atai Life Sciences Increases Loan in Principal by US$6m to Support IntelGenx’s Graduation to Toronto Stock Exchange After Positive Early Feasibility Study Data

atai Life Sciences Increases Loan in Principal by US$6m to Support IntelGenx’s Graduation to Toronto Stock Exchange After Positive Early Feasibility Study Data

NEW YORK, Sept. 15, 2021 (GLOBE NEWSWIRE) — atai Life Sciences (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced it has entered into an amended and restated loan agreement (“Loan Agreement”) with strategic partner IntelGenx Technologies Corp. (“IntelGenx”) to support IntelGenx’s conditionally approved graduation from the TSX Venture Exchange to the Toronto Stock Exchange (“TSX”). Completion of the uplisting and the commencement of trading of IntelGenx’s common shares, 8% convertible debentures with a maturity date of June 30, 2022, and share purchase warrants expiring on February 11, 2023 is subject to the satisfaction by IntelGenx of all of the final conditions of listing.

atai has agreed to increase the principal amount of its outstanding US$2,500,000 loan to IntelGenx by an additional US$6,000,000, with US$3,000,000 to become available to IntelGenx in each of January 2022 and January 2023, subject to customary conditions. The loan is in addition to atai’s previously announced initial equity investment of an approximately 25% interest in IntelGenx. The loan bears interest at a rate of 8% per annum, payable at maturity, and matures in January 2024. The borrower under the secured loan is IntelGenx’s wholly-owned subsidiary, IntelGenx Corp., and the loan is guaranteed by IntelGenx.

As part of the strategic partnership, IntelGenx partnered exclusively with atai to develop formulations of compounds for the prevention or treatment of mental health diseases or disorders, including compounds that have psychedelic, entactogenic and/or oneirophrenic properties (such as DMT and psilocybin, among others). atai agreed to increase the loan principal in part on the basis of early data generated from its ongoing feasibility studies conducted with IntelGenx.

“We are proud to deepen our relationship with atai, while strengthening our positions of leadership and boldly innovating novel psychedelic therapies,” said Dr. Horst G. Zerbe, CEO of IntelGenx. “I’m excited about our companies’ mutual efforts to advance our robust pipelines, while finding synergistic ways to work together to develop better compounds and modes of delivery to benefit patients.”

“This transaction illustrates our confidence in IntelGenx’s film technology and the potential it has in the development of product candidates to treat mental health disorders,” said Florian Brand, CEO of atai. “We look forward to collaborating to transition this innovative film delivery technology into the clinic.”

About atai
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 IntelGenx
IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.

IntelGenx’s superior film technologies, including VersaFilm®, DisinteQ™, VetaFilm™ and transdermal VevaDerm™, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offers significant benefits to patients and physicians for many therapeutic conditions.

IntelGenx’s highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx’s state-of-the-art manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit www.intelgenx.com.

Forward-Looking Information

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,
the uplisting of IntelGenx to the TSX and continued strategic cooperation between atai and IntelGenx. 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.

Contact Information

For atai Life Sciences:

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

For IntelGenx:
Stephen Kilmer
Investor Relations
(514) 331-7440 ext 232
stephen@intelgenx.com

Or

Andre Godin, CPA, CA
President and CFO
IntelGenx Technologies Corp.
(514) 331-7440 ext 203
andre@intelgenx.com

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

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 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

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.

Two new companies join psychedelic ETF

Optimi Health Joins First Psychedelic Exchange Traded Fund

PSYK, the world’s first psychedelic ETF that launched in January 2020, was rebalanced for the quarter based on respective float market capitalization. Optimi Health (OPTI) and Atai Life Sciences (ATAI) were added to the fund at 1.9% and 5.0% respectively, and Cybin (CYBN) accounts for the largest stake at 15.9%. The chart below shows the distribution of the ETF’s 24 holdings as of July 9.

Atai gains celebrity support

Liam Payne becomes the latest star to invest in a depression treatment made from psychedelic drugs

Since debuting on the NASDAQ last month, Atai Life Sciences (ATAI) has gained support from some celebrity investors. Steve Bartlett, the youngest venture capitalist on Dragon’s Den, became Atai’s creative director, claiming that it is the most important company he has ever invested in. Bartlett believes that “if any company is to effectively tackle the global mental health crisis, it is $Atai.” He recently convinced One Director star Liam Payne to invest in the company, joining the American DJ Diplo.