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Angermayer bought directly from Cathie Woods (+1.2M shares)
Share buyback...
https://atai.gcs-web.com/static-files/3fd4ef21-896f-4141-bdad-e9b205531809
You are in at the right time.
Well I can tell you that from where it started this is a great entry point. I rode MNMD up from IPO to NASDAQ... I have reentered both this and that one again. Ripe.
The more research I do, the more I like what I am seeing. I've never been part of a Unicorn. I've seen em. I've heard of them. I have never been in on one. Maybe this is it? Time will tell.
14 reasons why I am increasing my stake in atai Life Sciences
Christian Angermayer
Christian Angermayer
Founder bei Apeiron Investment Group
25 articles
March 29, 2023
Dear fellow shareholders of atai Life Sciences,
Biotech has been a tough sector for investors over the last 24 months. More or less since the IPO in June 2021 of atai Life Sciences (Nasdaq: ATAI) – the mental health biotech company I founded, of which I am the Chairman, and which is my most important passion project – the entire biotech sector has been trending downwards.
But even worse, compared to the XBI, the leading biotech index, atai has underperformed. I know this is unpleasant and frustrating – to say the least – for all investors, including myself as the largest shareholder. I didn’t just start atai, but also invested in the private rounds and significantly in the IPO as well. And have not sold a single share.
I personally believe that this pain also creates an opportunity: As an investor, I believe that purchasing atai shares has never been more attractive imho – for multiple reasons. This is why I am once again increasing my personal stake in atai this week via my own family office Apeiron Investment Group.
I believe that atai Life Sciences is the biggest entrepreneurial opportunity I have ever encountered as an investor. I truly believe this company has an incredible future and is well-positioned to make a positive and meaningful difference to one of humanity’s major challenges – the escalating mental health crisis.
With this blog post, I want to share my personal views both on atai and the biotech market more broadly.
1) A simple sum-of-the-parts calculation
Most important – numbers first (as of Tuesday, March 28th): In its most recent earnings press release, atai reported a strong balance sheet with NET cash of approx. USD 258 million.
Furthermore, atai owns 22.4% of COMPASS Pathways, a psilocybin-focused, Nasdaq-listed biotech company. This stake is worth roughly $98M as of Tuesday, March 28, based on COMPASS Pathways’ closing price of $10.23/share on that day.
You can find atai’s filed 10-K from last Friday here
With approx. 166 million shares outstanding, net cash plus the value of COMPASS stake makes approx. USD 356 million or USD 2.14 per share.
So, you can buy atai right now at a 38% discount to “Cash + Compass stake” - not to mention additionally – practically for free - getting ownership interests in additional 7 clinical-stage drug development programs PLUS atai’s digital therapeutics (DTx) PLUS a very strong early-stage discovery engine.
If, like me, you are already a believer in what atai is doing, you can stop reading here. That’s all you need to know.
2) atai’s pipeline
You can find more info about atai’s pipeline here.
In short: a pipeline of 5 clinical-stage drug development programs (and ownership interests in a total of 7 such programs), some of which are envisioned to be paired with digital therapeutics plus the 22.4% stake in COMPASS plus strong drug discovery programs driven by AI, for the next generation of psychedelics.
Of the aforementioned 7 clinical drug candidates, 4 are psychedelic and 3 are non-psychedelic substances.
3) Prior evidence in humans
For most compounds within atai’s pipeline, atai reports examples of prior human use and/or anecdotal evidence. Either from previous clinical studies or former medical use – like psilocybin – or because many people have found healing in traditional rituals, with the original flora and fungi, which have been used for thousands of years.
I believe that this is what makes atai different from other “standard” biotech companies, and personally gives me such confidence in atai’s future success. We already know the history and profile of these compounds. atai ‘just’ – and don’t get me wrong, there is a lot of work to be done – needs to turn this anecdotal evidence into robustly-assessed trial results that permit FDA approval.
4) Market size
We all regularly quote the shocking “1 billion people suffer worldwide from mental health issues” statistic. Unfortunately, though, I believe this number is understated and the real number is way higher, mainly for 3 reasons:
This is still a pre-COVID-19 figure. I expect, and recent data suggest, that COVID-19 has substantially worsened the global mental health situation, though it will take more time for accurate global figures to be compiled and reported
Mental health issues like depression, anxiety, addiction and PTSD continue to be stigmatized. Not everybody who needs help is coming forward to be diagnosed and treated. Many still suffer in silence. This is gradually changing, and great work is underway to reduce such stigma. As it does, I believe the number of diagnoses will increase substantially.
In general, I firmly believe the world we are building is not good for our mental health. Constant change, misuse of social media, relentless over-stimulation – all of this is totally toxic for our brain and taking its toll on us all. Read more about this in one of my latest blog posts.
My personal, sad belief is that the number of patients globally living with mental health conditions will continue to increase in the years to come. However, I’m also confident that atai is on its way to helping solve the mental health crisis.
5) Market share
Most equity research analysts in their respective models use a market share for each respective indication for atai’s and COMPASS’s psychedelic compounds – once approved – only in the single-digit percentage range.
And I know that many investors doubt rapid commercial success once psychedelic treatments are approved. Their mind is too preoccupied with the “pop a pill every day” business model, and they cannot see the transformative potential psychedelic-assisted therapy offers for patients. And I do believe that if you offer outstanding value, you will be paid accordingly. My own early discussions with insurance companies confirm my general view on the topic of reimbursement.
And then there is the ‘virality’ of psychedelic therapy: I personally know so many people who have already found healing in psychedelics – and virtually all have since become an advocate. Some have simply shared their stories only in their own private circles, while others have done so very publicly. Quite simply, I never have met anybody who benefitted from psychedelics who does not want to talk about it and extol their potential to others. Based on these personal experiences, I believe that once approved, the market penetration will outpace conservative estimates, driven by word of mouth, personal testimonies and a passionate ‘patients turned ambassadors’ movement, all of course within the appropriate medical regulation and oversight.
6) Patents
I fully recognize and respect sensitivities here, but I need to be clear that I am very proud that atai and COMPASS Pathways have been diligent in mapping out the landscape of psychedelics for medical use and, where appropriate, securing the necessary patents, intellectual property (IP) and data exclusivity steps to do so.
Patents and IP are a critical pillar of research and development and the ability to bring any promising new drug to market, and psychedelics are no exception. Patents foster innovation, and innovation benefits patients in need.
In my opinion, atai and COMPASS together are clear market leaders.
Is it possible that we forgot some niches here and there? Sure. Are the niches big? I don’t think so. And atai continues to build and strengthen its IP portfolio, using its strong balance sheet and entrepreneurial agility to identify further areas that have the potential to optimize its platform and future offerings.
7) Regulation
atai embraces regulation. Psychedelics had already been ‘regulated’ for thousands of years by shamans and priests – the healers of their times - and have been ‘prescribed’ within strict frameworks.
atai strives to bring psychedelics back into the world of science and make them valuable therapy tools for therapists and doctors. atai aims to do so by proving their safety and efficacy in rigorous clinical trials.
The latest company failures in the so-called ‘psychedelic industry’ – which doesn’t really deserve that title, as there are just a handful of companies with a real, viable strategy imo, and the rest have no business model – show that cutting corners is not the right way.
atai's way might take longer. atai's way might have setbacks as we saw with the R-Ketamine results. But personally, I am convinced that atai’s way is the right one and in the long term will bring the best yield for patients and investors.
8) Digital & Data
While for many investors digital therapeutics seem to be a mere adjunct to atai’s drug development candidates, atai has a bold vision of owning the entire mental health journey.
Access, scalability, remote support, and the tracking of (digital) biomarkers to optimize treatment response – these are just a few of the areas atai’s innovative enabling technologies seek to serve. The overarching vision, in my opinion, is that atai will first and foremost help people in their efforts to stay mentally healthy, while developing a broad set of therapeutics directed to helping bring relief and healing to those who suffer from a mental health issue.
9) A diversified pipeline – which can be better communicated
While I personally regard psychedelics as a very important and promising tool in fighting the mental health crisis, there are very interesting NON-psychedelic compounds as well. atai has two such non-psychedelic drug development programs:
RL-007 (Pro-Cognitive Neuromodulator for Cognitive Impairment Associated with Schizophrenia (CIAS))
RL-007 is an orally available compound that modulates cholinergic, glutamatergic and GABA-B receptors, thereby putatively altering the excitatory/inhibitory balance in the brain to produce pro-cognitive effects. It has previously been evaluated in 10 clinical studies with over 500 unique participants dosed to-date and in which it was well tolerated at all doses tested.
Notably, in four clinical studies that assessed cognition, including one in patients with CIAS, the compound consistently demonstrated pro-cognitive effects. In atai’s previous Phase 2a proof-of-mechanism study in CIAS of RL-007, the compound showed a large effect size on Symbol Coding, a sub-component of the MCCB that correlates with the overall composite.
The first patient was recently dosed in the phase 2b study of RL-007 in patients with CIAS and topline results from this study are expected in the 2nd half of 2024.
GRX-917 (Deuterated Etifoxine for Anxiety Disorders)
In January 2022, positive results were announced from the phase 1 single and multiple ascending dose study of GRX-917. In this study, GRX-917 was well-tolerated. Additionally, GRX-917 had an improved pharmacokinetic profile relative to etifoxine and provided pharmacodynamic evidence of GABA receptor target engagement through qEEG.
GRX-917 is a deuterated version of etifoxine, a drug used for anxiety and first approved in France in 1979. Etifoxine has a rapid onset and efficacy comparable to benzodiazepines, which are currently considered standard of care. In contrast to benzodiazepines, etifoxine appears to be non-addictive, less sedating, and better tolerated. It is believed that etifoxine achieves its anxiolytic activity by increasing the endogenous production of brain neurosteroids like allopregnanolone.
In January 2022, positive results were announced from the phase 1 single and multiple ascending dose study of GRX-917. In this study, GRX-917 was well-tolerated. Additionally, GRX-917 had an improved pharmacokinetic profile relative to etifoxine and provided pharmacodynamic evidence of GABA receptor target engagement through qEEG. As a next step, GRX-917 will be evaluated in a phase 2 study in patients.
Looking at atai’s valuation, I have the feeling investors assign zero value to those two late-stage programs (and atai’s other 5 clinical stage assets for that matter) at the moment; however, I personally believe these 2 non-psychedelic drugs are “gems within a goldmine”.
Communicating this better and effectively and taking action to crystalize the value of these non-psychedelic assets is one of my personal goals for 2023.
10) Inflation and interest rates don’t matter in the medium term
One reason biotech stocks are down so much is that interest rate hikes negatively influence any DCF model, especially when cashflows are far out in the future. So, it is reasonable that very early-stage biotech companies have corrected. But atai’s pipeline is not early stage at all. COMPASS/psilocybin has entered phase 3. RL-007 is in phase 2. And several others are in phase 1.
Let me put it simply: I believe in ANY interest rate environment, an approved drug for just one of the many mental health indications being targeted by atai could be worth billions. And atai has several drugs in its pipeline, for which it is seeking approval, often for several indications…
11) Setbacks make us stronger
In early January atai released results for the first placebo-controlled proof-of-concept trial of R-ketamine in Treatment-Resistant Depression (TRD). While the compound did not hit statistical significance on the primary endpoint, there are encouraging trends in efficacy and placebo-like safety profile at the 60 mg dose.
As you might remember: We do know that ketamine works for depression. The approval of J&J’s Spravato/S-ketamine in TRD and the existing market of ketamine clinics (using both racemic ketamine and S-ketamine) is a testament to that. However, because of the high rates of dissociation and sedation, you need to take racemic ketamine and S-ketamine in a clinic.
atai intended to test a very specific hypothesis with R-ketamine in this trial: Can one achieve sufficiently large anti-depressant effects similar to ketamine and S-ketamine, while not producing the sedation and dissociation seen with the latter? If so, this profile could potentially allow PCN-101 to be dosed at home without medical supervision.
While this first placebo-controlled proof-of-concept trial of R-ketamine in patients was negative and it is disappointing that the drug is not a ‘home run’, it is not the end of the world imho - just to put things into perspective: J&J had two negative Phase 3 trials with S-ketamine.
I see a way forward for this interesting drug, and I look forward to atai’s announcements on next steps.
12) Quality of the management
I sometimes hear that the atai leadership team is not your traditional biotech executive team. I agree. And I see that as a strength.
In fact, I believe that atai does have one of the best ‘traditional’ teams in CNS drug development, on the C-level represented by my co-founder and CSO Srinivas Rao (formerly at Axial Therapeutics, Depomed, Retrophin, Kyalin Biosciences, and more), atai’s CMO Rolando Gutiérrez-Esteinou (formerly at Takeda, Novartis, Bristol-Myers Squibb, Covance, and others), and atai’s CBO Sahil Kirpekar (formerly at Otsuka Pharmaceutical Co, Double Helix Consulting, Inderm, the WHO, and others).
But psychedelics in part require novel and entrepreneurial thinking. This is added by my co-founder Florian Brand, who has a strong tech background, atai’s CFO Stephen Bardin (formerly BridgeBio), and myself.
And most importantly: There’s the entire atai team of 90 people – 90 individual talents with a strong background in drug development and commercialization. Collectively, this team has led more than 140 investigational new drug applications and 40 new drug applications through to regulatory approval.
atai's team has been relentlessly building the company with passion, dedication, a driving sense of urgency and especially with lots of entrepreneurial thinking since 2018.
13) Strong cash position coupled with entrepreneurship
According to its most recent 10-K filing, atai not just has approx. USD 258 million NET cash as of year-end 2022, but additionally access to a term loan facility of up to an additional USD 160 million.
Makes USD 418 million “firepower”.
And I dare to say: I am absolutely certain that the excellent leadership team – including yours truly - will make good use of this firepower in 2023 and beyond.
14) I am not alone in my assessment
atai is covered by 14 research analysts, 8 of whom have provided updated price targets so far following atai’s most recent earnings release. These price targets of those 7 analysts range between USD 9 and USD 21 per share.
Dear fellow atai shareholders, it is imperative to me to be on this journey for the long run.
As you know, I have signed a voluntary lock-up till the end of 2024.
Of course, I do not intend to sell any shares even after that date. To the contrary: as you will see in the next few days, I am increasing my stake.
I truly believe that atai Life Sciences is one of those rare companies where the stars are aligned: the mission, the strategy, the execution, and the macro-environment. As you can tell, I couldn’t be more excited about atai’s future and its potential to play a vital role in solving one of humanity's biggest challenges.
I am grateful for the trust my fellow atai shareholders have placed in atai and me and I am confident that atai will work relentlessly to pay back this trust – most importantly in the form of drug approvals.
Published by
Christian Angermayer
Christian Angermayer
Founder bei Apeiron Investment Group
Published • 5h
25 articles
I am increasing my stake in atai Life Sciences.
Net cash plus the value of COMPASS stake makes approx. USD 356 million or USD 2.14 per share. Shares are trading with 38% discount to that!
But that's just one reason. I have 13 more.
Check out my latest blog post
hashtag#future hashtag#investing hashtag#biotechnologie
https://www.linkedin.com/pulse/14-reasons-why-i-am-increasing-my-stake-atai-life-angermayer/
Christian Angermayer
@C_Angermayer
I am increasing my stake in @atai_life
Net cash + value of @COMPASSPathway
stake makes approx. USD 356m or USD 2.14/share. Shares trading with 38% discount to that! But that's just one reason. I have 13 more. Check out my latest blog post! $ATAI $CMPS
I am increasing my stake in @atai_life
— Christian Angermayer (@C_Angermayer) March 29, 2023
Net cash + value of @COMPASSPathway stake makes approx. USD 356m or USD 2.14/share. Shares trading with 38% discount to that! But that's just one reason. I have 13 more. Check out my latest blog post! $ATAI $CMPShttps://t.co/IDrV5XH0s9
This one I will be holding until FDA approval. It will be a lottery 75-100 stock one day in the next few years... Lots of insider buying.
I just received an early alert on ATAI. One of those AI stock places. Says tomorrow and Friday should be interesting on this one. I am in as of two days ago. I'm liking what I see here.
$ATAI PSAR just flipped. This likely will have some interest though the next few months. Keep it on watch if you aren't already in.
@atai_life
#psychedelics #stockstowatch
$ATAI is a major playing the 🍄 PSAR just flipped. This likely will have some interest though the next few months. Keep it on watch if you aren't already in.@atai_life #psychedelics #stockstowatch pic.twitter.com/oMa5WngwuZ
— 4andaHalf (@4andahalfFarm) March 28, 2023
This is the best response I've ever gotten on IHUB. Thanks for that.
I am buying and holding this one and MNMD - over the next few years they will merge, be bought out or a combination of the two. They both have great cash runways and all the small players are falling.
this sector has taken a beating and the reentry point is now. I picked up more today. It is a sleeper category until the trust is built. It is a drug class that makes people raise an eyebrow. Wait until the real flood gates open.
Not being a contrarian. Trying to figure things out. Top Analysts are giving ATAI a price of $14.00 a share at some point of the year. It's in type and for everyone to read. This is as of March 27, 2023 at 11:01. At the current price, this is a steal. Can someone explain why there is not a buying frenzy going on with this ticker atm? It all sounds exciting as hell to me. cause even if it manages to hit a 1/3 of price prediction this a win. I try not to buy on emotion but this looks like a winner to me.
Last Signal: BUY
Last Pattern: BULLISH HOMING PIGEON
Last Close:
1.2500
Change:
+0.0600
Percent change
+5.04%
Signal Update
Our system’s recommendation today is to BUY. The BULLISH HOMING PIGEON pattern finally received a confirmation because the prices crossed above the confirmation level which was at 1.2150, and our valid average buying price stands now at 1.2250. The previous SHORT signal was issued on 03/20/2023, 4 days ago, when the stock price was 1.2100. Since then ATAI has risen by +1.24%.
https://www.americanbulls.com/SignalPage.aspx?lang=en&Ticker=ATAI
Live ATAI - AMA on Reddit
https://www.reddit.com/r/shroomstocks/comments/11wlqp1/hi_this_is_florian_brand_and_srinivas_rao/
atai Life Sciences Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Clinical Pipeline Highlights
https://uk.finance.yahoo.com/news/atai-life-sciences-reports-fourth-105900699.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAKKb-7TpGGzGCgudpqBnttD1wImKuB_QCGh2zpNIddZNTQRmAlw280wjjCZNs7IVjHfzBY3gwBIAbJ_3iQ8NV7gY2Y4-UwfyFs45BLuUkHDGDHTBi07lnuziLyt4DoptbOBDoUk-P4F0OwBAHDzoR-xQkIzbxo10_0lRaTshs3YA
atai Life Sciences
Fri, 24 March 2023 at 6:59 am GMT-4·15-min read
In this article:
ATAI
+1.71%
atai Life Sciences
atai Life Sciences
atai’s development candidates, such as RL-007 and GRX-917, all represent significant opportunities to address unmet medical needs of patients living with mental health conditions
Continued operational progress on robust clinical pipeline, with multiple phase 1 and phase 2 proof-of-concept datasets expected in the next two years
$273 million in cash, cash equivalents and short-term investments at end of 2022 and access to a term loan facility of up to an additional $160 million provide anticipated runway into the first half of 2026
NEW YORK and BERLIN, March 24, 2023 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, reported fourth quarter and full year 2022 financial results and provided clinical pipeline highlights.
“With multiple clinical-stage programs aimed at addressing significant unmet patient needs in mental health and the capital to fund us into the first half of 2026, we believe we are in a strong position to advance our clinical candidates towards proof of concept in patients,” said Florian Brand, CEO and Co-Founder of atai. “Recently we announced dosing the first patient in our Phase 2 study of RL-007 in CIAS and the modification of the GRX-917 clinical development plan to advance directly into a proof-of-concept study in patients with anxiety.”
Clinical Pipeline Highlights
RL-007 (Pro-Cognitive Neuromodulator for Cognitive Impairment Associated with Schizophrenia (CIAS))
The first patient was recently dosed in the phase 2b study of RL-007 in patients with CIAS and topline results from this study are expected in the 2nd half of 2024.
The phase 2b US-based study is a randomized, placebo-controlled, double-blind, 3-arm study evaluating 20mg and 40mg of RL-007 vs placebo in approximately 230 patients with CIAS. The primary endpoint of the study is the change from baseline in the MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite score, a well-established regulatory endpoint, at week 6.
RL-007 is an orally available compound that modulates cholinergic, glutamatergic and GABA-B receptors, thereby putatively altering the excitatory/inhibitory balance in the brain to produce pro-cognitive effects. It has previously been evaluated in 10 clinical studies with over 500 unique participants dosed to-date and in which it was well tolerated at all doses tested.
Notably, in four clinical studies that assessed cognition, including one in patients with CIAS, the compound consistently demonstrated pro-cognitive effects. In atai’s previous Phase 2a proof-of-mechanism study in CIAS of RL-007, the compound showed a large effect size on Symbol Coding, a sub-component of the MCCB that correlates with the overall composite.
GRX-917 (Deuterated Etifoxine for Anxiety Disorders)
The clinical development plan was modified to proceed with a phase 2 study in patients, which is intended to generate the robust clinical data needed to best inform a future registrational program. More details of the phase 2 clinical development plan will be provided upon initiation of the study.
In January 2022, positive results were announced from the phase 1 single and multiple ascending dose study of GRX-917. In this study, GRX-917 was well-tolerated. Additionally, GRX-917 had an improved pharmacokinetic profile relative to etifoxine and provided pharmacodynamic evidence of GABA receptor target engagement through qEEG.
GRX-917 is a deuterated version of etifoxine, a drug used for anxiety and first approved in France in 1979. Etifoxine has a rapid onset and efficacy comparable to benzodiazepines, which are currently considered standard of care. In contrast to benzodiazepines, etifoxine appears to be non-addictive, less sedating, and better tolerated. It is believed that etifoxine achieves its anxiolytic activity by increasing the endogenous production of brain neurosteroids like allopregnanolone.
COMP360 (Psilocybin Therapy for Treatment-Resistant Depression (TRD))
COMPASS Pathways (“COMPASS”) recently announced an acceleration of the Pivotal Trial 1 (COMP 005) part of the phase 3 program in TRD, with top line data from Pivotal Trial 1 now expected in the summer 2024.
The on-going phase 3 program is composed of two pivotal trials, each of which will have a long-term follow-up component. The primary endpoint in both pivotal trials is the change from baseline in MADRS total score at week 6.
COMP360 is a proprietary formulation of synthetic psilocybin that is administered in conjunction with psychological support. Previously, COMPASS completed a phase 2b study with top line data showing a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support.
VLS-01 (N,N-dimethyltryptamine (DMT) for TRD)
In the fourth quarter of 2022, the first subject was dosed in a Phase 1 study of VLS-01. Initial results from the study are expected in the 1st half of 2023.
The phase 1 study is a two-part single-ascending dose study designed to evaluate the safety, tolerability and relative bioavailability of oral transmucosal film (OTF) versus intravenous (IV) formulations of VLS-01.
The study includes atai’s IDEA-1 companion digital therapeutic for psychological support to be used in combination with VLS-01. The app-based support comprises “(mind)set-and-setting” prior to dosing and limited post-dose integration appropriate for healthy volunteers.
VLS-01 is an OTF formulation of DMT. DMT is a partial agonist of the 5-HT 1A/2A/2C receptors, characterized by an intrinsically short duration of psychedelic effect, with a serum half-life estimated at less than 10 minutes. DMT results in rapid-acting antidepressant effects when administered via IV infusion in patients with major depressive disorder (MDD). VLS-01 is formulated for oral delivery, potentially eliminating the need for IV infusion.
DMX-1002 (Ibogaine for Opioid Use Disorder)
In the third quarter of 2022, the first subject was dosed in a phase 1/2 study of Ibogaine. Initial results from the Phase 1 portion of the study are expected in the 1st half of 2023.
EMP-01 (MDMA Derivative for PTSD)
In the third quarter of 2022, a phase 1 study of EMP-01 was initiated. Initial results from this study are expected in the 2nd half of 2023.
Consolidated Financial Results
Cash, Cash Equivalents, and Short-term investments: Cash and cash equivalents and short-term investments were $273.1 million as of December 31, 2022, as compared to $362.3 million as of December 31, 2021. The decrease of $89.2 million was primarily driven by net cash used in operating activities of $104.5 million and $3.6 million additional investment in platform companies, partially offset by $15.0 million draw on the Hercules debt, $4.6 million of proceeds from the conversion of notes and $2.9 million of proceeds from stock sales and stock option exercises. The Company expects its cash position, combined with access to up to $160M in additional capital from its term loan facility with Hercules Capital, Inc., will be sufficient to fund operations into 1H 2026.
Research and development (R&D) expenses: R&D expenses were $21.9 million and $74.3 million for the three and twelve months ended December 31, 2022, respectively, as compared to $13.0 million and $48.0 million for the same prior year periods. The year-over-year full-year increase of $26.3 million was primarily attributable to an increase of $22.2 million of contract research organization expenses related to advancements of R&D programs and $3.5 million increase in R&D personnel costs.
General and administrative (G&A) expenses: G&A expenses for the three and twelve months ended December 31, 2022 were $15.7 million and $70.4 million, respectively, as compared to $25.9 million and $92.7 million in the same prior year periods. The year-over-year decrease of $22.3 million was primarily attributable to a decrease of $18.0 million in non-cash stock compensation expense, $9.8 million decrease in value added tax expense, $4.0 million decrease in professional consulting services. These decreases were partially offset by an increase of $7.3 million in personnel expenses and $1.9 million increase in insurance expense.
Net loss: Net loss attributable to shareholders for the three and twelve months ended December 31, 2022 was $45.0 million and $152.4 million, respectively, as compared to $88.9 million and $167.8 million for the comparable prior year periods.
About atai Life Sciences
atai Life Sciences is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. Founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape, atai is dedicated to acquiring, incubating, and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders.
By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies to achieve clinically meaningful and sustained behavioral change in mental health patients.
atai's vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. For more information, please visit www.atai.life.
ATAI / ATAI Life Sciences N.V. - Forecast and Price Target
https://fintel.io/sfo/us/atai
atai Life Sciences Announces Key Clinical Pipeline and Corporate Updates
Published: Mar 06, 2023
RL-007: First patient dosed in the on-going phase 2b study in cognitive impairment associated with schizophrenia
GRX-917: Intention to progress GRX-917 into a phase 2 study in an anxiety disorder as the next step in clinical development
COMP360: Recently announced acceleration of the Pivotal Trial 1 (COMP 005) part of the phase 3 program, with top line data now expected in the summer of 2024
Corporate: As a result of our recent restructuring and pipeline updates, the company has extended its cash runway, which is now expected into 1H 2026
NEW YORK and BERLIN, March 06, 2023 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, provided key clinical pipeline and corporate updates.
“The dosing of the first patient in the phase 2b study of RL-007 in CIAS earlier this quarter exemplifies the execution capabilities of our team as we advance our programs into later-stage clinical studies,” said Florian Brand, CEO and Co-Founder of atai. “Along these lines, we are excited to announce the updated clinical strategy for GRX-917. The compound will progress directly into a phase 2 study in patients living with an anxiety disorder to accelerate development and generate the robust clinical data needed to inform a potential future registration.”
Mr. Brand continued, “As part of our efforts to further focus our capital allocation towards generating meaningful clinical readouts in the near-term and to optimize our operational efficiency, we reduced our team by approximately 30%. I am grateful for the dedication of the team members impacted by this decision and their contributions towards our mission.”
Pipeline Updates
RL-007 (Pro-Cognitive Neuromodulator for Cognitive Impairment Associated with Schizophrenia (CIAS))
The first patient was recently dosed in the phase 2b study of RL-007 in patients with CIAS. Initial results from this study are expected in the 2nd half of 2024.
The phase 2b study is a randomized, placebo-controlled, double-blind, 3-arm study evaluating 20mg and 40mg of RL-007 vs placebo in approximately 230 patients with CIAS. The primary endpoint of the US-based study is the MATRICS Consensus Cognitive Battery neurocognitive composite score at 6-weeks.
RL-007 is an orally available compound that modulates cholinergic, glutamatergic and GABA-B receptors, thereby putatively altering the excitatory/inhibitory balance in the brain to produce pro-cognitive effects. It has previously been evaluated in 10 clinical studies with over 500 unique participants dosed to-date and in which it was well tolerated at all doses tested.
Notably, in four clinical studies that assessed cognition, including one in patients with CIAS, the compound consistently demonstrated pro-cognitive effects.
GRX-917 (Deuterated Etifoxine for Anxiety Disorders)
The clinical development plan has been updated to now proceed with a phase 2 study in patients. The updated plan is anticipated to generate the robust clinical data needed to best support potential registration. More details on the clinical development plan will be provided upon initiation of the study.
The updated plan follows the positive results from the phase 1 single and multiple ascending dose study of GRX-917. In this trial, GRX-917 was well-tolerated. Additionally, GRX-917 had an improved pharmacokinetic profile relative to etifoxine and provided pharmacodynamic evidence of GABA receptor target engagement through qEEG.
GRX-917 is a deuterated version of etifoxine, a drug used for anxiety and first approved in France in 1979. Etifoxine has a rapid onset and efficacy comparable to leading benzodiazepines, like alprazolam and lorazepam, which are currently considered standard of care. In contrast to these benzodiazepines, however, and based on more than 40 years of the use of etifoxine in clinical practice, etifoxine appears to be non-addictive and does not seem to have the same sedation and other common adverse events. It is believed that etifoxine achieves its anxiolytic activity by increasing endogenous production of brain neurosteroids like allopregnanolone.
PCN-101 (R-Ketamine for Treatment-Resistant Depression)
In January 2023, in conjunction with the phase 2a study results of PCN-101, atai announced it would further evaluate the data and work with its subsidiary Perception Neuroscience (“Perception”) to determine next steps for the program.
atai will continue to support Perception’s development of PCN-101 through the IV-to-subcutaneous bridging study, which is currently on-track to be completed in the middle of 2023. In parallel, atai continues to work with Perception Neuroscience to explore strategic partnership options.
PCN-101 is a single isomer of ketamine and belongs to a new generation of glutamate receptor modulators with the potential for rapid-acting antidepressant activity and anti-suicidal effects. Pharmacologically, PCN-101 is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. Both depression model studies in rodents and clinical data suggest that R-ketamine could possess more durable effects than S-ketamine despite a lower affinity to the NMDA receptor and potentially a more favorable safety and tolerability profile.
COMP360 (Psilocybin Therapy for Treatment-Resistant Depression)
On February 28th, COMPASS Pathways (“COMPASS”) announced an acceleration of the Pivotal Trial 1 (COMP 005) part of the phase 3 program in treatment-resistant depression, with top line data now expected in the summer 2024.
COMP360 is a proprietary formulation of synthetic psilocybin that is administered in conjunction with psychological support. Previously, COMPASS completed a phase 2b study with top line data showing a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support.
Corporate Updates
As part of a strategic review of its pipeline and to enhance operational efficiency and focus, the Company has reduced its workforce by approximately 30%.
The majority of the cost savings will result from a workforce reduction in general and administration and non-clinical development.
The Company has extended its cash runway, which is now expected into 1H 2026.
About atai Life Sciences
atai Life Sciences is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. Founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape, atai is dedicated to acquiring, incubating, and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders.
By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies to achieve clinically meaningful and sustained behavioral change in mental health patients.
atai's vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. For more information, please visit www.atai.life.
got in right at the right time ;)
CNN Reporting
Psychedelics such as psilocybin, ketamine, LSD and MDMA are lately being discussed because of their alleged potential to treat mental health disorders. As interest from the medical community and investors grows, what’s next for the psychedelic therapy market?
Psychedelics such as psilocybin, ketamine, LSD and MDMA are lately being discussed because of their alleged potential to treat mental health disorders. As interest from the medical community and investors grows, what’s next for the psychedelic therapy market? pic.twitter.com/DLTylnbsja
— CNBC International (@CNBCi) February 16, 2023
Neo Kuma holds big positions here.
https://www.neokuma.co/
Now i think we hit bottom. Just added big here!
Bottom is IN between $2.60 & today's closing!
Me too. Big confidence in ATAI.
Canadian micro penny stock,
who are you tryin to kid bro!?!
atai Life Sciences Announces Initiation of Phase 1 Proof-of-Concept Clinical Trial for Its Sol-gel Based Direct-to-Brain Drug Delivery Technology:
Post published:October 19, 2022
Post category:Press Release
– atai has initiated a Phase 1 proof-of-concept clinical trial to demonstrate the safety, tolerability, and direct-to-brain delivery of intranasal INB-01, a sol-gel based drug-delivery technology.
– INB-01 may enable direct-to-brain delivery of various compounds in development across atai’s pipeline, with topline results expected in H1 2023.
– Potential advantages may include ease of administration, increased patient compliance, lower dose requirements, rapid onset of action, and minimized systemic exposure.
NEW YORK and BERLIN, Oct. 18, 2022 (GLOBE NEWSWIRE) — atai Life Sciences (“atai” or the “Company”) (NASDAQ: ATAI), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders today announced the initiation of the Phase 1 proof-of-concept (PoC) clinical trial of intranasal INB-01, a sol-gel based, excipient (drug-delivery) technology.
This is a Phase 1 two-stage, open-label, randomized study of the safety, tolerability, and effective brain delivery of INB-01. INB-01 or placebo will be administered to subjects using the Aptar Nasal Drug Delivery Device. Topline results are expected in H1 2023.
Traditional oral or intravenous drug delivery methods can be problematic in the treatment of central nervous system (CNS) disorders. When drugs are delivered via these peripheral methods, the blood–brain barrier restricts the entry of therapeutic agents to the CNS, thereby decreasing drug efficacy.
A potential solution is direct-to-brain delivery through the nose. This method has the potential to be a non-invasive administration route and may offer additional advantages such as ease of administration, increased patient compliance, lower dose requirements, rapid onset of action, and minimized systemic exposure, which may reduce the risk of peripheral toxicity.
Our INB-01 technology is designed to deliver pharmaceutical compounds as a liquid at room temperature, which becomes a gel instantaneously in the nasal cavity. The novel technology has been successfully utilized with both water-soluble and insoluble compounds and extracts. Prior to launching this PoC trial in humans, dosing of INB-01 has shown positive results in animals when measuring levels of INB-01 in the brain as well as MRI imaging of the brain. These results are a promising predictor for the use of INB-01 in human subjects for intranasal direct-to-brain drug delivery.
“Exploring the mechanism of drug delivery is an opportunity for us to further enhance the treatment experience,” said Florian Brand, Co-Founder, and CEO of atai Life Sciences. “INB-01 has the potential to provide superior drug uptake via the nose-brain barrier, reducing dose administered and dosing frequency. We are confident this will help patients and healthcare practitioners by easing administration, dosing, and providing faster relief to improve compliance.”
Dr. Majed Fawaz, Vice President, Chemistry, Manufacturing & Controls at atai, further commented, “INB-01 offers a novel direct-to-brain delivery technology that will support the lifecycle of atai’s drug development pipeline. We are thrilled to commence the Phase 1 proof-of-concept trial for INB-01. This is the first important step in understanding the safety, tolerability, and brain delivery potential of INB-01 in healthy adult subjects prior to pairing it with active pharmaceutical ingredients.”
About atai Life Sciences
atai Life Sciences is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. Founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape, atai is dedicated to acquiring, incubating, and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders.
By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies to achieve clinically meaningful and sustained behavioral change in mental health patients.
atai’s vision is to heal mental health disorders so that everyone, everywhere, can live a more fulfilled life. For more information, please visit www.atai.life
IntelGenx's Collaboration With ATAI Life Sciences Culminates In The Initiation Of First-In-Human Clinical Study Of An Oral Thin Film Psychedelic Drug Candidate
9:23 am ET October 13, 2022 (Benzinga) Print
ntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") today provided an update on its collaboration with its strategic partner, atai Life Sciences (NASDAQ:ATAI) ("atai"), for the development of novel formulations of pharmaceutical-grade psychedelics based on IntelGenx's polymeric film technologies.
Pursuant to the first of two current feasibility agreements between the companies, IntelGenx conducted pre-development, formulation development work and clinical supply manufacturing to provide a product prototype to atai for further clinical investigation. That previously undisclosed candidate, buccal VLS-01, is a buccal film containing a synthetic form of N,N-dimethyltryptamine. atai is developing the product as a novel therapy for treatment-resistant depression ("TRD") in combination with atai's digital therapeutic designed to provide contextual "(mind)set-and-setting" support to patients prior to dosing.
"We were very pleased with atai's recent announcement that it had dosed the first subject in its Phase 1 clinical trial of buccal VLS-01, with topline results expected in H1 2023," commented Dr. Horst G. Zerbe, CEO of IntelGenx. "The initiation of this first-in-human study of a pharmaceutical-grade psychedelic buccal film drug candidate represents the achievement of another major milestone for IntelGenx, and what we expect will be the first of many for our strategic partnership with atai."
"Exploring novel approaches to drug delivery can potentially simplify in-clinic administration and allow greater pharmacokinetic control of the psychedelic experience and its overall duration of hallucinogenic effects," said Dr. Srinivas Rao, Chief Scientific Officer of atai Life Sciences, said in a recent statement. "We're pleased to see this trial move forward as we establish the safety and tolerability of our compound."
An estimated 100 million people live with TRD globally – or a third of people with depression – who are undertreated or unresponsive to available treatment options. In addition to its impact on patients, families, and caregivers, TRD significantly burdens healthcare systems and payers. Direct medical costs for TRD patients are estimated to be two times higher than for non-TRD major depressive disorder patients, with an average of twice the number of inpatient visits and hospital stays that are over one-third longer.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Started a hefty position here given the company fundamentals plus the growing space.
Price target of $27 just released for ATAI.
Biotech Industry Update
Summary. Following a period of biotech underperformance, we review some causal factors, industry outlook, and specific opportunities. The SPDR S&P Biotech ETF (XBI; NR) is down ~35% vs the S&P 500 ~10% over the trailing 1-year. Attribution for this underperformance has run the gamut from macroeconomic factors like rising rates and XBI price correlation with measures of the money supply, to industry-specific factors like the impact of Covid on FDA timelines, and mean-reversion after a prior period of outperformance, among others. As we see it, this broad-based weakness and negative sentiment have occurred without regard to specific company fundamentals, in many cases.
Biotech industry sentiment offers opportunities, we think... We believe the pull-back in biotech share prices has created a buying opportunity for investors who are able to appreciate the potential of emerging technologies (incl. cell and gene therapy, immuno-oncology, microbiome therapeutics, personalized medicine, psychedelic-assisted therapy, and delivery modality innovation, among others) to usher-in next gen treatments. In addition to the large number of biotechs trading below cash (we counted 110 most recently among the biotech companies in FactSet's biotech industry grouping which has 1,281 companies, with some trading at ~25% of cash), many of which could be interesting as acquisition targets or to hold through a sentiment shift, we've also identified numerous biotechs with below-average clinical-development risk coupled with extensive cash runways.
...With a subset of biotech companies likely offering the best risk/reward. We reviewed 1,385 upcoming drug events (now through the end of 2023), against which we've applied: (1) screening criteria to the associated companies for cash runway and market cap, among other features, and (2) PoS calculations to each of these events, predicated on AI/ML-derived PoS tables published by a leading academic and industry consortium. We end up with 108 events and 70 unique companies of interest, serving to highlight the vast amount of opportunity in the space. A visual summary of the findings is located on page 2. We think the outlook for biotech remains largely positive, inasmuch as we believe healthcare innovation is driven by perennial patient need. The chart on page 3 highlights the long periods of time during which the XBI has outperformed the broader index. We think well-capitalized companies with lower-than-average clinical PoS risk and near-to-mid-term catalysts well-within their cash-runway represent the subset with the most appealing risk/reward.
Specific opportunities. Within our healthcare coverage, we're highlighting three biotech companies: atai Life Sciences (ATAI; BUY/ $27 PT) remains a dominant force in the psychedelic medicine space and has multiple upcoming clinical readouts each of which we see as material to increasing market appreciation for the pipeline potential (recent note). Trevi Therapeutics (TRVI; BUY/ $10 PT) reported positive results for Haduvio in chronic pruritus associated with prurigo nodularis (PN) and chronic cough associated with idiopathic pulmonary fibrosis (IPF), meaningfully de-risking the company's clinical profile, is well-capitalized, and has significant strategic optionality, as we see it (recent note). XOMA (XOMA; BUY/ $56 PT) is a biotech royalty aggregator with over 70 assets in its portfolio, providing an attractive and inherently diversified way to gain exposure to the sector (recent note), in our view.
Risks & disclosures. Risks: (1) clinical, (2) financial, (3) sentiment, (4) macroeconomic, (5) regulatory, (6) reimbursement, (7) competition, and others. Disclosures: Aegis Capital served as a co-manger for an offering of depositary shares for XOMA in April 2021, and as co-placement agent for a private placement for Trevi in April 2022.
Someone is going to merge... not really sure who and when but I am super heavy in mindmed.
Atai and Mimdmed need to merge. Especially in a market where the street is only going to buy cash flow and positive earnings stocks. I am sure there would be a lot of synergies if they merged.
Investors are beginning to warm to the idea of digital therapeutics, too, and the raise comes on the back of a good run around the pitch table for healthtechs developing digitally delivered clinical therapies.
In the past 12 months, Swiss startup MindMaze secured $230m; Berlin’s Peter Thiel-backed Atai Life Sciences IPO’d at a valuation of $3.2bn, and a number of others — like London’s Huma and Germany’s Ada Health — also picked up sizeable rounds. The sector is rising on the other side of the Atlantic, too, and just last month Boston-based Biofourmis raised $300m and hit unicorn status.
Cathie Wood Finds Elon Musk's Comment On Psychedelics, Ketamine An 'Interesting Thesis' For This Stock
by
Rachit Vats, Benzinga Staff Writer
May 2, 2022 6:01 AM | 1 min read
Thousands of traders are getting 2 bear-market beating options trade ideas every single month. Click Here to See if You Qualify to get these Trade Ideas!
Popular stock picker Cathie Wood said on Sunday she finds Tesla Inc
TSLA
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CEO Elon Musk’s comments on the effectiveness of psychedelics and other plant-based substances as treatments for mental health-related issues an “interesting thesis.”
What Happened: Wood’s firm Ark Investment Management has been building exposure in billionaire entrepreneur Peter Thiel-backed ATAI Life Sciences NV
ATAI
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, a clinical-stage biopharmaceutical company that focuses on the use of psychedelics for the treatment of mental health disorders.
“I’ve talked to many more people who were helped by psychedelics [and] ketamine than SSRIs & amphetamines,” Musk had earlier tweeted in response to a thread discussing “Adderall” and how “prescribed psychedelics could replace amphetamines and SSRIs over the next decade.”
Why It Matters: St. Petersburg, Florida-based Ark Invest has piled a total of 1.6 million shares, worth $6.9 million, in ATAI Life Sciences since the beginning of the year.
The fast-growing psychedelics sector is drawing investor interest with many now listed on the Nasdaq and NYSE.
Price Action: ATAI closed 2.9% lower at $4.3 on Friday.
About atai Life Sciences
atai Life Sciences is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. Founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape, atai is dedicated to acquiring, incubating, and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders.
atai's business model combines funding, technology, scientific, and regulatory expertise with a focus on innovative compounds, including psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies to achieve clinically meaningful and sustained behavioral change in mental health patients.
atai's vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. atai has offices in New York, San Diego, Boston, London, and Berlin. For more information, please visit https://www.atai.life/.
Contact Information
Investor Contact:
Greg Weaver
Chief Financial Officer
Email: greg.weaver@atai.life
Media Contact:
Maggie Gordon
Senior Manager, Communications
Email: maggie@atai.life
NEW YORK, May 05, 2022 (GLOBE NEWSWIRE) -- In a release issued yesterday under the headline "atai Life Sciences to Announce First-Quarter 2022 Financial Results" by atai Life Sciences N.V. (Nasdaq: ATAI), please note the first and second paragraphs, which contained statements referencing the 2022 IR financial results posting and executives on the video interview, as well as forward-looking statements, have been modified. The corrected release follows:
atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, plans to announce its first quarter 2022 financial results and business update on Monday, May 16, 2022.
Best mushroom play is PSYCF!!! Pay Attn.
.PSYCF
.
Is this company mostly about ibogaine which is a chemical in certain species of mushrooms?
The BEST Mushroom play is PSYCF by far!
Product will be on shelves in months!!! Not Years like all the other Mushroom players!
PSYCF Will be 1ST to Market! = BIG MONEY $$$$$
PSYCF
MOVE ON ATAI COMING - HIGH RISK
ATA, Inc. engages in the provision of computer-based testing services. It serves professional licensure and certification tests in various industries, which include IT services, banking, teaching, and insurance. The company was founded by Kevin Xiaofeng Ma and Walter Lin Wang in 1999 and is headquartered in Beijing, China.
SHORT INTEREST
83.41K 07/31/19
P/E Current
-3.13
P/E Ratio (with extraordinary items)
0.38
$ATAI She's back
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