NEW YORK, Dec. 13, 2021 (GLOBE NEWSWIRE) — atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced it has been selected for addition to the Nasdaq Biotechnology Index (Nasdaq: NBI), effective as of market open on Monday, December 20, 2021. The NBI is a stock market index made up of securities of Nasdaq-listed companies classified according to the Industry Classification Benchmark as either Biotechnology or Pharmaceuticals which also meet other eligibility criteria.
The NBI is widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Exchange traded funds (ETFs) that track the NBI include the ProShares Ultra NASDAQ Biotechnology ETF (BIB), ProShares UltraShort NASDAQ Biotechnology ETF (BIS), Invesco NASDAQ Biotech UCITS ETF (SBIO), and iShares Nasdaq Biotechnology Index Fund (IBB), among others.
The NBI constituent basket has grown from 100 at the beginning of 2010 to 274 companies today. In terms of market capitalization for the overall group of companies in the NBI, the average was $5.7Bn, while the weighted average was $43.9 billion.
Companies listed in the NBI must be classified as Biotechnology & Pharmaceuticals by ICB (FTSE Russell’s Industry Classification Benchmark); have a minimum market capitalization of $200MM; demonstrate an average daily trading volume of at least 100,000 shares; and must be Nasdaq-listed. The index is modified market capitalization-weighted such that constituents are capped at 8% (for the top 5) and at 4% (for the remaining) at each quarterly index rebalance; the entire index is reviewed and reconstituted annually in December.
“We are proud to be included in the prestigious Nasdaq Biotechnology Index,” said Florian Brand, CEO and Co-Founder of atai Life Sciences. “Since our IPO in June, we have continued to make good progress against our clinical milestones. Being part of this index enables us to reach new audiences and further amplifies our vision: to heal mental health disorders so that everyone, everywhere can live a more fulfilled life.”
For more information about the NASDAQ Biotechnology Index visit www.nasdaq.com.
About atai Life Sciences atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was 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 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, seeking to effectively treat and ultimately heal mental health disorders.
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, London, and Berlin. For more information, please visit www.atai.life.
Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things: continued investor confidence in atai’s platform and its potential to serve the growing mental health crisis; the success, cost and timing of development of our product candidates; and our business strategy and plans. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond our control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.
We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including without limitation the important factors described in the section titled “Risk Factors” in our final prospectus, dated June 17, 2021, filed with the Securities and Exchange Commission (“SEC”) pursuant to Rule 424(b) under the Securities Act, and in our other filings with the SEC, that may cause our actual results, performance or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements. Any forward-looking statements made herein speak only as of the date of this press release, and you should not rely on forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, performance, or achievements reflected in the forward-looking statements will be achieved or will occur. Except as required by applicable law, we undertake no obligation to update any of these forward-looking statements for any reason after the date of this press release or to conform these statements to actual results or revised expectations.
Contact Information
Media Contact: Camilla Dormer VP, Communications Email:camilla@atai.life
Investor Contact: Chad Messer VP, Investor Relations Email: chad@atai.life
🍄 Psilocybin works twice as well as nicotine patches!
🍄 Two stock that could quadruple in price 📈
🍄 And more.
Be sure to check out this week’s Daily Mushroom podcast:
Can DMT really help cure addiction?
In this episode of the Daily Mushroom Podcast, we have David Mayoh, communication manager for Entheon Biomedical. David talks about how psychedelic therapy changed his life and how DMT can help those who are suffering from addiction.
GH Research (GHRS) discovered that the most powerful psychedelic, 5-MeO-DMT (aka toad venom), is highly effective at curing treatment-resistant depression.
Out of eight patients, seven were in remission from depression just one day after receiving the company’s proprietary formulation, and five of those were in remission in as little as two hours.
All eight patients showed improved depression scores, with an average reduction of 76%.
Dr. Matthew Johnson’s research found that 59% of nicotine-addicted patients remained abstinent from smoking for 12 months after receiving a single macrodose of psilocybin. Only 28% of patients on a nicotine patch remained abstinent for the same time period.
His other research shows that multiple psilocybin doses can have an 80% success rate!
A recent survey shows that spirituality increases with psychedelic use, and that increased spirituality is linked to improved emotional regulation. The findings suggest that better emotional regulation is associated with decreased scores for depression, anxiety, and disordered eating.
This semester, the University of Ottawa launched a three-course “microprogram” on Psychedelics and Spirituality. The school will offer a master’s program in psychedelics in the fall of 2022 and aims to develop a Ph.D. program after that!
Why?
“I was getting emails almost on a daily basis from people who wanted to know how they could become psychedelic therapists,” said Dr. Monica Williams, who created the program.
Delix Therapeutics, a private Boston-based company, is partnering with The National Institute on Drug Abuse (NIDA) to develop a treatment for substance abuse. The partnership will evaluate Delix’s non-hallucinogenic formulation of ibogaine, which has already shown promise of reducing alcohol- and heroin-seeking behavior.
BetterLife Pharma (BETR)found that its LSD formulation successfully increased exploratory and grooming behaviours in rats, two indicators of an antidepressant effect.
atai Life Sciences (ATAI) launched TryptageniX, a majority-owned joint venture with CB Therapeutics that will focus on discovering new compounds, both psychedelic and non-psychedelic.
Mycotopia Therapies (TPIA) is planning a $360M merger with Ei.Ventures to form PSLY.COM and intends to list on the NASDAQ. The new company would focus on Ei.Ventures’ flagship product Psilly, which combines psilocybin with other plant and fungi extracts for a synergistic effect.
Vine Ventures and MAPS formed a $70M special purpose vehicle called the Regenerative Financing Vine to fund MDMA research for PTSD and promote patient access.
The Drug Enforcement Administration (DEA) and National Institute On Drug Abuse (NIDA) showed support for Biden’s plan to accelerate research on cannabis and certain psychedelics. The plan would reduce the requirements to research Schedule I substances, making them more similar to the Schedule II requirements. Read more…
The majority of people are deficient in vitamin D. Mushrooms could provide a solution!
Wild mushrooms are rich in the vitamin, but commercial production (which is often done in the dark) reduces concentration levels.
Scientists discovered that exposing mushrooms to UV radiation can increase vitamin D levels to over 4,000% of your daily value per serving! The exposure also causes mushrooms to produce more antioxidants and anti-inflammatory molecules.
Industry Quick Hits
Dec 6 – Novamind (NM) Opens New Salt Lake City Clinic with Specialized Focus on Substance Use DisordersRead more…
Dec 6 – Mydecine (MYCO) Files Full Patent Application Covering Multiple Families of Psilocin Analogs Read more…
Dec 8 – Ketamine One (MEDI) Adds Seattle Location To US Clinical NetworkRead more…
Dec 8 – Silo Wellness (SILO) Announces U.S. DTC Eligibility Read more…
Dec 8 – Nue Life announces donations to MAPS and Ketamine Research Foundation Read more…
Dec 9 – Cannabis company Nextleaf Solutions (OILFF) Receives a Controlled Substance Dealers License Read more…
atai Life Sciences (ATAI) launched TryptageniX, a majority-owned joint venture with CB Therapeutics that will focus on discovering new compounds, both psychedelic and non-psychedelic.
TryptageniX, a majority-owned joint venture with CB Therapeutics, employs bioprospecting to develop new chemical entities with potential applications in mental health.
This new platform company will focus on the generation of intellectual property and further strengthen atai’s drug development pipeline of psychedelic and non-psychedelic compounds.
TryptageniX will also develop scalable and environmentally friendly biosynthetic manufacturing methods for atai’s naturally derived compounds.
NEW YORK, Dec. 09, 2021 (GLOBE NEWSWIRE) — atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced the launch of TryptageniX. This new platform company will specialize in both the discovery of new chemical entities (NCEs) for the atai pipeline through bioprospecting and on biosynthesis of atai’s naturally derived development candidates. Both approaches are expected to further strengthen atai’s already robust intellectual property (IP) portfolio spanning psychedelic and non-psychedelic compounds.
Bioprospecting refers to the search for natural products from which medicines can be developed, while biosynthesis is the production of complex molecules within living organisms or cells. Both are central to TryptageniX’s approach to the development of NCEs. In addition, the development of innovative biosynthetic methods will further optimize the scalability of compound manufacturing, allowing atai to address the escalating mental health crisis in an ecologically sustainable manner.1
“We are constantly seeking opportunities to further extend the capabilities of our platform,” said Florian Brand, Chief Executive Officer and Co-Founder of atai Life Sciences. “TryptageniX’s approach to drug discovery is highly complementary to that of EntheogeniX, our existing AI-enabled drug discovery company. The launch of TryptageniX demonstrates our ongoing commitment to harness the most promising scientific advancements of our age for the good of patients.”
“atai is delighted to be collaborating with CB Therapeutics to form TryptageniX,” said Srinivas Rao, Chief Scientific Officer and Co-Founder of atai Life Sciences. “We both share a strong commitment to driving novel approaches in the treatment of mental health disorders. This is yet another important step forward for atai in developing innovative and scalable solutions to serve the ever-growing needs of patients and support our dynamic clinical development strategy.”
“CB Therapeutics is very excited to be joining forces with atai Life Sciences with the launch of TryptageniX,” said Dr. Jacob Vogan, Chief Scientific Officer of CB Therapeutics. “It is our shared ambition that this platform will lead the way in exploring psychedelic-centric biosynthesis solutions and enable the discovery of important new chemical entities. Sensitivity to sustainability and the wider ecosystem is paramount, which we believe can be accomplished through innovative biosynthetic manufacturing methods for naturally derived compounds.”
“Our expertise in synthetic biology, precision fermentation, and downstream processing, along with the opening of our new world-class pilot facility will enable rapid development and deployment of much needed, cutting-edge solutions for mental health and wellness, and we are very excited to be at the forefront of this revolution,” said Sher Ali Butt, Chief Executive Officer of CB Therapeutics.
Naturally derived compounds play an important role across drug development for the central nervous system (CNS). TryptageniX will be a strong complement to atai’s existing drug discovery and development expertise, while also allowing atai to minimize its ecological footprint and ensure a sustainable supply chain for the future.
References:
Rehm J, Shield KD. Global Burden of Disease and the Impact of Mental and Addictive Disorders. Curr Psychiatry Rep. 2019;21(2):10.
About atai Life Sciences atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was 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 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, seeking to effectively treat and ultimately heal mental health disorders.
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, London, and Berlin. For more information, please visit www.atai.life.
Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things: statements regarding TryptageniX and biosynthetic NCE development, the success, cost and timing of development of our product candidates, including the progress of preclinical and clinical trials and related milestones; our business strategy and plans; potential acquisitions; and the plans and objectives of management for future operations and capital expenditures. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond our control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.
We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including without limitation: we are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception, and we anticipate that we will continue to incur significant losses for the foreseeable future; we will require substantial additional funding to achieve our business goals, and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our product development efforts; our limited operating history may make it difficult to evaluate the success of our business and to assess our future viability; we have never generated revenue and may never be profitable; our product candidates contain controlled substances, the use of which may generate public controversy; clinical and preclinical development is uncertain, and our preclinical programs may experience delays or may never advance to clinical trials; we rely on third parties to assist in conducting our clinical trials and some aspects of our research and preclinical testing, and those clinical trials, including progress and related milestones, may be impacted by several factors including the failure by such third parties to meet deadlines for the completion of such trials, research, or testing, changes to trial sites and other circumstances; we currently rely on qualified therapists working at third-party clinical trial sites to administer certain of our product candidates in our clinical trials and we expect this to continue upon approval, if any, of our current or future product candidates; if third-party sites fail to recruit and retain a sufficient number of therapists or effectively manage their therapists, our business, financial condition and results of operations would be materially harmed; we cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized; research and development of drugs targeting the central nervous system, or CNS, is particularly difficult, and it can be difficult to predict and understand why a drug has a positive effect on some patients but not others; we face significant competition in an environment of rapid technological and scientific change; third parties may claim that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and may prevent or delay our development and commercialization efforts; a change in our effective place of management may increase our aggregate tax burden; we identified material weaknesses in connection with our internal control over financial reporting; and a pandemic, epidemic, or outbreak of an infectious disease, such as the COVID-19 pandemic, may materially and adversely affect our business, including our preclinical studies, clinical trials, third parties on whom we rely, our supply chain, our ability to raise capital, our ability to conduct regular business and our financial results. Other risk factors include the important factors described in the section titled “Risk Factors” in our final prospectus, dated June 17, 2021, filed with the Securities and Exchange Commission (“SEC”) pursuant to Rule 424(b) under the Securities Act, and in our other filings with the SEC, that may cause our actual results, performance or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements.
Any forward-looking statements made herein speak only as of the date of this press release, and you should not rely on forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, performance, or achievements reflected in the forward-looking statements will be achieved or will occur. Except as required by applicable law, we undertake no obligation to update any of these forward-looking statements for any reason after the date of this press release or to conform these statements to actual results or revised expectations.
Contact Information
Media Contact: Camilla Dormer VP, Communications Email: camilla@atai.life
Investor Contact: Chad Messer VP, Investor Relations Email: chad@atai.life
🍄 More positive findings from biggest psilocybin trial
🍄 Psychedelic cream?
🍄 And more.
Be sure to check out this week’s Daily Mushroom podcast:
Why a psychedelic retreat might be the best vacation you’ve ever been on
In this episode of the Daily Mushroom Podcast, we have the CEO of Silo Wellness, Douglas Gordon. Silo Wellness offers legal, psychedelic retreats in Jamaica and Oregon. Their mission is heavily rooted in the education around the physical and mental benefits of mushrooms. We hope you enjoy this one!
Escitalopram (aka Lexapro) did not affect the way psilocybin was processed and helped reduce negative side effects like anxiety and high blood pressure.
COMPASS Pathways (CMPS) announced additional findings from the world’s largest psilocybin trial for depression.
In addition to reduced depression scores, patients showed improvements in anxiety, daily functioning, cognition, and quality of life. Just one day after the treatment, patients had increased positive feelings such as “interested, excited, strong” and decreased negative feelings like “distressed, upset, afraid.”
Psycheceutical Inc., a private Florida company, is developing a unique way to deliver psychedelics – through a cream or patch applied to the back of the neck. This method allows psychedelics to enter the brain in just 5-10 minutes without entering the bloodstream, which reduces negative side effects.
Quantified Citizen is a platform made in collaboration with Paul Stamets to accelerate health research. It allows anyone to participate in studies anonymously from their phone.
The platform was used to conduct the world’s largest mobile microdosing study, which revealed that microdosers exhibit lower levels of depression, anxiety, and stress.
For years, Brad Badelt suffered from debilitating cluster headaches (which are often called “suicide headaches” and described as the worst pain known to humans.
After seeing countless neurologists, chiropractors, acupuncturists, and naturopaths, he would still experience the horrible headaches several times a day for weeks on end.
After taking one dose of shrooms, things finally changed.
“When I woke the next morning, I felt different: the mental fog brought on by my cluster headaches was gone. For the next twelve months, I remained headache free. Every year since, I’ve downed a dose of shrooms, and every year my cluster headaches have remained in remission.”
It’s the ultimate tool to help you prepare for, navigate, and deeply integrate your psychedelic experiences. The journal features:
Prompts to discover your intentions and reflect on your trip
Dose tracking
Tips to support you along the journey
Colouring pages to unlock your creativity
If you want to start with microdosing rather than a full-on trip, the Wakeful Intention Journalis for you! It guides you through a 6-week microdosing protocol and helps you set intentions, notice patterns, and integrate your insights.
MYND Life Sciences (MYND) received $45,600 in government funding to support a psilocybin research project on treatment resistant depression and neuroinflammation. The project will run now until March 2022.
Novamind (NM)partnered with Bienstar Wellness to develop the first network of integrative mental health clinics in Latin America. The companies plan to bring psychedelic medicine to Uruguay, Brazil, Mexico, Peru, and Panama.
PharmaTher (PHRM) was granted a Japanese patent for KETBET, a combination of ketamine and betaine anhydrous that can be used for various mental health and pain disorders. Betaine anhydrous enhances the antidepressant effect of ketamine while reducing the side effects.
Telescope Innovations (TELI) acquired the rights to the University of British Columbia’s research on synthetic psilocybin in exchange for 1M common shares at $0.99 each.
Bright Minds Biosciences (DRUG) announced that its drug discovery program has synthesized hundreds of patentable psychedelic compounds. Researchers are optimizing the most encouraging molecules and aim to announce the lead molecule early next year.
Shanti Therapeutics, a subsidiary of Global Wellness (GWS), is awaiting ethics committee approval to conduct one of the first studies on MDMA for pain management.
These companies announced their financial highlights:
New Zealand is legalizing drug testing so users can check the purity of illegal substances. The services will be available at events like concerts and festivals. Read more…
The DEA is once again increasing the production quotas of these psychedelic drugs for 2022:
Psilocybin increased from 3,000 to 8,000 grams
Psilocin increased from 2,000 to 3,000 grams
MDMA increased from 3,200 to 8,200 grams
DMT increased from just 250 to 3,000 grams
The new limits will allow more researchers to study the drugs!Read more…
A Florida Rep. filed a bill to decriminalize all illegal substances and implement rehabilitative health intervention or civil fines instead. Read more…
Demonstrates atai’s confidence in COMPASS’ Phase 2b data and its potential for patients with treatment-resistant depression
Reinforces COMPASS as highly complementary to atai’s diversified approach to innovation in mental health
NEW YORK, Nov. 29, 2021 (GLOBE NEWSWIRE) — atai Life Sciences (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced that it has increased its ownership interest in COMPASS Pathways (“COMPASS”), from 19.4% to 20.8%.
This equity stake increase is a demonstration of atai’s confidence in COMPASS Pathways and in the potential of COMP360 in mental health care, following the recent COMP360 data in treatment-resistant depression (TRD). This solidifies atai’s position as COMPASS’ largest shareholder.
“We’ve supported COMPASS Pathways since the early days, when they were our very first psychedelic initiative, as part of our quest for more effective solutions for mental health patients. We believe this month’s Phase 2b data was a true milestone for innovation in mental health and COMP360 shows strong potential as a future treatment for patients with TRD,” said Florian Brand, Co-Founder and Chief Executive Officer of atai Life Sciences. “This further confirms our belief in COMPASS’ psilocybin-assisted psychotherapy as a valued part of our diversified approach to develop novel solutions for patients with unmet needs in mental health.”
“Today’s announcement underscores our belief in the potential of COMPASS and COMP360 in the future of mental health care. In my personal opinion, the market doesn’t seem to appreciate the full upside potential given these impressive COMP360 data, the size of the unmet patient need and the potential of COMPASS’ broad patent portfolio,” said Christian Angermayer, Founder and Chairman of atai Life Sciences.
Over 300 million people worldwide live with depression and, of these, a third struggle with TRD that cannot be managed by currently available options.1,2
COMPASS’s Phase 2b trial of COMP360 psilocybin in TRD is the largest and most robust trial ever to be conducted with psilocybin. Participants in this COMPASS trial had previously failed on two to four antidepressants. The 233-patient, 22-site, randomized, controlled, double-blind dose-controlled trial with COMP360 reported rapid and durable results in reducing depression, when combined with psychological support, and was generally well tolerated. A single 25mg dose achieved a 6.6 point reduction (vs 1mg), from baseline to week three, on the Montgomery-Åsberg Depression Rating Scale (MADRS) (p<0.001), successfully meeting the primary endpoint.
Most standard selective serotonin reuptake inhibitor (SSRI) antidepressants were approved on just a 2-3 MADRS point reduction in a general major depressive disorder patient population, and several weeks are typically required to show a significant benefit. Another comparable, intranasal esketamine has demonstrated only a 4 MADRS point reduction at 28 days vs. placebo in TRD (in third party studies), thus highlighting the potential of COMP360 in this challenging patient population.3-5
Despite the mounting problem of mental health in recent years, further compounded by the pandemic, innovation has been sorely lacking; only seven new treatments have been approved by the FDA for psychiatric disorders since 2015.6,7
In 2018, COMP360 received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for TRD.8 COMPASS has recently expanded the indications of interest to post-traumatic stress disorder and initiated an additional Phase 2 study. COMPASS also reported positive signals from an open-label investigator-initiated study in the U.S. of COMP360 for depression in cancer.9,10 COMPASS’ Phase 3 study of psilocybin in TRD is anticipated to launch in 2022. Furthermore, COMPASS is exploring the potential of COMP360 towards several further potential indications including type 2 bipolar disorder depression, anorexia nervosa, body dysmorphia, suicidal ideation and autism.
As we ultimately believe there is no one-size-fits-all solution in the treatment of mental health conditions, atai is progressing a pharmacologically-diverse array of programs, spanning psychedelics, non-psychedelics, and is developing innovative digital therapeutics to address the areas of highest unmet need in mental health. By developing COMP360 and other novel 5-HT2a agonists, COMPASS is highly complementary to our diversified platform and fully aligns with our vision to heal mental health disorders, so that everyone, everywhere can live a more fulfilled life.
References
1. World Health Organization. Depression. Published September 13, 2021. Accessed November 24, 2021. https://www.who.int/news-room/fact-sheets/detail/depression.
2. Pandarakalam JP. Challenges of Treatment-resistant Depression. Psychiatr Danub. 2018;30(3):273-284.
3. Kennedy SH, Andersen HF, Lam RW. Efficacy of escitalopram in the treatment of major depressive disorder compared with conventional selective serotonin reuptake inhibitors and venlafaxine XR: a meta-analysis [published correction appears in J Psychiatry Neurosci. 2006 Jul;31(4):228]. J Psychiatry Neurosci. 2006;31(2):122-131.
4. Mayo Clinic. Selective serotonin reuptake inhibitors (SSRIs). September 17, 2019. Accessed November 24, 2021. https://www.mayoclinic.org/diseases-conditions/depression/in-depth/ssris/art-20044825.
5. SPRAVATO (esketamine) nasal spray [Prescribing Information]. Titusville, NJ. Janssen Pharmaceuticals, Inc.
6. Abbott A. COVID’s mental-health toll: how scientists are tracking a surge in depression. Nature. 2021;590(7845):194-195.
7. EvaluatePharma (as of March 19, 2021). New drugs include new molecular entities or new active ingredients.
8. COMPASS Pathways receives FDA Breakthrough Therapy designation for psilocybin therapy for treatment-resistant depression. [Press Release] https://ir.compasspathways.com/news-events/news-releases. Published October 23, 2018. Accessed November 24, 2021.
9. COMPASS Pathways to launch phase II trial of COMP360 psilocybin therapy for post-traumatic stress disorder. [Press release] https://ir.compasspathways.com/news-releases/news-release-details/compass-pathways-launch-phase-ii-trial-comp360-psilocybin. Published November 3, 2021. Accessed November 24, 2021.
10. Open-label study of COMP360 psilocybin therapy for depression in cancer patients demonstrates feasibility of simultaneous psilocybin administration in small groups. [Press Release] https://ir.compasspathways.com/news-releases/news-release-details/open-label-study-comp360-psilocybin-therapy-depression-cancer. Published October 20, 2021. Accessed November 24, 2021.
About atai Life Sciences
atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was 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 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, seeking to effectively treat and ultimately heal mental health disorders.
atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai has offices in New York, London, and Berlin. For more information, please visit www.atai.life.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things: the success, cost and timing of development of our product candidates and COMPASS Pathways’ COMP360, including the progress of preclinical and clinical trials and related milestones; our business strategy and plans; potential acquisitions; and the plans and objectives of management for future operations and capital expenditures. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond our control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.
We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including without limitation: we are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception, and we anticipate that we will continue to incur significant losses for the foreseeable future; we will require substantial additional funding to achieve our business goals, and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our product development efforts; our limited operating history may make it difficult to evaluate the success of our business and to assess our future viability; we have never generated revenue and may never be profitable; our product candidates contain controlled substances, the use of which may generate public controversy; clinical and preclinical development is uncertain, and our preclinical programs may experience delays or may never advance to clinical trials; we rely on third parties to assist in conducting our clinical trials and some aspects of our research and preclinical testing, and those clinical trials, including progress and related milestones, may be impacted by several factors including the failure by such third parties to meet deadlines for the completion of such trials, research, or testing, changes to trial sites and other circumstances; we currently rely on qualified therapists working at third-party clinical trial sites to administer certain of our product candidates in our clinical trials and we expect this to continue upon approval, if any, of our current or future product candidates; if third-party sites fail to recruit and retain a sufficient number of therapists or effectively manage their therapists, our business, financial condition and results of operations would be materially harmed; we cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized; research and development of drugs targeting the central nervous system, or CNS, is particularly difficult, and it can be difficult to predict and understand why a drug has a positive effect on some patients but not others; we face significant competition in an environment of rapid technological and scientific change; third parties may claim that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and may prevent or delay our development and commercialization efforts; a change in our effective place of management may increase our aggregate tax burden; we identified material weaknesses in connection with our internal control over financial reporting; and a pandemic, epidemic, or outbreak of an infectious disease, such as the COVID-19 pandemic, may materially and adversely affect our business, including our preclinical studies, clinical trials, third parties on whom we rely, our supply chain, our ability to raise capital, our ability to conduct regular business and our financial results. Other risk factors include the important factors described in the section titled “Risk Factors” in our final prospectus, dated June 17, 2021, filed with the Securities and Exchange Commission (“SEC”) pursuant to Rule 424(b) under the Securities Act, and in our other filings with the SEC, that may cause our actual results, performance or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements.
Any forward-looking statements made herein speak only as of the date of this press release, and you should not rely on forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, performance, or achievements reflected in the forward-looking statements will be achieved or will occur. Except as required by applicable law, we undertake no obligation to update any of these forward-looking statements for any reason after the date of this press release or to conform these statements to actual results or revised expectations.
Contact Information
For atai:
Media Contact:
Camilla Dormer
VP, Communications, atai Life Sciences
Email: camilla@atai.life
Investor Contact:
Chad Messer
VP, Investor Relations, atai Life Sciences
Email: chad@atai.life
Demonstrates atai’s confidence in COMPASS’ Phase 2b data and its potential for patients with treatment-resistant depression
Reinforces COMPASS as highly complementary to atai’s diversified approach to innovation in mental health
NEW YORK, Nov. 29, 2021 (GLOBE NEWSWIRE) — atai Life Sciences (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced that it has increased its ownership interest in COMPASS Pathways (“COMPASS”), from 19.4% to 20.8%.
This equity stake increase is a demonstration of atai’s confidence in COMPASS Pathways and in the potential of COMP360 in mental health care, following the recent COMP360 data in treatment-resistant depression (TRD). This solidifies atai’s position as COMPASS’ largest shareholder.
“We’ve supported COMPASS Pathways since the early days, when they were our very first psychedelic initiative, as part of our quest for more effective solutions for mental health patients. We believe this month’s Phase 2b data was a true milestone for innovation in mental health and COMP360 shows strong potential as a future treatment for patients with TRD,” said Florian Brand, Co-Founder and Chief Executive Officer of atai Life Sciences. “This further confirms our belief in COMPASS’ psilocybin-assisted psychotherapy as a valued part of our diversified approach to develop novel solutions for patients with unmet needs in mental health.”
“Today’s announcement underscores our belief in the potential of COMPASS and COMP360 in the future of mental health care. In my personal opinion, the market doesn’t seem to appreciate the full upside potential given these impressive COMP360 data, the size of the unmet patient need and the potential of COMPASS’ broad patent portfolio,” said Christian Angermayer, Founder and Chairman of atai Life Sciences.
Over 300 million people worldwide live with depression and, of these, a third struggle with TRD that cannot be managed by currently available options.1,2
COMPASS’s Phase 2b trial of COMP360 psilocybin in TRD is the largest and most robust trial ever to be conducted with psilocybin. Participants in this COMPASS trial had previously failed on two to four antidepressants. The 233-patient, 22-site, randomized, controlled, double-blind dose-controlled trial with COMP360 reported rapid and durable results in reducing depression, when combined with psychological support, and was generally well tolerated. A single 25mg dose achieved a 6.6 point reduction (vs 1mg), from baseline to week three, on the Montgomery-Åsberg Depression Rating Scale (MADRS) (p<0.001), successfully meeting the primary endpoint.
Most standard selective serotonin reuptake inhibitor (SSRI) antidepressants were approved on just a 2-3 MADRS point reduction in a general major depressive disorder patient population, and several weeks are typically required to show a significant benefit. Another comparable, intranasal esketamine has demonstrated only a 4 MADRS point reduction at 28 days vs. placebo in TRD (in third party studies), thus highlighting the potential of COMP360 in this challenging patient population.3-5
Despite the mounting problem of mental health in recent years, further compounded by the pandemic, innovation has been sorely lacking; only seven new treatments have been approved by the FDA for psychiatric disorders since 2015.6,7
In 2018, COMP360 received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for TRD.8 COMPASS has recently expanded the indications of interest to post-traumatic stress disorder and initiated an additional Phase 2 study. COMPASS also reported positive signals from an open-label investigator-initiated study in the U.S. of COMP360 for depression in cancer.9,10 COMPASS’ Phase 3 study of psilocybin in TRD is anticipated to launch in 2022. Furthermore, COMPASS is exploring the potential of COMP360 towards several further potential indications including type 2 bipolar disorder depression, anorexia nervosa, body dysmorphia, suicidal ideation and autism.
As we ultimately believe there is no one-size-fits-all solution in the treatment of mental health conditions, atai is progressing a pharmacologically-diverse array of programs, spanning psychedelics, non-psychedelics, and is developing innovative digital therapeutics to address the areas of highest unmet need in mental health. By developing COMP360 and other novel 5-HT2a agonists, COMPASS is highly complementary to our diversified platform and fully aligns with our vision to heal mental health disorders, so that everyone, everywhere can live a more fulfilled life.
References
1. World Health Organization. Depression. Published September 13, 2021. Accessed November 24, 2021. https://www.who.int/news-room/fact-sheets/detail/depression. 2. Pandarakalam JP. Challenges of Treatment-resistant Depression. Psychiatr Danub. 2018;30(3):273-284. 3. Kennedy SH, Andersen HF, Lam RW. Efficacy of escitalopram in the treatment of major depressive disorder compared with conventional selective serotonin reuptake inhibitors and venlafaxine XR: a meta-analysis [published correction appears in J Psychiatry Neurosci. 2006 Jul;31(4):228]. J Psychiatry Neurosci. 2006;31(2):122-131. 4. Mayo Clinic. Selective serotonin reuptake inhibitors (SSRIs). September 17, 2019. Accessed November 24, 2021. https://www.mayoclinic.org/diseases-conditions/depression/in-depth/ssris/art-20044825. 5. SPRAVATO (esketamine) nasal spray [Prescribing Information]. Titusville, NJ. Janssen Pharmaceuticals, Inc. 6. Abbott A. COVID’s mental-health toll: how scientists are tracking a surge in depression. Nature. 2021;590(7845):194-195. 7. EvaluatePharma (as of March 19, 2021). New drugs include new molecular entities or new active ingredients. 8. COMPASS Pathways receives FDA Breakthrough Therapy designation for psilocybin therapy for treatment-resistant depression. [Press Release] https://ir.compasspathways.com/news-events/news-releases. Published October 23, 2018. Accessed November 24, 2021. 9. COMPASS Pathways to launch phase II trial of COMP360 psilocybin therapy for post-traumatic stress disorder. [Press release] https://ir.compasspathways.com/news-releases/news-release-details/compass-pathways-launch-phase-ii-trial-comp360-psilocybin. Published November 3, 2021. Accessed November 24, 2021. 10. Open-label study of COMP360 psilocybin therapy for depression in cancer patients demonstrates feasibility of simultaneous psilocybin administration in small groups. [Press Release] https://ir.compasspathways.com/news-releases/news-release-details/open-label-study-comp360-psilocybin-therapy-depression-cancer. Published October 20, 2021. Accessed November 24, 2021.
About atai Life Sciences
atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was 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 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, seeking to effectively treat and ultimately heal mental health disorders.
atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai has offices in New York, London, and Berlin. For more information, please visit www.atai.life.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things: the success, cost and timing of development of our product candidates and COMPASS Pathways’ COMP360, including the progress of preclinical and clinical trials and related milestones; our business strategy and plans; potential acquisitions; and the plans and objectives of management for future operations and capital expenditures. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond our control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.
We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including without limitation: we are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception, and we anticipate that we will continue to incur significant losses for the foreseeable future; we will require substantial additional funding to achieve our business goals, and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our product development efforts; our limited operating history may make it difficult to evaluate the success of our business and to assess our future viability; we have never generated revenue and may never be profitable; our product candidates contain controlled substances, the use of which may generate public controversy; clinical and preclinical development is uncertain, and our preclinical programs may experience delays or may never advance to clinical trials; we rely on third parties to assist in conducting our clinical trials and some aspects of our research and preclinical testing, and those clinical trials, including progress and related milestones, may be impacted by several factors including the failure by such third parties to meet deadlines for the completion of such trials, research, or testing, changes to trial sites and other circumstances; we currently rely on qualified therapists working at third-party clinical trial sites to administer certain of our product candidates in our clinical trials and we expect this to continue upon approval, if any, of our current or future product candidates; if third-party sites fail to recruit and retain a sufficient number of therapists or effectively manage their therapists, our business, financial condition and results of operations would be materially harmed; we cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized; research and development of drugs targeting the central nervous system, or CNS, is particularly difficult, and it can be difficult to predict and understand why a drug has a positive effect on some patients but not others; we face significant competition in an environment of rapid technological and scientific change; third parties may claim that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and may prevent or delay our development and commercialization efforts; a change in our effective place of management may increase our aggregate tax burden; we identified material weaknesses in connection with our internal control over financial reporting; and a pandemic, epidemic, or outbreak of an infectious disease, such as the COVID-19 pandemic, may materially and adversely affect our business, including our preclinical studies, clinical trials, third parties on whom we rely, our supply chain, our ability to raise capital, our ability to conduct regular business and our financial results. Other risk factors include the important factors described in the section titled “Risk Factors” in our final prospectus, dated June 17, 2021, filed with the Securities and Exchange Commission (“SEC”) pursuant to Rule 424(b) under the Securities Act, and in our other filings with the SEC, that may cause our actual results, performance or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements.
Any forward-looking statements made herein speak only as of the date of this press release, and you should not rely on forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, performance, or achievements reflected in the forward-looking statements will be achieved or will occur. Except as required by applicable law, we undertake no obligation to update any of these forward-looking statements for any reason after the date of this press release or to conform these statements to actual results or revised expectations.
Contact Information
For atai:
Media Contact: Camilla Dormer VP, Communications, atai Life Sciences Email: camilla@atai.life
Investor Contact: Chad Messer VP, Investor Relations, atai Life Sciences Email: chad@atai.life
Be sure to check out this week’s Daily Mushroom podcast:
Functional Mushrooms for Health & Nutrition with FreshCap CEO Tony Shields
In the episode of the Daily Mushroom Podcast, we have Tony Shields, CEO of FreshCap. Tony’s knowledge on mushrooms is deep and expansive and stems from a childhood fascination with these magnificent fungi. If you want to learn more about the benefits of functional mushrooms, this podcast is for you.
Psychedelic drug users had less psychological distress and more social support during pandemic lockdowns, according to a recent Tilburg University survey.
Users were more likely to spend time outdoors, maintain healthy diets, meditate, play music, and do yoga. Non-users spent more time watching TV and following COVID news.
Clearmind Medicine’s (CMND) proprietary compound could treat alcohol addiction, but that’s not all. It is now being evaluated to treat other addictive behaviours such as compulsive consumption of food, television, technology, shopping, gambling, and even sex.
A study discovered that psilocybin can reduce the odds of alcohol relapse!
How does it work? Alcohol reduces a protein in the brain called mGluR2. In a rat model, researchers found that the more protein lost, the more alcohol the rats craved, creating an addictive cycle.
Psilocybin was able to restore protein levels, thus decreasing relapses.
A survey shows that parents, especially those who have experienced mental illness, are very open to ketamine therapy for children. The average acceptance score was 7/10 and over 60% said they would allow their child to try ketamine therapy to treat depression.
Allied Corp. (ALID) sourced the active ingredients to produce Psilonex™, its formulation of psilocybin, functional mushrooms, and vitamins. It will be used in conjunction with a daily dose of CBD in an upcoming clinical trial on depression, anxiety, and PTSD.
Way2Grow Biopharma, a private BC company, received a license from Health Canada to create a psychedelic production campus. The company can produce up to $30 worth of compounds to sell to pharmacies and clinics.
Delic (DELC) launched a free, virtual education program to teach the families of ketamine therapy patients how they can best support their loved ones through the healing journey.
These companies announced their quarterly highlights:
A psychiatrist is suing the Australian state of Victoria for denying a patient access to MDMA-assisted therapy. The case has been adjourned until early next year, as the government may decide to reschedule MDMA from a Schedule 9 to a Schedule 8 substance.
Researchers in Australia are training oyster mushrooms to digest cigarette butts, including their microplastics. The goal is to turn some of the 4.5 trillion cigarette butts that are littered annually into a reusable material!
Made with organic Lion’s Mane mushrooms to support cognition, immune-boosting Chaga, and stress-relieving Ashwagandha, it’s everything you love about coffee – made even better.
Use promo code DAILY for 10% off your order at FreshCaps.com!
You’re welcome in advance 😉
Industry Quick Hits
Nov 15 – Lobe Sciences Announces Common Stock to Trade Under the Symbol “LOBEF” in US MarketsRead more…
Nov 16 – Michael J. Fox Foundation Donates $2M to Fund Ketamine Trial to Treat Depression in Patients with Parkinson’s Disease Read more…
Nov 16 – Ketamine One (MEDI) Subsidiary IRP Health Opens Two New Veteran-Focused Clinics in Comox Valley and OttawaRead more…
Nov 17 – Pasithea Therapeutics (KTTA) Expands At-Home Ketamine Therapy to New York City, Los Angeles, San Diego, and San Francisco Read more…
Nov 19 – Numinus to Begin Trading on the OTC Under Symbol “NUMIF” Read more…
Nov 19 – PsyBio Therapeutics Furthers Intellectual Property Portfolio with Six New Manufacturing Patent Applications Read more…
-Positive topline results from COMP360’s Phase 2b study-
-RL-007 Phase 2a topline data in cognitive impairment associated with schizophrenia expected end of Q4-
-Continued progress across 11 therapeutic programs, including initiation ofPerception’s Phase 2a and DemeRx’s Phase 1/2 trials as well as interim Phase 2a RL-007 readout of first cohort-
-Launch of atai Impact, a philanthropic program to harness the power of innovative mental health approaches for social change-
-Company to host a webcast and conference call today at 08:30am EST-
BERLIN and NEW YORK, Nov. 15, 2021 (GLOBE NEWSWIRE) — atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today reported its financial results for the third quarter ended September 30, 2021, and provided its corporate update.
“Following our IPO in June, we continue to see positive momentum. We have 11 therapeutic programs underway and each clinical development milestone marks progress towards achieving our vision to heal mental health disorders so that everyone, everywhere can live a more fulfilled life,” said Florian Brand, CEO and Co-Founder.
“In response to the heterogeneity of the mental health patient population, we are developing a pharmacologically diverse array of treatments. We intend to support these treatments with innovative digital therapeutics and robust insights from our multi-modal data approach. Our ultimate goal is to tailor our treatments to individual patient needs by using a diverse set of biomarkers. We anticipate further growth of our drug development pipeline and our enabling technologies through our ‘buy and build’ approach and will remain highly active in business development.
“We recently initiated two new clinical trials: a Phase 2a trial with PCN-101 (R-ketamine) for treatment-resistant depression and a Phase 1/2 trial with DMX-1002 (ibogaine) in opioid use disorder. In terms of clinical readouts, just last week we saw positive Phase 2b data from COMPASS Pathways, the first company we funded to rigorously research the potential of psychedelics. This clinical trial demonstrated the rapid onset of effect, large effect size, and durability of COMP360 (a proprietary synthetic formulation of psilocybin) in treatment-resistant depression. We expect another important clinical readout before the end of the year for RL-007 in cognitive impairment associated with schizophrenia.
“The narrow focus on mental health treatments means that every single trial result offers important insights not only for the program in question but for all our programs, allowing us to accelerate the development of novel treatments for patients in need.”
Program Updates
COMP360 (psilocybin): Program Details: COMP360 is a proprietary formulation of synthetic psilocybin, a 5-HT2A-R agonist being developed as an oral, potentially rapid-acting antidepressant.
Recent Advancements:
In November, COMPASS announced positive topline results from its Phase 2b randomized, controlled, double-blind, dose-controlled trial of COMP360 psilocybin therapy for treatment-resistant depression.
The 233-patient study met its primary endpoint, showing a 6.6-point reduction on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to 3 weeks when comparing the 25mg dose to the 1mg dose.
COMP360 also showed both rapid response and durability of efficacy. Rapid onset of action with statistically significant treatment differences between the 25mg vs 1mg groups were apparent the day after COMP360 psilocybin administration. Responder rates at week 12 based upon a ≥50% decrease in MADRS total score from baseline were 32.9% and 16.4% for psilocybin doses of 25mg and 1mg respectively. Remitter rates at week 12 based upon a MADRS total score ≤10 were 26.6% and 11.4% for psilocybin doses of 25mg and 1mg respectively.
COMP360 was generally well tolerated.
Upcoming Milestones:
A pivotal Phase 3 study is anticipated to launch in 2022.
Affiliate: COMPASS Pathways
PCN-101 (R-ketamine): Program Details: PCN-101 is a parenteral formulation of R-ketamine, a glutamatergic modulator being developed as a potentially rapid-acting antidepressant, with the potential for at-home treatment.
Recent Advancements:
In September 2021, Perception Neuroscience initiated the Phase 2 trial of PCN-101 (R-ketamine) for TRD. This randomized, double blind, placebo-controlled trial is designed to assess the efficacy, safety, dose response and duration of action in patients with TRD.
Upcoming Milestones:
Topline data are expected at the end of 2022.
Affiliate: Perception Neuroscience
RL-007: Program Details: RL-007, a cholinergic, glutamatergic and GABA-B receptor modulator, is an orally available compound that is being developed for the treatment of cognitive impairments associated with schizophrenia (CIAS). The currently active open-label, multi-dose, biomarker-focused Phase 2a trial of RL-007 in patients with CIAS is designed to evaluate the compound’s safety, tolerability and its impact on electroencephalogram-based biomarkers.
Recent Advancements:
Following the encouraging results of a recently completed interim analysis of Quantitative Electroencephalogram (qEEG) data from the eight patients in the first cohort, atai advanced a portion of a future milestone payment aiming to accelerate initiation of the subsequent trial, which, broadly, will be a double-blind, placebo controlled, proof-of-concept study focused on more traditional cognitive endpoints, including subsets of the MATRICS battery.
Upcoming Milestones:
Topline data are expected by the end of 2021.
Affiliate: Recognify Life Sciences
GRX-917 (deuterated etifoxine): Program Details: GRX-917 is an oral formulation of a deuterated version of etifoxine, a mitochondrial translocator protein agonist, designed to provide potentially rapid anxiolytic activity with improved tolerability compared to current treatments for anxiety in the United States.
Recent Advancements:
The Phase 1 randomized, double blind, placebo-controlled trial of GRX-917 is designed to evaluate the compound’s safety, tolerability, pharmacokinetics, as well as pharmacodynamics using qEEG. We have recently completed the single ascending dose (SAD) component of the trial, and dosing in the multiple ascending dose (MAD) component is ongoing.
Upcoming Milestones:
Topline data are expected in mid-2022.
Affiliate: GABA Therapeutics
DMX-1002 (ibogaine): Program Details: DMX-1002 is an oral formulation of ibogaine, a cholinergic, glutamatergic and monoaminergic receptor modulator being developed for the treatment of opioid use disorder (OUD).
Recent Advancements:
In September 2021, DemeRx IB dosed the first subject in a Phase 1/2a trial of DMX-1002. This trial is designed to assess the safety, tolerability, pharmacokinetics, and efficacy of DMX-1002 and will inform future studies in patients with OUD.
Upcoming Milestones
Topline safety data are expected in early 2022.
Affiliate: DemeRx IB
Q3 and Recent Corporate Updates Discovery Programs
Launched PsyProtix, a precision psychiatry company creating new chemical entities targeting mitochondrial dysfunction related to TRD and other mental health conditions. PsyProtix is currently engaged in discovery and preclinical development and expects to launch clinical trials in 2023.
Created and pharmacologically tested over 250 novel compounds at EntheogeniX based upon structures generated using computational chemistry approach. Lead candidate selection is currently ongoing.
Formulation Technologies
Entered into an expanded agreement with strategic partner IntelGenx, building on positive early feasibility data, to support IntelGenx’s graduation from the TSX Venture Exchange to the Toronto Stock Exchange. As part of the strategic partnership, IntelGenx has exclusively partnered with atai to develop formulations of compounds for the prevention or treatment of mental health disorders.
Completed a proof-of-principle study demonstrating that InnarisBio’s sol-gel based excipient technology can effectively transport compounds from the nose directly to the brain in an animal model. InnarisBio is developing its nose-to-brain excipient technology to facilitate potentially rapid, non-invasive entry into the brain for use across various drug candidates in atai’s pipeline, including Revixia, Neuronasal, and DemeRx.
Digital Therapeutics
Initiated a user acceptability testing of our digital therapeutics (DTx) app, one of our key enabling technologies, in patients with TRD receiving ketamine treatment.
In addition, we have assembled a proof-of-concept, EEG- and VR-based digital therapeutic device to support patients undergoing psychedelic therapy, and we have kicked off user feedback testing to optimize across product parameters.
Both technologies are expected to be implemented in Viridia and Revixia Phase 1 trials and DemeRx IB Phase 2 trial starting next year.
New Initiatives
Launched atai Impact, atai’s philanthropic program, established to support and collaborate with nonprofits and institutions that share atai Life Sciences’ vision, with the key pillars of: advancing education, expanding access, and supporting the wider ecosystem of mental health care. atai Impact has an initial focus on the psychedelics sector, given its emerging potential in tackling the growing mental health crisis. Its formation is underpinned by atai’s belief that harmonization across commercial and non-profit entities represents the best path forward to harness the power of innovative mental health approaches for positive social change. The atai Impact program will be initially funded by 1% of the gross proceeds from our June 2021 IPO and founders’ and shareholders’ contributions.
Third Quarter 2021 Financial Results
Cash and Cash Equivalents
Cash and cash equivalents totaled $430.3 million as of September 30, 2021, compared to $97.2 million as of December 31, 2020. The nine month increase of $333.1 million is attributed to net proceeds of $231.6 million from atai’s IPO, net proceeds of $166.4 million from Series C and Series D and common stock issuances, $20.0 million of license revenue proceeds, and $10.1 million proceeds from the sale of investments and issuance and conversion of convertible notes. Offsetting were cash payments of $32.6 million for investments in platform companies and other assets, and $62.4 million in net operating expenses and effect of foreign exchange rate changes.
Operating Costs and Expenses
Research and development (R&D) expenses were $13.4 million and $35.0 million for the three and nine months ended September 30, 2021, respectively, as compared to $3.1 million and $8.1 million for the same prior year periods. The increase of $10.3 million and $26.9 million, respectively, were attributable to personnel costs, including stock-based compensation expense, and increased contract research organization expenses related to advancements in atai’s R&D programs.
atai recorded acquisition of in-process R&D expense of $9.0 million for the nine months ended September 30, 2021, relating to its investments in Neuronasal and InnarisBio.
General and administrative expenses for the three and nine months ended September 30, 2021 were $20.3 million and $66.9 million, respectively, as compared to $4.3 million and $8.7 million in the same prior year periods. The increases of $16.0 million and $58.2 million, respectively, were attributable to personnel costs, including stock-based compensation expense, professional fees, and other costs related to support of atai’s platform growth and public company requirements.
Total stock-based compensation expense for the three and nine months ended September 30, 2021 was $12.2 million and $50.0 million, respectively, as compared to $2.1 and $2.2 for the comparable prior year periods, reflecting the recognition of expense related to the achievement of IPO performance-based partial vesting conditions.
Net loss attributable to atai shareholders for the three and nine months ended September 30, 2021 was $31.2 million and $78.9 million, respectively, as compared to $83.2 million and $83.2 million for the comparable prior year periods.
Conference Call Information
atai will host a conference call and live audio webcast today at 08:30am EST to discuss its financial results and provide a corporate update. To access the live conference call, please dial 877-407-3982 from the United States, or +1 (201) 493-6780 internationally, using the conference ID: 13724750. The live and archived webcast of this call will be available in the “Events” section of the atai Life Sciences website at ir.atai.life. An archived copy of the webcast will be available on the atai website for at least 30 days after the conference call.
About atai Life Sciences
atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was 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 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, seeking to effectively treat and ultimately heal mental health disorders.
atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai is headquartered in Berlin, with offices in New York and London. For more information, please visit www.atai.life.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “anticipate,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, our future operating results and financial position; the success, cost and timing of development of our product candidates, including the progress of preclinical and clinical trials and related milestones; the commercialization of our current product candidates and any other product candidates we may identify and pursue, if approved, including our ability to successfully build a specialty sales force and commercial infrastructure to market our current product candidates and any other product candidates we may identify and pursue; the timing of and our ability to obtain and maintain regulatory approvals; our business strategy and plans; potential acquisitions; and the plans and objectives of management for future operations and capital expenditures. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond our control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.
We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including without limitation: we are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception, and we anticipate that we will continue to incur significant losses for the foreseeable future; we will require substantial additional funding to achieve our business goals, and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our product development efforts; our limited operating history may make it difficult to evaluate the success of our business and to assess our future viability; we have never generated revenue and may never be profitable; our product candidates contain controlled substances, the use of which may generate public controversy; clinical and preclinical development is uncertain, and our preclinical programs may experience delays or may never advance to clinical trials; we rely on third parties to assist in conducting our clinical trials and some aspects of our research and preclinical testing, and those clinical trials, including progress and related milestones, may be impacted by several factors including the failure by such third parties to meet deadlines for the completion of such trials, research, or testing, changes to trial sites and other circumstances; we currently rely on qualified therapists working at third-party clinical trial sites to administer certain of our product candidates in our clinical trials and we expect this to continue upon approval, if any, of our current or future product candidates; if third-party sites fail to recruit and retain a sufficient number of therapists or effectively manage their therapists, our business, financial condition and results of operations would be materially harmed; we cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized; research and development of drugs targeting the central nervous system, or CNS, is particularly difficult, and it can be difficult to predict and understand why a drug has a positive effect on some patients but not others; we face significant competition in an environment of rapid technological and scientific change; third parties may claim that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and may prevent or delay our development and commercialization efforts; a change in our effective place of management may increase our aggregate tax burden; we identified material weaknesses in connection with our internal control over financial reporting; and a pandemic, epidemic, or outbreak of an infectious disease, such as the COVID-19 pandemic, may materially and adversely affect our business, including our preclinical studies, clinical trials, third parties on whom we rely, our supply chain, our ability to raise capital, our ability to conduct regular business and our financial results. Other risk factors include the important factors described in the section titled “Risk Factors” in our final prospectus, dated June 17, 2021, filed with the Securities and Exchange Commission (“SEC”) pursuant to Rule 424(b) under the Securities Act, and in our other filings with the SEC, that may cause our actual results, performance or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements.
Any forward-looking statements made herein speak only as of the date of this press release, and you should not rely on forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, performance, or achievements reflected in the forward-looking statements will be achieved or will occur. Except as required by applicable law, we undertake no obligation to update any of these forward-looking statements for any reason after the date of this press release or to conform these statements to actual results or revised expectations.
Contact Information
Media Contact:
Camilla Dormer
VP, Communications, atai Life Sciences
Email: camilla@atai.life
Investor Contact:
Chad Messer
VP, Investor Relations, atai Life Sciences
Email: chad@atai.life
ATAI LIFE SCIENCES N.V.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share amounts)
(unaudited)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2021
2020
2021
2020
License revenue
$
266
$
–
$
20,146
$
–
Operating expenses:
Research and development
13,363
3,058
34,974
8,056
Acquisition of in-process research and development
–
–
8,934
120
General and administrative
20,264
4,328
66,868
8,749
Total operating expenses
33,627
7,386
110,776
16,925
Loss from operations
(33,361
)
(7,386
)
(90,630
)
(16,925
)
Other income (expense), net
6,887
(13,942
)
2,608
6,352
Net loss before income taxes
(26,474
)
(21,328
)
(88,022
)
(10,573
)
Provision for income taxes
(368
)
(4
)
(432
)
(4
)
Gain on investment dilution
–
–
16,923
–
Losses from investments in equity method investees, net of tax
(4,800
)
(61,862
)
(9,440
)
(73,693
)
Net loss
(31,642
)
(83,194
)
(80,971
)
(84,270
)
Net income (loss) attributable to redeemable noncontrolling
interests and noncontrolling interests
(484
)
1
(2,040
)
(1,021
)
Net loss attributable to ATAI Life Sciences N.V. stockholders
$
(31,158
)
$
(83,195
)
$
(78,931
)
$
(83,249
)
Net loss per share attributable to ATAI Life Sciences N.V. stockholders– basic and diluted
$
(0.21
)
$
(0.92
)
$
(0.59
)
$
(0.92
)
Weighted average common shares outstanding attributable to ATAI Life Sciences N.V.
stockholders — basic and diluted
151,130,212
90,709,312
134,334,685
90,709,312
ATAI LIFE SCIENCES N.V.
CONDENSED CONSOLIDATED BALANCE SHEET
(Amounts in thousands)
September 30,
December 31,
2021
2020
(unaudited)
(1)
Assets
Cash and cash equivalents
$
430,308
$
97,246
Prepaid expenses and other current assets
11,551
2,076
Short term notes receivable – related party
–
226
Property and equipment, net
138
71
Deferred offering costs
–
1,575
Equity method investments
15,086
–
Other investments held at fair value
6,816
–
Other investments
14,256
8,044
Long term notes receivable
908
911
Long term notes receivable – related parties
3,784
1,060
Other assets
1,262
339
Total assets
$
484,109
$
111,548
Liabilities and Stockholders’ Equity
Accounts payable
$
1,974
$
3,083
Accrued liabilities
13,075
9,215
Current portion of contingent consideration liability – related parties
50
–
Deferred revenue
180
–
Short-term notes payable
38
–
Non-current portion of contingent consideration liability – related parties
1,947
1,705
Convertible promissory notes – related parties, net of discounts and deferred issuance costs
800
1,199
Convertible promissory notes and derivative liability
–
978
Other liabilities
3,285
–
Total stockholders’ equity attributable to ATAI Life Sciences N.V. stockholders
453,186
90,822
Noncontrolling interests
9,574
4,546
Total liabilities and stockholders’ equity
$
484,109
$
111,548
(1) The condensed consolidated financial statements as of and for the year ended December 31, 2020 are derived from the audited consolidated financial statements as of that date.
-Positive topline results from COMP360’s Phase 2b study-
-RL-007 Phase 2a topline data in cognitive impairment associated with schizophrenia expected end of Q4-
-Continued progress across 11 therapeutic programs, including initiation ofPerception’s Phase 2a and DemeRx’s Phase 1/2 trials as well as interim Phase 2a RL-007 readout of first cohort-
-Launch of atai Impact, a philanthropic program to harness the power of innovative mental health approaches for social change-
-Company to host a webcast and conference call today at 08:30am EST-
BERLIN and NEW YORK, Nov. 15, 2021 (GLOBE NEWSWIRE) — atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today reported its financial results for the third quarter ended September 30, 2021, and provided its corporate update.
“Following our IPO in June, we continue to see positive momentum. We have 11 therapeutic programs underway and each clinical development milestone marks progress towards achieving our vision to heal mental health disorders so that everyone, everywhere can live a more fulfilled life,” said Florian Brand, CEO and Co-Founder.
“In response to the heterogeneity of the mental health patient population, we are developing a pharmacologically diverse array of treatments. We intend to support these treatments with innovative digital therapeutics and robust insights from our multi-modal data approach. Our ultimate goal is to tailor our treatments to individual patient needs by using a diverse set of biomarkers. We anticipate further growth of our drug development pipeline and our enabling technologies through our ‘buy and build’ approach and will remain highly active in business development.
“We recently initiated two new clinical trials: a Phase 2a trial with PCN-101 (R-ketamine) for treatment-resistant depression and a Phase 1/2 trial with DMX-1002 (ibogaine) in opioid use disorder. In terms of clinical readouts, just last week we saw positive Phase 2b data from COMPASS Pathways, the first company we funded to rigorously research the potential of psychedelics. This clinical trial demonstrated the rapid onset of effect, large effect size, and durability of COMP360 (a proprietary synthetic formulation of psilocybin) in treatment-resistant depression. We expect another important clinical readout before the end of the year for RL-007 in cognitive impairment associated with schizophrenia.
“The narrow focus on mental health treatments means that every single trial result offers important insights not only for the program in question but for all our programs, allowing us to accelerate the development of novel treatments for patients in need.”
Program Updates
COMP360 (psilocybin): Program Details: COMP360 is a proprietary formulation of synthetic psilocybin, a 5-HT2A-R agonist being developed as an oral, potentially rapid-acting antidepressant.
Recent Advancements:
In November, COMPASS announced positive topline results from its Phase 2b randomized, controlled, double-blind, dose-controlled trial of COMP360 psilocybin therapy for treatment-resistant depression.
The 233-patient study met its primary endpoint, showing a 6.6-point reduction on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to 3 weeks when comparing the 25mg dose to the 1mg dose.
COMP360 also showed both rapid response and durability of efficacy. Rapid onset of action with statistically significant treatment differences between the 25mg vs 1mg groups were apparent the day after COMP360 psilocybin administration. Responder rates at week 12 based upon a ≥50% decrease in MADRS total score from baseline were 32.9% and 16.4% for psilocybin doses of 25mg and 1mg respectively. Remitter rates at week 12 based upon a MADRS total score ≤10 were 26.6% and 11.4% for psilocybin doses of 25mg and 1mg respectively.
COMP360 was generally well tolerated.
Upcoming Milestones:
A pivotal Phase 3 study is anticipated to launch in 2022.
Affiliate: COMPASS Pathways
PCN-101 (R-ketamine): Program Details: PCN-101 is a parenteral formulation of R-ketamine, a glutamatergic modulator being developed as a potentially rapid-acting antidepressant, with the potential for at-home treatment.
Recent Advancements:
In September 2021, Perception Neuroscience initiated the Phase 2 trial of PCN-101 (R-ketamine) for TRD. This randomized, double blind, placebo-controlled trial is designed to assess the efficacy, safety, dose response and duration of action in patients with TRD.
Upcoming Milestones:
Topline data are expected at the end of 2022.
Affiliate: Perception Neuroscience
RL-007: Program Details: RL-007, a cholinergic, glutamatergic and GABA-B receptor modulator, is an orally available compound that is being developed for the treatment of cognitive impairments associated with schizophrenia (CIAS). The currently active open-label, multi-dose, biomarker-focused Phase 2a trial of RL-007 in patients with CIAS is designed to evaluate the compound’s safety, tolerability and its impact on electroencephalogram-based biomarkers.
Recent Advancements:
Following the encouraging results of a recently completed interim analysis of Quantitative Electroencephalogram (qEEG) data from the eight patients in the first cohort, atai advanced a portion of a future milestone payment aiming to accelerate initiation of the subsequent trial, which, broadly, will be a double-blind, placebo controlled, proof-of-concept study focused on more traditional cognitive endpoints, including subsets of the MATRICS battery.
Upcoming Milestones:
Topline data are expected by the end of 2021.
Affiliate: Recognify Life Sciences
GRX-917 (deuterated etifoxine): Program Details: GRX-917 is an oral formulation of a deuterated version of etifoxine, a mitochondrial translocator protein agonist, designed to provide potentially rapid anxiolytic activity with improved tolerability compared to current treatments for anxiety in the United States.
Recent Advancements:
The Phase 1 randomized, double blind, placebo-controlled trial of GRX-917 is designed to evaluate the compound’s safety, tolerability, pharmacokinetics, as well as pharmacodynamics using qEEG. We have recently completed the single ascending dose (SAD) component of the trial, and dosing in the multiple ascending dose (MAD) component is ongoing.
Upcoming Milestones:
Topline data are expected in mid-2022.
Affiliate: GABA Therapeutics
DMX-1002 (ibogaine): Program Details: DMX-1002 is an oral formulation of ibogaine, a cholinergic, glutamatergic and monoaminergic receptor modulator being developed for the treatment of opioid use disorder (OUD).
Recent Advancements:
In September 2021, DemeRx IB dosed the first subject in a Phase 1/2a trial of DMX-1002. This trial is designed to assess the safety, tolerability, pharmacokinetics, and efficacy of DMX-1002 and will inform future studies in patients with OUD.
Upcoming Milestones
Topline safety data are expected in early 2022.
Affiliate: DemeRx IB
Q3 and Recent Corporate Updates Discovery Programs
Launched PsyProtix, a precision psychiatry company creating new chemical entities targeting mitochondrial dysfunction related to TRD and other mental health conditions. PsyProtix is currently engaged in discovery and preclinical development and expects to launch clinical trials in 2023.
Created and pharmacologically tested over 250 novel compounds at EntheogeniX based upon structures generated using computational chemistry approach. Lead candidate selection is currently ongoing.
Formulation Technologies
Entered into an expanded agreement with strategic partner IntelGenx, building on positive early feasibility data, to support IntelGenx’s graduation from the TSX Venture Exchange to the Toronto Stock Exchange. As part of the strategic partnership, IntelGenx has exclusively partnered with atai to develop formulations of compounds for the prevention or treatment of mental health disorders.
Completed a proof-of-principle study demonstrating that InnarisBio’s sol-gel based excipient technology can effectively transport compounds from the nose directly to the brain in an animal model. InnarisBio is developing its nose-to-brain excipient technology to facilitate potentially rapid, non-invasive entry into the brain for use across various drug candidates in atai’s pipeline, including Revixia, Neuronasal, and DemeRx.
Digital Therapeutics
Initiated a user acceptability testing of our digital therapeutics (DTx) app, one of our key enabling technologies, in patients with TRD receiving ketamine treatment.
In addition, we have assembled a proof-of-concept, EEG- and VR-based digital therapeutic device to support patients undergoing psychedelic therapy, and we have kicked off user feedback testing to optimize across product parameters.
Both technologies are expected to be implemented in Viridia and Revixia Phase 1 trials and DemeRx IB Phase 2 trial starting next year.
New Initiatives
Launched atai Impact, atai’s philanthropic program, established to support and collaborate with nonprofits and institutions that share atai Life Sciences’ vision, with the key pillars of: advancing education, expanding access, and supporting the wider ecosystem of mental health care. atai Impact has an initial focus on the psychedelics sector, given its emerging potential in tackling the growing mental health crisis. Its formation is underpinned by atai’s belief that harmonization across commercial and non-profit entities represents the best path forward to harness the power of innovative mental health approaches for positive social change. The atai Impact program will be initially funded by 1% of the gross proceeds from our June 2021 IPO and founders’ and shareholders’ contributions.
Third Quarter 2021 Financial Results
Cash and Cash Equivalents Cash and cash equivalents totaled $430.3 million as of September 30, 2021, compared to $97.2 million as of December 31, 2020. The nine month increase of $333.1 million is attributed to net proceeds of $231.6 million from atai’s IPO, net proceeds of $166.4 million from Series C and Series D and common stock issuances, $20.0 million of license revenue proceeds, and $10.1 million proceeds from the sale of investments and issuance and conversion of convertible notes. Offsetting were cash payments of $32.6 million for investments in platform companies and other assets, and $62.4 million in net operating expenses and effect of foreign exchange rate changes.
Operating Costs and Expenses Research and development (R&D) expenses were $13.4 million and $35.0 million for the three and nine months ended September 30, 2021, respectively, as compared to $3.1 million and $8.1 million for the same prior year periods. The increase of $10.3 million and $26.9 million, respectively, were attributable to personnel costs, including stock-based compensation expense, and increased contract research organization expenses related to advancements in atai’s R&D programs.
atai recorded acquisition of in-process R&D expense of $9.0 million for the nine months ended September 30, 2021, relating to its investments in Neuronasal and InnarisBio.
General and administrative expenses for the three and nine months ended September 30, 2021 were $20.3 million and $66.9 million, respectively, as compared to $4.3 million and $8.7 million in the same prior year periods. The increases of $16.0 million and $58.2 million, respectively, were attributable to personnel costs, including stock-based compensation expense, professional fees, and other costs related to support of atai’s platform growth and public company requirements.
Total stock-based compensation expense for the three and nine months ended September 30, 2021 was $12.2 million and $50.0 million, respectively, as compared to $2.1 and $2.2 for the comparable prior year periods, reflecting the recognition of expense related to the achievement of IPO performance-based partial vesting conditions.
Net loss attributable to atai shareholders for the three and nine months ended September 30, 2021 was $31.2 million and $78.9 million, respectively, as compared to $83.2 million and $83.2 million for the comparable prior year periods.
Conference Call Information atai will host a conference call and live audio webcast today at 08:30am EST to discuss its financial results and provide a corporate update. To access the live conference call, please dial 877-407-3982 from the United States, or +1 (201) 493-6780 internationally, using the conference ID: 13724750. The live and archived webcast of this call will be available in the “Events” section of the atai Life Sciences website at ir.atai.life. An archived copy of the webcast will be available on the atai website for at least 30 days after the conference call.
About atai Life Sciences atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was 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 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, seeking to effectively treat and ultimately heal mental health disorders.
atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai is headquartered in Berlin, with offices in New York and London. For more information, please visit www.atai.life.
Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “anticipate,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, our future operating results and financial position; the success, cost and timing of development of our product candidates, including the progress of preclinical and clinical trials and related milestones; the commercialization of our current product candidates and any other product candidates we may identify and pursue, if approved, including our ability to successfully build a specialty sales force and commercial infrastructure to market our current product candidates and any other product candidates we may identify and pursue; the timing of and our ability to obtain and maintain regulatory approvals; our business strategy and plans; potential acquisitions; and the plans and objectives of management for future operations and capital expenditures. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond our control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.
We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including without limitation: we are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception, and we anticipate that we will continue to incur significant losses for the foreseeable future; we will require substantial additional funding to achieve our business goals, and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our product development efforts; our limited operating history may make it difficult to evaluate the success of our business and to assess our future viability; we have never generated revenue and may never be profitable; our product candidates contain controlled substances, the use of which may generate public controversy; clinical and preclinical development is uncertain, and our preclinical programs may experience delays or may never advance to clinical trials; we rely on third parties to assist in conducting our clinical trials and some aspects of our research and preclinical testing, and those clinical trials, including progress and related milestones, may be impacted by several factors including the failure by such third parties to meet deadlines for the completion of such trials, research, or testing, changes to trial sites and other circumstances; we currently rely on qualified therapists working at third-party clinical trial sites to administer certain of our product candidates in our clinical trials and we expect this to continue upon approval, if any, of our current or future product candidates; if third-party sites fail to recruit and retain a sufficient number of therapists or effectively manage their therapists, our business, financial condition and results of operations would be materially harmed; we cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized; research and development of drugs targeting the central nervous system, or CNS, is particularly difficult, and it can be difficult to predict and understand why a drug has a positive effect on some patients but not others; we face significant competition in an environment of rapid technological and scientific change; third parties may claim that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and may prevent or delay our development and commercialization efforts; a change in our effective place of management may increase our aggregate tax burden; we identified material weaknesses in connection with our internal control over financial reporting; and a pandemic, epidemic, or outbreak of an infectious disease, such as the COVID-19 pandemic, may materially and adversely affect our business, including our preclinical studies, clinical trials, third parties on whom we rely, our supply chain, our ability to raise capital, our ability to conduct regular business and our financial results. Other risk factors include the important factors described in the section titled “Risk Factors” in our final prospectus, dated June 17, 2021, filed with the Securities and Exchange Commission (“SEC”) pursuant to Rule 424(b) under the Securities Act, and in our other filings with the SEC, that may cause our actual results, performance or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements.
Any forward-looking statements made herein speak only as of the date of this press release, and you should not rely on forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, performance, or achievements reflected in the forward-looking statements will be achieved or will occur. Except as required by applicable law, we undertake no obligation to update any of these forward-looking statements for any reason after the date of this press release or to conform these statements to actual results or revised expectations.
Contact Information
Media Contact: Camilla Dormer VP, Communications, atai Life Sciences Email: camilla@atai.life
Investor Contact: Chad Messer VP, Investor Relations, atai Life Sciences Email: chad@atai.life
ATAI LIFE SCIENCES N.V.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share amounts)
(unaudited)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2021
2020
2021
2020
License revenue
$
266
$
–
$
20,146
$
–
Operating expenses:
Research and development
13,363
3,058
34,974
8,056
Acquisition of in-process research and development
–
–
8,934
120
General and administrative
20,264
4,328
66,868
8,749
Total operating expenses
33,627
7,386
110,776
16,925
Loss from operations
(33,361
)
(7,386
)
(90,630
)
(16,925
)
Other income (expense), net
6,887
(13,942
)
2,608
6,352
Net loss before income taxes
(26,474
)
(21,328
)
(88,022
)
(10,573
)
Provision for income taxes
(368
)
(4
)
(432
)
(4
)
Gain on investment dilution
–
–
16,923
–
Losses from investments in equity method investees, net of tax
(4,800
)
(61,862
)
(9,440
)
(73,693
)
Net loss
(31,642
)
(83,194
)
(80,971
)
(84,270
)
Net income (loss) attributable to redeemable noncontrolling
interests and noncontrolling interests
(484
)
1
(2,040
)
(1,021
)
Net loss attributable to ATAI Life Sciences N.V. stockholders
$
(31,158
)
$
(83,195
)
$
(78,931
)
$
(83,249
)
Net loss per share attributable to ATAI Life Sciences N.V. stockholders– basic and diluted
$
(0.21
)
$
(0.92
)
$
(0.59
)
$
(0.92
)
Weighted average common shares outstanding attributable to ATAI Life Sciences N.V. stockholders — basic and diluted
151,130,212
90,709,312
134,334,685
90,709,312
ATAI LIFE SCIENCES N.V.
CONDENSED CONSOLIDATED BALANCE SHEET
(Amounts in thousands)
September 30,
December 31,
2021
2020
(unaudited)
(1)
Assets
Cash and cash equivalents
$
430,308
$
97,246
Prepaid expenses and other current assets
11,551
2,076
Short term notes receivable – related party
–
226
Property and equipment, net
138
71
Deferred offering costs
–
1,575
Equity method investments
15,086
–
Other investments held at fair value
6,816
–
Other investments
14,256
8,044
Long term notes receivable
908
911
Long term notes receivable – related parties
3,784
1,060
Other assets
1,262
339
Total assets
$
484,109
$
111,548
Liabilities and Stockholders’ Equity
Accounts payable
$
1,974
$
3,083
Accrued liabilities
13,075
9,215
Current portion of contingent consideration liability – related parties
50
–
Deferred revenue
180
–
Short-term notes payable
38
–
Non-current portion of contingent consideration liability – related parties
1,947
1,705
Convertible promissory notes – related parties, net of discounts and deferred issuance costs
800
1,199
Convertible promissory notes and derivative liability
–
978
Other liabilities
3,285
–
Total stockholders’ equity attributable to ATAI Life Sciences N.V. stockholders
453,186
90,822
Noncontrolling interests
9,574
4,546
Total liabilities and stockholders’ equity
$
484,109
$
111,548
(1) The condensed consolidated financial statements as of and for the year ended December 31, 2020 are derived from the audited consolidated financial statements as of that date.
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