Watching alerts...
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I made out on the first runs... I am gobbling up this long loading zone. Will be a gangbuster when the top blows off.
It will be an empty promise, nothing substantial, a hoax. Better sell the news when it hits... make this post it will continue to fall into the trips and then RS.
Will you admit I am right 3 months from now... :)
Excellent stair stepping indeed. Lovely.
Nothing says is has to run and a price hike because of an RS is not a run either.
Ken is full of shit and loves your money.
sitting at the 52 week low. LOL
NOW IS THE TIME TO BUY...
Then sell for 100% gain at .0034
Then let her fall again and rinse and repeat. You bag holders are screwed.
Fine but the time to have gotten back in would be here. Not 24, 48, 64 months ago. It's just absurd to see the sheep follow literally nothing. These is no business at all here. 0.
Bone for all the pumping you've done here you surely have a huge bag at this point. Your opinion is that it should run so you can at least lighten your debt. I'm really sorry this company got ya.
Will send higher. Good times!
For 24 months I said sell... LOL!
Schwing!
That was all sells LMFAO
They can run at any given minute for any given reason. Point is to be in right before it happens :)
Great play here! healthy moves back up. Will be a good year for biotechs!
Undervalued biotech here. Super attractive pipeline and enough cash to get them through 2025 into 2026. I see a buyout happening. Get in this one along with ATAI if you are watching this board. Great plays.
This one is one of my favorite holds for a spring bounce. Everything is primed and ready here.
I think all the chatter either way is good at these levels. Let's give them something to talk about... something to figure out :)
I see this having one more good rally. Fits the recent chart patterns.
Good evening Resx! I see this heading toward a dollar through summer and hitting it in the fall. Easy .25-30 in spring. We are very close here with all this good news thats been released. Fins will be amazing!
Adam,,, go put your money elsewhere. This stock will not make you any money.... it will take money from you.
what do you think about this one here?
Delicious. Locked and loaded to move.
Oxetanes in Drug Discovery Campaigns
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10544023/
Various drug companies are using this method to create similar structures of medicines to renew patents and keep the functionality of the drug at hand. Again, I am not an expert, but this seems like a viable IP strategy around LSD and one that others have not matched MindMed on from what I can tell.
They are building commercial runway...
There are lots of analogs of LSD and typically they're made by tweaking three different positions on the LSD molecule. 1) the nitrogen on the five-membered ring, 2) the nitrogen in the six-membered ring and the ethyl groups on the amide nitrogen. This patent doesn't stray from this formula (as I saw from skimming the structures) but the specific modifications they make are interesting, like putting in alkynes or oxetanes. They also have some pharmacology data on receptor binding but I can't speak much to that.
Yes. Great company getting built here. Holding a good position. Many catalysts ahead.
This is going to run quite hard when the next fins are released I think. Just so many good things lining up and the company is healthy.
This is going to be a great one!
First of all did you simply ignore what Ken does? I posted recent issues with him. Second, I having a feeling that you made 0.00 on SPZI... You just are using it as an example of what this could be... which STEV will not turn into... I will continue to sit here and watch this suffering because it is amazing how hard headed this board is. STEV at one point in time was a great trade. It will never wake back up and will absolutely go to the trips here very soon.
Lysergic Acid Derivatives With Modified Lsd-like Action
https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2023250298&_cid=P21-LQSR22-38874-2
Abstract
(EN) A composition of a compound represented generically by FIGURE 1A for use in substance-assisted therapy. A method of changing neurotransmission, by administering a pharmaceutically effective amount of a compound of FIGURE 1A to a mammal, interacting with serotonin 5-HT2A receptors in the mammal, in particular also human beings, and inducing psychoactive effects. A method of treating an individual, by administering a pharmaceutically effective amount of a compound of FIGURE 1A to the individual and treating the individual.
(FR) L'invention concerne une composition d'un composé représenté de manière générale par la FIGURE 1A destinée à être utilisée dans une thérapie assistée par psychotrope. L'invention concerne également une méthode de modification de la neurotransmission, par administration d'une dose pharmaceutiquement efficace d'un composé de la FIGURE 1A à un mammifère, qui interagit avec les récepteurs 5-HT2A de la sérotonine chez le mammifère, et en particulier chez les êtres humains, et induit des effets psychoactifs. L'invention concerne en outre une méthode de traitement d'un individu, par administration d'une dose pharmaceutiquement efficace d'un composé de la FIGURE 1A à l'individu, ainsi que le traitement de l'individu.
Publication Number
WO/2023/250298
Publication Date
28.12.2023
International Application No.
PCT/US2023/068668
International Filing Date
19.06.2023
IPC
A61K 31/48 2006.1 C07D 457/06 2006.1
Applicants
MIND MEDICINE, INC. [US]/[US]
Inventors
TRACHSEL, Daniel
LIECHTI, Matthias Emanuel
LUSTENBERGER, Felix
Agents
KOHN, Kenneth I.
Priority Data
63/353,673 20.06.2022 US
Publication Language
English (en)
Filing Language
English (en)
Designated States
View all
Title
(EN) LYSERGIC ACID DERIVATIVES WITH MODIFIED LSD-LIKE ACTION
(FR) DÉRIVÉS D'ACIDE LYSERGIQUE AYANT UNE ACTION DE TYPE LSD MODIFIÉE
front page image
They are losing it. Mark this post. No one is being pulled from this. :)
It's coming :)
R-MDMA Patent Application Data
https://image-ppubs.uspto.gov/dirsearch-public/print/downloadPdf/20240010628
Abrois probably 99% of the people on this board need this to go back to .02+ to make even. LOL
Float 86,856,772
I agree it's been rough. But I got in early 2023 and reinvested those profits back down here. Swining his was easy but if you missed that last run I see this unlisting over the next year to year and a half so it need to get to a dollar to be able to do that and I do not see with the share structure them doing an RA to pull that off.
This is also a penny stock exempt OTC play which is a green flag for me :)
I'm just hoping to be able to get more before it takes off!
I think we are going to get some huge catalysts this year and head back to fair valuation... then from there it will be merger, buyout or commercialization on the 1-2 year mark. Hang tight. This is a good investment.
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.
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.
I see 8-10x here upon business plan and share restructure easy. Could go higher than that on those metrics.