Psychedelic: Atai, Enveric, Incannex and Relmada report quarterly results

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on earnings, a manufacturing engagement and an analyst initiation.

EARNINGS RESULTS: On Wednesday, atai Life Sciences (ATAI) reported a first quarter loss per share of (15c) on revenue of $1.5M, which compared to analyst estimates of a loss per share of (18c) and revenue of $0 for the same period last year. As of March 31, the company had cash, cash equivalents, restricted cash and short-term securities of $108.2M compared to $72.3M as of December 31. The company expects its cash, cash equivalents, short-term securities, and public equity holdings to be sufficient to fund operations into 2027.

“In the first quarter of 2025, we made meaningful progress across our pipeline, thus advancing our mission to transform the treatment of mental health conditions,” stated Srinivas Rao, CEO. “Dosing the first patient in our exploratory Phase 2 study of EMP-01 in social anxiety disorder represents a significant milestone in our quest to address an area of high unmet need with a novel therapeutic approach. Looking ahead, we are excited about the upcoming mid-year data readouts for BPL-003 in treatment-resistant depression and RL-007 in cognitive impairment associated with schizophrenia. We believe that these milestones have the potential to reinforce our position as a leader in mental health innovation.”

Additionally on Tuesday, atai Life Sciences announced that the first patient has been dosed in the exploratory Phase 2 study of EMP-01 for the treatment of social anxiety disorder. The Phase 2 study is an exploratory, randomized, double-blind, placebo-controlled trial to assess the safety, tolerability and efficacy of EMP-01 in approximately 60 adults with SAD. Patients will be randomized 1:1 to receive two double-blind administrations of either EMP-01 or placebo, spaced four weeks apart. Symptoms will be monitored for six weeks following the first dose. The primary objective of the study is to assess the safety and tolerability of EMP-01 in adults with SAD. The secondary objective is to estimate any improvements in social anxiety symptoms compared to placebo.

On Thursday, Enveric Biosciences (ENVB) reported a Q1 loss per share of ($1.22), which compared to a loss per share of ($9.21) for the same period last year. 

“The first quarter of 2025 was highlighted by continued progress in the development of EB-003, our neuroplastogenic molecule that is designed to address difficult-to-treat mental health disorders,” said Joseph Tucker, CEO. “We continue to focus our development efforts on the completion of the data package to support filing an Investigational New Drug application for EB-003, which we aim to submit to the FDA by the end of the first quarter of 2026. Ongoing development of EB-003 is supported by the data accumulated to date, which have demonstrated oral bioavailability and brain exposure in preclinical studies. Preclinical work has also shown encouraging pharmacology and safety results from in vitro pharmacology studies.”

Incannex Healthcare (IXHL) also reported earnings on Thursday with a Q3 loss per share of (20c), which compared to a loss per share of (38c) for the same period last year. “The third quarter of 2025 represents a pivotal period of progress for Incannex as we continue to execute on our IHL-42X development program,” said Joel Latham, CEO. “With the rapid completion of Phase 2 enrollment in the Phase 2/3 RePOSA, recent positive and confirmatory PK and safety clinical results, and the addition of expert sleep medicine clinical advisory leadership, we are well-positioned to deliver on key upcoming milestones and to advance IHL-42X as a potential treatment for millions of underserved patients living with OSA.”

On Monday, Relmada Therapeutics (RLMD) reported a Q1 loss per share of (58c), which compared to a loss per share of (72c) for the same period last year.  “2025 is off to an outstanding start for Relmada,” said Sergio Traversa, CEO. “With the addition of NDV-01 and sepranolone, two differentiated Phase 2 product candidates targeting large, underserved markets, we’ve significantly enhanced our pipeline and long-term value proposition. The recently announced proof-of-concept data for NDV-01 presented at AUA 2025 reinforce its potential to become a best-in-class, bladder-sparing treatment for non-muscle invasive bladder cancer. Our strategic focus remains on developing a diverse pipeline with strong scientific rationale, intellectual property protection, and capital-efficient development paths. Looking ahead, we are prioritizing the advancement of NDV-01 and sepranolone into further clinical development.”

CYBIN ENGAGES THERMO FISHER FOR CYB003 PROGRAM: Cybin (CYBN) announced Thursday that it has engaged Thermo Fisher Scientific (TMO) to support the Phase 3 clinical supply and potential commercial manufacturing of CYB003, the company’s proprietary deuterated psilocin program in Phase 3 development for the adjunctive treatment of Major Depressive Disorder.

“This is an exciting time for Cybin as we focus on the execution of our Phase 3 CYB003 pivotal program,” said Doug Drysdale, CEO. “Thermo Fisher, which offers leading Contract Development and Manufacturing Organization services, has a successful track record across the manufacturing spectrum, and their expertise will help to accelerate our drug development trajectory. We are pleased to broaden our existing strong relationship with Thermo Fisher for both the drug substance and drug product capsules for CYB003. Cybin has established its manufacturing operations in the United States, including partnering with Thermo Fisher’s pharma services sites in Florence, South Carolina, for Phase 3 clinical supply and future commercialization, and Cincinnati, Ohio, for Phase 3 capsule production and commercialization.”

BRIGHT MINDS INITIATED WITH BUY: On Tuesday, TD Cowen initiated coverage of Bright Minds Biosciences (DRUG) with a Buy rating and no price target. The company’s lead asset BMB-101 is a biased 5-HT2C agonist that has the potential to be best in class for the treatment of certain refractory seizure disorders, the analyst said. The firm said its key opinion leaders have highlighted the unmet need by current options in absence epilepsy.

Additionally on Tuesday, Bright Minds announced findings from its DBA/2 mouse model study. BMB-101 demonstrated a complete elimination of drop attacks in the DBA/2 mouse model. The DBA/2 mouse model is an inbred mouse strain in which young DBA/2 mice are susceptible to audiogenic seizures, making them a model for epilepsy studies. This epilepsy model does re-capitulate phenomenon such as tonic/clonic seizures, drop attacks, and sudden unexpected death in epilepsy. 

“DBA/2 is an excellent model for understanding the effect of anti-epileptic drugs on the etiology of seizures,” stated Jan Torleif Pedersen, CEO. “BMB-101 demonstrated dose-dependent efficacy in the DBA/2 mouse model of epilepsy, and drop seizures were completely eliminated. Notably, BMB-101 achieved 100% survival in the DBA/2 model, reversing brainstem serotonin deficits and preventing seizure-induced respiratory arrest. SUDEP is the leading cause of seizure-related premature death, particularly in drug-resistant epilepsy patients, and we are extremely pleased to advance our investigative work and build on this preclinical validation.”

HOPE THERAPEUTICS TO ACQUIRE KADIMA: HOPE Therapeutics, a wholly-owned subsidiary of NRx Pharmaceuticals (NRXP), announced Tuesday signing of a definitive agreement to purchase the Kadima Neuropsychiatry Institute.  Kadima is expected to serve as the clinical model for treatment offerings in HOPE-acquired clinics and is expected to continue its role as a leading investigative site for research into neuroplastic therapies including psychedelic medications, transcranial magnetic stimulation, and hyperbaric therapy. Kadima is one of California’s flagship interventional psychiatry clinics and was among the first to bring ketamine treatment for central nervous system disorders out of academic research settings and into clinical practice.  The clinic offers a full range of treatments for suicidal depression, PTSD and other CNS disorders, including ketamine, Spravato, transcranial magnetic stimulation as well as medication management.  The planned acquisition of Kadima is subject to satisfaction of standard closing conditions and finalization of financing.

“The signing of a definitive agreement to acquire Kadima marks a pivotal moment in the execution of our strategy to redefine mental healthcare access and delivery of care through HOPE Therapeutics,” said Jonathan Javitt and Matthew Duffy, Co-CEOs of HOPE . “Dr. David Feifel is a true pioneer in interventional psychiatry and we are honored to have him join our leadership team. With his guidance, we are accelerating the buildout of a world-class clinic network that integrates cutting-edge science with community-based care.”

BETTERLIFE PROVIDES BETR-001 UPDATE: BetterLife Pharma (BETRF) announced Wednesday that it presented a scientific update at Bloom Burton Conference on May 5. BetterLife reported that its proprietary compound, BETR-001, is showing promising preclinical data of its breakthrough ability to provide therapeutic effect in depression/anxiety animal models. Current methods of treating depression/anxiety primarily focus on increasing the level of one of the three neurotransmitters: serotonin, norepinephrine and/or dopamine in the brain. Each neurotransmitter has different receptor targets, and each receptor performs different functions. The therapeutic effects of BETR-001 seen in preclinical models are primarily driven by its activation of serotonin’s 5HT2A receptor. Not only does BETR-001 activate the 5HT2A receptor, which plays a key role in depression/anxiety, this activation is via a mechanism that allows for efficacious therapeutic effect without hallucinogenic side effects. This stands in contrast to other potent 5HT2A activators, such as LSD, psilocybin and other psychedelics. BetterLife has reported on the details of BETR-001 activation of the 5HT2A receptor previously. Recently studies have shown that the activation of the 5HT2A receptor above 70% leads to hallucination. Ideally, a therapeutic agent should activate 5HT2A but stay below the 70% threshold. BETR-001 fulfills this parameter, activating 5HT2A maximally to 60%.

OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Pharmaceuticals (AGNPF), Allied Corp. (ALID), Clearmind (CMND), Compass Pathways (CMPS), Entheon Biomedical (ENTBF), Filament Health (FLHLF), GH Research (GHRS), Mind Medicine (MNMD), MIRA Pharmaceuticals (MIRA), Mydecine Innovations (MYCOF), Numinus Wellness (NUMIF), Optimi Health (OPTHF), Pasithea Therapeutics (KTTA), PharmAla (MDXXF), PharmaTher (PHRRF), Psyence Biomedical (PBM), Psyence Group (PSYGF), Quantum BioPharma (QNTM), Revive Therapeutics (RVVTF), SciSparc (SPRC), Seelos Therapeutics (SEEL), Silo Pharma (SILO) and Synaptogenix (SNPX).