atai Life Sciences (NASDAQ: ATAI), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, reported first quarter 2023 financial results and provided corporate updates.

“We continue to focus on our vision to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. This past quarter we made significant progress, including the dosing of the first patient with RL-007 in a randomized, placebo-controlled Phase 2 study. In addition, we shared detailed pharmacodynamic data from the Phase 1 study of GRX-917, underscoring its promise as an anxiolytic without the sedative side effects seen with benzodiazepines. On VLS-01, we are encouraged by the preliminary data we are seeing in the on-going Phase 1 study and look forward to further elucidating the PK and PD of our OTF formulation through the addition of Part 3 of the study.”

Florian Brand, CEO and Co-Founder of atai

Clinical Pipeline Recent Highlights and Updates:

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

  • In the first quarter of 2023, the first patient was dosed in the Phase 2b study of RL-007 in patients with Cognitive Impairment Associated with Schizophrenia (CIAS).
  • The Phase 2b study is a randomized, placebo-controlled, double-blind, study of 6 weeks duration evaluating 20mg and 40mg of RL-007 vs placebo.
  • The primary endpoint of the study is the change from baseline in the MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite score, a well-established regulatory endpoint.
  • Topline results from this study are expected in the 2nd half of 2024.

GRX-917 (Deuterated Etifoxine for Anxiety Disorders)

  • In January 2023, Phase 1 results were announced from the study of GRX-917 in healthy volunteers.
    • GRX-917 was well-tolerated, with no dose-limiting toxicities and sedation comparable to placebo.
    • GRX-917 had an improved pharmacokinetic (PK) profile relative to non-deuterated etifoxine and demonstrated pharmacodynamic (PD) evidence of GABA receptor target engagement.
  • In April 2023, the company detailed PD data from the Phase 1 study in a poster presentation at the Society for Biological Psychiatry (SOBP) Annual Meeting.
    • As measured by EEG, GRX-917 demonstrated a statistically significant increase in beta power, a marker of potential anxiolytic effects, comparable to what is seen with exogenous neurosteroids and benzodiazepines.
    • Unlike benzodiazepines, however, GRX-917 was found to not reduce alpha power, a marker of potential sedative effects.
  • The company expects to proceed GRX-917 into a Phase 2 study in patients living with anxiety disorder. More details of the Phase 2 clinical development plan will be provided upon study initiation.

VLS-01 (N,N-dimethyltryptamine [DMT] for TRD)

  • The company recently completed Part 1 and Part 2 of an ongoing Phase 1 open-label, single-ascending dose study of VLS-01 in healthy adult participants.
  • The Phase 1 study is designed to evaluate the safety, tolerability, PK and PD of VLS-01 delivered by intravenous (IV) infusion and using our proprietary oral transmucosal film (OTF) formulation.
    • In Part 1 (IV) and Part 2 (OTF), VLS-01 was well-tolerated, with no dose-limiting toxicity and a favorable safety profile.
    • VLS-01 IV was consistent with the known pharmacological profile of DMT, producing robust exposure-dependent increases in the subjective intensity of psychedelic experience.
    • VLS-01 OTF produced generally dose-dependent increases in exposure, approaching that seen with IV administration. In addition, VLS-01 OTF administration resulted in subjective psychedelic experiences in the majority of subjects.
  • To further optimize the PK and PD of our proprietary OTF formulation, a protocol amendment was implemented to add Part 3, which will explore further dose ranging.
  • The company expects to report additional clinical data in Q3 2023.

COMP360 (Psilocybin Therapy for TRD, Anorexia Nervosa and PTSD)

  • COMPASS Pathways announced an acceleration of the Pivotal Trial 1 (COMP 005) part of the Phase 3 program in TRD, with topline data from Pivotal Trial 1 now expected in the summer of 2024.
  • The on-going Phase 3 program is composed of two pivotal trials, each of which will have a long-term follow-up component. The primary endpoint in both pivotal trials is the change from baseline in MADRS total score at week 6.

Consolidated Financial Results

Cash, Cash Equivalents, and Short-term investments: Cash and cash equivalents and short-term investments totaled $249.9 million as of March 31, 2023, compared to $273.1 million of December 31, 2022. The decrease of $23.2 million was primarily driven by net cash used in operating activities of $21.1 million and $3.0 million of loans to related parties, partially offset by $0.2 million of proceeds from stock option exercises. The Company expects its cash position and committed term loan funding will be sufficient to fund operations into 1H 2026.

Research and Development (R&D) Expenses: Research and development expenses were $19.3 million for the three months ended March 31, 2023, compared to $15.5 million for the same prior year period. The increase of $3.8 million was primarily attributable to a $2.3 million increase of contract research organization expenses related to the advancement of R&D programs, a $1.4 million net increase in personnel costs, which included a $0.3 million decrease in stock-based compensation and a $0.1 million increase in professional and consulting services fees.

General and Administrative (G&A) Expenses: General and administrative expenses were $14.0 million for the three months ended March 31, 2023, compared to $18.0 million for the same prior year period. The decrease of $4.0 million was largely attributable to a decrease of $2.0 million in VAT and other non-income taxes, $1.3 million decrease in stock-based compensation, $0.8 million decrease in accounting and legal fees, $0.8 million decrease in personnel related costs, $0.6 million decrease in D&O and other insurance costs, offset by $1.4 million of restructuring costs related to the reduction in force in February 2023.

Net Loss: Net loss attributable to shareholders was $33.1 million for the three months ended March 31, 2023, (including non-cash share-based compensation expense of $8.7 million) compared to $36.9 million (including non-cash share-based compensation expense of $10.2 million) for same prior year period.

About atai Life Sciences

atai Life Sciences is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. Founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape, atai is dedicated to acquiring, incubating, and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders.

By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies 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. 

ATAI LIFE SCIENCES N.V.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share amounts)
(unaudited)
    
 Three Months Ended
 March 31,
  2023   2022 
License revenue$37  $— 
Operating expenses:   
Research and development 19,281   15,460 
General and administrative 13,970   17,982 
Total operating expenses 33,251   33,442 
Loss from operations (33,214)  (33,442)
Other income (expense), net 58   1,521 
Loss before income taxes (33,156)  (31,921)
Provision for income taxes (165)  (41)
Losses from investments in equity method investees, net of tax (1,033)  (5,596)
Net loss (34,354)  (37,558)
Net loss attributable to noncontrolling interests (1,219)  (689)
Net loss attributable to ATAI Life Sciences N.V. stockholders$(33,135) $(36,869)
Net loss per share attributable to ATAI Life Sciences N.V.
stockholders — basic and diluted		$(0.21) $(0.24)
Weighted average common shares outstanding attributable to ATAI
Life Sciences N.V. stockholders — basic and diluted		 155,792,490   153,529,268 
ATAI LIFE SCIENCES N.V.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands)
     
  March 31 December 31,
  2023 2022
  (unaudited)  (1) 
Assets    
Cash and cash equivalents $185,885 $190,613 
Securities carried at fair value  63,998  82,496 
Prepaid expenses and other current assets  9,199  14,036 
Short term notes receivable – related parties, net  8,851  — 
Property and equipment, net  1,114  928 
Operating lease right-of-use asset, net  1,489  226 
Other investments  5,846  6,755 
Long term notes receivable – related parties, net  1,155  7,262 
Other assets  3,180  3,125 
Total assets $280,717 $305,441 
Liabilities and Stockholders’ Equity    
Accounts payable  4,915  2,399 
Accrued liabilities  13,819  17,306 
Current portion of lease liability  317  180 
Other current liabilities  902  12 
Non-current portion of contingent consideration liability – related parties  918  953 
Non-current portion of lease liability  1,185  44 
Convertible promissory notes – related parties, net of discounts and deferred issuance costs  422  415 
Long-term debt, net  14,783  14,702 
Other liabilities  2,816  3,664 
Total stockholders’ equity attributable to ATAI Life Sciences N.V. stockholders  236,825  260,740 
Noncontrolling interests  3,815  5,026 
Total liabilities and stockholders’ equity $280,717 $305,441 
     
(1) The condensed consolidated financial statements as of and for the year ended December 31, 2022 are derived from the audited consolidated financial statements as of that date.