Firefly Neuroscience, Inc.(AIFF)

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Firefly Neuroscience, Inc.(AIFF) - 2025 Q1 - Quarterly Report
2025-05-14 10:02
Product Development and Launch - The BNA Platform has been developed using AI and includes a database of over 18,000 patients, focusing on twelve disorders[78] - The company plans to commercially launch the BNA Platform in 2025, with no expected material additional development costs[79] - The company aims to enhance patient outcomes through the BNA Platform by establishing objective baseline measurements of brain function[82] - The company expects to incur significant costs for at least two to four years to commercialize and distribute its flagship product, the BNA Platform[102] Financial Performance - Revenue for the three months ended March 31, 2025, was $43,000, compared to $12,000 for the same period in 2024, representing an increase of $31,000 or 258%[96] - Research and development expenses increased to $312,000 for the three months ended March 31, 2025, from $289,000 in 2024, an increase of $23,000 or 8%[97] - Selling and marketing expenses decreased to $208,000 in Q1 2025 from $249,000 in Q1 2024, a decrease of $41,000 or 16%[98] - General and administration expenses rose significantly to $1,588,000 in Q1 2025 from $565,000 in Q1 2024, an increase of $1,023,000 or 181%[99] - Other income (expense) for the three months ended March 31, 2025, was $(10,865,000), compared to $(31,000) in 2024, representing an increase in expenses of $10,834,000[100] - Net cash used in operating activities was $(2,511,000) for Q1 2025, compared to $(1,319,000) in Q1 2024, an increase of $1,192,000 or 90%[107] - Net cash provided from financing activities was $10,253,000 in Q1 2025, compared to $945,000 in Q1 2024, an increase of $9,308,000 or 985%[109] Acquisitions and Financing - On April 30, 2025, the company acquired Evoke Neuroscience, Inc. for approximately $6 million, consisting of $3 million in cash and 857,149 shares valued at $3.50 each[84] - The company acquired all outstanding stock of Evoke for approximately $6,000,000, consisting of $3,000,000 in cash and 857,142 shares of common stock[101] - The company has no committed source of financing and may not be able to raise funds as needed to continue operations[113] Operational Expenses - Research and development expenses are expected to continue to be the largest component of operating expenses as the company updates and maintains the BNA Platform[88] - Selling and marketing expenses include employee-related costs and consulting fees, which are expected to increase as the company expands its market presence[89] - General and administrative expenses will rise due to compliance with SEC and Nasdaq regulations, as well as other public company-related costs[90] Revenue Generation Strategy - Revenue generation will focus on two segments: use of the BNA Platform by neurologists in the U.S. and collaborations with pharmaceutical companies[87] Capital Raising Activities - A private placement agreement was entered into on March 28, 2025, to issue 547,737 units at a price of $3.00 per unit[86] - The company received total proceeds of $8.825 million from the exercise of warrants to purchase 1,623,530 shares of common stock[85]
Correction From Source: Firefly Neuroscience Achieves Multi-Fold Database, IP Portfolio, and Commercial Footprint Expansion Through Acquisition of Evoke Neuroscience, Inc.
GlobeNewswire News Room· 2025-05-06 01:00
Core Insights - Firefly Neuroscience, Inc. has acquired Evoke Neuroscience, Inc., enhancing its proprietary database, intellectual property portfolio, and commercial footprint significantly [1][2] - The acquisition is expected to facilitate the development of a foundation model of the human brain using Firefly's FDA-cleared Brain Network Analytics (BNA™) technology [1][2] Company Overview - Firefly Neuroscience, Inc. (NASDAQ: AIFF) focuses on developing AI solutions aimed at improving brain health outcomes for patients with neurological and mental disorders [3] - The company has built a comprehensive database of brain wave tests and secured patent protection over the past 15 years, with its BNA™ technology revolutionizing diagnostic methods for various mental health conditions [3][4] Acquisition Details - The acquisition of Evoke Neuroscience will result in a more than two-fold increase in proprietary brain scans, a three-fold increase in patents, and a ten-fold increase in commercial sites [2] - The purchase terms include a total payment of $6 million, split 50% in cash and 50% in Firefly's common stock priced at $3.50 per share, along with a potential earn-out of $500,000 for Evoke's investors [4] Technological Synergies - The combined resources of Firefly and Evoke are expected to create significant technological, clinical, and commercial synergies, enhancing the capabilities of both companies [2] - Firefly's BNA™ technology, developed using AI and machine learning, utilizes a large proprietary database of standardized EEGs to provide comprehensive insights into brain function [4][5] Market Position - Firefly targets pharmaceutical companies involved in drug research and clinical trials, as well as medical practitioners for clinical use, positioning itself as a leader in brain health diagnostics [3][4]
Firefly Neuroscience Achieves Multi-Fold Database, IP Portfolio, and Commercial Footprint Expansion Through Acquisition of Evoke Neuroscience, Inc.
GlobeNewswire· 2025-05-05 11:45
Core Insights - Firefly Neuroscience, Inc. has acquired Evoke Neuroscience, Inc., marking a significant step towards developing a proprietary foundation model of the human brain using its FDA-cleared Brain Network Analytics (BNA™) technology [1][2]. Company Overview - Firefly is an AI company focused on improving brain health outcomes for patients with neurological and mental disorders, utilizing its BNA™ technology for diagnostics and treatment monitoring [3][4]. - The company has built a comprehensive database of brain wave tests and secured patent protection over the past 15 years, now targeting pharmaceutical companies and medical practitioners for commercial use [3]. Acquisition Details - The acquisition of Evoke will enhance Firefly's assets, including a more than two-fold increase in proprietary brain scans, a three-fold increase in patents, and a ten-fold increase in commercial sites [2]. - The purchase terms include a total payment of $6 million, split 50% in cash and 50% in Firefly's common stock priced at $3.50 per share, along with a potential $500,000 earn-out for Evoke's investors based on future revenue performance [5]. Technological Synergies - The integration of Evoke's technologies is expected to create significant technological, clinical, and commercial synergies, enhancing Firefly's capabilities in brain health assessment [2]. - Firefly's BNA™ technology utilizes AI and machine learning on a proprietary database of over 17,000 patients, providing comprehensive insights into brain function and improving diagnostic accuracy for mental and cognitive disorders [4]. Market Position - Firefly possesses the largest known proprietary database of over 180,000 standardized EEG/ERP assessment records and has 27 granted patents, positioning the company strongly in the brain health technology market [5].
Firefly Neuroscience, Inc.(AIFF) - 2024 Q4 - Annual Report
2025-04-03 10:01
Financial Performance - Revenue for the year ended December 31, 2024, was $108,000, a decrease of $390,000 or 76% compared to $498,000 in 2023[380]. - Cash used in operating activities was $6,155,000 in 2024, an increase of $3,983,000 or 183% from $2,172,000 in 2023, attributed to rising operating costs and research expenses[395]. - Net cash provided from financing activities was $6,299,000 in 2024, an increase of $1,656,000 or 36% from $4,643,000 in 2023, primarily due to proceeds from a convertible note[397]. - The company had an accumulated deficit of $87,084,000 as of December 31, 2024, raising substantial doubt about its ability to continue as a going concern[387]. - The company expects to continue incurring negative cash flows from operations over the next 12 months while investing in sales, marketing, and research for the BNA Platform[389]. Capital Raising - The company raised approximately $3.5 million from a private placement prior to the merger with WaveDancer, with the purchase price of each PIPE Share set at $4.25[358]. - A total of $3,039,000 was raised from the private placement of 246,919 Series C units, sold at a combined purchase price of $12.31 per unit[359]. - The company entered into a convertible promissory note agreement for $2,400,000, with a purchase price of $2,040,000, and issued 800,000 shares of common stock upon conversion[360]. - The ELOC Purchase Agreement allows the company to sell up to $10,000,000 of common stock to Arena, providing flexibility in capital raising[361]. - Subsequent to December 31, 2024, the company raised $10.4 million through the exercise of stock warrants and additional sales of common stock[388]. Expenses - Research and development expenses are expected to increase as the company refines the BNA Platform and explores strategic partnerships[370]. - Selling and marketing expenses include employee-related costs and consulting fees, reflecting the company's commitment to market the BNA Platform[371]. - General and administrative expenses will rise due to public company operations, including compliance and investor relations costs[372]. - Research and development expenses increased to $1,954,000 in 2024, up $1,213,000 or 164% from $741,000 in 2023, primarily due to management options vesting related to the Merger[381]. - Selling and marketing expenses rose to $1,201,000 in 2024, an increase of $562,000 or 88% from $639,000 in 2023, driven by professional marketing services and brand awareness initiatives[382]. - General and administration expenses increased to $6,113,000 in 2024, up $3,937,000 or 179% from $2,196,000 in 2023, largely due to costs associated with the Merger[383]. - Impairment of intangible assets was recorded at $874,000 in 2024, compared to $0 in 2023, due to a change in management direction[385]. Business Development - The BNA Platform is in pre-commercial stages, with a planned commercial launch in 2025, targeting revenue generation from U.S. neurologists and pharmaceutical collaborations[353]. - The company plans to generate revenue through BNA testing, equipment rental, and collaborations with pharmaceutical companies for neuroscience drug development[369]. - The company aims to enhance patient outcomes through the BNA Platform by identifying clinically relevant biomarkers and optimizing therapy[356].
Firefly Neuroscience Announces Exercise of Warrants for Total Proceeds of $8.8 Million
GlobeNewswire· 2025-02-21 13:00
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]
Firefly Neuroscience Accepted into NVIDIA Connect Program
GlobeNewswire· 2025-02-11 12:45
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]
Firefly Neuroscience Congratulates Scientific Advisor, Dr. Christopher Wilson, Recipient of Prestigious UW Faculty of Engineering Award for Work on Superconducting Quantum Electronics
GlobeNewswire· 2025-02-07 12:30
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]
Firefly Neuroscience Announces Publications Demonstrating the Utility of Advanced EEG Analytics in Drug Development and Neuropsychiatric Care
GlobeNewswire· 2025-01-24 14:00
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]
Crude Oil Down 1%; Firefly Neuroscience Shares Spike Higher
Benzinga· 2025-01-14 17:25
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]
Firefly Neuroscience Discovers Breakthrough Cognitive Brain Age Biomarker Using its FDA-Cleared BNA™ Platform
GlobeNewswire· 2025-01-14 12:45
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]