Financial Performance - Net sales for Q3 2025 reached $811,414, an increase of 21.7% compared to $666,625 in Q3 2024[9] - Gross profit for the nine months ended September 30, 2025, was $2,179,890, up 30.7% from $1,667,811 in the same period of 2024[9] - Operating loss for Q3 2025 was $(2,100,085), compared to $(1,651,273) in Q3 2024, reflecting an increase in selling expenses[9] - Net loss available to common stockholders for Q3 2025 was $(2,321,503), compared to $(1,800,054) in Q3 2024[9] - Basic and diluted loss per share for Q3 2025 was $(0.24), slightly improved from $(0.25) in Q3 2024[9] - The company reported a net loss of $(6,091,898) for the nine months ended September 30, 2025, down from $(6,793,596) in the same period of 2024[9] - For the nine months ended September 30, 2025, NeurAxis reported a net loss of $6,091,898, a decrease of 10.3% compared to a net loss of $6,793,596 for the same period in 2024[12] - As of September 30, 2025, the Company reported a net loss of $2,122,796 for the three months ended, compared to a net loss of $1,755,234 for the same period in 2024, indicating an increase in losses of approximately 20.9%[36] Equity and Cash Position - Total stockholders' equity as of September 30, 2025, was $2,284,941, compared to a deficit of $(1,793,932) as of September 30, 2024[11] - Cash and cash equivalents at the end of the period increased to $4,377,109 from $260,885 at the end of September 2024, representing a significant growth[12] - The Company had stockholders' equity of $2,284,941 and cash of $4,377,109 as of September 30, 2025, indicating a strong liquidity position despite ongoing losses[53] - The company had cash of $4,377,109 and a working capital surplus of $1,840,599 as of September 30, 2025[53] Expenses and Costs - Research and development expenses for the nine months ended September 30, 2025, totaled $347,433, a 17.7% increase from $295,188 in the prior year[9] - Selling expenses for the nine months ended September 30, 2025, amounted to $414,134, a significant increase from $154,299 in the same period of 2024[25] - Selling expenses for Q3 2025 were $292,678, a significant increase from $34,468 in Q3 2024, representing a growth of 748%[25] - The company recorded expired and other inventory charges of $24,339 for the nine months ended September 30, 2025, compared to $2,030 for the same period in 2024, indicating a significant increase in inventory-related expenses[24] Inventory and Reserves - Inventory reserves totaled $28,793 as of September 30, 2025, compared to $4,454 at the end of 2024, indicating increased inventory management efforts[24] - The estimated returns reserve totaled $8,714 as of September 30, 2025, up from $5,000 as of December 31, 2024[48] Financing Activities - The company generated $5,204,211 in net cash from financing activities, compared to $4,550,198 in the same period of 2024, indicating a 14.4% increase[12] - NeurAxis raised $4,999,999 from the issuance of common shares during the nine months ended September 30, 2025, contributing to its cash flow from financing activities[12] - Common stock issued from agreements in Q3 2025 included 39,471 shares, contributing $112,493 to additional paid-in capital[11] Legal and Regulatory Matters - The Company recorded a tentative settlement of $750,000 related to ongoing litigation, with payments starting in January 2026[114] - The Company has no pending or threatened legal proceedings that could materially affect its operations[124] Future Outlook - The company plans to continue expanding its market presence and investing in new product development to drive future growth[9] - Future capital requirements will depend on various factors, including the ability to secure purchase orders and the adoption of insurance coverage by commercial insurance carriers, which is a top priority for the Company[54] - The Company has incurred losses and negative cash flows from operations since inception, raising substantial doubt about its ability to continue as a going concern[56] Stock and Shares - The weighted average shares of common stock outstanding for basic and diluted EPS were 9,878,020 for the three months ended September 30, 2025, compared to 7,172,229 for the same period in 2024, reflecting a 37.7% increase in shares outstanding[37] - The Company had 9,886,294 shares of common stock issued and outstanding as of September 30, 2025, an increase from 6,990,227 shares as of December 31, 2024[81] - During the nine months ended September 30, 2025, the Company issued 1,538,461 shares of common stock for gross proceeds of $4,999,999 at a price of $3.25 per share[84] Research and Development - Research and development expenses are primarily focused on clinical studies and new product development, with costs expensed as incurred[26] - The Company has developed four FDA cleared products, including the IB-STIM and the Rectal Expulsion Device (RED), with ongoing efforts to expand their indications[15] Lease and Asset Management - The Company recognized operating lease expense of $24,193 for the three months ended September 30, 2025, compared to $27,891 for the same period in 2024[79] - As of September 30, 2025, the Company reported operating lease right-of-use assets of $277,219 and operating lease liabilities of $219,933, with a total present value of lease payments amounting to $282,767[80] - The total present value of operating lease payments as of September 30, 2025, was $282,767, with total lease payments amounting to $363,523[80]

Core Viewpoint - NeurAxis, Inc. is set to release its financial results for the third quarter of 2025 on November 11, 2025, before market open, followed by a conference call to discuss the results [1] Group 1: Financial Results Announcement - The financial results for the third quarter of 2025 will be reported on November 11, 2025, for the period ending September 30, 2025 [1] - A conference call is scheduled for the same day at 9:00 a.m. Eastern Time to review the financial results [1] Group 2: Conference Call Details - Interested parties can access the conference call via a live webcast available on the Company's Investor Relations website [2] - Participants can submit questions through the webcast portal or via email [2] Group 3: Company Overview - NeurAxis, Inc. focuses on neuromodulation therapies for chronic and debilitating conditions in both children and adults [4] - The Company is advancing its proprietary IB-Stim™ therapy, which is FDA cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 8-21 [4] - Additional clinical trials for PENFS technology are ongoing for various pediatric and adult conditions with significant unmet healthcare needs [4]

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Click Holdings Limited (CLIK) is up 81% at $11.17 [3] - Avidity Biosciences, Inc. (RNA) is up 43% at $70.72 [3] - Dyne Therapeutics, Inc. (DYN) is up 37% at $23.58 [3] - Zenas BioPharma, Inc. (ZBIO) is up 21% at $29.00 [3] - ProPetro Holding Corp. (PUMP) is up 18% at $7.47 [3] - PepGen Inc. (PEPG) is up 17% at $5.35 [3] - Unusual Machines, Inc. (UMAC) is up 15% at $14.85 [3] - Semler Scientific, Inc. (SMLR) is up 14% at $27.32 [3] - ETHZilla Corporation (ETHZ) is up 13% at $20.51 [3] - Relmada Therapeutics, Inc. (RLMD) is up 13% at $2.38 [3] Premarket Losers - Smart Logistics Global Limited (SLGB) is down 37% at $3.21 [4] - MaxsMaking Inc. (MAMK) is down 22% at $4.08 [4] - Prenetics Global Limited (PRE) is down 14% at $14.40 [4] - United States Antimony Corporation (UAMY) is down 14% at $10.22 [4] - NeurAxis, Inc. (NRXS) is down 12% at $3.01 [4] - Obook Holdings Inc. (OWLS) is down 9% at $11.39 [4] - Qualigen Therapeutics, Inc. (QLGN) is down 9% at $3.30 [4] - Critical Metals Corp. (CRML) is down 8% at $13.70 [4] - Neuphoria Therapeutics Inc. (NEUP) is down 8% at $5.73 [4] - Beam Therapeutics Inc. (BEAM) is down 7% at $25.86 [4]

Core Insights - NeurAxis, Inc. has received FDA 510(k) clearance for its percutaneous electrical nerve field stimulation (PENFS) technology to treat functional abdominal pain (FAP) associated with functional dyspepsia (FD) and related nausea in patients aged 8 years and older, marking a historic milestone as the first FDA clearance for a treatment specifically addressing functional dyspepsia in adults [1][2] Company Overview - NeurAxis is a medical technology company focused on neuromodulation therapies for chronic and debilitating conditions in both children and adults, with a commitment to advancing science and evidence-based medicine [3] Market Expansion - The FDA clearance significantly expands NeurAxis's total addressable market by including patients aged 8 years and older, which is expected to drive substantial revenue growth in the gastrointestinal (GI) space [2][5] - The upcoming January 1, 2026, Category I CPT Code for PENFS procedures will apply to this new adult indication, facilitating broader clinical impact [2][5] Clinical Significance - Functional dyspepsia can lead to severe abdominal pain and nausea, significantly impacting quality of life, and the approval of PENFS technology provides a new treatment option for adult patients who previously had limited options [2]

Summary of NeurAxis Conference Call Company Overview - NeurAxis is a growth-stage medtech company focused on pediatric gastrointestinal (GI) conditions, specifically functional abdominal pain and functional dyspepsia in children aged 8 to 21 years [4][9] - The company has two FDA indications: one for functional abdominal pain and another for functional dyspepsia, which includes nausea symptoms [4][9] - The technology used is a percutaneous electrical nerve field stimulator, which operates for four weeks with significant data supporting its efficacy at six and twelve months post-treatment [5][6] Unmet Medical Need - There is a significant unmet need in treating functional abdominal pain and functional dyspepsia, with no FDA-approved treatments available for 30 to 50 years [8][9] - Current treatment options include medications with FDA black box warnings, which are often undesirable for both parents and physicians [8][9] - Approximately 6 million children in the U.S. suffer from functional abdominal pain, with 600,000 being severely affected, missing three or more days of school per week [10][11] Market Opportunity - The total addressable market for NeurAxis is estimated at $5 billion, based on a treatment cost of approximately $5,000 per patient for the 1 million debilitated children [11] - The company has seen organic growth of about 40% per quarter, but penetration remains low at around 0.2% to 1% [30][31] Challenges and Solutions - Major challenges include lack of insurance coverage and reimbursement for the technology, which hampers scaling efforts [13][14] - A Category I CPT code is set to take effect on January 1, 2026, which is expected to streamline billing and improve reimbursement for physicians [17][18] - The proposed RVU for the CPT code is 1.46, which is viewed positively by physicians [17] Insurance Coverage and Guidelines - NeurAxis has made progress with insurance coverage, with approximately 55 million covered lives under various plans, including strong Blue Cross Blue Shield policies [23] - The publication of guidelines by NASPGHAN recommending IB-Stim as a treatment has bolstered the company's position in discussions with payers [25][26] Commercial Strategy - NeurAxis is building a commercial infrastructure to drive utilization, including hiring experienced personnel and leveraging key opinion leaders (KOLs) for outreach [32][33] - The company aims to establish IB-Stim clinic days in children's hospitals to facilitate treatment for multiple patients [35][36] - The focus is on increasing penetration in existing accounts and ensuring that hospitals are prepared for the launch of the CPT code [37][41] Financial Outlook - The company anticipates that the implementation of the Category I CPT code and improved insurance coverage will significantly enhance revenue potential [41][44] - There is cautious optimism regarding the speed of uptake post-launch, with expectations for a substantial increase in patient treatment [44] Conclusion - NeurAxis is positioned for growth with the upcoming CPT code and increasing insurance coverage, aiming to address a critical unmet need in pediatric GI treatment [45]

Core Viewpoint - NeurAxis, Inc. is actively engaging with investors through a webcast presentation and one-on-one meetings at the Lytham Partners Fall 2025 Investor Conference, highlighting its focus on neuromodulation therapies for chronic conditions [1][2][3]. Company Overview - NeurAxis, Inc. specializes in medical technology, particularly in neuromodulation therapies aimed at treating chronic and debilitating conditions in both children and adults [4]. - The company is advancing its proprietary IB-Stim™ therapy, which utilizes Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, and is FDA cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 8-21 years [4]. - NeurAxis is conducting additional clinical trials for PENFS targeting various pediatric and adult conditions with significant unmet healthcare needs [4].

Core Viewpoint - NeurAxis, Inc. (NRXS) reported a mixed performance in Q2 2025, with revenue growth but continued net losses and margin compression, while management anticipates improved financial health with upcoming insurance coverage changes and product approvals [1][2][5][6]. Revenue and Earnings Performance - NeurAxis reported Q2 2025 revenues of $0.9 million, a 46.2% increase from $0.6 million in Q2 2024, driven by a 58% increase in unit sales due to greater adoption of the IB-Stim device [2] - Gross margin decreased to 83.6% from 88% year-over-year, attributed to deeper discounting for uninsured patients and expired inventory [2] Expense Management - Operating expenses fell by 10.2% to $2.5 million from $2.7 million, primarily due to the absence of one-time costs and lower investor relations and insurance costs [3] - The operating loss narrowed to $1.7 million from $2.2 million a year earlier, while the net loss was $1.7 million, or $0.22 per share, compared to a $2.9 million loss, or $0.42 per share, in Q2 2024 [3] Cash and Liquidity - NeurAxis ended the quarter with $5.9 million in cash, supported by a $5 million equity financing round and $1 million from warrant exercises [4] - Cash used in operations was $3.1 million for the first half of 2025, up from $2.9 million in the same period last year [4] Future Outlook - Management expects gross margins to recover as more patients gain access through commercial reimbursement with the new permanent Category I CPT code effective January 1, 2026 [5] - CEO Brian Carrico indicated that national insurance coverage and inclusion of IB-Stim in clinical guidelines will enhance patient access and revenue growth [6] Regulatory Developments - NeurAxis received FDA clearance to extend IB-Stim's indication to treat pediatric functional dyspepsia, nearly doubling its addressable market [7] - The company also secured FDA clearance for the Rectal Expulsion Device (RED) and terminated its NSS-2 Bridge license with Masimo, regaining associated intellectual property [12][13] Guidance and Expectations - Although no explicit numerical guidance was provided, executives expressed confidence in achieving breakeven in 2026, contingent on broader payer adoption of IB-Stim [10] - Management anticipates continued revenue growth in the second half of 2025, supported by further insurance policy adoption and early traction for RED [11]

Financial Data and Key Metrics Changes - Revenues for Q2 2025 were $894,000, up 46% compared to $612,000 in Q2 2024, marking the fourth consecutive quarter of double-digit growth [27] - Revenue for the six months ended June 30, 2025, increased to $1,800,000, up 42% from $1,300,000 for the same period in 2024 [27] - Operating loss in 2025 was $1,700,000, a decrease of 22% compared to a $2,200,000 loss in 2024 [33] - Net loss in 2025 was $1,700,000, down 42% from $2,900,000 in 2024 [34] Business Line Data and Key Metrics Changes - Unit sales increased approximately 5853% for the three and six months ended June 30, 2025, due to volume growth from patients with health insurance coverage and the company's financial assistance program [27] - Average selling prices for patients receiving IV stem through financial assistance are about 65% below the list price [9] Market Data and Key Metrics Changes - Approximately 53 million covered lives have been reached for medical policy coverage, which is seen as a key driver for revenue growth [12] - The company expects revenue growth to accelerate as payer medical policy coverage increases and the new category one CPT code becomes effective on January 1, 2026 [22] Company Strategy and Development Direction - The company is focused on securing broad medical policy coverage and advancing disciplined commercial execution to drive utilization and scale [25] - The introduction of the category one CPT code is expected to facilitate easier billing and reimbursement, significantly impacting revenue potential [19] - The company is also advancing the RED product line, which is in the soft launch phase, with plans for a hard launch [23] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the commercialization strategies and the expected revenue growth due to recent milestones, including FDA indication expansion and published clinical practice guidelines [7][14] - The management highlighted that the guidelines published by academic societies are crucial for gaining insurance coverage and improving treatment access [16] Other Important Information - The gross margin for 2025 was 83.6%, down from 88% in 2024, primarily due to higher discounting in the financial assistance program [28] - Cash on hand as of June 30, 2025, was $6,000,000, with the company having secured $5,000,000 through an equity financing round [34] Q&A Session Summary Question: Perceptions from larger insurance plans post-guideline publishing - Management noted positive responses from insurance plans, with some agreeing to interim reviews due to the guidelines, indicating favorable perceptions [40][41] Question: Goals for coverage and prior authorization expectations - Management expects some medication requirements to be removed, allowing for earlier use of IV stem treatments, although this will be a gradual process [44][45] Question: Salesforce expansion triggers - The urgency for payer policy coverage is aligned with the urgency on the commercial side, with plans to expand the sales force as insurance coverage increases [48][49] Question: Discount rates and cash pay devices - Management clarified that 70% of patients initially face a "no auth required" response, limiting treatment options, and discussed the average selling price for patients receiving financial assistance [54][58] Question: Approval for adults to use the IV stem device - The company is in discussions with the FDA regarding adult usage and expects to have an answer by the Q4 call [65] Question: Satisfaction with RVUs and reimbursements - Management expressed satisfaction with the RVU assignment of 1.46 and noted that reimbursement values are favorable, exceeding the cost of the device [70][71] Question: General and administrative expenses and leverage - Management discussed achieving operating expense leverage while continuing to invest in growth areas such as sales and R&D [73][74] Question: Current cash balance and future outlook - The current cash position is sufficient to support operations into 2026, with expectations for improved insurance coverage positively impacting liquidity [78]

Financial Performance - Itaúsa achieved a net income of R$ 8.0 billion in 1H25, a 10% increase compared to 1H24[14] - Recurring net income reached R$ 7.9 billion in 1H25, also a 10% increase year-over-year[14] - Shareholders' equity increased by 7% to R$ 89.6 billion as of June 30, 2025, compared to June 30, 2024[16] - Portfolio market value grew by 24% to R$ 159.3 billion as of June 30, 2025, compared to June 30, 2024[16] - Recurring and Adjusted EBITDA increased 31% to R$ 1.0 billion[31] Dividends - Itaúsa declared R$ 2.7 billion of dividends in 1H25 (net)[70] - Payment of R$ 2.3 billion in Interest on Capital (IOC) (net)[65] Macroeconomic Context - Brazilian GDP is projected to grow by 2.2% in 2025[10] - The Selic rate is expected to be 15.00% p.y. in 2025[10] - IPCA is forecasted at 5.2% in 2025[10] Liability Management - Gross debt reduced to R$ 3.6 billion[52] - Net Debt R$ 587 million[58]

Core Insights - NeurAxis, Inc. reported strong revenue growth in Q2 2025, with revenues increasing 46% year-over-year to $894 thousand, compared to $612 thousand in Q2 2024 [8][9] - The company achieved significant operational milestones, including FDA clearance for expanded indications and a new CPT code for reimbursement, which are expected to drive future revenue growth [6][7] Financial Highlights - Revenues for Q2 2025 were $894 thousand, a 46% increase from $612 thousand in Q2 2024 [8][9] - Operating expenses decreased by 10% year-over-year to $2.5 million in Q2 2025 from $2.7 million in Q2 2024 [11] - Operating loss improved by 22% to $1.7 million in Q2 2025 from $2.2 million in Q2 2024 [12] - Net loss decreased by 42% to $1.7 million in Q2 2025 from $2.9 million in Q2 2024 [13] - Cash balance as of June 30, 2025, was $6 million, bolstered by a $5 million equity financing round [14] Operational Highlights - The company is approaching a major inflection point with national insurance coverage, as a new CPT code for IB-Stim is set to take effect on January 1, 2026 [6] - NeurAxis secured FDA clearance to expand IB-Stim's indication to include pediatric Functional Dyspepsia, significantly increasing its total addressable market [7] - The company expanded its total covered lives to approximately 53 million [8] Management Commentary - CEO Brian Carrico expressed optimism about the company's trajectory, highlighting strong revenue growth and the focus on expanding insurance coverage and commercializing IB-Stim [4] - The company is confident in achieving breakeven in 2026 based on strong top-line momentum and strategic positioning [9]