-- Anticipated topline data readouts on track for ongoing Phase 3 studies of MM120 Orally Disintegrating Tablet $(ODT)$ in GAD: Voyage (1H 2026) and Panorama (2H 2026)--
--Anticipated topline data readout from first Phase 3 study of MM120 ODT in MDD (Emerge) accelerated to mid-2026, aligning with the anticipated initiation of second Phase 3 study in MDD (Ascend)--
--MM120 Phase 2b GAD Study published in the Journal of the American Medical Association (JAMA)--
--Continued advancement of pipeline with planned Phase 2a study initiation of MM402 in Autism Spectrum Disorder (ASD) in 4Q 2025--
--Cash, cash equivalents and marketable securities totaled $209.1 million as of September 30, 2025; completed underwritten public offering of common stock with net proceeds of $242.8 million on October 31, 2025--
--Conference call scheduled today at 4:30 p.m. EST--
NEW YORK--(BUSINESS WIRE)--November 06, 2025--
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 reported financial results for the third quarter ended September 30, 2025 and provided business updates.
"2025 continues to be a year of strong execution, and our recent $258.9 million financing further strengthens our position as we prepare for a transformational 2026," said Rob Barrow, Chief Executive Officer of MindMed. "Enrollment across all three pivotal MM120 ODT trials remains on track. Given faster than expected enrollment in Emerge, our first Phase 3 study in MDD, we have accelerated guidance for topline data readout which is now expected in mid-2026. We plan to initiate Ascend, our second Phase 3 study in MDD, in mid-2026 and remain focused on advancing toward FDA submissions in both generalized anxiety disorder (GAD) and major depressive disorder (MDD). We are also excited to advance our pipeline with the start of a Phase 2a study of MM402 in ASD. With multiple anticipated Phase 3 topline data readouts ahead, 2026 is set to be the most significant year in our history to date, as our team works to bring new treatment options to both providers and patients."
Business Updates
-- On October 31, 2025, the Company completed an underwritten public
offering of 21,131,250 common shares of the Company for gross proceeds of
$258.9 million. Net proceeds from the offering were approximately $242.8
million, after deducting underwriting discounts and commissions and other
estimated offering expenses payable by the Company.
-- The Company published full study results in JAMA from its randomized,
placebo-controlled Phase 2b trial evaluating a single dose of MM120
across four dose levels in patients with moderate to severe GAD. The
Phase 2b study demonstrated a statistically significant dose-response
relationship at the primary endpoint following a single administration of
MM120 across four dose levels, with improvements sustained throughout the
12-week observation period. MM120 100 ug was determined to be the optimal
dose, meeting its primary and key secondary endpoints, demonstrating a
clinically and statistically significant improvement vs. placebo, and a
65% clinical response rate and 48% clinical remission rate at Week 12.
MM120 was well-tolerated with mostly mild-to-moderate adverse events that
were limited to the dosing day and consistent with the mechanism of
action of lysergide D-tartrate (LSD). These results represent a
substantial improvement over currently approved therapies for GAD, which
led to MM120 being granted Breakthrough Therapy Designation (BTD) from
FDA in March 2024.
Program Status and Anticipated Milestones
MM120 ODT (lysergide D-tartrate) for GAD
-- Enrollment is on track in the Phase 3 Voyage study of MM120 ODT for the
treatment of GAD. Voyage is expected to enroll approximately 200
participants in the U.S. who will be randomized 1:1 to receive MM120 ODT
100 ug or placebo. Topline data from the 12-week double-blind period
(Part A) is anticipated in the first half of 2026.
-- Enrollment is on track in the Panorama study, the Company's second Phase
3 study of MM120 ODT for the treatment of GAD. Panorama is expected to
enroll approximately 250 participants (randomized 2:1:2 to receive MM120
ODT 100 ug, MM120 ODT 50 ug control, or placebo) in the U.S. and Europe.
Topline data from the 12-week double-blind period (Part A) is anticipated
in the second half of 2026.
MM120 (lysergide D-tartrate) for MDD
-- Enrollment in the Phase 3 Emerge study of MM120 ODT for the treatment of
MDD has progressed faster than previously expected and topline data from
the 12-week double-blinded period (Part A) is now anticipated in mid-2026
(previously 2H 2026). Emerge is expected to enroll approximately 140
participants (randomized 1:1 to receive MM120 ODT 100 ug or placebo).
-- The Company plans to initiate Ascend, its second Phase 3 study in MDD, in
mid-2026. Similar to Emerge, Ascend will consist of two parts: Part A, a
12-week, randomized, double-blind, placebo-controlled, parallel group
assessing the efficacy and safety of MM120 ODT versus placebo, and Part B,
a 40-week open-label extension period. The primary endpoint will be the
change from baseline in Montgomery Åsberg Depression Rating Scale
(MADRS) score at Week 6 between MM120 ODT 100 ug and placebo. The trial
is expected to enroll approximately 175 participants (randomized 2:1:2 to
receive MM120 ODT 100 ug, MM120 ODT 50 ug control or placebo).
MM402 (R(-)-MDMA) for Autism Spectrum Disorder (ASD)
-- Following the completion of its single-ascending dose Phase 1 study of
MM402 in adult healthy volunteers, the Company plans to initiate a Phase
2a study in the fourth quarter of 2025. This study will be a single-dose,
open-label study to assess early signals of efficacy of MM402 in treating
core socialization and communication symptoms of ASD in up to 20 adult
participants. The objectives and endpoints of the study are designed to
characterize the pharmacodynamics and clinical effects of MM402 in adults
with ASD, including on multiple functional biomarkers.
Third Quarter 2025 Financial Results
Cash, Cash Equivalents and Investments. As of September 30, 2025, MindMed had cash, cash equivalents and investments totaling $209.1 million compared to $273.7 million as of December 31, 2024. Based on the Company's current operating plan and anticipated milestones, the Company believes that its cash, cash equivalents and investments as of September 30, 2025, along with the net proceeds of $242.8 million from the recently completed offering, will be sufficient to fund the Company's operations into 2028.
Research and Development (R&D). R&D expenses were $31.0 million for the quarter ended September 30, 2025, compared to $17.2 million for the quarter ended September 30, 2024, an increase of $13.8 million. The increase was primarily due to increases of $11.7 million in MM120 program expenses, $2.5 million in internal personnel costs reflecting expanded research and development capabilities, and $0.2 million in preclinical and other program expenses, partially offset by a $0.6 million reduction in MM402 program expenses.
General and Administrative (G&A). G&A expenses were $14.7 million for the quarter ended September 30, 2025, compared to $7.6 million for the quarter ended September 30, 2024, an increase of $7.1 million. The increase was primarily due to increases of $3.0 million in personnel-related expenses, $2.0 million in commercial-preparedness related expenses, $1.6 million in corporate affairs expenses and $0.5 million in other miscellaneous administrative expenses.
Conference Call and Webcast Reminder
MindMed management will host a webcast at 4:30 p.m. EST today to provide a corporate update and review the Company's third quarter 2025 financial results and business highlights. Listeners can register for the webcast via this link. Analysts wishing to participate in the question-and-answer session should use this link. A replay of the webcast will be available via the Investor Relations section of the MindMed website, ir.mindmed.co and archived for at least 30 days after the webcast. Those who plan on participating are advised to join 15 minutes prior to the start time.
About MM120 Orally Disintegrating Tablet (ODT)
MM120 ODT (lysergide D-tartrate or LSD) is an ergoline derivative belonging to the group of classic serotonergic psychedelics which acts as a partial agonist at specific serotonin receptors (human serotonin-2A (5-HT2A) receptors). MM120 ODT is MindMed's proprietary and pharmaceutically optimized formulation of LSD. MM120 ODT is an advanced formulation incorporating Catalent's Zydis$(R)$ ODT fast-dissolve technology, which is designed to deliver several unique advantages, such as faster absorption and faster onset of transient cognitive, perceptual, and affective changes, improved bioavailability, and lower incidence of gastrointestinal side effects. MindMed is developing MM120, the tartrate salt form of lysergide, for generalized anxiety disorder (GAD), major depressive disorder (MDD), and is exploring its potential applications in other serious brain health disorders.
About MM402
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November 06, 2025 16:01 ET (21:01 GMT)
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