Firefly Neuroscience, Inc. - AIFF STOCK NEWS

Firefly Neuroscience (NASDAQ: AIFF) has announced a significant breakthrough in brain age assessment using its FDA-cleared BNA™ technology platform. The company has developed a method to estimate biological brain age using Resting EEG and Cognitive EEG (ERP) data, marking the first successful use of cognitive ERP data for brain age assessment.

The technology can identify significant disparities between brain age and chronological age, which could serve as a potential risk factor for dementia. This breakthrough represents a potential advancement in early screening and monitoring capabilities for Alzheimer's patients, offering a proactive and scalable approach to brain health assessment.

The research findings were presented at AD/PD 2024, demonstrating the platform's innovative capabilities to researchers and clinicians in the field of neurological disorders.

Arrivo BioVentures reported positive results from its SP-624-103 study evaluating SP-624's impact on neurological pathways. The double-blind, placebo-controlled study's first cohort, comprising 12 healthy subjects, showed significant brain activity changes after a single 20mg dose. Key findings include increased beta power in frontal-central regions and decreased delta power, suggesting enhanced neural synchronization and cortical activation.

The study utilized Firefly Neuroscience's (NASDAQ: AIFF) brain network analytics (BNA™) and qEEG assessments. SP-624, a SIRT6 activator, demonstrated potential for treating females with Major Depression. The company is currently conducting a Phase 2b/3 study for major depressive disorder, with Cohort 2 actively enrolling 12 MDD patients.

Firefly Neuroscience (NASDAQ: AIFF) has secured financing of up to $12.4 million, comprising $2.4 million in senior secured convertible notes at $3.00 per share and a $10 million equity line of credit. The AI company, which develops solutions for neurological and mental disorders, will use the proceeds to support growth initiatives and commercialize its FDA-510(k) cleared Brain Network Analytics (BNA™) technology. The funding will accelerate two strategic commercialization pathways: partnering with neuroscience pharmaceutical companies and supporting US neurologists and psychiatrists in patient care optimization.

Firefly Neuroscience (NASDAQ: AIFF) has appointed current board member Greg Lipschitz as Executive Chairman, effective December 3, 2024. Lipschitz, who has served as director since December 2022, brings over 13 years of experience in private equity, merchant banking, capital markets, and finance. He previously served as Vice President of Lazer Capital and currently serves as Managing Director of Old Stone Advisors. The appointment comes as the company prepares to commercialize its AI technology for brain health solutions.

Former Executive Chairman David Johnson has resigned from the board effective November 30, 2024, with no disagreements reported regarding company operations, policies, or practices.

Firefly Neuroscience (NASDAQ: AIFF), an AI company focused on brain health solutions, reported its Q3 2024 results and strategic updates. The company has successfully established partnerships with major pharmaceutical companies including Bright Minds Bioscience, Novartis, and Takeda to advance its FDA-cleared Brain Network Analytics (BNA™) technology. Firefly is pursuing a dual strategy: supporting US neurologists in patient care and collaborating with pharmaceutical companies for drug development. The company leverages a proprietary database of over 77,000 EEG scans across twelve disorders. As of September 30, 2024, Firefly reported cash holdings of $1.2 million and 8,503,365 outstanding shares as of November 12, 2024.

Firefly Neuroscience (NASDAQ: AIFF), an AI company focused on brain health solutions, has announced its participation in the Capital Event Management Conference. The event will take place at the JW Marriott Miami in Aventura, Florida from November 22-24, 2024. The company, which develops innovative solutions for patients with neurological and mental disorders, is offering one-on-one investor meetings during the conference. Interested parties can schedule meetings through CEM representatives or by contacting KCSA Strategic Communications.

Firefly Neuroscience (NASDAQ: AIFF) announced that its Board of Directors has granted 557,885 restricted shares as an inducement grant to David Johnson, the Company's Executive Chairman. The shares will vest in two equal installments at six and twelve months from the grant date, contingent on Johnson's continued service. The grant was made in accordance with Nasdaq Listing Rule 5635(c)(4) and falls under the Company's 2024 Long-Term Incentive Plan.

Firefly Neuroscience (NASDAQ: AIFF) has announced a collaboration with Bright Minds Biosciences to analyze data from Bright Minds' positive Phase 1 study using Firefly's AI-powered BNA™ technology. The study focused on Bright Minds' lead compound, BMB-101, and utilized EEG headsets provided by Firefly's partner, Zeto.

The qEEG data analysis demonstrated positive results, with EEG recordings taken at multiple timepoints during the study. Firefly's advanced EEG analysis platform was used to process the data. Jon Olsen, CEO of Firefly, highlighted the value of their AI platform for clinical studies, while Ian McDonald, CEO of Bright Minds, stated that the results validate their approach and indicate that BMB-101 is achieving brain penetration as predicted.

With the completion of this Phase 1 study, BMB-101 is now considered a Phase 2 ready asset, and Bright Minds plans to move forward with an investigative new drug submission.

Firefly Neuroscience (NASDAQ: AIFF) announced that its FDA-510(k) cleared Brain Network Analytics (BNA™) biomarker discovery AI platform will support Arrivo Bioventures' Phase 1 exploratory study of SP-624, a first-in-class SIRT6 activator for major depressive disorder (MDD). The study will evaluate SP-624's impact on neurological pathways and cognitive domains in healthy volunteers and MDD patients.

SP-624 is also being studied in a large Phase 2b trial, focusing on efficacy in females. In a previous Phase 2 study, SP-624 showed statistically significant improvement versus placebo in female subjects with MDD, but not in males. Firefly's BNA™ technology aims to identify target engagement and biomarkers for future neurological studies, potentially addressing the unmet medical need in women's mental health.