Mr. Alex Vasilkevich reports

BRIGHT MINDS BIOSCIENCES AND FIREFLY NEUROSCIENCE TO COLLABORATE AFTER THE BREAKTHROUGH STUDY: A PHASE 2 TRIAL OF BMB-101 IN ABSENCE EPILEPSY AND DEVELOPMENTAL EPILEPTIC ENCEPHALOPATHY FOR FULL ANALYSIS OF EEG DATA

Bright Minds Biosciences Inc. is once again collaborating with Firefly Neuroscience Inc. 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-HT2C 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 (Food and Drug Administration) 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 enrolment 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-HT2C 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 per cent of all epilepsy patients who experience drug resistance."

About BMB-101

BMB-101 is a novel scaffold 5-HT2C 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-HT2C 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 signalling 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 Inc.

Bright Minds Biosciences is a biotechnology company developing innovative treatments for patients with neurological and psychiatric disorders. The company's pipeline includes novel compounds targeting key receptors in the brain to address conditions with high unmet medical need, including epilepsy, depression and other CNS (central nervous system) 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.

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