Disruptive, Impulse Control, and Conduct Disorders

TORONTO, March 14, 2024 /PRNewswire/ - Rochon Genova LLP announces that a national class action has been authorized by the Superior Court of Québec on behalf of all persons in Canada who were prescribed and used the prescription antipsychotic drug REXULTI® during the Class Period, starting from February 16, 2017, and who developed one or more of the following Compulsive Behaviours and Impulse Control Disorders: compulsive gambling, hypersexuality, binge eating, compulsive shopping and/or spending. REXULTI® is an atypical antipsychotic medication prescribed for schizophrenia and as adjunct treatment for major depressive disorder. The Plaintiffs alleged that REXULTI® causes Compulsive Behaviours and Impulse Control Disorders, including compulsive gambling, hypersexuality, compulsive shopping, and binge eating, and that the Defendants, Otsuka Canada Pharmaceutical Inc. and Lundbeck Canada Inc., failed to warn the Class Members and their physicians of this risk. They allege that the Defendants failed to conduct adequate research and testing in relation to those side effects and conspired to conceal the risks of these harmful side effects from the Class Members. It is also alleged that the Defendants' failures and acts caused the Class Members harm. The action seeks, among other things, damages for both personal injuries and financial loss as well as damages allegedly suffered by family members of individuals taking REXULTI®. The Defendants deny these allegations, and the Superior Court has not yet ruled on the merits of the class action. However, if you were prescribed and used REXULTI® during the Class Period, starting from February 16, 2017, and developed one or more of the Compulsive Behaviours and Impulse Control Disorders described above, your rights are affected by this action. If you wish to remain in the action, you do not need to take any further action. If you wish to exclude yourself from the action, you must deliver a signed Opt Out Form by May 15, 2024 by courier, registered or certified mail, to Clerk of the Superior Court of Québec, Montreal Courthouse, 1, Notre-Dame Street East, Room 1.120, Montreal (Quebec) H2Y 1B6, Court file no. 500-06-000948-188. To learn more about your rights, contact Class Counsel or visit their website at: Class Counsel Rochon Genova LLP Barristers ● Avocats 900-121 Richmond St. W. Jon Sloan Tel: (416) 363-1867 [email protected] The publication of this notice was authorized by the Superior Court of Québec Please Do Not Contact the Court SOURCE Rochon Genova LLP

- PRODUODOPA® (foslevodopa/foscarbidopa) is the first-and-only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of advanced Parkinson's disease - PRODUODOPA demonstrated sustained improvements in "Off" time (when symptoms return between medication doses), "On" time (when symptoms are controlled) without dyskinesia (involuntary movement), and morning akinesia ("Off" time upon waking) NORTH CHICAGO, Ill., Jan. 9, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the launch of PRODUODOPA® (foslevodopa/foscarbidopa) in the European Union for the treatment of advanced Parkinson's disease with severe motor fluctuations and hyperkinesia (excessive movement) or dyskinesia (involuntary movement), and when available combinations of Parkinson's medicinal products have not given satisfactory results.1 PRODUODOPA is the first-and-only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of severe motor fluctuations in people living with advanced Parkinson's disease whose symptoms are inadequately controlled by other therapies. The continuous delivery of PRODUODOPA provides levodopa 24-hours a day which may help patients by extending the period when symptoms are well-controlled, often referred to as "On" time.2 AbbVie was granted marketing authorization of PRODUODOPA through the Decentralized Procedure in the third quarter of 2022. The VYAFUSER™ pump for the subcutaneous delivery of PRODUODOPA received Conformité Européenne (CE) Mark in November of 2023. Parkinson's disease is a chronic, progressive neurodegenerative disorder affecting approximately 6.1 million people globally3 and is expected to double by 2040. Parkinson's disease is characterized by tremor, muscle rigidity, slowness of movement and difficulty with balance.4 As the disease progresses, the severity of symptoms increases5, and patients tend to experience greater disability and an impaired ability to perform activities of daily living6, as well as the reemergence of symptoms as standard treatment wears off.7 Characteristics of advanced Parkinson's disease may include needing help with performing daily activities, increased motor fluctuations (changes in the ability to move referred to as "On-Off" times), difficulty swallowing, recurrent falls, dementia, dyskinesia (involuntary movements) and other symptoms.5 "People living with Parkinson's disease experience daily challenges and uncertainty, especially as their disease progresses and symptoms are no longer adequately controlled," said Roopal Thakkar, Senior Vice President, Development and Regulatory Affairs and Chief Medical Officer, AbbVie. "This approval is an example of our unwavering commitment to this community by developing new, transformative therapeutic options for people experiencing advanced Parkinson's disease, their families, and care partners." The launch was supported by three studies: the Phase 3, 12-month open label study (M15-741 study) which evaluated the long-term safety, tolerability, and efficacy of continuous subcutaneous infusion of PRODUODOPA8, the Phase 3, 12-week study (M15-736 study) which compared the efficacy and safety of PRODUODOPA to oral levodopa/carbidopa2, and a Phase 1 pharmacokinetic comparability study.9 Findings from the M15-741 safety and tolerability study showed a favorable benefit/risk profile and demonstrated sustained improvements in "Off" time and "On" time without dyskinesia, and morning akinesia as measured by the percentage of patients in early morning "Off" time as recorded by PD diary.8 The majority of adverse events (AEs) with PRODUODOPA were non-serious and mild or moderate in severity. The most frequent AEs (greater than or equal to 10 percent) were infusion site events (infusion site erythema, infusion site cellulitis, infusion site nodule, infusion site pain, infusion site oedema, infusion site reaction, and infusion site infection), hallucination, fall, and anxiety.1 "This approval represents a significant advancement for those with Parkinson's disease who have historically had limited treatment options for advanced stages," said Angelo Antonini, MD, PhD, Professor of Neurology at the Department of Neuroscience, University of Padua, Italy. "When oral treatment no longer sufficiently helps with improvement in motor fluctuations, patients need alternative options. PRODUODOPA's around-the-clock infusion allows for continuous delivery of levodopa, the gold standard of treatment." "As Parkinson's progresses, it can take a significant physical and emotional toll not only on the person but also on their family and care partners, who often play a critical role in their daily lives," said Josefa Domingos, President, Parkinson's Europe. "It is vital that the Parkinson's community have more options that can help them manage their symptoms." About the Phase 3 M15-741 Study8 The Phase 3, single arm, open-label study evaluated the safety and tolerability, and efficacy of 24-hour daily exposure of continuous subcutaneous infusion of PRODUODOPA in people with advanced Parkinson's disease whose motor symptoms were inadequately controlled by their current treatment. The primary endpoint was to evaluate the safety and tolerability of PRODUODOPA. Secondary endpoints included changes from baseline in normalized "Off" and "On" time, percentage of patients reporting morning akinesia, and total scores from quality-of-life surveys. The study was conducted at 58 sites across 13 countries (Australia, Belgium, Canada, Denmark, Germany, Italy, Japan, Netherlands, Russia, Spain, Sweden, United Kingdom, and United States). Eligible patients included adults 30 years or older diagnosed with levodopa-responsive idiopathic Parkinson's disease experiencing an average of greater than or equal to 2.5 hours of "Off" time per day, as assessed by patient's Parkinson's disease diaries. Reduction in motor fluctuations was observed as early as one week and persisted through week 52. The percentage of patients experiencing morning akinesia dropped from 77.7 percent at baseline to 27.8 percent at week 52. Indicators of sleep and quality of life were assessed from baseline through week 52 as published in the Journal of Neurology & Therapy (). More information on the study can be found on (NCT03781167). About the Phase 3 M15-736 Study2 The Phase 3 randomized, double-blind, double-dummy, active-controlled study compared the efficacy, safety and tolerability of PRODUODOPA to oral immediate-release levodopa/carbidopa (LD/CD) in patients with advanced Parkinson's disease. Participants were provided with a home diary (the PD Diary) to assess their motor state during the day. The primary endpoint was "On" time without troublesome dyskinesia. The study included 141 participants who were randomly assigned and received treatment at 65 centers in the U.S. and Australia. Participants were randomized one to one to receive either the PRODUODOPA solution as a continuous delivery under the skin (subcutaneous) plus oral placebo capsules for LD/CD or oral capsules containing immediate-release LD/CD plus continuous subcutaneous delivery of placebo solution for PRODUODOPA. The treatment duration was 12 weeks. The increase in "On" time without troublesome dyskinesia at week 12 was an average of 2.72 hours for PRODUODOPA versus 0.97 hours for oral LD/CD (p= 0.0083). Improvements in "On" time were observed as early as the first week and persisted throughout the 12 weeks. This study also assessed changes from baseline to week 12 in motor experiences of daily living, morning akinesia, sleep, and quality of life indicators, however results did not achieve statistical significance. More information on the study can be found on (NCT04380142) and in The Lancet Neurology ((22)00400-8). About the Phase 1 Pharmacokinetic study9 A Phase 1, open label, randomized, two period cross over study was conducted to compare the pharmacokinetics (PK) of levodopa from 24-hour continuous subcutaneous infusion of PRODUODOPA (foslevodopa/foscarbidopa) to the PK of levodopa from 16-hour levodopa-carbidopa intestinal gel (LCIG), followed by two night-time oral levodopa/carbidopa (LD/CD) doses. The levodopa exposures following subcutaneous infusion of PRODUODOPA over 24 hours were similar (less than 8 percent difference) to those of LCIG mg LD/CD administered over 16 hours, followed by two oral doses at 18 and 21 hours after the start of LCIG delivery. The study concluded that 24-hour continuous subcutaneous infusion of PRODUODOPA provides levodopa exposures comparable to LCIG throughout the day. More information on the study can be found on (35339102) and in Science Direct (). About PRODUODOPA® (foslevodopa/foscarbidopa) PRODUODOPA® (foslevodopa/foscarbidopa) is a solution of levodopa and carbidopa prodrugs for 24-hour continuous subcutaneous infusion for the treatment of advanced levodopa-responsive Parkinson's disease with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results. PRODUODOPA® (foslevodopa and foscarbidopa solution for infusion) Indication and Summary of Important Treatment Considerations1 Indication Treatment of advanced levodopa-responsive Parkinson's disease with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results. Contraindications PRODUODOPA is contraindicated in patients with hypersensitivity to the active substances or to any of the excipients, narrow-angle glaucoma, severe heart failure, acute stroke, severe cardiac arrhythmia, co-medication with selective MAO type A inhibitors and nonselective MAO inhibitors, conditions contraindicated for adrenergics (e.g. pheochromocytoma, hyperthyroidism, and Cushing's syndrome), and suspicious undiagnosed skin lesions or history of melanoma. Select special warnings and precautions for PRODUODOPA Special warnings and precautions for PRODUODOPA Several warnings and precautions below are generic for levodopa and, therefore, also for PRODUODOPA. Not recommended for the treatment of drug-induced extrapyramidal reactions. Caution use in patients with: severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease, or history of peptic ulcer disease or of convulsions. History of myocardial infarction with residual atrial nodal or ventricular arrhythmias, cardiac function should be monitored during the initial dosage adjustments. Monitor all patients for the development of mental changes, depression with suicidal tendencies, and other serious mental changes. Caution with past or current psychosis and antipsychotics used concomitantly with dopamine receptor-blocking properties (observe for loss of antiparkinsonian effect). Higher frequency of hallucinations may occur with dopamine agonists and/or other dopaminergic treatments including PRODUODOPA. Monitor patients regularly for the development of impulse control disorders, for example Dopamine Dysregulation Syndrome (DDS). Before initiation of treatment, warn patients and caregivers of the potential risk of developing DDS. The dose of PRODUODOPA may need to be adjusted downwards in order to avoid levodopa induced dyskinesias. Caution in chronic wide-angle glaucoma; monitor for intra-ocular pressure changes. PRODUODOPA may induce orthostatic hypotension and should be given cautiously in patients taking other medicinal products that may cause orthostatic hypotension. Concomitant use of selegiline and levodopa/carbidopa has been associated with serious orthostatic hypotension. Levodopa may induce somnolence and sudden sleep: caution should be exercised when driving and operating machines. Risk of symptoms resembling Neuroleptic Malignant Syndrome following abrupt dose reduction or discontinuation. Infusion site events (see section 4.8) have been reported in patients receiving PRODUODOPA. Follow aseptic techniques and frequently rotate the infusion site to reduce the risk. In clinical studies, few patients who reported infusion site reactions also experienced infusion site infections. Therefore, monitor for serious infusion site reactions and infusion site infections. Patients with Parkinson's disease have a higher risk of developing melanoma. Monitor patients for melanomas on a regular basis when using PRODUODOPA. Periodic evaluation of hepatic, haematopoietic, cardiovascular and renal function is recommended during extended therapy with PRODUODOPA. PRODUODOPA contains hydrazine (foscarbidopa degradation product), that can be genotoxic and probably carcinogenic. The approximately median exposure of hydrazine is 0.2 mg/day, with a maximum of 0.5 mg/day. The clinical significance of this hydrazine exposure is not known. Reduced ability to handle the delivery system can lead to complications. In such patients a caregiver should assist the patient. A sudden or gradual worsening of bradykinesia may indicate an obstruction in the device for whatever reason and needs to be explored. Polyneuropathy has been reported; evaluate for history/signs of and known risk factors before starting therapy. PRODUODOPA is high in sodium; considered especially in patients on a low salt diet. Caution is needed in concomitant administration of PRODUODOPA with the following medicinal products: Antihypertensives, antidepressants, COMT inhibitors, dopamine antagonists, MAO inhibitors, amantadine. Sympathomimetics may increase cardiovascular adverse events related to levodopa. Foscarbidopa is a potential inducer of CYP1A2 in vitro. Care should be taken when prescribing PRODUODOPA in combination with sensitive CYP1A2 substrates (e.g. caffeine). Review section of interactions with other medicinal products in SmPC for further details about these and a complete list of interactions. Fertility, pregnancy and lactation PRODUODOPA is not recommended during pregnancy. Breast-feeding should be discontinued during treatment with PRODUODOPA. Undesirable effects Summary of the safety profile The most frequent adverse reactions (≥10%) reported in all Phase 3 studies in patients exposed to PRODUODOPA were infusion site events (infusion site erythema, infusion site cellulitis, infusion site nodule, infusion site pain, infusion site oedema, infusion site reaction, and infusion site infection), hallucination, fall, and anxiety. This is not a complete summary of all safety information. Globally, prescribing information varies; please refer to your country specific product labeling for complete product prescribing and safety information. About AbbVie in Neuroscience At AbbVie, our commitment to preserving personhood of people around the world living with neurological and psychiatric disorders is unwavering. With more than three decades of experience in neuroscience, we are providing meaningful treatment options today and advancing innovation for the future. AbbVie's Neuroscience portfolio consists of approved treatments in neurological conditions, including migraine, movement disorders, and psychiatric disorders, along with a robust pipeline of transformative therapies. We have made a strong investment in research and are committed to building a deeper understanding of neurological and psychiatric disorders. Every challenge makes us more determined and drives us to discover and deliver advancements for those impacted by these conditions, their care partners, and clinicians. For more information, visit . About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @AbbVie on X (formerly Twitter), Facebook, Instagram, YouTube, and LinkedIn Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2022 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References 1 PRODUODOPA® (foslevodopa/foscarbidopa solution for infusion) Summary of Product Characteristics. November 2023. 2 Soileau, M., et al. Safety and efficacy of continuous subcutaneous foslevodopa-foscarbidopa in patients with advanced Parkinson's disease: a randomised, double-blind, active-controlled, phase 3 trial. The Lancet Neurology. December 2022. 3 Armstrong, MJ. and Okun, MS. (2020). Diagnosis and Treatment of Parkinson Disease. A Review. JAMA 2020; 323(6): 548-560. 4 "What is Parkinson's?" Parkinson's Foundation. Available at: . Accessed: August 29, 2023. 5 Luquin M-R et al. Parkinson's Dis. 2018; 4047392. 6 Malaty IA et al. (2022). Does the 5-2-1 criteria identify patients with advanced Parkinson's disease? Real-world screening accuracy and burden of 5-2-1-positive patients in 7 countries. Gainsville: BCM Neurology. 7 "Wearing off and motor fluctuations". Parkinson's Europe. Available at . Accessed November 6, 2023. 8 Aldred, J., et al. Continuous Subcutaneous Foslevodopa/Foscarbidopa in Parkinson's Disease: Safety and Efficacy Results From a 12-Month, Single-Arm, Open-Label, Phase 3 Study. Journal of Neurology & Therapy. August 2023. 9 Rosebraugh, M., et al. Foslevodopa/foscarbidopa subcutaneous infusion maintains equivalent levodopa exposure to levodopa-carbidopa intestinal gel delivered to the jejunum. Science Direct. April 2022. SOURCE AbbVie

-- BMB-101 is a highly selective and potent 5-HT2C agonist being developed for the treatment of refractory epilepsies and other indications, such as psychosis, addiction, and impulse control disorders -- qEEG study was conducted in healthy individuals in Cohort 4 of the Multiple Ascending Dose arm of the study -- Proof of Mechanism and target engagement in the brain was established using blood biomarkers and qEEG -- In qEEG, BMB-101 demonstrated robust increase in central delta power and robust reduction in central alpha and beta power in active group, as previously reported for Anti-Epileptic Drugs (AEDs) in healthy individuals -- Company to host webcast to discuss findings of the Phase 1 study today, August 8, 2023, at 4:30pm ET VANCOUVER, British Columbia, Aug. 08, 2023 (GLOBE NEWSWIRE) -- 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, today announced positive results of the qEEG (Quantitative Electroencephalogram) data in Cohort 4 of its first-in-human Phase 1 study of its lead compound, BMB-101. On July 20, 2023, the Company announced completion of the study, along with positive topline data that demonstrated BMB-101's excellent safety and tolerability pro the single ascending dose, multiple ascending dose and food effects parts of the study. BMB-101 also demonstrated central target engagement and predictable plasma pharmacokinetics. In the qEEG study, BMB-101 demonstrated: Central target engagement, as the treatment group was easily identified in blinded data using qEEG power signature. A robust increase in central delta power and robust reduction in central alpha and beta power in active group, as previously reported for Anti-Epileptic Drugs (AEDs) in healthy individuals. Increased gamma frontal parietal connectivity in treatment group. This constitutes an improved AED principle over benzodiazepine (GABA receptor) AED drugs. Power and connectivity changes were concentration dependent. “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. “We are especially pleased that BMB-101 has demonstrated central target engagement by transient prolactin increase, and qEEG changes. The treatment group was readily identified in blinded data using the qEEG power signature. In addition, increased frontal gamma power represents an improved AED principle over [existing] benzodiazepine (GABA receptor) AED drugs. We believe that BMB-101 has the potential to be a best-in-class, novel pharmacophore 5-HT2C agonist for the treatment of seizure disorders, and our team is committed to advancing this product candidate for application where serotonin 2C agonists would be useful,” said Jan Torleif Pedersen, PhD, MSc, Chief Science Officer of Bright Minds. During the EEG recording, subjects were seated with a U.S. Food and Drug Administration (FDA)- approved 19 electrode EEG headset provided by 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 were analyzed using the FireFly Neuroscience advanced EEG analysis platform. BMB-101 is a highly selective and potent 5-HT2C agonist being developed for the treatment of refractory epilepsies and other indications, such as psychosis, addiction, and impulse control disorders. BMB-101 demonstrated an excellent safety and tolerability profile. 5-HT2C target engagement was demonstrated by transient, dose-dependent increases in prolactin. BMB-101 exhibited predictable plasma pharmacokinetics with relatively small inter-individual variability. The current formulation allows for twice-a-day oral dosing, and with further formulation development, there may be potential for once-a-day dosing. Based on these observations, the Company believes that moderate doses of BMB-101 will fully engage 5-HT2C receptors, and therefore not be dose-limited by side effects, which will help to achieve maximal efficacy in future Phase 2 studies. Dose limited side effects exhibited by first generation 5-HT2C agonists have prevented exploiting the full potential of this pharmacological mechanism. The Phase 1 study was conducted in Adelaide, Australia, by CMAX Clinical Research, a clinical trial center specializing in a range of early-phase trials and first-in-human studies. The study evaluated the safety, tolerability, pharmacokinetic (PK), and food effect of BMB-101 in healthy volunteers. About the Phase 1 Study Part 1 – Single Ascending Dose 4 cohorts (6 drug and 2 placebo) – single dose (oral solution) Reached the planned top dose of 180 mg/70 kg, which approached preclinical exposure limits Well tolerated with predictable PK Most common adverse event was oral paresthesias from liquid formulation Part 2 – Food Effect 12 subjects – crossover with and without breakfast, 120 mg/70kg Effect of food on BMB-101 levels was relatively small, and therefore BMB-101 can be administered without the need for fasting Part 3 – Multiple Ascending Dose 4 cohorts (6 drug and 2 placebo) – twice a day dosing for seven days after meals Reached a top dose of 150 mg/70 kg twice a day Biomarkers for central target engagement: Prolactin release and qEEG Good Manufacturing Practices (GMP) production completed for BMB-101 drug substance and drug product. Webcast Information Bright Minds management will host a webcast to discuss the Phase 1 study as follows: Date: Tuesday, August 8, 2023 Time: 4:30pm ET Webcast link: Click here About BMB-101 BMB-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 pro 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 Minds Bright 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. Investor Contacts: Lisa Wilson E: lwilson@insitecony.com T: 917-543-9932 Ian McDonald CEO and Director E: ian@brightmindsbio.com T: 917-543-9932 This news release includes certain statements that may be deemed “forward-looking statements.” All statements in this new release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects,” “plans,” “anticipates,” “believes,” “intends,” “estimates,” “projects,” “potential,” and similar expressions, or that events or conditions “will,” “would,” “may,” “could,” or “should” occur. Forward-looking information in this news release includes statements related to potential future success in indications that have been validated with the 5-HT2C mechanism, the implementation of Phase 2 trials for BMB-101 and the submission of applications related to the same, BMB-101 becoming a best-in-class, novel pharmacophore 5-HT2C agonist for the treatment of seizure disorders, and plans for future formulation development including to achievement of once-a-day dosing in respect of BMB-101. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Factors that could cause the actual results to differ materially from those in forward-looking statements include continued availability of capital and financing, results of Phase 2 clinical trials with respect to BMB-101 and other compounds that the Company may seek to test in the future, results of further development activities related to dosing and the findings specifically related to once-a-day dosing, regulatory conditions with respect to in-human drug trials, and general economic, market or business conditions. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of the Company’s management on the date the statements are made. Except as required by applicable securities laws, the Company undertakes no obligation to update these forward-looking statements in the event that management's beliefs, estimates or opinions, or other factors, should change. Neither the Canadian Securities Exchange nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of this release.