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MORRISVILLE, N.C.--( BUSINESS WIRE )-- Arrivo BioVentures today announced positive data from its SP-624-103 study evaluating the impact of SP-624’s novel epigenetic mechanism of action on neurological pathways. The findings provide insights into the potential antidepressant and cognitive effects of SP-624, a SIRT6 activator that may be the first treatment specifically for females with Major Depression based on previous studies. Arrivo’s SP-624-103 study is a double blind, placebo-controlled study with three cohorts. Cohort 1 is comprised of 12 healthy subjects (8 active, 4 placebo) who received 20mg of SP-624 over a 15-day dosing period. Assessments, including quantitative EEG (qEEG) and Firefly Neuroscience’s ( NASDAQ: AIFF ) brain network analytics (BNA™), were performed at Day One and Day 15 pre- and post-dose. Cohort 2 is actively enrolling 12 patients diagnosed with major depressive disorder (MDD). The subject composition of the 3 rd cohort will be determined after the completion of the second cohort. Cohort 1 results of the SP-624-103 study include: Subjects showed an increase in beta power, particularly in the frontal-central regions compared to patients taking placebo after a single dose, suggesting enhanced synaptic plasticity and neuronal connectivity. Subjects showed a decrease in delta power. This is important as increases in delta activity are often associated with reduced cortical arousal and depressive states. Evoked potential response findings suggest enhanced neural efficiency in early perceptual processing and improved decision-making speed and context updating. “ An increase in beta power and decrease in delta power are indicative of enhanced neural synchronization, excitability and cortical activation,” said Arrivo BioVentures Chief Medical Officer Dr. Joel Raskin. “ These findings could be indicative of SP-624’s ability to alleviate depressive symptoms by normalizing cortical activity, potentially improving cognitive processing, attention and cortical arousal, with implications for numerous neuropsychiatric diseases.” “ We are continuing to explore the possibilities with SP-624 and the SIRT6 mechanism of action in this trial along with a Phase 2b/3 study for major depressive disorder that we are currently enrolling,” said Arrivo Chief Executive Officer, Steve Butts. “ The SP-624-103 study provides solid evidence that we have an active drug in the central nervous system and increases our confidence in the potential of SP-624 in MDD and other cognitive disorders.” About Arrivo BioVentures Arrivo is developing first-of-its-kind medicines that target the root cause of hard-to-treat diseases with the goal of achieving meaningful outcomes for patients, allowing them to live longer, healthier lives. Arrivo has two clinical-stage pipeline candidates, SP-624 for major depressive disorder and RABI-767 for predicted severe acute pancreatitis. Arrivo is based in Morrisville, N.C., on the edge of Research Triangle Park. For more information, visit www.arrivobio.com . About Firefly Firefly (NASDAQ: AIFF) is an Artificial Intelligence (“AI”) company developing innovative solutions that improve brain health outcomes for patients with neurological and mental disorders. Firefly’s FDA-510(k) cleared Brain Network Analytics (BNA™) technology revolutionizes diagnostic and treatment monitoring methods for conditions such as depression, dementia, anxiety disorders, concussions, and ADHD. Over the past 15 years, Firefly has built a comprehensive database of brain wave tests, securing patent protection, and achieving FDA clearance. The Company is now launching BNA™ commercially, targeting pharmaceutical companies engaged in drug research and clinical trials, as well as medical practitioners for clinical use. Brain Network Analytics was developed using artificial intelligence and machine learning on Firefly’s extensive proprietary database of standardized, high-definition longitudinal electroencephalograms (EEGs) of over 17,000 patients representing twelve disorders, as well as clinically normal patients. BNA™, in conjunction with an FDA-cleared EEG system, can provide clinicians with comprehensive insights into brain function. These insights can enhance a clinician’s ability to accurately diagnose mental and cognitive disorders and to evaluate what therapy and/or drug is best suited to optimize a patient’s outcome. Please visit https://fireflyneuro.com for more information. *BNA™ is a trademark of Firefly Neuroscience, Inc.

Company successfully listed on Nasdaq under the symbol “AIFF” Partnered with multiple neuroscience pharmaceutical companies, including Bright Minds Bioscience, and neurologists to advance Company’s dual go-to-market strategy TORONTO, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Firefly Neuroscience, Inc. (“Firefly,” “we,” or the “Company”) (NASDAQ: AIFF), an Artificial Intelligence (“AI”) company developing innovative solutions that improve brain health outcomes for patients with neurological and mental disorders, today announced its financial results for the third quarter ended September 30, 2024, and provided a stockholder update. Firefly is dedicated to improving outcomes for people suffering with brain health illnesses by bringing objective measurement of brain activity to the front lines of healthcare. The Company’s go-to-market strategies include both supporting US neurologists in the diagnosis and optimization of patient care for conditions such as dementia, anxiety disorders, concussions, and ADHD, and collaborating with neuroscience pharmaceutical companies to reduce costs and accelerate drug development. “We are deeply committed to executing upon two key strategic pathways to commercialize our FDA-cleared Brain Network Analytics (BNA™) technology. Through partnering with neuroscience pharmaceutical companies and by supporting US neurologists in the diagnosis and optimization of patient care, we are driven to improve outcomes for people suffering from brain health illnesses,” said Jon Olsen, CEO of Firefly. “We are thrilled to be forging strategic partnerships with globally recognized and well-respected pharmaceutical companies such as Bright Minds, Novartis and Takeda, that we believe will accelerate our growth and expand our capabilities, leveraging our proprietary database of over 77,000 EEG scans across twelve disorders. We believe that these collaborations will not only enhance our ability to drive innovations in drug development, but also position us to deliver solutions to neurologists. We are eager to deepen these relationships and harness our technology expertise to unlock new opportunities and achieve meaningful, shared success.” Third Quarter 2024 to Date Operational and Financial Highlights: Announced collaboration with Bright Minds Bioscience on Phase 2 Trial of BMB-101 in absence epilepsy and developmental epileptic encephalopathy for full analysis of EEG dataPartnered with Bright Minds Bioscience to analyze data from first-in-human Phase 1 study of BMB-101Announced use of BNA™ platform in Arrivo BioVentures’ Phase 1 Study of SP-624, the first potential treatment designed for women with major depressive disorderAnnounced advances in AI-driven BNA™ technology in neuroscience drug development after completing successful research collaborations with Takeda Pharmaceutical Company Limited and NovartisPartnered with Zeto, Inc. to deploy BNA™ technology with Zeto's advanced EEG device platformIntegrated BNATM technology at Neurology Consultants of Dallas to enhance early detection efforts and disease management for patients with cognitive disordersAppointed Dr. Stella Vnook to the Board of DirectorsCompleted merger with WaveDancer Inc. and successfully listed on the Nasdaq under the symbol “AIFF”As of September 30, 2024, cash was $1.2 million. As of November 12, 2024, the Company had 8,503,365 shares of common stock outstanding About FireflyFirefly (NASDAQ: AIFF) is an Artificial Intelligence (“AI”) company developing innovative solutions that improve brain health outcomes for patients with neurological and mental disorders. Firefly’s FDA-510(k) cleared Brain Network Analytics (BNA™) technology revolutionizes diagnostic and treatment monitoring methods for conditions such as depression, dementia, anxiety disorders, concussions, and ADHD. Over the past 15 years, Firefly has built a comprehensive database of brain wave tests, securing patent protection, and achieving FDA clearance. The Company is now launching BNA™ commercially, targeting pharmaceutical companies engaged in drug research and clinical trials, as well as medical practitioners for clinical use. Brain Network Analytics was developed using artificial intelligence and machine learning on Firefly’s extensive proprietary database of standardized, high-definition longitudinal electroencephalograms (EEGs) of over 17,000 patients representing twelve disorders, as well as clinically normal patients. BNA™, in conjunction with an FDA-cleared EEG system, can provide clinicians with comprehensive insights into brain function. These insights can enhance a clinician’s ability to accurately diagnose mental and cognitive disorders and to evaluate what therapy and/or drug is best suited to optimize a patient’s outcome. Please visit https://fireflyneuro.com/ for more information. Forward-Looking StatementsCertain statements in this press release and the information incorporated herein by reference may constitute “forward-looking statements” for purposes of the federal securities laws concerning Firefly. These forward-looking statements include express or implied statements relating to Firefly’s management teams’ expectations, hopes, beliefs, intentions, or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Firefly will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Firefly’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: risks related to development and commercialization of BNATM technology; risks related to Firefly’s ability to recognize the anticipated benefits of the merger (the “Merger”) with WaveDancer, Inc. (“WaveDancer”); risks related to Firefly’s ability to correctly estimate its operating expenses and unanticipated spending and costs that could reduce Firefly’s cash resources; the ability of Firefly to protect its intellectual property rights; competitive responses to the Merger; unexpected costs, charges or expenses resulting from the Merger; potential adverse reactions or changes to business relationships resulting from the completion of the Merger; legislative, regulatory, political and economic developments; and those factors described under the heading “Risk Factors” in the in the registration statement on Form S-4 filed by WaveDancer with the Securities and Exchange Commission on January 22, 2024, as amended, and declared effective on February 6, 2024. Should one or more of these risks or uncertainties materialize, or should any of Firefly’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. It is not possible to predict or identify all such risks. Forward-looking statements included in this press release only speak as of the date they are made, and Firefly does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Investor ContactKCSA Strategic CommunicationsValter Pinto or Jack Perkins(212) 896-1254Firefly@KCSA.com Media ContactKCSA Strategic CommunicationsRaquel Cona, Vice President(516) 779-2630Rcona@KCSA.com