Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended: December 31, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to _____________ Commission File No. 000-41092 FIREFLY NEUROSCIENCE, INC. (Exact name of registrant as specified in its charter) Delaw ...

Core Insights - Firefly Neuroscience, Inc. has successfully raised $8,824,710 through the exercise of warrants, significantly enhancing its cash position and extending its cash runway into mid-2026 [1][3] - The funds will be allocated for general working capital and to support the strategic initiative of developing a foundation model of the human brain using its FDA-cleared Brain Network Analytics (BNA™) technology [2][3] Company Overview - Firefly is an AI company focused on improving brain health outcomes for patients with neurological and mental disorders, utilizing its FDA-cleared BNA™ technology [3][4] - The BNA™ technology is based on a proprietary database of over 17,000 patients' high-definition longitudinal electroencephalograms (EEGs), enabling comprehensive insights into brain function for better diagnosis and treatment of mental and cognitive disorders [4] Strategic Initiatives - The company is launching BNA™ commercially, targeting pharmaceutical companies involved in drug research and clinical trials, as well as medical practitioners for clinical applications [3][4]

Core Insights - Firefly Neuroscience, Inc. has been accepted into the NVIDIA Connect program, which will provide technical resources to enhance its FDA-cleared BNA™ platform [1][2][3] - The company aims to develop the world's first foundation model of the human brain using its BNA™ technology, which utilizes Resting EEG and Cognitive EEG data [1][4] Company Overview - Firefly is an AI company focused on improving brain health outcomes for patients with neurological and mental disorders, with its BNA™ technology revolutionizing diagnostic and treatment monitoring methods [5] - The company has built a comprehensive database of brain wave tests over the past 15 years, secured patent protection, and achieved FDA clearance for its BNA™ technology [5][6] Technology and Development - The BNA™ technology was developed using AI and machine learning on a proprietary database of high-definition longitudinal EEGs from over 17,000 patients, covering twelve disorders [6] - This technology provides clinicians with insights into brain function, enhancing their ability to diagnose mental and cognitive disorders and optimize patient outcomes [6]

Core Insights - Firefly Neuroscience, Inc. is recognized for its innovative solutions aimed at improving brain health outcomes for patients with neurological and mental disorders [5] - Dr. Christopher Wilson has been awarded the Faculty Research Excellence Award by the University of Waterloo for his significant contributions to research and scholarship [1][4] - The company is preparing to unveil a new brain model initiative, which Dr. Wilson is collaborating on [4] Company Overview - Firefly is an AI company focused on developing solutions that enhance brain health outcomes, particularly for conditions like depression, dementia, anxiety disorders, concussions, and ADHD [5] - The company has developed the FDA-510(k) cleared Brain Network Analytics (BNA™) technology, which revolutionizes diagnostic and treatment monitoring methods [5] - Firefly has built a comprehensive database of brain wave tests over the past 15 years, securing patent protection and achieving FDA clearance for its technologies [5] Research and Development - Dr. Wilson's research involves superconducting quantum electronics and has secured $13 million in funding from various agencies [2] - He has supervised over 40 research associates and students, contributing to more than 100 refereed publications, with 30 high-impact publications featuring students or postdocs as first authors [3] - His textbook, "Building Quantum Computers," was published in 2024, co-authored with notable figures in the field [3] Technology and Applications - BNA™ utilizes AI and machine learning on a proprietary database of standardized, high-definition longitudinal electroencephalograms (EEGs) from over 17,000 patients [6] - This technology provides clinicians with insights into brain function, enhancing their ability to diagnose and evaluate therapies for mental and cognitive disorders [6]

Core Insights - Firefly Neuroscience, Inc. is leveraging its FDA-cleared BNA™ platform to provide objective measures of drug efficacy and cognitive change, positioning itself as a leader in neuropharmacology and psychiatry [1][6] Study Summaries Study 1: Advancing Neuropharmacology with Novartis' MIJ821 - The first study focuses on MIJ821 (onfasprodil) and demonstrates the use of EEG in assessing its antidepressant effects, highlighting the drug's safety, pharmacokinetics, and pharmacodynamics [2][4] - Key findings indicate dose-dependent EEG changes, validating EEG as a pharmacokinetic-pharmacodynamic tool, and suggesting clinical potential for EEG-driven biomarker development [8] Study 2: Objective Cognitive Assessments in Major Depressive Disorder (MDD) Treatment - The second study evaluates an EEG-based tool for assessing cognitive changes in MDD patients treated with vortioxetine, showcasing the application of EEG in monitoring treatment efficacy [4][9] - Findings reveal that baseline brain activation latencies in MDD patients normalized post-treatment, indicating improved cognitive functioning [9] Company Overview - Firefly is an AI company focused on improving brain health outcomes for patients with neurological and mental disorders, with its BNA™ technology revolutionizing diagnostic and treatment monitoring methods [7][11] - The company has developed its BNA™ technology using AI and machine learning on a comprehensive database of over 17,000 patients, enhancing diagnostic accuracy and treatment evaluation [11]

U.S. Stock Market Performance - U.S. stocks traded lower, with the Nasdaq Composite falling more than 100 points on Tuesday [1] - The Dow decreased by 0.21% to 42,216.81, the NASDAQ fell 0.55% to 18,982.63, and the S&P 500 dropped 0.39% to 5,813.49 [1] - Consumer discretionary shares rose by 1.3%, while health care shares tumbled by 1% [1] Producer Prices - U.S. producer prices rose 0.2% month-over-month in December, down from 0.4% in November and below market estimates of 0.3% [2][8] Commodity Market - Oil traded down 1% to $78.07, while gold decreased by 0.1% to $2,677.50 [5] - Silver and copper both rose by 0.1%, with silver at $30.345 and copper at $4.3290 [5] European Market Performance - European shares were mostly higher, with the eurozone's STOXX 600 rising 0.08%, Germany's DAX 40 gaining 0.69%, and France's CAC 40 increasing by 0.50% [6] Asian Market Performance - Asian markets closed mixed, with Japan's Nikkei 225 falling 1.83%, while China's Shanghai Composite Index jumped 2.54% [7] Notable Company Stock Movements - Firefly Neuroscience, Inc. shares surged 141% to $4.5810 after announcing advancements in brain age assessment technology [9] - Nature's Miracle Holding Inc. shares increased by 177% to $3.13 following a Securities Purchase Agreement [9] - H&E Equipment Services, Inc. shares rose 106% to $90.46 after United Rentals announced an acquisition for $92 per share [9] - Phio Pharmaceuticals Corp. shares dropped 40% to $3.98 after announcing a registered direct offering [9] - Signet Jewelers Limited shares fell 20% to $59.08 due to a drop in same-store sales and lowered guidance [9] - Mustang Bio, Inc. shares decreased by 31% to $0.1534 after announcing a reverse stock split [9]

Company Overview - Firefly Neuroscience Inc is an AI company focused on developing innovative solutions to improve brain health outcomes for patients with neurological and mental disorders [5] - The company's FDA-cleared Brain Network Analytics (BNA™) technology revolutionizes diagnostic and treatment monitoring methods for conditions such as depression, dementia, anxiety disorders, concussions, and ADHD [5] - Firefly has built a comprehensive database of brain wave tests over 15 years, securing patent protection and achieving FDA clearance [5] - The company is now commercially launching BNA™, targeting pharmaceutical companies engaged in drug research and clinical trials, as well as medical practitioners for clinical use [5] Technology Innovation - Firefly's BNA™ technology platform utilizes Resting EEG and Cognitive EEG (ERP) data to assess patients' brain age, marking the first instance where cognitive data measured by ERP has been successfully utilized for assessing biological brain age [2] - The BNA™ system was developed using AI and machine learning on Firefly's extensive proprietary database of standardized, high-definition longitudinal EEGs of over 17,000 patients representing twelve disorders, as well as clinically normal patients [8] - BNA™, in conjunction with an FDA-cleared EEG system, provides clinicians with comprehensive insights into brain function, enhancing their ability to accurately diagnose mental and cognitive disorders and evaluate optimal therapies [8] Research Advancement - Firefly announced the advancement of research to assess a patient's brain age via its FDA-cleared BNA™ technology platform, potentially paving the way for a proactive and scalable approach to early screening and monitoring for Alzheimer's patients [1] - The BNA™ data assessment can identify significant disparities between brain age and chronological age, which could serve as a valuable risk factor for dementia [2] - This breakthrough underscores the company's commitment to pushing the boundaries of innovation in brain health, aiming to make a meaningful impact on patients' lives [2]

Financial Results - Firefly Neuroscience, Inc. reported financial results for Q3 2024, ending September 30, 2024[4]. - The financial results include key metrics that will be detailed in the press release, which is referenced as Exhibit 99.1[4]. Compliance and Regulations - The report is filed under Form 8-K, indicating compliance with the Securities Exchange Act of 1934[5]. - The company is not classified as an emerging growth company under the relevant regulations[3]. - The financial results and updates are not deemed "filed" under the Exchange Act, limiting liability under Section 18[5]. Company Information - The trading symbol for Firefly Neuroscience, Inc. is AIFF, listed on the Nasdaq Capital Market[2]. - The company’s principal executive offices are located at 1100 Military Road, Kenmore, NY 14217[1]. - Jon Olsen serves as the Chief Executive Officer, signing the report on November 14, 2024[7]. Press Release - The company issued a press release on November 14, 2024, detailing its stockholder update[4]. - The report includes an Interactive Data File formatted as Inline XBRL as part of its exhibits[6].

Core Viewpoint - Firefly Neuroscience, Inc. has successfully listed on Nasdaq under the symbol "AIFF" and is focused on improving brain health outcomes through innovative AI solutions for neurological and mental disorders [1][5]. Company Overview - Firefly is dedicated to enhancing outcomes for individuals with brain health issues by providing objective measurements of brain activity [2]. - The company has developed FDA-cleared Brain Network Analytics (BNA™) technology, which aims to revolutionize diagnostic and treatment monitoring methods for conditions such as depression, dementia, anxiety disorders, concussions, and ADHD [5][6]. Strategic Partnerships - Firefly is pursuing a dual go-to-market strategy by partnering with neuroscience pharmaceutical companies and supporting US neurologists [3]. - Collaborations with notable pharmaceutical companies such as Bright Minds, Novartis, and Takeda are expected to accelerate growth and enhance capabilities [3]. Recent Developments - In Q3 2024, Firefly announced several key collaborations, including a partnership with Bright Minds Bioscience for a Phase 2 trial of BMB-101 and the use of BNA™ technology in Arrivo BioVentures' Phase 1 study of SP-624 [4]. - The company has integrated BNA™ technology at Neurology Consultants of Dallas to improve early detection and disease management for cognitive disorders [4]. Financial Highlights - As of September 30, 2024, Firefly reported cash reserves of $1.2 million and had 8,503,365 shares of common stock outstanding as of November 12, 2024 [4].

Financial Performance - Revenue for the three months ended September 30, 2024, was $33,000, up 43% from $23,000 in the same period of 2023[13] - Operating loss for the nine months ended September 30, 2024, was $6,675,000, compared to a loss of $1,526,000 for the same period in 2023, indicating a significant increase in losses[13] - Net loss for the three months ended September 30, 2024, was $4,289,000, compared to a loss of $650,000 in the same period of 2023, representing a 558% increase in losses[13] - Basic and diluted loss per share for the three months ended September 30, 2024, was $(0.61), compared to $(0.18) for the same period in 2023[13] - For the nine months ended September 30, 2024, Firefly Neuroscience reported a net loss of $6,675,000, compared to a net loss of $1,526,000 for the same period in 2023, representing a significant increase in losses[18] - The net loss for the period ending September 30, 2024, is $(6,675,000), compared to a net loss of $(1,526,000) for the same period in 2023[15] - Total operating expenses for the three months ended September 30, 2024, were $4,301,000, up from $670,000 in the same period of 2023, indicating a significant increase of 541.6%[13] Assets and Liabilities - Total assets increased to $5,311,000 as of September 30, 2024, compared to $2,641,000 as of December 31, 2023, representing a growth of 101%[9] - Cash decreased to $1,230,000 as of September 30, 2024, from $2,143,000 as of December 31, 2023, a decline of 43%[9] - Total current liabilities remained stable at $2,535,000 as of September 30, 2024, compared to $2,532,000 as of December 31, 2023[9] - The company reported an accumulated deficit of $83,299,000 as of September 30, 2024, compared to $76,624,000 as of December 31, 2023[10] Expenses - Research and development expenses rose to $1,517,000 for the nine months ended September 30, 2024, compared to $712,000 in the same period of 2023, reflecting a 113% increase[13] - Selling and marketing expenses increased to $973,000 for the nine months ended September 30, 2024, compared to $399,000 in the same period of 2023, a rise of 144%[13] - General and administration expenses for the three months ended September 30, 2024, were $2,992,000, an increase of $2,809,000 or 1535% from $183,000 in the same period of 2023[13] Cash Flow - The company experienced negative cash flow from operating activities of $4,937,000 for the nine months ended September 30, 2024, compared to $1,662,000 for the same period in 2023, indicating a worsening cash burn situation[29] - Net cash used in investing activities for the nine months ended September 30, 2024, was $401,000, compared to no cash used in the same period in 2023, primarily due to investments in the next generation of the BNA Platform[138] - Net cash provided from financing activities was $4,425,000 for the nine months ended September 30, 2024, representing an increase of $1,928,000 or 77% compared to $2,497,000 for the same period in 2023, mainly due to secured private financing related to the Merger[140] Shareholder Equity - Total shareholders' equity increased to $2,776,000 as of September 30, 2024, from $109,000 as of December 31, 2023[10] - The number of shares outstanding as of September 30, 2024, is 8,476,202[15] - The weighted average number of shares outstanding for basic and diluted was 7,080,897 as of September 30, 2024, compared to 3,678,906 for the same period in 2023, reflecting an increase of 92.5%[13] Mergers and Acquisitions - The merger with WaveDancer, completed on August 12, 2024, was treated as a reverse recapitalization, with Private Firefly deemed the accounting acquirer[25] - Following the merger, there were 7,472,555 shares of the New Firefly Common Stock outstanding as of August 12, 2024[27] - The merger between Private Firefly and WaveDancer was completed on August 12, 2024, with Private Firefly being treated as the accounting acquirer[39] Future Outlook - The company expects to continue incurring negative cash flows from operations over the next 12 months while investing in sales, marketing, and research and development[131] - The company anticipates significant costs for at least two to four years to commercialize and distribute its flagship product, the BNA Platform, requiring substantial capital to support ongoing operations[132] - Firefly Neuroscience is focused on negotiating further funding with existing and new investors to raise additional capital and has implemented cost control measures to reduce operational cash burn[29] - The company aims to commercialize its products to generate recurring sales as part of its strategy to strengthen liquidity[29] Product Development - Firefly Neuroscience's Brain Network Analytics (BNA) product received FDA clearance for marketing in the USA in July 2014 and CE approval for use in the European Union in September 2014, indicating ongoing product development and market presence[22] - The BNA Platform, developed over 15 years with an investment of approximately $60 million, aims to improve brain health outcomes for patients with mental illnesses and neurological disorders[105] - The BNA Platform is expected to be commercially launched in the first half of 2025, with no material additional development costs anticipated[106] - The BNA Platform utilizes AI and a proprietary database of over 17,000 patients to enhance diagnostic capabilities for mental illnesses and cognitive disorders[105]