Plexus Corp for the design, development, and manufacturing of N-SENSE™[245]. - The company signed a research agreement with the University of Minnesota to develop novel therapies for sympathetic nervous system diseases[243]. Regulatory and Compliance - The PURE EP™ System received FDA 510(k) clearance in August 2018, enabling its market introduction[168]. - The company is assessing the impact of recent accounting pronouncements, including ASU 2023-09, which will affect disclosures starting in 2025[121]. - The company plans to appeal the Nasdaq delisting determination, with a hearing scheduled for May 7, 2024[203].