ATAI Life Sciences (NASDAQ:ATAI) Stock

ATAI Life Sciences

ATAI Life Sciences NV is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. Its product candidates include COMP360/Psilocybin therapy, PCN-101/R-ketamine, RL-007/Compound, DMX-1002/Ibogaine, GRX-917/Deuterated etifoxine, VLS-01/DMT, EMP-01/MDMA derivative, RLS-01/Salvinorin A, KUR-101/Deuterated Mitragynine, and DMX-1001/Noribogaine. The business operates geographically in two regions being the United States and Germany.

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Trade Desk Posts Downbeat Revenue, Joins Aspen Aerogels, Fastly And Other Big Stocks Moving Lower In Thursday&#39;s Pre-Market Session

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Why AppLovin Shares Are Trading Higher By Around 29%; Here Are 20 Stocks Moving Premarket

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AI and psychedelic medicine are merging, with research showing AI&#39;s role in drug discovery, trials, and personalized mental health care.

AI And Psychedelics: A Marriage Made In Heaven For Mental Health Care?

ATAI Life Sciences NV

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ATAI Life Sciences shares are trading lower after the company announced the pricing of a $55 million public offering of 26.19 million shares at $2.10 per share.

U.S. stock futures were mixed this morning, with the Nasdaq futures gaining around 0.1% on Thursday.
Shares of The Trade Desk, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TTD#NASDAQ">TTD</a>) fell sharply in today's pre-market trading after the company reported <a href="https://in.benzinga.com/news/earnings/25/02/43675459/the-trade-desk-stock-drops-after-q4-revenues-miss-estimates-details">worse-than-expected quarterly revenue results.</a>
Trade Desk reported quarterly earnings of 59 cents per share, which beat the analyst consensus estimate of 56 cents. Quarterly revenue came in at $741.01 million, which missed the analyst consensus estimate of $758.93 million.
Trade Desk shares tumbled 27% to $89.34 in the pre-market trading session.
Here are some other stocks moving lower in pre-market trading.
<ul>
<li>Aspen Aerogels, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ASPN#NYSE">ASPN</a>) shares fell 30.6% to $8.15 in pre-market trading after the company issued first-quarter guidance below estimates.</li>
<li>Fastly, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/FSLY#NYSE">FSLY</a>) shares tumbled 20.6% to $8.00 in pre-market trading. Fastly reported a fourth-quarter loss of 3 cents per share, down from earnings of 1 cent per share in the prior year&#8217;s quarter. Quarterly revenue came in at $140.58 million, beating the $138.27 million analyst consensus estimate. Fastly expects first-quarter losses of between 9 cents and 5 cents per share, versus the loss of 1 cent estimate, and revenue in a range of $136 million to $140 million, versus the $137.05 million estimate.</li>
<li>Atai Life Sciences N.V. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATAI#NASDAQ">ATAI</a>) fell 14.5% to $2.1800 in pre-market trading after the company announced the pricing of public offering of common shares.</li>
<li>Reddit, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/RDDT#NYSE">RDDT</a>) fell 14.1% to $185.94 in pre-market trading after the company reported fourth-quarter results.</li>
<li>Open Lending Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LPRO#NASDAQ">LPRO</a>) shares dipped 13% to $5.02 in pre-market trading.</li>
<li>British American Tobacco p.l.c. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BTI#NYSE">BTI</a>) fell 9.6% to $38.66 in pre-market trading.</li>
<li>Unilever PLC (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/UL#NYSE">UL</a>) declined 6.8% to $55.14 in pre-market trading as the company reported 2024 underlying sales growth of 4.2%.</li>
<li>Pegasystems Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PEGA#NASDAQ">PEGA</a>) fell 6.2% to $99.50 in pre-market trading following fourth-quarter results.</li>
<li>Lionsgate Studios Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LION#NASDAQ">LION</a>) slipped 3.3% to $8.27 in pre-market trading.</li>
</ul>
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Trade Desk Posts Downbeat Revenue, Joins Aspen Aerogels, Fastly And Other Big Stocks Moving Lower In Thursday's Pre-Market Session

HC Wainwright &amp; Co. analyst Patrick Trucchio reiterates ATAI Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATAI#NASDAQ">ATAI</a>) with a Buy and maintains $10 price target.

Price Target

Reiteration

Analyst Ratings

HC Wainwright & Co. Reiterates Buy on ATAI Life Sciences, Maintains $10 Price Target

Shares of AppLovin Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/APP#NASDAQ">APP</a>) rose sharply in today's pre-market trading after the company reported better-than-expected fourth-quarter financial results and issued first-quarter revenue guidance <a href="https://www.benzinga.com/news/earnings/25/02/43676556/applovin-stock-soars-on-q4-earnings-revenue-beat-eps-beat-strong-guidance-and-more">above estimates</a>.
Applovin reported fourth-quarter revenue of $1.37 billion, beating analyst estimates of $1.26 billion, according to Benzinga Pro. The company reported fourth-quarter earnings of $1.73 per share, beating analyst estimates of $1.25 per share.
AppLovin shares jumped 28.9% to $490.10 in the pre-market trading session.
Here are some other stocks moving in pre-market trading.
<h3 class="wp-block-heading">Gainers</h3>
<ul>
<li>Phoenix Motor Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PEV#NASDAQ">PEV</a>) gained 81.2% to $0.4570 in pre-market trading after the company said third-quarter revenue jumped 1,557% year-over-year to $4.77 million.</li>
<li>Tivic Health Systems, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TIVC#NASDAQ">TIVC</a>) rose 42% to $0.9937 in pre-market trading. Tivic Health Systems shares jumped 198% on Wednesday after the company announced it acquired the exclusive license rights from Statera Biopharma for its Phase III TLR5 agonist entolimod treatment of acute radiation syndrome.</li>
<li>Avinger, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AVGR#NASDAQ">AVGR</a>) shares jumped 45.6% to $0.6701 in pre-market trading.</li>
<li>MGO Global, Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MGOL#NASDAQ">MGOL</a>) gained 38.5% to $0.6326 in pre-market trading after dipping 24% on Wednesday.</li>
<li>ProPhase Labs, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PRPH#NASDAQ">PRPH</a>) gained 26% to $0.3535 in pre-market following a 7% gain in the previous session.</li>
<li>Dutch Bros Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BROS#NYSE">BROS</a>) shares climbed 24.6% to $80.72 in pre-market trading following better-than-expected fourth-quarter financial results.</li>
<li>Twin Disc, Incorporated (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TWIN#NASDAQ">TWIN</a>) gained 19.4% to $11.99 in pre-market trading after dipping 10% on Wednesday.</li>
<li>Robinhood Markets, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HOOD#NASDAQ">HOOD</a>) gained 15.6% to $64.72 in pre-market trading after the company reported better-than-expected quarterly financial results.</li>
<li>CEVA, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CEVA#NYSE">CEVA</a>) gained 8.5% to $34.41 in pre-market trading.</li>
</ul>
<h3 class="wp-block-heading">Losers</h3>
<ul>
<li>Aspen Aerogels, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ASPN#NYSE">ASPN</a>) shares fell 30.6% to $8.15 in pre-market trading after the company issued first-quarter guidance below estimates.</li>
<li>The Trade Desk, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TTD#NASDAQ">TTD</a>) dipped 27% to $89.34 in pre-market trading after the company reported worse-than-expected quarterly revenue results.</li>
<li>Omega Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OMGA#NASDAQ">OMGA</a>) fell 24.6% to $0.1960 in today's pre-market trading after surging 35% on Wednesday. Omega Therapeutics' restructuring committee recently approved a workforce reduction of up to 17 employees for cost-reduction amid a Chapter 11 case and potential asset sale.</li>
<li>NKGen Biotech, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NKGN#NASDAQ">NKGN</a>) shares fell 24.4% to $0.6363 in pre-market trading. NKGen Biotech shares jumped 122% on Wednesday after the company received FDA Fast Track designation for Troculeucel for the treatment of moderate Alzheimer&#8217;s disease.</li>
<li>Mynaric AG (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MYNA#NASDAQ">MYNA</a>) fell 23.7% to $0.4730 in pre-market trading after jumping 134% on Wednesday.</li>
<li>Fastly, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/FSLY#NYSE">FSLY</a>) shares tumbled 20.6% to $8.00 in pre-market trading. Fastly reported a fourth-quarter loss of 3 cents per share, down from earnings of 1 cent per share in the prior year&#8217;s quarter. Quarterly revenue came in at $140.58 million, beating the $138.27 million analyst consensus estimate. Fastly expects first-quarter losses of between 9 cents and 5 cents per share, versus the loss of 1 cent estimate, and revenue in a range of $136 million to $140 million, versus the $137.05 million estimate.</li>
<li>Solaris Resources Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SLSR#NYSE">SLSR</a>) declined 18.1% to $3.30 in pre-market trading.</li>
<li>Atai Life Sciences N.V. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATAI#NASDAQ">ATAI</a>) fell 14.5% to $2.1800 in pre-market trading after the company announced the pricing of public offering of common shares.</li>
<li>Reddit, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/RDDT#NYSE">RDDT</a>) fell 14.1% to $185.94 in pre-market trading after the company reported fourth-quarter results.</li>
<li>Open Lending Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LPRO#NASDAQ">LPRO</a>) shares dipped 13% to $5.02 in pre-market trading.</li>
</ul>
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Reported Earlier, atai Life Sciences Prices Public Offering Of 26.19M Common Shares At $2.10 Each, Raising $55M

ATAI Life Sciences shares are trading lower after the company commenced a proposed offering worth $55 million of common stock.

Offerings

ATAI Life Sciences Commences Proposed Registered Underwritten Offering Of $55M Of Its Common Shares

Co Reports: - A single dose of BPL-003, combined with relapse prevention therapy, produced meaningful and sustained reductions in alcohol use, with 50% of patients maintaining complete abstinence out to three months
- BPL-003 was well-tolerated with no serious or severe adverse events reported

Biotech

General

Atai Life Sciences Highlights Topline Results From Beckley Psytech's BPL-003 Phase 2a Open-Label Study For Alcohol Use Disorder

HC Wainwright &amp; Co. analyst Patrick Trucchio maintains ATAI Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATAI#NASDAQ">ATAI</a>) with a Buy and lowers the price target from $15 to $10.

HC Wainwright & Co. Maintains Buy on ATAI Life Sciences, Lowers Price Target to $10

Canaccord Genuity analyst Sumant Kulkarni maintains ATAI Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATAI#NASDAQ">ATAI</a>) with a Buy and maintains $11 price target.

Canaccord Genuity Maintains Buy on ATAI Life Sciences, Maintains $11 Price Target

Advanced <a href="https://www.benzinga.com/topic/ai">AI</a> has evolved over decades through research in computer science, neuroscience and machine learning. Early AI was rule-based, but breakthroughs in data processing, neural networks and deep learning have enhanced its ability to recognize patterns and learn from experience. With advances in algorithms, AI now handles complex tasks like healthcare diagnostics and personalized mental health treatments, paving the way for integration with <a href="https://www.benzinga.com/topic/psychedelic-assisted-therapies">psychedelic therapies</a>. 
According to a new <a href="https://nyaspubs.onlinelibrary.wiley.com/doi/full/10.1111/nyas.15229">white paper</a> from Psychae Therapeutics, a Melbourne-based pharmaceutical company, the application of AI for the <a href="https://www.benzinga.com/general/biotech/24/05/38768537/from-hype-to-reality-ai-reshapes-pharmaceutical-industry-across-drug-discovery-to-marketing-stock">discovery and development of new drugs</a> could reshape the future of mental health care. As Double Blind <a href="https://doubleblindmag.com/ai-is-changing-psychedelic-medicine/">reported</a>, the paper explores the potential of AI to revolutionize psychedelic medicine, highlighting the significant progress already underway.
<h3 class="wp-block-heading">Accelerating Drug Discovery With AI</h3>
AI is revolutionizing drug discovery by rapidly screening thousands of compounds to identify new psychedelic medicines. This speeds up the process of predicting a drug's effects, safety and efficacy, helping develop treatments that maintain therapeutic benefits while reducing side effects.
Pharmaceutical companies are already utilizing AI for drug discovery. For instance, researchers at the University of California-San Francisco recently <a href="https://www.benzinga.com/general/biotech/24/05/38711266/google-deepmind-develops-latest-ai-model-to-aid-scientists-in-fighting-disease">used AI program AlphaFold</a> to identify hundreds of thousands of potential new psychedelic compounds, which could be promising candidates for treating mental health disorders like depression.
<h3 class="wp-block-heading">Enhancing Clinical Trials Through AI</h3>
AI is making clinical trials for psychedelic therapies <a href="https://www.benzinga.com/markets/cannabis/23/06/32788090/ai-powered-psychedelic-treatments-special-status-and-next-gen-contests-winners">faster and more precise</a>. By analyzing patient data, AI can help determine the best dosing strategies and predict which patients are most likely to benefit from specific treatments. This tailored approach is a step beyond current practices like genetic screening, offering a more individualized treatment plan.
Moreover, AI can utilize wearable technology during clinical trials to monitor patients in real-time, providing immediate feedback on how the psychedelic treatments are affecting them. This data-driven approach can help fine-tune therapies and ensure more effective outcomes.
<h3 class="wp-block-heading">AI's Role In Shaping The Psychedelic Experience</h3>
Though the white paper does not specifically mention virtual reality (VR), <a href="https://www.benzinga.com/markets/cannabis/23/09/34097039/psychedelic-journeys-2-0-how-virtual-reality-is-revolutionizing-therapy">other recent developments </a>suggest that VR could enhance the psychedelic experience. AI could be used to <a href="https://www.benzinga.com/markets/cannabis/24/10/41215655/ketamine-clinics-los-angeles-partners-with-fireflyvr-for-virtual-reality-enhanced-patient-care">augment the therapeutic setting</a>, employing visual algorithms and personalized sensory inputs to create tailored environments that amplify the effects of the treatment. This could include immersive VR experiences designed to enhance the therapeutic impact of psychedelic sessions.
<h3 class="wp-block-heading">Supporting Post-Treatment Integration With AI</h3>
AI's influence extends beyond the treatment session itself. After therapy, AI-powered tools could offer personalized support to help patients integrate their psychedelic experiences into everyday life. By tracking patients' progress, these tools could provide ongoing strategies for maintaining mental health improvements, making post-treatment care more effective.
<h3 class="wp-block-heading">Addressing Ethical Concerns In Psychedelic Medicine</h3>
As AI becomes more deeply integrated into psychedelic medicine, ethical issues cannot be overlooked. While AI has shown promise in assisting with ethical decision-making, there are still significant concerns around data privacy and the protection of sensitive patient information. Ensuring that AI applications in this field adhere to strict ethical standards is critical, especially given the deeply personal nature of psychedelic therapies.
<h3 class="wp-block-heading">Innovative Companies Paving The Way</h3>
MindMed (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MNMD#NASDAQ">MNMD</a>), Atai Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATAI#NASDAQ">ATAI</a>), COMPASS Pathways (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CMPS#NASDAQ">CMPS</a>) and Delic Holdings (OTCQB:<a class="ticker" href="https://www.benzinga.com/stock/DELCF#OTCQB">DELCF</a>) are leading the way in integrating AI with psychedelic medicine to advance mental health treatments. MindMed uses AI to identify psychedelic compounds and optimize treatments for anxiety, depression, and addiction. Atai Life Sciences partners with AI firms to improve clinical trials for treatment-resistant depression and anxiety. COMPASS Pathways applies AI to enhance data analysis and personalize depression treatments, while Delic Holdings integrates AI into its wellness services to create personalized plans. Together, these companies are transforming psychedelic medicine and mental health care with AI.
Photo by PopTika on Shutterstock

Atai Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATAI#NASDAQ">ATAI</a>), a clinical-stage biopharmaceutical company focused on mental health innovation, announced its third-quarter 2024 financial results Wednesday as well as updates on its clinical and corporate strategies. With notable advancements in its investigational programs, the company remains optimistic about its pipeline's potential to address <a href="https://www.benzinga.com/topic/psychedelic-assisted-therapies">treatment-resistant mental health conditions</a>.
<h3 class="wp-block-heading">Financial Overview: Strategic Investments And Cash Runway</h3>
Despite a challenging market environment, Atai's financial position remains strong, with sufficient resources to fund operations into 2026. The company reported cash, cash equivalents and short-term securities totaling $101 million as of September 30, 2024, compared to $154.2 million at the end of 2023. The decrease was primarily driven by operating expenses and strategic investments, including a $10 million commitment to <a href="https://www.benzinga.com/topic/beckley-psytech">Beckley Psytech</a>.
<ul>
<li>R&amp;D and G&amp;A Expenses: Research and development expenses for Q3 totaled $12.4 million, a slight decline from $13.3 million in Q3 2023. This reduction was attributed to lower personnel-related costs, partially offset by increased spending on advancing clinical trials. General and administrative expenses dropped to $10.3 million, down from $13.6 million in the prior year period, reflecting a $3.3 million reduction due to cost-saving measures.</li>
<li>Net Loss: Atai reported a net loss of $26.3 million for Q3 2024, compared to a net income of $44.2 million in the same period last year. The previous year's results were bolstered by a significant, non-cash gain from changes in the fair value of investments, an advantage not repeated this year.</li>
</ul>
<h3 class="wp-block-heading">Corporate Developments: Acquisition And Future Catalysts</h3>
In a strategic move to bolster its drug delivery capabilities, Atai completed the acquisition of IntelGenx Corp., a firm specializing in innovative oral thin film technologies. Notably, the transaction was structured without using Atai's cash or equity, underscoring the company's disciplined approach to capital management.
Looking ahead, Atai has set its sights on several key milestones:
<ul>
<li>Initiation of Phase 2 trials for VLS-01 and EMP-01 by year-end 2024.</li>
<li>Topline data from Beckley Psytech's BPL-003 Phase 2b trial for treatment-resistant depression, expected in Q2 2025.</li>
<li>Results from the ongoing Phase 2b study of RL-007, targeting cognitive impairment associated with schizophrenia, anticipated by mid-2025.</li>
</ul>
<h3 class="wp-block-heading">Key Pipeline Advancements</h3>
Atai&#8217;s pipeline gains momentum, with two major Phase 2 trials set to launch by year-end 2024:
VLS-01 for Treatment-Resistant Depression: Atai has received FDA approval for its IND application for VLS-01, a buccal film formulation of DMT for treatment-resistant depression. This novel delivery method, applied to the inside of the cheek, offers a streamlined two-hour in-clinic treatment. Atai plans to begin a Phase 2 study by the end of 2024 to evaluate VLS-01's safety, efficacy and durability in TRD patients.
EMP-01 for Social Anxiety Disorder: EMP-01 is an oral R-MDMA formulation with dose-dependent effects similar to classical psychedelics. Atai plans to begin a Phase 2 trial for social anxiety disorder (SAD) by the end of 2024. The trial will assess EMP-01's safety, tolerability and efficacy, addressing an unmet need as no new treatments for SAD have been approved in over 20 years.
IBX-210: IV Ibogaine for Opioid Use Disorder: Atai has completed a pre-IND meeting with the FDA for IBX-210, an intravenous ibogaine formulation for opioid use disorder. The company plans further non-clinical studies before launching a Phase 1b trial to explore its potential for substance use disorder, as part of Atai's broader research into addiction treatments.
<h3 class="wp-block-heading">Strategic Focus On Mental Health Innovation</h3>
"Atai is committed to transforming mental health treatment," emphasized Dr. Srinivas Rao, Co-CEO of Atai. "We believe that by advancing our diversified pipeline with scientific rigor, we are paving the way for novel, effective therapies for patients who have long been underserved by traditional treatments."
The company's emphasis on innovative delivery methods and AI-informed drug design highlights its strategic focus on developing <a href="https://www.benzinga.com/markets/cannabis/24/10/41191696/psychedelics-2-0-companies-explore-safer-more-targeted-therapies">next-generation therapies</a>. By targeting complex conditions such as treatment-resistant depression, social anxiety disorder and opioid use disorder, Atai aims to address significant gaps in the mental health treatment landscape.
Cover image made with AI

Earnings

Atai Q3 Report: Strong Cash Position, Clinical Pipeline Growth

ATAI Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATAI#NASDAQ">ATAI</a>) reported quarterly losses of $(0.16) per share which met the analyst consensus estimate. This is a 164 percent decrease over earnings of $0.25 per share from the same period last year. The company reported $40.00 thousand in sales this quarter. This is a 54.02 percent decrease over sales of $87.00 thousand the same period last year.

ATAI Life Sciences Q3 EPS $(0.16), Inline, Sales $40.00K Down From $87.00K YoY

Researchers from Emory University, the University of Wisconsin-Madison and UC-Berkeley have identified a significant opportunity for <a href="https://www.benzinga.com/topic/psilocybin-assisted-therapy">psilocybin-assisted therapy</a> in the U.S. mental healthcare landscape. As U.S. News <a href="https://www.usnews.com/news/health-news/articles/2024-09-13/over-5-million-americans-could-benefit-if-psilocybin-approved-for-depression-study">reported</a>, if approved by the <a href="https://www.benzinga.com/topic/food-and-drug-administration">FDA</a>, psilocybin could be used to treat depression, with an estimated 5.1 to 5.6 million Americans potentially benefiting from the therapy.
Examining a group of patients undergoing treatment for depression, researchers determined that psilocybin could be a game-changing solution, particularly for individuals suffering from major depressive disorder (MDD) or treatment-resistant depression (TRD). These conditions, which affect millions across the country, are typically unresponsive to standard treatments, underscoring the urgent need for new solutions.
<h3 class="wp-block-heading">A Breakthrough Approach To Treating Depression</h3>
The study, <a href="https://pp.genomicpress.com/wp-content/uploads/2024/09/PP0025-Rab-2024.pdf">published</a> in Psychedelics by Genomic Press, explored the FDA's consideration of psilocybin from <a href="https://www.benzinga.com/markets/cannabis/22/11/29549541/the-strongest-magic-mushroom-species">Psilocybe cubensis</a> mushrooms as a <a href="https://www.benzinga.com/general/biotech/24/03/37665900/fda-grants-cybin-breakthrough-therapy-status-for-major-depression-psilocybin-therapy-company-anno">breakthrough therapy,</a> which is a designation that allows drugs with the potential to address life-threatening conditions like severe depression, to be fast-tracked through the approval process. If green-lighted, psilocybin would likely be reserved for individuals with the most severe forms of depression or those who have not responded to traditional treatments.
The study found that some 1.7 million Americans with TRD could immediately benefit from psilocybin-assisted therapy. When including those with MDD, the number of potential beneficiaries rises to 5.6 million. Dr. Syed Fayzan Rab, an MD candidate at Emory University and the study's lead author, highlighted the importance of recognizing the scope of this opportunity. "This underscores the importance of understanding the practical realities of rolling out this novel treatment on a large scale."
<h3 class="wp-block-heading">A Market Ready To Take Off</h3>
Implications of this study go beyond healthcare. The psilocybin-assisted therapy market holds immense economic potential. A 2023 <a href="https://www.frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2023.1293243/full">report</a> estimated that a single psilocybin-assisted therapy session could cost around $1,500 per patient. Considering the millions of individuals who may be eligible for treatment, this could translate into billions of dollars in revenue once psilocybin gains FDA approval.
Several companies are already preparing to capitalize on this potential market. Compass Pathways (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CMPS#NASDAQ">CMPS</a>), Atai Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATAI#NASDAQ">ATAI</a>) and Mindset Pharma (OTC:<a class="ticker" href="https://www.benzinga.com/stock/MSSTF#OTC">MSSTF</a>) are among the pharmaceutical firms actively developing psilocybin-based treatments. 
<h3 class="wp-block-heading">Beyond Depression: Psilocybin's Expanding Horizon</h3>
While psilocybin's most immediate application lies in depression treatment, its therapeutic potential extends further. Ongoing studies are investigating psilocybin's efficacy in treating chronic pain and <a href="https://www.benzinga.com/topic/ptsd">post-traumatic stress disorder</a>. These developments signal that psilocybin could revolutionize not just mental healthcare but also the treatment of other chronic conditions.
However, psilocybin remains classified as a <a href="https://www.benzinga.com/topic/controlled-substances-act">Schedule I</a> drug at the federal level, meaning it is considered to have no accepted medical use and a high potential for abuse. This classification, shared with substances like marijuana, heroin and <a href="https://www.benzinga.com/topic/lsd">LSD</a>, complicates the path toward legalizing its medical use. 
Despite these federal restrictions, several U.S. states and local jurisdictions have <a href="https://www.benzinga.com/topic/psychedelics-decriminalization">decriminalized psilocybin</a> in recent years, signaling a growing push for policy reform at higher levels. 
"It's our hope that these findings spur productive discussions and proactive preparations to optimize the benefit to patients while minimizing unintended consequences," said Dr. Charles Raison, a professor of psychiatry at the University of Wisconsin and co-author of the study. 
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Regulations

Health Care

MSSTF

Could Psilocybin Be A Game-Changer For Millions Battling Depression? New Study Says Yes

Psychedelics have shown promise in treating various mental health issues, including <a href="https://www.benzinga.com/topic/ptsd">PTSD</a> and depression, but they&#8217;ve often faced notable challenges. Side effects like nausea, cardiovascular risks, and the potential for "bad trips" have raised concerns among both clinicians and patients. As Time <a href="https://time.com/7027173/new-psychedelic-drug-companies/">reported</a>, companies like Mindstate Design Labs and Atai Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATAI#NASDAQ">ATAI</a>) are developing new forms of psychedelics, sometimes called Psychedelics 2.0, designed to offer therapeutic benefits with fewer risks.
<h3 class="wp-block-heading">Challenges And Limitations Of Traditional Psychedelics</h3>
Traditional psychedelics like <a href="https://www.benzinga.com/topic/psilocybin">psilocybin</a>, <a href="https://www.benzinga.com/topic/mdma">MDMA</a> and <a href="https://www.benzinga.com/topic/lsd">LSD</a> work by <a href="https://www.benzinga.com/markets/cannabis/23/02/30965404/delix-elucidating-how-psychedelics-actually-induce-neuroplasticity-vs-ssris">promoting neuroplasticity</a>, which helps the brain form new connections and process trauma. However, these substances can be time-intensive, sometimes requiring patients to endure hours-long sessions under medical supervision. This protocol not only strains mental health resources but can also be daunting for patients.
Dillan DiNardo, CEO of <a href="https://www.benzinga.com/topic/mindstate-design-labs">Mindstate Design Labs</a>, describes classic psychedelics as "effective, but they're scary and unpredictable." His company aims to refine psychedelics to retain their mental health benefits while minimizing adverse effects. These novel drugs may also ease the burden on the mental health system, as the reduced risk could potentially allow for fewer monitoring requirements.
The FDA recently <a href="https://www.benzinga.com/markets/cannabis/24/08/40300943/fda-rejects-mdma-for-ptsd-treatment-calls-for-more-research-on-psychedelic-therapy">withheld approval of MDMA for PTSD treatment</a>, citing concerns over potential heart risks and the need for constant monitoring. Dr. Srinivas Rao, co-CEO of Atai Life Sciences, explains that these challenges have encouraged companies to find safer alternatives. One such development is <a href="https://www.benzinga.com/general/biotech/24/03/37973466/pharmalas-novel-mdma-mixture-awarded-us-patent-enabling-ip-protection-and-further-development">R-MDMA</a>, which offers a more introspective experience with fewer side effects.
<h3 class="wp-block-heading">Rethinking Psychedelic Therapy</h3>
Companies like Enveric Biosciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ENVB#NASDAQ">ENVB</a>) are taking a different approach by attempting to strip psychedelics of their hallucinogenic effects altogether. Enveric's CEO Joseph Tucker suggests that a <a href="https://www.benzinga.com/markets/cannabis/22/12/30007837/tripping-without-the-trip-non-hallucinogenic-psychedelics">non-hallucinogenic version of psychedelics</a>, if effective, could function much like an antidepressant, providing relief without the need for extensive in-clinic sessions.
This approach has its critics, however, with some researchers arguing that the psychedelic experience itself is essential to therapeutic progress. Studies suggest that feelings of connectedness, common in psychedelic experiences, are linked to improved mental health outcomes.
<h3 class="wp-block-heading">Selective Psychedelics: Targeted Effects For Improved Safety</h3>
Mindstate Design Labs is exploring ways to create psychedelics with more targeted effects on the brain. DiNardo likens psychedelics to "promiscuous molecules" that influence various neural pathways. By honing in on specific effects, Mindstate seeks to reduce the chaotic nature of traditional psychedelics and make the treatment experience more predictable.
<h3 class="wp-block-heading">The Future Of Psychedelic Therapy</h3>
While these developments offer promising solutions, the path to FDA approval and widespread acceptance remains complex. Whether future psychedelics can provide mental health benefits without the downsides of traditional compounds will depend on ongoing research and clinical trials. As DiNardo notes, "psychedelics do not work for everyone in a positive way." But with advances in Psychedelics 2.0, companies seem to be optimistic about creating more patient-friendly therapies for mental health challenges.
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ENVB

Psychedelics 2.0: Companies Explore Safer, More Targeted Therapies

The U.S. Food and Drug Administration (FDA) has issued a complete response letter for <a href="https://www.benzinga.com/topic/mdma-assisted-therapy">MDMA-assisted psychotherapy (MDMA-AT)</a> for treating post-traumatic stress disorder (PTSD) in which it calls for an additional phase 3 trial to further evaluate its safety and efficacy. As Psychiatric Times <a href="https://www.psychiatrictimes.com/view/with-mdma-on-hold-whats-next-for-psychedelics">reported</a>, this decision puts on hold what could have been a landmark approval for the treatment of PTSD with MDMA, also known as midomafetamine.
Despite the <a href="https://www.benzinga.com/markets/cannabis/24/08/40300943/fda-rejects-mdma-for-ptsd-treatment-calls-for-more-research-on-psychedelic-therapy">setback</a>, <a href="https://www.benzinga.com/topic/lykos-therapeutics">Lykos Therapeutics</a>, the company behind the MDMA-AT treatment, remains determined. Lykos has expressed confidence that the FDA's concerns could be addressed using "existing data, post-approval requirements or through reference to the scientific literature." Discussions between the company and the FDA are ongoing, as Lykos seeks a clear path forward.
<h3 class="wp-block-heading">Other Psychedelics In The Pipeline</h3>
While MDMA's future remains in question, several other psychedelic treatments continue to progress through clinical trials. Atai Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATAI#NASDAQ">ATAI</a>) recently announced promising results from a <a href="https://www.benzinga.com/markets/cannabis/24/08/40376236/atais-dmt-depression-drug-shows-promise-prepares-for-phase-ii-trial-and-future-collaboration-wit">phase 1b trial of VLS-01</a>, a buccal film formulation of N,N-dimethyltryptamine (DMT), for treatment-resistant depression (TRD). The next phase 2 study is expected to start by the end of 2024, focusing on safety, efficacy and durability of response.
Numinus Wellness (OTC:<a class="ticker" href="https://www.benzinga.com/stock/NUMIF#OTC">NUMIF</a>), another key player in the psychedelic space, is <a href="https://www.benzinga.com/markets/cannabis/23/11/35548014/single-dose-of-cybins-psilocybin-shows-compelling-patient-outcomes-phase-2-results-find">moving forward with studies</a> involving Cybin's CYB003, a deuterated psilocybin molecule designed for treating moderate to severe depressive disorders. Meanwhile, Compass Pathways (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CMPS#NASDAQ">CMPS</a>) is testing COMP360, a synthetic form of psilocybin, which <a href="https://www.benzinga.com/markets/cannabis/23/09/34291309/compass-pathways-explores-ai-powered-predictive-model-on-psilocybin-therapy-for-depression">has shown promising early results</a> in treating PTSD. These developments highlight the continued push toward psychedelic-assisted therapies for a range of psychiatric conditions.
<h3 class="wp-block-heading">Progress With LSD And Ketamine</h3>
MindBio Therapeutics (NASDAQU:MBIO) has also made strides with MB22001, <a href="https://www.benzinga.com/markets/cannabis/24/04/38512570/lsd-microdosing-for-pms-after-confirming-antidepressant-effects-clinical-trials-will-assess-if-i">a titratable microdosing form of LSD</a>, showing promise in phase 2a trials for major depressive disorder (MDD). They are investigating LSD's potential for treating other conditions like premenstrual dysphoric disorder and depression associated with cancer. MindMed is <a href="https://www.benzinga.com/markets/cannabis/22/08/28637136/mindmed-keeps-hitting-the-news-now-dosing-on-their-clinical-trial-on-lsd-for-anxiety">progressing with its own LSD compound</a>, MM-120, which has shown potential for treating generalized anxiety disorder (GAD), with a phase 3 trial set to begin this year.
Ketamine-based therapies are advancing as well, with Awakn Life Sciences (OTC:<a class="ticker" href="https://www.benzinga.com/stock/AWAKNF#OTC">AWAKNF</a>) leading the charge in <a href="https://www.benzinga.com/markets/cannabis/23/06/32820420/awakn-to-focus-on-r-d-of-addiction-therapies-moves-away-from-ketamine-treatment-for-alcoholism">addressing alcohol use disorder</a>. Their MORE-KARE phase 3 trial is underway, testing the efficacy of ketamine infusions combined with psychosocial support.
<h3 class="wp-block-heading">Lykos And The Future Of MDMA</h3>
As the psychedelic field expands, all eyes are on Lykos Therapeutics as they navigate the FDA&#8217;s requirements for MDMA-assisted psychotherapy. The company has undergone a <a href="https://www.benzinga.com/markets/cannabis/24/08/40421048/lykos-therapeutics-strategic-reorganization-following-fdas-decision-rejecting-mdma-for-ptsd-trea">significant reorganization</a>, including a 75% reduction in workforce, and appointed Dr. David Hough as senior medical advisor to guide the next phase of clinical work. Hough has extensive experience in psychiatric drug development, having led successful projects such as Spravato.
Rick Doblin, PhD, founder of the Multidisciplinary Association for Psychedelic Studies (MAPS), has stepped down from Lykos to focus on public advocacy for global access to MDMA and other psychedelics. Doblin&#8217;s resignation from the Lykos Board comes as the company continues its dialogue with the FDA.
<h3 class="wp-block-heading">What's Next?</h3>
Despite the challenges facing <a href="https://www.benzinga.com/topic/mdma-assisted-therapy">MDMA-assisted psychotherapy</a>, the field of psychedelic research remains vibrant. With more than 185 clinical studies on psilocybin, 104 on MDMA and 58 on LSD ongoing according to clinicaltrials.gov, the future holds promise for these novel treatments. As companies continue their work, patients and researchers alike are hopeful that these therapies will become more widely available in the near future.
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AWAKNF

MBIO

NUMIF

MDMA Therapy For PTSD Faces FDA Delay: Are There Other Ways Forward?

The global <a href="https://www.benzinga.com/markets/psychedelics">psychedelic drugs</a> market is poised for significant growth over the next five years, with an estimated increase of USD 1.37 billion from 2024 to 2028, according to a <a href="https://www.prnewswire.com/news-releases/psychedelic-drugs-market-to-grow-by-usd-1-37-billion-from-2024-2028--driven-by-increasing-mental-health-disorders-report-highlights-ais-impact-on-the-market-landscape---technavio-302236016.html">report</a> by Technavio. The market is projected to grow at a compound annual growth rate (CAGR) of 11.82%, fueled by the rising prevalence of mental health disorders and the development of next-generation therapies for psychiatric conditions.
<h3 class="wp-block-heading">Expanding Market For Psychedelics In Mental Health</h3>
Increasing awareness of the <a href="https://www.benzinga.com/topic/psychedelic-assisted-therapies">therapeutic potential</a> of psychedelic substances, such as <a href="https://www.benzinga.com/topic/ketamine">ketamine</a>, <a href="https://www.benzinga.com/topic/psilocybin">psilocybin</a>, and <a href="https://www.benzinga.com/topic/mdma">MDMA</a>, has spurred investment in research and development. These substances have shown promise in treating disorders like treatment-resistant depression, PTSD, narcolepsy and addiction. The market is also witnessing a trend towards AI-driven advancements in the understanding and development of psychedelic therapies.
However, regulatory challenges and potential side effects associated with psychedelic drugs present obstacles to market growth. Many substances remain classified as <a href="https://www.benzinga.com/topic/federal-schedule-i">Schedule I</a> drugs, creating barriers to widespread availability, especially in hospital and retail pharmacies.
<h3 class="wp-block-heading">Major Players And Market Segments</h3>
Key players in the psychedelic drugs market include AbbVie Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>), ATAI Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATAI#NASDAQ">ATAI</a>), COMPASS Pathways (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/COMP#NYSE">COMP</a>), Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>), Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) and Mind Medicine Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MNMD#NASDAQ">MNMD</a>). These companies are at the forefront of developing safe and effective psychedelic therapies for mental health conditions.
The market is segmented by type, including ketamine, GHB, MDMA and psilocybin. Distribution channels such as hospital pharmacies, retail pharmacies and others play a critical role in the accessibility of these therapies. Geographically, North America, Europe, Asia and the rest of the world (ROW) are identified as major regions driving growth.
<h3 class="wp-block-heading">AI's Role In Shaping The Psychedelic Drugs Market</h3>
<a href="https://www.benzinga.com/topic/artificial-intelligence">Artificial intelligence</a> is becoming an essential tool in drug development and market evolution, helping companies streamline research, clinical trials, and product development. By integrating AI, firms can accelerate the creation of targeted therapies and better understand the complex interactions between psychedelic drugs and mental health conditions.
<h3 class="wp-block-heading">Market Challenges And Ethical Concerns</h3>
Despite its growth potential, the psychedelic drugs market faces significant challenges, including regulatory scrutiny and ethical concerns. The potential for misuse and psychological distress associated with psychedelic substances, especially in forms like injectable or intranasal psilocybin, remains a concern. Cultural norms, conservative values, and religious beliefs also influence the pace of adoption in various regions.
<h3 class="wp-block-heading">Future Outlook</h3>
As companies continue to push forward with clinical trials and product development, the market for psychedelic drugs is expected to expand significantly. The anticipated approval of new psychedelic-based therapies, coupled with AI-driven innovations, holds promise for addressing the global mental health crisis. However, overcoming regulatory and cultural barriers will be critical to unlocking the full potential of this emerging field.

Press Releases

ABBV

COMP

Psychedelic Drugs Market Set To Grow By $1.37B By 2028, Driven By Mental Health Disorders And AI Integration

HC Wainwright &amp; Co. analyst Patrick Trucchio reiterates ATAI Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATAI#NASDAQ">ATAI</a>) with a Buy and maintains $15 price target.

HC Wainwright & Co. Reiterates Buy on ATAI Life Sciences, Maintains $15 Price Target

atai Life Sciences Reports Second Quarter 2024 Financial Results and Provides Corporate Updates

atai Life Sciences to Participate in the H.C. Wainwright 26th Annual Global Investment Conference

atai Life Sciences to Participate in the 2024 Maxim Healthcare Virtual Summit

Management

Altimmune Appoints Life Sciences Industry Veteran Greg Weaver as Chief Financial Officer

atai Life Sciences Reports Third Quarter 2024 Financial Results and Provides Corporate Updates

atai Life Sciences Announces Key Leadership Appointments as it Advances its Pipeline of Novel Psychedelic Therapeutics for Mental Health

atai Life Sciences Announces Positive Topline Results from Beckley Psytech's BPL-003 (intranasal 5-MeO-DMT benzoate) Phase 2a Open-Label Study for Alcohol Use Disorder

Financing

atai Life Sciences Announces Proposed Public Offering of Common Shares

atai Life Sciences Announces Pricing of Public Offering of Common Shares

atai Life Sciences Announces Closing of Public Offering and Full Exercise of Option to Purchase Additional Common Shares

HC Wainwright & Co.

Canaccord Genuity

Maxim Group

EF Hutton

Credit Suisse

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FTRP

Revolutionizing Mental Healthcare With The Rise Of Ketamine And Psychedelic Therapies

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