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During the Phase 1 study, subjects utilized EEG headsets provided by Firefly partner, Zeto, after which the data was analyzed using Firefly’s advanced AI BNA technology analysis platformTORONTO, Oct. 16, 2024 (GLOBE NEWSWIRE) -- Firefly Neuroscience, Inc. (“Firefly,” 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 collaborating with Bright Minds Biosciences Inc. (CSE:DRUG) (NASDAQ:DRUG) (“Bright Minds” or the “Company”), a biotechnology company focused on developing novel drugs for the targeted treatment of neuropsychiatric disorders and refractory epilepsy, to analyze the data from its first-in-human Phase 1 study of its lead compound, BMB-101. The study demonstrated positive results of the qEEG (Quantitative Electroencephalogram) data. During the EEG recording, subjects were seated with a U.S. Food and Drug Administration (FDA)- approved 19 electrode EEG headset provided by Firefly strategic partner, Zeto™ Inc. Channels were sampled at 250 or 500 Hz and referenced to A1/A2 channels (linked-ears reference) during recording. The EEG recording time was 10 minutes (~5 minutes resting with eyes closed and ~5 minutes resting with eyes open). There were four EEG recording timepoints: day 1 pre-dose (immediately before dosing) and post-dose (1h after dosing), and day 7 pre-dose and post-dose. Data was analyzed using the FireFly Neuroscience advanced EEG analysis platform. “Our artificial intelligence platform has tremendous value for the advancement and insight of clinical studies,” said Jon Olsen, CEO of Firefly. “We are pleased to have successfully collaborated with Bright Minds to analyze the data of their phase 1 study and look forward to working closely with their team once again as well as other leading biotechnology companies.” “The positive topline findings from our recently completed Phase 1 study of BMB-101, together with the observations from the qEEG portion of the study, validate our approach, as we continue to evaluate this important product candidate. BMB-101 is clearly [getting into the brain/achieving brain penetration] and activating the target receptors as we had predicted, setting us up for potential success in a number of indications that have been validated with the 5-HT2C mechanism. With this study complete, BMB-101 is now a Phase 2 ready asset, and we intend to move forward with an investigative new drug submission immediately,” stated Ian McDonald, CEO of Bright Minds. 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. About BMB-101BMB-101, a highly selective 5-HT2C, Gq-protein biased agonist, has demonstrated compelling activity in a host of in vitro and in vivo nonclinical tests. Compared to Lorcaserin, BMB-101 exhibits strong Gq biased signaling, coupled with minimal beta-arrestin recruitment. Bright Minds believes that G-protein biased signaling translates to better tolerance profile for this second-generation 5-HT2C agonist, making BMB-101 a best-in-class 5-HT2C agonist. Mechanistically, Serotonin (5-Hydroxytryptamine, 5-HT) is a monoamine neurotransmitter widely expressed in the central nervous system, and drugs modulating 5-HT have made a major impact in mental health disorders. Central 5-HT systems have long been associated with the control of ingestive behaviors and the modulation of the behavioral effects of psychostimulants, opioids, alcohol, and nicotine. Results of clinical trials and animal studies indicate that 5-HT2C receptor agonists may have therapeutic potential in the treatment of addiction by decreasing the intake of opioids as well as impulsive behavior that can escalate compulsive drug use. BMB-101 is a new chemical entity (NCE) and constitutes a novel scaffold 5-HT2C agonist. 5-HT2C agonism is a well proven anticonvulsant mechanism. In translational animal models, BMB-101 demonstrated a significant reduction in both the number and intensity of epileptic seizures and is a promising candidate for the treatment of Dravet Syndrome and other epilepsies. The Phase 1 trial (NCT 05397041) has been completed and BMB-101 is now Phase 2 ready. About Bright MindsBright Minds is focused on developing novel transformative treatments for neuropsychiatric disorders, epilepsy, and pain. Bright Minds has a portfolio of next-generation serotonin agonists designed to target neurocircuit abnormalities that are responsible for difficult to treat disorders such as treatment resistant epilepsy, treatment resistant depression, PTSD, and pain. The Company leverages its world-class scientific and drug development expertise to bring forward the next generation of safe and efficacious drugs. Bright Minds’ drugs have been designed to potentially retain the powerful therapeutic aspects of psychedelic and other serotonergic compounds, while minimizing the side effects, thereby creating superior drugs to first-generation compounds, such as fenfluramine, psilocybin, LSD, and ibogaine. 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 BNA™ 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 expenses associated with the Merger and other events 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 business combination; 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. Firefly Neuroscience Investor ContactsKCSA Strategic CommunicationsValter Pinto / Jack Perkins(212) 896-1254Firefly@KCSA.com Firefly Neuroscience Media ContactKCSA Strategic CommunicationsRaquel Cona, Vice President(516) 779-2630Rcona@KCSA.com

Neuroscience drug developer Lundbeck is expanding its scope to epilepsy via the $2.6 billion acquisition of Longboard Pharmaceuticals, a company whose lead asset is in late-stage clinical development for a rare, inherited seizure disorder that has few approved treatments. According to deal terms announced Monday, Lundbeck will pay $60 in cash for each Longboard share, representing a 54.2% premium to the biotech’s closing stock price on Friday and a 77% premium to the stock’s average price for the month of September. When La Jolla, California-based Longboard went public in 2021, it priced shares at $16 apiece. Longboard’s lead drug candidate, bexicaserin, is in development for developmental and epileptic encephalopathies (DEEs), a group of disorders that include the rare epilepsies Dravet syndrome and Lennox-Gastaut syndrome. The oral small molecule is an agonist of the 5-HT2C receptor, whose roles include regulating seizure severity. This receptor is already targeted by Fintepla, a UCB drug approved to treat seizures associated with Dravet and Lennox-Gastaut. But Fintepla’s label carries a black box warning for cardiovascular complications. Bexicaserin is designed to selectively target 5-HT2C without also hitting other receptors that can cause adverse effects. presented by Health IT Accelerating Claim Processing: Strategies to Shorten the Life of a Claim These strategies and practices can significantly shorten the life cycle of claims, leading to quicker resolutions and improved financial outcomes. By Greenway Health Jazz Pharmaceuticals’ cannabis-derived Epidiolex, approved for Dravet, Lennox-Gastaut, and tuberous sclerosis complex, has no black box warning. Some high-profile efforts in DEEs have encountered setbacks. In June, Takeda Pharmaceutical reported its drug candidate soticlestat failed separate placebo-controlled Phase 3 tests in Dravet and Lennox-Gastaut. Longboard had been making the case that bexicaserin can stand apart from other approaches to treat epilepsies. In January, the biotech reported Phase 1b/2a data showing a median 53.3% reduction in seizure frequency in patients with DEEs during the 75-day treatment period, results that had the company making claims of best-in-class potential. Shares of the biotech soared more than 300% after that data report. Bexicaserin’s efficacy results are holding up so far. According to a Lundbeck investor presentation, nine-month open-label data show a 57.7% reduction in countable motor seizures. In September, Longboard began a global Phase 3 test enrolling Dravet patients age 2 and older. This clinical trial is part of a broader program planned to evaluate the drug in about 480 patients who have a range of DEEs. The Longboard pipeline also includes LP659, a modulator of the S1P receptor that has potential applications in neuroinflammatory disorders. A Phase 1 single-ascending dose study has been completed but plans for a Phase 1 multiple-ascending dose study are subject to resolution of a partial clinical hold. Both bexicaserin and LP659 were licensed from Arena Pharmaceuticals. presented by Sponsored Post The Promise of Value-Based Care and MedTech Innovation Monica Vajani, Executive Director for mHUB’s MedTech Accelerator, discusses how mHUB is helping innovators transition healthcare towards value-based care. By Monica Vajani - mHUB Lundbeck focuses on neuroscience drugs. The Copenhagen-based company’s top-selling product is Rexulti, a schizophrenia and depression drug that last year expanded its approved uses to include agitation caused by Alzheimer’s disease. The product accounted for 4.5 billion Danish krone (about $661 million) in revenue last year, a 16% increase compared to the prior year, according to the company’s annual report. Within neuroscience, Lundbeck executives have identified rare neurological diseases as an opportunity for pipeline expansion. Lundbeck projects a fourth quarter 2028 launch for bexicaserin. The company estimates the drug could achieve peak sales of $1.5 billion to $2 billion. “This transformative transaction will become a cornerstone in Lundbeck’s neuro-rare franchise, with a potential to drive growth into the next decade,” Lundbeck President and CEO Charl van Zyl said in a prepared statement. “Bexicaserin addresses a critical unmet need for patients suffering from rare and severe epilepsies, for which there are very few good treatment options available.” The boards of directors of both Lundbeck and Longboard have approved the acquisition, which still needs the majority of Longboard’s outstanding voting shares to be tendered. The deal also must pass regulatory muster. The transaction is expected to close by the end of this year. Image: Getty Images, Iaremenko