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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.
Bullish! This is great stuff.
The PPS will be green after this... with Positive PR after it will turn from green to gold. Diamond inlays if we are lucky.
Great entry point today!
Agree this is a big reason I'm holding revenues will be solid on this point alone.
Good score. Going to be a good year! But Q1 will be solid. Great play here.
No one wants to defend King Ken and his amazing work he does? You diamond hands lost all your money here... should have sold long ago when some spaghetti eating idiot told you to.
Or at least sold it all before 12/31 for tax purposes...
Guys!!!!! Volume is off the charts. /s
On a move! ATAI and MNMD for the win!!!
On a tear!
Ha! That was perfect.
Weeeeeeeee!
MindMed Announces Business Update and Anticipated Milestones for 2024
https://www.businesswire.com/news/home/20240108449557/en/MindMed-Announces-Business-Update-and-Anticipated-Milestones-for-2024
-- Recently announced statistically significant and clinically meaningful topline Phase 2b data for MM-120 in Generalized Anxiety Disorder (GAD) position for multiple data readouts and catalysts throughout 2024 including initiation of Phase 3 clinical program --
-- Proof-of-Concept study evaluating repeated sub-perceptual dose (20 µg) of lysergide in adults with Attention-Deficit/Hyperactivity Disorder (ADHD) did not meet primary endpoint; no further development activities planned for sub-perceptual dose regimen --
-- Phase 1 Single Ascending Dose Study of MM-402 in Healthy Participants initiated in Q4 2023 --
January 08, 2024 07:45 AM Eastern Standard Time
NEW YORK--(BUSINESS WIRE)--Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the "Company" or "MindMed"), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today provided a corporate update and outlook for 2024.
“Management's Discussion and Analysis of Financial Condition and Results of Operations”
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“Our strong progress in 2023 culminated in the delivery of statistically and clinically significant topline results for our lead program (MM-120) in our Phase 2b study of GAD. These positive results reinforce our scientific understanding of the mechanism of action for MM-120 and emphasize the critical role we believe the perceptual effects of MM-120 play in driving clinical outcomes,” said Rob Barrow, Chief Executive Officer and Director of MindMed. “We are excited to enter 2024 with an enhanced focus on our lead program. In 2024, we plan to continue working diligently and efficiently to advance our MM-120 program into Phase 3, bringing us one step closer to potentially providing a new treatment option to the millions of patients suffering from GAD. We anticipate several key data milestones for our MM-120 program in 2024, including full 12-week results for MM-120 in GAD, results from our Phase 1 pharmacokinetics bridging study to support advancement of our MM-120 ODT formulation into pivotal clinical trials and additional results from our collaborator University Hospital Basel’s one-year follow-up study of lysergide in anxiety disorders. We will be working closely with the FDA to finalize our Phase 3 development program for MM-120 in GAD and expect to hold our End-of-Phase 2 meeting with FDA in the first half of the year with initiation of our Phase 3 clinical program in the second half of the year.”
Business Update
MindMed's management team will participate in the BIO Partnering at the J.P. Morgan Healthcare Conference in San Francisco that is being held from January 8-11, 2024.
The Company expects to host an analyst and investor day in the first half of 2024, at which the Company plans for its senior management, a physician expert and other leading key opinion leaders to provide an update on the Company’s lead development program MM-120 and discuss the treatment landscape, potential market and commercial opportunity for MM-120 in GAD and other psychiatric disorders.
Development Program Updates and Anticipated Milestones
MM-120 (lysergide D-tartrate)
Generalized Anxiety Disorder (GAD): In December 2023, the Company announced statistically significant and clinically meaningful topline 4-week results from the 198-patient Phase 2b dose-optimization study of MM-120 for the treatment of GAD.
MM-120 100 µg – the dose achieving the highest level of clinical activity – demonstrated a 7.6-point reduction on the Hamilton Anxiety rating scale (HAM-A) compared to placebo at Week 4 (-21.3 MM-120 vs. -13.7 placebo; p<0.0004; Cohen’s d effect size=0.88), which is more than double the effect sizes seen with the current standards of care1.
Clinical response (50% or greater improvement in HAM-A) at Week 4 was achieved in 78% of participants treated with MM-120 (100 µg or 200 µg) compared to 31% for placebo.
Clinical remission (HAM-A ≤ 7) at Week 4 was achieved in 50% of participants treated with MM-120 100 µg.
The Company plans to share topline 12-week results from the Phase 2b study by the end of the first quarter of 2024, and present full results at a scientific meeting in 2024.
The Company intends to share results in the first quarter of 2024 from its pharmacokinetics bridging study of the MM-120 Zydis® orally disintegrating tablet (ODT) formulation, its intended commercial formulation of MM-120 formulation that may enhance intellectual property and market protection with a potentially differentiated biopharmaceutical profile.
The Company plans to hold an End-of-Phase 2 meeting with the FDA in the first half of 2024 and expects to initiate its Phase 3 clinical program in the second half of 2024.
One-year follow-up data from a Phase 2 placebo-controlled investigator-initiated clinical trial of lysergide in the treatment of anxiety disorders is anticipated in 2024. This study was conducted by the Company’s collaborators at University Hospital Basel (UHB) in Switzerland.
Attention-Deficit/Hyperactivity Disorder (ADHD): The Company’s 53-patient Phase 2a proof-of-concept trial in ADHD was designed to assess the safety and efficacy of repeated sub-perceptual dose (20 µg) lysergide administration and did not meet its primary endpoint. In conjunction with the findings from our study of MM-120 in GAD, we believe that these results support the critical role of perceptual effects of MM-120 in mediating a clinical response. The Company intends to continue prioritizing development of its MM-120 program in GAD and other psychiatric indications, using the single perceptual dose (100 µg or greater) regimen that has shown strong positive results in numerous studies.
MM-402 (R(-)-MDMA) for Autism Spectrum Disorder (ASD)
The Company initiated its first clinical trial of MM-402 (R(-)-MDMA), a single-ascending dose study in adult healthy volunteers in Q4 2023. This Phase 1 study is intended to characterize the tolerability, pharmacokinetics and pharmacodynamics of MM-402 and will enable further clinical studies to characterize the effects of repeated daily doses of MM402 and the exploration of early signs of efficacy in the ASD population.
In October 2023, the Company presented results from a MM-402 nonclinical study in a model of ASD, titled “MM-402 demonstrates better efficacy than S(+)-3,4-MDMA or (±)-3,4-MDMA in Fmr1 knockout mice, an animal model of autism spectrum disorder” at the 36th Annual European College of Neuropsychopharmacology (ECNP) Congress.
UHB is currently conducting a Phase 1 investigator-initiated trial of R(-)-MDMA, S(+)-MDMA and R/S-MDMA in healthy adult volunteers. This trial is designed to assess the tolerability, pharmacokinetics and acute subjective, physiological and endocrine effects of the three molecules. The Company anticipates topline results to be presented in the first half of 2024.
About MM-120
Lysergide is a synthetic tryptamine belonging to the group of classic, or serotonergic, psychedelics, which acts as a partial agonist at human serotonin-2A (5-hydroxytryptamine-2A [5-HT2A]) receptors. MindMed is developing MM-120 (lysergide D-tartrate), the tartrate salt form of lysergide, for GAD and other psychiatric indications.
About MM-402
MM-402 is our proprietary form of R(-)-MDMA (rectus-3,4-methylenedioxymethamphetamine), which we are developing for the treatment of core symptoms of autism spectrum disorder (ASD). MDMA is a synthetic molecule that is often referred to as an empathogen because it is reported to increase feelings of connectedness and compassion. Preclinical studies of R(-)-MDMA demonstrate its acute pro-social and empathogenic effects, while its diminished dopaminergic activity suggest that it has the potential to exhibit less stimulant activity, neurotoxicity, hyperthermia and abuse liability compared to racemic MDMA or the S(+)-enantiomer.
About MindMed
MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative drug candidates, with and without acute perceptual effects, targeting the serotonin, dopamine, and acetylcholine systems.
MindMed trades on NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED.
Always is with a spicy meatball!
Ken is full of shit. Warned all of you to get out.
Whoops!!! CDBT Registers Magistrates Court of Queensland Judgments against Kenneth Maciora / Empire Relations Group
That was mere weeks ago... LOL!!! LMFAO!
https://finance.yahoo.com/news/cdbt-registers-magistrates-court-queensland-233000647.html
Background:
As disclosed on October 9, 2023, CDBT formally terminated the China Dasheng Biotechnology Co. Consulting Agreement with Kenneth Maciora, Empire Relations Group Inc., and Empire Holdings LLC. on October 5, 2023.
On October 11, 2023, CDBT filed claims for the return of advanced funds after placing before the court that Kenneth Maciora, Empire Relations Group, Inc. behavior, actions, and failure to deliver work product under the China Dasheng Biotechnology Co. Consulting Agreement after being paid in advance.
CDBT will now register those judgements in the USA and seek to enforce them.
CDBT acknowledges that it was courted by Kenneth Maciora after publishing a press release and that several other listed entities have contacted CDBT management after being canvassed by Kenneth Maciora from their published press releases.
Ken was hard at work getting fired from another company back in October of 2023 - LOL!
CDBT - Terminates Consulting Agreement with Kenneth Maciora / Empire Relations Group
https://finance.yahoo.com/news/cdbt-terminates-consulting-agreement-kenneth-010000357.html
Happy Weekend Res!
ATAI Company Presentation January 2024
https://ir.atai.life/static-files/4429bab6-4134-4e1f-ab8b-7c415e89399e
100% agree here. Nice find.
10 bagger?! might be a 20 bagger if we uplist which I think will happen!
Have to hit that 1.00 minimum first, but the CEO has talked about this in video interviews. I need to look back at which one. I trust this company will do well. I am holding onto my shares!
No volume Warren
Looking good. My top holding in order of size ATAI, MNMD, NUMI. :)
We're going to uplist... this will go to a 1.00 minimum!
That's what's happening.
Excellent!
I'm ok with any and all of the above. The drugs work. They will eventually make it to market in some form.
This is going to get juicy very soon I believe :)
Not happening
Keep an eye on MindMed MNMD as well.
Climbing toward that for sure over the next year. Great news today!
Still drunk from New Years
Would be sweet if ATAI and MindMed merged ;)
$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.