FIREFLY NEUROSCIENCE, INC.

Firefly Neuroscience, Inc. is an artificial intelligence company advancing precision neuroscience, applying AI and large-scale electrophysiological data to give clinicians a more complete, objective picture of how an individual patient's brain is functioning. The company operates in the brain health diagnostics market, which includes traditional EEG hardware manufacturers, digital health companies offering neurology-focused software, and academic medical centers with research-grade electrophysiological assessment capabilities. The filing describes four structural problems defining the current state of brain health diagnostics: adding electrophysiological insight to existing assessments, population-level context at the point of care, late detection of cognitive and neurological disease, and imprecise treatment selection.

The filing does not name specific primary competitors but describes the competitive landscape as including traditional EEG hardware manufacturers, digital health companies, and academic medical centers. The company believes the most significant long-term competitive determinant will be the depth and quality of the proprietary electrophysiological dataset underlying AI-driven analytics, and on this dimension management believes it holds a substantial and growing advantage. The company's competitive advantages include its FDA-cleared hardware platform deployed across more than 85 clinical sites, its intellectual property portfolio of 23 issued U.S. patents ¹, and its growing body of more than 20 peer-reviewed publications.

The company generates revenue through a tiered subscription model where clinics pay a monthly subscription fee that provides access to the Evoke System, a defined volume of assessments per month, and access to the analytics and reporting platform. Assessments performed in excess of the monthly allotment are billed at a per-scan overage rate, creating a recurring revenue stream that scales with clinical utilization. Revenue also includes per-use fees, equipment sales, equipment rentals, and the undertaking of projects and/or clinical studies and other related services. The company plans to generate revenue through two segments: through the use of its products by healthcare professionals in the United States and through collaborations with pharmaceutical companies in support of neuroscience drug development.

The Evoke System is the company's FDA-510(k) cleared EEG and ERP acquisition hardware and associated software, commercially deployed under the commercial brand name Evoke System. The system captures brain activity using a 19-channel EEG electrode array configured according to the International 10-20 system, incorporating a Heart Rate Variability (HRV) sensor for simultaneous measurement of autonomic nervous system function alongside neural activity. The system captures resting-state EEG and Event-Related Potentials (ERPs), enabling assessment of up to 20 distinct cognitive functional measures per session including early sensory processing, attention, working memory, response inhibition, and executive function. The Evoke System is in active use across more than 85 clinical sites in the United States as of December 31, 2025 ².

The Firefly System combines three interdependent layers: standardized hardware acquisition through the Evoke System, cloud-based electrophysiological analytics, and a growing proprietary data repository. The proprietary database includes more than 191,000 standardized EEG and ERP assessment records ³, spanning over 12 distinct neurological and psychiatric disorders and includes records from more than 100,000 patients ⁴. The database includes records from healthy individuals across the age range of 12 to 85. The analytics engine analyzes raw EEG and ERP signals and compares each patient's electrophysiological profile to a reference dataset, outputting a structured clinical report delivered to the clinician through a cloud-based portal. The company also engages with pharmaceutical companies and academic research institutions that seek access to its electrophysiological database and analytical capabilities in support of neuroscience drug development.

On April 30, 2025, the company completed the acquisition of Evoke Neuroscience Inc., which resulted in the acquisition of the Evoke business and a significant expansion of business operations and headcount. The consideration transferred was approximately $6,000 ⁵ and consists of $3,000 ⁶ in cash and 857,142 ⁷ shares of Common Stock valued at $3.50 per share. During the year ended December 31, 2025, management identified a triggering event for pre-acquisition assets following the strategic decision to discontinue the BNA software platform and Zeto headsets, recognizing impairment losses of $251 ⁸ in total. The company also entered into a warrants cancellation and exchange agreement on December 16, 2025, exchanging June 2025 Warrants to purchase an aggregate of 400,000 shares at $3.50 per share and 400,000 shares at $4.00 per share for New 2025 Warrants to purchase 800,000 shares at $0.50 per share ⁹.

Revenue for the year ended December 31, 2025 was $1,142 ¹⁰, as compared to $108 ¹¹ in the year ended December 31, 2024, representing an increase of $1,034 ¹² or 957%. Net loss and comprehensive loss for the year ended December 31, 2025 was $19,882 ¹³, as compared to $10,460 ¹⁴ for the year ended December 31, 2024. Basic and diluted loss per share was $1.97 ¹⁵ for 2025 versus $1.60 ¹⁶ for 2024. As of December 31, 2025, the company had an accumulated deficit of $111,615 ¹⁷ and negative cash flows from operating activities of $8,194 ¹⁸ for the year ended December 31, 2025.

The company's primary growth vector is the commercial deployment of the Evoke System through its subscription-based commercial model, which creates a recurring revenue stream that scales in lockstep with clinical utilization. The Evoke System is in active use across more than 85 clinical sites in the United States as of December 31, 2025 ¹⁹, and the company expects to continue to incur negative cash flows from operations as it integrates its products and continues to invest in the expansion of its sales organization. The company describes the Firefly Flywheel, where each clinical assessment simultaneously generates revenue and expands the proprietary database, compounding the intelligence of every future report.

The company is actively investing in research to develop and validate electrophysiological biomarkers of treatment response across additional conditions in its clinical footprint. The company's technology and dataset have been the subject of more than 20 peer-reviewed publications in indexed scientific journals, spanning conditions including early-stage Parkinson's disease detection, ADHD endophenotyping and treatment response prediction, major depressive disorder and cognitive biomarkers, traumatic brain injury assessment, drug pharmacodynamics in neuropharmacology trials, and genetic conditions affecting cognitive development. The company also conducts academic research collaborations, including a collaboration with the Institute of Human Genetics at Heidelberg University Hospital on EEG biomarker research in genetic neurodevelopmental conditions, and with the Pacific Neuroscience Institute Brain Center on a clinical study examining the electrophysiological signatures of Alzheimer's disease.The company expects research and development expenses to continue to increase in the future as it further refines and optimizes its products and invests in their evolution. The company expects to incur additional expenses as a result of operating as a public company, including expenses related to compliance with the rules and regulations of the SEC and Nasdaq, additional insurance, investor relations and other administrative expenses and professional services. The company expects to continue to incur negative cash flows from operations for the next 12 months as it integrates its products and continues to invest in the expansion of its sales organization.

The filing does not specify exact R&D spending levels, capital expenditure plans, or share repurchase authorization amounts for the upcoming period. The company has never declared or paid cash dividends on its Common Stock and currently intends to retain all available funds and any future earnings for use in the operation of its business, not anticipating paying any cash dividends in the near future. Subsequent to December 31, 2025, the company raised $150 ²⁰ through warrant exercises and $2,250 ²¹ through a private placement (1,500,000 units at $1.50 per unit), with investors having the right, but not the obligation, to purchase up to an additional $18,000 ²² of units within 30 days of the initial closing. The company also filed a Prospectus Supplement for an at-the-market offering of up to $7,434,266 ²³.

The company faces significant liquidity risks that raise substantial doubt about its ability to continue as a going concern. For the fiscal year ended December 31, 2025, the company had an accumulated deficit of $111,615 ²⁴ and negative cash flows from operating activities of approximately $8,194 ²⁵. The company has generated minimal revenue to date, and its ability to generate recurring revenue depends on the successful commercialization of its products, which remains in the early stages of market adoption. The report of the independent registered public accounting firm for the fiscal year ended December 31, 2025 includes an explanatory paragraph expressing substantial doubt about the company's ability to continue as a going concern.

The company conducts certain of its operations in Israel and has five full-time employees who are located in and/or reside in Israel. The active military conflict involving Iran, Israel and the United States poses immediate and material risks to the company's operations, employees, financial condition and business. The conflict has escalated into an active military war with significant regional and global consequences, including the closure of the Strait of Hormuz. The company also faces risks from tariffs and changes in trade policy, including new or increased tariffs imposed by the U.S. or other governments on imported goods, components, or materials, which could increase costs of goods or disrupt the supply chain.

The company faces significant liquidity risks that raise substantial doubt about its ability to continue as a going concern, with an accumulated deficit of $111,615 ²⁶ and negative cash flows from operating activities of $8,194 ²⁷ for the year ended December 31, 2025. The company has generated minimal revenue to date and its ability to generate recurring revenue depends on the successful commercialization of its products, which remains in the early stages of market adoption. The active military conflict involving Iran, Israel and the United States poses immediate and material risks to the company's operations, as the company has five full-time employees located in Israel and the conflict has escalated into an active military war with significant regional consequences, including the closure of the Strait of Hormuz. The company's subsidiary, Firefly Neuroscience Ltd., has received grants from the Israel Innovation Authority (IIA) in the aggregate amount of approximately $4.60 million ²⁸, and as of December 31, 2025, had a contingent obligation to the IIA (including interest) of $6.043 million ²⁹, with restrictions on manufacturing products and transferring know-how outside of Israel. The company identified material weaknesses in internal control over financial reporting related to not having adequate Information Technology General Controls or related Information Produced by Entity Controls, and lack of segregation of duties.

Management's message emphasizes the company's position as an artificial intelligence company advancing precision neuroscience, applying AI and large-scale electrophysiological data to give clinicians a more complete, objective picture of brain functioning. Management describes the Firefly Platform as a vertically integrated hardware, software, and data infrastructure that captures standardized EEG and ERP assessments at the point of care, analyzes data through a proprietary analytics engine, and delivers structured reports back to the provider. Management's strategic priorities include: (i) the pursuit of additional capital through equity or debt financings; (ii) disciplined operating expense management and integration synergies from the Evoke acquisition; and (iii) targeted commercial expansion to drive recurring revenue. Management has a reasonable expectation that the company can continue raising additional capital, noting that subsequent to December 31, 2025, the company raised $150 ³⁰ of proceeds through the exercise of stock warrants and $2,250 ³¹ as part of a private placement, with investors having the right, but not the obligation, to purchase up to an additional $18,000 ³² of Units in one or more subsequent closings within 30 days of the Initial Closing Date.