Psychedelic: Cybin completes enrollment in CYB004 Phase 2 study

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on an enrollment completion, analyst notes and a patent grant.

CYBIN COMPLETES ENROLLMENT IN CYB004 PHASE 2 STUDY: Cybin (CYBN) announced Monday the completion of enrollment in its Phase 2 study evaluating CYB004, a proprietary deuterated dimethyltryptamine program, for the treatment of Generalized Anxiety Disorder and reaffirms top line data guidance expected in 1Q26. The CYB004-002 Phase 2 study is a randomized, double-blind study evaluating the safety and efficacy of CYB004 in participants with moderate to severe GAD and are currently taking concomitant antidepressant or anxiolytic treatments. Participants with co-morbid depression are allowed. The study is evaluating safety and efficacy at 12 weeks, with an optional follow-up to assess efficacy at 12 months. The study will remain double-blinded through Week 12. The study has enrolled 36 participants, who were randomized into two groups. The first group received two intramuscular administrations of CYB004 three weeks apart at a dose predicted to be therapeutic, while the second group received two intramuscular administrations of CYB004 three weeks apart at a lower dose predicted to be sub-therapeutic. The primary endpoint is a change in the Hamilton Anxiety Rating Scale score from baseline at six weeks following the first administration of CYB004. Secondary endpoints include change in HAM-A through the double-blind period. Other endpoints include the Hamilton Depression Rating Scale, safety assessments, MEQ30 and EQ-5D-5L.

“Completing enrollment in our Phase 2 study of CYB004 marks a significant milestone on our path to bringing forth an effective treatment for GAD,” said Eric So, Interim CEO. “Improved treatments are greatly needed, as anxiety disorders affect more than 300M people worldwide. GAD is the most common anxiety disorder seen in primary care, with roughly 6.8M people living with GAD in the United States alone. Unfortunately, half of these patients do not respond to approved treatment with selective serotonin reuptake inhibitors and serotonin and norepinephrine reuptake inhibitors. We are excited about CYB004, and its potential to offer convenient intramuscular dosing for patients in need. We are proud of this work to date, as well as the robust patent protection in support of our CYB004 program, and we look forward to sharing topline data in the first quarter of 2026.”

BRIGHT MINDS INITIATED WITH A BUY RATING: BTIG initiated coverage of Bright Minds (DRUG) with a Buy rating and $72 price target. The company is developing a “very specific” 5-HT2C agonist, BMB-101, for epilepsies that has better dosing than bexicaserin, the analyst said. The firm believes the dosing advantage is relevant given data suggesting the side effects of the 5-HT2C class may be peak concentration-dependent. The relatively high percentage of absence seizures in otherwise healthy children suggests convenient dosing and low side effects “are a major positive,” contended BTIG. It expects Phase 2 data from Bright Minds around year-end 2025.

SILO ANNOUNCES JAPANESE PATENT: Silo Pharma (SILO) announced Tuesday that the Japan Patent Office has granted patent number 7683882 to Silo’s research and licensing partner Columbia University for the invention titled “Prophylactic efficacy of serotonin 4 receptor agonists against stress,” exclusively licensed to Silo by Columbia University. Columbia University recently received an Australian patent for the same invention. The patent reinforces protection for Silo’s lead asset, SPC-15, an intranasal treatment targeting post-traumatic stress disorder, originally developed by Columbia University.

“This Japanese patent adds another layer of protection for SPC-15, adding to our high-value international IP portfolio,” said Silo CEO Eric Weisblum. “Our expanding patent library is a cornerstone in the ongoing development and regulatory strategy for our novel PTSD therapy.”

PHARMALA COMPLETES LANEO MDMA IMPORT: PharmAla Biotech (MDXXF) announced Monday that it has completed import operations for LaNeo MDMA and release to the United States. PharmAla announced contracting of this new distribution site on March 24, 2025. PharmAla’s agreement with its partner provides for a streamlined domestically-stored GMP-compliant supply of LaNeo MDMA for all clients already contracted. It provides certainty against regulatory and import/export risks for any clients seeking MDMA for clinical trials in the United States.

“With the full onboarding of our distribution facility, PharmAla is now in a position to service clinical trial clients in the U.S. rapidly, and without the need for additional import operations,” said Nick Kadysh, CEO. “Our numerous US clients and potential customers can rest assured that PharmAla will continue to work to make their critical research faster, cheaper, and easier – even in the face of global trade uncertainty and tariff risk.”

Additionally, the company reported that Shane Morris has resigned from his role as COO of PharmAla Biotech. Morris’ role will be backfilled.

NRX PHARMACEUTICALS INITIATED WITH BUY RATING: H.C. Wainwright initiated coverage of NRx Pharmaceuticals (NRXP) with a Buy rating and $40 price target. The company is combining novel therapeutics with integrated mental health care delivery to address acute suicidality in depression, the analyst said. The firm believes NRx is positioned to become a leader in high-risk mood disorders and remains “significantly undervalued” at current share levels.

Additionally on Monday, HOPE Therapeutics, a multi-site clinical care delivery organization and wholly-owned subsidiary of NRx, announced the closing of the previously announced acquisition of Dura Medical. Dura, together with the pending Neurospa TMS and Cohen and Associates acquisitions, are planned to provide a comprehensive service offering to patients at more than eight locations along the West Coast of Florida. Dura is revenue generating and EBITDA positive. In conjunction with the acquisition, HOPE appointed Steve Durand, founder of Dura, as Director of Florida Clinic Operations.

“Steve Durand is a pioneer in combining the use of psychedelic medications with TMS and other neuroplastic technologies for advancing the treatment of suicidal depression and PTSD in Southwest Florida. He has brought his experience as an Army veteran to building Dura’s tradition of excellence and commitment to patient care for civilians and veterans alike. His commitment and sense of purpose align perfectly with HOPE’s vision for our Florida network,” said Jonathan Javitt and Matthew Duffy, Co-CEOs of HOPE Therapeutics. “We look forward to Steve’s partnership as we continue to build our network throughout the State of Florida and beyond.”

OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Pharmaceuticals (AGNPF), Allied Corp. (ALID), atai Life Sciences (ATAI), BetterLife (BETRF), Clearmind (CMND), Compass Pathways (CMPS), Enveric Biosciences (ENVB), Filament Health (FLHLF), GH Research (GHRS), Incannex (IXHL), Mind Medicine (MNMD), MIRA Pharmaceuticals (MIRA), Numinus Wellness (NUMIF), Pasithea Therapeutics (KTTA), PharmaTher (PHRRF), Psyence Biomedical (PBM), Psyence Group (PSYGF), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF), SciSparc (SPRC) and Seelos Therapeutics (SEEL).