MomsSpaghetti
5 months ago
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.
MomsSpaghetti
7 months ago
atai Life Sciences Announces Positive Initial Results from Beckley Psytech’s Phase 2a Open Label Study of BPL-003 (Intranasal 5-MeO-DMT) in Treatment Resistant Depression
https://www.globenewswire.com/news-release/2024/03/27/2853041/0/en/atai-Life-Sciences-Announces-Positive-Initial-Results-from-Beckley-Psytech-s-Phase-2a-Open-Label-Study-of-BPL-003-Intranasal-5-MeO-DMT-in-Treatment-Resistant-Depression.html
- A single dose of BPL-003 demonstrated a rapid and durable antidepressant effect in TRD patients, with 45% of patients in clinical remission at week 12
- 55% of patients achieved a clinical response on the day after dosing and this rate of response was maintained at week 4 and week 12
- BPL-003 showed a good safety profile and was well-tolerated with no serious adverse events reported
- Acute effects resolved on average in less than two hours, highlighting BPL-003’s potential to fit within the Spravato® two hour in-clinic treatment paradigm
- Phase 2b study of BPL-003 in 225 TRD patients is underway with top-line results expected in H2 2024
NEW YORK and BERLIN, March 27, 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 positive initial results from Beckley Psytech’s Phase 2a open label study of BPL-003 in Treatment Resistant Depression (TRD), a condition that affects approximately 100 million people worldwide.
BPL-003 is a novel, synthetic, patent-protected benzoate salt formulation of 5-MeO-DMT (mebufotenin) administered intranasally. Initial results demonstrated that a single 10mg dose of BPL-003 was well-tolerated and resulted in a rapid onset and durable antidepressant effect in patients living with TRD.
The open-label Phase 2a study investigated the safety, tolerability and efficacy of a single 10mg dose of BPL-003 alongside psychological support in patients with moderate-to-severe TRD who were not taking concomitant antidepressants. 12 subjects were dosed, and 11 met the criteria for per-protocol analysis1. Patients were followed for 12 weeks post-dosing, with assessments conducted at multiple points throughout the study. Efficacy was assessed using the Montgomery–Åsberg Depression Rating Scale (MADRS).
Initial analysis showed that a single dose of BPL-003 induced a rapid antidepressant response2 in 55% of patients on the day after dosing. The antidepressant effect was durable, with a 55% response rate maintained at week 4, which continued to week 12. There were 55% of patients in remission3 at week 4 and 45% in remission at week 12. These findings represent the longest known follow-up of depression outcomes in a clinical study of 5-MeO-DMT.
BPL-003 showed a good safety profile and was well tolerated. Adverse events (AEs) were predominantly mild or moderate and the most common AEs (>10%) were nasal discomfort, headaches, nausea and vomiting, broadly consistent with Phase 1 findings. No serious AEs were reported.
Acute effects resolved on average in less than two hours. These data suggest that BPL-003 could offer a shorter in-clinic treatment time when compared to other psychedelic treatments currently in development.
Commenting on the results, Florian Brand, Chief Executive Officer and Co-Founder of atai Life Sciences said: "We are thrilled with the progress the Beckley Psytech team has made on the BPL-003 program. The positive data from the Phase 2a study is highly encouraging as we await the results of the larger Phase 2b study anticipated later this year. With around half of TRD patients in remission three months after just a single dose of BPL-003 in this study, we are particularly excited about its antidepressant durability potential. The results indicate that BPL-003 could offer a scalable, single-dose administration within the two hour in-clinic treatment paradigm successfully established by Spravato®.”
A Part 2 extension of this Phase 2a open label study is now enrolling patients with TRD who are on stable doses of oral antidepressants to assess the safety and efficacy of BPL-003 co-administration (NCT05660642).
A randomized, quadruple-masked, controlled Phase 2b study of BPL-003 is currently underway (NCT05870540). The study is investigating the effects of a single 12mg or 8mg dose of BPL-003 against a sub-perceptual dose of 0.3mg in 225 patients with TRD. Efficacy will be assessed by masked raters using the MADRS scale at several time points with the primary endpoint at week 4 and final assessment at week 8. Top-line results are expected in H2 2024.
1 Prior to data analysis, one subject (from total of 12 patients) was determined not to meet multiple per protocol eligibility criteria and was excluded from the efficacy analysis.
2 Response rate defined as ≥50% reduction in MADRS score.
3 Remission rate defined as MADRS score ≤10.
About Beckley Psytech and BPL-003
Beckley Psytech is a private clinical-stage biopharmaceutical company developing BPL-003, which is 5-MeO-DMT, a short-duration psychedelic tryptamine that binds to a variety of serotonergic receptors. Epidemiological surveys and observational studies have reported that 5-MeO-DMT is associated with improvements in mood, anxiety, reduced stress, increased life satisfaction and mindfulness. 5-MeO-DMT has been reported to produce mystical experiences with comparative intensity as seen with high doses of psilocybin but has a significantly shorter duration of effect. Phase 1 data showed BPL-003 to be well-tolerated with consistent dose delivery and a reproducible, dose-linear pharmacokinetic profile.
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.
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.
H.E. Pennypacker
8 months ago
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.
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.
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.
[?IMG]
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.
MomsSpaghetti
10 months ago
atai Life Sciences: all major psychedelics – and more - in just one company
Christian Angermayer
Founder bei Apeiron Investment Group
https://www.linkedin.com/pulse/atai-life-sciences-all-major-psychedelics-more-just-angermayer-urpif/
Almost a year ago, in March 2023, I published a blog post about 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 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 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 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.
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 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 (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-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.
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 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 or X/Twitter to 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 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.
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 my 2023 blog post and 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.
MomsSpaghetti
10 months ago
$ATAI - atai Life Sciences Announces Strategic Investment in Beckley Psytech to Accelerate the Clinical Development of Short-Duration Psychedelics
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https://www.globenewswire.com/news-release/2024/01/04/2803828/0/en/atai-Life-Sciences-Announces-Strategic-Investment-in-Beckley-Psytech-to-Accelerate-the-Clinical-Development-of-Short-Duration-Psychedelics.html
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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.
MomsSpaghetti
1 year ago
ATAI LIFE SCIENCES ANNOUNCES FILING OF EARLY WARNING REPORT
https://www.newswire.ca/news-releases/atai-life-sciences-announces-filing-of-early-warning-report-886747079.html
News provided by
atai Life Sciences AG
10 Oct, 2023, 08:00 ET
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TORONTO, Oct. 10, 2023 /CNW/ - This press release is being issued pursuant to National Instrument 62-103 – The Early Warning System and Related Take-Over Bid and Insider Reporting Issues ("NI 62-103"), in connection with certain transactions completed by atai Life Sciences AG (Nasdaq: ATAI) ("atai") and IntelGenx Technologies Corp. (the "IntelGenx"), that were previously described in a press release issued by IntelGenx on August 31 2023.
On August 31, 2023, IntelGenx announced that, in connection with a non-brokered offering (the "Offering") of units (the "US Units"), each comprised of a US$1,000 principal amount convertible promissory note and 5,405 common stock purchase warrants, IntelGenx had agreed to, among other things: (i) enter into a second amendment (the "Second Amendment") to the amended and restated loan agreement dated as of September 14, 2021 (the "Loan Agreement") to provide, among other things, for the ability for atai to convert the principal and accrued interest outstanding under the Loan Agreement into common stock of IntelGenx ("Shares") at a price of US$0.185 per Share (the "Conversion Feature"); and (ii) enter into an amendment (the "Subscription Agreement Amendment") to the subscription agreement entered into by and between IntelGenx and atai in connection with the Offering, to provide atai with the right (the "Call Option") to purchase up to an additional 6,013 US Units at any time prior to August 31, 2026.
On October 6, 2023, atai and IntelGenx entered into the Second Amendment and the Subscription Agreement Amendment, both effective September 30, 2023 (the "Transaction"). In connection with the Second Amendment, atai and IntelGenx entered into a second amended and restated loan agreement to provide for the Conversion Feature. In connection with the Call Option, atai and IntelGenx entered into the Subscription Agreement Amendment, pursuant to which IntelGenx granted atai the option to purchase up to an additional 7,401 US Units (the "Call Option Units") at any time prior to August 31, 2026. Pursuant to the Subscription Agreement Amendment, the acquisition of any Call Option Units will result in a corresponding reduction in atai's remaining purchase right pursuant to the amended and restated securities purchase agreement dated May 14, 2021 (the "2021 Purchase Right"), with such right to be reduced by the maximum number of Shares issuable in connection with such Call Option Units, and (ii) in the event that the 2021 Purchase Right has been fully or partially exercised such that the aggregate number of Shares issued thereunder together with the number of Shares issuable in accordance with the Call Option would exceed 100,000,000, the number of Shares that may be issued in connection with the Call Option shall be reduced such that the aggregate number of Shares issued thereunder together with the number of Shares issuable in accordance with the Call Option does not exceed 100,000,000. The exercise of the Call Option is subject to the prior approval of the shareholders of IntelGenx.
Immediately prior to the Transaction, excluding Shares issuable upon the conversion of interest that may be outstanding from time to time, atai had ownership and control over securities convertible into approximately 269,152,849 Shares representing approximately 66.2% of the issued and outstanding Shares, on a partially diluted basis. Following the Transaction, assuming the conversion of the outstanding principal balance of the Loan Agreement and/or exercise of the Call Option (including the underlying securities) and excluding Shares issuable upon the conversion of interest that may be outstanding from time to time, atai would beneficially own or control in aggregate 237,732,850 Shares representing approximately 63.4% of the issued and outstanding Shares, on a partially diluted basis.
atai's acquisitions and dispositions were made in connection with atai's existing investment in IntelGenx. In accordance with applicable securities laws, atai may, from time to time and at any time, acquire additional shares and/or other equity, debt or other securities or instruments (collectively, "Securities") of IntelGenx in the open market or otherwise, and reserves the right to dispose of any or all of its Securities in the open market or otherwise at any time and from time to time, and to engage in similar transactions with respect to the Securities, the whole depending on market conditions, the business and prospects of IntelGenx and other relevant factors.
An early warning report will be filed under IntelGenx's profile on the SEDAR+ website at www.sedarplus.ca. To obtain more information or to obtain a copy of the early warning report filed in respect of this press release, please contact atai by email at ir@atai.life or by mail at c/o atai Life Sciences AG, Wallstraße 16, 10179, Berlin, Germany.
The mailing address of IntelGenx is located at 6420 Rue Abrams, Saint-Laurent, QC H4S 1Y2, Canada.
SOURCE atai Life Sciences AG
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