Psychedelic: Atai Beckley, Cybin report quarterly earnings

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on earnings, a trial approval and analyst notes.

EARNINGS RESULTS: On Wednesday, Atai Beckley (ATAI) reported a third quarter loss per share of (28c) on revenue of $749,000, which compared to analyst estimates of a loss per share of (12c) on a revenue of $55,560. As of September 30, the company had cash, cash equivalents and short-term securities of $114.6M, which it expects to fund operations into 2028.

“This has been a transformational quarter, highlighted by the establishment of AtaiBeckley, which solidifies our position as a global leader in developing transformative mental health therapies with short psychedelic duration,” stated Srinivas Rao, CEO. “The FDA’s Breakthrough Therapy designation for BPL-003 represents a major milestone, reinforcing its potential to address the significant unmet need in treatment-resistant depression. Alongside positive Phase 2a and Phase 2b data for BPL-003, we believe we are well positioned to advance BPL-003 into pivotal development pending discussions with the FDA at the upcoming End of Phase 2 Meeting. Beyond BPL-003, we advanced our pipeline by completing enrollment in the Phase 2a study of EMP-01 for social anxiety disorder, expanding clinical trial sites for VLS-01 and securing a NIDA grant to support innovation of 5-HT2A/2C receptor agonists for opioid use disorder. Supported by our recent financing, we remain steadfast in our mission to redefine mental health treatment for patients in need.”

On Monday, Atai Beckley announced topline results from the open-label extension study of its Phase 2b clinical trial of BPL-003 in patients with treatment-resistant depression. Findings show that a 12 mg dose of BPL-003 administered eight weeks after a 0.3 mg, 8 mg or 12 mg dose of BPL-003 was generally well-tolerated and provided additional rapid, clinically meaningful antidepressant effects, which were sustained for up to eight weeks.

Rao said, “These new data provide compelling support that redosing with BPL-003 may deliver additional and durable antidepressant effects in patients with treatment-resistant depression while maintaining a favourable safety and tolerability profile. Importantly, two doses, given eight weeks apart, provided antidepressant effects lasting up to four months, further supporting the viability of an intermittent-dose treatment paradigm with a short psychedelic duration, which has the potential to fit within the existing healthcare infrastructure and could minimize the burden on patients and providers. With a significant need for more effective therapies, our priority, following End-of-Phase 2 discussions with the FDA, is to advance BPL-003 into Phase 3 clinical trials with the hope of bringing this promising treatment option to patients as swiftly as possible.”

Additionally on Wednesday, Cybin (CYBN) reported a Q2 loss per share of ($1.39), which compared to analyst consensus of a loss per share of ($1.33). The company reported cash totaled $83.8M as of September 30.

“We are extremely pleased with the strong demand for our recently completed financing,” said Eric So, Interim CEO. “The participation of notable institutional investors underscores confidence in the strength of our science, the potential and differentiation of our therapeutic candidates, and our team’s proven ability to execute. This financing enables us to maintain strong momentum as we advance our Phase 2 and Phase 3 clinical trials toward key data readouts in 2026 and work to deliver meaningful clinical outcomes and potentially transformative therapies closer to patients in need. Across the organization we are focused on a disciplined execution strategy and building a strong foundation leading up to critical clinical milestones in 2026.”

Meanwhile on Friday, Filament Health (FLHLF) reported Q3 total revenue C$268,522 as well as cash and cash equivalents of C$337,082.

“This quarter, we achieved several significant regulatory and clinical milestones, including the first-ever approval for compassionate use of psilocybin in the European Union, and new phase 2 authorizations in both the United States and the United Kingdom,” said Benjamin Lightburn, CEO. “These developments continue to validate our botanical drug development platform and underscore growing global recognition of Filament’s leadership in the industry.”

CLEARMIND GETS FINAL APPROVAL TO EXPAND AUD TRIAL: Clearmind Medicine (CMND) announced Thursday that it has received final approval from the Hadassah Medical Center, Jerusalem, Israel, for its ongoing Phase 1/2a clinical trial evaluating CMND-100, a proprietary MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder. This approval will enable Hadassah Medical Center to join the company’s clinical trial, of which the first cohort treatment was completed.  The trial includes other institutions, such as Yale School of Medicine’s Department of Psychiatry, Johns Hopkins University School of Medicine and Tel Aviv Sourasky Medical Center, Israel. The study at Hadassah-University Medical Center will be led by Prof. Joseph Caraco, Director of Clinical Pharmacology Unit in the Department of Medicine.

Additionally on Wednesday, Clearmind Medicine announced notice of publication by the China National Intellectual Property Administration, referring to the company’s proprietary non hallucinogenic compound, MEAI, for the treatment of depression.

PSYENCE BIOMED ESTABLISHES IBOGAINE OPERATIONS IN AFRICA: Psyence BioMed (PBM) announced that, through its strategic investment in PsyLabs, it now has operations and manufacturing capabilities based in Africa, the natural and original source of ibogaine. Establishing a presence directly at the source strengthens traceable, sustainable, and responsible access to this rare compound, the company said, adding it also places Psyence BioMed in a uniquely advantageous position within the psychedelics sector, with direct access to ibogaine at its origin and the ability to control quality from source to finished product. PsyLabs operates from a GMP-compliant facility in Southern Africa, where it produces highly purified, EU GMP-grade psychedelic compounds from natural sources, including psilocybin and ibogaine.

Jody Aufrichtig, CEO, stated: “Our investment in PsyLabs strengthens a world-class supply chain and positions us at the forefront of nature-derived psychedelic drug development. This is not just about sourcing compounds – it’s about building a sustainable, ethical, and science-driven platform that can deliver breakthrough therapies to patients globally.”

GH RESEARCH PRICE TARGET LOWERED: H.C. Wainwright lowered the firm’s price target on GH Research (GHRS) to (ABBV) GM-2505, combined with the ongoing FDA hold, led the firm to fine-tune its expected GH001 launch timing and peak share in treatment-resistant depression, resulting in a revised price target. However, it continues to view GH001 as a leading asset within the short-duration psychedelics space and noted that its revised target still represents “robust upside potential.”

MIND MEDICINE PRICE TARGET RAISE: Canaccord raised the firm’s price target on Mind Medicine (MNMD) to $25 from $16 and kept a Buy rating on the shares. The firm added its MDD drug potential to its model and said the company is well capitalized and significantly undervalued heading into Phase 3 data.

OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Health (AGNPF), BetterLife (BETRF), Bright Minds (DRUG), Compass Pathways (CMPS), Enveric Biosciences (ENVB), Incannex (IXHL), 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).