Beckley Foundation

A single dose of BPL-003 demonstrated a rapid antidepressant response in 55% of patients the day after dosing. A durable antidepressant effect was also shown, with 55% of patients in remission from depression at day 29 and 45% in remission at day 85. BPL-003 demonstrated a short treatment duration, with acute effects resolving and patients deemed dischargeable within an average time of less than 2 hours. This underlies the potential to deliver a scalable single dose treatment model that, if approved, could fit within the existing treatment paradigm successfully established by Spravato®. BPL-003 was generally well-tolerated with no serious adverse events reported. Beckley Psytech’s Phase IIb study of BPL-003, currently the largest and only FDA-approved Phase IIb study of 5-MeO-DMT, is underway with topline data expected in H2 2024. OXFORD, United Kingdom--(BUSINESS WIRE)-- Beckley Psytech Ltd, the private, clinical-stage biopharmaceutical company dedicated to improving the lives of people living with neuropsychiatric disorders by developing effective and rapid-acting psychedelic medicines, today announced positive initial findings from its Phase IIa clinical study (NCT05660642) of BPL-003 for Treatment Resistant Depression (TRD). BPL-003 is Beckley Psytech’s novel, synthetic, patent-protected benzoate salt formulation of 5-MeO-DMT (Mebufotenin) and is administered intranasally. Initial results show that a single 10mg dose of BPL-003 was well-tolerated with a short treatment duration and rapid, durable efficacy in patients with TRD. The open-label Phase IIa study investigated the safety, efficacy and pharmacokinetics of a single 10mg dose of BPL-003 alongside psychological support in patients with moderate-to-severe TRD who were not taking concomitant antidepressants. 12 subjects were dosed, and 11 met the criteria for per-protocol analysis.1 Patients were followed for 12 weeks post-dosing, with assessments conducted at multiple points throughout the study. Initial analysis shows that a single dose of BPL-003 induced a rapid antidepressant response in 55% of patients the day after dosing (day 2). Furthermore, these effects were shown to be durable with 55% of patients in remission from depression at day 29 and 45% of patients in remission from depression at day 85. These findings represent the longest-known follow-up of improvement in depression outcomes for a clinical study of 5-MeO-DMT and indicate the durable antidepressant effects of a single administration of BPL-003. Response rate* Remission rate* Day 2 55% 36% Day 29 55% 55% Day 85 55% 45% *Response: ≥50% reduction in MADRS scores; Remission: MADRS score ≤10. MADRS stands for Montgomery–Åsberg Depression Rating Scale. The results also show that BPL-003 was generally well-tolerated, with convenient nasal administration. 95% of events were mild or moderate, and no serious adverse events were reported which is broadly consistent with Phase I findings. Acute effects were resolved and patients were deemed dischargeable within an average time of less than 2 hours. This signals the potential for a shorter treatment duration and reduced resource burden for healthcare systems compared to other psychedelic treatments currently in development. If confirmed in larger registration studies, these findings could support a scalable single dose treatment model that would fit within the existing treatment paradigm that has been successfully established by Spravato®. An extension of this Phase IIa study is now enrolling patients with TRD who are on stable doses of oral antidepressants in order to assess the safety and efficacy of BPL-003 as an adjunctive treatment. Commenting on the results, Cosmo Feilding Mellen, Chief Executive Officer at Beckley Psytech, said: "We are delighted to see that a single dose of BPL-003 delivered a rapid and durable antidepressant response in patients with Treatment Resistant Depression. Our single dose treatment model enables a short treatment duration which positions BPL-003 as a potentially exciting and scalable treatment opportunity. Less than 15% of patients with Treatment Resistant Depression achieve long-term remission with the current standard of care, and we look forward to further validating the potential of BPL-003 as a treatment option with our ongoing Phase IIb study and subsequent clinical development program.” The initial findings from this Phase IIa study increase confidence in Beckley Psytech's multi-centre Phase IIb study which seeks to further validate BPL-003’s safety and efficacy ahead of anticipated end-of-Phase II interactions with regulatory agencies. The Phase IIb study, which is the first, largest and currently only FDA-approved Phase IIb study of 5-MeO-DMT, is evaluating the effects of a medium or high dose of BPL-003 against a sub-perceptual dose in 225 patients with TRD. Efficacy of a single dose alongside psychological support will be assessed using the MADRS scale at several time points during the 8-week blinded follow-up in the trial. Initial results are expected in H2 2024. It is estimated that nearly 300 million people worldwide have depression, with around 52 million people suffering from the condition in Europe and the US combined. Treatment Resistant Depression occurs when an individual does not respond to two or more courses of antidepressants and it is estimated to affect around 33% of those living with depression. -Ends- Beckley Psytech - Beckley Psytech Ltd is a private, clinical-stage biopharmaceutical company dedicated to improving the lives of people living with neuropsychiatric disorders by developing effective and rapid-acting psychedelic medicines. Founded in 2019, and underpinned by more than two decades of pioneering scientific research from the Beckley Foundation, Beckley Psytech combines world-leading psychedelic science with extensive drug development expertise in order to optimise patient outcomes, improve treatment opportunities and ease the burden neuropsychiatric conditions have on individuals, healthcare systems and society. The company’s lead compound, BPL-003, is a novel, synthetic 5-MeO-DMT benzoate salt candidate currently under investigation for the treatment of Treatment Resistant Depression (TRD) and Alcohol Use Disorder (AUD). BPL-003 is covered by granted US, UK and European composition of matter patents, with multiple further claims pending in various jurisdictions. Beckley Psytech’s second clinical-asset, ELE-101, is a proprietary intravenous formulation of psilocin currently being developed as a potential treatment for Major Depressive Disorder (MDD). 1ior to data analysis, one subject (from a total of 12 patients) was determined not to meet multiple per protocol eligibility criteria and was excluded from the efficacy analysis.

New Programs for Veterans, Women, and People of Color Also Mark the Growth of Beckley Waves’ Accomplishments Heading into 2024LONDON, March 05, 2024 (GLOBE NEWSWIRE) -- Beckley Waves, the first venture studio explicitly formed to build and invest in the thriving psychedelic ecosystem to advance mental health and well-being, today celebrated a series of milestones from 2023, including the 25th anniversary of the Beckley Foundation, new funding and acquisitions. Through its portfolio of operating companies, Beckley Waves has also expanded programs for practitioner training and psilocybin retreats, accelerating the company’s growth. “Beckley Waves already has an impressive track record of founding and investing in startups that are building the care-delivery infrastructure for psychedelics, and we’re pausing to reflect on a year of notable achievements as we continue this important work,” said Amanda Feilding, Co-Founder and Director of Beckley Waves. “Our new funding and expanded programs across our portfolio will enable Beckley Waves to continue building and investing in startups that will provide the infrastructure and services for expanding safe and legal access to psychedelic therapies worldwide.” Beckley Waves has so far co-founded Beckley Retreats, which is setting the standard for legal, psilocybin-based retreats in a group setting; Beckley Academy, an ed-tech company for training and preparing therapists and clinicians to work with psychedelic therapies; and in 2023 relaunched The Trip Report, a newsletter and podcast that provides commentary and analysis for people who are curious, fascinated, excited, concerned, and hopeful about legal psychedelics in healthcare, spirituality, and society. In 2023, Beckley Waves closed a $3.3 million funding round, providing it with additional resources to fund catalytic strategic investments into selected early-stage teams to support and guide them toward successful seed rounds. In September, the company also acquired at-home ketamine therapy provider Nue Life and will continue Nue Life’s work to provide safe and scalable access to ketamine-assisted therapy in underserved areas across multiple US states. Beckley Retreats recently increased support for its scholarship program, which aims to foster diversity and expand access to psychedelic experiences for those who may not otherwise be able to participate. In 2024, Beckley Retreats will offer dedicated retreats in Jamaica and the Netherlands that will be exclusively for women, veterans, and the BIPOC community. Beckley Retreats CEO Neil Markey shared his story with the Ninth Circuit US Court of Appeals in 2023, with an amicus brief with case studies and stories to petition for a change of psilocybin’s status as a “Schedule I” substance under the US Controlled Substances Act. The company also continued its ongoing work in veteran suicide prevention by renewing a strategic partnership with the Heroic Hearts Project and Imperial College London (ICL) to further ICL’s research on the benefits of psychedelic-assisted therapies in combatting the veteran suicide epidemic among American service members. Beckley Academy, which trains practitioners to provide psychedelic-assisted therapy (PAT) with Ketamine, Psilocybin, and MDMA, announced an expanded curriculum in 2023, as well as the open-source publication of its research: A Psychedelic-Assisted Therapy Learning Framework. This industry-first learning framework will serve as a much-needed foundation to advance national training standards for clinicians to provide ethical and effective psychedelic-assisted therapy. "We are continually evaluating opportunities where we think we can have an outsized impact on the emerging psychedelics field by addressing currently underserved needs," said Daniel Love, co-founder and partner at Beckley Waves. "With our ongoing momentum, we will keep the flywheel spinning and continue to allow the Beckley Waves Ecosystem to play a catalytic role in our shared path to widespread access." About Beckley WavesBeckley Waves, a venture studio co-founded by Amanda Feilding, funds, supports, and mentors emerging leaders and entrepreneurs working to foster the operational infrastructure of a global psychedelic ecosystem. Beckley Waves is building the psychedelic ecosystem to advance mental well-being and foster a thriving psychedelic industry rooted in science, innovation, and compassion. Beckley Waves leverages research showing that psychedelics can be the tools to usher in a new paradigm of mental health and well-being that is needed by our society and the planet. Media ContactNeil Daviesneil@broadsheetcomms.com

Strategic investment in Beckley Psytech reinforces atai’s position as the biopharmaceutical company with the largest and most diverse portfolio of clinical-stage psychedelic candidatesTwo patent-protected, clinical-stage programs BPL-003 (intranasal 5-MeO-DMT) and ELE-101 (intravenous psilocin) complement atai’s existing drug development programs Multiple clinical readouts anticipated from this investment in Beckley Psytech within next 12 months, including a Phase 2b readout of BPL-003 in Treatment Resistant Depression in 2H24 BPL-003 has the potential to become a first-in-class short-duration psychedelic treatment with rapid acting and durable antidepressant effects Anticipated synergies through collaborating on digital therapeutics, commercial and market access activities in preparation for potential future commercialization atai to hold conference call & webcast on Thursday, January 4, 2024 at 8:00 a.m. ET NEW YORK and BERLIN, Jan. 04, 2024 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced a strategic investment in Beckley Psytech Limited (“Beckley Psytech”), a private clinical-stage biotechnology company dedicated to transforming short-duration psychedelics into effective and rapid-acting medicines for neuropsychiatric conditions. This strategic investment and collaboration aims to accelerate the development of Beckley Psytech’s two clinical-stage, patent-protected, short-duration psychedelic candidates, BPL-003 and ELE-101, by adding them to atai’s mental health innovation platform. BPL-003 is a novel, short-duration, intranasal formulation of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT also known as Mebufotenin), and ELE-101 is a novel intravenous formulation of psilocin, the primary moiety of psilocybin. “This transaction underscores our conviction in the potential of psychedelics as groundbreaking treatments for people living with mental health disorders. Short-duration psychedelics have the potential to offer similar clinical benefit to longer-acting psychedelics, in a more efficient and scalable way, which could lead to increased patient access. By including BPL-003 and ELE-101 in the atai platform, we are building the largest portfolio of psychedelic compounds with prior clinical evidence,” said atai Founder and Chairman, Christian Angermayer. Beckley Psytech’s CEO, Cosmo Feilding Mellen said: “Beckley Psytech and atai Life Sciences share a vision for the future of mental health treatment, and we are excited to join forces on the journey to develop effective, accessible, rapid-acting psychedelic medicines for people in need. Alongside the financial investment, we are optimistic about the numerous possible synergies of this collaboration, especially in developing digital tools to optimize patient support and planning for future commercialization. We look forward to exploring these in the coming months.” BPL-003 is currently in development for two indications: Treatment Resistant Depression (TRD) and Alcohol Use Disorder (AUD), with three clinical trials underway. The first trial is a global, multi-site, double-blind, randomized Phase 2b study in people living with TRD, evaluating the effects of a medium and high dose of BPL-003 against an active placebo comparator in 225 patients with moderate-to-severe TRD. Medium and high dosages were found to reliably induce profound psychedelic experiences in a completed Phase 1 trial, with a rapid onset of psychedelic effects within minutes and the resolution of all perceptual effects within 60-90 minutes. In addition to the Phase 2b study in TRD that is anticipated to read out in the second half of 2024, BPL-003 is also being investigated in two small Phase 2a open-label studies in TRD and AUD, with data expected in the first half of 2024 and mid 2024 respectively. Beckley Psytech’s second candidate ELE-101 is being developed for the treatment of Major Depressive Disorder (MDD). This compound has the potential to offer the therapeutic benefits of psilocybin, which has demonstrated significant antidepressant effects in multiple clinical studies, in a more consistent, controllable, and shorter treatment paradigm of less than 2 hours. Initial results from the current ELE-01 Phase 1/2a study are anticipated in the first half of 2024. atai Co-founder and Chief Executive Officer, Florian Brand added: “When it comes to mental health, there is no one-size-fits-all solution, and the diverse pharmacology of our drug candidates acknowledges the heterogeneity of neuropsychiatric patient populations. Looking ahead to the next 12 months, adding to our already strong pipeline of potential catalysts, we anticipate this investment will lead to several additional meaningful clinical readouts, including topline results from the BPL-003 Phase 2b study, expected in the second half of 2024.” Under the terms of the investment Beckley Psytech will remain an independent, privately-owned company and atai will own 35.5% of Beckley Psytech. This is based on a $50m total investment, with a $40m direct investment into the company to fund ongoing research programs, and an additional $10m in secondary share purchases from existing shareholders. Upon closing, atai will receive 1:1 warrant coverage at a 30% premium on the primary issuances. atai will also have the right to appoint and hold 3 of the 9 seats in Beckley Psytech’s Board of Directors, and will hold a time-limited right of first refusal on a future sale of the company, asset sales or other transfer of commercial rights, as well as an indefinite right of first negotiation for BPL-003 and ELE-101. Conference Call Informationatai Life Sciences will host a conference call and live webcast on Thursday January 4, 2024 at 8:00 a.m. ET. The conference call can be accessed on the Investors section of atai Life Sciences’ website under News, Events & Presentations, via the following link: https://ir.atai.life/news-events/events. The presentation and an archived replay of the webcast will be available in the same section of the website for a minimum of 30 days following the event. About Beckley PsytechBeckley Psytech Ltd is a private, clinical stage biotechnology company dedicated to improving the lives of people suffering from neuropsychiatric disorders by transforming psychedelics into effective and rapid-acting clinical medicines. The company’s most advanced programs are focused on the development of psychedelic-based medicines to treat people with TRD and MDD. Founded in 2019 and underpinned by more than two decades of pioneering scientific research from the Beckley Foundation, Beckley Psytech combines world-leading psychedelic science with extensive drug development expertise in order to optimize patient outcomes, improve treatment opportunities and ease the burden neuropsychiatric conditions have on individuals, healthcare systems and society. About atai Life Sciencesatai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders and was founded as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines to achieve clinically meaningful and sustained behavioral change in mental health patients. atai's vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. For more information, please visit www.atai.life. Forward-looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and the negative of these terms and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including statements concerning our expectations and projections regarding any or all of the following: statements concerning the terms and benefits of the strategic investment with Beckley Psytech; the timing of clinical and regulatory developments related to BPL-003 and ELE-101; our future operating results and financial position; the success, cost, and timing of development of our other product candidates, including the progress of preclinical studies and clinical trials and related milestones; the commercialization of our product candidates and any other product candidates we may identify and pursue, if approved; the timing for announcing our study results and development plans including our clinical trials for RL-007, VLS-01, DMX-1002, EGX-121 and EMP-01; the timing of our communications with regulatory authorities to discuss future studies and trials or ability to obtain and maintain regulatory approvals; the scope and breadth of our existing and future intellectual property and protection thereof; our business strategy and plans; the sufficiency of our cash position to fund our operations and the length of time it may do so; the plans and objectives of management for future operations and capital expenditures; and our participation in upcoming events and conferences. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. Because forward-looking statements are subject to known and unknown risks, uncertainties, and assumptions, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks uncertainties, and assumptions include, among others: our limited operating history, historical losses, and anticipation that we will continue to incur significant losses for the foreseeable future; we will require substantial additional funding to achieve our business goals, including the development and any commercialization of our product candidates; we have never generated revenue and may never be profitable; our product candidates contain controlled substances, the use of which may generate public controversy; clinical and preclinical development is uncertain, and our programs may experience delays or may never advance to clinical trials; our reliance on third parties to assist in conducting our clinical trials and impact to such trials based on factors including failure by third parties to meet trial or testing deadlines; our reliance on qualified therapists working at third-party clinical trial sites to administer certain of our product candidates and failure to recruit and retain a sufficient number of therapists; the timing and outcome of regulatory review and/or approvals, which are necessary prior to commercialization; research and development of drugs targeting the central nervous system, or CNS, is particularly difficult, and it can be difficult to predict and understand why a drug has a positive effect on some patients but not others; significant competition; obtaining, maintaining and protecting our intellectual property; restricted operating activity as a result of covenants in any financing arrangements, including our loan agreement with Hercules Capital, Inc.; our aggregate tax burden based on our management and operational activity. These forward-looking statements are subject to a number of important factors that could cause actual results to differ materially from those in the forward-looking statements, including the risks, uncertainties, and assumptions described in our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 30, 2023, and as any such factors may be updated from time to time in our other filings with the SEC. Any forward-looking statements made herein speak only as of the date of this press release. Except as required by applicable law, we undertake no obligation to update any of these forward-looking statements for any reason after the date of this press release or to conform these statements to actual results or revised expectations. Contact InformationInvestor Contact:IR@atai.life Media Contact:PR@atai.life