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Psyence BioMed Achieves Milestone in Natural Ibogaine HCl Production and Strengthens Balance Sheet With No Debt and $12m Cash
Globenewswire· 2026-01-05 14:15
Core Insights - Psyence Biomedical Ltd. has achieved a significant milestone by becoming the first Nasdaq-listed company to produce GMP-compliant, high-purity ibogaine hydrochloride derived from ethically sourced materials in Africa [2][3] - The production of ibogaine HCl enhances the stability, solubility, purity, and dosing precision of the compound, aligning it with pharmaceutical development requirements [2] - The company is well-positioned for growth entering 2026, with a cash balance of $12 million, no debt, and a Phase 2b psilocybin clinical trial in progress [3] Company Developments - The CEO of Psyence BioMed emphasized that the successful production of GMP-compliant ibogaine HCl supports the company's vertically integrated strategy and long-term objectives [3] - A change in the Board of Directors occurred with the resignation of Christopher Bull and the appointment of Graham Patrick, who brings extensive experience in governance and compliance [4] Company Overview - Psyence Biomedical Ltd. is a multi-asset, vertically integrated biopharmaceutical company focused on developing nature-derived psilocybin and ibogaine-based psychedelic therapeutics [5] - The company aims to address unmet mental health needs through evidence-based approaches and is committed to developing FDA-approved treatments for various mental health disorders [5]
Psyence BioMed Announces Approval for Use of PsyLabs’ Psilocybin Product in Phase IIb Clinical Trial
Globenewswire· 2025-12-19 12:00
Core Viewpoint - Psyence Biomedical Ltd. has received formal approval for its psilocybin product (NPX5) to be used in a Phase IIb clinical trial for psilocybin-assisted psychotherapy targeting Adjustment Disorder in cancer patients, positioning the company as a leader in the emerging psychedelics sector with strong cash reserves and a vertically integrated structure [1][2][4]. Financial Position - The company holds approximately $9.5 million in cash reserves and has no debt, enabling it to execute its strategic plans effectively [1][2]. Clinical Development - The Bellberry Human Research Ethics Committee has approved the use of PsyLabs' psilocybin product in the ongoing Phase IIb clinical trial, which will evaluate two therapeutic doses of psilocybin against a low-dose comparator [1][3][5]. - The Phase IIb study aims to enroll approximately 87 participants and is on track to deliver top-line results in 2026 [5]. Strategic Positioning - Psyence BioMed is evolving into a vertically integrated psychedelic enterprise with multiple assets across drug and clinical development, reinforcing its competitive positioning in the global psychedelics market [2][6]. - The approval of PsyLabs' psilocybin product is seen as a pivotal advancement in the company's clinical program and long-term strategy, enhancing supply-chain control and manufacturing excellence [4][6]. Company Overview - Psyence Biomedical Ltd. is a biopharmaceutical company focused on developing nature-derived psilocybin and ibogaine therapies for unmet mental health needs, being the first of its kind listed on Nasdaq [7]. - The company is dedicated to an evidence-based approach in developing safe and effective psychedelic treatments for various mental health disorders [7]. PsyLabs Overview - PsyLabs is a federally licensed company specializing in the cultivation, extraction, and export of psilocybin and other psychedelic compounds, ensuring high standards of safety and traceability [9][10]. - The company has successfully exported psilocybin products to multiple countries and is expanding its product pipeline to include other next-generation psychedelics [9][10].
Psyence BioMed Announces Approval for Use of PsyLabs' Psilocybin Product in Phase IIb Clinical Trial
Globenewswire· 2025-12-19 12:00
Core Viewpoint - Psyence Biomedical Ltd. has received formal approval from the Bellberry Human Research Ethics Committee for its psilocybin product (NPX5) to be used in a Phase IIb clinical trial for psilocybin-assisted psychotherapy targeting Adjustment Disorder in cancer patients [1][3]. Group 1: Company Developments - The approval marks a significant step in the company's evolution towards becoming a vertically integrated psychedelic enterprise with multiple assets in drug and clinical development [2]. - The company has a strong cash reserve of approximately USD $9.5 million, positioning it well within the emerging global psychedelics sector [2]. - The approved amendment confirms PsyLabs' psilocybin as the investigational product for the clinical trial, enhancing the company's ability to manage the development pathway from raw material sourcing to commercialization [4][6]. Group 2: Clinical Trial Details - The Phase IIb study will enroll approximately 87 participants and will evaluate two therapeutic doses of psilocybin against a low-dose comparator, combined with structured psychotherapy [5]. - The study is on track to deliver top-line results in 2026, with multiple clinical sites activated to accelerate patient recruitment [5]. Group 3: Manufacturing and Supply Chain - PsyLabs' psilocybin product is developed within a vertically integrated structure, ensuring supply-chain control, manufacturing excellence, and scalable production capacity [4]. - PsyLabs operates from an ISO 22000-certified facility, ensuring high standards of safety and traceability in its manufacturing processes [11].
Psyence BioMed CEO Letter Highlights Clinical Progress, Ethical Sourcing of Ibogaine, Strong Cash Position and Expanding Leadership in Longevity Science
Globenewswire· 2025-12-09 12:00
Core Insights - Psyence Biomedical Ltd. is positioned as a leader in nature-derived psychedelic therapies, focusing on psilocybin and ibogaine for mental health needs, and has outlined its strategic vision for 2026 in its year-end letter [1][2] Clinical Progress - The company has initiated a Phase IIb clinical trial for psilocybin-assisted psychotherapy targeting Adjustment Disorder in palliative care, with multiple patients dosed across Australian clinical sites [3] - Psyence BioMed ended the year with over USD $9 million in cash reserves and is debt-free, indicating strong financial health [3] Manufacturing and Supply Chain - A multi-million-dollar investment in PsyLabs has enhanced the company's vertical integration, ensuring a GMP-compliant supply of psilocybin and ibogaine for current and future programs [4] - The company achieved a breakthrough in high purity ibogaine production, reinforcing its manufacturing capabilities [4] Regulatory Environment - The Australian Therapeutic Goods Administration's public consultation on psilocybin-assisted therapy for existential distress is a significant regulatory development that aligns with the company's clinical trial efforts [5] Longevity Science Focus - Psyence BioMed is uniquely positioned as the only publicly listed psychedelics company investing in longevity science, emphasizing the emotional and neurobiological aspects of aging [6] 2026 Strategic Outlook - The company plans to accelerate enrollment in its Phase IIb clinical trial, expand its manufacturing footprint, and explore additional longevity-focused indications and strategic partnerships throughout 2026 [6]
Psyence BioMed Announces Groundbreaking Psilocybin Longevity Research Program
Globenewswire· 2025-11-25 12:00
Core Insights - Psyence Biomedical Ltd. is the first publicly listed company to investigate the potential impact of psilocybin on longevity, collaborating with researchers in South Africa [1][6] - The initiative aims to explore psilocybin's effects on biological markers associated with aging, which could redefine human longevity and transform aging [1][6] Industry Context - Longevity science is gaining global attention due to aging populations and rising healthcare costs, with public figures like Bryan Johnson promoting psychedelic therapies for longevity [2][6] - Scientific literature supports the intersection of psychedelics and aging biology, with preclinical research indicating that psilocin can extend survival in aged mouse models and increase the lifespan of human cells by over 50% [2] Research Initiative - Psyence BioMed is developing a preclinical protocol to evaluate psilocybin's influence on biological mechanisms related to aging, focusing on biomarkers of cellular stress, inflammation, and mitochondrial function [3] - The research will be led by Dr. Tanya Calvey, a recognized neuroscientist specializing in neuropsychopharmacology, to rigorously investigate the effects of psilocybin on aging [4][5] Strategic Positioning - The initiative complements Psyence BioMed's existing clinical programs, including psilocybin-assisted therapy trials for palliative care patients, advancing the company's mission to explore the therapeutic potential of psilocybin and ibogaine [7] - The company is positioned at the forefront of a new therapeutic arena, with significant interest in understanding how psilocybin may influence biological aging [6]
Curaechoice Selects CVS Caremark at its PBM
Globenewswire· 2025-11-24 15:58
Core Insights - Curaechoice has partnered with CVS Caremark as its pharmacy benefit manager, aiming to reduce prescription drug costs for its members [1][2] - The collaboration will enable Curaechoice members to access CVS Caremark's extensive network of 65,000 pharmacies starting January 1, 2026 [1] - The partnership is expected to help self-insured employers manage healthcare spending while providing quality care to employees [3] Company Overview - Curaechoice specializes in No-Cost Benefits Optimization, focusing on providing comprehensive healthcare solutions without copays, deductibles, or co-insurance [4] - CVS Caremark, a subsidiary of CVS Health, is recognized for its innovation and affordability in prescription drug delivery, operating a broad network of retail and mail-order locations [4] Market Context - Pharmacy costs account for nearly one-third of an employer's total healthcare spending, highlighting the significance of the partnership in addressing rising healthcare expenses [2] - The collaboration is positioned as a response to the increasing financial pressures faced by families, including costs related to groceries, gas, childcare, and healthcare [3]
Psyence(PBM) - 2025 Q2 - Quarterly Report
2025-11-20 21:01
Exhibit 99.1 Psyence Biomedical Ltd. Unaudited Condensed Consolidated Interim Financial Statements For the three and six months ended September 30, 2025 and 2024 Expressed in United States Dollars (USD $) PSYENCE BIOMEDICAL LTD. Condensed Consolidated Interim Financial Statements (unaudited) Condensed Consolidated Interim Statements of Financial Position As at September 30, 2025 and March 31, 2025 | | | As at | As at | | --- | --- | --- | --- | | | | September 30, | March 31, | | | | 2025 | 2025 | | USD $ | ...
Morning Market Movers: MNDR, PACS, SLMT, CRNC See Big Swings
RTTNews· 2025-11-20 13:08
Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Mobile-Network Solutions (MNDR) is up 96% at $3.26 - PACS Group, Inc. (PACS) is up 44% at $24.37 - Cerence Inc. (CRNC) is up 28% at $10.16 - Magnera Corporation (MAGN) is up 26% at $10.07 - Oddity Tech Ltd. (ODD) is up 17% at $43.75 - Allot Ltd. (ALLT) is up 14% at $9.80 - Artiva Biotherapeutics, Inc. (ARTV) is up 14% at $3.88 - Kulicke and Soffa Industries, Inc. (KLIC) is up 13% at $40.22 - Fossil Group, Inc. (FOSL) is up 12% at $2.29 - NVIDIA Corporation (NVDA) is up 5% at $195.84 [3] Premarket Losers - Brera Holdings PLC (SLMT) is down 33% at $3.84 - Bath & Body Works, Inc. (BBWI) is down 14% at $18.04 - Cemtrex, Inc. (CETX) is down 11% at $3.20 - Atkore Inc. (ATKR) is down 9% at $60.00 - Gloo Holdings, Inc. (GLOO) is down 9% at $7.30 - SMX (Security Matters) Public Limited Company (SMX) is down 9% at $4.60 - Sonim Technologies, Inc. (SONM) is down 8% at $7.31 - Psyence Biomedical Ltd. (PBM) is down 7% at $2.56 - MMTec, Inc. (MTC) is down 6% at $2.00 - Ridgetech, Inc. (RDGT) is down 5% at $4.78 [4]
Psyence BioMed Reaches Major Breakthrough in Pharmaceutical-Grade Ibogaine Supply for Worldwide Clinical and Therapeutic Markets
Globenewswire· 2025-11-20 12:00
Core Viewpoint - Psyence Biomedical Ltd. has established a sustainable supply of high-potency iboga bark through its partnership with PsyLabs, which is crucial for the clinical development of ibogaine for substance use disorders [1][2][4] Group 1: Supply Chain and Product Development - The collaboration with PsyLabs ensures a long-term supply of GMP-compliant ibogaine, with the first 50 kg received and being processed into pharmaceutical-grade ibogaine HCL and Total Alkaloid Extracts [2][3] - The company is committed to ethical sourcing and sustainability, ensuring that ibogaine and related alkaloids are derived from Tabernanthe iboga and Voacanga africana while respecting cultural traditions and benefiting source communities [3][4] Group 2: Strategic Positioning and Market Leadership - The establishment of a reliable and ethically sourced supply chain positions Psyence BioMed as a leader in the emerging ibogaine sector, enhancing its competitive advantage as international interest in ibogaine grows [4] - The company aims to set a new standard for ethical psychedelic production, emphasizing partnerships with traditional knowledge holders rather than treating them merely as suppliers [4][6] Group 3: Company Overview - Psyence Biomedical Ltd. is a vertically integrated biopharmaceutical company focused on developing nature-derived psilocybin and ibogaine-based psychedelic medicine, addressing unmet mental health needs [6] - The company is the first life sciences biotechnology firm specializing in psychedelic therapeutics to be listed on Nasdaq, reflecting its commitment to an evidence-based approach in developing safe and effective treatments [6]
Psyence BioMed Establishes Ibogaine Operations in Africa Through Strategic Investment in PsyLabs
Globenewswire· 2025-11-12 12:00
Core Viewpoint - Psyence BioMed is positioned as the only publicly listed psychedelics company with active operations and manufacturing capabilities in Africa, enhancing its access to ibogaine, a compound derived from the Tabernanthe iboga shrub, which is crucial for developing therapies for mental health needs [1][2]. Company Overview - Psyence BioMed focuses on nature-derived psilocybin and ibogaine therapies to address unmet mental health needs, particularly in palliative care [10]. - The company has established a strategic investment in PsyLabs, which operates a GMP-compliant facility in Southern Africa, producing highly purified psychedelic compounds [3][9]. Strategic Positioning - By operating at the source of ibogaine, Psyence BioMed can ensure sustainable and responsible access to this compound, allowing for quality control from cultivation to finished product [2][3]. - The vertical integration of Psyence BioMed's operations strengthens supply security and scalability, positioning the company favorably within the psychedelics sector [3][8]. Market Trends - There is a global surge in interest and research surrounding ibogaine as a potential treatment for addiction and mental health disorders, with significant findings indicating its effectiveness in reducing PTSD symptoms among veterans [4][5]. - The State of Texas has allocated $50 million for clinical research on ibogaine, aiming to develop FDA-approved treatments for opioid use disorder, which reflects growing governmental support for psychedelic medicine [5]. Industry Developments - Major pharmaceutical companies, such as AbbVie, are increasingly investing in psychedelic compounds, highlighting the clinical potential of ibogaine and its analogs [6][7]. - Psyence BioMed is actively engaged in developing next-generation analogs of ibogaine, aligning with the industry's shift towards innovative therapeutic solutions [6][8]. Supply Chain and Compliance - PsyLabs is federally licensed to cultivate and export various psychedelic compounds, ensuring compliance with safety and traceability standards [9][10]. - The company's operations are supported by an ISO 22000-certified facility, emphasizing its commitment to high safety standards and regulatory compliance [10].