Bright Minds Biosciences Inc. - DRUG STOCK NEWS

Bright Minds Biosciences (NASDAQ: DRUG) has announced a renewed collaboration with Firefly Neuroscience (NASDAQ: AIFF) for the analysis of EEG data from the BREAKTHROUGH study, a Phase 2 clinical trial of BMB-101. This open-label trial is evaluating the safety, tolerability, and efficacy of BMB-101, a selective 5-HT2C receptor agonist, in adult patients with classic Absence Epilepsy and Developmental Epileptic Encephalopathy (DEE).

The study is designed as a basket clinical trial, targeting enrollment of 20 adult participants aged 18-65. It aims to address rare epilepsy disorders characterized by refractory seizures resistant to current treatments. Bright Minds believes BMB-101 has the potential to be a best-in-class 5-HT2C agonist with broad applicability across 30% of epilepsy patients experiencing drug resistance.

Bright Minds Biosciences (NASDAQ: DRUG) has announced positive preclinical data for its proprietary compound BMB-201, a 5-HT2C/2A mixed agonist. The study, conducted through the National Institute of Health pain screening program, demonstrated that BMB-201 had similar efficacy to morphine in several pain models, including plantar incision and L5/L6 nerve ligation in rats.

Key findings include:

• BMB-201 showed superior reductions in mechanical allodynia and pain-related behaviors compared to morphine in nerve ligation models
• Female rodents experienced significant improvement in pain relief and guarding behavior at higher doses
• The compound's efficacy suggests potential for better pain relief than traditional opioids without associated risks

Bright Minds plans to advance BMB-201 into clinical trials, aiming to position it as a non-opioid alternative for neuropathic pain relief.

At the request of CIRO, Bright Minds Biosciences (CSE: DRUG) (NASDAQ: DRUG) has confirmed that the company's management is unaware of any material changes in its operations that could explain the recent increase in market activity. This statement was made in response to unusual trading patterns observed in the company's stock.

The press release, dated October 15, 2024, serves as a formal declaration to investors and regulatory bodies that Bright Minds has not undergone any significant operational changes that would justify the recent market behavior. This type of announcement is often made to ensure transparency and compliance with stock exchange regulations.

Bright Minds Biosciences (NASDAQ: DRUG), a company developing selective 5-HT2 agonists for CNS disorders, announces participation in upcoming scientific conferences and partnering events. The company will present at:

• Neuroscience 2024 annual meeting in Chicago, October 5–9
• Therapeutic Development at NINDS Chicago, October 7
• BIO-Europe in Stockholm, November 4-6
• Chicago Biocapital Summit, November 6-7
• AES Annual Meeting 2024 in Los Angeles, December 6-10

Presentations will cover novel 5-HT2A-selective agonists, Phase I study results of BMB-101, and biased 5-HT2C agonism for epilepsy management. The company also granted 70,000 stock options to employees and board members, exercisable at $1.65 per share for five years, subject to vesting periods.

Bright Minds Biosciences (NASDAQ / CSE: DRUG) is hosting a Key Opinion Leader (KOL) event on September 25th, 2024, focusing on their Phase 2 BREAKTHROUGH clinical trial of BMB-101 for drug-resistant epilepsies. The event will feature renowned epilepsy experts Dr. Dennis Dlugos, Dr. Joe Sullivan, and Dr. Jo Sourbron, who will discuss unmet needs in epilepsy treatment and the potential of novel therapies.

BMB-101 is the first 5-HT2C agonist in clinical studies designed to target therapeutic pathways without receptor desensitization. The KOL event will provide insights into the evolving landscape of drug-resistant seizures and highlight the scientific innovations driving the trial design. Interested parties can register for the webcast in advance, with a replay available for those unable to attend live.

Bright Minds Biosciences (NASDAQ: DRUG) has initiated the BREAKTHROUGH Study, a Phase 2 clinical trial evaluating BMB-101, a selective 5-HT2C agonist, for Absence Epilepsy and Developmental Epileptic Encephalopathy (DEE). The open-label trial aims to assess safety, tolerability, and efficacy in 20 adult patients aged 18-65. Key points include:

1. 4-week baseline period, followed by 8-12 week treatment phase and 4-week follow-up
2. Primary endpoints: change in generalized spike-wave discharges and seizure frequency
3. Planned open-label extension for responders
4. Financial runway extending into 2026
5. Investor call scheduled for September 25, 2024

The company believes BMB-101 has potential to be a best-in-class treatment for refractory epilepsy, addressing a significant unmet need.

Bright Minds Biosciences (CSE:DRUG, NASDAQ:DRUG) has received a positive Written Opinion from the International Searching Authority on its international patent application for phenethylamine compounds, which includes its lead clinical candidate BMB-202. This selective 5-HT_2A agonist shows over 30-fold selectivity against 5-HT_2C and over 500-fold against 5-HT_2B. The favorable report supports the company's strategy in drug discovery aimed at neuropsychiatric disorders, epilepsy, and pain. BMB-202's potential as a best-in-class treatment is highlighted, with optimized properties such as a short half-life and strong potency, outperforming psilocin in vitro. The CEO emphasized this as a crucial step in protecting their innovative compounds globally.

Bright Minds Biosciences (CSE:DRUG, NASDAQ:DRUG) announced significant advancements in its lead program, BMB-101, a selective 5-HT_2C agonist, which is undergoing a first-in-human Phase 1 clinical trial in Adelaide, Australia. The company presented at the 20^th International Meeting of the International Society for Serotonin Research, highlighting BMB-101's therapeutic potential for neuropsychiatric disorders. Compared to Lorcaserin, BMB-101 exhibits superior Gq signaling and minimal beta-arrestin recruitment. The ongoing trial aims to evaluate the compound's safety, tolerability, pharmacokinetics, and food effect in healthy volunteers. With promising preclinical data suggesting efficacy against addiction and epilepsy, particularly Dravet Syndrome, Bright Minds aims to innovate treatments that address serotonin system dysfunctions.

Bright Minds Biosciences has initiated a Phase 1 clinical trial for its lead drug candidate, BMB-101, a 5-HT_2C agonist, in Australia. The trial focuses on evaluating the drug's safety and pharmacokinetics. The company is transitioning to a development phase, aiming to address neuropsychiatric disorders and epilepsy. BMB-101 has shown promise in preclinical studies for treating refractory epilepsies and is well-tolerated in early trials. Additionally, BMB-202, another candidate, is expected to enter human trials by late 2023. The company has strengthened its leadership with key medical and scientific appointments.