Psychedelic: Compass Pathways, GH Research report Q3 earnings

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on earnings, a patent filing and the completion of a combination.

Q3 EARNINGS RESULTS: On Tuesday, Compass Pathways (CMPS) reported a third quarter loss per share of ($1.44), which compared to a loss per share of (56c) for the same period last year. Cash and cash equivalents were $185.9M as of September 30, compared with $165.1M as of December 31, 2024. Full year 2025 net cash used in operating activities is expected to be in the range of $120M to $145M. The cash position at September 30 is expected to be sufficient to fund operating expenses and capital expenditure requirements into 2027.

“With the completion of COMP006 enrollment and our recent positive discussions with the FDA, we are excited about pulling forward our expected launch timing for COMP360 in TRD by 9-12 months,” said Kabir Nath, CEO. “We are accelerating commercial launch plans to match this new expected timeline with the goal of advancing our mission of transforming the mental health landscape and how patients living with depression are treated.”

On Thursday, GH Research (GHRS) reported a Q3 loss per share of (23c), which compared to analyst estimates of a loss per share of (23c). Cash, cash equivalents and marketable securities were $293.9M as of September 30, compared to cash, cash equivalents, other financial assets and marketable securities of $182.6M as of December 31, 2024.

The company said, “In July 2025, we announced that we received a communication from the U.S. Food and Drug Administration relating to our complete response to the clinical hold of our Investigational New Drug Application for GH001, with only one hold topic remaining. We are actively working with experts to address the remaining topic and engagement with the FDA on our IND complete response is ongoing…In July 2025, we reported on the full dataset from the Phase 2b clinical trial of GH001 in treatment-resistant depression. The primary endpoint was met with a highly significant placebo adjusted reduction from baseline of -15.5 points in Montgomery-Asberg Depression Rating Scale total score on Day 8. The full analysis of the open-label extension confirms a 73% remission rate at 6 months with infrequent treatment visits and no mandated psychotherapeutic intervention. There were no treatment-related serious adverse events during the full 6-month duration of the trial. No treatment-emergent events of suicidal intent or suicidal behavior occurred during the 6-month duration of the trial…We continue to expect to initiate our global pivotal program in 2026.”

CLEARMIND FILES SOUTH KOREA PATENT APPLICATION: On Wednesday, Clearmind Medicine (CMND) announced the filing of a patent application in South Korea covering compositions containing its proprietary compound, 5-methoxy-2-aminoindane, for the treatment of depression. Preclinical studies have demonstrated MEAI’s potential to enhance mood regulation and reduce anhedonia, offering a differentiated therapeutic approach for patients who do not respond to conventional antidepressants.

“This patent filing marks another important milestone in expanding our IP protection and advancing MEAI as a novel, next-generation treatment for depression,” said Adi Zuloff-Shani, CEO. “As we continue to broaden our global footprint, we are also preparing for the next stages of clinical development and commercialization to potentially bring our non-hallucinogenic neuroplastogen therapies to patients worldwide.”

Additionally on Friday, Clearmind Medicine announced the publication of a U.S. patent application expanding coverage of its non-hallucinogenic proprietary compound, 5-methoxy-2-aminoindane, for the treatment of cocaine addiction.

“Securing protection for MEAI’s potential use in cocaine addiction supports our broader strategy to build a robust pipeline of non-hallucinogenic neuroplastogens,” said Adi Zuloff-Shani, CEO. “We believe this patent filing represents another key step in positioning Clearmind as a leader in next-generation addiction therapeutics.”

ATAI COMPLETES COMBINATION WITH BECKLEY PSYTECH: Atai Beckley (ATAI) announced Wednesday the completion of the strategic combination between atai Life Sciences and Beckley Psytech in an all-share transaction. AtaiBeckley’s lead program is BPL-003, an investigational, novel mebufotenin benzoate nasal spray designed to produce rapid and durable antidepressive effects from a single dose and with a short psychedelic duration. BPL-003 is currently being investigated as a potential treatment for patients with treatment-resistant depression and was granted Breakthrough Therapy designation by the FDA. The company is scheduled to meet with the FDA for an End-of-Phase 2 meeting to discuss the design of a Phase 3 clinical program for BPL-003 in the coming months, with initiation of Phase 3 studies expected in 2Q26. AtaiBeckley’s pipeline also includes VLS-01, currently being evaluated in a Phase 2 clinical trial for patients with TRD, with topline data expected in 2H26; EMP-01, currently in an exploratory Phase 2a study for adults with social anxiety disorder, with topline results anticipated in 1Q26; and a portfolio of novel 5-HT2A receptor agonists, including non-hallucinogenic neuroplastogens, in earlier stages of development.

Srinivas Rao, CEO of AtaiBeckley, said “We are bringing together the assets, expertise and vision of atai Life Sciences and Beckley Psytech to transform patient outcomes. Around the world, too many people continue to suffer without effective treatments and AtaiBeckley is taking a decisive step toward changing this. We are a well-financed, Phase 3-ready company with a strong team in place to execute on our mission and I am excited by what we can achieve together, with our team fully committed to creating breakthroughs in mental health.”

BRIGHT MINDS INITIATES PWS PROGRAM: Bright Minds Biosciences (DRUG) announced Thursday the initiation of its Prader-Willi Syndrome program, and nomination of BMB-105 as a new clinical candidate. As part of the development program, Bright Minds will commence: A Phase 2a study to assess the efficacy, safety and tolerability of BMB-101 for the treatment of patients with PWS. This study is designed as a proof-of-pharmacology study to demonstrate that 5-HT2C agonism will address symptom complex in PWS patients. A randomized Phase 1 placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and food effect of BMB-105 in healthy volunteers. Following completion of the ongoing Phase 2a proof-of-pharmacology study with BMB-101, Bright Minds plans to select and advance a 5-HT2C molecule as the dedicated compound for the PWS program. This approach will reduce the time to market by approximately one year. To date, BMB-101 has been well tolerated, with no drug-related Serious Adverse Events nor any safety signals requiring any protocol adjustments. Exposure levels and tolerability achieved are consistent with expectations from Phase 1 study, supporting dose selection for future studies. Participation in the open-label extension is proceeding well, with nearly all eligible patients electing to remain on therapy under investigator supervision. Top-line data will be released in early January. The company is planning a Ph 2/3 in DEE and Ph 2/3 in 2026.

“The initiation of our PWS program and NOVA clinical study are exciting next steps as we continue our development efforts to serve patients with rare diseases,” said Ian McDonald, CEO. “The current therapeutic landscape is inadequate. 5-HT2C agonism offers a novel mechanism for PWS by targeting the underlying aspects of the disease. This proof-of-pharmacology clinical study is designed to evaluate BMB-101’s utility in addressing both hyperphagia and the behavioral/neuropsychiatric symptoms of PWS. We believe it will pave the way forward for a pivotal study with BMB-105, our dedicated compound, and expedite the development of the drug that aims at directly targeting the pathophysiology of PWS. As we continue to develop our pipeline and extensive portfolio of next-generation serotonergic agents, we believe that our 5-HT2C selective agonists provide a unique approach with the potential to deliver a novel and effective treatment option that PWS patients and their families desperately need.”

PSYENCE BIOMED EXPANDS CLINICAL SITES IN PHASE IIB STUDY: Psyence Biomedical (PBM) announced Thursday multiple patients dosed in its ongoing Phase IIb clinical trial evaluating nature-derived psilocybin, in combination with psychotherapy, as a potential treatment for Adjustment Disorder in palliative care. Patients have now been dosed across two active clinical sites, the Empax Center in Perth and the Mind Medicine Australia Clinic in Melbourne. The company has also activated Paratus Clinical Research in Melbourne to expand the study to three actively enrolling sites and accelerate data collection toward topline results anticipated by year-end 2026. The multi-site, double-blind, placebo-controlled study is designed to enroll 87 patients across Australia. Participants receive one of two therapeutic doses of psilocybin or a low-dose comparator, each administered alongside structured psychotherapy. The study will assess efficacy, safety, and durability of response, with the goal of advancing psilocybin as a potential first-in-class treatment for Adjustment Disorder in palliative care settings.

“The randomization and dosing of these patients across multiple independent trial sites marks an exciting and validating milestone for Psyence BioMed,” said Clive Ward-Able, Medical Director. “With multiple sites now operational and patients progressing through screening, we are seeing strong interest and momentum. This level of engagement reinforces the importance of our work in developing psilocybin-based therapies for palliative care.”

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