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Psyence Biomedical Secures Exclusive U.S. Ibogaine License
In this week's "Psychedelic," The Fly's recurring series focused on psychedelic stock news, The Fly looks back on a license agreement, a psilocybin shipment and a reverse share split.PSYENCE BIOMED REPORTS EXCLUSIVE U.S. IBOGAINE LICENSE:Psyence Biomedicalannounced Monday that its wholly-owned subsidiary, Texas Ibogaine Research Corporation, has entered into a binding term sheet with Psyence Labs, under whichfor PsyLabs' pharmaceutical-grade ibogaine in the United States. The term sheet is binding on the parties and is to be superseded by a definitive agreement, which the parties have agreed to conclude on or before November 30; if a definitive agreement is not signed by that date, the term sheet will lapse.Under the term sheet, PsyLabs will grant TIRC an exclusive license in the U.S. to PsyLabs' know-how, trade secrets, cultivation, extraction and processing methods, analytical methods, specifications, standard operating procedures, batch records and technical and regulatory information relating to its pharmaceutical-grade ibogaine hydrochloride, to the extent necessary or useful to develop, manufacture and commercialize ibogaine drug candidates in the U.S. PsyLabs will be TIRC's exclusive supplier of ibogaine, and TIRC will be appointed PsyLabs' exclusive wholesaler and distributor of that product in the U.S. PsyLabs retains all rights outside the U.S. In consideration, TIRC will pay PsyLabs development and regulatory milestone payments totaling up to approximately $1.3M for the first drug candidate, an annual exclusivity fee commencing on the first anniversary of the first FDA approval and creditable against royalties, and a low single-digit percentage royalty on net sales of each drug candidate, together with a margin-sharing arrangement on any resale of product by TIRC."Exclusivity matters. This term sheet is intended to give TIRC a defined position in U.S. ibogaine development, backed by access to PsyLabs' material, manufacturing know-how and technical documentation. For any federal agency, state programme or clinical partner, we believe that the question of who to work with on ibogaine in the USA has a clear answer," said Jody Aufrichtig, CEO of Psyence BioMed.FILAMENT SHIPS PEX010 TO UNIVERSITY OF CALGARY:Rhelion Life Sciencesannounced Tuesday that subsidiary Filament Health has shippedfor the Phase 2 trial titled "Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence", known as PsiPTSD. PsiPTSD will evaluate psilocybin-assisted therapy for chronic PTSD in adult survivors of intimate partner violence. The trial is led by Dr. Chantel Debert at the University of Calgary. The University of Calgary is the sponsor of the trial. Filament is not the sponsor of the trial and is not responsible for its conduct. PsiPTSD is the second trial led by Dr. Debert at the University of Calgary to use PEX010, following a Phase 2b trial of psilocybin-assisted therapy for persisting symptoms after concussion.The company also announced Friday that Filament has expanded its supply and licence agreement with the University G. d'Annunzio of Chieti-Pescara for the supply of PEX010 to TEMPO, a clinical trial of psilocybin for treatment-resistant depression conducted at the Psychiatric Clinic of the University in Chieti, Italy. TEMPO was authorized under the European Union Clinical Trials Regulation. During the regulatory review, the number of trial participants was increased, and the amended agreement expands the supply of PEX010 25 mg capsules to match. Filament also provides regulatory support for the trial and release of PEX010 for use in the European Union. The trial is coordinated with the Istituto Superiore di Sanità and has been reported in the Italian press as the first clinical trial of psilocybin in Italy.CLEARMIND TO EFFECT REVERSE SHARE SPLIT:In a Wednesday regulatory filing, Clearmind Medicineannounced that it will effect asuch that each eight common shares, no par value, shall be consolidated into one common share, no par value. The first date when the company's ordinary shares will begin trading on the Nasdaq Capital Market after implementation of the reverse split will be Monday, October 5. Following the implementation of the reverse split, the company's authorized share capital will remain unchanged. The reverse split will adjust the number of issued and outstanding common shares of the company from 4,059,227 ordinary shares to 507,404 ordinary shares.HELUS PHARMA COMPLETES LEGAL NAME CHANGE:Helus Pharmaannounced Thursdayfrom "Cybin Inc." to "Helus Pharma Inc." The name change was approved by shareholders at the company's annual and special meeting of shareholders held on September 22. The name change follows the company's adoption of the business name "Helus Pharma" on January 5 and reflects the company's anticipated transformation from a clinical stage discovery and development company to a commercial-ready pharmaceutical company. The company's common shares will continue to trade on the Nasdaq Global Market and Cboe Canada under the ticker symbol "HELP".NRX AWARDED DARPA PRIME CONTRACT:NRx Defense Systemsannounced Wednesday the award of ana Branch of the United States Department of War. The underlying clinical trial, the Synaptic Plasticity Augmented Rapid Circuit Stimulation trial has been approved by the U.S. Food and Drug Administration and will now begin enrolling patients. The SPARC-TMS trial will be conducted at Harvard Medical School's McLean Hospital, Arizona State University, and HOPE Therapeutics. Several leading military hospitals will also be affiliated with the study.The focus of SPARC-TMS is to test whether an entire course of transcranial magnetic stimulation delivered in a single day can effectively treat major depressive disorder when combined with mechanism-guided pharmacologic augmentation with NRX-101. TMS is thought to exert its therapeutic effects primarily through synaptic plasticity – the cellular basis of learning and memory. Synaptic plasticity is mediated by NMDA receptors. NRX-101 combines two drugs that may enhance NMDA receptor function through complementary mechanisms: d-cycloserine, an NMDA receptor partial agonist, and lurasidone, which has been shown to increase NMDA receptor expression through 5-HT7 antagonism. The treatment to be tested requires a single day in an outpatient clinic, involves no psychedelic experience or intense supervision, no anesthesia, and can be delivered by a robotic targeting system originally developed for neurosurgery with precision of 1mm or less.OTHER PSYCHEDELIC STOCKS:Publicly-traded companies in the space include Grey Matters Health, BetterLife, Bright Minds Biosciences, Compass Pathways, Definium Therapeutics, Eli Lilly, Enveric Biosciences, GH Research, Incannex, MIRA Pharmaceuticals, NRx Pharmaceuticals, Numinus Wellness, Optimi Health, Pasithea Therapeutics, PharmAla Biotech, PharmaTher, Revive Therapeutics, Sibannacand Silo Pharma.
Helus Pharma Changes Legal Name to Helus Pharma Inc.
Helus Pharma announces the Company's legal name has been changed from "Cybin Inc." to "Helus Pharma Inc." effective October 1, 2026. The name change was approved by shareholders at the Company's annual and special meeting of shareholders held on September 22, 2026. The name change follows the Company's adoption of the business name "Helus Pharma" on January 5, 2026.
Optimi Completes Psychedelic Production and Starts Clinical Trial
In this week's "Psychedelic," The Fly's recurring series focused on psychedelic stock news, The Fly looks back on a production completion, a strategic investment and patent publications.OPTIMI COMPLETES PSILOCYBIN PRODUCTION:Optimi Healthannounced Wednesday the completion and quality release of amanufactured end to end at the company's cGMP facility in Princeton, British Columbia, under a Health Canada Drug Establishment Licence. The batch will supply the recently announced Phase 2 clinical trial of psilocybin-assisted therapy in the treatment of major depressive disorder and commercial customers in Australia. This Health Canada-authorized trial is a multisite, open-label study of up to 200 participants, each receiving a single supervised dose. Patient dosing is expected to be completed by the end of 2027. Data from the trial are intended to assess the safety and efficacy of psychedelic-assisted therapy in the hope of building the necessary evidentiary base to support registration in Canada and other jurisdictions. The same batch will also supply the company's Australian customer base of licensed clinics, where 5mg psilocybin capsules are prescribed to patients with treatment-resistant depression under the Therapeutic Goods Administration's Authorised Prescriber Scheme, with reimbursement from public and private payers."Since 2025, Optimi has supplied this psilocybin product commercially to licensed clinics in Australia, where it is prescribed and reimbursed for treatment-resistant depression," said Dane Stevens, CEO. "We are excited to be collecting our own clinical data on the same product in our Health Canada-approved Phase 2 clinical trial for major depressive disorder. One drug, two indications with significant unmet need, one batch serving both. Because we manufacture, encapsulate and release-test within our own licensed facility, the trial product and the commercial product are the same formulation from the same batch, and the Chemistry, Manufacturing and Controls file that supports registration is already ours."Optimi also announced Tuesday the appointment of Michael Blough as Chief Clinical Development Officer. In this newly created position, he will oversee Optimi's clinical development strategy and related operations. Blough is a medical researcher with more than 20 years of experience directing research programs spanning bench science, pre-clinical studies, and clinical trials.PSYENCE BIOMED ANNOUNCES IBOGAINE INVESTMENT:Psyence Biomedicalannounced Wednesday that it has agreed to make atogether with a value-matched share exchange between the two companies. The transactions are intended to support the scientific, manufacturing and development capabilities required for Psyence BioMed's planned U.S. ibogaine program. TIRC, registered and headquartered in Texas, has been established to provide a dedicated corporate structure through which the company can coordinate its planned U.S. regulatory, clinical and development activities involving pharmaceutical-grade ibogaine. The company is currently evaluating the feasibility and design of a potential ibogaine clinical trial in Texas. Any clinical program would be subject to protocol development, regulatory review and authorization, institutional approvals, funding, site selection and other customary requirements."Access to pharmaceutical-grade ibogaine is fundamental to the U.S. program we are planning," said Jody Aufrichtig, CEO. "Our investment in PsyLabs, together with the share exchange, is intended to align Psyence BioMed more closely with the manufacturing and supply capabilities we believe a regulated clinical program will require, while TIRC provides the dedicated U.S. structure through which we intend to advance that program. Our objective is to advance this program responsibly, supported by rigorous clinical research and pharmaceutical-grade manufacturing."CLEARMIND REPORTS PUBLICATION OF THREE PATENT APPLICATIONS:Clearmind Medicineannounced Wednesday thecovering novel proprietary combinations of lysergic acid diethylamide, ketamine and ibogaine with N-acylethanolamines, such as palmitoylethanolamide. The covered applications address potential therapeutic uses across a range of indications, including mental health disorders, such as depression, post-traumatic stress disorder pain and substance use disorders. The publications expand the intellectual property generated through Clearmind's ongoing collaboration with NeuroThera Labs, a subsidiary of SciSparc, under which NeuroThera's PEA technology is integrated into Clearmind's psychedelic-derived therapeutic programs."The publication of these patents come at a significant time as clinical and regulatory interest in LSD, ketamine and ibogaine continues to receive growing recognition and support for their therapeutic potential. Clearmind believes its combination approach may offer the potential for an effective and safer treatment paradigm, aiming to achieve therapeutic benefits at lower doses while preserving efficacy. By reducing the dose required to achieve the intended pharmacological effect, this approach may support improved tolerability while maintaining therapeutic potential," said Adi Zuloff‑Shani, CEO.FILAMENT DELIVERS PEX010 TO BHRI:Rhelion Life Sciencesannounced Monday that Bruyere Health Research Institute in Ottawa hasa patented, standardized, GMP manufactured botanical psilocybin drug candidate, from Filament for the Phase 3 trial titled "Psilocybin Microdose for Psychological and Existential Distress in Palliative Care: A Multi-Site Phase 3 Double-Blind, Placebo-Controlled, Parallel-Arm Clinical Trial". The trial will compare microdose psilocybin with placebo in people with advanced illness who are experiencing psychological distress, such as depression, anxiety and loss of meaning. It plans to enroll 120 participants from inpatient, outpatient and community palliative care settings across seven sites in Canada. Participants take small daily doses that do not cause hallucinations and do not require accompanying psychotherapy, an approach designed to be practical for patients near the end of life. Bruyère Health Research Institute is the sponsor of the trial. The Phase 3 trial builds on the Phase I/II PSYCHED-PAL study, sponsored by The Ottawa Hospital Research Institute, which also used PEX010. Results published in Palliative Medicine in 2026 found that microdose psilocybin was safe, feasible and potentially effective for psychological distress in a palliative setting, with participants reporting improvements in depression, anxiety, demoralization and well-being and no serious adverse effects.The company also announced Tuesday that the Canadian Intellectual Property Office has issued a new patent to Filament, titled "Psychoactive Alkaloid Extraction and Composition with Controlled Dephosphorylation."BARCLAYS SAYS HELUS SELLOFF 'A BUYING OPPORTUNITY":Barclays said it viewed the selloff Friday in shares of Helus Pharmaas a buying opportunity. The firm initiated the stock on Friday morning withBarclays said its initiation was not intended to serve as a preview of the Phase 3 APPROACH study of HLP003 in adjunctive treatment of MDD in isolation. The 7-8 point range discussed in the initiation "was neither our base-case expectation nor a required outcome for our $35 price target," the analyst said. The firm said it represented an illustrative extrapolation of the Phase 2 HLP003 result using attenuation observed in selected Phase 2-to-Phase 3 precedents.OTHER PSYCHEDELIC STOCKS:Publicly-traded companies in the space include Grey Matters Health, BetterLife, Bright Minds Biosciences, Compass Pathways, Definium Therapeutics, Eli Lilly, Enveric Biosciences, GH Research, Incannex, MIRA Pharmaceuticals, NRx Pharmaceuticals, Numinus Wellness, Pasithea Therapeutics, PharmAla Biotech, PharmaTher, Revive Therapeutics, Sibannacand Silo Pharma.
Helus Pharma Presents HLP003 Research Posters at Psych Congress 2026
Helus Pharma announced the presentation of four posters evaluating HLP003 at Psych Congress 2026, September 15-19, 2026, at the Ernest Morial Convention Center in New Orleans, Louisiana. Three of the poster presentations build on findings from Helus Pharma's completed Phase 1/2a randomized, double-blind study of HLP003 as a potential adjunctive therapy in participants with major depressive disorder, MDD. Data presented includes 12-month efficacy results. A trial-in-progress overview of PARADIGM, the ongoing Phase 3 clinical program of HLP003 was also presented.
TD Cowen Raises Helus Price Target to $62
In this week's "Psychedelic," The Fly's recurring series focused on psychedelic stock news, The Fly looks back on earnings, analyst notes and a notice of allowance.EARNINGS:On Monday, Bright Minds Biosciencesreported a third quarter loss per share of (C$0.24), which compared to a loss per share of (C$0.74) for the same period last year. At June 30, the company had working capital of C$307,739,740 including cash and cash equivalents of C$307,828,515. The company's current and expected cash resources are sufficient to satisfy working capital requirements of running the operations for the following twelve months; however, the company has not realized a source of revenue therefore, management will continue to seek new sources of capital to maintain its operations.Also on Monday, NRx Pharmaceuticalsreported a Q2 loss per share of (44c), which compared to a loss per share of (98c) for the same period last year. As of June 30, the company had approximately $26.7M in cash and cash equivalents versus $7.8M as of December 31, 2025. The increase was primarily related to the company's completion of a public offering of common stock with gross proceeds of more than $22M. Management believes current cash resources, anticipated growth in clinic revenue, and opportunistic utilization of the company's active at-the-market offering facility will be sufficient to support operations for at least one year. "The second quarter of 2026 was a major inflection point for NRx as we advance our mission to bring hope to the most vulnerable patients battling depression and suicidal ideation," said Jonathan Javitt, CEO. "We have continued to drive towards our key objective of first commercial ketamine sales in 2026 with corresponding manufacturing operations and build-out of our first commercial team. Our path to approval of NRX-100 has been advanced by support from the White House and Congress for the use of Real World Evidence that our drug has comparable or superior efficacy to that of current market leaders. Our partnership with the Department of War and its Defense Advanced Research Projects Agency led by Prof. Brown and Dr. Dennis McBride is the culmination of a multi-year endeavor. Similarly, our acquisition of the GeNeuro assets and the resulting partnership with NIH offers a clinical stage and potentially humanity-changing opportunity for the Company – including potentially the first disease-modifying drug to treat ALS – in ALS and other serious disorders, with strong governmental partnership and support from non-dilutive sources of capital. Combat veterans face a two-fold increased risk of ALS, and advancing a cure remains a high priority with strong Congressional support."On Friday, Enveric Biosciencesreported a Q2 loss per share of (76c), which compared to a loss per share of ($11.65) last year. The company had cash-on-hand of $8.3M as of June 30. "The second quarter was highlighted by important progress across the key activities supporting our planned first-in-human clinical trial of EB-003," said Joseph Tucker, CEO. "Over the past several months, we advanced multiple IND-enabling studies and generated additional preclinical data that support EB-003's potential non-hallucinogenic profile. Collectively, these accomplishments strengthen the scientific foundation of our lead program as we work toward an IND submission for the anticipated Phase 1 trial…As we enter the second half of 2026, our priorities remain clear: complete the remaining IND-enabling activities, submit our planned IND application, and advance EB-003 into a first-in-human clinical trial. We believe the progress over the past several months has strengthened both our lead development program and the broader Enveric platform, positioning the Company to continue creating long-term strategic and shareholder value."Helus Pharmaalso reported earnings Friday, with a Q1 loss per share of (91c), which compared to loss per share of ($1.10) for the same period last year. Cash totaled $166.4M as of June 30. "Since joining Helus Pharma, I have been impressed by the quality of the Company's science, the strength of its development programs, and the team's disciplined execution," said Michael Halstead, CEO. "With enrollment in APPROACH completed and topline data expected in Q4 2026, we are entering an important period for HLP003. We are also advancing HLP004 as a promising short-acting candidate for generalized anxiety disorder and remain focused on executing our clinical, regulatory and commercial priorities in support of our mission to deliver transformative treatment options for patients."TD Cowen raised the firm's price target on Helus to $62 from $8 and kept a Buy rating on the shares. The firm said its target increase is due to three major recent value-creating tailwinds to their thesis. The increased visibility into Phase 3 HLP003 adjunct MDD data timing, now expected mid-November, a new, seasoned CEO with an extensive operational and strategic track record in neuropsych, and new M&A, regulatory and executive branch tailwinds for the psychedelic neuropsych sector.DEFINIUM INITIATED WITH A BUY:BofA initiated coverage of Definium Therapeuticswith a Buy rating and $75 price target. The company's lead asset, DT120 – LSD, is in pivotal studies for major depressive disorder and generalized anxiety disorder with recent best-in-class potential demonstrated in the phase 3 studies for both indications, the analyst said. If replicated in ongoing pivotal studies, the firm believes that DT120 could be a go-to option for patients with severe MDD and GAD, representing multi-billion dollar commercial opportunities, BofA added.Maxim raised the firm's price target on Definium to $55 from $50 and kept a Buy rating on the shares. The firm cited the company having announced topline data from Voyage, its first pivotal study in GAD, meeting the primary and all key secondary endpoints, also noting that data from the confirmatory pivotal study, Panorama, are expected in September, the analyst said.ATAIBECKLEY DOWNGRADE:Oppenheimer downgraded AtaiBeckleyto Perform from Outperform without a price target after Eli Lillyagreed to acquire the company for $6.75 per share upfront cash plus up to $2.50 per share in contingent payments.SILO PHARMA RECEIVES NOTICE OF ALLOWANCE:Silo Pharmaannounced Tuesday that the Canadian Intellectual Property Office has issued a Notice of Allowance for a patent application covering its lead asset, SPC-15, an intranasal 5-HT4 receptor agonist targeting post-traumatic stress disorder and other stress-induced psychiatric disorders. The company has an exclusive license for the Canadian patent application as part of its broader license agreement with Columbia University to further develop, manufacture, and commercialize SPC-15 globally. The allowed patent application, titled "Prophylactic Efficacy of Serotonin 4 Receptor Agonists Against Stress," covers methods of preventing or delaying stress-induced fear and depressive-like behavior and methods for inducing and/or enhancing stress resilience by administering selected serotonin 4 receptor agonists prior to a stressor."The Canadian patent allowance adds to our momentum in securing broad international protection for SPC-15," said Eric Weisblum, CEO. "With corresponding claims receiving protection across multiple markets, we continue to strengthen the global IP position of SPC-15 and our broader therapeutic portfolio."OTHER PSYCHEDELIC STOCKS:Publicly-traded companies in the space include Grey Matters Health, BetterLife, Clearmind, Compass Pathways, Filament Health, GH Research, Incannex, MIRA Pharmaceuticals, Numinus Wellness, Optimi Health, Pasithea Therapeutics, PharmAla Biotech, PharmaTher, Psyence Biomedical, Revive Therapeutics, Sibannacand Silo Pharma.
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