Psychedelic: Clearmind reports results from first cohort in AUD trial

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

CLEARMIND REPORTS RESULTS FROM FIRST COHORT IN AUD TRIAL: Clearmind Medicine (CMND) announced Tuesday top-line results from the first cohort of its Phase I/IIa clinical trial evaluating CMND-100, the company’s proprietary non-hallucinogenic MEAI-based oral drug candidate for the treatment of Alcohol Use Disorder. The top-line data from the first cohort demonstrate a favorable safety profile, with no serious adverse events reported and the treatment generally well-tolerated across all participants. Additionally, the cohort showed strong treatment observance, with high adherence to the dosing regimen and protocol requirements, underscoring the feasibility and patient acceptability of CMND-100 in a clinical setting. These early findings support the ongoing evaluation of CMND-100 as a potential breakthrough therapy for AUD, a condition affecting millions worldwide where effective treatments remain limited.

“We are thrilled with these initial top-line results from the first cohort, which “indicate an encouraging safety profile and excellent treatment observance of CMND-100,” said CEO Adi Zuloff-Shani. “Building on our recent milestone of completing dosing at premier institutions like Johns Hopkins and Yale, these data provide strong momentum as we advance toward full data readout and subsequent cohorts. Our goal remains to pioneer neuroplastogen -derived therapies that offer real hope to those battling addiction, and these results bring us one step closer to that vision.”

The company also announced Thursday the initiation of its Phase I/IIa clinical trial for CMND-100 at Hadassah Medical Center in Jerusalem, Israel. 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.

Additionally on Monday, Clearmind announced the filing of(SPRC).

PSYENCE BIOMED ESTABLISHES SUPPLY OF IBOGA BARK: Psyence Biomedical (PBM) announced Thursday it has established a sustainable supply of high-potency iboga bark from sourcing channels through its strategic partner, PsyLabs, which comes as the company prepares for the clinical development of ibogaine for substance use disorders. PsyLabs’ ibogaine is fully GMP-compliant, ensuring it meets the rigorous standards required for clinical development. The first 50 kg has already been received and is now being processed into ibogaine HCL, the purified, pharmaceutical-grade form of ibogaine, and into Total Alkaloid Extracts, which preserve the broader spectrum of iboga alkaloids found in the natural plant. Together, these products will be supplied to the legal research and treatment industries, supporting both standardized clinical trials and research into full-spectrum therapeutic approaches.

“A reliable, ethically sourced supply of ibogaine is critical to our development pipeline,” said Jody Aufrichtig, CEO. “This achievement not only strengthens our ability to advance our ibogaine-based clinical programs but also positions Psyence BioMed as a global leader in the emerging ibogaine sector. As international interest in ibogaine continues to accelerate, securing a sustainable and culturally respectful supply chain gives us a meaningful competitive advantage and reinforces our commitment to scientific rigor, responsible innovation, and the preservation of traditional knowledge.”

Q3 EARNINGS: On Friday, Enveric Biosciences (ENVB) reported a third quarter loss per share of ($10.81), which compared to a loss per share of ($43.10) for the same period last year.  As of September 30, Enveric had cash and cash equivalents of $3.8M. The company continues to fund its operations through the use of various financing tools.

“The third quarter of 2025 marked another highly productive period as we continue to advance our lead candidate EB-003 towards clinical trials in 2026,” said Joseph Tucker, CEO. “Importantly, we recently received a written response from the U.S. Food and Drug Administration to our request for a Pre-Investigational New Drug Type B meeting for EB-003, which we believe is consistent with our view that the preparations are sufficiently advanced to proceed to IND submission. Driving towards this significant inflection point, we also completed key chemistry, manufacturing, and controls milestones, as well as dose range studies that helped to establish a maximum tolerated dose of EB-003.”

On Monday, NRx Pharmaceuticals (NRXP) reported a Q3 loss per share of (27c), which compared to a loss per share of (15c) for the same period last year. As of September 30, NRx Pharmaceuticals had approximately $7.1M in cash and cash equivalents. The company believes that its current cash position will support operations at least through the second quarter of 2026, as well as provide sufficient capital to reach expected regulatory inflection points and complete potential additional select acquisition opportunities to expand the growing footprint of HOPE clinics.

“In 2025 we have advanced each of our corporate objectives and entered into revenue-generating activity for the first time. For NRX-100 in suicidal depression, we received an expanded Fast Track designation, opened an Expanded Access program and enhanced our regulatory package. Additionally, FDA granted our Suitability Petition for a single patient, preservative free ketamine strength and we have received validation that our ANDA filing is on track with no major deficiencies. In parallel, the Real World Data demonstrating a doubling of antidepressant and antisuicidal effect of Transcranial Magnetic Stimulation when D-cycloserine is added creates a new and significant indication for NRX-101 that has potential for approval, if confirmed in an additional phase 3 trial. For HOPE, we continue to execute on building our delivery platform of three active facilities in Florida, with three more planned by year-end. Dr. Rebecca Cohen and LTC Charles Paul, RN are assembling a network of best-in-class interventional psychiatrists to meet the needs of people, including active duty military, first responders, and veterans, across Florida and beyond,” said Jonathan Javitt, CEO.

SILO PHARMA PARTNERS WITH ALLUCENT: Silo Pharma (SILO) announced Monday that it has selected Allucent to support the company’s final preparations and planned submission of its investigational new drug application to the FDA for a Phase 1 clinical trial of its intranasal prophylactic SPC-15 as a treatment for PTSD. The company currently expects to submit the IND in 2026 and commence its first-in-human SPC-15 trial subsequent to FDA approval.

“We believe that a partnership with Allucent, is a significant move forward in bringing our novel PTSD therapeutic to the clinic,” said CEO Eric Weisblum. “With Allucent’s expertise, we believe our IND will provide a sound rationale for clinical development, beginning with protocols for dose-ranging studies to assess the pharmacokinetics and safety profile for SPC-15. We expect to receive positive preclinical results in these categories which should meet the FDA’s clinical trial standards.”

CYBIN PRICE TARGETS LOWERED: Canaccord lowered the firm’s price target on Cybin (CYBN) to $45 from $70 and kept a Buy rating on the shares. The firm updated its model to reflect its recent capital raise of about $175M and paydown of its convertible debt. The company is poised for a catalyst rich 2026 and shares remain significantly undervalued.

Additionally, H.C. Wainwright lowered the firm’s price target on Cybin to $55 from $150 and kept a Buy rating on the shares. Strong clinical execution, commercial groundwork, and financial strengthening leave Cybin well-positioned ahead of two major 2026 readouts, the firm said. The increased share count from the recent financing, normalization of expenses in Wainwright’s model, and fine-tuning its expected CYB003 launch to 2028 and CYB004 launch to 2029 resulted in a revised price target, Wainwright added.

OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Health (AGNPF), Atai Beckley (ATAI), BetterLife (BETRF), Bright Minds (DRUG), Compass Pathways (CMPS), Filament Health (FLHLF), GH Research (GHRS), Incannex (IXHL), Mind Medicine (MNMD), MIRA Pharmaceuticals (MIRA), Numinus Wellness (NUMIF), Pasithea Therapeutics (KTTA), PharmAla (MDXXF), PharmaTher (PHRRF), Psyence Group (PSYGF), Relmada Therapeutics (RLMD) and Revive Therapeutics (RVVTF).