ATAI - atai Life Sciences

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  1. Twiggs462

    Twiggs462 Member

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    Subject: atai: I have increased my stake from 19.9% to 22.3% by investing 22.75m USD

    Dear Friends!

    I am very happy to announce that within the recently completed capital raise of atai Life Sciences (Nasdaq: ATAI) of a total of USD 63.25 million (in gross proceeds, including full exercise of the “greenshoe”, less costs), my family office, Apeiron Investment Group (www.apeiron-investments.com), has invested USD 22.75 million, which equals approximately 36% of the total offering.

    With this step, as reported in Form 13-D (https://ir.atai.life/node/8796/html), Apeiron has increased its stake in atai from 33,885,999 shares to 44,721,717 shares, increasing Apeiron’s ownership stake from 19.9% to 22.3%.



    Here is the news about completion of the offering: https://ir.atai.life/news-releases/...es-announces-closing-public-offering-and-full



    I personally believe that psychedelic medicines will be a game-changer for mental health issues, and that the next two years will be decisive for the industry, and especially for atai as a (if not, the) leader in the space.



    The most comprehensive overview is still my blog post from last year: https://christianangermayer.substack.com/p/atai-life-sciences



    Here are some reasons why I chose to increase my stake now – as always, publicly available information only, and this represents my personal view as founder and largest shareholder of atai:



    1. As reported by atai, the capital increase extends runway into 2027



    2. J&J’s Spravato (Esketamine) – which takes approximately two hours to apply – has become a blockbuster drug according to figures released by J&J.

    1. Esketamine IMHO is like a “semi-psychedelic” in that it is weaker but gives us a preview of the potential power of “real” psychedelics.

    2. While it had a slow start, Spravato sales are really picking up now, which is all the more impressive when you consider that only ~ 55k patients are treated with Spravato per year so far. I personally believe that in a few years this will be hundreds of thousands, potentially millions of patients.

    3. As outlined in my previous blog posts, I deeply believe that once approved, psychedelic therapies will soon outperform the conservative analysts’ expectations. IMHO, they are not “last resort treatments”, but treatments with a very broad use case, potentially following the “Ozempic playbook”.

    4. See my views on the broader topic of “Human Enhancement” here: https://christianangermayer.substack.com/p/the-future-is-enhanced



    3. The two-hour treatment window established by Spravato is the most interesting one to me commercially because:

    1. The shorter, the better in terms of clinician and patient burden and ultimate commercial viability, and

    2. There is an existing delivery infrastructure now, thanks to Spravato.

    3. Two of atai’s compounds – DMT and 5-Meo-DMT – are designed to fall into this window.



    4. atai has four Phase 2 catalysts/top line read-outs before the end of Q1/2026, two of which are designed to fit into the “Spravato two-hour window”, namely:

    1. Phase 2b for 5-MeO-DMT (indication: treatment resistant depression/TRD), anticipated mid this year (via atai’s 35% stake in Beckley Psytech)

    2. Phase 2b for RL-007 (cognitive impairment associated with schizophrenia/CIAS), anticipated mid this year (via atai’s 51.9% stake in Recognify Life Sciences)

    3. Phase 2 for DMT (TRD), anticipated in Q1 2026 (fully owned program)

    4. Phase 2a for R-MDMA (social anxiety disorder/SAD), anticipated in Q1 2026 (fully owned program)



    5. The failure of Lykos/MAPS has proven to me that the for-profit, medical model is the right one. As racemic MDMA is IMHO most likely off the table for good, atai’s R-MDMA is emerging as the public front runner.



    6. I personally expect that there will be consolidation - and I believe atai will be the driver (e.g., atai’s publicly-disclosed ability to exercise warrants it holds in Beckley at a fixed valuation to just below 50%).



    7. Patents and medical viability matter. The universe of “real” psychedelics companies is much smaller than many investors realize, as I still see companies out there doing “studies” and pretending they’re heading towards approval without having a solid patent position and/or a reasonably short = medical viable treatment window.



    8. The new US administration is outspokenly psychedelic-friendly.



    I also believe atai has been too quiet about its successes and strategic positioning, something that I believe needs to change. Stay tuned.



    All the best,

    Christian
     
  2. Twiggs462

    Twiggs462 Member

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    atai Life Sciences and Beckley Psytech to Combine Creating a Global Leader in Psychedelic Mental Health Therapies
    June 2, 2025

    atai Life Sciences and Beckley Psytech to Combine Creating a Global Leader in Psychedelic Mental Health Therapies | Atai Life Sciences N.V.

    • Strategic combination establishes a market-leading mental health company with a pipeline that includes potentially transformative, rapid-acting psychedelic assets differentiated by their convenient route of administration and short time-in-clinic
    • Combined company will operate under the name atai Beckley with a joint leadership team and Board that leverage the deep psychedelic, drug development and CNS expertise within both organizations
    • Topline data from the Phase 2b study of BPL-003 in patients with treatment-resistant depression (TRD) is expected in mid-2025 - the largest controlled trial of mebufotenin (5-MeO-DMT) and the first and only controlled trial to investigate mebufotenin in the U.S.
    • The all-share transaction is expected to close in the second half of 2025
    • Concurrent $30.0M private placement by Ferring Ventures S.A. and Adage Capital Partners LP
    • Conference call scheduled for 8:00am EDT today
    NEW YORK and BERLIN and OXFORD, United Kingdom, June 02, 2025 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company on a mission to develop highly effective mental health treatments to transform patient outcomes, and Beckley Psytech Limited (“Beckley”), a private clinical-stage biopharmaceutical company pioneering the next generation of mental health treatments, today announced a definitive agreement under which atai and Beckley plan to combine in an all-share transaction subject to pre-agreed BPL-003 (mebufotenin benzoate) Phase 2b success criteria.

    “The strategic combination marks a transformational moment, solidifying us as a leader in rapid-acting and accessible psychedelic treatments for mental health conditions with a pipeline of potential first-in-class and best-in-class assets,” stated Srinivas Rao, M.D., Ph.D., Chief Executive Officer and Co-Founder of atai. “With a unified vision and a synergistic pipeline, we believe we are well-positioned to unlock the strategic value of our clinical development programs for both patients and shareholders. Together, we plan to move confidently towards our goal of bringing innovative interventional psychiatry therapies to patients in need of new treatments.”

    Cosmo Feilding Mellen, Chief Executive Officer and Co-Founder of Beckley added, “This combination brings together two highly complementary pipelines to create a market leader at the forefront of psychiatric care. Clinical data has shown the rapid and durable effects of our compounds, as well as their potential to fit within the existing treatment paradigm established by SPRAVATO®. We believe that the unified business will be even better positioned to accelerate development, drive long-term value for shareholders, and - most importantly - deliver meaningful innovation for patients.”

    “This transaction marks a pivotal milestone in delivering on the strategic vision we set forth from the start of atai in 2018: to be the leader in the psychedelic space,” added Christian Angermayer, Co-Founder and Chairman of atai. “I am also very pleased to announce the concurrent financing with existing investors from both companies. The continued support from Ferring Ventures, a valued investor in atai, and Adage Capital, a longstanding investor in Beckley, further validates the strength and potential of this combination.”

    Transaction Benefits

    • Market-Leading Pipeline: atai Beckley will boast a synergistic fully owned pipeline that includes proprietary, rapid-acting psychedelic compounds differentiated by their convenient route of administration and short time-in-clinic.

    • Near-Term Clinical Milestones: Topline data from the eight-week, randomized core stage of Beckley’s BPL-003 Phase 2b trial in treatment-resistant depression (NCT05870540) is expected in mid-2025, representing a potentially significant value inflection point. The study builds on previously reported open-label results which demonstrated that a single dose of BPL-003, when given as a monotherapy or alongside SSRIs, was well-tolerated and could produce a rapid and lasting antidepressant effect for up to three months.

    • Financial Synergies and Strong IP Portfolio: Cash runway through multiple Phase 2 clinical catalysts, near and long-term operational synergies, as well as a strong IP portfolio with granted U.S. patents out to 2043.

    • Unified Vision and Team: The new entity is expected to leverage the expertise, teams, and networks of both organizations to accelerate the development and commercialization of transformative mental health treatments.
    Transaction Terms
    atai made a strategic investment in Beckley in January 2024. Under the terms of the deal, Beckley’s shareholders (other than atai) will be issued approximately 105 million new shares as consideration for the remaining shares of Beckley not presently held by atai. These newly issued shares equate to approximately 31% of the combined company on a fully diluted basis, based on the treasury stock method, upon closing of the transaction and the concurrent private placement, and value Beckley at approximately $390 million.

    These newly issued atai shares are subject to a lock-up wherein, following the completion of the lock-up period, 1/12 of the shares are released every month. Additionally, Apeiron Investment Group, the family office of Mr. Angermayer, voluntarily entered into a similar lock-up agreement covering all of its shares in atai.

    Beckley also intends to distribute Eleusis Holdings Limited and its subsidiaries, which hold assets and funding related to its second clinical-stage asset, ELE-101, out of Beckley prior to closing of the transaction.

    Timing and Approvals
    atai’s Supervisory Board and Management Board and Beckley’s Board of Directors have approved the transaction.

    The transaction is expected to close in the second half of 2025, subject to approval of the share issuance by the shareholders of atai and satisfaction of other customary closing conditions.

    Concurrent Financing
    Concurrent with the transaction, atai also executed a $30.0 million private placement with Ferring Ventures S.A. and Adage Capital Partners LP. This financing is not contingent on closing of the transaction. The private placement is expected to close on June 3, 2025, subject to customary closing conditions.

    The securities being issued and sold in the private placement have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state’s securities laws, and will be issued and sold in a private placement in reliance on Section 4(a)(2) of the Securities Act. The securities may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. atai granted registration rights to the purchasers in the private placement, and has agreed to file a registration statement with the Securities and Exchange Commission (the “SEC”) registering the resale of the common shares issued in the private placement and the shares of common stock issuable upon exercise of the pre-funded warrants issued in the private placement.

    This press release does not constitute an offer to sell or a solicitation of an offer to buy any securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    Conference Call
    atai and Beckley will host a conference call and live webcast today Monday, June 2, 2025 at 8:00 a.m. EDT. The conference call can be accessed by dialing 1-800-715-9871 for participants in the U.S. and 1-646-307-1963 for international callers, with the Conference ID: 1459387. The webcast can be accessed on the Investors section of atai’s corporate website under 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.

    Advisors
    Guggenheim Securities is serving as financial advisor to atai and Latham & Watkins LLP is serving as its legal counsel. Cantor is serving as financial advisor to Beckley, and CMS and Mayer Brown are serving as its legal counsel.

    Guggenheim Securities is acting as the lead placement agent for the private placement. Berenberg is acting as joint-lead placement agent for the private placement.

    About atai Life Sciences
    atai is a clinical-stage biopharmaceutical company on a mission to develop highly effective mental health treatments to transform patient outcomes. atai’s pipeline of psychedelic-based therapies includes VLS-01 (buccal film DMT) for treatment-resistant depression (TRD) and EMP-01 (oral R-MDMA) for social anxiety disorder, which are in Phase 2 clinical development. They are also advancing a drug discovery program to identify novel, non-hallucinogenic 5-HT2AR agonists for TRD. These programs aim to address the complex nature of mental health providing commercially scalable interventional psychiatry therapies that can integrate seamlessly into healthcare systems. For the latest updates and to learn more about atai’s mission, visit www.atai.com or follow the Company on LinkedIn and on X.

    About Beckley Psytech
    Beckley Psytech Ltd is a private biopharmaceutical company dedicated to improving the lives of people living with neuropsychiatric disorders by developing 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. For more information about Beckley Psytech, visit www.beckleypsytech.com or follow the Company on LinkedIn.

    About BPL-003
    BPL-003 is Beckley Psytech’s patent-protected, proprietary intranasal formulation of mebufotenin benzoate, administered via a nasal spray device used in a previously approved drug product. BPL-003 is designed to deliver rapid and durable effects from a single dose, with a short time in the clinic, and is being investigated as a potential therapy for treatment resistant depression (TRD) and for 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.
     
  3. Twiggs462

    Twiggs462 Member

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    1.6B valuation at minimum...

    [​IMG]
     
  4. Twiggs462

    Twiggs462 Member

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    NeuroGram+

    Taking A Break from The Festival of Fools
    It might seem a shallow and all-too-brief flight from the daily tawdry display of malevolent incompetence, but the past couple months have offered an occasional glimmer of solid work yielding the hope of better things to come. May 27 was one of those welcome moments: It was a day that saw Neurvati/GRIN announce both a healthy Series D and a European partner; Syneido came up with a new name and $90 million; Lilly acquired a pain company; and Gilgamesh reported positive PhIII results in MDD. Any one of these would have been a worthy headline for a day. To have them unveiled simultaneously was to open the cupboard to find forgotten supplies of dopamine.

    And that's not all: In recent weeks there has been a slew of licensings and acquisitions in CNS, some from Big Pharmas that tend to keep a low profile in their neuroscience Business Development: Sanofi paid $470 million upfront for Vigil Neuroscience, GSK partnered with ABL Bio, paying $49.5 million upfront. As noted above, Lilly acquired SiteOne for its now semi-validated (by Vertex) Nav1.8 analgesic; and Biogen's departure from neuroscience is less binary than we once feared, as they partnered with City Therapeutics on a CNS-relevant RNAi technology.

    The Psychedelic Space is Indeed at a Fundamental Inflection Point
    The next issue (in early July) of NeuroPerspective will include our reviews of Parkinson's, Stroke, and our annual overview of Psychedelics. The Psychedelics area is in a particularly high-beta phase of volatile potential, just eight months after our Fall 2024 issue noted that a backlash to the hype was in full force after the Lykos/MDMA debacle at the FDA.

    There are two critical datasets scheduled for release in the next month or two that will reset the industry calculus around the value of these highly anticipated treatment advances. Compass Pathways will unveil the results from the first PhIII trial of psilocybin, in Treatment-Resistant Depression: Compass has devoted vast resources to secularizing and routinizing psychedelic therapy, molding it into a semi-conventional, systematized drug development program geared to pass regulatory and investor muster. This was necessary if psychedelic therapy is ever to be something more than an ultra-boutique treatment option, even if some of the psychotherapeutic art that maximizes psychedelic efficacy had to be sacrificed along the way.

    We are optimistic that this trial will be successful: if for some reason it were to fall short, that would presage a nuclear fiscal winter for Psychedelics, but we expect the opposite—that it will fuel a surge of interest in a viable treatment option. Soon thereafter, a substantial PhIIb study of 5-MeO-DMT in depression will be unblinded by Atai and Beckley Psytech, the most rigorous test thus far of a rapid-acting psychedelic. Atai is sufficiently optimistic about this dataset that they have already announced their acquisition of the roughly two-thirds of Beckley they do not already own, even though that agreement is contingent upon a positive outcome for the PhIIb.

    Over 26% of the institutional investment in neurotherapeutics thus far in 2025 has been for Psychedelics companies; that share will expand still further if both these trials perform as we expect. As our friends at the estimable, indeed essential, information resource Psychedelic Alpha have written, “2025 is set to be a watershed year for the psychedelics field.”

    Illogical Extrapolation from the Tiny to the Enormous
    A recently published (JAMA Neurology) population-based study run by a Karolinska Institute team suggested that there could be factors in common underlying both Autism Spectrum Disorder and Parkinson's: they asserted that ASD increases the risk of PD fourfold, and speculated that PARK2 could constitute such a genetic common ground.

    This caught our attention, but not in a good way. In looking more closely at the findings we found it noteworthy—but not credible—that the prevalence of ASD in this Swedish sample was reported as just 0.02%, far below the most recent US estimate of 3%, and even minuscule compared with a recent 1% prevalence estimate for Sweden. Secondly, with all due respect for a reported p value of .05, there were just 462 individuals with early-onset PD out of the 2.3 million subjects tracked for twenty-two years, and only 24 who also carried an Autism diagnosis. Such infinitesimally small cohorts provide a curiously skimpy basis for their broad-brush conclusion that there is a “potentially shared etiology between neurodevelopmental disorders and PD.”

    2025 and a Flood of Clinical Data
    Beyond the two datasets cited above, the next seven months will see a raft of fascinating datasets in a range of treatment indications, including trials from AbbVie, Actinogen, Alto, Autobahn, BMS, Cybin, Engrail, GSK/Alector, HMNC, Lundbeck, Noema, Neuphoria, Novo Nordisk, Reunion, Taysha, Vesper Bio, Takeda/Denali, and VistaGen.

    At the very least, they will provide both information and temporary distraction from the societal and governmental tumult that seems currently unavoidable.

    6/3/25
    An Interim Note from NeuroPerspective

    Source: https://www.linkedin.com/posts/harr...p&rcm=ACoAAAJoK6EBnIwCn0E2NHL-1bXmpN-YL5WhzPk
     
  5. Twiggs462

    Twiggs462 Member

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