Psychedelic: atai Life Sciences reports Phase 2a study data on BPL-003

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on study results, a patent filing and a CFO appointment.

ATAI REPORTS PHASE 2A STUDY DATA ON BPL-003: On Tuesday, atai Life Sciences (ATAI) announced topline data from Part 2 of Beckley Psytech’s Phase 2a study of BPL-003 for treatment-resistant depression. The findings show that a single dose of BPL-003, when given to patients who were also taking defined selective serotonin reuptake inhibitors was well-tolerated, with rapid and durable antidepressive effects of up to three months with an average in-clinic treatment time of less than two hours following dosing. The open-label Phase 2a study investigated the safety, efficacy and pharmacokinetics of a single dose of BPL-003 in 12 patients with moderate-to-severe depression, who had failed to respond to at least two or more prior treatments and were taking defined SSRIs. Patients were followed for 12 weeks post-dosing with assessments conducted at multiple points throughout the study. BPL-003 was also shown to be well-tolerated. All adverse events were mild or moderate in severity and there were no serious adverse events reported. Furthermore, acute effects resolved on the day of dosing with patients deemed dischargeable within an average time of less than two hours after dosing. A single dose of BPL-003 induced rapid and long-lasting antidepressant effects, with a mean Montgomery-Asberg Depression Rating Scale reduction of 18 points from baseline observed the day after dosing, a mean MADRS reduction of 19 points from baseline observed one month after dosing, and a mean MADRS reduction of 18 points from baseline observed three months after dosing.

“We’re very encouraged by the growing body of data supporting BPL-003 as a potentially differentiated and commercially scalable interventional psychiatric treatment for depression,” stated Srinivas Rao, CEO. “Patients with treatment-resistant depression face limited options and these results show that a single dose of BPL-003 can deliver rapid and durable antidepressant effects when co-administered with an SSRI, extending the positive results observed in the Part 1 monotherapy study. Although a small, open-label study, the data validates the co-administration approach, which could improve accessibility in the real-world setting. Congratulations to Cosmo, Rob and the Beckley team for continued execution of the BPL-003 program, and we look forward to the Phase 2b readout mid-year.”

Following the report, Jefferies noted Beckley Psytech shared positive Phase 2a data that the firm calls “encouraging.” The drug’s profile seems to be consistent across multiple studies, incrementally de-risking the key Phase 2b TRD study in mid-2025, the analyst said. Although the BPL-003 program is controlled by Beckley Psytech, Atai Life Sciences currently holds about a 34% stake in Beckley that can be increased to 45%-plus for about $60M, added the analyst, who has a Buy rating and $5 price target on Atai shares.

ENVERIC FILES PROVISIONAL PATENT APPLICATION: Enveric Biosciences (ENVB) announced Tuesday that it has filed a new provisional patent application with claims to methods and pharmaceutical formulations for use on a family of molecules discovered to offer potential to address neurodegenerative disease. If confirmed through further testing, the potential of this newly identified group of molecules expands the market potential for Enveric drug candidates in a new direction. Broad claims in the patent application describe a group of molecules that enhance brain derived neurotrophic factor activity and address conditions where the BDNF/TrKB pathway plays a major role. BDNF and its receptor TrKB support neuroprotection and adult neurogenesis and enhance myelination by increasing the density of oligodendrocyte progenitor cells. While additional pre-clinical testing is needed to confirm the enhancement of BDNF activation, preliminary studies have revealed promotion of neuronal development in a cell-based assay. The preliminary PK profile suggests that the orally delivered compound effectively enters the bloodstream, penetrates the brain, and is subsequently and rapidly cleared from plasma. Further, this molecule did not display 5HT2B receptor activation, which would have been an indicator of cardiovascular risk potential.

“Based on our team’s research, future molecules that emerge from this family could represent therapeutic candidates to develop for Alzheimer’s Disease and other neurodegenerative diseases,” said Joseph Tucker, CEO. “In addition to the potential to promote BDNF signaling, an established therapeutic target in neurodegenerative diseases, a prototype molecule from the family has been tested in vivo and revealed encouraging pharmaceutical and pharmacokinetic characteristics.”

MIRA PHARMACEUTICALS APPOINTS NEW CFO: In a Wednesday regulatory filing, MIRA Pharmaceuticals (MIRA) announced that Michelle Yanez and the company mutually agreed to release Yanez from her position as CFO, Treasurer and Secretary. Yanez’s resignation was a mutual separation from the company and was not based on any disagreement. Effective May 15, the company appointed Alan Weichselbaum as CFO. In 2011, he founded The Wexus Group, an outsourced CFO advisory firm that partners with small and mid-sized companies.

PHARMATHER REPORTS EXTENDED FDA REVIEW FOR KETAMINE: PharmaTher Holdings (PHRRF) announced Friday the U.S. Food and Drug Administration has extended the approval goal date for the review of its new drug application for ketamine. The new approval goal date is August 9, revised from the previous date of June 4. The extension allows the FDA additional time to review additional information requests, which the FDA has classified as a MINOR amendment. Importantly, this is not a Complete Response Letter. PharmaTher confirms it has previously addressed all issues raised in the FDA’s Complete Response Letter dated October 22.

“While we were prepared for a decision by June 4, 2025, we acknowledge the FDA’s need for additional time to review our recent submission and additional information request for the ketamine new drug application,” said Fabio Chianelli, CEO. “We do not anticipate this extension to August 9, 2025, will materially impact our ongoing operational, business development, and commercialization initiatives for 2025.”

SILO PHARMA PARTNERS WITH RESYCA: Silo Pharma announced Wednesday it has entered into a service agreement with Resyca for a drug-device study of the formulation-specific microchip-based nasal spray system used in its lead asset SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder. The company is currently conducting two additional SPC-15 studies: an IND-enabling GLP-compliant toxicology and toxicokinetics study, and an FDA requested 7-day safety and toxicology large animal study.

“This study is expected to provide the final necessary device data and documentation for SPC-15’s IND, which we plan to submit to the FDA this year,” said Eric Weisblum, CEO. “Our chosen device transports the molecules to the brain directly, bypassing the blood-brain barrier, to increase drug concentration. We believe this method can drive faster onset of therapeutic benefit with optimized safety for the treatment of PTSD patients.”

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