Psychedelic: Cybin receives European approval for EMBRACE study

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

CYBIN RECEIVES EUROPEAN APPROVAL FOR EMBRACE STUDY: Cybin (CYBN) announced Thursday that its Clinical Trial Application has been approved by the Irish Medicines Board, acting as the reference Member state, to initiate the EMBRACE study in Ireland, Poland, and Greece. EMBRACE is the second pivotal study in PARADIGM, the company’s Phase 3 multinational program evaluating CYB003, a proprietary deuterated psilocin analog. The company also recently announced approval from the Medical and Healthcare products Regulatory Agency to commence EMBRACE in the United Kingdom. CYB003 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the adjunctive treatment of Major Depressive Disorder.

“Securing European approval to commence the EMBRACE component of PARADIGM, especially on the heels of the recent UK MHRA approval, validates the quality of our Phase 3 clinical development program and reaffirms the strength of our results to date,” said Doug Drysdale, CRO. “We appreciate the trust placed in us by the European Regulatory Agencies and are eager to leverage Europe’s well-established clinical trial infrastructure. The EMBRACE study aims to enroll 330 participants who live with moderate to severe MDD and whose symptoms are inadequately controlled with antidepressant treatments. With this additional approval, which enables us to enroll participants in Ireland, Poland, and Greece, we are pleased to expand the reach for this critical research. The rise in mental health disorders knows no borders, and we are committed to an international research base to develop new and more effective treatments for MDD patients everywhere.”

GH RESEARCH REPORTS Q2 EARNINGS: On Thursday, GH Research (GHRS) reported second quarter loss per share of (15c), which compared to analyst consensus of (20c). Cash, cash equivalents and marketable securities were $308.7M as of June 30, compared to cash, cash equivalents, other financial assets and marketable securities of $182.6M as of December 31.

The company said, “We recently announced that we received a communication from the U.S. Food and Drug Administration relating to our complete response to the clinical hold of our Investigational New Drug Application for GH001, with only one hold topic remaining. Engagement with the FDA on our IND complete response is ongoing. We are actively working on a plan with our respiratory, toxicology and regulatory experts to address the remaining topic.”

CLEARMIND RECEIVES IRB APPROVAL FOR AUD TRIAL: Clearmind Medicine (CMND) announced Tuesday that it has received Institutional Review Board approval from 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 patient enrollment at Hadassah Medical Center, prior to commencing this first-in-human trial at the site. 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.

“Securing IRB approval from Hadassah-University Medical Center, a globally respected institution, marks another important step in our journey to address the deep unmet need in Alcohol Use Disorder,” said Dr. Adi Zuloff-Shani, CEO. “The addition of Hadassah to our growing network of top-tier research centers, including Yale and Johns Hopkins, reflects the strong momentum behind our clinical program and reinforces our commitment to pioneering next-generation psychedelic-based therapies that can truly change lives.”

Additionally on Thursday, Clearmind announced the (SPRC). The patent application published under the European Patent Office covers a combination therapy of Clearmind’s proprietary 5-methoxy-2-aminoindane and SciSparc’s Palmitoylethanolamide for the treatment of metabolic syndrome and obesity. Metabolic syndrome, characterized by conditions such as high blood pressure, high blood sugar, excess abdominal fat, and elevated cholesterol levels, affects up to one-third of U.S. adults and increases the risk of heart disease, stroke, obesity and type 2 diabetes. This proprietary combination therapy leverages MEAI’s pharmacological profile alongside PEA’s anti-inflammatory and neuroprotective properties to offer a potential safe and effective treatment for these widespread health challenges.

ANALYST NOTES: H.C. Wainwright lowered the firm’s price target on Compass Pathways (CMPS) on Monday to $40 from $45 and kept a Buy rating on the shares. Compass confirmed that no further development is planned in anorexia nervosa following completion of the Phase 2 trial, the analyst said. As such, the firm removed the indication from its model post the Q2 report.

Additionally on Monday, Oppenheimer resumed coverage of Mind Medicine (MNMD) with an Outperform rating and $25 price target. The firm previously had no rating on the shares. The analyst has “high conviction” that the company’s lead asset MM120 will “revolutionize” neuropsychiatry with its potential to drive durable remission. MM120 has a “unique” clinical profile with its less-intense but longer psychedelic experience compared to other approaches, the analyst said.

PHARMALA DELIVERS MDMA TO MERHAVIM: PharmAla Biotech (MDXXF) announced Thursday that it has completed customs clearance and delivery of over 500 capsules of the company’s LaNeo 40mg MDMA to Merhavim Mental Health Centre of Beer Yaakov, Israel. All data generated in the clinical trial, entitled “MDMA Assisted Psychotherapy for PTSD of Early Sexual Trauma Compared to All Trauma in Adulthood”, will be licensed to PharmAla for regulatory and commercial purposes in exchange for the clinical trial material. MAPS Israel, an Israeli non-profit organization whose mission is to develop psychedelic research and educational programs based in public health, is also a partner to the clinical trial.

“We believe that this delivery sets a precedent in terms of the innovative terms agreed-to with Merhavim , terms that allows researchers to explore new and complex mental health indications with less financial risk while allowing PharmAla to develop important intellectual property in a cost-effective manner,” said Nick Kadysh, CEO. “However it also continues to show PharmAla’s ability to work rapidly on behalf of our clients, with just 6 months between execution and delivery of the shipment, even with complexity in not only cross-border trade and tariff pressure, but also a significant conflict in the region.”

OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Pharmaceuticals (AGNPF), Allied Corp. (ALID), atai Life Sciences (ATAI), BetterLife (BETRF), Bright Minds (DRUG), Enveric Biosciences (ENVB), Filament Health (FLHLF), Incannex (IXHL), MIRA Pharmaceuticals (MIRA), NRx Pharmaceuticals (NRXP), Numinus Wellness (NUMIF), Pasithea Therapeutics (KTTA), PharmaTher (PHRRF), Psyence Biomedical (PBM), Psyence Group (PSYGF), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF), Seelos Therapeutics (SEEL) and Silo Pharma (SILO).