5-HT6 receptor

Open-label study at Psychiatric Centre Copenhagen found that alcohol consumption significantly decreased amongst participants dosed with Filament’s botanical psilocybin drug candidate After a single dose of PEX010, the mean percentage of heavy drinking days was reduced by more than 50% over the 12-week observation period Vancouver, British Columbia, March 17, 2025 – Filament Health Corp. (OTCQB:FLHLF) (CBOE:FH) (FSE:7QS) (“Filament” or the “Company”), a clinical‐stage natural psychedelic drug development company, today announced positive data from an open-label phase 2 clinical trial studying the effects of its botanical psilocybin drug candidate, PEX010, for the treatment of alcohol use disorder (AUD) at Psychiatric Centre Copenhagen. The results were published in the Journal of Psychopharmacology and found that a single 25mg dose of PEX010 was safe and effective in reducing alcohol consumption in AUD patients. “We are thrilled to announce positive results which support the efficacy of PEX010,” said Benjamin Lightburn, Co-Founder and Chief Executive Officer at Filament Health. “These data reinforce our confidence in the potential of botanical psilocybin to help the millions of people suffering from substance use disorders like AUD. We look forward to advancing to the next stage of development.” The open-label phase 2 study investigated single-dose psilocybin therapy in 10 treatment-seeking adults with severe AUD. The treatment involved two preparation sessions, a high-dose psilocybin session (25 mg), and two integration sessions. Alcohol consumption significantly decreased over the 12 weeks following the administration of PEX010. The percentage of heavy drinking days was reduced from 53.6% before receiving PEX010 to 16.1% at week 12 and drinks per day decreased by an average of 3.4 drinks over the 12-week follow up period. This was corroborated by reports of rapid and sustained reductions in craving and temptation and significant increases in self-efficacy. All participants completed the therapy course, and the safety profile was favourable with no serious adverse events. “These results highlight the promising potential of psilocybin as a treatment for alcohol use disorder,” said Dr. Mathias Ebbesen Jensen, MD, PhD-student at Psychiatric Centre Copenhagen and the trial’s Co-Principal Investigator. “Our findings suggest that this therapy could offer a much-needed novel approach and we are currently investigating PEX010 for AUD in a larger randomized, placebo-controlled trial to establish firm conclusions.” PEX010 is authorized for investigation in 51 clinical trials worldwide for 14 mental health indications. Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament’s platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates. Learn more at www.filament.health and on Twitter, Instagram, and LinkedIn. Anna Cordon, Vice President, Marketing & Communications anna@filament.health ir@filament.health Certain statements and information contained in this press release and the documents referred to herein may constitute “forward‐looking statements” and “forward‐looking information,” respectively, under Canadian securities legislation. Generally, forward‐looking information can be identified by the use of forward‐looking terminology such as, “expect”, “anticipate”, “continue”, “estimate”, “may”, “will”, “should”, “believe”, “intends”, “forecast”, “plans”, “guidance” and similar expressions are intended to identify forward‐looking statements or information. The forward‐looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward‐looking statements. Forward‐looking statements regarding the Company are based on the Company’s estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward‐looking statements or forward‐looking information, including the timing and results of clinical trials, the ability of the parties to receive, in a timely manner and on satisfactory terms, the necessary regulatory, court and shareholders approvals; the ability of the parties to satisfy, in a timely manner, the other conditions to the completion of the proposed business combination; other expectations and assumptions concerning the transactions contemplated in the proposed business combination; the available funds of the parties and the anticipated use of such funds; the availability of financing opportunities; legal and regulatory risks inherent in the psychedelic drug development industry; risks associated with economic conditions, dependence on management and currency risk; risks relating to U.S. regulatory landscape; risks relating to anti-money laundering laws and regulation; other governmental and environmental regulation; public opinion and perception of the psychedelic drug development industry; risks related to the economy generally; risk of litigation; conflicts of interest; risks relating to certain remedies being limited and the difficulty of enforcement of judgments and effect service outside of Canada; and risks related to future acquisitions or dispositions. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward‐ looking statements and forward‐looking information. Filament will not update any forward‐looking statements or forward‐looking information that are incorporated by reference herein, except as required by applicable securities laws. ‍

Exclusive Industry Role: Avextra is the industry partner in the first EU-funded project focused on psychedelic-assisted therapy for patients in palliative care suffering from depression, with a total grant of over 6.5 million EUR from the Horizon Europe fund. Pioneering Research: The grant will fund the first multi-centre Phase II study across four European countries, with the University Medical Center Groningen in the Netherlands as sponsor. Collaborative Effort: 19 partner organizations (universities, companies, foundations, institutes and patient organizations) from 9 European countries formed the PsyPal consortium to address significant unmet patient need. Patient-Centered Approach: PsyPal will evaluate the safety and efficacy of psilocybin-assisted therapy as an innovative therapeutic option to improve mental health, well-being, and overall quality of life for patients suffering from life-limiting or life-threatening diseases and their caregivers. Expanded Pipeline: The PsyPal trial is part of Avextra’s expanding Phase 2 research portfolio, with multiple clinical trials across Europe, including ongoing studies in Italy and Germany. BENSHEIM, Germany, Dec. 12, 2024 (GLOBE NEWSWIRE) -- Avextra is proud to announce the EU approval of the groundbreaking PsyPal study, the first EU-funded research into psilocybin-assisted therapy, scheduled to commence in 2025. Supported by a €6.5 million grant from Horizon Europe—the EU's flagship program for research and innovation—this pioneering randomized controlled trial will examine psilocybin’s potential to ease psychological distress in palliative care patients across four European countries: Denmark, Portugal, the Netherlands, and Czechia. The PsyPal study represents a historic milestone as the first EU-funded investigation into psilocybin therapy. It was initiated by a multidisciplinary pan-European consortium comprising clinical sites, universities, companies, and non-profits, all united in their commitment to advancing psychedelic therapies in palliative care. Avextra was selected as exclusive provider of the study drug by the consortium earlier this year. It will supply both the study drug and placebo while providing critical regulatory support to the consortium throughout the submission process. Avextra is committed to continuing supporting the study towards Marketing Authorization (MA), aiming to broaden patient access to groundbreaking therapies. With a proven track record of securing regulatory approvals across its pipeline of exploratory studies, Avextra is strategically positioned as a leader in the development and future commercialization of innovative botanical medicines. PsyPal is the first clinical trial to examine the safety, efficacy, and long-term impact of psilocybin therapy for non-oncology palliative care patients suffering from one of four different progressive diseases: the lung condition chronic obstructive pulmonary disorder (COPD), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS, also known as MND), and atypical Parkinson’s disease (APD). The study will also explore patient access models and evaluate its impact on caregivers, emphasizing the importance of holistic care for both patients and their families. The multidisciplinary consortium spearheading the study comprises 19 organizations from nine countries. It is coordinated by the University Medical Centre Groningen in the Netherlands, in partnership with HumanKindLabs, a key catalyst in advancing psychedelic clinical research focused on set and setting and integrating optimized treatment protocols into mainstream practice. “This study is a testament to what’s possible when academia, industry, and patient advocates unite for a common cause. Together, we’re creating a holistic approach that addresses terminal illness care in a comprehensive way,” said Ulf Bremberg, CEO of HumanKindLabs. “For Avextra, PsyPal is not a one-off but an additional milestone of our clinical journey. We are paving the way for a future where psychoactive plant-based substances seamlessly integrate into evidence-based mainstream health care,” said Bernhard Babel, CEO of Avextra. Learn More Further details about the PsyPal project and its groundbreaking work can be found at the following links: Psypal Project InformationPsypal Press Release About Avextra AG Avextra is one of Europe’s leading vertically integrated medical cannabis and research operators focused on developing and producing regulatory-approved medicines. Founded in 2019 and based in Germany, Avextra collaborates closely with doctors and pharmacists to create precisely formulated cannabis-based medicines. With cultivation facilities in Portugal and EU-GMP-certified manufacturing in Germany, Avextra ensures the highest standards of quality and innovation in every stage of its operations. Avextra Investor Relations: For further information, please contact our Investor Relations Team:Email: investors@avextra.com Avextra Media Enquiries: For media enquiries or to set up an interview please contact:Email: press@avextra.comPhone: +49 30 408174037

Outcome of pre-planned Reliance II interim analysis anticipated by YE 2024 Enrollment in Phase 3 Reliance II study expected to be completed by YE 2024 Preparations on track to initiate Phase 1 study for REL-P11 for metabolic disorders by YE 2024 Cash position of $70.4 million provides runway through key milestones, into 2025 Management hosting conference call and webcast today at 4:30 PM ET CORAL GABLES, Fla., Aug. 7, 2024 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada", "the Company"), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today provided a corporate update and announced preliminary and unaudited financial results for the second quarter ended June 30, 2024. The Company will host a conference call today, Wednesday, August 7, at 4:30 PM ET. "Relmada's clinical programs have made meaningful progress this year. We believe that the portfolio, led by the Phase 3 program for REL-1017 as a potential adjunctive treatment for major depressive disorder (MDD), is poised to reach important milestones that could represent inflection points for Relmada," said Sergio Traversa, Chief Executive Officer of Relmada. "We believe that our two ongoing Phase 3 trials, Reliance II and Relight, have been carefully designed to enhance the probability of success by appropriate patient adjudication in each study. We expect to complete enrollment in Reliance II by year-end 2024, to be followed by Relight 6-months after that." Dr. Traversa continued, "The Reliance II study design incorporates a pre-planned interim analysis to evaluate futility and a sample size re-estimation, if necessary, aimed at de-risking the program. We expect to conduct this analysis and report the outcome before year-end 2024. In addition, we are advancing preparations to begin the clinical program for REL-P11, our low-dose, modified-release psilocybin formulation for potential treatment of metabolic disorders, and intend to initiate a Phase 1 study in Canada before year-end 2024. Importantly, we believe that our financial resources are adequate to support our planned operations through key milestones, into 2025." Upcoming Anticipated Milestones Output of Reliance II Interim Analysis Expected before YE 2024: Relmada intends to announce the output of a pre-planned interim analysis for the Phase 3 Reliance II study as soon as available. The interim analysis will assess futility and, if recommended, provide a sample size re-estimation for the study. Completion of Enrollment in Phase 3 Reliance II Study Anticipated by YE 2024: Relmada expects to complete enrollment in the randomized, controlled Phase 3 Reliance II study by YE 2024, to be followed by Relight approximately 6-months after. The two pivotal studies are designed to evaluate REL 1017's potential to improve treatment outcomes, measured by a change in the Montgomery-Asberg Depression Rating Scale (MADRS10) at Day 28. Initiate Enrollment in the REL-P11 Program by YE 2024: Relmada plans to initiate a Phase 1 safety study in Canada for REL-P11 by YE 2024. The Phase 1 study will define the pharmacokinetic, safety and tolerability profile of REL-P11 in obese subjects. Topline Phase 1 results and the initiation of a Phase 2a proof-of-concept study are expected in H1 2025. Second Quarter 2024 Financial Results Research and development expense for the three months ended June 30, 2024, totaled $10.7 million, compared to $13.7 million for the three months ended June 30, 2023, a decrease of $3.0 million. The decrease was primarily driven by a decrease in study costs associated with the completion of two Phase 3 trials and the long-term, open-label, safety trial (Study 310). General and administrative expense for the three months ended June 30, 2024, totaled $8.1 million compared to $12.3 million for the three months ended June 30, 2023, a decrease of approximately $4.2 million. The decrease was primarily driven by a decrease in stock-based compensation expense. Net cash used in operating activities for the three months ended June 30, 2024, totaled $13.3 million compared to $13.3 million for the three months ended June 30, 2023. The net loss for the three months ended June 30, 2024, was $17.8 million, or $0.59 per basic and diluted share, compared with a net loss of $25.3 million, or $0.84 per basic and diluted share, for the three months ended June 30, 2023. Six Month Ended June 30, 2024 Financial Results Research and development expense for the six months ended June 30, 2024, totaled $24.0 million, compared to $29.6 million for the six months ended June 30, 2023, a decrease of $5.6 million. The decrease was primarily driven by a decrease in study costs associated with the completion of two Phase 3 trials and the long-term, open-label, safety trial (Study 310). General and administrative expense for the six months ended June 30, 2024, totaled $17.8 million compared to $24.6 million for the six months ended June 30, 2023, a decrease of approximately $6.8 million. The decrease was primarily driven by a decrease in stock-based compensation expense. Net cash used in operating activities for the six months ended June 30, 2024, totaled $26.3 million compared to $29.8 million for the six months ended June 30, 2023. The net loss for the six months ended June 30, 2024, was $39.6 million, or $1.31 per basic and diluted share, compared with a net loss of $51.6 million, or $1.72 per basic and diluted share, for the six months ended June 30, 2023. As of June 30, 2024, the Company had cash, cash equivalents, and short-term investments of approximately $70.4 million, compared to cash, cash equivalents, and short-term investments of approximately $96.3 million at December 31, 2023. The company believes its cash balance is adequate to support planned operations through key milestones, into 2025. The Company had 30,174,202 common shares outstanding, as of August 2, 2024. Conference Call and Webcast Information: Relmada will host a conference call and webcast today at 4:30 PM ET to discuss recent business progress and financial results. To access the call, please dial: 1-800-717-1738 (United States) or 1-646-307-1865 (International) and reference conference ID: 39584 or to access the webcast, please Click Here. Participants can also use the "Call me™" feature by clicking the link , which will be made active 15 minutes prior to scheduled start time. A replay of the webcast will be available in the "Investors" section of the Relmada website at . About REL-1017 and the Phase 3 Program REL-1017 is a new chemical entity (NCE) and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission. Relmada is developing REL-1017 as a rapid-acting, oral, once-daily adjunctive treatment for major depressive disorder (MDD). The clinical program includes two Phase 3 randomized, double-blind, placebo-controlled studies, Reliance II (Study 302, NCT04855747) and Relight (Study 304, NCT06011577). The studies are designed to evaluate the safety and efficacy of REL-1017. The primary endpoint of each study is the change in the Montgomery-Asberg Depression Rating Scale (MADRS10) at Day 28. About REL-P11 Relmada acquired the development and commercial rights to a novel psilocybin and derivatives program in July of 2021. Psilocybin has neuroplastogen™ effects that have the potential to ameliorate neurodegenerative conditions. Relmada identified the potential to use low dose psilocybin as a treatment for metabolic diseases and published the data at the American Society for the Study of Liver Disease (AASLD 2023). Relmada intends to initiate a Phase 1 study of its proprietary low-dose, modified-release formulation of psilocybin, REL-P11, by YE 2024. About Relmada Therapeutics, Inc. Relmada Therapeutics is a late-stage biotechnology company addressing diseases of the central nervous system (CNS), with a focus on major depressive disorder (MDD). Relmada's experienced and dedicated team is committed to making a difference in the lives of patients and their families. Relmada's lead program, REL-1017, is a new chemical entity (NCE) and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission. REL-1017 is in late-stage development as an adjunctive treatment for MDD in adults. Learn more at . Forward-Looking Statements The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as "expects", "anticipates", "believes", "will", "will likely result", "will continue", "plans to", "potential", "promising", and similar expressions. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including potential failure of clinical trial results to demonstrate statistically and/or clinically significant evidence of efficacy and/or safety, failure of top-line results to accurately reflect the complete results of the trial, failure of the Reliance-OLS (study 310) to accurately reflect the results of the ongoing Reliance II (study 302) and Relight (study 304) blinded, randomized and controlled studies of REL-1017, failure of the planned Phase 1 and Phase 2a trials for REL-P11, the Company's modified release psilocybin formulation, to be successfully carried out, failure to obtain regulatory approval of REL-1017 for the treatment of major depressive disorder, and the other risk factors described under the heading "Risk Factors" set forth in the Company's reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be a complete list. Investor Contact: Tim McCarthy LifeSci Advisors [email protected] Media Inquiries: Corporate Communications [email protected] SOURCE Relmada Therapeutics, Inc.