ATAI Life Sciences NV【ATAI】株式ニュース

atai Life Sciences Reports Third Quarter 2024 Financial Results and Provides Corporate Updates
November 13, 2024
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- The United States Food and Drug Administration cleared the investigational new drug application for VLS-01 (buccal film DMT); atai expects to initiate a Phase 2 study in treatment-resistant depression patients around YE’24

- Remain on track to initiate a Phase 2 study of EMP-01 (oral R-MDMA) in social anxiety disorder patients around YE’24

- Cash, marketable securities, and committed term loan funding expected to fund operations into 2026

NEW YORK and BERLIN, Nov. 13, 2024 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced third quarter 2024 financial results and provided corporate updates.

“As we approach the end of 2024, we continue to see progress and momentum across our pipeline, both with our wholly owned programs and strategic investments,” stated Dr. Srinivas Rao, Co-Chief Executive Officer and Co-founder of atai. “We are on track to initiate Phase 2 trials for VLS-01 and EMP-01 around year-end and we look forward to topline Phase 2b data from Beckley Psytech’s BPL-003 in the second quarter of 2025. Our team is focused on executing these trials with the utmost scientific rigor and is driven by our goal of being the leader in developing new psychedelic treatment options to mental health patients in need of innovative, safe and effective solutions.”

Recent Clinical Highlights
VLS-01: N,N-dimethyltryptamine (DMT) for Treatment-Resistant Depression (TRD)

VLS-01 is a proprietary oral transmucosal film formulation of DMT applied to the buccal surface designed to fit within a two-hour in-clinic treatment paradigm.
The United States Food and Drug Administration (FDA) cleared the investigational new drug (IND) application for VLS-01, allowing the Company to proceed with its plans to initiate a randomized, double-blind, placebo-controlled Phase 2 study to assess the safety, efficacy and durability of response of repeated doses of VLS-01 buccal film in patients with TRD.
The Phase 2 study is expected to initiate the study in U.S. around year-end 2024.

EMP-01: R-enantiomer of 3,4-methylenedioxy-methamphetamine (R-MDMA) for Social Anxiety Disorder (SAD)

EMP-01 is an oral formulation of R-MDMA that demonstrated a unique, dose-dependent subjective effect profile in a Phase 1 trial that was generally found to be more similar to classical psychedelics than to racemic MDMA.
atai expects to initiate an exploratory, randomized, double-blind, placebo-controlled Phase 2 study to assess the safety, tolerability and efficacy of EMP-01 in adults with SAD around year-end 2024.
SAD is an area of high unmet medical need with approximately 18 million people in the U.S. diagnosed in the past year and no novel molecules approved in over two decades.

IBX-210: Intravenous (IV)-Ibogaine for Opioid Use Disorder (OUD)

IBX-210 is a novel IV formulation of ibogaine, which is an indole alkaloid with potential for clinical benefit for substance use disorder
Completed productive FDA pre-IND meeting to initiate discussions and alignment on a modern ibogaine IND.
atai plans to run additional non-clinical studies prior to launching a Phase 1b study.

Novel 5-HT2A Receptor Agonists

Discovery program to identify novel, non-hallucinogenic 5-HT2AR agonists for TRD using artificial intelligence (AI)/machine learning (ML)-informed drug design and medicinal chemistry.
Presented data at the Society for Neuroscience (SfN) annual meeting aimed to show that these compounds are promising chemical starting points for new analogs with further improved 5-HT2AR vs. 5-HT2BR agonist selectivity that maintain translational antidepressant-like activity with potential for non-hallucinogenic effects.

RL-007: Pro-Cognitive Neuromodulator for Cognitive Impairment Associated with Schizophrenia (CIAS)

RL-007 is an orally bioavailable compound that has demonstrated pro-cognitive effects in multiple pre-clinical and clinical studies, including two Phase 1 and two Phase 2 trials.
The ongoing Phase 2b study is evaluating 20mg and 40mg of RL-007 vs. placebo in patients living with CIAS. Topline results are expected mid-2025.

Recent Corporate Updates
Completed the acquisition of IntelGenx Corp.

IntelGenx is a drug delivery company focused on the development and manufacturing of novel oral thin film products for the pharmaceutical market and manufactures VLS-01 (buccal film DMT).
Neither equity nor cash from the Company was used to acquire IntelGenx.

Anticipated Upcoming R&D Catalysts

H2’24
VLS-01 TRD: Phase 2 initiation (around YE’24)
EMP-01 SAD: Phase 2 initiation (around YE’24)
BPL-003 alcohol use disorder (AUD): Phase 2a topline open-label data
ELE-101 major depressive disorder (MDD): Phase 2a topline open-label data
2025
BPL-003 TRD: Phase 2b topline data (Q2’25)
RL-007 cognitive impairment associated with schizophrenia (CIAS): Phase 2b topline data (mid’25)
VLS-01 TRD: Phase 2 topline data (around YE’25)
EMP-01 SAD: Phase 2 topline data (around YE’25)

Consolidated Financial Results
Cash, cash equivalents, and short-term securities (primarily US treasuries and government agency securities): As of September 30, 2024, the Company had cash, cash equivalents, restricted cash and short-term securities of $101.0 million compared to $154.2 million as of December 31, 2023. The decrease of $53.2 million was primarily driven by $58.1 million net cash used in operating activities, $10.0 million for the Beckley Psytech investment, and $7.7 million investment to advance our programs; partially offset by $16.1 million in proceeds from the partial sale of our ADSs holdings in Compass Pathway, and $5.0 million in proceeds from our committed term loan with Hercules Capital, Inc. The Company expects its cash, short-term securities, public equity holdings, and committed term loan facility to be sufficient to fund operations into 2026.

Research and development (R&D) expenses: R&D expenses were $12.4 million for the three months ended September 30, 2024, as compared to $13.3 million for the same prior year period. The year-over-year decrease of $0.9 million was primarily attributable to a decrease of $2.7 million in R&D personnel-related expenses, partially offset by an increase of $1.7 million in program-specific expenses. Within program-specific expenses, the increase was primarily driven by additional clinical trial expenses in the current year. The Company is anticipating R&D spend to increase as its R&D programs progress into later stage clinical trials.

General and administrative (G&A) expenses: G&A expenses for the three months ended September 30, 2024, were $10.3 million as compared to $13.6 million in the same prior year period. The year-over-year decrease of $3.3 million was primarily attributable to a $3.5 million decrease in personnel-related expenses and administrative costs. The Company expects the reduction in G&A spend over prior years to continue.

Net income (loss): Net loss attributable to stockholders for the three months ended September 30, 2024, was $26.3 million, which included $2.0 million of non-cash change in fair value of notes receivables and other investments and $5.0 million of non-cash share-based compensation. Net income attributable to stockholders for the three months ended September 30, 2023 was $44.2 million, which included a $69.0 million non-cash change in fair value of other investments related to an accounting change of our Compass Pathways plc investment and $8.3 million of non-cash share-based compensation.

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.

All major psychedelics – and more - in just one company

https://christianangermayer.substack.com/p/atai-life-sciences

Christian Angermayer
Feb 27, 2024

I originally published this blog post on January 10th on Linkedin. Today, the XBI Biotech Index (a stock market index that tracks the performance of companies primarily involved in the biotechnology sector) crossed 100. I stand by my prediction that biotech will be one of the best performing asset classes this year. A good occasion to re-post my views on atai Life Sciences. Enjoy reading!

Almost a year ago, in March 2023, I published a blog post about why I, as atai’s founder and its largest shareholder, had increased my stake in atai.

Everything I said then IMHO still stands the test of time. I would encourage you to revisit that post if you can find the time.

2024 has started with some very exciting news, so I thought it’s time for an update.

The past year: atai was hit hard by the “biotech winter”

Since its IPO in June 2021 and through the ‘biotech winter’, atai has been in a continuous downward trend. In my opinion, the main reason is that the last 18 months have been the worst biotech has seen in more than 20 years. Rising interest rates have warranted lower biotech valuations, and with the entire sector coming from a generational high, the severe drop in valuations across biotech stocks generally created carnage and distortion. The market went from one extreme – very high valuations in early 2021 – to the other with absurdly low valuations now.

In times of uncertainty and stress like these, investors adopt a ‘risk-off’ mentality and don’t seek exposure to especially innovative companies that are pursuing novel approaches and pushing the envelope. In a risk-averse environment, investors tend to stick with traditional treatment paradigms, which is why atai (Nasdaq: ATAI), in my opinion, whose drug portfolio requires a novel view on how to treat mental health issues, has suffered one of the hardest hits.

However, I believe the biotech industry as a whole will come back with force in 2024, which should also make investors revisit atai’s groundbreaking and innovative approach to addressing the treatment of mental health conditions.

For me personally, atai is the biggest entrepreneurial opportunity I have ever encountered. I believe that this company has an incredibly bright future and is well-positioned to make a meaningful difference in addressing one of humanity’s major challenges – the escalating global mental health crisis.

Needless to say, I have never sold any stock, but have continuously (and proudly) increased my stake in atai.

I am very optimistic that 2024 and the years to come will be great for atai. Since the beginning of the year, a re-rating of the stock has started, which I believe is just the beginning of a long-term change in sentiment to the better. Here is why:

1. Numbers first - atai is still trading close to cash + CMPS value

According to its most recent 10-Q filing, as of 30 September 2023, atai had approximately USD 194 million NET cash. Additionally, per its most recent 10-K , atai owns roughly 9.565m shares of Compass Pathways (Nasdaq: CMPS), which as of closing on Friday, 5 January 2024 (at closing price of USD 8.94) had a market value of roughly USD 85.5m. Hence, cash + CMPS stake alone makes USD 279.5m.

atai’s market cap as of closing on Monday, 8 January 2024, was approximately USD 335 million.

So, in other words, right now, investing in atai means investing in a company trading close to cash + CMPS and with a strong pipeline of eight (!) clinical-stage (!) mental health programs, and which (per its most recent public filings), has runway into 2026.

2. Novelty is an advantage, not a burden

The psychedelic treatment paradigm is indeed novel. It is not ‘pop a pill a day’ to put a band-aid over your struggles. It is ‘therapy combined with a psychedelic’ that aims to get to the root cause of a person’s trauma and help people truly get better.

Because of this difference in approach, I know that many investors have doubts about the rapid commercial success of psychedelic treatments once they are potentially approved. They cannot yet see the transformative potential psychedelic-assisted therapy offers for patients. I believe that if you offer outstanding value and outcomes, you will be paid accordingly. My own early discussions with insurance companies confirm my general view on the topic of reimbursement.

And then there is the ‘virality’ of psychedelic therapy: I personally know many people who have found significant healing in psychedelics – and almost all have since become advocates. Some have shared their stories only in their own private circles, while others have done so very publicly. I personally believe that, once approved, the market penetration will likely significantly outpace estimates, driven by exceptional patient outcomes and a passionate patient advocacy movement.

3. For patient access: the shorter, the better

When it comes to mental health, there is no ‘one size fits all’ solution. A suite of psychedelic-based treatment options will be needed to address the varieties of patient populations even within indications, such as depression. atai wants to provide that toolbox to therapists, so that they can decide which psychedelics might fit best the needs of the respective patient.

I believe that short-duration psychedelics - those that elicit psychedelic experiences of around or under two hours – will be especially important in driving access and scale. This is why I am excited by atai’s decision to expand its focus early-on. atai started with DMT already in 2019 and has now enlarged its portfolio to other shorter-duration psychedelics like 5-MeO-DMT and psilocin (more below).

Data to date suggests that short-duration psychedelics could offer clinical benefits comparable to longer-duration psychedelic compounds, but with shorter treatment times and reduced medical resource requirements. Additionally, I support atai’s belief that the two-hour interventional treatment window that has already been established by J&J’s SPRAVATO (esketamine) could potentially be leveraged for the commercial roll-out of short-duration psychedelics - if approved - in the future.

4. Strategic investment into Beckley Psytech

In this context, I am very excited to tell you more about atai’s recently announced strategic investment in Beckley Psytech, a private biopharmaceutical company focused on transforming short-duration psychedelics into clinical treatments.

atai acquired 35.5% of Beckley Psytech through a total investment of USD 50 million. In addition, atai received a 1:1 warrant coverage with a 30% premium on the primary issuances and has the right to appoint and hold three of nine seats on Beckley Psytech’s Board of Directors. If atai were to exercise its warrants, it would come close to owning 50% of Beckley Psytech.

Importantly, atai will hold a time-limited right of first refusal on any future sale of the company, asset sales, or other transfer of commercial rights, as well as an indefinite right of first negotiation for BPL-003 and ELE-101, highlighting the potential for an even closer collaboration of these two firms in the future.

Since its founding in 2018, atai has always had the ambition to be ‘THE’ psychedelics company. The psychedelic mothership, so to speak.

With the acquisition of the stake in Beckley, atai continues to cement and strengthen its position as the leading company focused on the renaissance of psychedelics globally, with a portfolio that I believe encompasses all major psychedelics with therapeutic use cases – what I call the Big Five, so to say:

· Psilocybin (& psilocin)

· DMT

· 5-MeO-DMT

· MDMA

· Ibogaine

While I take great pride in atai being one of the first companies to bring psychedelics back to the medical world in this century, we are indeed standing on the shoulders of giants who have been advocating for their therapeutic use since the 1960s.

Beckley’s founder, Lady Amanda Feilding, is one of these giants. Joining forces with Amanda, her family and her team makes me especially proud for atai.

5. Beckley adds two best-in-class drug candidates

The stake in Beckley brings BPL-003 (intranasal 5-MeO-DMT) and ELE-101 (intravenous psilocin) onto atai’s mental health innovation platform.

BPL-003 and ELE-101 are on-track for multiple anticipated clinical readouts within the next 12 months, including a Phase 2b readout of BPL-003 in treatment resistant depression (TRD), anticipated in the second half of 2024.

BPL-003 is a patent-protected, intranasal, dry powder formulation of 5-MeO-DMT. Three trials are currently ongoing with BPL-003, with a Phase 2b trial actively recruiting in the US under an IND that was accepted by the FDA in February of last year. Compared to other ways of administering 5-MeO-DMT, we believe the Beckley version is far superior.

ELE-101 is a patent-protected, intravenous formulation of psilocin, which is the active moiety in the body when psilocybin is administered orally. As such, we view ELE-101 as a relatively de-risked asset for its stage of development, as it leverages the robust proof-of-concept data that has been established with psilocybin across multiple trials.

It is currently being developed for the treatment of Major Depressive Disorder (MDD) and has the potential to offer the therapeutic benefits of psilocybin in a more consistent, controllable, and shorter (!) treatment paradigm of less than 2 hours. Initial results from the current ELE-01 Phase 1/2a study are anticipated in the first half of 2024.

6. Strong news flow pipeline

As I said earlier, I am very excited for 2024. Firstly, because I firmly believe the biotech market will come back with force and gusto. But more importantly, I’m excited because atai anticipates plenty of inflection points.

[?IMG]
7. R-MDMA is the new rising star in atai’s portfolio

In addition to the acquisition of the stake in Beckley, atai reported very good news for R-MDMA last week.

Fully in line with one of my life’s missions to ‘spread the love’, atai has been working on a new, improved version of MDMA over the past few years. As you might know, MDMA has shown strong therapeutic potential, especially in PTSD, and approval by the FDA of MAPS’ MDMA product is expected in 2024.

Last week, atai reported positive results from its Phase 1 study evaluating orally administered EMP-01, the R-enantiomer of MDMA. As stated in its most recent 10-K, atai has a range of patents pending on this moiety, as well as on derivatives and prodrugs of (R-)MDMA.

The goals of this Phase 1 study were to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EMP-01. EMP-01 was well-tolerated, and treatment-related adverse events (AEs) were all expected and generally dose dependent. There were no study discontinuations, and no serious or severe adverse effects were observed in the study.

Even better, EMP-01 administration resulted in a differentiated subjective experience compared to racemic MDMA on standard psychedelic experience questionnaires. Furthermore, dose dependent changes on measures of emotional breakthrough, a phenomenon thought to be a key mediator of the long-term psychological changes associated with psychedelics, were noted in this healthy volunteer population.

Building upon the decades of research into MDMA as a potential treatment for mental health disorders, including two positive Phase 3 studies in PTSD, I believe the unique characteristics of EMP-01 are very encouraging and look forward to exploring the implications for further clinical development.

8. A rich pipeline of novel psychedelics

I see the world of clinical psychedelics in three stages:

· First movers: These are Psilocybin (Compass) and MDMA (MAPS). atai is delighted to support their trailblazing efforts by being the largest single shareholder of Compass and as a donor to MAPS. They are doing the hard work, truly paving the way.

· Short-duration: The second generation will be imo shorter-duration psychedelic products that combine known short-acting psychedelic moieties - DMT, 5-MEO-DMT, and Psilocin—with proprietary formulation technologies that result in psychedelic experiences with rapid onset, a duration of 30-45 minutes, and resolution within 90 minutes.

· Third-generation: And then you have the third generation, which are completely novel compounds, optimizing to reduce side effects, treatment effects and practical matters like duration. atai’s R-MDMA program is the perfect example, and atai has a very rich pipeline of more of these third generation psychedelics coming up via its discovery engines.

Ibogaine stands out and is separate, being a very long duration psychedelic of more than 24 hours, requiring a clinical stay of 2-3 days. But in return, Ibogaine has the potential to be ‘disease modifying’ in substance-use-disorders, even in the most severe forms of this condition like opioid addiction for which existing therapies leave much to be desired.

9. And there’s more…

While I personally regard psychedelics as the most important and promising tool in fighting the mental health crisis, there are also very interesting non-psychedelic compounds that can play a role in supporting mental health. In its most recent public flings, atai has two such non-psychedelic drug development programs:

RL-007, a Pro-Cognitive Neuromodulator for Cognitive Impairment Associated with Schizophrenia (in phase 2b) and GRX-917, Deuterated Etifoxine for Anxiety Disorders (ready for phase 2).

You can find more info about those 2 programs in my 2023 blog post and on the atai website.

I personally believe these two non-psychedelic drugs are ‘gems within a goldmine’.

10. Being an atai shareholder makes the world a better and happier place

Over the years, many philanthropists have decided to support scientific research via non-profits. While I am a huge believer in the immense value of scientific research, when it comes to psychedelics, I believe thanks to decades of this scientific work there is now a robust evidence base to show that they work in treating mental health disorders.

Now it is all about bringing those treatments to the patients!

For this, we need clinical trials such as those that atai, Beckley, and Compass Pathways are running. The funding needed to bring psychedelics through the full FDA approval process is too big for non-profit work. A clear testament of this is the transformation of MAPS, the mother of all psychedelic non-profits, to a for-profit model under its new name, Lykos Therapeutics. This is the model needed to bring potentially transformative new treatments to patients successfully, safely, and quickly.

I am an investor in atai not just because of my conviction that it will pay off financially in a massive way, but because I believe in making the world a happier and better place.

The future is bright

I hope you can feel my excitement about the potential of atai. And I am not alone. atai is covered by 9 research analysts. The price targets of those analysts’ range between USD 6 and USD 21 per share.

I want to thank all fellow shareholders who have gone through the ups and downs of the atai share price together with me. As an investor, I am very confident in the potential of atai and am convinced that me and my fellow investors will be rewarded – with performance, and with knowing that we will have made a transformational difference for people suffering from mental health issues.

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