Move Over Xanax? New Research on LSD Offers Hope for Anxiety https://www.psychologytoday.com/us/...x-new-research-on-lsd-offers-hope-for-anxiety
PUBMED - Single Treatment With MM120 (Lysergide) in Generalized Anxiety Disorder: A Randomized Clinical Trial - https://pubmed.ncbi.nlm.nih.gov/40906494/
Reimagining LSD to Treat Mental Health Disorders - https://themedicinemaker.com/issues...agining-lsd-to-treat-mental-health-disorders/
(Video) Trial shows promise for treating anxiety with LSD https://www.10news.com/news/local-news/trial-shows-promise-for-treating-anxiety-with-lsd
MindMed Corporate Presentation - October 2025 https://d1io3yog0oux5.cloudfront.ne...f/MindMed+Corporate+Presentation_Oct+2025.pdf 1. Company Overview Mind Medicine (MindMed) Inc. is a neuro-pharmaceutical company developing psychedelic-inspired medicines to treat psychiatric and neurodevelopmental disorders, with a focus on generalized anxiety disorder (GAD) and major depressive disorder (MDD) — two of the largest drivers of psychiatric disease burden. Lead asset: MM120 ODT (Lysergide D-tartrate) — an orally disintegrating tablet version of LSD, now in Phase 3 trials for GAD and MDD. Secondary asset: MM402 (R-(-)-MDMA) — a proprietary MDMA enantiomer being advanced for autism spectrum disorder (ASD). Cash position: $209.1 million (as of Sept 30, 2025) with a runway into 2027, and an additional $120 million credit facility. 2. MM120 Program Highlights Clinical Progress Three Phase 3 readouts expected in 2026: GAD (two studies: MM120-300 and MM120-301) MDD (one study: MM120-310) Phase 3 design mirrors successful Phase 2b results, which showed: Rapid and durable anxiety reduction after a single dose Large effect size (Cohen’s d = 0.81), more than double standard GAD treatments 48% remission at 12 weeks Favorable tolerability with mostly transient, mild-to-moderate adverse events Regulatory Status Breakthrough Therapy Designation (U.S. FDA) Innovation Passport (U.K. MHRA) Phase 3 protocols aligned with FDA guidance for psychedelic drug development Comparative Efficacy MM120’s single-dose 12-week effect surpassed leading SSRIs/SNRIs like Duloxetine, Escitalopram, and Venlafaxine in historical HAM-A improvement data. No psychotherapy is required — the observed benefit was a standalone drug effect. 3. Market Opportunity Unmet Need 26 million U.S. adults live with GAD; 41 million with MDD. >50% fail first-line pharmacological therapy. Existing options have slow onset, poor efficacy, and low tolerability (sexual dysfunction, weight gain, dependency). Commercial Potential MM120 could deliver: Fast onset and durable response Intermittent dosing reducing long-term side effects Single-session treatment model (5–8 hours, outpatient setting) If approved, MM120 could access billion-dollar markets in both GAD and MDD. Reimbursement & Delivery Fits within existing psychiatric care infrastructure. Reimbursement anticipated via existing CPT codes for psychedelic therapy monitoring. Potential 56× fewer administration sessions and 14× fewer monitoring hours per year vs. Spravato® (esketamine). 4. MM402 (R-(-)-MDMA) Program Completed Phase 1 in 2024 — well-tolerated up to 255 mg. Phase 2a study in autism spectrum disorder (ASD) to begin Q4 2025, exploring effects on social and communication symptoms. ASD prevalence: ~1 in 31 U.S. children; no approved treatments for core symptoms. 5. Financial Summary & Outlook Metric Detail Cash & Investments $209.1 M (Sept 30 2025) Credit Facility Up to $120 M ($42 M drawn) Shares Outstanding 75.8 M (June 30 2025) Operating Expenses (Q2 2025) $40.9 M (R&D $29.8 M / G&A $11.1 M) Cash Runway Funding operations into 2027 Upcoming Catalysts Three Phase 3 topline readouts in 2026; MDD Phase 3 initiation mid-2026 6. Strategic Takeaways Strong execution: successful end-of-Phase 2 meeting with FDA; robust IP protection through 2041. Clinical ambition: potential first-in-class psychedelic-derived oral therapy for anxiety and depression. Commercial readiness: scalable delivery model, existing infrastructure, and positive economics for providers. Outlook: if MM120 achieves expected Phase 3 outcomes, MindMed could become a leader in next-generation psychiatric therapeutics with first-mover advantage in both GAD and MDD.
Minnesota Psychedelic Medicine Task Force LEGISLATIVE REPORT https://www.lrl.mn.gov/docs/2024/mandated/241756.pdf MindMed's study is listed in this document - State's are watching and gearing up... Hold. --- Executive summary The Minnesota legislature created the Psychedelic Medicine Task Force to advise it on the legal, medical, and policy issues associated with the legalization of psychedelic medicine in the state. Within that legislation and this report, “psychedelic medicine” means 3,4-methylenedioxymethamphetamine (MDMA), lysergic acid diethylamide (LSD), and psilocybin, which can be synthetic or with psilocybin, found naturally in certain mushrooms (often referred to as “magic mushrooms”). The task force met once a month between November 2023 and December 2024 to discuss the scientific, cultural, and legal considerations of the legislative charge, as well as questions of cost, access, and equity. Smaller working groups also met outside of the larger monthly meeting. The task force regularly consulted subject matter experts, both during full task force meetings and working groups. The report this task force produced is a product of the shared perspectives and experiences of its appointed members, and not of any one individual nor of any of the state agencies that served on it. Recommendations By a two-thirds supermajority vote of its members, the task force recommends the Minnesota legislature: 1. Create a state-regulated clinical program for the therapeutic administration of psilocybin-containing mushrooms. 2. Remove criminal penalties for the personal use and possession of psilocybin-containing mushrooms. 3. Allocate funding for more research into the health benefits of MDMA, psilocybin, and LSD. The task force considered additional proposals that did not reach a two-thirds supermajority, including: 1. The removal of criminal penalties for the personal use and possession and noncommercial (without remuneration) cultivation and sharing of psilocybin-containing mushrooms. 2. Remove criminal penalties for the personal use and possession of MDMA, synthetic psilocybin, and LSD. 3. The creation of a state-regulated program for the clinical administration of MDMA and LSD. 4. Creating a regulated, adult use market for psilocybin-containing mushrooms.
Vendor Dispute from 2024 Turns into a Win for MindMed https://www.govinfo.gov/content/pkg...v-00709/pdf/USCOURTS-paed-2_24-cv-00709-0.pdf There was a court filing made mid last year I just uncovered involving Signant Health and EMA Wellness could actually be a mild positive for MindMed. See the attached link. The dispute was between two vendors competing for MindMed’s Phase III clinical trial work... Not against MindMed itself! (I need to disclaim that because people misconstrue statements or informaiton). The judge denied Signant’s request to stop EMA from working with MindMed, finding no evidence of trade secret misuse or wrongdoing, and even accepted MindMed’s statement that Signant was never in contention for the contract. This outcome clears the way for MindMed’s clinical trial to continue without disruption, validates that the company managed its vendor relationships properly, and suggests its program is valuable enough to spark competition among major trial service providers. In short, MindMed was just the prize these vendors were fighting over, and the court’s ruling removes any legal overhang while confirming business as usual. A quietly bullish development for shareholders. MindMed was in demand as a client. Two specialized clinical-trial technology firms (Signant and EMA) were competing for its business. That suggests MindMed’s Phase III program is viewed as valuable and high-profile within the industry. Vendors don’t fight over small, low-potential clients. The court validated MindMed’s independence. MindMed was not implicated in wrongdoing, and the judge accepted MindMed’s statement that it made an independent decision to award the contract to EMA. That protects MindMed from any legal entanglement and shows it’s managing its vendor relationships cleanly. EMA can now focus on execution. The injunction denial means EMA’s work for MindMed can continue uninterrupted. Regulatory delays or disruptions to trial data collection are avoided — which is key for investor confidence. MindMed likely got more leverage. Vendor competition often leads to better pricing, service levels, and innovation for the client. If Signant and EMA were fighting to prove who could deliver better eCOA tools, MindMed might have benefited from improved technology or lower costs.
MindMed to Participate in Upcoming Investor Conferences NEW YORK--(BUSINESS WIRE)-- Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (the “Company” or “MindMed”), a late-stage clinical biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced that members of the Company’s management team will participate in the following investor conferences: https://www.businesswire.com/news/home/20251105303331/en
