Enveric Biosciences Inc

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11/5 11:00

Compass Pathways Reports Quarterly Earnings with $444M Cash

In this week's "Psychedelic," The Fly's recurring series focused on psychedelic stock news, The Fly looks back on earnings, an extraction completion and analyst views.COMPASS REPORTS EARNINGS:On Tuesday, Compass Pathwaysreported awhich compared to analyst estimates of a loss per share of (33c). Cash and cash equivalents were $444M as of September 30, compared with $149.6M as of December 31, 2025. The current cash position is expected to be sufficient to fund operating expenses and capital expenditure requirements into 2028."Compass is leading one of the most important advances in mental health care in decades. Millions of people living with TRD are waiting for new treatments that can deliver meaningful and lasting benefit, and we believe COMP360 has the potential to change the paradigm," said Kabir Nath, CEO. "With the imminent completion of our NDA submission and the potential for a quick approval, we are executing with urgency and discipline to launch this much needed treatment in the first half of 2027. At the same time, we continue to advance our PTSD program, extending the potential impact of COMP360 to additional patient populations with significant unmet need. With a robust clinical package, a clear path forward, and a launch-ready organization, Compass is well positioned to deliver a successful TRD launch."FILAMENT COMPLETES EXTRACTION OF IBOGAINE CANDIDATE:Rhelion Life Sciencesannounced Monday that subsidiary Filament Health hasits naturally derived ibogaine drug candidate. The company has begun the next stages for stability testing on the new extract. This follows the company's September 10 announcement that Filament had begun planning a stability program for IBEX011. Stability testing is intended to support a shelf life and specification for IBEX011 and its potential future supply to regulated clinical research. IBEX011 is a total alkaloid iboga extract produced using Filament's proprietary extraction, purification and stabilization methods, the same platform used to produce PEX010, Filament's botanical psilocybin drug candidate.The company also announced Tuesday that Filament has shipped PEX010 to the University of Southern California, on behalf of its Keck School of Medicine, for the trial titled "Mindfulness Assisted Psychedelic Therapy". This is the first shipment under the supply and licensing agreement announced on September 15. The trial will evaluate whether and how mindfulness and meditation training can augment psilocybin-assisted therapy. The trial is led by Dr. Rael Cahn at the Keck School of Medicine of USC. USC is the sponsor of the trial.IMPLICATIONS SEEN FROM USONA FILING:Canaccord noted that trade publication Psychedelic Alpha published an article, citing anonymous sources "close to Usona," which suggested that the not-for-profit organization has filed a new drug application with the FDA for its psilocybin for major depressive disorder. The news has implications for Compass Pathways, which is developing the same molecule, but for treatment-resistant depression and has started a rolling NDA submission with the goal to complete its submission in Q4, and for Definium Therapeutics, which is developing DT-120 for MDD and generalized anxiety disorder with a potential filing in 1H27, the analyst said. The potential filing "makes things more real from a competitive standpoint," added the analyst, who pointed out that publicly-listed developers of psychedelic therapeutics were trading down on the news, while also discussing read through to Helus Pharmaand GH Research.Additionally, Jefferies noted that psychedelic stocks were weak intraday Monday after the Usona report. Although the firm had anticipated Usona to file an NDA, it was "surprised to see Usona file first," the analyst said. However the firm thinks sponsors like Compass Pathways and Definium Therapeutics have generated "more robust clinical data" to support pricing power and added that covered public companies in the space should have access to more resources to launch their psychedelics successfully.ENVERIC REPORTS EB-003 RESULTS:Enveric Biosciencesannounced Wednesday results from a, in mice. The study demonstrated modulation of brain activity in prefrontal and parietal regions of the cortex, providing functional evidence of central nervous system penetration and revealing a neurophysiological profile differentiated from dimethyltryptamine, a classic hallucinogenic psychedelic. The study evaluated EB-003 in mice using continuous qEEG recording across a broad range of brain-wave frequency bands, with DMT included as a comparator. The study achieved its primary objective of establishing a translational pharmacodynamic measure of EB-003's effects on cortical brain-wave oscillations. Additionally, in the study, DMT induced notable epileptic-like EEG activity and acute body spasms. EB-003 did not elicit similar findings, indicating a more favorable neurophysiological profile. Quantitative EEG measures the brain's electrical activity across different frequency bands, and maps them across brain regions, providing a method to characterize how a drug affects brain electrical function. The results generated in this study strengthen the rationale for evaluating qEEG in EB-003's planned first-in-human program, where it could complement safety and pharmacokinetic assessments and help inform dose selection for later studies."These results demonstrate EB-003 induces measurable activity in relevant brain regions with a profile differentiated from DMT, providing additional evidence of EB-003's unique pharmacological profile and mechanism of action," said Joseph Tucker, CEO. "The research has also identified qEEG as a suitable objective biomarker that we can utilize in upcoming human studies. As we advance toward our planned Phase 1 clinical trial of EB-003, the ability to correlate drug exposure to changes in brain activity on qEEG could help us identify biologically active doses and make more informed decisions for subsequent trials."PHARMALA, COREALIS SIGN AGREEMENT:PharmAla Biotech Holdingsannounced Thursday that it has signed an agreement with Corealis Pharma, a GMP-compliant contract development and manufacturing organization based in Laval, Québec, for thefor clinical supply. The agreement adds a high quality drug product manufacturer to PharmAla's ALA-002 supply chain. Corealis was selected following a technical, quality, and regulatory evaluation of Contract Development and Manufacturing Organizations. Corealis has already begun R&D on the drug product formulation, with GMP manufacturing of the first ALA-002 drug product batch scheduled upon completion of development activities. ALA-002 will initially be developed and launched as a 50mg capsule."We're confident that Corealis is the right partner to execute this work," said Farnoud Kazemzadeh, COO. "We are also excited to bring this drug development work back to Canada."FDA PLACES CLINICAL HOLD ON BMB-101-105 IND APPLICATION:Bright Minds Biosciencesannounced Monday that the FDA notified the company via email that its investigational new drug application for Developmental and Epileptic Encephalopathies and related Protocol BMB-101-105 has beenThe proposed trial related to this IND is a randomized, placebo-controlled, double-blind Phase 2 study designed to evaluate the efficacy and safety of ascending doses of BMB-101, up to a maximum tolerated dose, for the treatment of seizures associated with DEEs. The company believes that the partial clinical hold covers only the planned Phase 2 trial of BMB-101 in DEE in the United States, and the partial clinical hold does not affect the Company's other ongoing clinical trials. The primary reason given by the FDA relates to identified toxicity in mice, and inadequate pharmacokinetic and juvenile toxicity data to support the proposed pediatric enrollment. The company believes that the FDA's observation of toxicity in mice was not seen in any other species. The company further believes, based on its toxicity reports, peer reviewers, and multiple independent toxicology expert opinions, that the adverse mouse findings were incidental and not drug-related. The company plans to review the FDA's Partial Clinical Hold Letter and refine the study in accordance with the FDA's recommendations with the objective of addressing the identified issues and advancing future U.S. clinical trials.H.C. Wainwright said based on the initial disclosure, the issues appear potentially addressable. However, the firm preliminarily expects at least a one-year delay to the U.S. DEE development timeline, subject to the FDA's requirements. Wainwright's estimates are under review. The firm has a Buy rating on the shares with a price target of $145.BTIG lowered the firm's price target on Bright Minds to $37 from $147 and kept a Buy rating on the shares. While the firm awaits further detail of the hold, it admits "this could be a nice 60% off sale on the stock," but added that this issue - which it calls "the meeting of an incompletely convincing clinical package meeting the high wall for treating children with non-life threatening conditions" - could take some time to be cleared up.Baird lowered the firm's price target on Bright Minds to $107 from $126 and kepy an Outperform rating on the shares.NRX RECEIVES FDA APPROVAL FOR KETAMINE ANDA:NRx Pharmaceuticalsannounced Friday that the FDA has approved the company'sThe approval comes ahead of the FDA-announced November 10, approval goal date."We are excited to bring Preservative-Free Ketamine to market and to give patients and their physicians an option for repeat treatments without the potential dangers of a preservative that has been classified as unacceptable for inclusion in multiple product categories by the US Food and Drug Administration," said Jonathan Javitt, CEO. "Ketamine injection has been in short supply since 2018 and currently appears on the FDA drug shortage list with some manufacturers discontinuing production. The Secretary of Health and FDA Commissioner have previously identified ketamine as a strategic drug whose supply in the US must be assured. With manufactured commercial supply on hand, we can now label our product and supply American hospitals and clinics. In those settings, ketamine is used primarily for anesthesia and pain control, including in labor and delivery, where it is the only IV anesthetic that minimizes suppression of breathing in the baby. We are pleased to work with our partners at Nephron Pharmaceuticals in West Columbia, South Carolina, who have helped us prove that sterile, preservative-free injectables can be made in America."OTHER PSYCHEDELIC STOCKS:Publicly-traded companies in the space include Grey Matters Health, BetterLife, Clearmind, Eli Lilly, Incannex, MIRA Pharmaceuticals, Numinus Wellness, Optimi Health, Pasithea Therapeutics, PharmaTher, Psyence Biomedical, Revive Therapeutics, Sibannacand Silo Pharma.

10/21 08:30

Enveric Biosciences EB-003 Shows Positive ADMET Study Results

Enveric Biosciences announced positive results from recently completed IND-enabling in vitro Absorption, Distribution, Metabolism, Excretion and Toxicity, ADMET, studies for its lead non-hallucinogenic, neuroplastogenic candidate EB-003. The comprehensive in vitro screen, involving a battery of over 70 individual assays, demonstrated favorable properties of EB-003 including: Predicted to have favorable intestinal absorption potential when evaluated in human cell-based membrane permeability tests; Does not show significant in vitro plasma protein binding suggesting favorable biodistribution and clearance properties when the drug enters the bloodstream; Demonstrates stability when evaluated against liver metabolism enzymes from multiple species, including human; Is not a substrate of key liver and renal transporters in vitro, suggesting favorable systemic drug exposure and a more predictable drug elimination profile; Does not show significant inhibition or induction of major metabolic enzymes and multidrug transporter proteins, reducing the possibility of drug-drug interactions

9/15 08:30

Enveric Biosciences Receives Patent Allowance for EVM401 Series

Enveric Biosciences announced that it has received a Notice of Allowance from the United States Patent and Trademark Office, USPTO, for a patent application covering novel compounds within its EVM401 Series of drug candidates. The EVM401 Series comprises proprietary, non-hallucinogenic mescaline-derived compounds designed to promote neuroplasticity for the potential treatment of psychiatric and neurological disorders.

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