Psychedelic: MindMed reports Q4 earnings results

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on earnings, a study approval and an enrollment completion.

MINDMED REPORTS Q4 EARNINGS: On Thursday, Mind Medicine (MNMD) reported a fourth quarter loss per share of (41c), which compared to analyst estimates of loss per share of (28c). As of December 31, MindMed had cash and cash equivalents totaling $273.7M compared to $99.7M as of December 31, 2023. The company believes that its cash and cash equivalents will be sufficient to fund operations into 2027. 

“2024 was a year of significant progress for MindMed. We successfully achieved several key milestones that have built momentum for multiple clinical readouts from our MM120 ODT Phase 3 development program, which are expected to drive our next phase of growth,” said Rob Barrow, CEO. “The positive data from our MM120 Phase 2b study in Generalized Anxiety Disorder helped secure breakthrough therapy designation from the FDA and led to the expansion of our pipeline into Major Depressive Disorder. In 2025, we are focused on enrolling our Phase 3 GAD and MDD studies, as well as regulatory and pre-commercialization activities to support the development of MM120 ODT. We are well positioned to deliver transformational innovation that has the potential to redefine treatment for the over 50 million people living with anxiety and depression.”

MIRA ANNOUNCES TRIAL APPROVAL FOR KETAMIR-2: MIRA Pharmaceuticals (MIRA) announced Tuesday the approval and upcoming initiation of its Phase 1 clinical trial for Ketamir-2, the company’s novel oral ketamine analog in development for neuropathic pain, with subject recruitment scheduled to begin in Q1. The study has received authorization from the Israeli Ministry of Health and the Institutional Review Board and will be conducted at the Clinical Pharmacology Unit, Hadassah Medical Center in Jerusalem, Israel. This Phase 1, randomized, double-blind, placebo-controlled, single-center study is designed to evaluate the safety, tolerability, and pharmacokinetics of orally administered Ketamir-2 in healthy adult volunteers. The trial consists of two parts: Single Ascending Dose Part: 32 participants; Multiple Ascending Dose Part: 24 participants. In addition to assessing the frequency and severity of adverse events and serious adverse events, the study will closely evaluate ketamine-related behavioral side effects and assess Ketamir-2’s distinct pharmacological profile. The decision to conduct the study in Israel was made to accelerate timelines and optimize costs, allowing Mira to efficiently allocate resources and extend its operational runway. The company expects Phase 1 to conclude by Q4, paving the way for a Phase 2a study in neuropathic pain patients to be initiated by the end of the year.

“The neuropathic pain market continues to grow, yet current treatments leave millions of patients without adequate relief,” said Erez Aminov, CEO. “Ketamir-2 has demonstrated remarkable potential in reversing neuropathic pain while maintaining a strong safety profile. With this Phase 1 trial now set to begin, we are moving closer to bringing a much-needed oral treatment to patients suffering from chronic neuropathic pain.”

ATAI REPORTS ENROLLMENT COMPLETION IN BPL-003 TRIAL: atai Life Sciences (ATAI) announced Wednesday the completion of patient enrollment in the eight-week, double-blind, core stage of the global Phase 2b clinical trial evaluating BPL-003 in patients with treatment-resistant depression. BPL-003 is Beckley Psytech’s patent-protected, proprietary intranasal formulation of mebufotenin benzoate, administered via a nasal spray device used in a previously approved drug product. BPL-003 is designed to deliver rapid and durable effects from a single dose, with a short time in clinic. Topline results from the core stage of the Phase 2b clinical trial are expected in mid-2025. 

“We are impressed by the Beckley Psytech team’s execution of the Phase 2b clinical trial of BPL-003 in patients with treatment-resistant depression, which is the largest controlled trial of mebufotenin and the first and only Phase 2b clinical trial to investigate mebufotenin in the U.S.,” stated Srinivas Rao, CEO. “The promising data from earlier clinical studies of BPL-003 have demonstrated that a single dose can induce rapid, significant, and lasting antidepressant effects, further reinforcing our confidence in its potential to revolutionize treatment for difficult-to-treat depression. We look forward to the topline results from the eight-week core stage of the Phase 2b clinical trial of BPL-003, which remains on track for mid-2025.”

The eight-week, quadruple-masked, dose-finding, core stage of the Phase 2b clinical trial is evaluating the efficacy and safety of a single medium or high dose of BPL-003 against a sub-perceptual dose. The trial enrolled 196 patients with moderate-to-severe depression that had failed to respond to at least two or more prior treatments in the current episode of depression across 38 sites in six countries. Patients are followed for eight weeks, and efficacy is assessed at various timepoints by centralized, blinded raters using the Montgomery-Asberg Depression Rating Scale. 

ANALYSTS REITERATE BUY ON COMPASS: On Tuesday, H.C. Wainwright said Compass Pathways (CMPS) is one of the most compelling stories in neuropsychiatry, and that COMP360’s differentiated profile positions it as a “transformative” treatment in treatment-resistant depression. The firm believes the current valuation fails to reflect the full scope of its opportunity across multiple large-market psychiatric disorders with COMP360 on track to become a blockbuster treatment, if approved. The firm reiterated a Buy rating and $45 price target on the shares.

Additionally on Friday, Canaccord lowered the firm’s price target on Compass Pathways to $15 from $23 and kept a Buy rating on the shares. The firm said the key update was that the company is on track to report top-line 6-week data from its COMP005 Phase 3 trial for COMP360 for treatment-resistant depression in 2Q25, the trial is roughly 90% enrolled and they believe the company has the potential to generate significant upside.

PHARMALA SHIPS LANEO MDMA TO UCLA: PharmAla Biotech (MDXXF) announced Monday it has completed its shipment of LaNeo MDMA to UCLA, which will be used for a clinical trial investigating Schizophrenia. 

“We are incredibly pleased to have delivered our clinical trial materials to Dr. Bershad and Dr. Marder. Unfortunately, the past 2 years since the signing of our contract have highlighted some of the exceptional difficulties in running a clinical exploring a novel indication with a controlled substance. From addressing ethics committee comments and FDA data requests, to waiting for the Research Advisory Panel of California to approve the trial,” said Nick Kadysh, CEO. “I know that the UCLA team has had to work mightily to kick this trial off, and we’ve been glad to do our small part. We’re confident that their work will add significantly to the body of scientific evidence around MDMA, and will be in close coordination to support them if needed.”

OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Pharmaceuticals (AGNPF), Allied Corp. (ALID), BetterLife (BETRF), Bright Minds Biosciences (DRUG), Clearmind (CMND), Cybin (CYBN), Entheon Biomedical (ENTBF), Enveric Biosciences (ENVB), Filament Health (FLHLF), GH Research (GHRS), Incannex Healthcare (IXHL), Mydecine Innovations (MYCOF), NRx Pharmaceuticals (NRXP), Numinus Wellness (NUMIF), Optimi Health (OPTHF), Pasithea Therapeutics (KTTA), PharmaTher (PHRRF), Psyence Biomedical (PBM), Psyence Group (PSYGF), Quantum BioPharma (QNTM), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF), SciSparc (SPRC), Seelos Therapeutics (SEEL), Silo Pharma (SILO) and Synaptogenix (SNPX).