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Press Release : atai Life Sciences Reports Second Quarter 2021 Financial Results and Business Update

08/16/2021 | 07:01am EDT

-Successfully completed Initial Public Offering on Nasdaq raising $258.8 million in gross proceeds, including the underwriters' over-allotment-

-Received $20 million upfront payment from Otsuka as part of the first major collaboration between a biopharmaceutical company developing psychedelics and large pharma-

-Advancement of 11 therapeutic programs, including initiation of Recognify's Phase 2 and GABA's Phase 1 trials-

-18 significant catalysts across atai's platform anticipated over next 18 months including two clinical trials to be completed and four clinical trials to be initiated in 2021-

-Solidified leadership position with strong cash position of $453.6 million to advance our current programs and incubate, acquire and invest in new programs-

-Company to host a webcast and conference call today at 08:30am EDT-

BERLIN and NEW YORK, Aug. 16, 2021 (GLOBE NEWSWIRE) -- atai Life Sciences N.V. (Nasdaq: ATAI) ("atai"), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today reported its financial results for the second quarter ended June 30, 2021 and provided a corporate update.

"In the second quarter of 2021, we made significant advancements to build our business and successfully completed an initial public offering on Nasdaq, raising approximately US$258.8 million in gross proceeds," said Florian Brand, CEO and co-founder of atai. "We have the financial resources to maximize the value of our decentralized drug development platform for improved probability of clinical success and leverage the value of our transformative pipeline. 2021 continues to be a pivotal year for atai with multiple upcoming catalysts across our expanding pipeline."

Q2 Corporate Updates

   -- Received $20 million as part of Perception's collaboration with Otsuka 
      for the development of R-ketamine, the first major collaboration between 
      a biopharmaceutical company developing psychedelics and large pharma. 
 
   -- Entered a strategic partnership with IntelGenx, a leader in 
      pharmaceutical films. As part of the strategic partnership, IntelGenx 
      will exclusively partner with atai to develop compounds for the 
      prevention or treatment of mental health diseases or disorders. 
 
   -- Announced InnarisBio in partnership with UniQuest, Australia's leading 
      university technology transfer company commercializing the research of 
      The University of Queensland (UQ), to develop a novel sol-gel-based 
      intranasal drug delivery technology to improve treatments for mental 
      health disorders. 

Recent Advancements and Upcoming Milestones for atai's Core Value Drivers

Perception Neuroscience:

Program Details: PCN-101 is a parenteral formulation of R-ketamine, a glutamatergic modulator being developed as a rapid-acting antidepressant, with the potential to be an at-home non-dissociative alternative to S-ketamine (marketed as SPRAVATO).

Upcoming Milestones

   -- Phase 2 randomized, double blind, placebo-controlled trial in patients 
      with treatment-resistant depression (TRD) to be initiated in the third 
      quarter and expected to run through late 2022. 
 
   -- The trial will assess efficacy and safety, dose response and duration of 
      action in patients with TRD. 

Recognify Life Sciences:

Program Details:

   -- RL-007, a cholinergic, glutamatergic and GABA-B receptor modulator, is an 
      orally available compound that is thought to alter the 
      excitatory/inhibitory balance in the brain to produce pro-cognitive 
      effects. 
 
   -- atai is developing this compound for the treatment of cognitive 
      impairments associated with schizophrenia. 

Q2 Advancements

   -- In April 2021, Recognify initiated a Phase 2a study for RL-007, after 
      receiving IND clearance from the U.S. Food and Drug Administration to 
      commence clinical trials for the treatment of Cognitive Impairment 
      Associated with Schizophrenia (CIAS). 
 
   -- The study is designed to evaluate the effects of RL-007 on safety, 
      tolerability, electroencephalogram-based biomarkers, and cognition. 

Upcoming Milestones: Topline results from the Phase 2a single-arm, multiple dose trial in patients with CIAS expected in late 2021.

GABA:

Program Details

   -- GRX-917 is an oral formulation of a deuterated version of etifoxine, a 
      compound that has a long history of prescription use in France for 
      treating anxiety disorders. 
 
   -- GRX-917 is designed to provide rapid anxiolytic activity with improved 
      tolerability compared to current treatments for anxiety in the United 
      States. 

Q2 Advancements

   -- In June 2021, GABA initiated a randomized, double blind, 
      placebo-controlled Phase 1 trial. 
 
   -- The study will evaluate safety, tolerability, pharmacokinetics, as well 
      as pharmacodynamics using qEEG. 

Upcoming Milestones: Topline results from the Phase 1 single ascending dose/multiple ascending dose program expected early in 2022.

DemeRx:

Program Details: DMX-1002 is an oral formulation of ibogaine, a cholinergic, glutamatergic and monoaminergic receptor modulator being developed for the treatment of opioid use disorder.

Q2 Advancements: DemeRx received approval from the UK Medicines and Healthcare products Regulatory Agency to commence subject enrollment in our proposed Phase 1/2 clinical trial.

Upcoming Milestones

   -- Phase 1 component of Phase 1/2 trial of DMX-1002 in recreational drug 
      users and healthy volunteers to be initiated in Q3 2021 and is expected 
      to read out safety data in early 2022. 
 
   -- The trial is designed to assess safety, tolerability, pharmacokinetics, 
      and efficacy, and the results will inform future studies in patients with 
      opioid use disorder. 

COMPASS Pathways:

Program Details: COMP360 is a proprietary formulation of synthetic psilocybin, a 5-HT2A-R agonist being developed as an oral, rapid-acting antidepressant.

Q2 Advancements

   -- In June 2021, COMPASS completed dosing in the Phase 2b clinical trial of 
      COMP360 psilocybin therapy for treatment-resistant depression. 
 
   -- The randomized, double-blind, dose-ranging study investigated the safety 
      and efficacy of psilocybin therapy in 233 patients, making it the largest 
      clinical trial with psilocybin to date. 

Upcoming Milestones: Phase 2b trial results are expected in late 2021.

Second Quarter 2021 Financial Results

Cash and Cash Equivalents

Cash and cash equivalents totaled $453.6 million as of June 30, 2021, compared to $97.2 million as of December 31, 2020. The six month increase of $356.4 million is attributed to net proceeds of $231.6 million from our Initial Public Offering, net proceeds of $168.6 million from Series C and Series D common stock issuances, $20.0 million of license revenue proceeds, and $4.0 million proceeds from the sale of investments and conversion of convertible notes. Offsetting were cash payments of $32.0 million for investments in platform companies, and $35.8 million in net operating expenses.

Revenues

License revenue in the first half 2021 of $19.9 million was related to proceeds received from Perception's License and Collaboration Agreement with Otsuka.

Operating Costs and Expenses

Research and development expenses were $16.0 million and $21.6 million for the three and six months ended June 30, 2021, as compared to $2.9 million and $5.0 million for the same prior year periods. The increase of $13.1 million and $16.6 million, respectively, were attributable to personnel costs, including stock-based compensation expense, and increased CRO expenses related to advancements in our R&D programs.

We recorded acquisition of in-process research and development expense of $8.0 million and $9.0 million for the three and six months ended June 30, 2021, relating to our investments in Neuronasal and InnarisBio.

General and administrative expenses for the three and six months ended June 30, 2021 were $37.3 million and $46.6 million, as compared to $2.9 million and $4.4 million in the same prior year periods. The increases of $34.4 million and $42.2 million, respectively, were attributable to personnel costs, including stock-based compensation expense, professional fees, and other costs related to support of our platform growth and public company requirements.

Total stock-based compensation expense for the three and six months ended June 30, 2021 was $37.5 million and $37.7 million, respectively, as compared to $41,000 and $82,000 for the comparable prior year periods, reflecting the recognition of expense related to the achievement of IPO performance-based partial vesting conditions.

Net loss attributable to atai stockholders for the three and six months ended June 30, 2021 was $48.5 million and $47.8 million, respectively, as compared to $16.4 million and $0.1 million for the comparable prior year periods.

Conference Call Information

atai will host a conference call and live audio webcast today at 08:30am ET to discuss its financial results and provide a corporate update. To access the live conference call, please dial 877-407-3982 from the United States, or +1 (201) 493-6780 internationally, using the conference ID: 13721888. The live and archived webcast https://www.globenewswire.com/Tracker?data=jsDy2w8fzMQkredYJzOVzEkXhLch8N8r2EKSQC5SjFaz9Ghj5Yfu61hw7QlJIxhLDhmpqnbbtWGEvTHS3nC_L-vf1J--8SBLnaN2r-cg6hcE0D4ZpFnMvqO6_VedtS6qkxfyU2EyhN6eEPoty8D0Uh08xJ0GuoV0QXq8N98_qyU7zeZ2TdXwiwXh6iTKyAf4_1SPLST7AqLlOyAymq0Jlzm7RrhszjbL5YL9pKBae2I6wEegXTJY41PpxjXvVjsk of this call will be available in the "Events" section of the atai Life Sciences website at ir.atai.life https://www.globenewswire.com/Tracker?data=Uq-zaM54pQLMxjatpNco4nEiJVForYvCF1H6kFycR7JEggPsoLBfjrDe0vcc3nd5qwcikGYxeuNr03M3DDjy1b3R5Hzt1XGb3APMDzHX406LQ_QvyCYNjDSuO9RsZeYAYLlM1VKRavks5QQwEGzJw59nbOaptxttRmaGpXd-ONATUrksC6mp0bQzbHaFQ8SZVZ6dNPWHbQiRkO1FtyOACSUSJuthRilsRq7r3U5mHMc= . An archived copy of the webcast will be available on the atai website for at least 30 days after the conference

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August 16, 2021 07:00 ET (11:00 GMT)

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