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atai Life Sciences Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Corporate Highlights

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atai Life Sciences (NASDAQ: ATAI) reported its Q4 and full year 2024 financial results, highlighting significant clinical progress and a strengthened financial position. The company completed an equity offering raising $59.2 million, extending its operational runway into 2027.

Key clinical developments include: dosing the first patient in Phase 2 Elumina trial of VLS-01 for treatment-resistant depression; initiating Phase 2 trial of EMP-01 for social anxiety disorder; and Beckley Psytech completing enrollment in Phase 2b study of BPL-003. Topline data for VLS-01 and EMP-01 are expected in Q1'26, while BPL-003 results are anticipated in mid-2025.

Financial highlights: Cash position of $72.3 million as of December 31, 2024, down from $154.2 million year-over-year. R&D expenses were $55.5 million for 2024, decreased from $62.2 million in 2023. G&A expenses reduced to $47.5 million from $63.6 million. Net loss increased to $149.3 million in 2024 compared to $40.2 million in 2023.

atai Life Sciences (NASDAQ: ATAI) ha riportato i risultati finanziari del quarto trimestre e dell'intero anno 2024, evidenziando significativi progressi clinici e una posizione finanziaria rafforzata. L'azienda ha completato un'offerta di equity raccogliendo 59,2 milioni di dollari, estendendo la sua operatività fino al 2027.

I principali sviluppi clinici includono: la somministrazione del primo paziente nella fase 2 dello studio Elumina di VLS-01 per la depressione resistente al trattamento; l'avvio della fase 2 dello studio di EMP-01 per il disturbo d'ansia sociale; e Beckley Psytech ha completato l'arruolamento nello studio di fase 2b di BPL-003. I dati preliminari per VLS-01 e EMP-01 sono attesi nel primo trimestre del '26, mentre i risultati di BPL-003 sono previsti per metà 2025.

Risultati finanziari: Posizione di cassa di 72,3 milioni di dollari al 31 dicembre 2024, in calo rispetto a 154,2 milioni di dollari rispetto all'anno precedente. Le spese per R&S sono state di 55,5 milioni di dollari per il 2024, in diminuzione rispetto a 62,2 milioni di dollari nel 2023. Le spese generali e amministrative sono scese a 47,5 milioni di dollari da 63,6 milioni di dollari. La perdita netta è aumentata a 149,3 milioni di dollari nel 2024 rispetto a 40,2 milioni di dollari nel 2023.

atai Life Sciences (NASDAQ: ATAI) informó sus resultados financieros del cuarto trimestre y del año completo 2024, destacando un progreso clínico significativo y una posición financiera fortalecida. La compañía completó una oferta de acciones recaudando 59,2 millones de dólares, extendiendo su capacidad operativa hasta 2027.

Los principales desarrollos clínicos incluyen: la dosificación del primer paciente en el ensayo de fase 2 Elumina de VLS-01 para la depresión resistente al tratamiento; el inicio del ensayo de fase 2 de EMP-01 para el trastorno de ansiedad social; y Beckley Psytech completando la inscripción en el estudio de fase 2b de BPL-003. Se esperan datos preliminares para VLS-01 y EMP-01 en el primer trimestre de '26, mientras que los resultados de BPL-003 se anticipan para mediados de 2025.

Aspectos financieros: Posición de efectivo de 72,3 millones de dólares al 31 de diciembre de 2024, en comparación con 154,2 millones de dólares del año anterior. Los gastos de I+D fueron de 55,5 millones de dólares para 2024, disminuyendo desde 62,2 millones de dólares en 2023. Los gastos generales y administrativos se redujeron a 47,5 millones de dólares desde 63,6 millones de dólares. La pérdida neta aumentó a 149,3 millones de dólares en 2024 en comparación con 40,2 millones de dólares en 2023.

atai Life Sciences (NASDAQ: ATAI)는 2024년 4분기 및 연간 재무 결과를 보고하며, 중요한 임상 발전과 강화된 재무 상태를 강조했습니다. 이 회사는 5,920만 달러를 모금하는 주식 공모를 완료하여 2027년까지 운영 연한을 연장했습니다.

주요 임상 개발에는 치료 저항성 우울증을 위한 VLS-01의 2상 Elumina 시험에서 첫 환자 투여; 사회 불안 장애를 위한 EMP-01의 2상 시험 시작; 그리고 Beckley Psytech의 BPL-003 2b 연구 등록 완료가 포함됩니다. VLS-01 및 EMP-01의 초기 데이터는 '26년 1분기에 예상되며, BPL-003의 결과는 2025년 중반에 예상됩니다.

재무 하이라이트: 2024년 12월 31일 기준 현금 보유액은 7,230만 달러로, 전년 대비 1억 5,420만 달러에서 감소했습니다. 연구개발 비용은 2024년 5,550만 달러로, 2023년의 6,220만 달러에서 감소했습니다. 일반 및 관리 비용은 6,360만 달러에서 4,750만 달러로 줄어들었습니다. 2024년 순손실은 2023년의 4,020만 달러에 비해 1억 4,930만 달러로 증가했습니다.

atai Life Sciences (NASDAQ: ATAI) a publié ses résultats financiers pour le quatrième trimestre et l'année entière 2024, mettant en avant des progrès cliniques significatifs et une position financière renforcée. L'entreprise a complété une offre d'actions levant 59,2 millions de dollars, prolongeant sa capacité opérationnelle jusqu'en 2027.

Les principaux développements cliniques incluent : l'administration du premier patient dans l'essai de phase 2 Elumina de VLS-01 pour la dépression résistante au traitement ; le lancement de l'essai de phase 2 d'EMP-01 pour le trouble d'anxiété sociale ; et Beckley Psytech a terminé l'inscription dans l'étude de phase 2b de BPL-003. Les données préliminaires pour VLS-01 et EMP-01 sont attendues au premier trimestre '26, tandis que les résultats de BPL-003 sont anticipés pour le milieu de 2025.

Points financiers : Position de trésorerie de 72,3 millions de dollars au 31 décembre 2024, en baisse par rapport à 154,2 millions de dollars d'une année sur l'autre. Les dépenses de R&D se sont élevées à 55,5 millions de dollars pour 2024, en baisse par rapport à 62,2 millions de dollars en 2023. Les dépenses générales et administratives ont été réduites à 47,5 millions de dollars contre 63,6 millions de dollars. La perte nette a augmenté à 149,3 millions de dollars en 2024 par rapport à 40,2 millions de dollars en 2023.

atai Life Sciences (NASDAQ: ATAI) hat seine Finanzzahlen für das vierte Quartal und das gesamte Jahr 2024 veröffentlicht und dabei bedeutende klinische Fortschritte sowie eine gestärkte Finanzlage hervorgehoben. Das Unternehmen hat eine Aktienplatzierung abgeschlossen und 59,2 Millionen Dollar gesammelt, wodurch die operative Laufzeit bis 2027 verlängert wurde.

Wichtige klinische Entwicklungen umfassen: die Dosierung des ersten Patienten in der Phase-2-Studie Elumina von VLS-01 zur behandlungsresistenten Depression; den Beginn der Phase-2-Studie von EMP-01 zur sozialen Angststörung; und Beckley Psytech hat die Einschreibung in die Phase-2b-Studie von BPL-003 abgeschlossen. Die vorläufigen Daten für VLS-01 und EMP-01 werden im ersten Quartal '26 erwartet, während die Ergebnisse von BPL-003 für Mitte 2025 prognostiziert werden.

Finanzielle Höhepunkte: Die Liquiditätsposition betrug zum 31. Dezember 2024 72,3 Millionen Dollar, ein Rückgang von 154,2 Millionen Dollar im Jahresvergleich. Die F&E-Ausgaben beliefen sich 2024 auf 55,5 Millionen Dollar, ein Rückgang von 62,2 Millionen Dollar im Jahr 2023. Die allgemeinen und Verwaltungskosten sanken auf 47,5 Millionen Dollar von 63,6 Millionen Dollar. Der Nettoverlust stieg 2024 auf 149,3 Millionen Dollar im Vergleich zu 40,2 Millionen Dollar im Jahr 2023.

Positive
  • Secured $59.2M equity offering extending runway into 2027
  • Reduced R&D expenses by $6.7M year-over-year
  • Decreased G&A expenses by $16.0M compared to previous year
  • Positive initial data for BPL-003 in alcohol use disorder treatment
  • Multiple advanced clinical trials progressing with clear timelines
Negative
  • Net loss increased significantly to $149.3M from $40.2M year-over-year
  • Cash position decreased by $81.9M to $72.3M from previous year
  • R&D spend expected to increase with later stage clinical trials
  • Non-cash decrease in fair value of assets of $48.9M

Insights

atai Life Sciences presents a robust clinical pipeline with significant progress across multiple psychedelic compounds for mental health indications. The company has reached critical milestones with first patient dosing in the Phase 2 Elumina trial of VLS-01 (DMT) for treatment-resistant depression and initiated a Phase 2 trial of EMP-01 (R-MDMA) for social anxiety disorder. Both trials have clear timelines with topline data expected in Q1'26.

Particularly noteworthy is their strategic investment in Beckley Psytech's BPL-003 program, which completed enrollment for its Phase 2b study in treatment-resistant depression with results expected mid-2025. The preliminary Phase 2a data in alcohol use disorder showed 50% of patients maintaining complete abstinence at three months following a single dose, suggesting significant therapeutic potential.

The company's approach of developing shorter-acting psychedelics (VLS-01 and BPL-003) designed to fit within a two-hour treatment window demonstrates strategic thinking about clinical adoption. This format could significantly improve healthcare delivery efficiency compared to longer-acting alternatives, potentially increasing both provider adoption and patient access if approved.

atai's financial position shows careful capital management amid clinical advancement. The $59.2 million equity offering completed in February 2025 extends their operational runway into 2027, strategically timed to cover multiple key clinical readouts. This runway extension is important as it removes near-term financing risk during a critical phase of clinical development.

The company reduced G&A expenses by $16.0 million year-over-year, demonstrating effective cost discipline. R&D expenses decreased by $6.7 million, reflecting the wind-down of certain programs while focusing resources on advancing priority candidates.

While the net loss increased to $149.3 million from $40.2 million year-over-year, this includes $48.9 million in non-cash decreases in fair value of assets. Cash position decreased to $72.3 million from $154.2 million, but with the recent capital raise, atai has built a financial bridge to potential value-creating clinical data in 2025-2026.

The company's disciplined investment strategy is evident in targeted spending on key programs while anticipating increased R&D expenses as trials advance. This balanced approach to clinical progression and financial sustainability positions atai well to navigate the typically challenging mid-stage clinical development period.

atai Life Sciences presents a compelling case of strategic advancement in psychedelic medicine for mental health. The company has successfully dosed its first patient in the Phase 2 Elumina trial of VLS-01 (buccal DMT) for treatment-resistant depression and initiated a Phase 2 trial of EMP-01 (R-MDMA) for social anxiety disorder, both with clear timelines for topline data in Q1'26.

The completed enrollment in Beckley Psytech's Phase 2b study of BPL-003 represents significant progress, with data expected mid-2025. Early results from BPL-003 in alcohol use disorder demonstrated 50% of patients maintaining complete abstinence at three months following a single dose, suggesting substantial therapeutic potential.

Financially, atai has strengthened its position with a $59.2 million equity offering that extends its runway into 2027, crucially covering the expected clinical readouts from core programs. The company demonstrated fiscal discipline by reducing G&A expenses by $16.0 million and R&D expenses by $6.7 million year-over-year.

While the net loss increased to $149.3 million (from $40.2 million in 2023), this includes $48.9 million in non-cash decreases in fair value of assets. The company's focus on developing psychedelics that fit within a two-hour treatment paradigm shows strategic thinking about real-world clinical adoption and healthcare delivery efficiency.

The extended financial runway paired with advancing clinical programs positions atai to potentially deliver multiple value-creating data readouts over the next 12-18 months without immediate financing pressure.

 - Dosed the first patient in the Phase 2 Elumina trial of VLS-01 (buccal film DMT) for patients with treatment-resistant depression; topline data anticipated in Q1’26

- Initiated a Phase 2 clinical trial of EMP-01 (oral R-MDMA) for patients with social anxiety disorder; topline data anticipated in Q1’26

- Beckley Psytech completed enrollment in the Phase 2b study of BPL-003 (intranasal mebufotenin benzoate) in patients with treatment-resistant depression; topline data anticipated in mid-25

- Completed an equity offering with net proceeds of $59.2 million; extending operational runway into 2027

NEW YORK and BERLIN, March 17, 2025 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company on a mission to develop highly effective mental health treatments to transform patient outcomes, today announced fourth quarter and full year 2024 financial results and recent corporate highlights.

“We are beginning the year in a strong financial position, thanks to the recent capital raise, which extends our runway into 2027, beyond when we expect the topline data readouts from the Phase 2 clinical trials of our two core programs, VLS-01 and EMP-01, in Q1’26” stated Srinivas Rao, M.D., Ph.D., Chief Executive Officer and Co-founder of atai. “Our team is focused on executing these trials rigorously and efficiently to drive forward our mission to transform patient outcomes in mental health. We also look forward to several key milestones this year, notably Beckley Psytech’s BPL-003 Phase 2b topline results in patients with treatment-resistant depression as well as RL-007 in patients with cognitive impairment associated with schizophrenia, both expected mid-2025.”

Recent Clinical Highlights and Upcoming Milestones
VLS-01: N,N-dimethyltryptamine (DMT) for treatment-resistant depression (TRD)

  • VLS-01 is an investigational proprietary oral transmucosal film formulation of DMT applied to the buccal surface, designed to fit within the established two-hour interventional psychiatry treatment paradigm.
  • Dosed the first patient in Elumina, a Phase 2, multicenter, double-blind, randomized, placebo-controlled trial to assess the safety and efficacy of repeated doses of VLS-01 in patients with TRD.
  • Topline data from the Phase 2 Elumina trial of VLS-01 are anticipated in the first quarter of 2026.

EMP-01: R-enantiomer of 3,4-methylenedioxy-methamphetamine (R-MDMA) for social anxiety disorder (SAD)

  • EMP-01 is an oral formulation of R-MDMA that demonstrated a unique, dose-dependent subjective effect profile in a Phase 1 trial that was generally found to be more similar to classical psychedelics than to racemic MDMA.
  • Initiated an exploratory Phase 2, randomized, double-blind, placebo-controlled clinical study to assess the safety, tolerability and efficacy of EMP-01 in adults with SAD.
  • Topline data from the Phase 2 study of EMP-01 are anticipated in the first quarter of 2026.

BPL-003: 5-Methoxy N,N-dimethyltryptamine (mebufotenin) benzoate for TRD and alcohol use disorder (AUD) (strategic investment in Beckley Psytech)

  • BPL-003 is an intranasal transmucosal formulation of mebufotenin benzoate designed to fit within the established two-hour interventional psychiatry treatment paradigm.
  • In March 2025, Beckley Psytech completed patient enrollment in the eight-week, double-blind, core stage of the global Phase 2b clinical trial of BPL-003 in 196 patients with TRD. Topline results from the core phase of the study are expected in mid-2025.
  • In January 2025, Beckley Psytech announced positive topline data from its open-label Phase 2a study of BPL-003 in 12 patients with moderate-to-severe AUD. Initial data demonstrated that 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 and was well-tolerated with no serious adverse events reported.

RL-007: Pro-cognitive neuromodulator for cognitive impairment associated with schizophrenia (CIAS) (strategic investment in Recognify Life Sciences)

  • RL-007 is an orally bioavailable compound that has demonstrated pro-cognitive effects in multiple pre-clinical and clinical studies, including two Phase 1 and two Phase 2 trials.
  • Recognify Life Sciences is running a Phase 2b proof-of-concept study in 234 patients living with CIAS. Topline results are expected in mid-2025.

Consolidated Financial Results
Cash, cash equivalents, and short-term securities: As of December 31, 2024, the Company had cash, cash equivalents, restricted cash and short-term securities of $72.3 million compared to $154.2 million as of December 31, 2023. The decrease of $81.9 million was primarily driven by $82.4 million net cash used in operating activities, $15.0 million for the Beckley Psytech investment, and $7.7 million of additional investments to advance our programs; partially offset by $16.1 million in proceeds from the partial sale of our ADS holdings in Compass Pathways, and $5.0 million in proceeds from our committed term loan with Hercules Capital, Inc. In February 2025, the Company completed an equity offering with net proceeds of $59.2 million and now expects its cash, short-term securities, and public equity holdings to be sufficient to fund operations into 2027.

Research and development (R&D) expenses: R&D expenses were $18.9 million and $55.5 million for the three and twelve months ended December 31, 2024, respectively, as compared to $14.2 million and $62.2 million for the comparable prior year periods. The year-over-year full-year decrease of $6.7 million was primarily attributable to a $5.5 million decrease in R&D personnel-related expenses and a $1.4 million decrease in program-specific expenses. The overall decrease in program-specific spend relates to the wind-down of certain programs, offset by the increase in on-going clinical trials and our non-hallucinogenic discovery program. The Company is anticipating R&D spend to increase as its R&D programs progress into later stage clinical trials.

General and administrative (G&A) expenses: G&A expenses for the three and twelve months ended December 31, 2024 were $11.3 million and $47.5 million, respectively, as compared to $19.4 million and $63.6 million for the comparable prior year periods. The year-over-year full-year decrease of $16.0 million was primarily attributable to a $16.2 million decrease in personnel-related expenses and professional services. The Company expects the reduction in G&A spend over prior years to continue.

Net income (loss): Net loss attributable to shareholders for the three and twelve months ended December 31, 2024 was $39.0 million and $149.3 million, respectively, as compared to $18.3 million and $40.2 million for the comparable prior year periods. Net loss attributable to shareholders for the twelve months ended December 31, 2024 includes $48.9 million of non-cash decrease in fair value of assets and liabilities, net and $25.5 million of non-cash share-based compensation. Net loss attributable to shareholders for the twelve months ended December 31, 2023 includes $86.6 million of non-cash increase in fair value of assets and liabilities, net, of which $69.0 million relates to a one-time accounting change, and $33.0 million of non-cash share-based compensation.

About atai Life Sciences
atai is a clinical-stage biopharmaceutical company on a mission to develop highly effective mental health treatments to transform patient outcomes. Our pipeline of psychedelic-based therapies includes VLS-01 (buccal film DMT) for treatment-resistant depression (TRD) and EMP-01 (oral R-MDMA) for social anxiety disorder, which are in Phase 2 clinical development. We are also advancing a drug discovery program to identify novel, non-hallucinogenic 5-HT2AR agonists for TRD. These programs aim to address the complex nature of mental health providing commercially scalable interventional psychology therapies that can integrate seamlessly into healthcare systems. For the latest updates and to learn more about our mission, visit www.atai.com or follow us on LinkedIn.

Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). 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 business strategy and plans; the potential, success, cost and timing of development of our product candidates, including the progress of preclinical and clinical trials and related milestones; expectations regarding our strategic investment in Beckley Psytech and other investments; expectations regarding our cash runway; and the plans and objectives of management for future operations, research and development and capital expenditures.

Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors described in the section titled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”), as such factors may be updated from time to time in atai's other filings with the SEC. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by applicable law.

Contact Information
Investor Contact:
IR@atai.com

Media Contact:
PR@atai.com

-- Financial Statements Attached --

ATAI LIFE SCIENCES N.V.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share amounts)
         
  Three Months Ended Twelve Months Ended
  December 31, December 31,
   2024   2023   2024   2023 
  (unaudited)  
License revenue $(5) $18  $308  $314 
Operating expenses:        
Research and development  18,942   14,156   55,455   62,203 
General and administrative  11,318   19,423   47,544   63,582 
Total operating expenses  30,260   33,579   102,999   125,785 
Loss from operations  (30,265)  (33,561)  (102,691)  (125,471)
Other income (expense), net  (8,919)  15,241   (45,714)  86,185 
Net loss before income taxes  (39,184)  (18,320)  (148,405)  (39,286)
Benefit from (provision for) income taxes  193   (428)  356   (1,016)
Losses from investments in equity method investees, net of tax     (394)  (2,000)  (3,593)
Net loss  (38,991)  (19,142)  (150,049)  (43,895)
   Net loss attributable to noncontrolling interests  (33)  (850)  (780)  (3,671)
Net loss attributable to ATAI Life Sciences N.V. stockholders $(38,958) $(18,292) $(149,269) $(40,224)
Net loss per share attributable to ATAI Life Sciences N.V. stockholders — basic and diluted $(0.24) $(0.12) $(0.93) $(0.25)
Weighted average common shares outstanding attributable to ATAI Life Sciences N.V. stockholders — basic and diluted  160,711,543   158,842,995   160,159,983   158,833,785 
         


ATAI LIFE SCIENCES N.V. 
CONDENSED CONSOLIDATED BALANCE SHEET 
(Amounts in thousands) 
  December 31, December 31, 
   2024  2023 
Assets     
Cash and cash equivalents $17,505 $45,034 
Securities carried at fair value  44,825  109,223 
Short-term restricted cash for other investments  10,000  - 
Committed investment funds  -  25,000 
Prepaid expenses and other current assets  7,795  5,830 
Short-term notes receivable - related party, net  -  505 
Property and equipment, net  2,535  981 
Operating lease right-of-use assets, net  1,334  1,223 
Other investments held at fair value  28,887  89,825 
Other investments  42,079  1,838 
Intangible assets, net  3,246  1,772 
Goodwill  331  - 
Long-term notes receivable - related party, net  -  97 
Convertible notes receivable - related party  -  11,202 
Other assets  850  948 
Total assets $159,387 $293,478 
Liabilities and Stockholders' Equity     
Accounts payable $2,616  $4,589 
Accrued liabilities  9,847  15,256 
Current portion of lease liabilities  477  275 
Short-term convertible promissory notes and derivative liability - related party  1,150  - 
Short-term convertible promissory notes and derivative liability  1,840  - 
Current portion of long-term debt  6,374  - 
Other current liabilities  2,647  - 
Contingent consideration liability - related party  110  620 
Contingent consideration liabilities  212  1,637 
Noncurrent portion of lease liabilities  732  990 
Convertible promissory notes and derivative liability - related party  -  164 
Convertible promissory notes and derivative liability  -  2,666 
Long-term debt, net  14,133  15,047 
Other liabilities  2,695  7,918 
Total stockholders' equity attributable to ATAI Life Sciences N.V. stockholders  116,297  242,962 
Noncontrolling interests  257  1,354 
Total liabilities and stockholders' equity $159,387 $293,478 
      

FAQ

What is the expected timeline for ATAI's major clinical trial results?

VLS-01 and EMP-01 topline data expected in Q1'26, while BPL-003 and RL-007 results anticipated in mid-2025.

How much did ATAI raise in their recent equity offering?

ATAI completed an equity offering with net proceeds of $59.2 million in February 2025.

What was ATAI's cash position at the end of 2024?

ATAI had $72.3 million in cash, cash equivalents, restricted cash and short-term securities as of December 31, 2024.

How did ATAI's R&D expenses change in 2024 compared to 2023?

R&D expenses decreased to $55.5 million in 2024 from $62.2 million in 2023, a reduction of $6.7 million.

What were the initial results of BPL-003 in alcohol use disorder trials?

50% of patients maintained complete abstinence for three months after a single dose, with no serious adverse events reported.
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