Firefly Neuroscience Advances AI-Driven BNA™ Technology in Neuroscience Drug Development after Completing Successful Research Collaborations with Takeda and Novartis

TORONTO, Sept. 20, 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 advancing its artificial intelligence-powered Brain Network Analytics (BNA™) technology after successful research collaborations with Takeda Pharmaceutical Company Limited (“Takeda”) and Novartis, two global leaders in pharmaceutical R&D, illustrating the value of Firefly’s AI-based technology in providing objective measures in neuroscience drug development.

“Our collaborations with Takeda and Novartis mark a pivotal step in accelerating drug development,” said Jon Olsen, Firefly’s CEO. “By using our BNA™ technology, pharmaceutical companies can leverage the additional objective measures of brain activity to enhance the design of future trials and advance their drug candidates faster toward regulatory approval. Additionally, integrating Firefly's BNA™ technology into neuroscience drug development allows researchers to reduce costs and time by precisely measuring drug effects on the brain and identifying patients most likely to respond, leading to improved clinical outcomes.”

Incorporating Firefly’s BNA™ technology into CNS drug development provides biotechnology and pharma companies with tools to enhance patient and dose selection, thus reducing cost and accelerating drug development. Firefly intends to continue leveraging its unique database and technology to expand its partnerships with neuroscience pharmaceutical companies, building on its collaborations with industry leaders like Novartis and Takeda.

“Many new drugs being developed are expensive, and there is considerable resistance from healthcare providers, governments, and insurers to absorb the high cost of new drugs without knowing who is most likely to benefit from the drug,” continued Mr. Olsen. “Firefly believes that electrophysiology-based biomarkers, like BNA, represent a significant opportunity for neuroscience drug development companies.”

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.

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Forward-Looking Statements

Certain 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.

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