Psychedelic: Enveric, Filament Health report earnings results

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on earnings, an EDC system launch and trial enrollment.

PSYCHEDELIC FIRMS REPORT EARNINGS: On Monday, Enveric Biosciences (ENVB) reported a fourth quarter loss per share of ($4.83), which compared to a loss per share of ($21.90) for the same period last year. The company had cash-on-hand of $2.2M for the quarter ended December 31, 2024.

“Enveric is entering 2025 with a clear mission – enhance shareholder value by cementing our leadership position in the promising neuroplastogen field with the continued development of EB-003,” stated Joseph Tucker, CEO. “With EB-003, we believe Enveric is at the forefront of redefining the treatment of severe mental health conditions, an area of medicine that has been without substantial innovation for many years. We are now focused on completing the data package needed to file an Investigational New Drug application for EB-003. After the completion of a pre-IND meeting with the U.S. Food and Drug Administration and the filing of the IND, we will be poised to advance EB-003 into Phase 1 clinical trials and towards the goal of capitalizing on the estimated $35B future market opportunity for neuroplastogens.”

On Tuesday, Filament Health (FLHLF) reported fiscal year 2024 revenues of $616,678 and cash and cash equivalents of $391,237 as of December 31, 2024.

“Over the course of 2024, we continued to expand Filament’s position as a leading global supplier of cGMP botanical psilocybin,” said Benjamin Lightburn, CEO. “While this past year presented challenges, we remain steadfast in our mission to unlock the therapeutic potential of botanical psilocybin, and our other botanical drug candidates. We continue to focus on the advancement of our lead program, PEX010, into clinical trials around the world. Our emphasis on the treatment of substance use disorders was further validated by the recent positive results seen with PEX010 in patients with severe alcohol use disorder.”

CLEARMIND LAUNCHES EDC SYSTEM FOR AUD TRIAL: Clearmind Medicine (CMND) announced Tuesday the launch of its Electronic Data Capture system to support its Phase I/II clinical trial of its MEAI-based treatment for Alcohol Use Disorder. The activation of the EDC system marks an operational milestone, enabling real-time, secure and compliant data collection across all stages of the study. The clinical trial is designed to evaluate the safety, tolerability and efficacy of Clearmind’s psychedelic-derived, MEAI-based compound in individuals with AUD. The EDC system, which was custom designed for Clearmind’s clinical protocol, incorporates automated edit checks, real-time validation and a secure randomization process. The platform supports compliant data capture across multiple study parts, including future protocol amendments. 

“The activation of our customized EDC system represents another major operational milestone for Clearmind,” said Dr. Adi Zuloff-Shani, CEO of Clearmind. “This platform is central to our ability to manage clinical data with precision, ensure compliance and maintain the integrity of our trial. Its robust design provides real-time oversight and supports the flexible structure of our multi-part study, which is critical as we advance our MEAI-based treatment through clinical development.”

MIRA ENROLLS FIRST SUBJECTS IN KETAMIR-2 TRIAL: MIRA Pharmaceuticals (MIRA) announced Tuesday the enrollment of the first subjects in its Phase 1 clinical trial of Ketamir-2, a novel oral ketamine analog in development for the treatment of neuropathic pain. The Phase 1 trial is being conducted at the Clinical Pharmacology Unit of Hadassah Medical Center in Jerusalem, Israel. This randomized, double-blind, placebo-controlled study will assess the safety, tolerability, and pharmacokinetics of Ketamir-2 in healthy adult volunteers. A total of 56 subjects will be enrolled across both Single Ascending Dose and Multiple Ascending Dose cohorts. This clinical milestone follows preclinical data, where Ketamir-2 demonstrated superior efficacy compared to FDA-approved neuropathic pain treatments, including pregabalin and gabapentin. It also showed a strong safety profile and oral bioavailability, without the dissociative or psychedelic effects commonly associated with ketamine. MIRA anticipates completing the Phase 1 study by 4Q25. The company plans to initiate a Phase 2a trial in patients with diabetic neuropathic pain by year-end, with first human efficacy data expected in 1H26.

“The Phase 1 trial is progressing smoothly and according to plan,” said Dr. Itzchak Angel, Chief Scientific Advisor. “Ketamir-2’s unique mechanism and pharmacological profile make it a highly promising candidate for neuropathic pain. If successful, it could represent a safer, non-addictive alternative to opioids and a more effective option than current standard treatments like pregabalin and gabapentin.”

INCANNEX COMPLETES REPOSA PHASE 2 ENROLLMENT: Incannex Healthcare (IXHL) announced Thursday that the company has completed Phase 2 patient enrollment in the global Phase 2/3 RePOSA study of IHL-42X for the treatment of Obstructive Sleep Apnea. IHL-42X is an oral fixed dose combination medicine designed to reduce the incidence of interruptions to breathing during sleep and improve sleep quality. The RePOSA Phase 2/3 is a randomized, double-blind clinical trial designed to evaluate the safety and efficacy of IHL-42X in patients with mild to severe OSA, who are intolerant, non-compliant, or naïve to positive airway pressure herapy. At least 560 patients will be recruited, with a total of 355 patients receiving IHL-42X over the course of the study. The Phase 2 study is a four-week, dose-finding study comparing two dose strengths of IHL-42X — 2.5 mg dronabinol/125 mg acetazolamide and 5 mg dronabinol/250 mg acetazolamide — to placebo. More than 120 patients were enrolled across 11 study sites in the U.S. Phase 2 results will determine the optimal dose strength to advance into the larger Phase 3 trial.

“We are excited to have achieved this milestone and deeply grateful to our investigators, site coordinators, and, especially to the sleep apnea patient community for its support. The pace at which we fully enrolled the Phase 2 portion of the RePOSA Phase 2/3 study strengthens our confidence in this program. OSA is a serious, chronic, and life-threatening condition, and we believe our once-daily oral medication – designed to target underlying causes of OSA – could offer meaningful benefits to patients,” Lou Barbato, CMO.

NRX PHARMACEUTICALS INITIATED WITH BUY: BTIG initiated coverage of NRx Pharmaceuticals (NRXP) on Wednesday with a Buy rating and $18 price target. NRx Pharmaceuticals is working broadly in suicidal ideation and behavior, a large area of unmet need that has seen essentially no improvement in treatment outcomes in 50 years, and is seeking to generate an FDA-approved version of IV ketamine to help standardize the treatment landscape, the analyst said. The initial IV ketamine FDA submission package is supported by a collection of high-quality and controlled trials supporting the drug’s activity in suicidal ideation and depressive symptoms, and BTIG sees this approach as reasonably likely to be enough for approval as the real-world evidence for this indication is significant and includes huge composite data sets collected across the current treatment landscape.

The company also announced Monday that its psychiatry network HOPE Therapeutics signed a definitive agreement to acquire Dura Medical. Dura, together with the previously announced Neurospa network, are anticipated to provide a comprehensive service offering to patients on Florida’s west coast. Dura is revenue generating and EBITDA positive. Dura Medical was founded in 2018 to offer a precision approach to treating mental health and chronic pain on the west coast of Florida.  The clinics leverage the latest interventional psychiatry procedures, including Ketamine Infusion Therapy, Transcranial Magnetic Stimulation Spravato and Stellate Ganglion Blocks, augmented by traditional psychiatry and therapy to provide a full continuum of care for people with depression, suicidality, PTSD, anxiety, and related disorders.

Additionally on Thursday, HOPE Therapeutics announced the signing of a term sheet with a global medical device manufacturer. The term sheet, which is non-binding and subject to the execution of a definitive stock purchase agreement, contemplates an investment of $2.5M to purchase Series A Convertible Preferred Stock at a $50M pre-money valuation.

OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Pharmaceuticals (AGNPF), Allied Corp. (ALID), atai Life Sciences (ATAI), BetterLife (BETRF), Bright Minds Biosciences (DRUG), Compass Pathways (CMPS), Cybin (CYBN), Entheon Biomedical (ENTBF), GH Research (GHRS),  Mind Medicine (MNMD), Mydecine Innovations (MYCOF), Numinus Wellness (NUMIF), Optimi Health (OPTHF), Pasithea Therapeutics (KTTA), PharmAla (MDXXF), PharmaTher (PHRRF), Psyence Biomedical (PBM), Psyence Group (PSYGF), Quantum BioPharma (QNTM), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF), SciSparc (SPRC), Seelos Therapeutics (SEEL), Silo Pharma (SILO) and Synaptogenix (SNPX).