Bright Minds Biosciences, Inc.

NEW YORK AND VANCOUVER, British Columbia, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Bright Minds Biosciences Inc. (Bright Minds or the Company) (NASDAQ: DRUG), a biotechnology company focused on developing novel therapies for neurological and neuropsychiatric disorders, today announced that it is once again collaborating with Firefly Neuroscience, Inc. (Firefly) (NASDAQ: AIFF), an Artificial Intelligence (AI) company developing innovative solutions that improve brain health outcomes for patients with neurological and mental disorders, 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-HT 2C 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-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 enrollment 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-HT 2C 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% of all epilepsy patients who experience drug resistance.” About BMB-101 BMB-101 is a novel scaffold 5-HT 2C 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-HT 2C 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 signaling 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 Bright Minds Biosciences is a biotechnology company developing innovative treatments for patients with neurological and psychiatric disorders. Our pipeline includes novel compounds targeting key receptors in the brain to address conditions with high unmet medical need, including epilepsy, depression, and other CNS 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. 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. Please visit for more information. Forward-Looking Statements This news release contains “forward-looking information”. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, or “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward-looking statements in this news release include design, progress, and completion of the BREAKTHROUGH Study, future clinical development of BMB-101, and future intended use or therapeutic benefit of BMB-101 to treat refractory epilepsy disorders. A variety of factors, including known and unknown risks, many of which are beyond our control, could cause actual results to differ materially from the forward-looking information in this news release. These factors include the company’s financial position and operational runway, regulatory risk to operating in the pharmaceutical industry, and inaccuracies related to the assumption made by management relating to general availability of resources required to operate the studies noted in this news release. Additional risk factors can also be found in the Company’s public filings under the Company’s SEDAR+ pro Forward-looking statements contained herein are made as of the date of this news release and the Company disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or results or otherwise. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. The Company undertakes no obligation to update forward-looking statements if circumstances, management’s estimates or opinions should change, except as required by securities legislation. Accordingly, the reader is cautioned not to place undue reliance on forward-looking statements. The Canadian Securities Exchange has neither approved nor disapproved the information contained herein and does not accept responsibility for the adequacy or accuracy of this news release. Contact Information Alex Vasilkevich Chief Operating Officer Bright Minds Biosciences Inc. Phone: (414)7316422 Email: alex@brightmindsbio.com Website: Investor Relations Lisa M. Wilson T: 212-452-2793 E: lwilson@insitecony.com

Plus, news about Verastem Oncology, Bright Minds Biosciences and Telix Pharmaceuticals: Aura Biosciences unveils early bladder cancer data: The Boston biotech shared that its light-activated drug led to four complete responses in five patients with low-grade non-muscle invasive bladder cancer. In high-grade NMIBC, the drug did not lead to complete responses, but two of three patients saw “visual tumor shrinkage” via a cystoscopy. Last month, Aura unveiled results in a rare eye cancer, the lead indication for its experimental drug that’s known as bel-sar for short. Aura’s shares $AURA jumped about 10% Friday morning. — Lei Lei Wu Poseida scores $15M milestone payment from Roche: Poseida received the milestone after Roche nominated a new dual CAR-T therapy per a 2022 deal. The therapy targets antigens expressed in hematologic malignancies, including multiple myeloma. The companies now have three programs in development, and their lead program is a CAR-T therapy targeting BCMA in the third-line multiple myeloma setting. — Katherine Lewin Verastem Oncology’s stock falls despite positive mid-stage data: In a Phase 2 trial, ovarian cancer patients taking avutometinib and defactinib saw median progression-free survival of 12.9 months, and those with the KRAS mutation had 22 months. The company said it plans to complete its NDA submission this month. Verastem’s stock $VSTM fell about 20% in after-hours trading on Thursday, with Mizuho analysts attributing the stock’s weakness to Verastem’s decision to first seek approval for patients with a KRAS mutation, and not those with wild-type KRAS. — Katherine Lewin Bright Minds Biosciences’ $35M private placement : The funds are set to go toward R&D expenses and general working capital. The company’s stock $DRUG soared about 70% on Friday following the announcement. Earlier this week, Bright Minds announced positive preclinical data for BMB-201, which showed that it outperformed morphine in efficacy. The company now plans to move the drug into clinical trials. — Katherine Lewin Telix Pharmaceuticals files for NASDAQ inclusion: The Australian radiopharma company said listing on the NASDAQ will increase interest from both US and global investors. Last month, Telix paid $230 million upfront to buy radioisotope manufacturer RLS Radiopharmacies. — Katherine Lewin

NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR RELEASE, PUBLICATION, DISTRIBUTION OR DISSEMINATION DIRECTLY OR INDIRECTLY, IN WHOLE OR IN PART, IN OR INTO THE UNITED STATES VANCOUVER, British Columbia, Oct. 18, 2024 (GLOBE NEWSWIRE) -- Bright Minds Biosciences Inc. (CSE: DRUG) (NASDAQ: DRUG) (“Bright Minds” or the “Company”) is pleased to announce a non-brokered private placement of common shares in the capital of the Company (“Shares”) at a price of USD$21.70 per Share (the “Share Offering”). In addition to the Shares issued under the Share Offering, the Company reserves the right to issue pre-funded warrants of the Company (“PFWs”) at USD$21.699 per PFW (the “PFW Offering”, together with the Share Offering, the “Offering”). The aggregate gross proceeds of the Share Offering and the PFW Offering, on a combined basis, is for up to USD$35,000,000. The Company, in its sole discretion, may determine the number of PFWs issued pursuant to the PFW Offering and the number of Shares issued pursuant to the Share Offering. Each PFW is exercisable into one Share (each, a “PFW Share”) at an exercise price of $0.001 per PFW Share on the date that is the earlier of (a) the date the holder thereof elects to exercise the PFWs and pays the exercise price therefor, and (b) 5 years from the date of closing (the “Closing Date”). The Company intends to use the aggregate gross proceeds from the Offering for research and development related to its drug development programs, and general working capital. Each of the Share Offering and the PFW Offering may close on one or more dates as the Company may determine. The Company may pay a finder’s fee in connection with the Offering to eligible arm’s length finders in accordance with the policies of the Canadian Securities Exchange. All securities issued in connection with the Offering will be subject to a statutory hold period of four months and one day following the Closing Date in accordance with applicable Canadian securities laws. The Shares, the PFWs and PFW Shares (collectively, the “Securities”) have not been registered under the U.S. Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws. Accordingly, the Securities of the Company may not be offered or sold in the United States or to, or for the account or benefit of, “U.S. persons” (as defined in Regulation S under the U.S. Securities Act) absent registration or an applicable exemption from the registration requirements of the U.S. Securities Act and applicable state securities laws. Any Securities offered and sold in the United States shall be issued as “restricted securities” as defined in Rule 144(a)(3) under the U.S. Securities Act. This press release shall not constitute an offer to sell or the solicitation of any offer to buy, nor shall there be any sale of the Securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. The Company intends to use its reasonable commercial efforts to file a registration statement with the Securities and Exchange Commission after closing to register the Shares and any PFW Shares underlying PFWs for resale under the U.S. Securities Act. About Bright Minds Bright Minds Biosciences is a biotechnology company developing innovative treatments for patients with neurological and psychiatric disorders. Our pipeline includes novel compounds targeting key receptors in the brain to address conditions with high unmet medical need, including epilepsy, depression, and other CNS 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. Company Contact:Alex Vasilkevich Chief Operating Officer Bright Minds Biosciences Inc. T: (414)7316422 E: alex@brightmindsbio.com www.brightmindsbio.com Investor Relations:Lisa WilsonT: 917-543-9932E: lwilson@insitecony.com The Canadian Securities Exchange has neither approved nor disapproved the information contained herein and does not accept responsibility for the adequacy or accuracy of this news release. This news release contains “forward-looking information”. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, or “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward-looking statements in this news release include the completion of the Offering as well as the use of proceeds for the Offering. A variety of factors, including known and unknown risks, many of which are beyond our control, could cause actual results to differ materially from the forward-looking information in this news release. These factors include the company’s financial position and operational runway, regulatory risk to operating in the pharmaceutical industry, and inaccuracies related to the assumption made by management relating to general availability of resources required to operate the studies noted in this news release. Additional risk factors can also be found in the Company’s public filings under the Company’s SEDAR+ profile at www.sedarplus.ca. Forward-looking statements contained herein are made as of the date of this news release and the Company disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or results or otherwise. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. The Company undertakes no obligation to update forward-looking statements if circumstances, management’s estimates or opinions should change, except as required by securities legislation. Accordingly, the reader is cautioned not to place undue reliance on forward-looking statements.