HOUSTON, TX, Aug. 25, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (the “Company” or “Nexalin”) (Nasdaq: NXL; NXLIW) is pleased to invite investors to a webinar on September 9, 2025, at 4:15 p.m. ET. Attendees will gain an inside look at Nexalin’s game-changing approach to mental healthcare through its proprietary, non-invasive Deep Intracranial Frequency Stimulation (DIFS™) technology. CEO Mark White will detail the Company’s growing body of clinical evidence, including collaborations with leading in ...

PART I. FINANCIAL INFORMATION [Item 1. Unaudited Condensed Consolidated Financial Statements](index=4&type=section&id=ITEM%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Unaudited Q2 2025 financials reveal a net loss and negative cash flow, offset by increased equity from a recent stock offering [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights (Unaudited) | Balance Sheet Item | June 30, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $431,320 | $574,485 | | Short-term investments | $5,361,465 | $2,905,438 | | Total Current Assets | $6,269,111 | $3,961,141 | | Total Assets | $6,563,982 | $4,222,732 | | **Liabilities & Equity** | | | | Total Current Liabilities | $600,584 | $546,694 | | Total Liabilities | $600,584 | $546,694 | | Total Stockholders' Equity | $5,963,398 | $3,676,038 | - Total assets increased significantly to **$6.56 million** from **$4.22 million**, primarily driven by a rise in short-term investments following a stock offering[11](index=11&type=chunk) - Total stockholders' equity grew to **$5.96 million** from **$3.68 million**, reflecting the net proceeds from the recent equity issuance, partially offset by the accumulated deficit[11](index=11&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Statement of Operations Summary (Unaudited) | Metric | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :--- | :--- | :--- | :--- | :--- | | Revenues, net | $70,588 | $26,840 | $111,603 | $105,511 | | Gross profit | $47,750 | $19,593 | $75,207 | $89,108 | | Total operating expenses | $1,668,608 | $1,316,614 | $3,707,290 | $2,459,841 | | Loss from operations | $(1,620,858) | $(1,297,021) | $(3,632,083) | $(2,370,733) | | Net loss | $(1,580,987) | $(1,284,493) | $(3,569,324) | $(2,325,650) | | Net loss per share (Basic & Diluted) | $(0.10) | $(0.17) | $(0.25) | $(0.31) | - Revenues for Q2 2025 more than doubled year-over-year, reaching **$70.6 thousand**, while revenues for the six-month period showed modest growth[13](index=13&type=chunk) - Operating expenses increased significantly for both the three and six-month periods, leading to wider net losses compared to the prior year[13](index=13&type=chunk) [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity) - Stockholders' equity increased from **$3.68 million** on January 1, 2025, to **$5.96 million** on June 30, 2025[15](index=15&type=chunk) - The primary driver for the increase in equity was the issuance of 4,090,000 shares as part of an offering, which contributed approximately **$4.65 million** in additional paid-in capital[15](index=15&type=chunk) - The increase from the stock issuance was partially offset by a net loss of **$3.57 million** for the six-month period[15](index=15&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary for the Six Months Ended June 30 (Unaudited) | Cash Flow Activity | 2025 ($) | 2024 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | $(2,343,379) | $(2,009,704) | | Net cash provided by (used in) investing activities | $(2,446,183) | $2,278,270 | | Net cash provided by financing activities | $4,646,397 | $0 | | **Net (decrease) increase in cash** | **$(143,165)** | **$268,566** | - Financing activities provided **$4.65 million** in cash during the first six months of 2025, entirely from the sale of common stock, compared to zero in the same period of 2024[18](index=18&type=chunk) - Cash used in operations increased to **$2.34 million**, reflecting the larger net loss during the period[18](index=18&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes provide critical context to the financial statements, covering business operations, liquidity, accounting policies, and key financial items [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=ITEM%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management highlights new device development, Q2 2025 revenue growth, increased losses from R&D, and expresses substantial doubt about the company's going concern - The company's strategy is focused on developing its new Gen-2 SYNC and Gen-3 HALO neurostimulation devices, which use a more powerful **15 milliamp** waveform, and navigating the FDA regulatory process for U.S. market entry[118](index=118&type=chunk)[119](index=119&type=chunk) - Sales of the older Gen-1 device **remain paused** in the U.S. following an FDA reclassification in 2019, though the company continues to derive some revenue from legacy units[117](index=117&type=chunk) - The company is developing a virtual clinic platform to allow physicians to prescribe and monitor the Gen-3 HALO headset for at-home patient use, aiming to address the stigma associated with traditional mental health treatments[131](index=131&type=chunk) - Recent international progress includes **regulatory approval** for the Gen-2 device in Brazil and operational use in Oman[138](index=138&type=chunk)[139](index=139&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Comparison of Three Months Ended June 30, 2025 and 2024 | Metric | 2025 ($) | 2024 ($) | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenues, net | $70,588 | $26,840 | $43,748 | 163% | | Gross profit | $47,750 | $19,593 | $28,157 | 144% | | Total operating expenses | $1,668,608 | $1,316,614 | $351,994 | 27% | | Net loss | $(1,580,987) | $(1,284,493) | $(296,494) | 23% | - The **163%** increase in Q2 2025 revenue was primarily due to a large shipment of boards to China[141](index=141&type=chunk) - The **27%** increase in Q2 2025 operating expenses was driven by higher stock-based compensation (**~$260 thousand**), increased consulting expenses (**~$50 thousand**), and higher R&D costs for clinical trials[143](index=143&type=chunk)[145](index=145&type=chunk)[146](index=146&type=chunk) - For the six months ended June 30, 2025, the net loss widened by **53%** to **$3.6 million**, largely due to a **$740.0 thousand** increase in stock-based compensation and a **$357.0 thousand** increase in R&D expenses[149](index=149&type=chunk)[153](index=153&type=chunk)[154](index=154&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2025, the company had approximately **$431.0 thousand** in cash and cash equivalents and **$5.4 million** in short-term investments[162](index=162&type=chunk) - The company has a significant accumulated deficit of **$88.2 million** and negative operating cash flows of **$2.3 million** for the first six months of 2025[162](index=162&type=chunk) - Management has concluded that the company will not have sufficient cash to satisfy its anticipated cash requirements for the next twelve months, which raises **substantial doubt about its ability to continue as a going concern**[163](index=163&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=37&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Nexalin is not required to provide the information for this item - The company is **not required to provide this information** as it qualifies as a smaller reporting company[178](index=178&type=chunk) [Item 4. Controls and Procedures](index=37&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were ineffective due to material weaknesses in internal control over financial reporting - Management identified **material weaknesses** in internal control over financial reporting[179](index=179&type=chunk) - The identified weaknesses include: (i) lack of sufficient resources for adequate segregation of duties in financial reporting, and (ii) insufficient IT controls related to user access to the financial reporting system[179](index=179&type=chunk) - Due to these weaknesses, management concluded that disclosure controls and procedures were **not effective** as of the end of the period[180](index=180&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=39&type=section&id=ITEM%201.%20Legal%20Proceedings) The company reports no material pending legal proceedings - There are **no material pending legal proceedings** involving the company[184](index=184&type=chunk) [Item 1A. Risk Factors](index=39&type=section&id=ITEM%201A.%20Risk%20Factors) The company reports a new risk factor related to U.S. trade policy changes and tariffs, which could adversely affect business with China - A new risk factor has been added regarding recent changes to U.S. trade policy, including tariffs, which could adversely affect the business[186](index=186&type=chunk) - Ongoing trade tensions between the U.S. and China could harm sales and operations by impacting the importation of products or subjecting the company's exports to retaliatory tariffs[188](index=188&type=chunk)[189](index=189&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities or use of proceeds from registered securities for the period - **None reported for the period**[190](index=190&type=chunk) [Item 6. Exhibits](index=40&type=section&id=ITEM%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including material contracts and corporate governance documents - The report lists numerous exhibits, including the Underwriting Agreement from the May 2025 offering, the Joint Venture Agreement with Wider Come Limited, and various employment and consulting agreements[195](index=195&type=chunk)

Core Insights - Nexalin Technology, Inc. has appointed Justin Van Fleet as Chief Financial Officer effective August 1, 2025, bringing over 20 years of experience in public accounting and assurance services [1][2] - Mr. Van Fleet has a strong track record in financial systems development, regulatory compliance, and strategic financial management, particularly in guiding companies through complex financial transactions [2][3] - The company is at a pivotal moment with its innovative neurostimulation technology aimed at treating serious mental health conditions, and Mr. Van Fleet's expertise will be crucial for scaling operations and advancing the technology [4] Company Overview - Nexalin Technology designs and develops non-invasive neurostimulation products to address the global mental health epidemic, utilizing bioelectronic medical technology [6] - The company's Generation 2 and Generation 3 devices are currently under FDA review and are designed to provide deep-brain stimulation without drugs or invasive procedures, targeting conditions such as anxiety and depression [4][6] - Nexalin's Gen-2 15 milliamp neurostimulation device has received approval in China, Brazil, and Oman, indicating its potential for international market expansion [6]

Core Insights - Nexalin Technology, Inc. is hosting a webinar on June 3, 2025, to discuss its innovative approach to mental healthcare using its proprietary Deep Intracranial Frequency Stimulation (DIFS™) technology [1][2] - The company is positioned in a $537 billion mental health market, with international regulatory approvals and U.S. expansion plans underway [2] - Nexalin's technology includes real-time AI-driven patient monitoring and aims to provide scalable, at-home treatment options [2] Company Overview - Nexalin designs and develops non-invasive neurostimulation products aimed at addressing the global mental health epidemic [4] - The company's devices are believed to penetrate deep brain structures associated with mental health disorders, enhancing patient response without adverse side effects [4] - The Nexalin Gen-2 15 milliamp neurostimulation device has received approval in China, Brazil, and Oman [4]

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the company's financial statements, management's analysis, market risk, and internal controls assessment [Item 1. Financial Statements](index=4&type=section&id=ITEM%201.%20Financial%20Statements) Nexalin Technology reported a significant Q1 2025 revenue decrease and wider net loss, with reduced assets and going concern doubts despite a May 2025 public offering Condensed Consolidated Balance Sheet Summary | Metric | March 31, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Total Current Assets** | $2,620,591 | $3,961,141 | | **Total Assets** | $2,900,111 | $4,222,732 | | **Total Current Liabilities** | $574,736 | $546,694 | | **Total Stockholders' Equity** | $2,325,375 | $3,676,038 | Condensed Consolidated Statement of Operations Summary | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | **Revenues, net** | $41,015 | $78,671 | | **Gross profit** | $27,457 | $69,515 | | **Loss from operations** | $(2,011,225) | $(1,073,712) | | **Net loss** | $(1,988,337) | $(1,041,157) | | **Net loss per share** | $(0.15) | $(0.14) | Condensed Consolidated Statement of Cash Flows Summary | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | **Net cash used in operating activities** | $(1,426,214) | $(763,289) | | **Net cash provided by investing activities** | $1,473,758 | $729,314 | | **Cash and cash equivalents - end of period** | $622,029 | $546,255 | [Note 1: Nature of the Organization and Business](index=8&type=section&id=NOTE%201%20%E2%80%94%20NATURE%20OF%20THE%20ORGANIZATION%20AND%20BUSINESS) The company develops neurostimulation products, focusing on Gen-2/3 FDA pre-submission, managing a joint venture, and addressing Nasdaq compliance - The company designs and develops neurostimulation products for mental health, with its Gen-1 device facing U.S. marketing restrictions following a 2019 FDA reclassification[23](index=23&type=chunk)[24](index=24&type=chunk) - The company is now focused on developing its next-generation devices, Gen-2 (SYNC) and Gen-3 (HALO), which use a more powerful 15 milliamp waveform and are currently in the FDA's pre-submission process[26](index=26&type=chunk) - A joint venture was formed on May 31, 2023, with Wider Come Limited to develop, market, and sell the Gen-2 SYNC device in China and other Asian countries, with Nexalin owning **48%** of the JV and accounting for it using the equity method[40](index=40&type=chunk)[43](index=43&type=chunk) - The company has faced and regained compliance with Nasdaq's minimum bid price and minimum stockholder equity requirements, highlighting ongoing risks to its stock listing[48](index=48&type=chunk)[51](index=51&type=chunk)[52](index=52&type=chunk) [Note 2: Liquidity](index=13&type=section&id=NOTE%202%20%E2%80%94%20LIQUIDITY) The company faces substantial going concern doubt due to accumulated deficit, operating losses, and negative cash flow, despite a recent public offering - The company's financial statements were prepared on a going concern basis, but significant factors raise substantial doubt about its ability to continue, including an accumulated deficit of approximately **$86.7 million**, a Q1 operating loss of **$2.0 million**, and negative operating cash flow of **$1.4 million** as of March 31, 2025[54](index=54&type=chunk) - Management believes that a public offering completed on May 6, 2025, provides sufficient cash for the next twelve months, though these plans were deemed insufficient to overcome the presumption of substantial doubt about the company's ability to continue as a going concern[56](index=56&type=chunk) [Note 7: Commitments and Contingencies](index=24&type=section&id=NOTE%207%20%E2%80%94%20COMMITMENTS%20AND%20CONTINGENCIES) The company settled the Sarah Veltz lawsuit and is in discussions with the California EDD regarding worker classification issues - The company entered into a confidential settlement agreement on May 12, 2025, to resolve the Sarah Veltz lawsuit, with the settlement amount not expected to have a material effect on the company's financials[119](index=119&type=chunk) - The company is in settlement discussions with the California Employment Development Department (EDD) regarding worker classification issues, with the potential liability reduced to approximately **$40,000**, which has been accrued[120](index=120&type=chunk) [Note 8: Concentration of Credit Risk](index=25&type=section&id=NOTE%208%20%E2%80%94%20CONCENTRATION%20OF%20CREDIT%20RISK) The company faces significant customer concentration risk, with a few customers accounting for a large portion of revenues and accounts receivable - The company has significant customer concentration risk, with two customers accounting for **50%** of revenues for the three months ended March 31, 2025[122](index=122&type=chunk) - As of March 31, 2025, three customers accounted for **90%** of accounts receivable[123](index=123&type=chunk) [Note 10: Subsequent Events](index=27&type=section&id=NOTE%2010%20%E2%80%94%20SUBSEQUENT%20EVENTS) A public offering completed on May 6, 2025, raised approximately $5.005 million in gross proceeds for the company - On May 6, 2025, the company completed a public offering of **3,850,000** shares of common stock, raising aggregate gross proceeds of approximately **$5,005,000**[130](index=130&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=ITEM%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Q1 2025 revenue declined 48% with net loss widening 91% due to higher operating expenses, highlighting liquidity concerns despite a recent $5 million equity offering and Gen-2 device approvals [Results of Operations](index=31&type=section&id=Results%20of%20Operations) Q1 2025 revenue declined due to lower device sales, while operating expenses increased significantly, leading to a wider net loss Comparison of Operations (Q1 2025 vs Q1 2024) | Metric | Q1 2025 | Q1 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | **Revenues, net** | $41,015 | $78,671 | $(37,656) | (48%) | | **Gross Profit** | $27,457 | $69,515 | $(42,058) | (61%) | | **Total Operating Expenses** | $2,038,682 | $1,143,227 | $895,455 | 78% | | **Loss from Operations** | $(2,011,225) | $(1,073,712) | $(937,513) | 87% | | **Net Loss** | $(1,988,337) | $(1,041,157) | $(947,180) | 91% | - The decrease in revenue was primarily due to the sale of devices to a new overseas customer in Q1 2024, which was not repeated in Q1 2025[155](index=155&type=chunk) - The significant increase in operating expenses was driven by higher professional fees (approximately **$140,000**), R&D costs (approximately **$301,000**), and stock compensation (approximately **$475,000**)[157](index=157&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) The company continues to incur operating losses and negative cash flows, funding operations through equity sales, with a recent offering expected to cover the next twelve months - As of March 31, 2025, the company had an accumulated deficit of **$86.7 million** and cash of approximately **$622,000**, continuing to incur operating losses and negative cash flows, funding these primarily through equity sales[163](index=163&type=chunk) - Management believes the capital raised from the May 2025 public offering will be sufficient to satisfy cash requirements for the next twelve months, but acknowledges this is not sufficient to overcome the substantial doubt about the company's ability to continue as a going concern[165](index=165&type=chunk) [Recent Developments](index=31&type=section&id=Recent%20Developments) The company received regulatory approvals for its Gen-2 device in the Sultanate of Oman and Brazil, expanding its international market access - The company received conditional approval for its Gen-2 device from the Ministry of Health in the Sultanate of Oman, with the first device shipped in January 2024[152](index=152&type=chunk) - On June 13, 2024, the Gen-2 device was granted regulatory approval by the Brazilian Health Regulatory Agency[153](index=153&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company, as a smaller reporting company, is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, Nexalin is not required to provide the information for this item[180](index=180&type=chunk) [Item 4. Controls and Procedures](index=36&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were ineffective as of March 31, 2025, due to material weaknesses in segregation of duties and IT controls, with remediation efforts underway - Management identified material weaknesses in internal control over financial reporting and concluded that disclosure controls and procedures were not effective as of March 31, 2025[181](index=181&type=chunk)[182](index=182&type=chunk) - The specific material weaknesses include: (i) lack of adequate segregation of duties related to financial reporting, and (ii) insufficient IT controls, particularly regarding user access to the financial reporting system[181](index=181&type=chunk) - The company intends to engage an outside firm and implement new controls to remediate the material weaknesses, but no material changes to internal controls were made during the quarter[182](index=182&type=chunk)[184](index=184&type=chunk) [PART II. OTHER INFORMATION](index=37&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, unregistered equity sales, and a list of exhibits filed with the report [Item 1. Legal Proceedings](index=37&type=section&id=ITEM%201.%20Legal%20Proceedings) This section states there are no material pending legal proceedings - The report states there are no material pending legal proceedings under this item[185](index=185&type=chunk) [Item 1A. Risk Factors](index=37&type=section&id=ITEM%201A.%20Risk%20Factors) The company reports no material changes to the risk factors previously disclosed in its Annual Report on Form 10-K for the year ended December 31, 2024 - There have been no material changes from the risk factors previously disclosed in the company's 2024 Form 10-K[186](index=186&type=chunk)[187](index=187&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or use of proceeds from registered securities during the period - None reported for the period[188](index=188&type=chunk) [Item 6. Exhibits](index=38&type=section&id=ITEM%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including underwriting agreements, corporate governance documents, material contracts such as employment and joint venture agreements, and officer certifications - The report includes a list of exhibits filed, such as an Underwriting Agreement dated May 4, 2025, various employment and consulting agreements, and certifications from the Principal Executive Officer[193](index=193&type=chunk)

Core Insights - Nexalin Technology, Inc. has reconstituted its Scientific Advisory Board (SAB) to enhance its focus on Alzheimer's disease, reflecting a strategic prioritization within its clinical development pipeline [1][3] - The newly appointed members of the SAB include Dr. Mingxiong Huang, Dr. David Owens, and Dr. Abe Scheer, who bring extensive expertise in neurology and neuroimaging [2][3] - The company plans to initiate new Alzheimer's-focused clinical studies in Q3 2025, incorporating cognitive testing and imaging biomarkers to assess treatment efficacy [11][12] Company Developments - The restructuring of the SAB aims to provide scientific and clinical oversight for Nexalin's initiatives in neurodegenerative and neuropsychiatric disorders [2][3] - Nexalin's proprietary Deep Intracranial Frequency Stimulation (DIFS™) technology is designed to penetrate deep brain structures associated with cognitive decline and mental illness [3][12] - The company emphasizes the potential of DIFS™ to promote neuroplasticity and functional recovery, particularly in memory and executive function areas [3][12] Advisory Board Expertise - Dr. Mingxiong Huang specializes in magnetoencephalography (MEG) and neuroimaging, with over 25 years of experience in advanced imaging techniques for neurological disorders [4][5] - Dr. Abe Scheer has over four decades of experience in neurology and psychiatry, and has previously served on Nexalin's SAB [6][7] - Dr. David Owens, the Chief Medical Officer, is a board-certified neuroradiologist with expertise in advanced imaging techniques and clinical research on transcranial stimulation therapies [8][10] Future Directions - The SAB will guide the scientific direction and clinical strategy for Nexalin's Alzheimer's initiatives, ensuring adherence to regulatory standards and scientific rigor [11][12] - The company aims to leverage the combined expertise of the SAB members to advance its technology through clinical trials addressing Alzheimer's disease [3][11]

Core Viewpoint - Nexalin Technology, Inc. has successfully closed a public offering of 3,850,000 shares at a price of $1.30 per share, raising approximately $5.0 million in gross proceeds before expenses [1]. Company Overview - Nexalin Technology, Inc. specializes in developing innovative neurostimulation products aimed at addressing the global mental health crisis. The company's products are designed to be non-invasive and are believed to provide relief for mental health issues [5]. - The company utilizes bioelectronic medical technology to treat mental health disorders, with a focus on penetrating deep brain structures associated with these conditions. Nexalin's next-generation devices are expected to enhance patient response without adverse side effects [5]. - The Nexalin Gen-2 15 milliamp neurostimulation device has received approval in China, Brazil, and Oman [5]. Offering Details - The public offering was conducted under an effective shelf registration statement filed with the U.S. Securities and Exchange Commission (SEC) on April 23, 2025, and declared effective on April 29, 2025 [3]. - Maxim Group LLC served as the sole book-running manager for the offering [2].

Company Overview - Nexalin Technology, Inc. is a leader in Deep Intracranial Frequency Stimulation (DIFS™) technology aimed at addressing mental health issues through innovative neurostimulation products [5] - The company's products are designed to be non-invasive and are believed to provide relief for individuals suffering from mental health disorders [5] Public Offering Details - Nexalin announced a public offering of 3,850,000 shares of common stock priced at $1.30 per share, with expected gross proceeds of approximately $5.0 million [1] - The offering is set to close on or about May 6, 2025, subject to customary closing conditions [1] - An additional 577,500 shares may be purchased by underwriters within a 45-day option period at the public offering price [1] Use of Proceeds - The net proceeds from the offering will be utilized for working capital and general corporate purposes, including sales and marketing, product development, and capital expenditures [2] Regulatory Compliance - A shelf registration statement for the shares was filed with the SEC on April 23, 2025, and was declared effective on April 29, 2025 [3] - The offering is being conducted through a written prospectus and prospectus supplement available on the SEC's website [3]

Core Viewpoint - Nexalin Technology, Inc. is initiating formal regulatory engagement with the FDA for its Gen-2 SYNC system, aimed at treating Alzheimer's disease, dementia, and mild cognitive impairment (MCI) [1][2]. Regulatory Engagement - The company plans to submit a Q-Submission ("Q-Sub") to the FDA to facilitate structured dialogue regarding clinical trial design [1][2]. - This decision follows recent publications, encouraging internal data, and preliminary feedback from the FDA, marking a critical step in advancing Gen-2 SYNC as a non-invasive therapeutic option [2]. Product Development - The Gen-2 SYNC system features technical enhancements over prior generations, including a redesigned enclosure and a proprietary 15 milliamp advanced waveform [3]. - The company is rebranding the device to clearly differentiate it from earlier versions, marketing it as "Gen-2 SYNC" [3]. Company Focus - Nexalin is committed to progressing regulatory engagement and advancing its neuromodulation platform as a promising therapeutic alternative for cognitive and neuropsychiatric disorders [3]. - The company designs and develops innovative neurostimulation products aimed at addressing the global mental health epidemic, utilizing bioelectronic medical technology [5].

Core Insights - Nexalin Technology, Inc. has successfully completed and launched phases one through five of its proprietary virtual clinic and digital research ecosystem, which supports data capture, remote monitoring, and virtual treatment with its HALO™ headset [1][2][3] Group 1: Virtual Clinic Launch - The virtual clinic was launched at the University of California, San Diego (UCSD) to facilitate patient recruitment for a military study on TBI/PTSD [1] - The platform enables real-time data capture and clinical oversight, allowing patients to receive treatment in their homes while ensuring compliance with research protocols [1][2] Group 2: Digital Infrastructure - Nexalin has established a comprehensive digital infrastructure that includes an AI-integrated Electronic Data Capture (EDC) platform and a Patient Monitoring System (PMS) [2][7] - This infrastructure enhances capabilities for remote research studies and streamlines patient care using non-invasive DIFS™ technology [2][4] Group 3: Clinical Research and Treatment - The virtual clinic facilitates clinical research on the HALO™ device, focusing on mental health disorders, traumatic brain injury, addiction, and neurodegenerative conditions [3][4] - The system allows for remote monitoring of treatment adherence and tracking of patient outcomes, optimizing clinical protocols [4][7] Group 4: Future Prospects - The completion of the virtual clinic positions Nexalin to expand research collaborations, advance regulatory approvals, and accelerate commercialization efforts for HALO™ and future DIFS™ technology applications [4]