Mergers and Acquisitions - The company completed a merger on February 14, 2025, with Predecessor ENvue, resulting in ENvue Medical Holdings LLC becoming a wholly-owned subsidiary[121]. - Following the merger, holders of Predecessor ENvue's equity own 85.0% of the outstanding equity of the company, assuming conversion of Series X Preferred Stock[136]. Financial Performance - For the three months ended March 31, 2025, revenues were approximately $1,025,000, an increase of approximately 11% compared to $921,000 for the same period in 2024, primarily due to the merger with ENvue[165]. - Gross profit for the three months ended March 31, 2025, was approximately $369,000, a decrease of approximately 44% from $664,000 in 2024, with gross profit as a percentage of revenues dropping to 36% from 72%[167][168]. - Research and development expenses increased by approximately 338% to $530,000 for the three months ended March 31, 2025, compared to $121,000 in 2024, representing 52% of total revenues[169][170]. - Selling and marketing expenses rose by approximately 112% to $349,000 for the three months ended March 31, 2025, compared to $165,000 in 2024, accounting for 34% of total revenues[171]. - General and administrative expenses increased by approximately 42% to $1,342,000 for the three months ended March 31, 2025, compared to $946,000 in the same period of 2024[173]. - General and administrative expenses as a percentage of total revenues were approximately 131% for the three months ended March 31, 2025, up from 103% in 2024[175]. - Net loss decreased by approximately $1,907,000 or 324% to approximately $2,495,000 for the three months ended March 31, 2025, from approximately $588,000 in the same period of 2024[177]. - Cash used in operating activities was approximately $1,343,000 for the three months ended March 31, 2025, compared to approximately $579,000 for the same period in 2024[184]. - Cash provided by financing activities was approximately $1,050,000 during the three months ended March 31, 2025, primarily from the issuance of a short-term loan payable[185]. - The company incurred net losses of approximately $2,523,000 during the three months ended March 31, 2025, with negative cash flow from operating activities of $1,343,000[178]. - As of March 31, 2025, the company had cash of approximately $601,000, down from approximately $752,000 as of December 31, 2024[183]. Stock and Securities - The company raised approximately $10 million from the underwritten public offering of 400,000 shares of Series G Convertible Preferred Stock on May 16, 2025[124]. - Holders of Series G Preferred Stock are entitled to receive cumulative dividends at a rate of 9% per annum until the fifth anniversary of issuance[123]. - The company issued a promissory note for $360,000 on April 11, 2025, with an interest rate of 8.0% and a maturity date of June 11, 2025[127]. - A reverse stock split of 1-for-11 was executed on March 12, 2025, affecting all common stock share amounts[132]. - The company entered into a private placement agreement on February 13, 2025, selling a senior convertible debenture with an aggregate principal amount of $1.3 million[138]. - The A&R Debenture has a conversion price of $4.8906, subject to customary anti-dilution adjustments[139]. - The January 2025 Warrant has an exercise price of $6.8296 per share and is exercisable for a term of five and a half years from stockholder approval received on February 24, 2025[142]. Market and Operational Insights - The company has initiated commercialization efforts for its medical devices through its subsidiary ENvue[121]. - The percentage of revenues attributable to PainShield MD was 56% for the three months ended March 31, 2025, compared to 59% in 2024, while PainShield Plus accounted for 19% in 2025, up from 10% in 2024[166]. - The largest direct medical equipment distributor, Ultra Pain Products LLC, contributed 49% of revenues in Q1 2025, up from 38% in Q1 2024[166]. - The company’s revenues may fluctuate due to varying consumer purchases, indicating that growth may not be linear or consistent[165]. - Major changes in assets were primarily attributable to the merger, significantly impacting the overall asset base of the company[182]. - Future operating results may be affected by various factors, including regulatory approvals, clinical trial phases, and geopolitical conditions[186]. Compliance and Regulatory Matters - The company did not regain compliance with Nasdaq's minimum bid price requirement by October 7, 2024, leading to a hearing request to avoid delisting[145][146]. - On April 9, 2025, the company received confirmation of compliance with Nasdaq's Bid Price Rule and Equity Rule, following a reverse stock split[148][149]. Financial Outlook - The company expects to continue incurring losses and negative cash flows from operations, indicating a need for additional capital to finance ongoing operations[179].
NanoVibronix(NAOV) - 2025 Q1 - Quarterly Report