atai Life Sciences Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Clinical Pipeline Highlights https://uk.finance.yahoo.com/news/a...tbOBDoUk-P4F0OwBAHDzoR-xQkIzbxo10_0lRaTshs3YA atai Life Sciences Fri, 24 March 2023 at 6:59 am GMT-4·15-min read atai’s development candidates, such as RL-007 and GRX-917, all represent significant opportunities to address unmet medical needs of patients living with mental health conditions Continued operational progress on robust clinical pipeline, with multiple phase 1 and phase 2 proof-of-concept datasets expected in the next two years $273 million in cash, cash equivalents and short-term investments at end of 2022 and access to a term loan facility of up to an additional $160 million provide anticipated runway into the first half of 2026 NEW YORK and BERLIN, March 24, 2023 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, reported fourth quarter and full year 2022 financial results and provided clinical pipeline highlights. “With multiple clinical-stage programs aimed at addressing significant unmet patient needs in mental health and the capital to fund us into the first half of 2026, we believe we are in a strong position to advance our clinical candidates towards proof of concept in patients,” said Florian Brand, CEO and Co-Founder of atai. “Recently we announced dosing the first patient in our Phase 2 study of RL-007 in CIAS and the modification of the GRX-917 clinical development plan to advance directly into a proof-of-concept study in patients with anxiety.” Clinical Pipeline Highlights RL-007 (Pro-Cognitive Neuromodulator for Cognitive Impairment Associated with Schizophrenia (CIAS)) The first patient was recently dosed in the phase 2b study of RL-007 in patients with CIAS and topline results from this study are expected in the 2nd half of 2024. The phase 2b US-based study is a randomized, placebo-controlled, double-blind, 3-arm study evaluating 20mg and 40mg of RL-007 vs placebo in approximately 230 patients with CIAS. The primary endpoint of the study is the change from baseline in the MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite score, a well-established regulatory endpoint, at week 6. RL-007 is an orally available compound that modulates cholinergic, glutamatergic and GABA-B receptors, thereby putatively altering the excitatory/inhibitory balance in the brain to produce pro-cognitive effects. It has previously been evaluated in 10 clinical studies with over 500 unique participants dosed to-date and in which it was well tolerated at all doses tested. Notably, in four clinical studies that assessed cognition, including one in patients with CIAS, the compound consistently demonstrated pro-cognitive effects. In atai’s previous Phase 2a proof-of-mechanism study in CIAS of RL-007, the compound showed a large effect size on Symbol Coding, a sub-component of the MCCB that correlates with the overall composite. GRX-917 (Deuterated Etifoxine for Anxiety Disorders) The clinical development plan was modified to proceed with a phase 2 study in patients, which is intended to generate the robust clinical data needed to best inform a future registrational program. More details of the phase 2 clinical development plan will be provided upon initiation of the study. In January 2022, positive results were announced from the phase 1 single and multiple ascending dose study of GRX-917. In this study, GRX-917 was well-tolerated. Additionally, GRX-917 had an improved pharmacokinetic profile relative to etifoxine and provided pharmacodynamic evidence of GABA receptor target engagement through qEEG. GRX-917 is a deuterated version of etifoxine, a drug used for anxiety and first approved in France in 1979. Etifoxine has a rapid onset and efficacy comparable to benzodiazepines, which are currently considered standard of care. In contrast to benzodiazepines, etifoxine appears to be non-addictive, less sedating, and better tolerated. It is believed that etifoxine achieves its anxiolytic activity by increasing the endogenous production of brain neurosteroids like allopregnanolone. COMP360 (Psilocybin Therapy for Treatment-Resistant Depression (TRD)) COMPASS Pathways (“COMPASS”) recently announced an acceleration of the Pivotal Trial 1 (COMP 005) part of the phase 3 program in TRD, with top line data from Pivotal Trial 1 now expected in the summer 2024. The on-going phase 3 program is composed of two pivotal trials, each of which will have a long-term follow-up component. The primary endpoint in both pivotal trials is the change from baseline in MADRS total score at week 6. COMP360 is a proprietary formulation of synthetic psilocybin that is administered in conjunction with psychological support. Previously, COMPASS completed a phase 2b study with top line data showing a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. VLS-01 (N,N-dimethyltryptamine (DMT) for TRD) In the fourth quarter of 2022, the first subject was dosed in a Phase 1 study of VLS-01. Initial results from the study are expected in the 1st half of 2023. The phase 1 study is a two-part single-ascending dose study designed to evaluate the safety, tolerability and relative bioavailability of oral transmucosal film (OTF) versus intravenous (IV) formulations of VLS-01. The study includes atai’s IDEA-1 companion digital therapeutic for psychological support to be used in combination with VLS-01. The app-based support comprises “(mind)set-and-setting” prior to dosing and limited post-dose integration appropriate for healthy volunteers. VLS-01 is an OTF formulation of DMT. DMT is a partial agonist of the 5-HT 1A/2A/2C receptors, characterized by an intrinsically short duration of psychedelic effect, with a serum half-life estimated at less than 10 minutes. DMT results in rapid-acting antidepressant effects when administered via IV infusion in patients with major depressive disorder (MDD). VLS-01 is formulated for oral delivery, potentially eliminating the need for IV infusion. DMX-1002 (Ibogaine for Opioid Use Disorder) In the third quarter of 2022, the first subject was dosed in a phase 1/2 study of Ibogaine. Initial results from the Phase 1 portion of the study are expected in the 1st half of 2023. EMP-01 (MDMA Derivative for PTSD) In the third quarter of 2022, a phase 1 study of EMP-01 was initiated. Initial results from this study are expected in the 2nd half of 2023. Consolidated Financial Results Cash, Cash Equivalents, and Short-term investments: Cash and cash equivalents and short-term investments were $273.1 million as of December 31, 2022, as compared to $362.3 million as of December 31, 2021. The decrease of $89.2 million was primarily driven by net cash used in operating activities of $104.5 million and $3.6 million additional investment in platform companies, partially offset by $15.0 million draw on the Hercules debt, $4.6 million of proceeds from the conversion of notes and $2.9 million of proceeds from stock sales and stock option exercises. The Company expects its cash position, combined with access to up to $160M in additional capital from its term loan facility with Hercules Capital, Inc., will be sufficient to fund operations into 1H 2026. Research and development (R&D) expenses: R&D expenses were $21.9 million and $74.3 million for the three and twelve months ended December 31, 2022, respectively, as compared to $13.0 million and $48.0 million for the same prior year periods. The year-over-year full-year increase of $26.3 million was primarily attributable to an increase of $22.2 million of contract research organization expenses related to advancements of R&D programs and $3.5 million increase in R&D personnel costs. General and administrative (G&A) expenses: G&A expenses for the three and twelve months ended December 31, 2022 were $15.7 million and $70.4 million, respectively, as compared to $25.9 million and $92.7 million in the same prior year periods. The year-over-year decrease of $22.3 million was primarily attributable to a decrease of $18.0 million in non-cash stock compensation expense, $9.8 million decrease in value added tax expense, $4.0 million decrease in professional consulting services. These decreases were partially offset by an increase of $7.3 million in personnel expenses and $1.9 million increase in insurance expense. Net loss: Net loss attributable to shareholders for the three and twelve months ended December 31, 2022 was $45.0 million and $152.4 million, respectively, as compared to $88.9 million and $167.8 million for the comparable prior year periods. About atai Life Sciences atai Life Sciences is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. Founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape, atai is dedicated to acquiring, incubating, and 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 across its companies 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.
Live ATAI - AMA on Reddit https://www.reddit.com/r/shroomstocks/comments/11wlqp1/hi_this_is_florian_brand_and_srinivas_rao/
14 reasons why I am increasing my stake in atai Life Sciences https://www.linkedin.com/pulse/14-reasons-why-i-am-increasing-my-stake-atai-life-angermayer/ Christian Angermayer Founder bei Apeiron Investment Group 25 articles March 29, 2023 Dear fellow shareholders of atai Life Sciences, Biotech has been a tough sector for investors over the last 24 months. More or less since the IPO in June 2021 of atai Life Sciences (Nasdaq: ATAI) – the mental health biotech company I founded, of which I am the Chairman, and which is my most important passion project – the entire biotech sector has been trending downwards. But even worse, compared to the XBI, the leading biotech index, atai has underperformed. I know this is unpleasant and frustrating – to say the least – for all investors, including myself as the largest shareholder. I didn’t just start atai, but also invested in the private rounds and significantly in the IPO as well. And have not sold a single share. I personally believe that this pain also creates an opportunity: As an investor, I believe that purchasing atai shares has never been more attractive imho – for multiple reasons. This is why I am once again increasing my personal stake in atai this week via my own family office Apeiron Investment Group. I believe that atai Life Sciences is the biggest entrepreneurial opportunity I have ever encountered as an investor. I truly believe this company has an incredible future and is well-positioned to make a positive and meaningful difference to one of humanity’s major challenges – the escalating mental health crisis. With this blog post, I want to share my personal views both on atai and the biotech market more broadly. 1) A simple sum-of-the-parts calculation Most important – numbers first (as of Tuesday, March 28th): In its most recent earnings press release, atai reported a strong balance sheet with NET cash of approx. USD 258 million. Furthermore, atai owns 22.4% of COMPASS Pathways, a psilocybin-focused, Nasdaq-listed biotech company. This stake is worth roughly $98M as of Tuesday, March 28, based on COMPASS Pathways’ closing price of $10.23/share on that day. You can find atai’s filed 10-K from last Friday here With approx. 166 million shares outstanding, net cash plus the value of COMPASS stake makes approx. USD 356 million or USD 2.14 per share. So, you can buy atai right now at a 38% discount to “Cash + Compass stake” - not to mention additionally – practically for free - getting ownership interests in additional 7 clinical-stage drug development programs PLUS atai’s digital therapeutics (DTx) PLUS a very strong early-stage discovery engine. If, like me, you are already a believer in what atai is doing, you can stop reading here. That’s all you need to know. 2) atai’s pipeline You can find more info about atai’s pipeline here. In short: a pipeline of 5 clinical-stage drug development programs (and ownership interests in a total of 7 such programs), some of which are envisioned to be paired with digital therapeutics plus the 22.4% stake in COMPASS plus strong drug discovery programs driven by AI, for the next generation of psychedelics. Of the aforementioned 7 clinical drug candidates, 4 are psychedelic and 3 are non-psychedelic substances. 3) Prior evidence in humans For most compounds within atai’s pipeline, atai reports examples of prior human use and/or anecdotal evidence. Either from previous clinical studies or former medical use – like psilocybin – or because many people have found healing in traditional rituals, with the original flora and fungi, which have been used for thousands of years. I believe that this is what makes atai different from other “standard” biotech companies, and personally gives me such confidence in atai’s future success. We already know the history and profile of these compounds. atai ‘just’ – and don’t get me wrong, there is a lot of work to be done – needs to turn this anecdotal evidence into robustly-assessed trial results that permit FDA approval. 4) Market size We all regularly quote the shocking “1 billion people suffer worldwide from mental health issues” statistic. Unfortunately, though, I believe this number is understated and the real number is way higher, mainly for 3 reasons: This is still a pre-COVID-19 figure. I expect, and recent data suggest, that COVID-19 has substantially worsened the global mental health situation, though it will take more time for accurate global figures to be compiled and reported Mental health issues like depression, anxiety, addiction and PTSD continue to be stigmatized. Not everybody who needs help is coming forward to be diagnosed and treated. Many still suffer in silence. This is gradually changing, and great work is underway to reduce such stigma. As it does, I believe the number of diagnoses will increase substantially. In general, I firmly believe the world we are building is not good for our mental health. Constant change, misuse of social media, relentless over-stimulation – all of this is totally toxic for our brain and taking its toll on us all. Read more about this in one of my latest blog posts. My personal, sad belief is that the number of patients globally living with mental health conditions will continue to increase in the years to come. However, I’m also confident that atai is on its way to helping solve the mental health crisis. 5) Market share Most equity research analysts in their respective models use a market share for each respective indication for atai’s and COMPASS’s psychedelic compounds – once approved – only in the single-digit percentage range. And I know that many investors doubt rapid commercial success once psychedelic treatments are approved. Their mind is too preoccupied with the “pop a pill every day” business model, and they cannot see the transformative potential psychedelic-assisted therapy offers for patients. And I do believe that if you offer outstanding value, you will be paid accordingly. My own early discussions with insurance companies confirm my general view on the topic of reimbursement. And then there is the ‘virality’ of psychedelic therapy: I personally know so many people who have already found healing in psychedelics – and virtually all have since become an advocate. Some have simply shared their stories only in their own private circles, while others have done so very publicly. Quite simply, I never have met anybody who benefitted from psychedelics who does not want to talk about it and extol their potential to others. Based on these personal experiences, I believe that once approved, the market penetration will outpace conservative estimates, driven by word of mouth, personal testimonies and a passionate ‘patients turned ambassadors’ movement, all of course within the appropriate medical regulation and oversight. 6) Patents I fully recognize and respect sensitivities here, but I need to be clear that I am very proud that atai and COMPASS Pathways have been diligent in mapping out the landscape of psychedelics for medical use and, where appropriate, securing the necessary patents, intellectual property (IP) and data exclusivity steps to do so. Patents and IP are a critical pillar of research and development and the ability to bring any promising new drug to market, and psychedelics are no exception. Patents foster innovation, and innovation benefits patients in need. In my opinion, atai and COMPASS together are clear market leaders. Is it possible that we forgot some niches here and there? Sure. Are the niches big? I don’t think so. And atai continues to build and strengthen its IP portfolio, using its strong balance sheet and entrepreneurial agility to identify further areas that have the potential to optimize its platform and future offerings. 7) Regulation atai embraces regulation. Psychedelics had already been ‘regulated’ for thousands of years by shamans and priests – the healers of their times - and have been ‘prescribed’ within strict frameworks. atai strives to bring psychedelics back into the world of science and make them valuable therapy tools for therapists and doctors. atai aims to do so by proving their safety and efficacy in rigorous clinical trials. The latest company failures in the so-called ‘psychedelic industry’ – which doesn’t really deserve that title, as there are just a handful of companies with a real, viable strategy imo, and the rest have no business model – show that cutting corners is not the right way. atai's way might take longer. atai's way might have setbacks as we saw with the R-Ketamine results. But personally, I am convinced that atai’s way is the right one and in the long term will bring the best yield for patients and investors. 8) Digital & Data While for many investors digital therapeutics seem to be a mere adjunct to atai’s drug development candidates, atai has a bold vision of owning the entire mental health journey. Access, scalability, remote support, and the tracking of (digital) biomarkers to optimize treatment response – these are just a few of the areas atai’s innovative enabling technologies seek to serve. The overarching vision, in my opinion, is that atai will first and foremost help people in their efforts to stay mentally healthy, while developing a broad set of therapeutics directed to helping bring relief and healing to those who suffer from a mental health issue. 9) A diversified pipeline – which can be better communicated While I personally regard psychedelics as a very important and promising tool in fighting the mental health crisis, there are very interesting NON-psychedelic compounds as well. atai has two such non-psychedelic drug development programs: RL-007 (Pro-Cognitive Neuromodulator for Cognitive Impairment Associated with Schizophrenia (CIAS)) RL-007 is an orally available compound that modulates cholinergic, glutamatergic and GABA-B receptors, thereby putatively altering the excitatory/inhibitory balance in the brain to produce pro-cognitive effects. It has previously been evaluated in 10 clinical studies with over 500 unique participants dosed to-date and in which it was well tolerated at all doses tested. Notably, in four clinical studies that assessed cognition, including one in patients with CIAS, the compound consistently demonstrated pro-cognitive effects. In atai’s previous Phase 2a proof-of-mechanism study in CIAS of RL-007, the compound showed a large effect size on Symbol Coding, a sub-component of the MCCB that correlates with the overall composite. The first patient was recently dosed in the phase 2b study of RL-007 in patients with CIAS and topline results from this study are expected in the 2nd half of 2024. GRX-917 (Deuterated Etifoxine for Anxiety Disorders) In January 2022, positive results were announced from the phase 1 single and multiple ascending dose study of GRX-917. In this study, GRX-917 was well-tolerated. Additionally, GRX-917 had an improved pharmacokinetic profile relative to etifoxine and provided pharmacodynamic evidence of GABA receptor target engagement through qEEG. GRX-917 is a deuterated version of etifoxine, a drug used for anxiety and first approved in France in 1979. Etifoxine has a rapid onset and efficacy comparable to benzodiazepines, which are currently considered standard of care. In contrast to benzodiazepines, etifoxine appears to be non-addictive, less sedating, and better tolerated. It is believed that etifoxine achieves its anxiolytic activity by increasing the endogenous production of brain neurosteroids like allopregnanolone. In January 2022, positive results were announced from the phase 1 single and multiple ascending dose study of GRX-917. In this study, GRX-917 was well-tolerated. Additionally, GRX-917 had an improved pharmacokinetic profile relative to etifoxine and provided pharmacodynamic evidence of GABA receptor target engagement through qEEG. As a next step, GRX-917 will be evaluated in a phase 2 study in patients. Looking at atai’s valuation, I have the feeling investors assign zero value to those two late-stage programs (and atai’s other 5 clinical stage assets for that matter) at the moment; however, I personally believe these 2 non-psychedelic drugs are “gems within a goldmine”. Communicating this better and effectively and taking action to crystalize the value of these non-psychedelic assets is one of my personal goals for 2023. 10) Inflation and interest rates don’t matter in the medium term One reason biotech stocks are down so much is that interest rate hikes negatively influence any DCF model, especially when cashflows are far out in the future. So, it is reasonable that very early-stage biotech companies have corrected. But atai’s pipeline is not early stage at all. COMPASS/psilocybin has entered phase 3. RL-007 is in phase 2. And several others are in phase 1. Let me put it simply: I believe in ANY interest rate environment, an approved drug for just one of the many mental health indications being targeted by atai could be worth billions. And atai has several drugs in its pipeline, for which it is seeking approval, often for several indications… 11) Setbacks make us stronger In early January atai released results for the first placebo-controlled proof-of-concept trial of R-ketamine in Treatment-Resistant Depression (TRD). While the compound did not hit statistical significance on the primary endpoint, there are encouraging trends in efficacy and placebo-like safety profile at the 60 mg dose. As you might remember: We do know that ketamine works for depression. The approval of J&J’s Spravato/S-ketamine in TRD and the existing market of ketamine clinics (using both racemic ketamine and S-ketamine) is a testament to that. However, because of the high rates of dissociation and sedation, you need to take racemic ketamine and S-ketamine in a clinic. atai intended to test a very specific hypothesis with R-ketamine in this trial: Can one achieve sufficiently large anti-depressant effects similar to ketamine and S-ketamine, while not producing the sedation and dissociation seen with the latter? If so, this profile could potentially allow PCN-101 to be dosed at home without medical supervision. While this first placebo-controlled proof-of-concept trial of R-ketamine in patients was negative and it is disappointing that the drug is not a ‘home run’, it is not the end of the world imho - just to put things into perspective: J&J had two negative Phase 3 trials with S-ketamine. I see a way forward for this interesting drug, and I look forward to atai’s announcements on next steps. 12) Quality of the management I sometimes hear that the atai leadership team is not your traditional biotech executive team. I agree. And I see that as a strength. In fact, I believe that atai does have one of the best ‘traditional’ teams in CNS drug development, on the C-level represented by my co-founder and CSO Srinivas Rao (formerly at Axial Therapeutics, Depomed, Retrophin, Kyalin Biosciences, and more), atai’s CMO Rolando Gutiérrez-Esteinou (formerly at Takeda, Novartis, Bristol-Myers Squibb, Covance, and others), and atai’s CBO Sahil Kirpekar (formerly at Otsuka Pharmaceutical Co, Double Helix Consulting, Inderm, the WHO, and others). But psychedelics in part require novel and entrepreneurial thinking. This is added by my co-founder Florian Brand, who has a strong tech background, atai’s CFO Stephen Bardin (formerly BridgeBio), and myself. And most importantly: There’s the entire atai team of 90 people – 90 individual talents with a strong background in drug development and commercialization. Collectively, this team has led more than 140 investigational new drug applications and 40 new drug applications through to regulatory approval. atai's team has been relentlessly building the company with passion, dedication, a driving sense of urgency and especially with lots of entrepreneurial thinking since 2018. 13) Strong cash position coupled with entrepreneurship According to its most recent 10-K filing, atai not just has approx. USD 258 million NET cash as of year-end 2022, but additionally access to a term loan facility of up to an additional USD 160 million. Makes USD 418 million “firepower”. And I dare to say: I am absolutely certain that the excellent leadership team – including yours truly - will make good use of this firepower in 2023 and beyond. 14) I am not alone in my assessment atai is covered by 14 research analysts, 8 of whom have provided updated price targets so far following atai’s most recent earnings release. These price targets of those 7 analysts range between USD 9 and USD 21 per share. Dear fellow atai shareholders, it is imperative to me to be on this journey for the long run. As you know, I have signed a voluntary lock-up till the end of 2024. Of course, I do not intend to sell any shares even after that date. To the contrary: as you will see in the next few days, I am increasing my stake. I truly believe that atai Life Sciences is one of those rare companies where the stars are aligned: the mission, the strategy, the execution, and the macro-environment. As you can tell, I couldn’t be more excited about atai’s future and its potential to play a vital role in solving one of humanity's biggest challenges. I am grateful for the trust my fellow atai shareholders have placed in atai and me and I am confident that atai will work relentlessly to pay back this trust – most importantly in the form of drug approvals. Published by Christian Angermayer Founder bei Apeiron Investment Group Published • 5h 25 articles I am increasing my stake in atai Life Sciences. Net cash plus the value of COMPASS stake makes approx. USD 356 million or USD 2.14 per share. Shares are trading with 38% discount to that! But that's just one reason. I have 13 more. Check out my latest blog post hashtag#futurehashtag#investinghashtag#biotechnologie
Christian Angermayer @C_Angermayer I am increasing my stake in @atai_life Net cash + value of @COMPASSPathway stake makes approx. USD 356m or USD 2.14/share. Shares trading with 38% discount to that! But that's just one reason. I have 13 more. Check out my latest blog post! $ATAI$CMPS https://twitter.com/C_Angermayer/status/1641060572278972417
atai Life Sciences Announces First Subject Dosed in the Phase 1 IV-to-Subcutaneous Bridging Study of PCN-101 (R-Ketamine) April 13, 2023 06:59 ET | Source: atai Life Sciences https://www.globenewswire.com/news-...ous-Bridging-Study-of-PCN-101-R-Ketamine.html NEW YORK and BERLIN, April 13, 2023 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, announced that the first subject has been dosed in Perception Neuroscience’s Phase 1 intravenous-to-subcutaneous bridging study of PCN-101 (R-ketamine). This Phase 1 open-label study is designed to assess the safety, tolerability, and pharmacokinetic profile of 60mg, 90mg and 120mg of PCN-101 delivered subcutaneously as compared to 60mg of PCN-101 delivered intravenously (IV). The trial will enroll approximately 16 healthy volunteers across the four cohorts and is expected to be completed in the middle of 2023. In January 2023, atai announced results from the Phase 2a proof-of-concept study evaluating a single IV administration of PCN-101 in patients with treatment-resistant depression across three arms – 30mg, 60mg and placebo. While the results did not reach statistical significance on the primary endpoint, PCN-101 demonstrated an encouraging safety profile and signals of efficacy across all timepoints out to two weeks, potentially indicating a sustained duration of effect. This IV-to-subcutaneous bridging study will potentially inform dosing regimens of the new subcutaneous formulation that may optimize the therapeutic index—the balance of safety, tolerability and efficacy—of PCN-101 in future studies, thereby supporting further exploration of the potential of R-ketamine as a rapid acting anti-depressant for at-home use. atai continues to work with Perception Neuroscience to explore strategic partnership options. About Perception Neuroscience, Inc. Perception Neuroscience is a New York City- based biopharmaceutical company committed to developing therapies for neuropsychiatric diseases. Perception’s mission is to provide substantially more effective treatment solutions to serious psychiatric disorders. The company is a majority-owned subsidiary of atai Life Sciences AG. PCN-101 is a single isomer of ketamine and belongs to a new generation of glutamate receptor modulators with the potential for rapid-acting antidepressant activity and anti-suicidal effects. Pharmacologically, PCN-101 is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. Depression model studies in rodents suggest that R-ketamine could possess more durable effects than S-ketamine and a more favorable safety and tolerability profile. About atai Life Sciences atai Life Sciences is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. Founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape, atai is dedicated to acquiring, incubating, and 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 across its companies 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 Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including without limitation statements regarding the success, cost, and timing of development of PCN-101 (R-ketamine) and related studies; our business strategy and plans, including potential partnerships and other strategic arrangements; and the plans and objectives of management for future operations and capital expenditures. 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. These forward-looking statements are neither promises nor guarantees, and are subject to a number of important factors that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by the forward-looking statements, including without limitation: we are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception, and we expect to incur losses for the foreseeable future and may never be profitable; if we are unable to obtain funding when needed and on acceptable terms, we could be forced to delay, limit or discontinue our product development efforts; our limited operating history may make it difficult to evaluate the success of our business and to assess our future viability; we rely on third parties to assist in conducting our clinical trials and some aspects of our research and preclinical testing, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research, or testing; we currently rely on qualified therapists working at third-party clinical trial sites to administer certain of our product candidates in our clinical trials and we expect this to continue upon approval, if any, of our current or future product candidates, and if third-party sites fail to recruit and retain a sufficient number of therapists or effectively manage their therapists, our business, financial condition and results of operations would be materially harmed; our product candidates are in preclinical or clinical development, which is a lengthy and expensive process with uncertain outcomes, and we cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized; 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; the production and sale of our product candidates may be considered illegal or may otherwise be restricted due to the use of controlled substances, which may also have consequences for the legality of investments from foreign jurisdictions; we face significant competition in an environment of rapid technological and scientific change, and there is a possibility that our competitors may achieve regulatory approval before we do or develop therapies that are safer, more advanced or more effective than ours, which may negatively impact our ability to successfully market or commercialize any product candidates we may develop and ultimately harm our financial condition; if we are unable to obtain and maintain sufficient intellectual property protection for our existing product candidates or any other product candidates that we may identify, or if the scope of the intellectual property protection we currently have or obtain in the future is not sufficiently broad, our competitors could develop and commercialize product candidates similar or identical to ours, and our ability to successfully commercialize our existing product candidates and any other product candidates that we may pursue may be impaired; third parties may claim that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and may prevent or delay our development and commercialization efforts; our future success depends on our ability to retain key employees, directors, consultants and advisors and to attract, retain and motivate qualified personnel; as a result of covenants to our loan agreement with Hercules Capital, Inc., our operating activities may be restricted and we may be required to repay the outstanding indebtedness in the event of a breach by us, or an event of default thereunder, which could have a materially adverse effect on our business; if we fail to maintain an effective system of disclosure controls and internal control over financial reporting our ability to produce timely and accurate financial statements or comply with applicable regulations could be impaired; our business is subject to economic, political, regulatory and other risks associated with international operations; a pandemic, epidemic, or outbreak of an infectious disease, such as the COVID-19 pandemic, may materially and adversely affect our business, including our preclinical studies, clinical trials, third parties on whom we rely, our supply chain, our ability to raise capital, our ability to conduct regular business and our financial results, and other risks, uncertainties, and assumptions described under “Risk Factors” in Item 1A of Part I, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Item 7 of Part II and elsewhere in our Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission. Any forward-looking statements made herein speak only as of the date of this press release, and you should not rely on forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, performance, or achievements reflected in the forward-looking statements will be achieved or will occur. 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 Information Investor Contact: Stephen Bardin Chief Financial Officer [email protected] Media Contact: Allan Malievsky Senior Director, External Affairs [email protected]
atai Life Sciences Announces Strategic Investment in Beckley Psytech to Accelerate the Clinical Development of Short-Duration Psychedelics --- https://www.globenewswire.com/news-...velopment-of-Short-Duration-Psychedelics.html --- January 04, 2024 07:00 ET | Source: atai Life Sciences Strategic investment in Beckley Psytech reinforces atai’s position as the biopharmaceutical company with the largest and most diverse portfolio of clinical-stage psychedelic candidates Two 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 Information atai 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 Psytech Beckley 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 Sciences atai 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.
atai Life Sciences: all major psychedelics – and more - in just one company Christian Angermayer Founder bei Apeiron Investment Group 28 articles January 10, 2024 https://www.linkedin.com/pulse/atai-life-sciences-all-major-psychedelics-more-just-angermayer-urpif/ Almost a year ago, in March 2023, I published ablog postabout why I, as its founder and largest shareholder, had increased my stake in atai Life Sciences. IMHO, everything I said then still stands the test of time. I would encourage you to revisit that post if you can find the time. 2024 has kicked off with some very exciting news, so I thought it’s time for an update. The past year: atai was hit hard by the “biotech winter” Since its IPO in June 2021 and through the “biotech winter”, atai's stock has been in a continuous downward trend. In my opinion, the main reason for this is that the last 18 months have been the worst biotech has seen in more than 20 years. Rising interest rates have warranted lower biotech valuations, and with the entire sector coming from a generational high, the severe drop in valuations across biotech stocks created carnage and distortion. The market went from one extreme – very high valuations in early 2021 – to the other, with absurdly low valuations today. In times of uncertainty and stress like these, investors adopt a ‘risk-off’ mentality and don’t seek exposure to pioneering, innovative companies that are pursuing novel approaches and pushing the envelope. In a risk-averse environment, investors tend to stick with traditional treatment paradigms, which is why atai (Nasdaq: ATAI), in my opinion, whose drug portfolio requires a novel view on how to treat mental health issues, has suffered one of the hardest hits. However, I believe the biotech industry as a whole will come back with force in 2024, which should also make investors revisit atai’s groundbreaking and innovative approach to addressing the treatment of mental health conditions. For me, atai is the biggest entrepreneurial opportunity I have ever encountered. I believe that this company has an incredibly bright future and is well-positioned to make a meaningful difference in addressing one of humanity’s major challenges – the escalating global mental health crisis. Needless to say, I have never sold any stock, but have continuously (and proudly) increased my stake in atai. Please read more about my macro views on the mental health crisis here: The geopolitical dimension Why the total addressable market is in fact 100% of the world population How to stay mentally healthy in a challenging world I am very optimistic that 2024 and the years that follow will be great for atai. Since the beginning of the year a re-rating of the stock has started, which I believe is just the beginning of a long-term change in sentiment to the better. Here’s why: 1. Numbers first: atai is still trading close to cash + CMPS value According to itsmost recent 10-Q filing, as of 30 September 2023, atai had approximately USD 194 million NET cash. Additionally, per itsmost recent 10-Katai owns roughly 9.565m shares ofCompass Pathways(Nasdaq: CMPS), which as of closing on Friday, 5 January 2024 (at closing price of USD 8.94) had a market value of roughly USD 85.5m. Hence, cash + CMPS stake alone makes USD 279.5m. atai’s market cap as of closing on Monday, 8 January 2024, was approximately USD 335 million. So, in other words, right now,investing in atai means investing in a company trading close to cash + CMPSand with a strong pipeline of eight (!) clinical stage (!) mental health programs, and which has runway into 2026 (as per its most recent public filings). 2. Novelty is an advantage, not a burden The psychedelic treatment paradigm is indeed novel. It is not ‘pop a pill a day’ to put a band-aid over one’s struggles. It is ‘therapy combined with a psychedelic’ that aims to get to the root cause of a person’s trauma and help people truly get better. Because of this difference in approach, I know that many investors have doubts about the rapid commercial success of psychedelic treatments once they are potentially approved. They cannot yet see the transformative potential psychedelic-assisted therapy offers for patients. I believe that if you offer outstanding value and outcomes, you will be paid accordingly. My own early discussions with insurance companies confirm my general view on the topic of reimbursement. And then there is the ‘virality’ of psychedelic therapy: I personally know many people who have found significant healing in psychedelics – and almost all have since become advocates. Some have shared their stories only in their own private circles, while others have done so very publicly. I personally believe that, once approved, the market penetration will likely significantly outpace estimates, driven by exceptional patient outcomes and a passionate patient advocacy movement. 3. For patient access: the shorter, the better When it comes to mental health, there is no ‘one size fits all’ solution. A suite of psychedelic-based treatment options will be needed to address the varieties of patient populations even within indications, such as depression. atai wants to provide that full toolbox to therapists, so that they can decide which psychedelics might fit best the needs of the respective patient. I believe that short-duration psychedelics – those that elicit psychedelic experiences of around or under two hours – will be especially important in driving access and scale. This is why I am excited by atai’s decision to expand its focus early-on. atai started with DMT as early as 2019 and has now enlarged its portfolio to other shorter-duration psychedelics like 5-MeO-DMT and psilocin (more below). Data to date suggests that short-duration psychedelics could offer clinical benefits comparable to longer-duration psychedelic compounds, but with shorter treatment times and reduced medical resource requirements. Additionally, I support atai’s belief that the two-hour interventional treatment window that has already been established by J&J’s SPRAVATO® (esketamine) could potentially be leveraged for the commercial roll-out of short-duration psychedelics - if approved - in the future. 4. Strategic investment into Beckley Psytech In this context, I am very excited to tell you more about atai’s recently announcedstrategic investment in Beckley Psytech, a private biopharmaceutical company focused on transforming short-duration psychedelics into clinical treatments. atai acquired 35.5% of Beckley Psytech through a total investment of USD 50 million. In addition, atai received a 1:1 warrant coverage with a 30% premium on the primary issuances and has the right to appoint and hold three of nine seats on Beckley Psytech’s Board of Directors. If atai were to exercise its warrants, it would come close to owning 50% of Beckley Psytech. Importantly, atai will hold a time-limited right of first refusal on any 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, highlighting the potential for an even closer collaboration of these two firms in the future. 5. atai’s portfolio now encompasses all ‘Big Five’ psychedelics Since its founding in 2018, atai has always had the ambition to be ‘THE’ psychedelics company -the psychedelic mothership, so to speak. With the acquisition of the stake in Beckley, atai continues to cement and strengthen its position as theleading company focused on the renaissance of psychedelics globally, with a portfolio that I believe encompasses all major psychedelics with therapeutic use cases – what I call the Big Five, so to say: Psilocybin (& psilocin) DMT (the active compound in Ayahuasca) 5-MeO-DMT (the "God Molecule") MDMA Ibogaine The Big Five of psychedelics While I take great pride in atai being one of the first companies to bring psychedelics back to the medical world in this century, we are indeed standing on the shoulders of giants who have been advocating for their therapeutic use since the 1960s. Beckley’s founder, Lady Amanda Feilding, is one of these giants. Joining forces with Amanda, her family and her team makes me especially proud for atai. 6. Beckley adds two best-in-class drug candidates The stake in Beckley brings BPL-003 (intranasal 5-MeO-DMT) and ELE-101 (intravenous psilocin) onto atai’s mental health innovation platform. BPL-003 and ELE-101 are on-track for multiple anticipated clinical readouts within the next 12 months, including a Phase 2b readout of BPL-003 in treatment resistant depression (TRD), anticipated in the second half of 2024. BPL-003is a patent-protected, intranasal, dry powder formulation of 5-MeO-DMT. Three trials are currently ongoing with BPL-003, with a Phase 2b trial actively recruiting in the US under an IND that was accepted by the FDA in February of last year. Compared to other ways of administering 5-MeO-DMT, we believe the Beckley version is far superior. Compared to other ways of administering 5-MeO-DMT, we believe the Beckley version is far superior. ELE-101is a patent-protected, intravenous formulation of psilocin, which is the active moiety in the body when psilocybin is administered orally. As such, we view ELE-101 as a relatively de-risked asset for its stage of development, as it leverages the robust proof-of-concept data that has been established with psilocybin across multiple trials. It is currently being developed for the treatment of Major Depressive Disorder (MDD) and has the potential to offer the therapeutic benefits of psilocybin in a more consistent, controllable, and shorter (!) treatment paradigm of less than two hours. Initial results from the current ELE-01 Phase 1/2a study are anticipated in the first half of 2024. 7. Strong news flow pipeline As I said earlier, I am very excited for 2024. Firstly, because I firmly believe the biotech market will come back with force and gusto. But more importantly, I’m excited because atai anticipates plenty of inflection points. Anticipated inflection points Make sure you follow me here on LinkedIn orX/Twitterto stay updated. 8. R-MDMA is the new rising star in atai’s portfolio In addition to the acquisition of the stake in Beckley, atai reported very good news for R-MDMA last week. Fully in line with one of my life’s missions to ‘spread the love’, atai has been working on a new, improved version of MDMA over the past couple of years. As you might know, MDMA has shown strong therapeutic potential, especially in post-traumatic stress disorder (PTSD), and approval by the FDA of MAPS’ MDMA product is expected in 2024. Last week,atai reported positive results from its Phase 1 studyevaluating orally administered EMP-01, the R-enantiomer of MDMA. As stated in its most recent 10-K, atai has a range of patents pending on this moiety, as well as on derivatives and prodrugs of (R-)MDMA. The goals of this Phase 1 study were to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EMP-01. EMP-01 was well-tolerated, and treatment-related adverse events (AEs) were all expected and generally dose dependent. There were no study discontinuations, and no serious or severe adverse effects were observed in the study. Even better, EMP-01 administration resulted in a differentiated subjective experience compared to racemic MDMA on standard psychedelic experience questionnaires. Furthermore, dose dependent changes on measures of emotional breakthrough, a phenomenon thought to be a key mediator of the long-term psychological changes associated with psychedelics, were noted in this healthy volunteer population. Building upon the decades of research into MDMA as a potential treatment for mental health disorders, including two positive Phase 3 studies in PTSD, I believe the unique characteristics of EMP-01 are very encouraging and look forward to exploring the implications for further clinical development. 9. A rich pipeline of novel psychedelics I see the world of clinical psychedelics in three stages: First movers:These are psilocybin (Compass) and MDMA (MAPS/Lykos Therapeutics). atai is delighted to support their trailblazing efforts by being the largest single shareholder of Compass and as a donor to MAPS. They are doing the hard work, truly paving the way. Short-duration:The 2nd generation will be imo shorter-duration psychedelic products that combine known short-acting psychedelic moieties - DMT, 5-MEO-DMT, and Psilocin—with proprietary formulation technologies that result in psychedelic experiences with rapid onset, a duration of 30-45 minutes, and resolution within 90 minutes. Third generation:And then you have the 3rd generation, which are completely novel compounds, optimizing to reduce side effects, treatment effects and practical matters like duration. atai’s R-MDMA program is the perfect example, and atai has a very rich pipeline of more of these 3rd generation psychedelics coming up via its discovery engines. Ibogaine stands out and is separate, being a very long duration psychedelic of more than 24 hours, requiring a clinical stay of 2-3 days. But in return, Ibogaine has the potential to be ‘disease modifying’ in substance-use-disorders, even in the most severe forms of this condition like opioid addiction for which existing therapies leave much to be desired. 10. And yes, there’s more… While I personally regard psychedelics as the most important and promising tool in fighting the mental health crisis, there are also very interesting non-psychedelic compounds that can play a role in supporting mental health. In its most recent public flings, atai has two such non-psychedelic drug development programs: RL-007:a Pro-Cognitive Neuromodulator for Cognitive Impairment Associated with Schizophrenia (in Phase 2b), and, GRX-917:Deuterated Etifoxine for Anxiety Disorders (ready for Phase 2). You can find more info about those two programs in my2023 blog postand on atai's website. I personally believe these two non-psychedelic drugs are ‘gems within a goldmine’. 11. Being an atai shareholder makes the world a better and happier place Over the years, many philanthropists have decided to support scientific research via non-profits. While I am a huge believer in the immense value of scientific research, when it comes to psychedelics, I believe that thanks to decades of this scientific work there is now a robust evidence base to show that they work in treating mental health disorders. Now it’s all about bringing those treatments to the patients! In order to do this, we need clinical trials such as those that atai, Beckley, and Compass Pathways are running. The funding needed to bring psychedelics through the full FDA approval process is too big for non-profit work. A clear testament of this is the transformation of MAPS, the mother of all psychedelic non-profits, to a for-profit model under its new name, Lykos Therapeutics. This is the model needed to bring potentially transformative new treatments to patients successfully, safely, and quickly. I am an investor in atai not just because of my conviction that it will pay off financially, but because I believe in making the world a happier and better place. The future is bright and happy I hope you can feel my excitement about the potential of atai. And I am not alone. atai's stock is covered by nine research analysts.The price targets of those analysts’ range between USD 6 and USD 21 per share. I want to thank all fellow shareholders who have gone through the ups and downs of the atai share price together with me. As an investor, I am very confident in the potential of atai and am convinced that me and my fellow investors will be rewarded – with performance, and with knowing that we will have made a transformational difference for people suffering from mental health issues.
Eight mental health biotech companies trying to make a difference to people’s lives https://www.labiotech.eu/best-biotech/mental-health-companies/ ATAI listed as number 2
All major psychedelics – and more - in just one company https://christianangermayer.substack.com/p/atai-life-sciences Christian Angermayer Feb 27, 2024 I originally published this blog post on January 10th on Linkedin. Today, the XBI Biotech Index (a stock market index that tracks the performance of companies primarily involved in the biotechnology sector) crossed 100. I stand by my prediction that biotech will be one of the best performing asset classes this year. A good occasion to re-post my views on atai Life Sciences. Enjoy reading! Almost a year ago, in March 2023, I published a blog post about why I, as atai’s founder and its largest shareholder, had increased my stake in atai. Everything I said then IMHO still stands the test of time. I would encourage you to revisit that post if you can find the time. 2024 has started with some very exciting news, so I thought it’s time for an update. The past year: atai was hit hard by the “biotech winter” Since its IPO in June 2021 and through the ‘biotech winter’, atai has been in a continuous downward trend. In my opinion, the main reason is that the last 18 months have been the worst biotech has seen in more than 20 years. Rising interest rates have warranted lower biotech valuations, and with the entire sector coming from a generational high, the severe drop in valuations across biotech stocks generally created carnage and distortion. The market went from one extreme – very high valuations in early 2021 – to the other with absurdly low valuations now. In times of uncertainty and stress like these, investors adopt a ‘risk-off’ mentality and don’t seek exposure to especially innovative companies that are pursuing novel approaches and pushing the envelope. In a risk-averse environment, investors tend to stick with traditional treatment paradigms, which is why atai (Nasdaq: ATAI), in my opinion, whose drug portfolio requires a novel view on how to treat mental health issues, has suffered one of the hardest hits. However, I believe the biotech industry as a whole will come back with force in 2024, which should also make investors revisit atai’s groundbreaking and innovative approach to addressing the treatment of mental health conditions. For me personally, atai is the biggest entrepreneurial opportunity I have ever encountered. I believe that this company has an incredibly bright future and is well-positioned to make a meaningful difference in addressing one of humanity’s major challenges – the escalating global mental health crisis. Needless to say, I have never sold any stock, but have continuously (and proudly) increased my stake in atai. Please read more about my macro view on the mental health crisis here: · The geopolitical dimension · Why the total addressable market in fact is 100% of the world population · How to stay mentally healthy in a challenging world I am very optimistic that 2024 and the years to come will be great for atai. Since the beginning of the year, a re-rating of the stock has started, which I believe is just the beginning of a long-term change in sentiment to the better. Here is why: 1. Numbers first - atai is still trading close to cash + CMPS value According to its most recent 10-Q filing, as of 30 September 2023, atai had approximately USD 194 million NET cash. Additionally, per its most recent 10-K , atai owns roughly 9.565m shares of Compass Pathways (Nasdaq: CMPS), which as of closing on Friday, 5 January 2024 (at closing price of USD 8.94) had a market value of roughly USD 85.5m. Hence, cash + CMPS stake alone makes USD 279.5m. atai’s market cap as of closing on Monday, 8 January 2024, was approximately USD 335 million. So, in other words, right now, investing in atai means investing in a company trading close to cash + CMPS and with a strong pipeline of eight (!) clinical-stage (!) mental health programs, and which (per its most recent public filings), has runway into 2026. 2. Novelty is an advantage, not a burden The psychedelic treatment paradigm is indeed novel. It is not ‘pop a pill a day’ to put a band-aid over your struggles. It is ‘therapy combined with a psychedelic’ that aims to get to the root cause of a person’s trauma and help people truly get better. Because of this difference in approach, I know that many investors have doubts about the rapid commercial success of psychedelic treatments once they are potentially approved. They cannot yet see the transformative potential psychedelic-assisted therapy offers for patients. I believe that if you offer outstanding value and outcomes, you will be paid accordingly. My own early discussions with insurance companies confirm my general view on the topic of reimbursement. And then there is the ‘virality’ of psychedelic therapy: I personally know many people who have found significant healing in psychedelics – and almost all have since become advocates. Some have shared their stories only in their own private circles, while others have done so very publicly. I personally believe that, once approved, the market penetration will likely significantly outpace estimates, driven by exceptional patient outcomes and a passionate patient advocacy movement. 3. For patient access: the shorter, the better When it comes to mental health, there is no ‘one size fits all’ solution. A suite of psychedelic-based treatment options will be needed to address the varieties of patient populations even within indications, such as depression. atai wants to provide that toolbox to therapists, so that they can decide which psychedelics might fit best the needs of the respective patient. I believe that short-duration psychedelics - those that elicit psychedelic experiences of around or under two hours – will be especially important in driving access and scale. This is why I am excited by atai’s decision to expand its focus early-on. atai started with DMT already in 2019 and has now enlarged its portfolio to other shorter-duration psychedelics like 5-MeO-DMT and psilocin (more below). Data to date suggests that short-duration psychedelics could offer clinical benefits comparable to longer-duration psychedelic compounds, but with shorter treatment times and reduced medical resource requirements. Additionally, I support atai’s belief that the two-hour interventional treatment window that has already been established by J&J’s SPRAVATO (esketamine) could potentially be leveraged for the commercial roll-out of short-duration psychedelics - if approved - in the future. 4. Strategic investment into Beckley Psytech In this context, I am very excited to tell you more about atai’s recently announced strategic investment in Beckley Psytech, a private biopharmaceutical company focused on transforming short-duration psychedelics into clinical treatments. atai acquired 35.5% of Beckley Psytech through a total investment of USD 50 million. In addition, atai received a 1:1 warrant coverage with a 30% premium on the primary issuances and has the right to appoint and hold three of nine seats on Beckley Psytech’s Board of Directors. If atai were to exercise its warrants, it would come close to owning 50% of Beckley Psytech. Importantly, atai will hold a time-limited right of first refusal on any 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, highlighting the potential for an even closer collaboration of these two firms in the future. (Closing celebration dinner with the legendary Amanda Feilding and her son Cosmo, CEO of Beckley Psytech.) Since its founding in 2018, atai has always had the ambition to be ‘THE’ psychedelics company. The psychedelic mothership, so to speak. With the acquisition of the stake in Beckley, atai continues to cement and strengthen its position as the leading company focused on the renaissance of psychedelics globally, with a portfolio that I believe encompasses all major psychedelics with therapeutic use cases – what I call the Big Five, so to say: · Psilocybin (& psilocin) · DMT · 5-MeO-DMT · MDMA · Ibogaine While I take great pride in atai being one of the first companies to bring psychedelics back to the medical world in this century, we are indeed standing on the shoulders of giants who have been advocating for their therapeutic use since the 1960s. Beckley’s founder, Lady Amanda Feilding, is one of these giants. Joining forces with Amanda, her family and her team makes me especially proud for atai. 5. Beckley adds two best-in-class drug candidates The stake in Beckley brings BPL-003 (intranasal 5-MeO-DMT) and ELE-101 (intravenous psilocin) onto atai’s mental health innovation platform. BPL-003 and ELE-101 are on-track for multiple anticipated clinical readouts within the next 12 months, including a Phase 2b readout of BPL-003 in treatment resistant depression (TRD), anticipated in the second half of 2024. BPL-003 is a patent-protected, intranasal, dry powder formulation of 5-MeO-DMT. Three trials are currently ongoing with BPL-003, with a Phase 2b trial actively recruiting in the US under an IND that was accepted by the FDA in February of last year. Compared to other ways of administering 5-MeO-DMT, we believe the Beckley version is far superior. ELE-101 is a patent-protected, intravenous formulation of psilocin, which is the active moiety in the body when psilocybin is administered orally. As such, we view ELE-101 as a relatively de-risked asset for its stage of development, as it leverages the robust proof-of-concept data that has been established with psilocybin across multiple trials. It is currently being developed for the treatment of Major Depressive Disorder (MDD) and has the potential to offer the therapeutic benefits of psilocybin 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. 6. Strong news flow pipeline As I said earlier, I am very excited for 2024. Firstly, because I firmly believe the biotech market will come back with force and gusto. But more importantly, I’m excited because atai anticipates plenty of inflection points. 7. R-MDMA is the new rising star in atai’s portfolio In addition to the acquisition of the stake in Beckley, atai reported very good news for R-MDMA last week. Fully in line with one of my life’s missions to ‘spread the love’, atai has been working on a new, improved version of MDMA over the past few years. As you might know, MDMA has shown strong therapeutic potential, especially in PTSD, and approval by the FDA of MAPS’ MDMA product is expected in 2024. Last week, atai reported positive results from its Phase 1 study evaluating orally administered EMP-01, the R-enantiomer of MDMA. As stated in its most recent 10-K, atai has a range of patents pending on this moiety, as well as on derivatives and prodrugs of (R-)MDMA. The goals of this Phase 1 study were to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EMP-01. EMP-01 was well-tolerated, and treatment-related adverse events (AEs) were all expected and generally dose dependent. There were no study discontinuations, and no serious or severe adverse effects were observed in the study. Even better, EMP-01 administration resulted in a differentiated subjective experience compared to racemic MDMA on standard psychedelic experience questionnaires. Furthermore, dose dependent changes on measures of emotional breakthrough, a phenomenon thought to be a key mediator of the long-term psychological changes associated with psychedelics, were noted in this healthy volunteer population. Building upon the decades of research into MDMA as a potential treatment for mental health disorders, including two positive Phase 3 studies in PTSD, I believe the unique characteristics of EMP-01 are very encouraging and look forward to exploring the implications for further clinical development. 8. A rich pipeline of novel psychedelics I see the world of clinical psychedelics in three stages: · First movers: These are Psilocybin (Compass) and MDMA (MAPS). atai is delighted to support their trailblazing efforts by being the largest single shareholder of Compass and as a donor to MAPS. They are doing the hard work, truly paving the way. · Short-duration: The second generation will be imo shorter-duration psychedelic products that combine known short-acting psychedelic moieties - DMT, 5-MEO-DMT, and Psilocin—with proprietary formulation technologies that result in psychedelic experiences with rapid onset, a duration of 30-45 minutes, and resolution within 90 minutes. · Third-generation: And then you have the third generation, which are completely novel compounds, optimizing to reduce side effects, treatment effects and practical matters like duration. atai’s R-MDMA program is the perfect example, and atai has a very rich pipeline of more of these third generation psychedelics coming up via its discovery engines. Ibogaine stands out and is separate, being a very long duration psychedelic of more than 24 hours, requiring a clinical stay of 2-3 days. But in return, Ibogaine has the potential to be ‘disease modifying’ in substance-use-disorders, even in the most severe forms of this condition like opioid addiction for which existing therapies leave much to be desired. 9. And there’s more… While I personally regard psychedelics as the most important and promising tool in fighting the mental health crisis, there are also very interesting non-psychedelic compounds that can play a role in supporting mental health. In its most recent public flings, atai has two such non-psychedelic drug development programs: RL-007, a Pro-Cognitive Neuromodulator for Cognitive Impairment Associated with Schizophrenia (in phase 2b) and GRX-917, Deuterated Etifoxine for Anxiety Disorders (ready for phase 2). You can find more info about those 2 programs in my 2023 blog post and on the atai website. I personally believe these two non-psychedelic drugs are ‘gems within a goldmine’. 10. Being an atai shareholder makes the world a better and happier place Over the years, many philanthropists have decided to support scientific research via non-profits. While I am a huge believer in the immense value of scientific research, when it comes to psychedelics, I believe thanks to decades of this scientific work there is now a robust evidence base to show that they work in treating mental health disorders. Now it is all about bringing those treatments to the patients! For this, we need clinical trials such as those that atai, Beckley, and Compass Pathways are running. The funding needed to bring psychedelics through the full FDA approval process is too big for non-profit work. A clear testament of this is the transformation of MAPS, the mother of all psychedelic non-profits, to a for-profit model under its new name, Lykos Therapeutics. This is the model needed to bring potentially transformative new treatments to patients successfully, safely, and quickly. I am an investor in atai not just because of my conviction that it will pay off financially in a massive way, but because I believe in making the world a happier and better place. The future is bright I hope you can feel my excitement about the potential of atai. And I am not alone. atai is covered by 9 research analysts. The price targets of those analysts’ range between USD 6 and USD 21 per share. I want to thank all fellow shareholders who have gone through the ups and downs of the atai share price together with me. As an investor, I am very confident in the potential of atai and am convinced that me and my fellow investors will be rewarded – with performance, and with knowing that we will have made a transformational difference for people suffering from mental health issues.
Primed to go sky high. This along with MNMD will be big players in this market. Also, while not related but will be a catalyst is the fact they are going to deschedule Cannabis. This is huge for this sector because of optics.
atai Life Sciences Announces Update on Beckley Psytech’s Phase 1/2a Trial of ELE-101 (IV Psilocin) for Major Depressive Disorder, with Initial Results from Phase 1 and First Patients Dosed in Phase 2a Thu, Jun 20, 2024, 7:00 AM EDT6 min read https://finance.yahoo.com/news/atai-life-sciences-announces-beckley-110000192.html atai Life Sciencesatai Life Sciences ELE-101 is a patent-protected, synthetic formulation of psilocin, designed to offer the therapeutic benefits of psilocybin in a more consistent, controllable, and shorter treatment paradigm of approximately two hours. The Phase 2a part of the study will evaluate the safety, tolerability, subjective effects, and efficacy of a single intravenous (IV) dose of ELE-101 in 6-12 participants with Major Depressive Disorder (MDD). Results are expected in H2 2024. The dose for Phase 2a was selected using preliminary pharmacokinetic (PK) and pharmacodynamic (PD) data from the Phase 1 randomized, double-blind, placebo-controlled, single ascending dose part of the study of ELE-101 in healthy participants, which showed that it was well-tolerated with no serious adverse events. ELE-101 showed a dose-proportional PK profile and a reliable induction of short-duration psychedelic experiences. NEW YORK and BERLIN, June 20, 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 an update on Beckley Psytech’s Phase 1/2a trial of ELE-101 (NCT05434156) for people living with MDD, with initial results from Phase 1 and the dosing of the first patients in the Phase 2a part of the study. ELE-101, a patent-protected IV formulation of psilocin, has been designed to provide consistent and controllable drug delivery in patients with neuropsychiatric conditions. As the active metabolite of psilocybin, psilocin has the potential to offer a rapid onset, significantly shorter treatment duration, and reduced inter-subject variability compared to oral formulations of psilocybin. This could enhance convenience and therapeutic outcomes for patients with depression while reducing the resource burden on healthcare systems. The open-label Phase 2a part of the study will evaluate the safety, tolerability, subjective effects, and efficacy of a single IV dose of ELE-101 in 6-12 patients diagnosed with MDD. Patients will be assessed at various time points in the study for up to three months after dosing, with results expected in H2 2024. The dose was selected using preliminary PK/PD data from the Phase 1 part of the study, a randomized, double-blind, placebo-controlled, single ascending dose study of ELE-101 in healthy participants. Initial data from Phase 1 supports the differentiated profile of ELE-101, showing that ELE-101: Was well-tolerated with no serious or severe adverse events (AE) reported, and an AE profile which is consistent with other compounds in this class. Demonstrated a dose-proportional PK profile, leading to reduced inter-subject variability compared to oral psilocybin. Induced high-intensity, short-duration psychedelic experiences, suggesting a potential treatment time of approximately two hours in the clinic. If validated in further studies, these findings could support the development of a scalable treatment model similar to the established paradigm of Spravato®, an esketamine nasal spray for treatment-resistant depression. Full data from the Phase 1 study is expected to be published at a later date. Commenting on the news, Dr Srinivas Rao, Co-CEO of atai said: “The data so far on ELE-101 indicates its potential as a promising candidate for treating depression. The consistent dose delivery and dose-proportional pharmacokinetic profile are particularly encouraging, as this could reduce variability among patients. At atai we are building a pipeline of short-duration psychedelics that target in-clinic treatments of approximately two hours. In addition to ELE-101, we believe Beckley Psytech’s lead candidate, BPL-003 (an intranasal 5-MeO-DMT), and our VLS-01 (an oral transmucosal formulation of DMT) could also fit this model.” About atai Life Sciences atai 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. About Beckley Psytech Beckley Psytech is a private clinical-stage biopharmaceutical company focused on improving the lives of people with neuropsychiatric disorders through the development of rapid-acting, short-duration psychedelic medicines. In January 2024, atai made a strategic investment in Beckley Psytech, resulting in a 35.5% ownership stake and 1:1 warrant coverage at a 30% premium on the primary issuances. atai holds a time-limited right of first refusal on a future sale of the company and an indefinite right of first negotiation for BPL-003 and ELE-101. atai and Beckley Psytech also agreed to collaborate on digital therapeutics, commercial and market access activities in preparation for future potential commercialization.
Christian Angermayer • Following • Following Founder bei Apeiron Investment GroupFounder bei Apeiron Investment Group 1d • 1 day ago https://www.linkedin.com/feed/update/urn:li:activity:7260721702991446017/ One thing which seems to be a given under President Trump: hashtag#Biotech will profit. Reasons are: · a general deregulation strategy the new administration will implement, · geopolitical tensions should calm down, and · interest rates will fall further. This should all lead to a renaissance of (small cap) biotech stocks. You all know my conviction both in psychedelics as promising compounds for various mental health issues, and especially in atai Life Sciences. With all "Big 5" on its platform – Psilocybin/Psilocin, DMT, 5-MeO-DMT, R-MDMA and Ibogaine – atai is imo the undisputed leader in the field and offers tremendous upside potential. So far, 2024 has not been kind to psychedelics stocks. There are many reasons, most of them ‘unjustified’ imho: · In times of uncertainty and stress, investors adopt a ‘risk-off’ mentality and don’t seek exposure to especially innovative companies that are pursuing novel approaches and pushing the envelope. · The psychedelic treatment paradigm is indeed novel. It is not ‘pop a pill a day’ to put a band-aid over your struggles. But it aims to get to the root cause of a person’s trauma and help people truly get better. · Because of this difference in approach, I know that many investors have particular doubts about the rapid commercial success of psychedelic treatments once they are potentially approved. They cannot yet see the transformative potential psychedelic-assisted therapy offers for patients. I believe that if you offer outstanding value and outcomes, you will be paid accordingly. My own early discussions with insurance companies confirm my general view on the topic of reimbursement. · Lykos failed. Big time. The FDA rejected their application for MDMA as treatment for PTSD. Many investors interpreted this is a general hesitation of the FDA towards psychedelics. However, MDMA (which is not even itself a psychedelic in the core definition) was NOT rejected per se, but the specific, poor data set provided by Lykos Therapeutics was. I believe that MDMA is in fact a promising drug with tremendous therapeutic potential for patients with severe mental health issues. And atai has a novel, patent protected version going into Phase 2. Hence, if it all, then the Lykos failure has proven the atai model of professional, for-profit medical drug development, based on strong patent positions. All those hesitations and doubts should vanish in a generally more positive market, especially since the Trump campaign has been outspokenly positive about psychedelics. Hence, please check out my blog post from earlier this year for all reasons why I believe atai deserves a closer look: https://lnkd.in/gws78cV9 The time for hashtag#psychedelics is NOW. I am absolutely certain of this.
