GAD

BetterLife Announces Closing of $1.168 Million Convertible Debentures to Further Advance IND-enabling Studies of its Non-hallucinogenic LSD-based Drug Candidate BETR-001

Retrieved on: 
Wednesday, April 3, 2024

The IND-enabling cardio-pulmonary GLP studies have been completed, and the metabolism and genotoxicity GLP studies are to be initiated shortly.

Key Points: 
  • The IND-enabling cardio-pulmonary GLP studies have been completed, and the metabolism and genotoxicity GLP studies are to be initiated shortly.
  • Dr. Ahmad Doroudian, CEO of BetterLife, commented, “We are very encouraged with FDA’s recent decision to grant breakthrough therapy designation to LSD for generalized anxiety disorder (GAD) patients.
  • In simple words, we believe BETR-001 will deliver all the therapeutic benefits of LSD without its side effects.”
    BetterLife issued a total of $1.168 million 10% convertible debentures (the “Convertible Debentures”).
  • $800,000 of the Convertible Debentures mature on March 27, 2026 and $368,000 mature on April 1, 2026.

Cybin Initiates Phase 2 Proof-of-Concept Study of CYB004 in Generalized Anxiety Disorder

Retrieved on: 
Friday, March 15, 2024

“Initiation of the Phase 2 study of CYB004 for GAD is an exciting step forward for our deuterated DMT program,” said Doug Drysdale, Chief Executive Officer of Cybin.

Key Points: 
  • “Initiation of the Phase 2 study of CYB004 for GAD is an exciting step forward for our deuterated DMT program,” said Doug Drysdale, Chief Executive Officer of Cybin.
  • The CYB004-002 Phase 2 study is a randomized, double-blind study which will evaluate the safety and efficacy of CYB004 in participants with GAD, with concomitant antidepressant/anxiolytic treatment and co-morbid depression allowed.
  • The study will enroll participants with moderate to severe GAD and a score of ≥10 on the GAD-7 anxiety scale.
  • Global, regional and national burden of anxiety disorders from 1990 to 2019: results from the Global Burden of Disease Study 2019.

Dr. Bill Winston Welcomed Thousands of Attendees and Awarded Nearly $20,000 to Entrepreneurs at 2024 Business & Leadership Conference

Retrieved on: 
Tuesday, April 2, 2024

CHICAGO, April 2, 2024 /PRNewswire/ -- Dr. Bill Winston, a globally renowned pastor, entrepreneur, and business leader, presented the 2024 Business & Leadership Conference (BLC) from March 22-23, where thousands of entrepreneurs and leaders gathered in-person and online, to equip themselves with business strategies and tools to create their own economies and dominate their industries. The free, two-day hybrid conference welcomed entrepreneurs, business, and faith leaders from around the world who were empowered to take the lead in areas of influence – business, government, religion, education, media, arts, entertainment, etc. – by receiving professional insights and the tools needed to bring their businesses to fruition.

Key Points: 
  • The free, two-day hybrid conference welcomed entrepreneurs, business, and faith leaders from around the world who were empowered to take the lead in areas of influence – business, government, religion, education, media, arts, entertainment, etc.
  • BLC was hosted by the nationally accredited Joseph Business School (JBS) , which celebrated 25 years this year.
  • Founded by Dr. Bill Winston, the school, which has a campus and online program, teaches business leaders and entrepreneurs how to excel in the marketplace using the practical and spiritual principles found in the Bible.
  • For more information or to view the 2024 speaking engagements, interviews and special events, please visit https://blc.billwinston.org , the JBS YouTube page , or https://jbs.edu/ .

Clemson University Finds Hazel Health Teletherapy Program Drives Clinically Significant Outcomes in School Mental Health

Retrieved on: 
Tuesday, March 19, 2024

Hazel Health , the nation's largest school-based telehealth provider, today released the results of a third-party analysis demonstrating the clinical effectiveness of its proprietary teletherapy program for K-12 students, H.E.A.R.T™ (Hazel Early Assessment Response Treatment).

Key Points: 
  • Hazel Health , the nation's largest school-based telehealth provider, today released the results of a third-party analysis demonstrating the clinical effectiveness of its proprietary teletherapy program for K-12 students, H.E.A.R.T™ (Hazel Early Assessment Response Treatment).
  • Each student-patient was scored for symptom severity pre vs. post-treatment (via the PHQ-9 for depression and the GAD-7 for anxiety).
  • The duration of the evidence-based treatment program was individualized to each participant, depending on their specific clinical needs at intake.
  • — William Edwards, PhD, BCBA, Director of the Center for Behavior Analysis at Clemson University Learning Institute.

Firefly Neuroscience’s White Paper Unveils BNA™ Platform’s Significant Impact on Disease Management in 2,253 U.S Patients

Retrieved on: 
Tuesday, March 5, 2024

FAIRFAX, Va. and TORONTO, March 05, 2024 (GLOBE NEWSWIRE) -- Firefly Neuroscience, Inc. (“Firefly”), a pioneering AI company developing innovative neuroscientific solutions to improve outcomes for patients with mental illnesses and neurological disorders, today announced the findings presented in a 2023 white paper “Brain Network Analytics (BNA) in the Psychiatric Practice: Real-Life Data Analysis” by Charlotte Baumeister, Ph.D., with analysis by Offir Laufer, Ph.D. Firefly has entered into an agreement (as amended, the “Merger Agreement”) to merge with WaveDancer, Inc. (“WaveDancer”) (NASDAQ: WAVD), subject to the approval of the stockholders of Firefly and WaveDancer (the “Merger”).

Key Points: 
  • This FDA-approved 510(k) tool harnesses vast data sets, including thousands of normative, age-matched electroencephalogram (“EEG”) recordings, empowering clinicians to make informed decisions in therapy and disease management.
  • The results suggest the transformative potential of the BNA™ Platform to significantly improve psychiatric care.
  • With the potential to revolutionize disease management, enhance treatment outcomes, and improve the overall well-being of patients with mental illnesses and cognitive disorders, we believe the BNA™ Platform can have a transformative impact.
  • We believe these findings will pave the way for widespread adoption of the BNA™ Platform into standard patient management protocols.”

MindMed Receives FDA Breakthrough Therapy Designation and Announces Positive 12-Week Durability Data From Phase 2B Study of MM120 for Generalized Anxiety Disorder

Retrieved on: 
Thursday, March 7, 2024

The Company also announced that its Phase 2b study of MM120 in GAD met its key secondary endpoint, and 12-week topline data demonstrated clinically and statistically significant durability of activity observed through Week 12.

Key Points: 
  • The Company also announced that its Phase 2b study of MM120 in GAD met its key secondary endpoint, and 12-week topline data demonstrated clinically and statistically significant durability of activity observed through Week 12.
  • MM120 was administered as a single dose in a monitored clinical setting with no additional therapeutic intervention.
  • “I’ve conducted clinical research studies in psychiatry for over two decades and have seen studies of many drugs under development for the treatment of anxiety.
  • MindMed management will host a webcast at 8:00 am ET today to discuss the Phase 2b results of MM120 in GAD.

MindMed to Host Conference Call and Webcast to Discuss Data Update for MM120

Retrieved on: 
Friday, March 1, 2024

Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (Cboe Canada: MMED), (the "Company" or "MindMed"), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced that it will host a conference call and webcast on March 7, 2024.

Key Points: 
  • Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (Cboe Canada: MMED), (the "Company" or "MindMed"), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced that it will host a conference call and webcast on March 7, 2024.
  • The event will begin at 8:00 a.m. Eastern Time on Thursday, March 7, 2024.
  • The webcast and slides will be accessible live under “News & Events” on the Investors page of the Company’s website at https://ir.mindmed.co/ or by clicking here .
  • A replay of the event will be available on MindMed’s website.

MindMed Reports 2023 Financial Results and Business Updates

Retrieved on: 
Wednesday, February 28, 2024

Mind Medicine (MindMed) Inc. (NASDAQ:MNMD), (Cboe Canada:MMED), (the "Company" or "MindMed"), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced its financial results for the year ended December 31, 2023 and provided a business update.

Key Points: 
  • Mind Medicine (MindMed) Inc. (NASDAQ:MNMD), (Cboe Canada:MMED), (the "Company" or "MindMed"), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced its financial results for the year ended December 31, 2023 and provided a business update.
  • “2023 was a highly productive year for MindMed, which concluded with positive Phase 2b results for MM120 in the treatment of adult patients with GAD,” said Rob Barrow, Chief Executive Officer and Director of the Company.
  • As of December 31, 2023, MindMed had cash and cash equivalents totaling $99.7 million compared to $142.1 million as of December 31, 2022.
  • MindMed management will host a conference call at 8:00 AM EST today to provide a corporate update and review the Company’s 2023 financial results.

Numinus Wellness Congratulates MindMed on Positive Results from Phase 2B Clinical Trials of MM120 for Generalized Anxiety Disorder

Retrieved on: 
Friday, March 8, 2024

Based on initial clinical data from the Phase 2b trial and the significant unmet medical need in treating GAD, the U.S. Food & Drug Administration ("FDA") has designated MM120 for GAD as a breakthrough therapy.

Key Points: 
  • Based on initial clinical data from the Phase 2b trial and the significant unmet medical need in treating GAD, the U.S. Food & Drug Administration ("FDA") has designated MM120 for GAD as a breakthrough therapy.
  • Numinus' Cedar Clinical Research Draper Utah research clinic was among the highest enrolling sites for the study, with its clinic at Murray, Utah, also participating.
  • Dr. Reid Robison, Numinus' Chief Clinical Officer and Dr. Paul Thielking, Chief Science Officer, were Principal Investigators.
  • "We look forward to continuing to work with MindMed as it advances its important research into MM120.

MycoMeditations Surveys Show Lasting Benefits of Psilocybin Therapy for Major Depression and Anxiety Disorders

Retrieved on: 
Tuesday, February 20, 2024

TREASURE BEACH, Jamaica, Feb. 20, 2024 /PRNewswire-PRWeb/ -- MycoMeditations, a pioneer in legal psilocybin-assisted therapy retreats, today announced the results of two years of longitudinal (long-term) client surveys exploring the impact of its psilocybin retreats on individuals suffering with Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), and Social Anxiety Disorder (SAD). The findings complement MycoMeditations' previously released surveys focused on Post-Traumatic Stress Disorder (PTSD).

Key Points: 
  • The findings complement MycoMeditations' previously released surveys focused on Post-Traumatic Stress Disorder (PTSD).
  • MycoMeditations employed the PHQ-9, GAD-7, and SM-SAD-Adult questionnaires to measure self-reported symptom severity and long-term outcomes across MDD, GAD, and SAD, respectively.
  • Clinically significant improvements were maintained for one year following retreat for each Major Depressive Disorder, Generalized Anxiety, and Social Anxiety, suggesting possible long-term efficacy of psilocybin-assisted therapy.
  • The data suggests the viability of multiple psilocybin treatments in a short period of time when coupled with therapy, as MycoMeditations retreats are 7-nights with 3 psilocybin sessions on alternating days.