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

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atai Life Sciences (NASDAQ: ATAI) reported Q2 2024 financial results and corporate updates. Key highlights:

  • Positive Phase 1b results for VLS-01 (buccal film DMT) in treatment-resistant depression
  • Plans to initiate Phase 2 studies for VLS-01 and EMP-01 (oral R-MDMA) around year-end 2024
  • Cash and securities of $103.3 million as of June 30, 2024
  • Funding expected to last into 2026
  • R&D expenses decreased to $12.6 million from $15.5 million year-over-year
  • G&A expenses decreased to $13.4 million from $16.6 million year-over-year
  • Net loss of $57.3 million, up from $33.0 million in Q2 2023

atai Life Sciences (NASDAQ: ATAI) ha riportato i risultati finanziari e aggiornamenti aziendali per il secondo trimestre del 2024. Punti salienti:

  • Risultati positivi della fase 1b per VLS-01 (film buccale DMT) nel trattamento della depressione resistente
  • Piani per avviare studi di fase 2 per VLS-01 ed EMP-01 (R-MDMA orale) intorno alla fine del 2024
  • Cassa e titoli di 103,3 milioni di dollari al 30 giugno 2024
  • Finanziamenti previsti per durare fino al 2026
  • Le spese per R&S sono diminuite a 12,6 milioni di dollari rispetto ai 15,5 milioni di dollari dell'anno precedente
  • Le spese generali e amministrative sono diminuite a 13,4 milioni di dollari rispetto ai 16,6 milioni di dollari dell'anno precedente
  • Perdita netta di 57,3 milioni di dollari, in aumento rispetto ai 33,0 milioni di dollari del secondo trimestre del 2023

atai Life Sciences (NASDAQ: ATAI) reportó los resultados financieros y actualizaciones corporativas del segundo trimestre de 2024. Puntos destacados:

  • Resultados positivos de la Fase 1b para VLS-01 (película bucal DMT) en la depresión resistente al tratamiento
  • Planes para iniciar estudios de Fase 2 para VLS-01 y EMP-01 (R-MDMA oral) a finales de 2024
  • Efectivo y valores por 103,3 millones de dólares al 30 de junio de 2024
  • Financiación prevista hasta 2026
  • Gastos en I+D disminuyeron a 12,6 millones de dólares desde 15,5 millones de dólares en comparación con el año anterior
  • Gastos generales y administrativos disminuyeron a 13,4 millones de dólares desde 16,6 millones de dólares en comparación con el año anterior
  • Pérdida neta de 57,3 millones de dólares, un aumento desde los 33,0 millones de dólares en el segundo trimestre de 2023

atai Life Sciences (NASDAQ: ATAI)가 2024년 2분기 재무 결과 및 기업 업데이트를 발표했습니다. 주요 하이라이트:

  • 치료 저항성 우울증에 대한 VLS-01 (구강 필름 DMT)의 긍정적인 1b상 결과
  • 2024년 연말 경 VLS-01 및 EMP-01 (구강 R-MDMA)에 대한 2상 연구를 시작할 계획
  • 2024년 6월 30일 기준으로 1억 3,330만 달러의 현금 및 증권
  • 2026년까지 자금 지원 예상
  • 연간 기준 R&D 비용이 1,260만 달러로 1,550만 달러에서 감소
  • 연간 기준 G&A 비용이 1,340만 달러로 1,660만 달러에서 감소
  • 2023년 2분기 3,300만 달러에서 증가한 5,730만 달러의 순손실

atai Life Sciences (NASDAQ: ATAI) a publié ses résultats financiers et ses mises à jour d'entreprise pour le deuxième trimestre 2024. Points clés :

  • Résultats positifs de la phase 1b pour VLS-01 (film buccal DMT) dans le traitement de la dépression résistante
  • Prévisions de lancement d'études de phase 2 pour VLS-01 et EMP-01 (R-MDMA oral) autour de la fin 2024
  • Trésorerie et titres de 103,3 millions de dollars au 30 juin 2024
  • Financement attendu jusqu'en 2026
  • Dépenses de R&D réduites à 12,6 millions de dollars contre 15,5 millions de dollars l'année précédente
  • Dépenses générales et administratives réduites à 13,4 millions de dollars contre 16,6 millions de dollars l'année précédente
  • Perte nette de 57,3 millions de dollars, en hausse par rapport à 33,0 millions de dollars au deuxième trimestre 2023

atai Life Sciences (NASDAQ: ATAI) hat die finanziellen Ergebnisse und Unternehmensaktualisierungen für das zweite Quartal 2024 veröffentlicht. Wesentliche Punkte:

  • Positive Ergebnisse der Phase 1b für VLS-01 (mundliches DMT-Film) bei behandlungsresistenter Depression
  • Pläne zur Einleitung von Phase 2-Studien für VLS-01 und EMP-01 (orale R-MDMA) gegen Ende 2024
  • Bar- und Wertpapierbestände von 103,3 Millionen Dollar zum 30. Juni 2024
  • Finanzierung wird bis 2026 voraussichtlich verfügbar sein
  • Forschungs- und Entwicklungskosten sanken auf 12,6 Millionen Dollar von 15,5 Millionen Dollar im Jahresvergleich
  • Allgemeine und Verwaltungskosten sanken auf 13,4 Millionen Dollar von 16,6 Millionen Dollar im Jahresvergleich
  • Nettoverlust von 57,3 Millionen Dollar, ansteigend von 33,0 Millionen Dollar im 2. Quartal 2023
Positive
  • Positive Phase 1b results for VLS-01 in treatment-resistant depression
  • Plans to initiate two Phase 2 studies around year-end 2024
  • Cash runway extended into 2026
  • Decrease in R&D expenses by $2.9 million year-over-year
  • Decrease in G&A expenses by $3.2 million year-over-year
Negative
  • Net loss increased to $57.3 million from $33.0 million year-over-year
  • Cash and securities decreased by $50.9 million since December 31, 2023
  • $30.6 million reduction in fair value of assets and liabilities

Insights

atai Life Sciences' Q2 2024 results reveal a mixed financial picture. The company's cash position of $103.3 million, down from $154.2 million at the end of 2023, raises concerns about cash burn. However, management's assertion of funding into 2026 provides some reassurance. The reduction in R&D and G&A expenses (18.7% and 19.3% respectively) demonstrates cost control efforts, but may impact future growth. The significant net loss increase to $57.3 million from $33.0 million year-over-year is concerning, primarily due to a $30.6 million reduction in fair value of assets and liabilities. This volatility in asset valuation could be a red flag for investors.

The clinical progress of atai's pipeline is promising. VLS-01's positive Phase 1b results for treatment-resistant depression (TRD) and plans for Phase 2 initiation are encouraging. The rapid onset and short duration of psychedelic effects could be a significant advantage in clinical settings. EMP-01's unique profile for social anxiety disorder (SAD) also shows potential, especially given the lack of novel treatments in this area for over two decades. The diverse pipeline targeting various mental health disorders demonstrates a robust R&D strategy. However, investors should note that these are early-stage results and success in later phases is important for long-term value creation.

atai's focus on mental health innovation positions it well in a growing market. The company's approach to developing novel treatments for treatment-resistant depression, social anxiety disorder and other mental health conditions addresses significant unmet needs. The potential for VLS-01 and EMP-01 to offer new treatment paradigms could be game-changing if successful. However, the competitive landscape in psychedelic medicine is intensifying and atai will need to differentiate its offerings. The company's ability to advance multiple candidates simultaneously is impressive, but also increases financial risk. Investors should closely monitor upcoming catalysts, particularly the Phase 3 results for COMP360 in TRD, as these could significantly impact the company's market position.

• Reported positive Phase 1b results of VLS-01 (buccal film DMT); expect to initiate a Phase 2 study in treatment-resistant depression patients around YE’24 

• Announced clinical development plans for EMP-01 (oral R-MDMA); expect to initiate a Phase 2 study of EMP-01 in social anxiety disorder patients around YE’24 

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

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

“Over the past quarter, we've made significant strides to advance our pipeline, with key updates from our VLS-01 and EMP-01 programs,” stated Dr. Srinivas Rao, Co-Chief Executive Officer and Co-founder of atai. “Our positive Phase 1b results for VLS-01 underscore its potential as a best-in-class oral treatment for patients suffering from treatment-resistant depression, and we look forward to initiating the Phase 2 study around year-end.

Clinical development plans for EMP-01 are advancing with a Phase 2 study in Social Anxiety Disorder (SAD) set to begin around year-end. This follows encouraging Phase 1 results, where EMP-01 demonstrated a unique subjective profile compared to racemic MDMA and classical psychedelics. With no novel molecules approved for SAD in over 20 years, it remains an area of critical unmet need.

Looking ahead, our team is focused on several important readouts and study initiations in the second half of the year. As such, we continue to establish our position as a leader in mental health innovation, with a robust set of high potential programs aimed at addressing the areas of most significant unmet need.”

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

  • VLS-01 is a proprietary oral transmucosal film formulation of DMT applied to the buccal surface designed to fit within a two-hour in-clinic treatment paradigm.
  • Recently, atai announced positive topline data from the Phase 1b trial of VLS-01 buccal film in 17 healthy participants. Peak plasma concentration of VLS-01 occurred within 30-45 minutes.  VLS-01 was shown to induce a short psychedelic experience, with subjective effects generally resolving within 90-120 minutes.
  • VLS-01 demonstrated a favorable safety profile and was well tolerated, with all adverse events classified as either mild or moderate, most resolving on the day of dosing, and none related to blood pressure, heart rate, or suicidality.
  • The Company expects to initiate a randomized, double-blind, placebo-controlled Phase 2 study to assess the safety, efficacy and durability of response of repeated doses of VLS-01 buccal film in patients with TRD around year-end 2024.

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

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

Anticipated Upcoming R&D Catalysts

  • H2’24
    • VLS-01 TRD: Phase 2 initiation (around YE’24)
    • EMP-01 SAD: Phase 2 initiation (around YE’24)
    • IBX-210 opioid use disorder (OUD): Phase 1b/2a initiation
    • BPL-003 TRD: Phase 2b complete patient enrollment
    • BPL-003 alcohol use disorder (AUD): Phase 2a topline open-label data
    • ELE-101 major depressive disorder (MDD): Phase 2a topline open-label data
    • COMP360 TRD: Phase 3 Pivotal Trial 1 topline data
       
  • 2025
    • RL-007 cognitive impairment associated with schizophrenia (CIAS): Phase 2b topline data (mid’25)
    • COMP360 TRD: Phase 3 Pivotal Trial 2 topline data (mid’25)

Consolidated Financial Results
Cash, cash equivalents, and short-term securities (primarily US treasuries and government agency securities): As of June 30, 2024, the Company had cash, cash equivalents, restricted cash and short-term securities of $103.3 million compared to $154.2 million as of December 31, 2023. The decrease of $50.9 million was primarily driven by $38.8 million net cash used in operating activities, $10 million for the Beckley Psytech investment, and $3.9 million funding of strategic investments. The Company expects its cash, short-term securities, public equity holdings, and committed term loan facility with Hercules Capital, Inc. to be sufficient to fund operations into 2026.

Research and development (R&D) expenses: R&D expenses were $12.6 million for the three months ended June 30, 2024, as compared to $15.5 million for the same prior year period.  The year-over-year decrease of $2.9 million was primarily attributable to a decrease of $1.0 million in program-specific expenses and $1.9 million in R&D personnel. Within program-specific expenses, the decrease was primarily driven by more clinical trial and discovery expenses in prior year. The Company is anticipating R&D spend to increase as its R&D programs progress into later stage clinical trials.

General and administrative (G&A) expenses: G&A expenses for the three months ended June 30, 2024, were $13.4 million as compared to $16.6 million in the same prior year period. The year-over-year decrease of $3.2 million was primarily attributable to a $1.9 million decrease in personnel related expenses, $1.8 million net decrease of professional services and other administrative expenses, partially offset by a $0.5 million increase in public company and investor relations expense. The Company expects the reduction in G&A spend over prior years to continue.

Other income (expense), net. Other expense for the three months ended June 30, 2024, was $31.3 million as compared to $0.2 million income in the same prior year period. Other expense for the 2024 second quarter includes a $30.6 million reduction in the fair value of our assets and liabilities, net. This primarily consists of a $29.1 million reduction in investments held at fair value, $7.5 million reduction in the fair value of related party notes receivable, and $4.8 million decrease in fair value of convertible note liability.

Net loss: Net loss attributable to stockholders for the three months ended June 30, 2024, was $57.3 million as compared to $33.0 million for the three months ended June 30, 2023.

About atai Life Sciences
atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders and was founded as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines to achieve clinically meaningful and sustained behavioral change in mental health patients. atai's vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. For more information, please visit www.atai.life.

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,” “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.life 

Media Contact:
PR@atai.life


-- 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 Six Months Ended
  June 30, June 30,
   2024   2023   2024   2023 
  (unaudited) (unaudited)
License revenue $273  $172  $273  $209 
Operating expenses:        
Research and development  12,605   15,476   24,136   34,757 
General and administrative  13,397   16,558   25,952   30,529 
Total operating expenses  26,002   32,034   50,088   65,286 
Loss from operations  (25,729)  (31,862)  (49,815)  (65,077)
Other income (expense), net  (31,348)  204   (32,943)  263 
Loss before income taxes  (57,077)  (31,658)  (82,758)  (64,814)
Provision for income taxes  (19)  (185)  (15)  (351)
Losses from investments in equity method investees, net of tax  (273)  (1,928)  (1,974)  (2,961)
Net loss  (57,369)  (33,771)  (84,747)  (68,126)
Net loss attributable to noncontrolling interests  (57)  (729)  (722)  (1,948)
Net loss attributable to ATAI Life Sciences N.V. stockholders $(57,312) $(33,042) $(84,025) $(66,178)
Net loss per share attributable to ATAI Life Sciences N.V.
   stockholders — basic and diluted
 $(0.36) $(0.21) $(0.53) $(0.42)
Weighted average common shares outstanding attributable to
   ATAI Life Sciences N.V. stockholders — basic and diluted
  160,387,701   155,792,490   159,643,518   155,793,323 



ATAI LIFE SCIENCES N.V.
CONDENSED CONSOLIDATED BALANCE SHEET
(Amounts in thousands)

  June 30, December 31,
  2024 2023
  (unaudited)  (1) 
Assets    
Cash and cash equivalents $19,333 $45,034 
Securities carried at fair value  69,013  109,223 
Short term restricted cash for other investments  15,000  - 
Committed investment funds  -  25,000 
Prepaid expenses and other current assets  4,690  5,830 
Short term convertible notes receivable - related party  7,976  - 
Short term notes receivable - related party, net  1,896  505 
Property and equipment, net  873  981 
Operating lease right-of-use asset, net  1,043  1,223 
Other investments held at fair value  61,141  89,825 
Other investments  32,381  1,838 
Long term notes receivable - related party, net  -  97 
Convertible notes receivable - related party  -  11,202 
Other assets  2,432  2,720 
Total assets $215,778 $293,478 
Liabilities and Stockholders' Equity    
Accounts payable  3,814  4,589 
Accrued liabilities  12,911  15,256 
Current portion of lease liability  239  275 
Other current liability  680   
Contingent consideration liability - related parties  580  620 
Contingent consideration liability  1,373  1,637 
Noncurrent portion of lease liability  838  990 
Convertible promissory notes and derivative liability - related party  1,270  164 
Convertible promissory notes and derivative liability  2,049  2,666 
Long term debt, net  15,236  15,047 
Other liabilities  8,255  7,918 
Total stockholders' equity attributable to ATAI Life Sciences N.V. stockholders  167,890  242,962 
Noncontrolling interests  643  1,354 
Total liabilities and stockholders' equity $215,778 $293,478 
(1) The condensed consolidated financial statements as of and for the year ended December 31, 2023 are derived from the audited consolidated financial statements as of that date.

FAQ

What were atai Life Sciences' (ATAI) Q2 2024 financial results?

atai reported a net loss of $57.3 million, cash and securities of $103.3 million, R&D expenses of $12.6 million, and G&A expenses of $13.4 million for Q2 2024.

What are the key clinical developments for atai Life Sciences (ATAI)?

atai reported positive Phase 1b results for VLS-01 in treatment-resistant depression and plans to initiate Phase 2 studies for VLS-01 and EMP-01 around year-end 2024.

How long is atai Life Sciences' (ATAI) current funding expected to last?

atai expects its current cash, securities, public equity holdings, and committed term loan facility to fund operations into 2026.

What are the upcoming R&D catalysts for atai Life Sciences (ATAI) in H2 2024?

Key catalysts include Phase 2 initiations for VLS-01 and EMP-01, Phase 1b/2a initiation for IBX-210, and topline data from various ongoing studies.

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