Perception Neuroscience initiates Phase 2a study of PCN-101 (R-ketamine) for treatment resistant depression

NEW YORK and BERLIN, Sept. 14, 2021 (GLOBE NEWSWIRE) — Perception Neuroscience (Perception), an atai Life Sciences (atai) biopharmaceutical company focused on developing innovative therapies in neuropsychiatric diseases, today announced the initiation of a Phase 2a clinical study to evaluate the safety and efficacy of PCN-101 (R-ketamine). R-ketamine is a stereoisomer of ketamine being developed for therapeutic treatment of psychiatric disorders such as Treatment Resistant Depression (TRD). The Phase 2a clinical trial has received the necessary regulatory and ethics approvals to initiate the study.

The Phase 2a trial is a double blind, placebo-controlled study in patients with TRD. Each of the 3 parallel arms will enroll 31 patients at multiple locations. Patients will receive either placebo, a 30 mg dose, or a 60 mg dose of R-ketamine intravenously.

Patients will be assessed for depressive symptomology over the subsequent 14 days using the Montgomery-Asberg Depression Rate Scale, or MADRS. Topline data from the study is expected to be reported at the end of 2022.

“We’re excited to take the next key step with this clinical trial to show the potential of PCN-101 for people living with TRD,” said Terence Kelly, PhD, CEO of Perception Neuroscience. “TRD impacts nearly 100 million people around the world, making up a third of patients living with depression; currently they are either undertreated or unresponsive to existing treatment options. We believe PCN-101 holds promise in helping such treatment-resistant patients, as a potential rapidly-acting antidepressant which can be administered at home.”

“We believe insight into the molecular properties of the single isomer, R-ketamine, has the potential to offer a highly differentiated profile from current treatment options,” added Florian Brand, CEO & Co-founder of atai Life Sciences. “Initiating this Phase 2 clinical study is a major step for our teams at Perception and atai and is a great achievement. We believe this work has the potential to deliver a novel option with diversified delivery capabilities that could decrease overall healthcare utilization, which may help us move toward our greater mission to improve care for patients who suffer from TRD.”

About PCN-101
Perception Neuroscience is developing PCN-101 (R-ketamine) for the treatment of Treatment Resistant Depression. PCN-101 is a single isomer of ketamine and belongs to a new generation of glutamate receptor modulators with the potential for rapid acting antidepressant (RAAD) activity and anti-suicidal effects. Pharmacologically, PCN-101 is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. Nonclinical depression model studies in rodents suggest that R-ketamine could possess more durable and potent effects than S-ketamine despite a lower affinity to the NDMA receptor and potentially a more favorable safety and tolerability profile.

About Perception Neuroscience, Inc
Perception Neuroscience is a New York City-based biopharmaceutical company committed to developing therapies for neuropsychiatric diseases. Perception’s mission is to provide substantially more effective treatment solutions to serious psychiatric disorders. The company is a majority-owned subsidiary of atai Life Sciences.

About atai Life Sciences
atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was 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. atai’s business model combines funding, technology, scientific, and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders. atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai has offices in New York, London, and Berlin. 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. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including without limitation statements regarding the initiation of the Phase 2a trial by Perception and future activities thereunder, the potential of PCN-101, and similar statements of a future or forward-looking nature. 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 discussed under the caption “Risk Factors” in atai’s prospectus pursuant to Rule 424(b) filed with the U.S. Securities and Exchange Commission (“SEC”) on June 21, 2021, as such factors may be updated from time to time in atai’s other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof and accordingly undue reliance should not be placed on such statements. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, whether as a result of new information, future events or otherwise, other than to the extent required by applicable law.

Investor Contact:
Greg Weaver
Chief Financial Officer
Email: greg.weaver@atai.life

Media Contact:
Anne Donohoe
KCSA Strategic Communications
Phone: +1 (212) 896-1265
Email: atai@KCSA.com

atai Life Sciences and Introspect Digital Therapeutics to test novel digital therapeutic approach in patients receiving ketamine for treatment resistant depression

atai Life Sciences and Introspect Digital Therapeutics to test novel digital therapeutic approach in patients receiving ketamine for treatment resistant depression

BERLIN and SAN DIEGO, Sept. 09, 2021 (GLOBE NEWSWIRE) — atai Life Sciences (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, and its digital therapeutic platform Introspect Digital Therapeutics, Inc. (“Introspect”), today announced a usability study of Introspect’s digital therapeutic (DTx) app technology in support of standard of care ketamine therapy for patients with treatment resistant depression (TRD) in collaboration with Kadima Neuropsychiatry. TRD impacts 100 million people globally, close to a third of the 300 million diagnosed with depression, many of whom are geographically restricted in their ability to access in-person psychological care.

Introspect’s DTx app approach to supported treatment in mental health will be integrated across 3 cohorts, with Cohort 1 focusing on user acceptability, Cohort 2 examining the introduction of therapeutic content via the app, and Cohort 3 assessing set and setting of treatment.

“We’re thrilled to be working with Kadima to test our digital therapeutic approach in a clinical setting with patients receiving with standard of care ketamine therapy,” said David Keene, CEO of Introspect. “Our goal is to show that our novel DTx app can be used alongside a drug; that it is useful, usable and intuitive to patients and providers.”

“The integration of Introspect’s digital therapeutic in a clinical environment is a pivotal step towards developing potentially scalable care,” said Florian Brand, Co-Founder and CEO of atai. “In our mission to improve the lives of millions living with mental health disorders, technology will be instrumental, ensuring that our pipeline of novel compounds can benefit patients everywhere.”

Introspect believes that high-quality digital combination therapies have the potential to improve the safety and effectiveness of many mental health treatments. In addition, Introspect considers DTx to be vital to the mission of providing personalized and scalable treatment to those who might not otherwise be able to access high-quality psychological care.

About atai Life Sciences

atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was 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. atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders. atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai has offices in New York, London and Berlin. For more information, please visit www.atai.life.

About Introspect Digital Therapeutics

Introspect is a wholly-owned enabling platform company providing tightly integrated DTx on a shared architecture across all of atai’s platform companies. Incorporating a DTx strategy from the very beginning of drug development, Introspect is dedicated to providing more comprehensive, personalized care management with potential to secure stronger IP protection. Introspect aims to develop digital biomarkers, which clinicians will be able monitor to predict patients’ recovery pathways, limiting trial and error while simultaneously streamlining therapeutic impact. A key goal for Introspect is to provide great precision psychiatry and personalization to assist therapists in making the best decisions for their patients.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including without limitation statements regarding the support of clinical trials by Introspect Digital Therapeutics and future activities thereunder, the potential Introspect’s digital therapeutics technology, and similar statements of a future or forward-looking nature. 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 discussed under the caption “Risk Factors” in atai’s prospectus pursuant to Rule 424(b) filed with the U.S. Securities and Exchange Commission (“SEC”) on June 21, 2021, as such factors may be updated from time to time in atai’s other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof and accordingly undue reliance should not be placed on such statements. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, whether as a result of new information, future events or otherwise, other than to the extent required by applicable law.

Investor Contact:

Greg Weaver

Chief Financial Officer

Email: greg.weaver@atai.life

Media Contact:

Anne Donohoe

KCSA Strategic Communications

Phone: +1 (212) 896-1265

Email: atai@KCSA.com

atai Life Sciences and Introspect Digital Therapeutics to test novel digital therapeutic approach in patients receiving ketamine for treatment resistant depression

BERLIN and SAN DIEGO, Sept. 09, 2021 (GLOBE NEWSWIRE) — atai Life Sciences (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, and its digital therapeutic platform Introspect Digital Therapeutics, Inc. (“Introspect”), today announced a usability study of Introspect’s digital therapeutic (DTx) app technology in support of standard of care ketamine therapy for patients with treatment resistant depression (TRD) in collaboration with Kadima Neuropsychiatry. TRD impacts 100 million people globally, close to a third of the 300 million diagnosed with depression, many of whom are geographically restricted in their ability to access in-person psychological care.

Introspect’s DTx app approach to supported treatment in mental health will be integrated across 3 cohorts, with Cohort 1 focusing on user acceptability, Cohort 2 examining the introduction of therapeutic content via the app, and Cohort 3 assessing set and setting of treatment.

“We’re thrilled to be working with Kadima to test our digital therapeutic approach in a clinical setting with patients receiving with standard of care ketamine therapy,” said David Keene, CEO of Introspect. “Our goal is to show that our novel DTx app can be used alongside a drug; that it is useful, usable and intuitive to patients and providers.”

“The integration of Introspect’s digital therapeutic in a clinical environment is a pivotal step towards developing potentially scalable care,” said Florian Brand, Co-Founder and CEO of atai. “In our mission to improve the lives of millions living with mental health disorders, technology will be instrumental, ensuring that our pipeline of novel compounds can benefit patients everywhere.”

Introspect believes that high-quality digital combination therapies have the potential to improve the safety and effectiveness of many mental health treatments. In addition, Introspect considers DTx to be vital to the mission of providing personalized and scalable treatment to those who might not otherwise be able to access high-quality psychological care.

About atai Life Sciences

atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was 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. atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders. atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai has offices in New York, London and Berlin. For more information, please visit www.atai.life.

About Introspect Digital Therapeutics

Introspect is a wholly-owned enabling platform company providing tightly integrated DTx on a shared architecture across all of atai’s platform companies. Incorporating a DTx strategy from the very beginning of drug development, Introspect is dedicated to providing more comprehensive, personalized care management with potential to secure stronger IP protection. Introspect aims to develop digital biomarkers, which clinicians will be able monitor to predict patients’ recovery pathways, limiting trial and error while simultaneously streamlining therapeutic impact. A key goal for Introspect is to provide great precision psychiatry and personalization to assist therapists in making the best decisions for their patients.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including without limitation statements regarding the support of clinical trials by Introspect Digital Therapeutics and future activities thereunder, the potential Introspect’s digital therapeutics technology, and similar statements of a future or forward-looking nature. 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 discussed under the caption “Risk Factors” in atai’s prospectus pursuant to Rule 424(b) filed with the U.S. Securities and Exchange Commission (“SEC”) on June 21, 2021, as such factors may be updated from time to time in atai’s other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof and accordingly undue reliance should not be placed on such statements. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, whether as a result of new information, future events or otherwise, other than to the extent required by applicable law.

Investor Contact:

Greg Weaver

Chief Financial Officer

Email: greg.weaver@atai.life

Media Contact:

Anne Donohoe

KCSA Strategic Communications

Phone: +1 (212) 896-1265

Email: atai@KCSA.com

atai Life Sciences to Participate in Upcoming September Investor Conferences

atai Life Sciences to Participate in Upcoming September Investor Conferences

BERLIN, Sept. 03, 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 announced that it will participate in in the following upcoming investor conferences in September:

Presentation details can be found below:

  • Citi 16th Annual BioPharma Conference
    Format: Panel Discussion
    Date and Time: Wednesday, September 8th, 2021, 2:20 p.m. ET
    Webcast Link: https://kvgo.com/citi-16th-annual-biopharma-vc/panel-atai-life-sciences-sept-2021
  • H.C. Wainwright 23rd Annual Global Investment Conference
    Format: Presentation
    Date and Time: Monday, September 13th, 2021, 9:00 a.m. ET
  • Baader Investment Conference (BIC)
    Format: Presentation
    Date and Time: Monday, September 20th, 2021, 11:30 a.m. ET
  • Cantor Fitzgerald Global Healthcare Conference
    Format: Fireside Chat
    Date and Time: Monday, September 27th, 2021, 10:00 a.m. ET
    Webcast Link: https://wsw.com/webcast/cantor12/atai/2059190

The presentations and archived webcasts will also be accessible in the Events section of atai’s website.

About atai Life Sciences

atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was 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. atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders. atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai is headquartered in Berlin, with offices in New York and London. 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. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. 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 discussed under the caption “Risk Factors” in atai’s prospectus pursuant to Rule 424(b) filed with the U.S. Securities and Exchange Commission (“SEC”) on June 21, 2021, 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.

Investor Contact:
Greg Weaver
atai – Chief Financial Officer
Email: greg.weaver@atai.life

Media Contact:
Anne Donohoe
KCSA Strategic Communications
Phone: +1 (212) 896-1265
Email: atai@KCSA.com

atai Life Sciences to Participate in Upcoming September Investor Conferences

BERLIN, Sept. 03, 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 announced that it will participate in in the following upcoming investor conferences in September:

Presentation details can be found below:

  • Citi 16th Annual BioPharma Conference
    Format: Panel Discussion
    Date and Time: Wednesday, September 8th, 2021, 2:20 p.m. ET
    Webcast Link: https://kvgo.com/citi-16th-annual-biopharma-vc/panel-atai-life-sciences-sept-2021
  • H.C. Wainwright 23rd Annual Global Investment Conference
    Format: Presentation
    Date and Time: Monday, September 13th, 2021, 9:00 a.m. ET
  • Baader Investment Conference (BIC)
    Format: Presentation
    Date and Time: Monday, September 20th, 2021, 11:30 a.m. ET
  • Cantor Fitzgerald Global Healthcare Conference
    Format: Fireside Chat
    Date and Time: Monday, September 27th, 2021, 10:00 a.m. ET
    Webcast Link: https://wsw.com/webcast/cantor12/atai/2059190

The presentations and archived webcasts will also be accessible in the Events section of atai’s website.

About atai Life Sciences

atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was 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. atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders. atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai is headquartered in Berlin, with offices in New York and London. 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. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. 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 discussed under the caption “Risk Factors” in atai’s prospectus pursuant to Rule 424(b) filed with the U.S. Securities and Exchange Commission (“SEC”) on June 21, 2021, 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.

Investor Contact:
Greg Weaver
atai – Chief Financial Officer
Email: greg.weaver@atai.life 

Media Contact:
Anne Donohoe
KCSA Strategic Communications
Phone: +1 (212) 896-1265
Email: atai@KCSA.com 

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

-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 of this call will be available in the “Events” section of the atai Life Sciences website at ir.atai.life. An archived copy of the webcast will be available on the atai website for at least 30 days after the conference call.

About atai Life Sciences

atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was 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. atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders. atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai is headquartered in Berlin, with offices in New York and London. 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. 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 future operating results and financial position; the success, cost and timing of development of our product candidates, including the progress of preclinical and clinical trials; the commercialization of our current product candidates and any other product candidates we may identify and pursue, if approved, including our ability to successfully build a specialty sales force and commercial infrastructure to market our current product candidates and any other product candidates we may identify and pursue; the timing of and our ability to obtain and maintain regulatory approvals; our business strategy and plans; potential acquisitions; and the plans and objectives of management for future operations and capital expenditures. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond our control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including without limitation: we are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception, and we anticipate that we will continue to incur significant losses for the foreseeable future; we will require substantial additional funding to achieve our business goals, and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our product development efforts; our limited operating history may make it difficult to evaluate the success of our business and to assess our future viability; we have never generated revenue and may never be profitable; our product candidates contain controlled substances, the use of which may generate public controversy; clinical and preclinical development is uncertain, and our preclinical programs may experience delays or may never advance to clinical trials; we currently rely on qualified therapists working at third-party clinical trial sites to administer certain of our product candidates in our clinical trials and we expect this to continue upon approval, if any, of our current or future product candidates; if third-party sites fail to recruit and retain a sufficient number of therapists or effectively manage their therapists, our business, financial condition and results of operations would be materially harmed; we cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized; research and development of drugs targeting the central nervous system, or CNS, is particularly difficult, and it can be difficult to predict and understand why a drug has a positive effect on some patients but not others; we face significant competition in an environment of rapid technological and scientific change; third parties may claim that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and may prevent or delay our development and commercialization efforts; a change in our effective place of management may increase our aggregate tax burden; we identified material weaknesses in connection with our internal control over financial reporting; and a pandemic, epidemic, or outbreak of an infectious disease, such as the COVID-19 pandemic, may materially and adversely affect our business, including our preclinical studies, clinical trials, third parties on whom we rely, our supply chain, our ability to raise capital, our ability to conduct regular business and our financial results. Other risk factors include the important factors described in the section titled “Risk Factors” in our final prospectus, filed with the Securities and Exchange Commission (“SEC”) on June 21, 2021 pursuant to Rule 424(b) under the Securities Act, and in our other filings with the SEC, that may cause our actual results, performance or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements.

Any forward-looking statements made herein speak only as of the date of this press release, and you should not rely on forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, performance, or achievements reflected in the forward-looking statements will be achieved or will occur. Except as required by applicable law, we undertake no obligation to update any of these forward-looking statements for any reason after the date of this press release or to conform these statements to actual results or revised expectations.

Investor Contact:
Greg Weaver
atai – Chief Financial Officer
Email: greg.weaver@atai.life

Media Contact:
Anne Donohoe
KCSA Strategic Communications
Phone: +1 (212) 896-1265
Email: atai@kcsa.com

 

ATAI LIFE SCIENCES N.V.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share amounts)
(unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
2021 2020 2021 2020
License revenue $ $ $ 19,880 $
Operating expenses:
Research and development 16,026 2,854 21,611 4,998
Acquisition of in-process research and development 7,962 120 8,934 120
General and administrative 37,331 2,851 46,604 4,421
Total operating expenses 61,319 5,825 77,149 9,539
Loss from operations (61,319 ) (5,825 ) (57,269 ) (9,539 )
Other income (expense), net (5,982 ) (1,321 ) (4,279 ) 20,294
Net loss before income taxes (67,301 ) (7,146 ) (61,548 ) 10,755
Provision for income taxes (58 ) (64 )
Gain on investment dilution 16,923 16,923
Losses from investments in equity method investees, net of tax (2,937 ) (9,811 ) (4,640 ) (11,831 )
Net loss (53,373 ) (16,957 ) (49,329 ) (1,076 )
Net loss attributable to redeemable noncontrolling
interests and noncontrolling interests (4,912 ) (600 ) (1,556 ) (1,022 )
Net loss attributable to ATAI Life Sciences N.V. stockholders $ (48,461 ) $ (16,357 ) $ (47,773 ) $ (54 )
Net loss per share attributable to ATAI Life Sciences N.V. stockholders– basic and diluted $ (0.37 ) $ (0.18 ) $ (0.38 ) $ (0.00 )
Weighted average common shares outstanding attributable to ATAI Life Sciences N.V. stockholders — basic and diluted
132,265,075 90,709,312 125,797,732 90,709,312

 

ATAI LIFE SCIENCES N.V.
CONDENSED CONSOLIDATED BALANCE SHEET
(Amounts in thousands)
June 30, December 31,
2021 2020
(unaudited) (1)
Assets
Cash and cash equivalents $ 453,622 $ 97,246
Prepaid expenses and other current assets 3,964 2,076
Short term notes receivable – related party 226
Property and equipment, net 331 71
Deferred offering costs 1,575
Equity method investments 19,780
Other investments held at fair value 6,886
Other investments 16,107 8,044
Long term notes receivable 1,388 911
Long term notes receivable – related parties 3,194 1,060
Other assets 689 339
Total assets $ 505,961 $ 111,548
Liabilities and Stockholders’ Equity
Accounts payable $ 6,202 $ 3,083
Accrued liabilities 7,824 9,215
Deferred revenue 120
Short-term notes payable 39
Contingent consideration liability – related parties 2,466 1,705
Convertible promissory notes – related parties, net of discounts and deferred issuance costs 1,176 1,199
Convertible promissory notes and derivative liability 978
Other liabilities 3,239
Total stockholders’ equity attributable to ATAI Life Sciences N.V. stockholders 474,850 90,822
Noncontrolling interests 10,045 4,546
Total liabilities and stockholders’ equity $ 505,961 $ 111,548
(1)The condensed consolidated financial statements as of and for the year ended December 31, 2020 are derived from the audited consolidated financial statements as of that date.

atai Life Sciences to Host Conference Call and Webcast to Discuss Second Quarter 2021 Financial Results and Provide Business Update

BERLIN, Aug. 09, 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 announced that it plans to host a conference call on Monday, August 16, 2021 at 8:30 a.m. ET to discuss its financial results for the quarter ended June 30, 2021 and provide a business 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 of this call will be available in the “Events” section of the atai Life Sciences website at ir.atai.life.

About atai Life Sciences

atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was 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. atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders. atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai is headquartered in Berlin, with offices in New York and London. 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. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including without limitation statements regarding atai’s participation in upcoming conferences and presentations and similar statements of a future or forward-looking nature. 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 discussed under the caption “Risk Factors” in atai’s prospectus pursuant to Rule 424(b) filed with the U.S. Securities and Exchange Commission (“SEC”) on June 21, 2021, as such factors may be updated from time to time in atai’s other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof and accordingly undue reliance should not be placed on such statements. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, whether as a result of new information, future events or otherwise, other than to the extent required by applicable law.

Investor Contact:
Greg Weaver
atai – Chief Financial Officer
Email: greg.weaver@atai.life

Media Contact:
Anne Donohoe
KCSA Strategic Communications
Phone: +1 (212) 896-1265
Email: atai@KCSA.com

atai Life Sciences to Present at the 41st Annual Canaccord Genuity Growth Conference

BERLIN, Aug. 06, 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 announced that it will participate in a fireside chat and one-on-one investor meetings at the Canaccord Genuity Growth Conference, to be held virtually from August 10-12, 2021.

Presentation details can be found below:

41st Annual Canaccord Genuity Growth Conference
Format: Fireside chat
Date and Time: Tuesday, August 10th, 2:30 p.m. ET
Webcast link: https://wsw.com/webcast/canaccord60/atai/2419868

About atai Life Sciences

atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was 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. atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders. atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai is headquartered in Berlin, with offices in New York and London. 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. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. 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 discussed under the caption “Risk Factors” in atai’s prospectus pursuant to Rule 424(b) filed with the U.S. Securities and Exchange Commission (“SEC”) on June 21, 2021, 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.

Investor Contact:
Greg Weaver
atai – Chief Financial Officer
Email: greg.weaver@atai.life

Media Contact:
Anne Donohoe
KCSA Strategic Communications
Phone: +1 (212) 896-1265
Email: atai@KCSA.com

 

Snorting shrooms?

atai Life Sciences launches InnarisBio, in partnership with the University of Queensland, with the aim to develop a more effective nose-to-brain delivery method for atai’s platform of mental health therapeutic programs

PsiloThera isn’t the only company changing the way we take drugs.

atai Life Sciences (ATAI) is partnering with the University of Queensland to commercialize a new nose-to-brain drug delivery technology for psychedelic and non-psychedelic compounds. The nasal method has potential to be more effective at treating central nervous system (CNS) disorders than oral administration because it bypasses the blood-brain barrier that can restrict the entry of therapeutic agents. The nose-to-brain technology may require a lower dose than oral methods and may reduce dosing frequency too  –  plus its non-invasive and painless.

atai Life Sciences launches InnarisBio, in partnership with the University of Queensland, with the aim to develop a more effective nose-to-brain delivery method for atai’s platform of mental health therapeutic programs

BERLIN and BRISBANE, Australia, July 28, 2021 (GLOBE NEWSWIRE) — atai Life Sciences (“atai” or the “Company”) (Nasdaq: ATAI), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, and UniQuest, Australia’s leading university technology transfer company commercializing the research of The University of Queensland (UQ), today announced the launch of InnarisBio Inc. (InnarisBio), to develop a novel sol-gel intranasal drug delivery technology to improve treatments for mental health disorders.

InnarisBio aims to commercialize the sol-gel intranasal drug delivery platform technology developed in the laboratory of UQ researcher Dr. Harendra (Harry) Parekh at the School of Pharmacy in the Faculty of Health and Behavioural Sciences. The platform technology, which also includes a patent filing, was licensed to InnarisBio by UniQuest. Under the terms of the license, InnarisBio will receive exclusive rights in their desired fields.

The sol-gel technology is designed to deliver pharmaceutical compounds as a liquid at room temperature which becomes a gel at body temperature. The platform technology has been successfully utilized with both water soluble and insoluble compounds and extracts.

Traditional drug delivery methods can be problematic in the treatment of central nervous system (CNS) disorders due to the blood–brain barrier that restricts the CNS entry of therapeutic agents, thereby decreasing drug efficacy. A potential solution is direct nose-to-brain delivery. It has the potential to be a painless and non-invasive administration route and may offer additional advantages such as increased patient compliance, lower dose requirements than oral administration, rapid onset of action and minimized systemic exposure, which may reduce the risk of peripheral toxicity.

“InnarisBio aims to be a revolutionary technology company for intranasal drug delivery in the treatment of CNS disorders. Dr Parekh and his team at The University of Queensland have worked diligently to develop a platform technology that may mitigate many of the drawbacks typically associated with traditional drug delivery in the CNS space,” said Florian Brand, CEO and co-founder of atai Life Sciences. “This novel technology has the potential to be superior to other intranasal drug delivery methods available by improving absolute uptake and duration of uptake through muco-adhesion in the nose, reducing dose administered and dosing frequency. We plan to explore the potential use of this technology for a variety of psychedelic and non-psychedelic compounds across atai’s platform.”

“We are excited by the role that UQ’s licensed technology may potentially play in solving one of the world’s most complex health problems,” said Dr. Dean Moss, CEO of UniQuest. “This innovative UQ technology could play a role in helping to tackle the scourge of mental illness; it is an exciting development for the sol-gel technology developed here at UQ and is another terrific example of the power of UQ research to create meaningful change.”

Under the terms of the license, InnarisBio will receive exclusive rights in their desired fields and UniQuest will receive equity in InnarisBio along with the potential to receive future development and commercial milestone payments and a royalty on product sales.

InnarisBio will collaborate with UniQuest, UQ’s Dr Parekh and his research team to formulate and develop bespoke sol-gel formulations for several psychedelic and non-psychedelic compounds nominated by InnarisBio.

About atai Life Sciences
atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was 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. atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders. atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai is headquartered in Berlin, with offices in New York and London. For more information, please visit www.atai.life.

About UniQuest

UniQuest is a leading university-based commercialisation company, managing the intellectual property (IP) of The University of Queensland (UQ). UniQuest has facilitated more than 100 start-up companies built on UQ IP, a milestone unsurpassed by any other Australian university. These companies have gone on to raise more than $794M to take UQ technologies to market. The Queensland Emory Drug Discovery Initiative (QEDDI), a division of UniQuest, is a small molecule drug discovery and development facility translating The University of Queensland and collaborator’s biomedical research into new medicines to deliver faster health benefits. UniQuest is a partner on the MRFF Biomedical Translation Bridge (BTB) Program with MTPConnect.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including without limitation statements regarding the launch of InnarisBio and future activities thereunder, the potential of sol-gel technology, and similar statements of a future or forward-looking nature. 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 discussed under the caption “Risk Factors” in atai’s prospectus pursuant to Rule 424(b) filed with the U.S. Securities and Exchange Commission (“SEC”) on June 21, 2021, as such factors may be updated from time to time in atai’s other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof and accordingly undue reliance should not be placed on such statements. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, whether as a result of new information, future events or otherwise, other than to the extent required by applicable law.

atai – Investor Contact:
Greg Weaver
Chief Financial Officer
Email: greg.weaver@atai.life

atai – Media Contact:
Anne Donohoe
KCSA Strategic Communications
Phone: +1 (212) 896-1265
Email: atai@KCSA.com

UniQuest – Media Contact:
Brooke Baskin
Manager, Media and Communications
Phone: +61 7 3365 7480
Mobile: +61 409 767 199
Email: b.baskin@uniquest.com.au