MindMed Announces Q2 2024 Financial Results and Business Updates

Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), a clinical-stage biopharmaceutical company, announced its financial results for the quarter ending June 30, 2024, and provided updates on its business operations.

Rob Barrow, CEO of MindMed, highlighted the company's progress, particularly the successful Phase 2b data for MM120 ODT in Generalized Anxiety Disorder (GAD). He confirmed the initiation of Phase 3 clinical trials for MM120 ODT in GAD set for later this year, with plans to extend this study to Major Depressive Disorder (MDD). The company completed its End-of-Phase 2 meeting with the FDA, confirming the requirements for Phase 3 trials. Additionally, MindMed extended its intellectual property protection for MM120 ODT through 2041.

Financially, MindMed is in a strong position with $243.1 million in cash as of June 30, 2024. The company raised an additional $75 million, boosting its cash runway into 2027. This financial stability will support the advancement of its research and development pipeline, with significant milestones anticipated beginning in 2026.

Key business updates include:
- A completed underwriting offering of common shares and pre-funded warrants, raising $75 million.
- Issuance of a new patent (USPN 12,036,220) covering MM120 ODT, extending its protection through 2041.
- Voluntarily delisting from Cboe Canada, while maintaining its NASDAQ listing under "MNMD".

Program Updates and Upcoming Milestones:
MM120 (lysergide D-tartrate) for GAD: 
- The Phase 3 program includes two trials: the Voyage Study (MM120-300) and the Panorama Study (MM120-301). Each trial comprises two parts: a 12-week randomized, double-blind, placebo-controlled study to assess efficacy and safety, and a 40-week extension study for open-label treatment eligibility.
- Voyage is expected to enroll about 200 participants, while Panorama aims for 240 participants. The primary endpoint is the change in Hamilton Anxiety Rating Scale (HAM-A) score at Week 12.
- Both trials will use adaptive designs to allow for sample size adjustments to maintain statistical power. Voyage and Panorama are scheduled to start in the second half of 2024 and the first half of 2025, respectively, with results expected by 2026.

MM120 (lysergide D-tartrate) for MDD:
- The Emerge Study (MM120-310) follows a similar structure to the GAD trials. It includes a 12-week randomized, double-blind, placebo-controlled study and a 40-week extension for open-label treatment.
- Emerge will enroll at least 140 participants, with the primary endpoint being the change in Montgomery Åsberg Depression Rating Scale (MADRS) score at Week 6.
- Initiation is planned for the first half of 2025, with results expected in the second half of 2026. A second registrational study will follow, informed by the Emerge Study and further regulatory discussions.

MM402 (R(-)-MDMA) for Autism Spectrum Disorder (ASD):
- Undergoing a Phase 1 single-ascending dose trial in healthy adults to evaluate tolerability, pharmacokinetics, and pharmacodynamics. This will set the stage for further trials to investigate its effects and potential efficacy in ASD.

Financial Results for Q2 2024:
- As of June 30, 2024, MindMed's cash and cash equivalents totaled $243.1 million, up from $99.7 million as of December 31, 2023. This increase results from an underwriting offering, bringing $75 million in gross proceeds.
- R&D expenses were $14.7 million, slightly down from $14.8 million in the same period in 2023, due to decreased expenses in the MM120 program and preclinical activities, offset by increased personnel and MM402 program costs.
- G&A expenses dropped to $9.8 million from $14.4 million, primarily due to reduced professional services fees and expenses.
- The net loss for the quarter was $5.9 million, a significant improvement from $29.1 million in the same quarter of 2023, primarily driven by changes in the fair value of USD Financing Warrants.

In summary, MindMed is progressing steadily with its clinical programs, maintaining a robust financial position to support its ambitious research and development goals. The advancement into Phase 3 trials for MM120 in GAD and MDD, alongside efforts in ASD, underscores its commitment to addressing critical brain health disorders.

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