Revenue Performance - Revenue for Q3 2025 was $6.9 million, a decrease of 21% compared to Q3 2024[6] - Total revenues for the three months ended September 30, 2025, decreased by 21.2% to $6.929 million from $8.797 million in the same period of 2024[28] - Global recurring revenue increased by 3% year-over-year to $5.5 million, while equipment revenue decreased by 60% to $1.4 million[6] Profitability and Loss - Net loss for Q3 2025 was $1.6 million, or EPS of negative $0.36, an improvement from a net loss of $2.1 million, or EPS of negative $0.51, in Q3 2024[7] - Net loss for the three months ended September 30, 2025, was $1.622 million, compared to a net loss of $2.074 million in the same period of 2024, representing a 22% improvement[28] - Gross profit for the nine months ended September 30, 2025, was $12.267 million, down 8.9% from $13.459 million in 2024[28] Operating Expenses - Total operating expenses decreased to $5.4 million from $6.9 million in the prior-year period[7] - Operating expenses for the nine months ended September 30, 2025, totaled $17.455 million, a decrease of 5.3% from $18.429 million in 2024[28] - The company recorded a stock-based compensation expense of $469,000 for the nine months ended September 30, 2025, compared to $301,000 in 2024[31] Cash and Assets - Cash and cash equivalents at September 30, 2025, were $7.1 million[8] - Cash and cash equivalents at the end of the period were $7.076 million, down from $8.396 million at the end of September 2024[30] - Total current assets decreased by 14% to $14.272 million as of September 30, 2025, from $16.595 million at December 31, 2024[26] Liabilities - Total liabilities decreased slightly by 1.8% to $29.403 million as of September 30, 2025, from $29.956 million at December 31, 2024[26] Market and Growth Potential - Positive developments in ongoing litigation are expected to translate to increased revenue in the coming quarters[3] - The company anticipates growth from newly approved reimbursement codes for XTRAC treatments, potentially tripling the covered patient population in the U.S.[5] Device Install Base - The U.S. install base of XTRAC devices declined by 6 to 838, while the install base of TheraClearX was 161[5] Billing Metrics - Average gross billings per device increased by 8.5% to $5,981, the highest since Q4 2022[5] Shareholder Information - The weighted average shares of common stock outstanding for the three months ended September 30, 2025, increased to 4,481,337 from 4,038,988 in 2024[28]

Revenue Performance - Revenue for the three months ended September 30, 2025, was $1.3 million, a 453% increase from $0.2 million in the same period in 2024, driven by expansion with multinational enterprise retailers[148] - Revenue for the nine months ended September 30, 2025, was $2.6 million, a substantial increase of 662% compared to $0.3 million in the same period of 2024[158] - The company recorded revenue of $2.6 million for the nine months ended September 30, 2025, compared to $0.3 million for the same period in 2024, representing a significant increase of 766.67%[181] Cost and Expenses - Cost of revenue increased to $0.8 million in Q3 2025 from $0.3 million in Q3 2024, representing a 166% increase, primarily due to higher sales volume of PowerBridge Pro transmitters[150] - Cost of revenue for the nine months ended September 30, 2025, was $1.7 million, a 217% increase from $0.5 million in 2024, driven by higher sales volume[160] - Research and development expenses decreased to $0.9 million in Q3 2025 from $1.5 million in Q3 2024, a reduction of 39% attributed to lower payroll costs from a reduced headcount[151] - Research and development costs decreased by 46% to $3.2 million in the nine months ended September 30, 2025, from $6.0 million in 2024[162] - Sales and marketing expenses were $0.5 million in Q3 2025, down 29% from $0.7 million in Q3 2024, primarily due to decreases in stock-based compensation and consulting fees[152] - General and administrative expenses for Q3 2025 were $1.2 million, a slight decrease of 1% from $1.3 million in Q3 2024[153] - General and administrative costs for the nine months ended September 30, 2025, were $3.4 million, down 31% from $5.0 million in 2024[164] - Total operating expenses decreased to $2.6 million in Q3 2025 from $3.5 million in Q3 2024, a reduction of 24%[148] - Severance expense for Q3 2025 was $8,000, a significant decrease of 90% from $0.1 million in Q3 2024[154] - Total other income for Q3 2025 was $78,000, down 54% from $169,000 in Q3 2024, primarily due to a change in fair value of warrant liability[155] - Expenses from abandoned financing transactions were $0.7 million for the nine months ended September 30, 2025, with no such expenses in 2024[166] Profitability and Loss - Gross profit improved significantly to approximately $0.5 million in Q3 2025, compared to a gross loss of $76,000 in Q3 2024, marking a 703% year-over-year improvement[150] - Loss from operations improved to $2.2 million in Q3 2025, compared to a loss of $3.6 million in Q3 2024, reflecting a 39% reduction in losses[149] - Net loss for Q3 2025 was $2.1 million, a 38% improvement from a net loss of $3.4 million in Q3 2024[148] - Net loss for the nine months ended September 30, 2025, was $8.3 million, a reduction of 42% from $14.3 million in the same period of 2024[169] - The net loss for the nine months ended September 30, 2025, was $8.3 million, an improvement from a net loss of $14.3 million in the same period of 2024, indicating a reduction of 42.0%[181] Cash Flow and Financing - Cash flows used in operating activities were $10.0 million for the nine months ended September 30, 2025, compared to $14.9 million for the same period in 2024, reflecting a decrease of 32.9%[185][186] - The company had cash and cash equivalents of $12.9 million as of September 30, 2025[181] - The company raised net proceeds of $4.5 million from a registered direct offering on September 11, 2025, issuing 120,000 shares of common stock and warrants[135] - The company raised net proceeds of $18.2 million during the nine months ended September 30, 2025, through the ATM Program, along with $4.1 million from the 2025 Offering[181][188] - The 2025 Offering included the issuance of 120,000 shares of common stock and warrants to purchase up to 585,347 shares at a combined price of $7.92 per share[172] - The company fully repaid the Amended Loan Agreement of $1.415 million on July 7, 2025, with no further obligations remaining[180] - The company expects to pursue additional financing options, including equity or debt securities, to sustain operations[183] - The company issued new unregistered warrants to purchase 47,764 shares at an exercise price of $7.79 per share as part of the Concurrent Warrant Exercise Transaction[176] - Cash flows provided by financing activities were $21.6 million for the nine months ended September 30, 2025, compared to $2.5 million for the same period in 2024, indicating a substantial increase[188][189] Product Development - The first WPN-enabled end product featuring the company's technology was launched in 2019, with further innovations anticipated, including the introduction of the battery-free e-Sense tag and e-Compass software platform in Q2 2025[134]

Financial Position - As of September 30, 2025, the company had $33.1 million in cash and cash equivalents and an accumulated deficit of $212.4 million[105]. - The company had an accumulated deficit of $212.4 million as of September 30, 2025[143]. - Cash and cash equivalents totaled $33.1 million as of September 30, 2025[143]. - Cash used in operating activities for the nine months ended September 30, 2025, was $19.6 million, compared to $15.7 million for the same period in 2024[158]. - Net cash provided by financing activities totaled $30.1 million during the nine months ended September 30, 2025, primarily from a Private Placement transaction totaling $28.1 million[161]. - Cash provided by investing activities was $4.5 million for the nine months ended September 30, 2025, primarily from maturities of short-term investments[159]. - The global credit and financial markets have experienced extreme volatility, which may affect the company's ability to obtain financing[154]. - The company has experienced negative cash flows from operating activities since inception and expects this trend to continue as it incurs costs related to product development[154]. Revenue and Losses - For the nine months ended September 30, 2025, the company reported a net loss of $18.6 million, compared to a net loss of $2.3 million for the same period in 2024[113]. - Revenue for the three months ended September 30, 2025, was $0, a decrease of $12.2 million compared to $12.2 million for the same period in 2024[132]. - The company has not generated any revenues from product sales, with past revenues derived from an upfront payment of $26.4 million under the Asset Purchase Agreement with Ono[118]. - The company expects to incur significant expenses and operating losses into the foreseeable future, with existing cash expected to fund operations through 2027[114]. - As of September 30, 2025, the company has an accumulated deficit of $212.4 million and expects to continue incurring net losses into the foreseeable future[154]. Research and Development - The company plans to commence a Phase 1 proof-of-mechanism study for EQ504 by mid-2026, with data expected approximately six months thereafter[108]. - The company plans to continue incurring substantial research and development expenses as it advances the development of EQ504 and potentially EQ302[124]. - The company expects research and development expenses to increase due to the advancement of EQ504 into clinical development[138]. - The company anticipates that future capital requirements will depend on the progress and costs of clinical studies for product candidates EQ504 and EQ302[153]. Financing Activities - The company entered into a Securities Purchase Agreement on August 10, 2025, resulting in gross proceeds of approximately $30.0 million from the initial closing[106]. - The company raised approximately $30.0 million in gross proceeds from a Private Placement on August 12, 2025[146]. - The company entered into an at-the-market facility with Jefferies LLC for an aggregate offering price of up to $21.95 million in October 2023[148]. - The company expects to finance cash needs through equity offerings, debt financings, and collaboration agreements, which may lead to dilution for existing stockholders[154]. Collaborations and Acquisitions - The company terminated its collaboration and license agreement with Biocon Limited, reverting all licenses related to itolizumab back to Biocon[109]. - The company acquired exclusive worldwide rights to EQ302 through the acquisition of Bioniz Therapeutics in February 2022, targeting gastrointestinal diseases[110].

Revenue Performance - Total revenues for the quarter ending September 30, 2025, were $6,680,823, an increase of 59.2% compared to $4,197,053 for the same period in the prior year [64]. - Revenue from Systems Manufacturing increased by 297.3% during the quarter, primarily due to significant increases in customer demand [65]. Profitability - Gross profit decreased to $946,358, with a gross margin of 14.2%, down from 26.6% in the same quarter of the previous year [67]. Expenses - R&D expenses decreased by $88,819 to $311,840, reflecting ongoing efforts in product improvements and new technology development [68]. - SG&A expenses increased by 13.6% to $2,229,773, primarily due to increased stock compensation and consulting expenses [69]. Cash Flow - Net cash provided by operating activities totaled $78,227, a significant improvement from $318,622 net cash used in the same period last year [71]. - Capital equipment expenditures during the quarter were $523,539, compared to $28,099 in the same period of the prior year [76]. Financial Commitments - Contractual cash commitments related to open purchase orders as of September 30, 2025, were approximately $7,402,000 [77]. - The company has no off-balance sheet arrangements that could materially affect its financial condition [78]. - The company may require external financing in the short term to meet working capital needs [70].

Financial Performance - Ainos reported revenues of $2,167 for Q3 2025, compared to $0 in Q3 2024, and $113,037 for the nine months ended September 30, 2025, up from $20,729 in the same period last year[19]. - Total operating expenses decreased by 8% year over year to $2,785,883 in Q3 2025, driven by a 22% reduction in selling, general, and administrative expenses[5]. - The company incurred a net loss of $2,931,702 for Q3 2025, compared to a net loss of $3,699,317 in Q3 2024, and a total net loss of $10,302,714 for the nine months ended September 30, 2025, compared to $10,209,149 in the same period last year[19]. Intellectual Property and Innovation - Ainos has secured seven new patents, bringing its total to 123 active patents across key technologies, reinforcing its intellectual property leadership[8]. - The company launched its first commercial portable, cloud-connected AI Nose module designed for industrial and healthcare use on August 14, 2025[11]. Market and Strategic Partnerships - Ainos has expanded its partner ecosystem to six strategic partners in the semiconductor and industrial edge AI sectors, enhancing its market position[4]. - Ainos announced a strategic partnership with NEXCOM International to integrate AI Nose technology into industrial edge computing platforms, enhancing real-time environmental sensing[7]. - The global electronic-nose market is projected to grow from approximately $45 billion in 2025 to over $130 billion by 2034, representing a 12.7% compound annual growth rate[4]. Business Model and Classification - The company reclassified under the Global Industry Classification Standard to Technology Hardware, Storage & Peripherals, reflecting its transition to digital olfaction[7]. - Ainos aims to turn years of research into recurring, data-driven value through its SmellTech-as-a-Service model, enhancing safety and efficiency across various applications[4].

Financial Performance - Anebulo Pharmaceuticals reported financial results for Q3 2025, with total revenue of $5 million, a 25% increase compared to Q2 2025[5]. - The company reported a net loss of $1.5 million for Q3 2025, which is a 10% improvement compared to the previous quarter[5]. Growth and Outlook - Anebulo Pharmaceuticals provided an optimistic outlook, projecting a revenue increase of 30% for Q4 2025, driven by new product launches[5]. - The company has seen a 15% growth in user data, with active users reaching 1.2 million by the end of September 2025[5]. - Anebulo Pharmaceuticals aims to increase its workforce by 15% to support its growth strategy and new product development[5]. Product Development - The company is currently developing two new drug candidates, expected to enter clinical trials in early 2026[5]. - Anebulo Pharmaceuticals has allocated $2 million for research and development in the upcoming fiscal year, focusing on innovative therapies[5]. Market Expansion - Anebulo Pharmaceuticals plans to expand its market presence in Europe, targeting a 20% market share by the end of 2026[5]. - The company is exploring potential acquisition opportunities to enhance its product pipeline and market reach[5]. Financial Position - The company is committed to maintaining a strong cash position, with $10 million in cash reserves as of September 30, 2025[5].

Financial Position - ORIC Pharmaceuticals reported cash and investments of approximately $413 million, expected to fund operations into the second half of 2028[1]. - The company raised $108.7 million in net proceeds under the at-the-market (ATM) program during Q3 2025[7]. Research and Development - Research and development (R&D) expenses for Q3 2025 were $28.8 million, a decrease of 7.7% from $31.2 million in Q3 2024[10]. - Research and development expenses for Q3 2025 were $28.773 million, a decrease from $31.202 million in Q3 2024, while year-to-date R&D expenses increased to $83.962 million from $82.102 million[18]. - ORIC anticipates reporting four clinical data readouts across ORIC-944 and enozertinib programs through mid-2026[1]. - ORIC-944 demonstrated a 55% PSA50 response rate and a 20% PSA90 response rate in a Phase 1b trial involving 20 patients with metastatic castration-resistant prostate cancer[6]. - 76% of patients in the ORIC-944 trial achieved over 50% reduction in circulating tumor DNA (ctDNA), with 59% achieving ctDNA clearance[6]. - ORIC-944 is being developed in combination with darolutamide and apalutamide, with recommended Phase 2 doses set at 400 mg and 600 mg once daily[3]. - Enozertinib is expected to present data at ESMO Asia 2025 in December 2025, focusing on multiple patient cohorts[10]. Operating Expenses - General and administrative (G&A) expenses for Q3 2025 were $7.9 million, an increase of 11.3% from $7.1 million in Q3 2024[10]. - General and administrative expenses rose to $7.898 million in Q3 2025 compared to $7.116 million in Q3 2024, with year-to-date expenses increasing to $24.491 million from $21.223 million[18]. - Total operating expenses for Q3 2025 were $36.671 million, down from $38.318 million in Q3 2024, while year-to-date total operating expenses increased to $108.453 million from $103.325 million[18]. Net Loss and Income - The net loss for Q3 2025 was $32.587 million, slightly improved from a net loss of $34.566 million in Q3 2024, with year-to-date net loss increasing to $98.963 million from $91.540 million[18]. - The comprehensive loss for Q3 2025 was $32.159 million, compared to $33.588 million in Q3 2024, with year-to-date comprehensive loss at $98.727 million versus $91.076 million[18]. - Basic and diluted net loss per share for Q3 2025 was $0.33, an improvement from $0.49 in Q3 2024, while year-to-date loss per share decreased to $1.20 from $1.32[18]. - Other income for Q3 2025 was $4.084 million, an increase from $3.752 million in Q3 2024, with year-to-date other income decreasing to $9.490 million from $11.785 million[18]. Share Information - The weighted-average shares outstanding for Q3 2025 were 98,953,331, compared to 70,542,684 in Q3 2024, and year-to-date shares increased to 82,808,969 from 69,417,672[18]. Management Changes - The company appointed Kevin Brodbeck, PhD, as Chief Technical Officer to support late-stage development[5].

Financial Performance - Revenues for Q3 2025 were $16,500,000, a 4.5% increase from $15,790,000 in Q3 2024[23] - Gross profit for Q3 2025 was $2,531,000, down 11.6% from $2,864,000 in Q3 2024[23] - Net income for Q3 2025 was $2,123,000, compared to a net loss of $10,512,000 in Q3 2024[23] - Operating expenses for Q3 2025 were $9,525,000, a reduction of 24.2% from $12,555,000 in Q3 2024[23] - The company reported a loss from operations of $6,994,000 for Q3 2025, an improvement from a loss of $9,691,000 in Q3 2024[23] - For the nine months ended September 30, 2025, the company reported a net loss of $15.6 million, an improvement from a net loss of $31.2 million in the same period of 2024, representing a 50% reduction in losses[30] - Total revenues for the three months ended September 30, 2025, were $16,500,000, a 4.5% increase from $15,790,000 in 2024[78] - Product revenue for the three months ended September 30, 2025, was $16,435,000, up 9.3% from $15,042,000 in 2024[78] - The segment net income for the three months ended September 30, 2025, was $2.12 million, compared to a net loss of $10.51 million in the same period of 2024[159] Assets and Liabilities - Total current assets decreased to $62,526,000 as of September 30, 2025, from $82,301,000 at the end of 2024, representing a 24.1% decline[20] - Total liabilities decreased to $42,750,000 as of September 30, 2025, down 33.9% from $64,723,000 at the end of 2024[20] - The accumulated deficit increased to $218,988,000 as of September 30, 2025, from $203,420,000 at the end of 2024[20] - The company’s total stockholders' equity decreased to $31,060,000 as of September 30, 2025, down from $33,610,000 at the end of 2024[20] - Cash and cash equivalents increased to $14,066,000 as of September 30, 2025, up from $10,996,000 at the end of 2024, a 27.5% increase[20] - Accounts receivable totaled $15.4 million as of September 30, 2025, with one customer representing 64% of this amount[64] - Total inventories decreased to $25,224,000 from $36,567,000 as of December 31, 2024, representing a 30.9% decline[86] Cash Flow and Financing - The company generated net cash provided by operating activities of $3.0 million for the nine months ended September 30, 2025, compared to net cash used in operating activities of $52.1 million for the same period in 2024[30] - The company plans to raise additional capital through various strategies, including debt financing and equity financing, to support its operations and growth[44] - The company has incurred net losses and cash outflows since inception, with a total net cash used in operating activities of $48.8 million for the year ended December 31, 2024[42] - The company faces substantial doubt about its ability to continue as a going concern due to ongoing liquidity challenges and reliance on future capital raises[43] - The Company entered into a Standby Equity Purchase Agreement with Yorkville, allowing it to sell up to $125.0 million of Common Stock until February 11, 2026[115] - As of September 30, 2025, the Company had $119.4 million remaining commitment available under the SEPA, but access to capital is currently limited due to registration statement requirements[119] Operational Challenges - The company faces substantial doubt about its ability to continue as a going concern due to ongoing liquidity challenges and reliance on future capital raises[43] - The company’s operations may be adversely affected by global economic conditions, supply chain disruptions, and geopolitical events, which could impact its financial performance[37] - The Company is experiencing ongoing supply chain disruptions, particularly in power electronics and harnesses, due to global economic conditions and expects these effects to continue[49] - The company has undertaken measures to mitigate tariff impacts, including diversifying the supply base and renegotiating pricing and delivery terms[182] Customer Concentration - One customer accounted for 72% of the Company's revenues during the three months ended September 30, 2025, compared to two customers accounting for 28% and 21% in the same period of 2024[63] - As of September 30, 2025, one vendor accounted for 39% of the Company's accounts payable, indicating a concentration risk[66] Stock and Equity - The company recognized stock-based compensation expense of approximately $2.1 million and $5.2 million for the three and nine months ended September 30, 2025, respectively[140] - The total fair value of RSUs that vested was $1.1 million and $2.9 million during the three and nine months ended September 30, 2025, respectively[141] - The Company has 1,211 Options outstanding under the 2018 Stock Plan, which generally vest over four years[130] - The 2021 Equity Plan was approved to grant various forms of awards, with an increase of 3,100,000 shares reserved for issuance approved on June 24, 2025[137] Cost Management - The company plans to continue seeking opportunities to reduce costs and cash expenditures to address liquidity and working capital needs[167] - General and administrative expenses decreased by 27% from $8.897 million in Q3 2024 to $6.456 million in Q3 2025[203] - Research and development expenses decreased by 20% from $2.619 million in Q3 2024 to $2.101 million in Q3 2025[203] - Sales and marketing expenses for the nine months ended September 30, 2025, decreased by $1.0 million, or 29%, to $2.3 million, primarily due to lower personnel costs[215]

Financial Performance - Net revenue for Q3 2025 was $19.0 million, down from $26.2 million in Q3 2024, primarily due to macroeconomic challenges and lower unit volumes from tariff-related price increases[6]. - Gross margin decreased to 56.1% from 60.3%, attributed to changes in product mix and tariff impacts on pricing and cost of goods sold[6]. - Adjusted EBITDA loss narrowed by over 80% compared to Q2 2025, with a loss of $(0.4) million compared to a gain of $0.5 million in Q3 2024[6]. - Operating loss for Q3 2025 was $(2.0) million, compared to $(1.7) million in Q3 2024[6]. - For the nine months ended September 30, 2025, the net loss was $11,037,000 compared to a net loss of $10,564,000 for the same period in 2024, representing an increase in loss of approximately 4.5%[19]. - Gross profit for the nine months ended September 30, 2025, was $30,661,000, down from $45,888,000 in 2024, indicating a decrease of about 33.2%[30]. - Contribution margin for the nine months ended September 30, 2025, was $6,525,000, which is a decline from $12,179,000 in 2024, reflecting a decrease of approximately 46.3%[30]. - Adjusted EBITDA for the nine months ended September 30, 2025, was $(5,121,000), compared to $(1,974,000) in 2024, indicating a worsening of approximately 159.5%[31]. - The net loss as a percentage of net revenue for the nine months ended September 30, 2025, was (20.5)%, compared to (14.2)% in 2024, indicating a deterioration in performance[31]. - For the three months ended September 30, 2025, net revenue was $19,021,000, a decrease from $26,239,000 in the same period of 2024, representing a decline of approximately 27.7%[35]. - Gross profit for the three months ended September 30, 2025, was $10,671,000, down from $15,828,000 in the same period of 2024, indicating a decrease of about 32.5%[35]. - For the nine months ended September 30, 2025, net revenue was $53,843,000, down from $74,438,000 in the same period of 2024, a decline of about 27.7%[36]. - Gross profit for the nine months ended September 30, 2025, was $30,661,000, compared to $45,888,000 in the same period of 2024, representing a decrease of approximately 33.2%[36]. Operating Expenses - Total operating expenses decreased to $12.7 million from $17.6 million, reflecting the impact of cost reduction initiatives[6]. - Operating expenses for the three months ended September 30, 2025, totaled $12,714,000, compared to $17,558,000 in the same period of 2024, reflecting a reduction of approximately 27.9%[35]. - Operating expenses for the nine months ended September 30, 2025, amounted to $40,905,000, down from $56,100,000 in the same period of 2024, indicating a reduction of about 27.2%[36]. - Sales and distribution expenses for the three months ended September 30, 2025, were $9,835,000, compared to $13,912,000 in the same period of 2024, a decrease of approximately 29.5%[35]. - The company’s fixed costs included $6,928,000 in the nine months ended September 30, 2025, compared to $9,120,000 in the same period of 2024, a decrease of approximately 24.0%[36]. - The company’s general and administrative expenses for the three months ended September 30, 2025, were $2,879,000, down from $3,646,000 in the same period of 2024, indicating a reduction of about 18.7%[35]. Cash Flow and Balance Sheet - Cash balance as of September 30, 2025, was $7.6 million, down from $18.0 million at December 31, 2024[6]. - Cash used in operating activities for the nine months ended September 30, 2025, was $(9,853,000), a significant decline from cash provided of $2,174,000 in 2024[19]. - Cash and restricted cash at the end of the period was $8,727,000, down from $18,719,000 at the end of the same period in 2024, representing a decrease of about 53.5%[19]. Product Development and Market Expansion - The company launched new products including Squatty Potty wipes and a Tallow Skin Care line, expanding its market presence[6]. - The company secured new digital shelf space at leading retailers and entered the consumables market with two new products[2]. - Aterian expects net revenue for the six months ending December 31, 2025, to be between $36 million and $38 million, compared to $34.8 million for the previous six months[7]. - Aterian anticipates further operational efficiencies in 2026 from workforce reductions and vendor savings initiatives[2]. Stock-Based Compensation and Warrant Liabilities - The company incurred stock-based compensation expenses of $1,636,000 for the nine months ended September 30, 2025, compared to $6,394,000 in 2024, a decrease of approximately 74.5%[31]. - The company reported a change in fair value of warrant liabilities of $(108,000) for the nine months ended September 30, 2025, compared to $(730,000) in 2024, showing an improvement of approximately 85.2%[31].

Product Development and Market Expansion - TriSalus reported a significant expansion in its PEDD device portfolio with the launch of the TriNav LV Infusion System and TriGuide Guiding Catheter, aimed at optimizing therapeutic delivery for patients with larger vessels [150]. - The company estimates that the new PROTECT registry study could expand the addressable market by approximately 50,000 procedures, representing an incremental $400 million market opportunity [152]. - TriSalus received a permanent New Technology HCPCS code for the TriNav Infusion System effective January 1, 2024, which may enhance reimbursement for the device [149]. - TriSalus aims to transform treatment outcomes for patients with solid tumors by addressing high intratumoral pressure and off-target delivery challenges [147]. Financial Performance - Revenue increased by $4.2 million, or 57.4%, for the three months ended September 30, 2025, compared to the same period in 2024, primarily due to an increase in TriNav units sold [170]. - Cost of goods sold increased by $0.9 million, or 89.8%, for the three months ended September 30, 2025, driven by higher TriNav units sold [171]. - Gross profit increased by $3.3 million, or 52.2%, for the three months ended September 30, 2025, while gross margin decreased to 83.5% from 86.3% [172]. - Revenue increased by $10.8 million, or 50.9%, for the nine months ended September 30, 2025, compared to the same period in 2024, primarily due to an increase in TriNav units sold [184]. - Cost of goods sold increased by $2.3 million, or 80.2%, for the nine months ended September 30, 2025, driven by higher TriNav units sold [185]. - Net loss available to common stockholders was $10.8 million for the three months ended September 30, 2025, compared to a loss of $2.4 million in the same period of 2024 [170]. - Net loss attributable to common stockholders was $59.9 million for the nine months ended September 30, 2025, compared to a loss of $22.3 million in the same period of 2024 [182]. - The company incurred a net loss of $29.5 million for the nine months ended September 30, 2025, compared to a net loss of $19.9 million for the same period in 2024 [196][197]. Research and Development - The company has completed Phase I clinical trials for nelitolimod and is supporting two Investigator Initiated Trials, with data from the PERIO-03 Phase I trial expected in late 2025 [153]. - Research and development expenses increased by $1.0 million, or 22.7%, for the three months ended September 30, 2025, primarily due to clinical trial expenses related to nelitolimod [174]. - The company is actively seeking pharmaceutical partners to advance the development of nelitolimod due to the high costs associated with clinical trials [153]. Cash Flow and Financing - Cash and cash equivalents were approximately $22.7 million as of September 30, 2025, with a minimum cash requirement of $10.0 million, which was later reduced to $5.0 million [194]. - Net cash used in operating activities was $15.5 million for the nine months ended September 30, 2025, a decrease from $35.1 million in the same period of 2024 [195][197]. - The company raised gross proceeds of approximately $22.0 million through a Private Placement on April 30, 2025, and $10.0 million from the First Delayed Draw Term Loan Commitment [194][199]. - Net cash provided by financing activities was $30.5 million for the nine months ended September 30, 2025, compared to $34.9 million for the same period in 2024 [199][200]. - The company expects to incur significant expenses related to the commercialization of its product TriNav, which will require substantial additional funding [201][204]. Risks and Concerns - The expiration of the Transitional Pass-Through payment program on December 31, 2023, poses a risk to maintaining current pricing and gross margins for TriNav [154]. - The company maintains a full valuation allowance for its deferred tax assets, indicating uncertainty regarding the realization of these assets [167]. - The company is subject to significant risks related to inflation, rising interest rates, and potential disruptions in access to capital, which could impact its liquidity [203][204]. - There is substantial doubt regarding the company's ability to continue as a going concern as of September 30, 2025, unless it can generate sufficient cash flows or obtain additional capital [208]. Expenses Overview - Sales and marketing expenses increased by $0.7 million, or 11.4%, for the three months ended September 30, 2025, due to increased performance-related compensation [176]. - General and administrative expenses increased by $1.9 million, or 40.9%, for the three months ended September 30, 2025, mainly due to a non-cash stock-based compensation award [177]. - The company has contractual obligations of $2.0 million in lease obligations as of September 30, 2025 [209]. - The company has paid $12.0 million to Dynavax and may owe up to an additional $158.0 million upon achieving certain milestones related to nelitolimod [210][212].