Psychedelic: atai Life Sciences, Beckley Psytech report BPL-003 study results

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on study results, patient dosing and an earnings report.

ATAI, BECKLEY PSYTECH REPORT PHASE 2B BPL-003 STUDY RESULTS: atai Life Sciences (ATAI) and Beckley Psytech announced Tuesday topline results from the eight-week, quadruple-masked, dose-finding, core stage of the Phase 2b clinical trial evaluating the efficacy and safety of a single dose of BPL-003 in patients with treatment-resistant depression. The study achieved its primary endpoint as well as all key secondary endpoints. At Day 29, a single 12 mg dose of BPL-003 demonstrated a statistically significant reduction in depressive symptoms, as measured by the Montgomery-Asberg Depression Rating Scale, with a mean decrease of 11.1 points from baseline compared to a 5.8 point reduction in the 0.3 mg comparator group. For the key secondary efficacy endpoints, a single 8 mg dose of BPL-003 also showed significant improvement at Day 29, with a mean MADRS score reduction of 12.1 points. Notably, both the 8mg and 12mg doses of BPL-003 showed statistically significant improvements in MADRS scores as early as one day after dosing, with effects generally maintained out to Week 8. Safety and efficacy results from this study support the selection of the 8 mg dose of BPL-003 for advancement into Phase 3 clinical studies. atai and Beckley Psytech plan to engage with the U.S. Food and Drug Administration and other applicable agencies regarding the Phase 3 trial design for patients with treatment-resistant depression in the coming months.

With these Phase 2b results, the pre-agreed success criteria for the proposed strategic combination between atai and Beckley Psytech, which was announced in June 2025, has been achieved and the strategic combination is now expected to progress to atai shareholder approval stage. The atai Beckley combination is expected to create a global leader in short time in-clinic psychedelic-based mental health therapies. The Phase 2b clinical study was conducted at 38 sites across six countries and enrolled a total of 193 patients with moderate-to-severe TRD. It is the largest controlled clinical study to investigate mebufotenin and the only blinded Phase 2b study of mebufotenin to include the United States. Patients were randomized to receive a single 12 mg, 8 mg, or 0.3 mg comparator dose of BPL-003 and were followed for eight weeks with efficacy assessments conducted by centralised, blinded raters using the MADRS at Day 2, Day 8, Day 29 and Day 57.

Cosmo Feilding Mellen, CEO of Backley Psytech, said, “The achievement of our primary and secondary endpoints in this study represents an important milestone in the development of BPL-003 and reinforces its potential to be a viable treatment option for patients and healthcare systems. We are particularly encouraged that a single 8 mg or 12 mg dose of BPL-003 showed rapid and durable efficacy results, favorable tolerability and a short time in-clinic, giving us important flexibility in optimizing the design of future trials. Thank you to all of the patients and study partners who participated in this study – we now look forward to preparing for end-of-Phase 2 meetings with regulators and moving forward with our strategic combination with atai Life Sciences to form atai Beckley, a global leader in psychedelic-based mental health treatments.”

Following the report, Jefferies said it sees potential for a 50%-100% stock move for shares of Atai Life Sciences. Given the “rapid efficacy,” followed by a “meaningful” and statistically significant reduction in depressive symptoms by Week 4 and “clear durability” to Week 8, the data “should instill confidence in a $1B+ drug,” the analyst saud. Jefferies has a Buy rating and $6 price target on Atai shares.

Additionally, H.C. Wainwright noted that the trial met its primary and all key secondary endpoints and argued that the “robust” data support the “first-in-class and best-in-class potential” in TRD for the rapid-acting psychedelic. The data meaningfully de-risk BPL-003 and “reinforce atai’s leadership in short-duration psychedelics,” added the analyst, who reiterates a Buy rating and $10 price target on the shares.

Meanwhile, Canaccord raised the firm’s price target on Atai Life Sciences to $12 from $11 and kept a Buy rating on the shares. The firm believes shares remain significantly undervalued following the release of solid Phase 2b data. It views the results as very encouraging as BPL-003 hit its primary and all key secondary endpoints convincingly. These results pave the way for the recently-announced ATAI-Beckley merger to close, which is on track for 2H25.

CLEARMIND ANNOUNCES FIRST PATIENT DOSED WITH CMND-100: Clearmind Medicine (CMND) announced Monday that the first participant has been dosed with CMND-100, its proprietary MEAI-based oral drug candidate, in its Phase I/IIa clinical trial for the treatment of Alcohol Use Disorder. This marks the first time a patient has received Clearmind’s treatment in a clinical setting, a critical step toward the development of a potential new therapy for millions affected by AUD worldwide. The dosing follows the company’s announcement on June 5, of the enrollment of the first participant in the trial, which is being conducted at clinical sites, including Yale School of Medicine’s Department of Psychiatry and Johns Hopkins University School of Medicine in the United States as well as Tel Aviv Sourasky Medical Center and Hadassah-University Medical Center in Jerusalem. The Phase I/IIa trial is designed to evaluate the safety, tolerability, and pharmacokinetic profile of CMND-100, while also assessing its preliminary efficacy in reducing alcohol cravings and consumption in patients with AUD.

“Dosing the first participant with CMND-100 in our study marks a landmark achievement towards the development of a new solution and offering new hope for the massive, underserved community suffering from alcoholism,” said Adi Zuloff-Shani, CEO. “This exciting event marks the first time our proprietary neuroplastogen compound has been given to humans under controlled clinical trial settings, bringing us closer to potentially delivering a revolutionary treatment for the millions of individuals and families suffering from AUD.”

Additionally on Thursday, Clearmind announced that it has received Institutional Review Board approval from Tel Aviv Sourasky Medical Center in Tel Aviv, Israel, for its trial evaluating CMND-100 for the treatment of AUD. This approval will enable patient enrollment at TASMC prior to commencing this first-in-human trial at the site.

CYBIN REPORTS FY25 RESULTS: On Monday, Cybin (CYBN) reported a FY25 loss per share of (C$5.59), which compared to a loss per share of (C$9.41) for the same period last year. Cash totaled C$135M as of March 31.

“During the past 12 months, we have continued to focus on building out the strong foundation that underpins the clinical and regulatory milestones we anticipate in the coming year,” said Doug Drysdale, CEO. “Heartened by U.S. Food and Drug Administration Commissioner Dr. Martin Makary’s recent comments in support of prioritizing this innovative scientific work, as well as the burgeoning government and media attention the field is receiving, we remain steadfastly committed to advancing our two lead programs, CYB003 and CYB004, toward potential approval and commercialization.”

BRIGHT MINDS ASSUMED WITH OVERWEIGHT: Cantor Fitzgerald assumed coverage of Bright Minds (DRUG) with an Overweight rating and no price target. Bright Minds’ lead asset, BMB-101, is a highly selective 5-HT2C receptor agonist in developmental and epileptic encephalopathies and absence epilepsy, the analyst said. BMB-101 may deliver improved efficacy, safety, and durability vs. competitors, the firm says.

PHARMATHER SEES PATH TO KETAMINE COMMERCIALIZATION: On Wednesday, PharmaTher (PHRRF) provided a corporate update to its shareholders, outlining a strategy to become the global leader in unlocking the pharmaceutical potential of ketamine. The U.S. Food and Drug Administration has set its approval goal date of August 9, for the potential approval of PharmaTher’s ketamine product on or before this date. PharmaTher is fully-funded through its FDA approval goal date of August 9, and for its initial U.S. commercial launch. The company has no plans for new equity or debt financing before the FDA approval goal date, underscoring its confidence in its current cash position and commitment to mitigating shareholder dilution through its existing capital structure. The manufacturing for the company’s ketamine product is based in the United States, ensuring supply chain security, quality control, and readiness for commercial scale-up. PharmaTher is preparing for international regulatory submissions in Europe, the United Kingdom, Canada, Japan, and the APAC regions, expected to commence in 2H25. The company is actively exploring the expansion of ketamine’s therapeutic applications, inspired by growing bipartisan support for psychedelic-assisted therapies, including recent federal initiatives on Kennedy-backed Make America Healthy Again movement. The Company has already submitted pre-INDs and INDs for ketamine in indications such as Parkinson’s disease, ALS, CRPS, and for novel delivery systems, including an on-body wearable pump and microneedle patch.

Fabio Chianelli, CEO, stated, “Receiving an approval goal date from the FDA provides a clear line of sight to potential approval and commercialization for our ketamine product. Our primary focus between now and August 9, 2025, is executing on our pre-commercial strategy. We have the team, the capital, and the plan in place to deliver on our commitment. We believe this milestone significantly de-risks our path forward and presents a powerful value proposition for our shareholders.”

OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Pharmaceuticals (AGNPF), Allied Corp. (ALID), BetterLife (BETRF), Compass Pathways (CMPS), Entheon Biomedical (ENTBF), Enveric Biosciences (ENVB), Filament Health (FLHLF), GH Research (GHRS), Incannex (IXHL), Mind Medicine (MNMD), MIRA Pharmaceuticals (MIRA), 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 Silo Pharma (SILO).