NanoVibronix(NAOV) - 2025 Q3 - Quarterly Report

Mergers and Acquisitions - As of September 30, 2025, NanoVibronix, Inc. completed a merger with ENvue Medical Holdings, resulting in the formation of two wholly-owned subsidiaries: NanoVibronix Ltd. and ENvue Medical Holdings LLC[179]. Financial Performance - For the three months ended September 30, 2025, revenues were approximately $722 thousand, an increase of 92% compared to $376 thousand in the same period of 2024[212]. - Gross profit for the three months ended September 30, 2025, was approximately $189 thousand, a 42% increase from $133 thousand in 2024[214]. - For the nine months ended September 30, 2025, revenues were approximately $2,241 thousand, a 6% increase from $2,114 thousand in 2024[225]. Expenses - Research and development expenses decreased by approximately 11% to $221 thousand for the three months ended September 30, 2025, compared to $249 thousand in 2024[216]. - Selling and marketing expenses surged by approximately 349% to $812 thousand for the three months ended September 30, 2025, from $181 thousand in 2024[218]. - General and administrative expenses increased by approximately 108% to $1,403 thousand for the three months ended September 30, 2025, compared to $673 thousand in 2024[220]. - Research and development expenses for the nine months ended September 30, 2025, increased by approximately 209% to $1,723 thousand from $557 thousand in 2024[229]. - Selling and marketing expenses for the nine months ended September 30, 2025, rose by approximately 245% to $1,878 thousand compared to $545 thousand in 2024[232]. - General and administrative expenses for the nine months ended September 30, 2025, were approximately $4,997 thousand, an increase of 114% from $2,335 thousand in 2024[234]. Cash Flow and Financing - As of September 30, 2025, the company reported a cash balance of approximately $6,980 thousand after incurring approximately $6,696 thousand in cash used in operating activities[240]. - As of September 30, 2025, the company had cash and cash equivalents of approximately $6,980 thousand, a significant increase from approximately $752 thousand as of December 31, 2024[246]. - Cash used in operating activities for the nine months ended September 30, 2025, was approximately $6,696 thousand, compared to approximately $1,968 thousand for the same period in 2024[247]. - Cash provided by financing activities during the nine months ended September 30, 2025, was approximately $12.8 million, primarily from net proceeds of $17.1 million from the issuance of common stock, preferred stock, and warrants[248]. Compliance and Regulatory Matters - The company received a compliance extension from Nasdaq to demonstrate adherence to the minimum bid price and equity requirements by March 31, 2025[189]. - On April 9, 2025, the company demonstrated compliance with Nasdaq's bid price and equity requirements, avoiding delisting[190]. - The company is subject to a one-year mandatory panel monitor following compliance with Nasdaq requirements[191]. - The company has identified inaccuracies in its 510(k) application for the PainShield MD Plus product and intends to halt future sales of the product[251]. - The company is subject to risks common in the biopharmaceutical industry, including regulatory approvals and competition from new products[252]. Capital Requirements and Future Outlook - The company's future capital requirements will depend on the successful commercialization of its products and the development of future product offerings[249]. - The company anticipates that future operating results will be subject to quarterly variations based on various factors, including distributor ordering patterns and regulatory approvals[250]. Asset Changes - Major changes in assets are primarily attributable to a merger, reflecting the revaluation and consolidation of assets[244]. - Cash provided in investing activities was approximately $111 thousand for the nine months ended September 30, 2025, mainly from cash acquired in the merger[247]. - The company has no off-balance sheet transactions or obligations that may materially affect its financial condition as of September 30, 2025[243]. Stock and Offerings - In September 2025, the company conducted a registered direct offering, issuing 74,114 shares of common stock and prefunded warrants for a total net proceeds of approximately $1.88 million[181]. - The Series H Initial Closing on July 22, 2025, generated gross proceeds of $8 million from the sale of 8,889 shares of Series H Convertible Preferred Stock[185]. - The Series H Purchase Agreement allows for the potential issuance of up to $44 million in additional Series H Preferred Stock over a 36-month period[184]. - The company executed a 1-for-10 reverse stock split effective August 11, 2025, to comply with Nasdaq listing requirements[182].