DRUG

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on study results, FDA alignment and a DSMB recommendation. Unlock hedge fund-level data and powerful investing tools for smarter, sharper decisions Stay ahead of the market with the latest news and analysis and maximize your portfolio's potential HELUS PHARMA REPORTS PHASE 2 HLP004 RESULTS: Helus Pharma (HELP) announced Thursday topline results from a Phase 2 signal detection study evaluating HLP004 as a potential treatment for adults with moderate-to-severe generalized anxiety disorder who remained symptomatic despite ongoing SoC antidepressant therapy, including selective serotonin reuptake inhibitors and related agents. In the Phase 2 signal detection study, 36 patients were randomized 2-to-1 active-to-placebo to HLP004 20 mg or 2mg and received two intramuscular doses three weeks apart. Patients were followed through Week 12, with continued observational follow-up extending up to one year. Participants had an average baseline HAM-A score of 22 and a General Anxiety Disorder-7 score of greater than or equal to 10 at screening. All study participants were already being treated, and continued treatment throughout the trial, with SoC medications for generalized anxiety disorder. The 10-point improvement in anxiety symptoms is above and beyond what was already being seen with SoC treatment. Patients that received 20mg HLP004 adjunctive to SoC therapy achieved mean reduction of 10.4-points in the HAM-A from baseline at six weeks. The study population consisted of moderate-to-severe patients who remained symptomatic despite ongoing antidepressant or anxiolytic therapy. At six months, the pooled study population showed 67% responders and 39% remitters. Participants randomized to both 20 mg and 2mg dosing arms experienced meaningful subjective effects and showed clinically significant responses over SoC, with 59% meeting the criteria for response and 32% for remission in the 20mg arm and a 30% responder and remitter rate in the 2mg arm at week 6. The study also found a short in-clinic treatment experience with acute drug effects lasting approximately 90 minutes and discharge readiness within approximately three hours, fitting within the treatment paradigm of existing interventional psychiatry clinics. Additionally, results show a favorable tolerability profile with no drug-related serious adverse events or suicidality-related safety signals. Michael Cola, CEO, said, “Patients living with generalized anxiety disorder remain significantly underserved, with many continuing to struggle despite currently available treatments. We are encouraged by these data and the potential for HLP004 to bring hope to GAD patients. The Company’s broad intellectual property portfolio has been leveraged once again to create what we feel are best in class products and we are further excited to release the data on HLP003 targeted at major depressive disorder in the fourth quarter of 2026.” ATAIBECKLEY ALIGNS WITH FDA ON BPL-003 PHASE 3 DESIGN: AtaiBeckley (ATAI) announced on Tuesday results of an End‑of‑Phase 2 meeting with the U.S. Food and Drug Administration regarding the development of BPL‑003, the company’s proprietary intranasal formulation of mebufotenin benzoate, for treatment‑resistant depression. Minutes from the meeting show that the FDA indicated support for AtaiBeckley’s proposed BPL-003 pivotal program and the compound’s advancement into Phase 3 studies in adults with TRD. The FDA also provided constructive feedback on the overall design and key components of the proposed program, including the overall size of the safety database for this chronic indication. The Phase 3 program is designed to include two pivotal studies, ReConnection 1 and ReConnection 2, conducted in parallel. Both will include a 12-week, randomized, double-blind, placebo-controlled core study followed by a 52-week open-label extension in which participants may receive individualized retreatment with BPL-003, subject to pre-specified eligibility criteria. The core study will enroll approximately 350 participants and will evaluate a single-dose of BPL-003 across three treatment arms – 8 mg, 4 mg, and placebo. This trial is designed to replicate and extend the treatment response observed in the Phase 2b study and to further characterize the dose–response relationship for BPL-003. ReConnection 2 will enroll approximately 300 participants and will evaluate BPL-003 administered on Day 1 and Day 15 across two arms – 8 mg BPL-003 and placebo. This trial is designed to investigate a two-dose induction model of BPL-003 as a potential treatment option to increase magnitude and durability of initial response. The primary endpoint in both pivotal trials will be the change from baseline in the Montgomery-Åsberg Depression Rating Scale total score at Week 4 of the response in the 8 mg BPL-003 treatment arm compared to placebo. In the OLE, participants may receive 8 mg BPL-003 at 8‑ or 12‑week intervals, subject to certain conditions for re-treatment eligibility, with the goal of maintaining remission and assessing long‑term safety, durability of effects, and treatment patterns. “Receiving clear guidance from the FDA at this stage is a major milestone for AtaiBeckley and for the BPL‑003 program,” said Srinivas Rao, CEO. “This feedback builds on our compelling Phase 2b data as well as the Breakthrough Therapy Designation granted to BPL-003 in October 2025 and firmly positions us to advance a robust Phase 3 clinical program designed to maximize the probability of regulatory and commercial success. With this development, we maintain our conviction that BPL-003 has the potential to offer a rapid, durable and convenient treatment option for the millions of people living with treatment-resistant depression.” CLEARMIND GETS DSMB RECOMMENDATION FOR TRIAL CONTINUATION: Clearmind Medicine (CMND) announced Wednesday that its independent Data and Safety Monitoring Board has completed the second scheduled interim review of the company’s ongoing FDA-approved Phase I/IIa clinical trial for CMND-100, a proprietary, non-hallucinogenic neuroplastogen, in the treatment of Alcohol Use Disorder. Based on the additional top-line data from the second cohort, which demonstrated a favorable safety profile, the DSMB recommended that the clinical trial continue. The results of the second cohort, in which twice the dose was administered compared to a single dose in the first cohort, reinforce no serious adverse events and overall good tolerability, consistent with the results reported from the first cohort. The results support the rapid progression enabled by the DSMB’s unanimous approval to advance for the third cohort, for which the dose is 80 mg per administration, which is double the dose administered in the second cohort. GH RESEARCH REPORTS Q4 EARNINGS: GH Research (GHRS) reported FY25 loss per share of (79c) on Thursday, which compared to analyst estimates of a loss per share of (82c). Cash, cash equivalents and marketable securities were $280.7M as of December 31. In 2025, the company completed its Phase 2b trial of GH001 in treatment-resistant depression and presented the full dataset at the 2025 American Society of Clinical Psychopharmacology Annual Meeting in Arizona, and the 2025 European College of Neuropsychopharmacology Congress in Amsterdam. GH Research is now actively seeking FDA alignment on the design of its global Phase 3 pivotal program, which is intended to replicate the Phase 2b study. The Phase 2b trial met its primary endpoint with a placebo-adjusted MADRS reduction of -15.5 points at Day 8. In the double-blind portion, 57.5% of patients on GH001 achieved remission at Day 8 versus 0% on placebo. The open-label extension confirmed durable efficacy, with a 73% remission rate at six months achieved with infrequent retreatment visits and no mandated psychotherapy. The median duration of psychoactive experience was ~11 minutes, with 99% of patients deemed discharge-ready within one hour of dosing. Safety was favorable, with no treatment-related serious adverse events and no treatment emergent suicidal intent or behavior. “Our Phase 2b results reinforce our conviction that GH001 has the potential to be a practice-changing therapy for patients with TRD,” said Dr. Velichka Valcheva, CEO. “We look forward to aligning with the FDA on our global Phase 3 program, replicating phase 2b design, and advancing this innovative program with initiation targeted for 2026.” PHARMALA SIGNS SUPPLY, DATA AGREEMENT WITH NAUTILUS SANCTUARY: PharmAla Biotech Holdings (MDXXF) announced Tuesday that it has executed a supply and data agreement with Nautilus Sanctuary of Brooklyn, New York, for the provision of MDMA for use in a Phase 2 clinical trial in the United States. Under the agreement, PharmAla will supply its LaNeo MDMA to Nautilus Sanctuary for use in an open-label clinical trial entitled “An Open Label Study to Treat Post-Traumatic Stress in Frontline Healthcare Workers and First Responders Using MDMA-Assisted Therapy”. In consideration for the supply of LaNeo MDMA, Nautilus Sanctuary will grant PharmAla a perpetual, non-exclusive license to the clinical trial data, which includes pseudonymized and de-identified raw data sets as well as Nautilus Sanctuary’s analysis of the safety and efficacy of the intervention. The license permits PharmAla to use the data for regulatory approvals and any commercial purpose in any jurisdiction globally. “This agreement represents a continuation of our innovative supply-for-data model, which we believe creates significant value for both parties,” said Nicholas Kadysh, CEO. “Frontline healthcare workers and first responders bear an enormous mental health burden, and we are proud to support Nautilus Sanctuary in their efforts to bring MDMA-assisted therapy to these critical populations. The clinical data generated in the United States under this agreement will be an important addition to our growing portfolio of clinical evidence supporting the safety and efficacy of LaNeo MDMA.” PSYENCE BIOMED REPORTS PSILOCYBIN EXPORT: Psyence Biomedical (PBM) announced Tuesday the export of fully GMP-compliant manufactured psilocybin product NPX-5 to Australia. The product was manufactured at the Psyence Labs GMP-controlled production facility, supporting pharmaceutical-grade psychedelic development. The exported NPX-5 product will now be used in Psyence BioMed’s ongoing Phase IIb clinical trial in Australia, a double-blind, randomized, low-dose comparator-controlled, multi-center study evaluating natural psilocybin for the treatment of Adjustment Disorder in patients with cancer in a palliative care context. The trial is enrolling 87 participants across multiple Australian sites, including Melbourne and Perth/ Patient dosing is underway, with initial participants having been dosed in late 2025, and all newly enrolled patients will be dosed with NPX-5. “This export demonstrates more than regulatory clearance – it validates the operational readiness of our vertically integrated model,” said Jody Aufrichtig, CEO. “The successful manufacture and export of GMP-compliant natural psilocybin at this stage of clinical development demonstrates that we are not simply participating in this sector – we are helping define its standards. Operational discipline, supply control, and product excellence are foundational to our platform.” PRICE TARGET RAISES: Maxim raised the firm’s price target on Definium Therapeutics (DFTX) to $40 from $18 and kept a Buy rating on the shares after its Q4 results. The company’s cash on the balance sheet should provide sufficient funding into 2028, through a busy 2026 with three Phase 3 pivotal readouts for DT120, the analyst said. As the readout in major depressive disorder approaches, the firm is factoring in revenues for MDD in 2029, Maxim added. H.C. Wainwright raised the firm’s price target on Bright Minds (DRUG) to $145 from $115 and kept a Buy rating on the shares. The firm says the BREAKTHROUGH Phase 2 data “de-risks” BMB-101 and establishes 5-HT2C agonist as potentially best-in-class. H.C. Wainwright increased its probability of success for the absence epilepsy program to 60% from 25%, reflecting what it believes is a “significant efficacy signal and validation from the trial.” H.C. Wainwright also raised the firm’s price target on NRx Pharmaceuticals (NRXP) to $45 from $40 and kept a Buy rating on the shares. The firm said the Type C FDA meeting “provides a clear” application pathway for NRX-100. This is “supported by real-world evidence and a broader proposed indication, significantly de-risking the program,” the analyst said. H.C. Wainwright expanded the addressable population for NRX-100 and increased its risk-adjusted NRX-100 valuation to $15 per share from $10. OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Health (AGNPF), BetterLife (BETRF), Compass Pathways (CMPS), Enveric Biosciences (ENVB), Filament Health (FLHLF), Incannex (IXHL), MIRA Pharmaceuticals (MIRA), Numinus Wellness (NUMIF), Pasithea Therapeutics (KTTA), PharmaTher (PHRRF), Psyence Group (PSYGF), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF) and Silo Pharma (SILO). Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders’ Hot Stocks on TipRanks >> Read More on HELP: Disclaimer & DisclosureReport an Issue Cybin’s Helus Pharma Posts Strong Phase 2 Data for HLP004 in Hard-to-Treat Anxiety Helus Pharma announces results in Phase 2 signal detection study of HLP004 Cybin Corrects Exhibit References in Form 6-K to Align With Active F-10 Shelf Psychedelic: AtaiBeckley reports EMP-01 met primary objective in Phase 2a trial Helus Pharma Names Former Pfizer CMO Freda Lewis-Hall to Board and Scientific Advisory Role

BMB-101 demonstrated significant anti-seizure benefit in both cohorts with favorable safety and tolerability Absence: 73.1% median reduction in the number of absence seizure ≥3s, p = 0.012 DEE: 63.3% median reduction in major motor seizures REM sleep improvement in patients with Absence Seizures: mean 90% increase in REM sleep with no change in total sleep duration Company has initiated preparations for global registrational trials in both DEE and Absence Seizure patients Bright Minds to hold conference call and live webcast at 8AM ET today NEW YORK, Jan. 06, 2026 (GLOBE NEWSWIRE) -- Bright Minds Biosciences Inc. (CSE: DRUG) (Nasdaq: DRUG) (“Bright Minds” or the “Company”), a clinical-stage biotechnology company focused on developing highly selective 5-HT receptor agonists for neurological and psychiatric disorders, today announced positive and significant topline results from its Phase 2 BREAKTHROUGH clinical trial evaluating BMB-101, a selective 5-HT2C biased agonist, in adult patients with drug-resistant Absence Seizures and Developmental and Encephalopathic Epilepsies. The study met its primary efficacy endpoints in both cohorts, demonstrating robust seizure reduction with a favorable safety and tolerability profile. Phase 2 BREAKTHROUGH Study Overview The Phase 2 open-label, multicenter study evaluated safety, tolerability and efficacy of BMB-101 in adults with drug-resistant Absence Seizures and DEE. A total of 24 patients were enrolled, exceeding the original target of 20. The study included a 4-week baseline, 4-week titration and maintenance period (2 weeks for Absence cohort, 4 weeks for DEE cohort). Primary Endpoints: Absence cohort: change from baseline in the number of Absence Seizures (lasting ≥3s) on 24h EEG, conducted by independent and blinded reviewers DEE cohort: change from baseline in major motor seizure frequency (seizure diary) Patient Profile The study enrolled 24 patients (15 with Absence Seizures and 9 with DEE), with a mean age of 30 years. Participants were receiving a median of 3 concomitant anti-seizure treatments in the Absence cohort and 5 in the DEE cohort, having previously failed up to 16 treatments (with a failed mean of 3.7 antiseizure treatments for the Absence cohort, and a failed mean of 9.8 for antiseizure treatments for the DEE cohort). The population also included patients treated with neuromodulation: 2 with Vagus Nerve Stimulators (VNS) in the Absence cohort and 5 in the DEE cohort. At baseline, the median number of Absence Seizures ≥3s was 22, and similarly, the median number of countable motor seizures for the DEE cohort was 22. Patient Disposition A total of 24 patients were enrolled (Absence cohort: n=15; DEE cohort: n=9). Absence cohort: 12/15 patients completed the maintenance period. Three patients discontinued during titration/early treatment. Reasons reported across discontinuations included taste intolerance (related; drug product formulation subsequently updated), flu-like symptoms with muscle ache/fatigue (possibly related), dizziness (possibly related) and with insufficient baseline seizure counts. The prespecified efficacy-evaluable population comprised of 11 patients (including one DEE patient with atypical Absence Seizures) with analyzable paired baseline and maintenance 24-hour ambulatory EEG recordings. One enrolled patient was excluded from the efficacy analysis because the baseline EEG did not meet entry criteria, and one maintenance EEG was of insufficient quality for reliable analysis. DEE cohort: 6/9 patients completed the maintenance period. Three patients discontinued during titration/early treatment. Reasons reported across discontinuations included fluctuation in a pre-existing behavioral condition, lethargy (possibly related) and an intercurrent shoulder fracture with associated drowsiness/opiate use (not drug-related). The prespecified efficacy-evaluable population comprised of 6 patients. The DEE cohort included 4 Lennox-Gastaut Syndrome (LGS) patients, 1 Dravet syndrome and 1 Rett syndrome patient. Efficacy Results Absence seizure Cohort (n=11): 73.1% median reduction in the number of absence seizure ≥3s. p = 0.012 (Wilcoxon Signed Rank Test) 74.4% median reduction in total time in seizures lasting ≥3s during 24h (Seizure Burden). p = 0.012 (Wilcoxon Signed Rank Test) Patients achieved robust reduction of Absence Seizures regardless of seizure duration. DEE Cohort (n=6): Cohort included 4 LGS patients, 1 Dravet Syndrome (who previously failed fenfluramine for efficacy), and 1 Rett Syndrome patient 63.3% median reduction in major motor seizures 60.3 % median reduction in LGS patients, and 76.1% in other DEE patients Last observation carried forward applied to two patients. Safety & Tolerability BMB-101 was generally well tolerated. Most treatment-emergent adverse events were mild (79.6%) or moderate (17.2%), with no treatment-related serious adverse events. Most common AEs (≥10%): respiratory infections (20.8%), fatigue (16.7%), constipation (16.7%), headache (12.5%), drowsiness (12.5%). There were three severe adverse events, including dry mouth (transient, no dose change, no discontinuation), and one patient who had fractured shoulder and opiate-related drowsiness (not related). Additional Effects beyond Seizure Control The study explored the effects of BMB-101 on sleep. There was a 90% increase in REM sleep (56.2 min at baseline to 106.7 min on BMB-101) in patients, while overall sleep duration remained unchanged (9.1 h at baseline vs 8.9 h on BMB-101). This is crucial since REM sleep increase was not due to increased sleep duration. REM sleep is important for memory consolidation, emotional-behavior regulation and cognitive function. Next Steps Bright Minds Biosciences has initiated preparations for global registrational trials in Absence Seizures and DEE. Additional data including long-term outcomes will be presented throughout the year. Bright Minds Biosciences will also be initiating a study in Prader Willi Syndrome, currently anticipated to begin in Q1 2026 (“PWS Program”). Conference Call/Webcast Information The Bright Minds virtual event will be webcast live by visiting the “Investors” section of the Company’s website and selecting “Events and Presentations.” A replay of the webcast will not be available after the event. Date and Time: January 6, 2026, 8AM ET Webcast: https://app.livestorm.co/bright-minds-biosciences/bmb-101-topline-data-announcement The call will include a discussion of the data followed by a Q&A session. Individuals who wish to ask questions should use the “Questions” tab available during the live webcast. About BMB-101 BMB-101 is a novel scaffold 5-HT2C Gq-protein biased agonist developed using structure-based drug design. It was explicitly designed for chronic treatment of neurological disorders where tolerance and drug resistance are common issues. Biased agonism at the 5-HT2C receptor is one of its key features and adds another layer of functional selectivity within a well-validated target. BMB-101 works exclusively via the Gq-protein signaling pathway and avoids beta-arrestin activation, which is crucial to minimize the risk of receptor desensitization and tolerance development. In preclinical studies, BMB-101 has demonstrated efficacy in animal models of epilepsy, binge eating, aggression, substance use disorder, and cognitive decline which highlights its potential for the use in multiple neurological and neuropsychiatric disorders, including drug-resistant epilepsy, Prader-Willi Syndrome (PWS) and others. In Phase 1 clinical studies, BMB-101 was given to 64 healthy volunteers in a Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and food-effects study. BMB-101 was demonstrated to be safe and well tolerated at all doses. No Serious Adverse Events (SAEs) were observed, and Adverse Events (AEs) were mild in nature and in line with on-target effects for serotonergic drugs. An extensive target-engagement study was conducted using both fluid biomarkers (transient prolactin release) and physical biomarkers (Quantitative Electroencephalogram, qEEG). Both methods confirmed robust central target engagement. A qEEG signature typical for anti-epileptic drugs was observed, with a selective depression of EEG power at frequencies observed during epileptic seizures. Furthermore, a potentiation of frontal gamma-power was observed in this study which could indicate the potential for improved cognition. About Bright Minds Biosciences Bright Minds is a biotechnology company developing innovative treatments for patients with neurological and psychiatric disorders. Our pipeline includes novel compounds targeting key receptors in the brain to address conditions with high unmet medical need, including epilepsy, PWS, depression, and other CNS disorders. Bright Minds is focused on delivering breakthrough therapies that can transform patients' lives. Bright Minds has developed a unique platform of highly selective serotonergic agonists exhibiting selectivity at different serotonergic receptors. This has provided a rich portfolio of NCE programs within neurology and psychiatry. Forward-Looking Statements The Canadian Securities Exchange has neither approved nor disapproved the information contained herein and does not accept responsibility for the adequacy or accuracy of this news release. This news release contains “forward-looking information”. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, or “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward-looking statements in this news release include statements related to the impact of results of the Company’s Phase 2 BREAKTHROUGH clinical trial evaluating BMB-101, the Company’s preparations for global registrational trials in Absence Seizures and DEE in 2026, the initiation of the PWS Program in Q1 2026, and the future clinical development of BMB-101. A variety of factors, including known and unknown risks, many of which are beyond our control, could cause actual results to differ materially from the forward-looking information in this news release. These factors include the Company’s financial position and operational runway, regulatory risk to operating in the pharmaceutical industry, and inaccuracies related to the assumption made by management relating to general availability of resources required to operate the studies noted in this news release. The Company also cautions that the data related to BMB-101 efficacy, safety and tolerability with regard to Phase 2 trials of BMB-101 are preliminary in nature, and may be subject to change with additional analysis and following the completion of audit and verification procedures. Additional risk factors can also be found in the Company’s public filings under the Company’s SEDAR+ profile at www.sedarplus.ca. Forward-looking statements contained herein are made as of the date of this news release and the Company disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or results or otherwise. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. The Company undertakes no obligation to update forward-looking statements if circumstances, management’s estimates or opinions should change, except as required by securities legislation. Accordingly, the reader is cautioned not to place undue reliance on forward-looking statements. Contact Information Alex Vasilkevich Chief Operating Officer Bright Minds Biosciences Inc. T: 414-731-6422 E: [email protected] Website: www.brightmindsbio.com Investor Relations Lisa M. Wilson T: 212-452-2793 E: [email protected]

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on earnings, a patent grant and study results. Discover companies with rock-solid fundamentals in TipRanks' Smart Value Newsletter. Receive undervalued stocks, resilient to market uncertainty, delivered straight to your inbox. Q1 EARNINGS: On Thursday, Compass Pathways (CMPS) reported a first quarter loss per share of (24c), which compared to analyst estimates of a loss per share of (49c). The company said cash and cash equivalents were $260.1M as of March 31, compared with $165.1M as of December 31. Compass also guided to full year 2025 net cash used in operating activities in the range of $120M to $145M. The cash position at March 31 is expected to be sufficient to fund operating expenses and capital expenditure requirements at least through the planned 26-week data read-out from the COMP006 study, which is expected in the second half of 2026. “We eagerly await the upcoming topline 6-week data readout, on track for late June, the first data from our pivotal phase 3 COMP360 program in treatment resistant depression.” said Kabir Nath, CEO.  “Our continued progress reinforces Compass’ leadership in psychedelic therapy development, which we believe represents the next generation of mental health therapeutic options and can lead to significant value creation.” GH Research (GHRS) also reported Q1 results Thursday with a loss per share of (19c), which compared to analyst consensus of a loss per share of (20c). Cash, cash equivalents, other financial assets and marketable securities were $315.3M as of March 31, compared to cash, cash equivalents, other financial assets and marketable securities of $182.6M as of December 31. Gross proceeds from public offering in Q1 were $150M. Additionally on Thursday, Mind Medicine (MNMD) reported a Q1 loss per share of (35c), which compared to analyst estimates of a loss per share of (37c). Cash, cash equivalents and investments totaled $245.5M as of March 31. The company believes that its cash, cash equivalents, and investments as of March 31 will be sufficient to fund the company’s operations into 2027. Based on the company’s current operating plan and anticipated R&D milestones, the company expects its cash runway to extend at least 12 months beyond its first Phase 3 topline data readout for MM120 ODT in General Anxiety Disorder. “We are proud to share that all three of our pivotal Phase 3 trials evaluating MM120 ODT in patients with GAD and MDD—Voyage, Panorama, and Emerge—are actively enrolling. Momentum is building, with strong and growing enthusiasm from both clinical sites and patients as recruitment continues to accelerate,” said Rob Barrow, CEO. “We’re on track to report topline data from Voyage in the first half of 2026, followed by Panorama and Emerge in the second half of the year. With our breakthrough therapy designation in GAD, a clearly defined regulatory strategy, and strong operational execution across our programs, we’re delivering on our goal of advancing MM120 ODT as a potential best-in-class, differentiated therapeutic option. Our team remains fully committed to delivering transformational innovation for the over 50 million people in the U.S. living with GAD or MDD as we drive toward commercialization.” CYBIN ANNOUNCES U.S. PATENT GRANT: Cybin (CYBN) announced Thusday that the United States Patent and Trademark Office has granted U.S. patent 12,291,499 in support of its CYB003 program in Major Depressive Disorder. The patent, which is expected to provide exclusivity until 2041, includes claims to pharmaceutical compositions and oral dosage forms within the company’s proprietary deuterated psilocin analog program, CYB003. “Securing an additional patent in support of CYB003 provides important validation of our program and reinforces the commercial potential of our pipeline,” said Doug Drysdale, CEO. “Robust patent protection is essential for drug development companies, and we are proud of our expanding intellectual property portfolio. As we continue to dose patients in our first Phase 3 study, we are focused on execution, delivering shareholder value, and ultimately, creating more effective treatments for those with mental health disorders.” MIRA REPORTS KETAMIR-2 NEUROTOXICITY RESULTS: On Tuesday, MIRA Pharmaceuticals (MIRA) announced results from a neurotoxicity study of Ketamir-2, its novel oral NMDA receptor antagonist. The study was required by the U.S. Food and Drug Administration prior to initiating human dosing in the United States. The preclinical study showed no evidence of brain toxicity, including the absence of Olney lesions-vacuolar brain changes historically associated with older NMDA-targeting drugs such as ketamine and MK-801. The neurotoxicity study was conducted in sexually mature Sprague-Dawley rats. High oral doses of Ketamir-2 were administered, while a positive control group received MK-801, a known neurotoxic NMDA receptor antagonist. Brain tissues were examined through detailed histopathological analysis at two time points. Key outcomes included no adverse clinical signs or mortality in any Ketamir-2-treated animals; No microscopic or macroscopic brain lesions detected at any dose; MK-801-treated animals showed clear evidence of brain toxicity, including vacuolation and neuronal necrosis. “These results represent a key milestone in the development of Ketamir-2,” said Erez Aminov, CEO. “The absence of NMDA-linked neurotoxicity, along with continued clinical progress, reinforces our confidence in Ketamir-2’s potential as a safe next-generation, oral candidate for CNS disorders.” Additionally on Thursday, MIRA announced that its Board of Directors has approved the planned acquisition of SKNY Pharmaceuticals, following the completion of independent valuation reports on both companies. The merger remains subject to MIRA and SKNY’s shareholder approval. A third-party analysis conducted by Moore Financial Consulting assigned SKNY Pharmaceuticals an enterprise value of approximately $30.5M, based on a risk-adjusted net present value of its lead compound, SKNY-1. MIRA was separately valued by Moore at $30M. As outlined in the previously announced binding letter of intent for the merger, upon the closing, SKNY must hold at least $5M in cash or other assets, to be transferred at closing, and the company is preparing a filing with the U.S. Securities and Exchange Commission to seek shareholder approval. BRIGHT MINDS INITIATED WITH BUY: On Wednesday, Chardan initiated coverage of Bright Minds (DRUG) with a Buy rating and $80 price target. The firm cites the potential of the company’s lead asset BMB-101 for the treatment of epilepsy for the Buy rating. Bright Minds is an “interesting story even at current valuation: as BMB-101 could be differentiated verses other 5-HT2C agonists with its unique binding profile, and it could potentially achieve greater than $1B peak sales in epilepsy, the analyst said. NRXP FILES PATENT APPLICATION: NRx Pharmaceuticals (NRXP) announced Monday the filing of a patent application for NRX-100, its preservative-free intravenous ketamine formulation for the treatment of suicidal depression. The application discloses pharmaceutical compositions, methods of treatment and methods of manufacture and currently includes twenty claims. While subject to the patent review process of the U.S. Patent and Trademark Office, if granted, the patent would provide NRX-100 exclusivity into 2045. “We are committed to delivering safer, more effective treatments for patients with suicidal depression,” said Jonathan Javitt, CEO. “NRX-100 eliminates the need for benzethonium chloride, a compound with well-documented safety concerns, and reflects our belief that patients in crisis deserve therapies formulated with their long-term well-being in mind. With the recent FDA fee waiver now in place, we remain on track to complete our NDA submission this quarter — a critical step toward bringing this innovation to patients in need.” OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Pharmaceuticals (AGNPF), Allied Corp. (ALID), atai Life Sciences (ATAI), BetterLife (BETRF), Clearmind (CMND), Entheon Biomedical (ENTBF), Enveric Biosciences (ENVB), Filament Health (FLHLF), Incannex (IXHL), 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). Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders’ Hot Stocks on TipRanks >> Read More on CMPS: Disclaimer & DisclosureReport an Issue Compass Pathways reports Q1 EPS (24c), consensus (49c) Compass Pathways enters strategic collaboration with HealthPort Psychedelic: Clearmind completes clinical site initiations for AUD trial Compass Pathways completes dosing in Part A of Phase 3 psilocybin trial COMPASS Pathways Amends Executive Employment Agreements