Mind Medicine - MNMD STOCK NEWS

MindMed (NASDAQ: MNMD), a late-stage biopharmaceutical company focused on brain health disorders, has announced its participation in the Oppenheimer 35th Annual Healthcare Life Sciences Conference. The company's management team will engage in a fireside chat and one-on-one meetings during the virtual event, scheduled for February 12, 2025, at 9:20 AM ET.

Audio webcasts and replays of the presentations will be made available on MindMed's Investor Relations website, remaining accessible for up to 90 days after the event. This conference participation represents an opportunity for the company to showcase its developments in brain health treatments to the investment community.

MindMed (NASDAQ: MNMD) has initiated Panorama, its second Phase 3 study of MM120 ODT (lysergide D-tartrate) for Generalized Anxiety Disorder (GAD), with the first patient now dosed. The study will evaluate a proprietary, pharmaceutically optimized form of LSD against placebo, enrolling approximately 250 participants across US and Europe.

The 52-week trial consists of two parts: a 12-week double-blind, placebo-controlled period and a 40-week extension period for open-label treatment. Participants will be randomized in a 2:1:2 ratio to receive MM120 ODT 100 µg, 50 µg, or placebo. The primary endpoint will measure changes in Hamilton Anxiety Rating Scale (HAM-A) score at week 12.

The study builds on 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 second half of 2026.

MindMed (MNMD) announced its upcoming addition to the Nasdaq Biotechnology Index (NBI), effective December 23, 2024. The company highlighted key 2024 achievements, including raising $250 million through equity financings, securing a new patent for MM120 orally disintegrating tablet (ODT) with protection through 2041, expanding their pipeline to include MM120 ODT for major depressive disorder, and launching Phase 3 Voyage study for generalized anxiety disorder. The NBI tracks biotechnology and pharmaceutical securities on Nasdaq, with companies meeting specific eligibility criteria including market capitalization, trading volume, and public company seasoning requirements.

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.