Psychedelic: Compass Pathways, NeuroKaire enter R&D collaboration

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on a research partnership, a treatment update and an analyst note.

COMPASS PATHWAYS, NEUROKAIRE ENTER R&D COLLABORATION: NeuroKaire announced Thursday that it has launched(CMPS). This collaboration aims to deepen the mechanistic understanding of psychedelic compounds by testing the structure of, and connectivity between neurons using patient-derived neurons with known clinical phenotypes. The study will make use of stem cell derived-neurons from individuals with treatment-resistant depression and major depressive disorder. The planned study leverages NeuroKaire’s proprietary platform, which applies biology and AI-powered image analysis to see how various compounds affect aspects of communication between the neurons using a proprietary neuroplasticity marker. This provides a unique window into the cellular mechanisms of these potential treatments, and to the differences between them.

Michael Gold, Chief R&D Officer at Compass Pathways, noted that “it is imperative to advance our understanding of how this class of compounds work to better serve patients. NeuroKaire’s innovative approach has the potential to bring much needed precision and clarity to psychedelic drug development.”

CLEARMIND TREATS LAST PATIENT IN FIRST COHORT OF AUD TRIAL: Clearmind Medicine (CMND) announced Thursday that the last patient of the first cohort in its Phase I/IIa clinical trial evaluating CMND-100, the company’s proprietary MEAI-based oral drug candidate for the treatment of Alcohol Use Disorder, has received treatment under the company’s U.S. FDA-approved clinical protocol. To date, six patients have been enrolled and treated in the trial, with two patients enrolled at Johns Hopkins University School of Medicine and four patients enrolled at Yale School of Medicine’s Department of Psychiatry. In addition, two sites in Israel have been activated for the clinical trial. The multinational, multicenter trial is designed as a single- and multiple-dose study to assess the safety, tolerability, and pharmacokinetic profile of CMND-100. It will also explore preliminary efficacy signals, such as reductions in alcohol cravings and consumption, among participants who are either non-treatment-seeking individuals reporting heavy binge drinking or treatment-seeking individuals diagnosed with AUD per DSM-5 criteria. All participants must express a desire to reduce or stop drinking.

“We were pleasantly surprised by the enrollment path so far. Reaching this milestone—treating the last patient in the first cohort of our FDA-approved Phase I/IIa trial for CMND-100—marks a pivotal step forward in advancing our mission to transform the treatment landscape for Alcohol Use Disorder” said Adi Zuloff-Shani, CEO. “With six patients successfully dosed at world-renowned centers like Johns Hopkins and Yale, we’re encouraged by the early progress in evaluating the safety, tolerability, and potential efficacy of this novel MEAI-based therapy. As we analyze the data ahead, our commitment remains steadfast: to deliver innovative, psychedelic-derived solutions that empower individuals to overcome addiction and reclaim their lives.”

ANALYST GIVES ATAI BUY RATING: Berenberg placed a Buy rating on atai Life Sciences (ATAI) with a $12 price target saying the company has made “exceptional progress” since its initiation with a Positive rating six months ago. Atai has a building pipeline momentum, its funding is secured, Phase 3 entry for its lead program is due in the first half 2026, and several more catalysts are expected over the next 12 months, the analyst said. Berenberg sees the stock’s momentum continuing.

INCANNEX PROVIDES FY25 PRIORITIES: Incannex Healthcare (IXHL) provided a shareholder update on Thursday highlighting recent progress across its clinical and corporate initiatives and outlining key priorities for the remainder of 2025. For PSX-001, the company’s psilocybin-assisted psychotherapy program for Generalized Anxiety Disorder, Incannex noted that the company reported statistically significant and clinically meaningful improvements versus placebo across the primary endpoint and multiple secondary measures, demonstrating both the robust efficacy and breadth of therapeutic impact of PSX-001. Participants experienced sustained symptom relief over 11 weeks, highlighting the durability of the treatment effect. The study also confirmed tolerability and safety, with no serious adverse events reported.

The company said, “We believe these results underscore PSX-001’s potential to set a new standard in the treatment of anxiety disorders, addressing a large unmet medical need with an innovative, well-tolerated therapy that could transform the lives of millions of patients worldwide.”

Following two Phase 2 readouts, Incannex is prioritizing regulatory engagement and next-phase planning to support the advancement of IHL-42X and PSX-001 into pivotal development. The company is actively working through the next steps of engagement with the U.S. FDA, including preparation for formal interactions and related development planning activities.

MIRA INITIATES MAD PHASE 1 STUDY OF ORAL KETAMIR-2: MIRA Pharmaceuticals (MIRA) announced Friday the initiation of the multiple ascending dose portion of its ongoing Phase 1 clinical trial evaluating its lead oral candidate, Ketamir-2, in healthy volunteers. The company also announced that it has selected chemotherapy-induced peripheral neuropathy as the lead indication for its planned Phase 2a clinical evaluation. The initiation follows the completion of dosing in the single ascending dose portion of the study. According to data reviewed to date, no serious or dose-limiting adverse events have been observed, and no clinically significant safety concerns have been reported. Comprehensive pharmacokinetic analyses will be performed following unblinding to further characterize Ketamir-2’s absorption and half-life profile. The ongoing randomized, double-blind, placebo-controlled Phase 1 study is evaluating single and multiple oral doses of Ketamir-2 to assess its safety, tolerability, and pharmacokinetics in healthy volunteers. The MAD portion includes three cohorts of repeat daily oral dosing, building on the safety and PK data from the SAD phase.

“We view Ketamir-2 not only as a promising clinical asset but as a potential value-creating platform for MIRA and our shareholders,” said Erez Aminov, CEO. “Our preclinical and clinical findings suggest that Ketamir-2 could represent a differentiated, non-opioid approach in a multi-billion-dollar pain market where effective therapies simply don’t exist. Advancing this program through Phase 2a development positions MIRA to address a major medical and commercial opportunity while maintaining our disciplined, data-driven approach.”

OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Health (AGNPF), BetterLife (BETRF), Bright Minds (DRUG), Cybin (CYBN), Enveric Biosciences (ENVB), Filament Health (FLHLF), GH Research (GHRS), Mind Medicine (MNMD), NRx Pharmaceuticals (NRXP), Numinus Wellness (NUMIF), Pasithea Therapeutics (KTTA), PharmAla (MDXXF), PharmaTher (PHRRF), Psyence Biomedical (PBM), Psyence Group (PSYGF), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF), SciSparc (SPRC), Seelos Therapeutics (SEEL) and Silo Pharma (SILO).