Mind Medicine (MindMed) Inc. Common Shares - MNMD STOCK NEWS

MindMed (NASDAQ: MNMD) has initiated its Phase 3 Voyage study by dosing the first patient with MM120 ODT, a pharmaceutically optimized form of lysergide D-tartrate (LSD) for treating Generalized Anxiety Disorder (GAD). The study, designed to enroll approximately 200 participants in the U.S., is the first of two Phase 3 trials. The 52-week study consists of a 12-week double-blind period and a 40-week extension period. The primary endpoint will measure changes in HAM-A scores at Week 12.

The second Phase 3 trial, Panorama, is scheduled to begin in the first half of 2025 across the U.S. and Europe. These trials build upon positive Phase 2b results presented at the American Psychiatric Association's Annual Meeting in May 2024. Topline data from the 12-week double-blind period is expected in the first half of 2026.

Mind Medicine (MindMed) (NASDAQ: MNMD), a clinical-stage biopharmaceutical company, announced the presentation of encore data from its Phase 2b study of MM120 (lysergide D-tartrate or LSD), the company's lead product candidate for treating generalized anxiety disorder (GAD), at the ACNP 2024 Congress held from December 8-11 in Phoenix, AZ.

The presentations included two posters:

• Functional and sexual disability, and quality of life after one dose of MM120 (lysergide) in adults with GAD, presented by Paula Jacobson, Ph.D., Executive Director, Clinical Development, MindMed.
• Rapid and durable response to a single dose of MM120 (lysergide) in GAD: A dose-optimization study, presented by Dan Karlin, M.D., M.A., Chief Medical Officer, MindMed.

The posters are available on MindMed’s Company website.

Mind Medicine (MindMed) (NASDAQ: MNMD), a clinical-stage biopharmaceutical company, announced that its MM120 Orally Disintegrating Tablet (ODT) has been granted an Innovation Passport by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) under the Innovative Licensing and Access Pathway (ILAP). This designation aims to accelerate the time to market and facilitate patient access to MM120 ODT for the treatment of Generalized Anxiety Disorder (GAD). The Innovation Passport provides access to various development tools and opportunities for enhanced regulatory input. Specific benefits include a potential 150-day accelerated Marketing Authorization Application assessment and continuous benefit-risk assessment. This follows the receipt of Breakthrough Therapy Designation by the U.S. FDA, highlighting MM120 ODT's potential to address critical needs in mental health.

MindMed (NASDAQ: MNMD) has appointed Dr. Javier A. Muniz as Vice President of Research and Development Strategy. Dr. Muniz brings over 20 years of experience in uniformed services, including 11 years at the FDA where he provided regulatory oversight for psychiatric drug development programs. He will strengthen R&D operations as the company prepares to initiate three Phase 3 studies of MM120 orally disintegrating tablet for generalized anxiety disorder and major depressive disorder. Dr. Muniz's expertise in psychiatry, regulatory science, and drug development, along with his experience in psychedelic and entactogen-based therapies, positions him to advance MindMed's pipeline toward potential approvals.

MindMed (NASDAQ: MNMD) has announced the issuance of inducement grants to four newly hired non-executive employees. The grants consist of options to purchase 171,000 common shares of the Company, with grant dates of November 18 and December 2, 2024. The options will vest over four years, with 25% vesting after one year and the remaining 75% vesting monthly over three years. The exercise price equals the closing price of MindMed shares on the last trading day before each grant. These grants were approved by MindMed's Compensation Committee on November 15, 2024, under NASDAQ Rule 5635(c)(4).

MindMed (NASDAQ: MNMD) has appointed Gregg A. Pratt, Ph.D. as Chief Regulatory and Quality Assurance Officer. Dr. Pratt will oversee regulatory and quality functions, as well as product registration strategies as the company prepares to launch three Phase 3 studies of MM120 orally disintegrating tablet for generalized anxiety disorder (GAD) and major depressive disorder (MDD). Dr. Pratt brings over 30 years of experience in drug development and previously led the regulatory approval of COBENFY™ at Karuna Therapeutics. As part of his appointment, Dr. Pratt received an inducement award of options to purchase 350,000 common shares, vesting over four years.

MindMed (NASDAQ: MNMD), a clinical-stage biopharmaceutical company focused on brain health disorders, has announced its participation in two upcoming investor conferences. The company will attend the Jefferies London Healthcare Conference for one-on-one meetings on November 20-21, 2024, in London, UK. Additionally, MindMed will participate in the 7th Annual Evercore HealthCONx Conference on December 5, 2024, in Coral Gables, FL, featuring a fireside chat at 11:15 PM ET. Audio webcasts and replays will be available on MindMed's Investor Relations website for 90 days after each event.

MindMed (NASDAQ: MNMD) reported Q3 2024 financial results and provided updates on its clinical programs. The company is preparing to launch three Phase 3 studies, including the Voyage study for GAD in Q4 2024, with topline data expected in H1 2026. Cash position stands at $295.3 million, expected to fund operations into 2027. Q3 2024 saw R&D expenses of $17.2 million and net loss of $13.7 million. The company's MM120 ODT program is advancing with additional Phase 3 studies Panorama (GAD) and Emerge (MDD) planned for H1 2025, targeting conditions affecting approximately 51 million U.S. adults.

MindMed (NASDAQ: MNMD), a clinical-stage biopharmaceutical company focused on brain health disorders, has scheduled a conference call and webcast for Thursday, November 7, 2024, at 4:30 p.m. ET. The event will cover the company's third quarter 2024 financial results and provide a corporate update. The webcast will be accessible through a registration link, with a replay available on the company's investor relations website for at least 30 days. Participants are encouraged to join 15 minutes before the start time.