BMB-101

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

NEW YORK AND VANCOUVER, British Columbia, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Bright Minds Biosciences Inc. (Bright Minds or the Company) (NASDAQ: DRUG), a biotechnology company focused on developing novel therapies for neurological and neuropsychiatric disorders, today announced that it is once again collaborating with Firefly Neuroscience, Inc. (Firefly) (NASDAQ: AIFF), an Artificial Intelligence (AI) company developing innovative solutions that improve brain health outcomes for patients with neurological and mental disorders, to provide a full analysis of the electroencephalogram (EEG) data in the Company’s BREAKTHROUGH study, an open-label Phase 2 clinical trial evaluating the safety, tolerability, and efficacy of BMB-101, a highly selective 5-HT 2C receptor agonist, in adult patients with classic Absence Epilepsy and Developmental Epileptic Encephalopathy (DEE). Bright Minds and Firefly have previously collaborated successfully to analyze the data of the Company’s first-in-human Phase 1 study of BMB-101 using Firefly’s advanced artificial intelligence, FDA-cleared BNA™ technology platform. The BREAKTHROUGH study is designed as a basket clinical trial that will include patients diagnosed with either Absence Epilepsy (with or without Eyelid Myoclonia) or DEE. This group of disorders consists of a range of rare epilepsy disorders, including Epilepsy with Eyelid Myoclonia (known as Jeavons Syndrome). These conditions are characterized by refractory seizures that are often resistant to current treatments. The BREAKTHROUGH study is targeting enrollment of 20 adult participants aged from 18 to 65 years old. “After successful use of the BNA platform to analyze the data from our Phase 1 study, we look forward to once again collaborating with the Firefly team at the conclusion of our Phase 2 program for our lead compound, BMB-101, to provide valuable insights into the EEG recordings during the study,” said Ian McDonald, Chief Executive Officer of Bright Minds Biosciences. “We believe BMB-101 has the potential to be a best-in-class 5-HT 2C agonist. This compound is not only poised to make a significant impact in both the DEE and Absence Epilepsy communities, but also has broad applicability across the 30% of all epilepsy patients who experience drug resistance.” About BMB-101 BMB-101 is a novel scaffold 5-HT 2C Gq-protein biased agonist developed using structure-based drug design. It was explicitly designed for chronic treatment of neurological disorders where tolerance and drug resistance are common issues. Biased agonism at the 5-HT 2C receptor is one of its key features and adds another layer of functional selectivity within a well-validated target. BMB-101 works exclusively via the Gq-protein signaling pathway and avoids beta-arrest in activation, which is crucial to minimize the risk of receptor desensitization and tolerance development. This provides a novel mechanism, anti-epileptic drug designed to provide sustained seizure relief in hard-to-treat patient populations. In preclinical studies, BMB-101 has demonstrated efficacy in animal models of Dravet Syndrome and numerous models of generalized seizures. In Phase 1 clinical studies, BMB-101 was given to 64 healthy volunteers in a Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and food-effects study. BMB-101 was demonstrated to be safe and well tolerated at all doses. No Serious Adverse Events (SAEs) were observed, and Adverse Events (AEs) were mild in nature and in line with on-target effects for serotonergic drugs. An extensive target-engagement study was conducted using both fluid biomarkers (transient prolactin release) and physical biomarkers (Quantitative Electroencephalogram, qEEG). Both methods confirmed robust central target engagement. A qEEG signature typical for anti-epileptic drugs was observed, with a selective depression of EEG power at frequencies observed during epileptic seizures. Furthermore, a potentiation of frontal gamma-power was observed in this study which could indicate the potential for improved cognition. About Bright Minds Biosciences Bright Minds Biosciences is a biotechnology company developing innovative treatments for patients with neurological and psychiatric disorders. Our pipeline includes novel compounds targeting key receptors in the brain to address conditions with high unmet medical need, including epilepsy, depression, and other CNS disorders. Bright Minds is focused on delivering breakthrough therapies that can transform patients’ lives. Bright Minds Biosciences has developed a unique platform of highly selective serotonergic agonists exhibiting selectivity at different serotonergic receptors. This has provided a rich portfolio of NCE programs within neurology and psychiatry. 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 for more information. Forward-Looking Statements This news release contains “forward-looking information”. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, or “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward-looking statements in this news release include design, progress, and completion of the BREAKTHROUGH Study, future clinical development of BMB-101, and future intended use or therapeutic benefit of BMB-101 to treat refractory epilepsy disorders. A variety of factors, including known and unknown risks, many of which are beyond our control, could cause actual results to differ materially from the forward-looking information in this news release. These factors include the company’s financial position and operational runway, regulatory risk to operating in the pharmaceutical industry, and inaccuracies related to the assumption made by management relating to general availability of resources required to operate the studies noted in this news release. Additional risk factors can also be found in the Company’s public filings under the Company’s SEDAR+ pro Forward-looking statements contained herein are made as of the date of this news release and the Company disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or results or otherwise. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. The Company undertakes no obligation to update forward-looking statements if circumstances, management’s estimates or opinions should change, except as required by securities legislation. Accordingly, the reader is cautioned not to place undue reliance on forward-looking statements. The Canadian Securities Exchange has neither approved nor disapproved the information contained herein and does not accept responsibility for the adequacy or accuracy of this news release. Contact Information Alex Vasilkevich Chief Operating Officer Bright Minds Biosciences Inc. Phone: (414)7316422 Email: alex@brightmindsbio.com Website: Investor Relations Lisa M. Wilson T: 212-452-2793 E: lwilson@insitecony.com