8-K
Atai Beckley N.V. (ATAI)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): November 13, 2024
ATAI LIFE SCIENCES N.V.
(Exact name of registrant as specified in its charter)
| The Netherlands | 001-40493 | Not Applicable |
|---|---|---|
| (State or other jurisdiction of incorporation or organization) | (Commission File Number) | (I.R.S. Employer Identification No.) |
Wallstraße 16
10179 Berlin, Germany
(Address of principal executive offices) (Zip Code)
+498921539035
(Registrant’s telephone number, including area code)
N/A
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| --- | --- |
Securities registered pursuant to Section 12(b) of the Act
| Title of each class | Trading<br><br> <br>Symbol(s) | Name of each exchange<br><br> <br>on which registered |
|---|---|---|
| Common shares, €0.10 par value per share | ATAI | The Nasdaq Stock Market LLC<br><br> <br>(Nasdaq Global Market) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 2.02. | Results of Operations and Financial Condition. |
|---|
On November 13, 2024, ATAI Life Sciences N.V. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2024 and provided a corporate and clinical update. A copy of the press release is being furnished to the Securities and Exchange Commission as Exhibit 99.1 to this Current Report on Form 8-K (“Form 8-K”).
The information in this Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such a filing.
| Item 7.01. | Regulation FD Disclosure. |
|---|
On November 13, 2024, the Company posted an updated investor presentation under the “Investors” portion of its website at https://ir.atai.life/news-events/presentations, a copy of which is also being furnished as Exhibit 99.2 to this Form 8-K and is incorporated herein by reference. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.2. Other than as indicated herein, information contained on the Company’s website is not incorporated into, and does not form a part of this Form 8-K.
The information in Item 7.01 of this Form 8-K (including Exhibit 99.2) shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such a filing.
| Item 9.01. | Financial Statements and Exhibits. |
|---|
(d) Exhibits
| Exhibit<br><br> <br>No. | Description |
|---|---|
| 99.1* | Press Release of ATAI Life Sciences N.V., dated November 13, 2024. |
| 99.2* | Atai Company Presentation, dated November 13, 2024. |
| 104 | Cover Page Interactive Data File (embedded within the inline XBRL document). |
| * | Furnished herewith |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ATAI LIFE SCIENCES N.V. | ||
|---|---|---|
| Date: November 13, 2024 | By: | /s/ Florian Brand |
| Name: | Florian Brand | |
| Title: | Co-Chief Executive Officer | |
| By: | /s/ Srinivas Rao, M.D. | |
| --- | --- | |
| Name: | Srinivas Rao, M.D. | |
| Title: | Co-Chief Executive Officer |
Exhibit 99.1
atai Life Sciences Reports Third Quarter 2024 Financial Results
and Provides Corporate Updates
- The United States Food and Drug Administration cleared the investigational new drug application for VLS-01 (buccal film DMT); atai expects to initiate a Phase 2 study in treatment-resistant depression patients around YE’24
- Remain on track to initiate a Phase 2 study of EMP-01 (oral R-MDMA) in social anxiety disorder patients around YE’24
- Cash, marketable securities, and committed term loan funding expected to fund operations into 2026
NEW YORK and BERLIN, November 13, 2024 – atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced third quarter 2024 financial results and provided corporate updates.
“As we approach the end of 2024, we continue to see progress and momentum across our pipeline, both with our wholly-owned programs and strategic investments,” stated Dr. Srinivas Rao, Co-Chief Executive Officer and Co-founder of atai. “We are on track to initiate Phase 2 trials for VLS-01 and EMP-01 around year-end and we look forward to topline Phase 2b data from Beckley Psytech’s BPL-003 in the second quarter of 2025. Our team is focused on executing these trials with the utmost scientific rigor and is driven by our goal of being the leader in developing new psychedelic treatment options to mental health patients in need of innovative, safe and effective solutions.”
Recent Clinical Highlights
VLS-01: N,N-dimethyltryptamine (DMT) for Treatment-Resistant Depression (TRD)
| • | VLS-01 is a proprietary oral transmucosal film formulation of DMT applied to the buccal surface designed to fit within a two-hour in-clinic treatment paradigm. |
|---|---|
| • | The United States Food and Drug Administration (FDA) cleared the investigational new drug (IND) application for VLS-01, allowing the Company to proceed with its plans to initiate a<br> randomized, double-blind, placebo-controlled Phase 2 study to assess the safety, efficacy and durability of response of repeated doses of VLS-01 buccal film in patients with TRD. |
| --- | --- |
| • | The Phase 2 study is expected to initiate the study in U.S. around year-end 2024. |
| --- | --- |
EMP-01: R-enantiomer of 3,4-methylenedioxy-methamphetamine (R-MDMA) for Social Anxiety Disorder (SAD)
| • | EMP-01 is an oral formulation of R-MDMA that demonstrated a unique, dose-dependent subjective effect profile in a Phase 1 trial that was generally found to be more<br> similar to classical psychedelics than to racemic MDMA. |
|---|---|
| • | atai expects to initiate an exploratory, randomized, double-blind, placebo-controlled Phase 2 study to assess the safety, tolerability and efficacy of EMP-01 in adults with SAD<br> around year-end 2024. |
| --- | --- |
| • | SAD is an area of high unmet medical need with approximately 18 million people in the U.S. diagnosed in the past year and no novel molecules approved in over two decades. |
|---|
IBX-210: Intravenous (IV)-Ibogaine for Opioid Use Disorder (OUD)
| • | IBX-210 is a novel IV formulation of ibogaine, which is an indole alkaloid with potential for clinical benefit for substance use disorder. |
|---|---|
| • | Completed productive FDA pre-IND meeting to initiate discussions and alignment on a modern ibogaine IND. |
| --- | --- |
| • | atai plans to run additional non-clinical studies prior to launching a Phase 1b study. |
| --- | --- |
Novel 5-HT2A Receptor Agonists
| • | Discovery program to identify novel, non-hallucinogenic 5-HT2AR agonists for TRD using artificial intelligence (AI)/machine learning (ML)-informed drug design and<br> medicinal chemistry. |
|---|---|
| • | Presented data at the Society for Neuroscience (SfN) annual meeting aimed to show that these compounds are promising chemical starting points for new analogs with<br> further improved 5-HT2AR vs. 5-HT2BR agonist selectivity that maintain translational antidepressant-like activity with potential for non-hallucinogenic effects. |
| --- | --- |
RL-007: Pro-Cognitive Neuromodulator for Cognitive Impairment Associated with Schizophrenia (CIAS)
| • | RL-007 is an orally bioavailable compound that has demonstrated pro-cognitive effects in multiple pre-clinical and clinical studies, including two Phase 1 and two<br> Phase 2 trials. |
|---|---|
| • | The ongoing Phase 2b study is evaluating 20mg and 40mg of RL-007 vs. placebo in patients living with CIAS. Topline results are expected mid-2025. |
| --- | --- |
Recent Corporate Updates
Completed the acquisition of IntelGenx Corp.
| • | IntelGenx is a drug delivery company focused on the development and manufacturing of novel oral thin film products for the pharmaceutical market and manufactures VLS-01 (buccal film<br> DMT). |
|---|---|
| • | Neither equity nor cash from the Company was used to acquire IntelGenx. |
| --- | --- |
Anticipated Upcoming R&D Catalysts
| • | H2’24 |
|---|---|
| o | VLS-01 TRD: Phase 2 initiation (around YE’24) |
| --- | --- |
| o | EMP-01 SAD: Phase 2 initiation (around YE’24) |
| --- | --- |
| o | BPL-003 alcohol use disorder (AUD): Phase 2a topline open-label data |
| --- | --- |
| o | ELE-101 major depressive disorder (MDD): Phase 2a topline open-label data |
| --- | --- |
| • | 2025 |
| --- | --- |
| o | BPL-003 TRD: Phase 2b topline data (Q2’25) |
| --- | --- |
| o | RL-007 cognitive impairment associated with schizophrenia (CIAS): Phase 2b topline data (mid’25) |
| --- | --- |
| o | VLS-01 TRD: Phase 2 topline data (around YE’25) |
|---|---|
| o | EMP-01 SAD: Phase 2 topline data (around YE’25) |
| --- | --- |
Consolidated Financial Results
Cash, cash equivalents, and short-term securities (primarily US treasuries and government agency securities): As of September 30, 2024, the Company had cash, cash equivalents, restricted cash and short-term securities of $101.0 million compared to $154.2 million as of December 31, 2023. The decrease of $53.2 million was primarily driven by $58.1 million net cash used in operating activities, $10.0 million for the Beckley Psytech investment, and $7.7 million investment to advance our programs; partially offset by $16.1 million in proceeds from the partial sale of our ADSs holdings in Compass Pathways, and $5.0 million in proceeds from our committed term loan with Hercules Capital, Inc. The Company expects its cash, short-term securities, public equity holdings, and committed term loan facility to be sufficient to fund operations into 2026.
Research and development (R&D) expenses: R&D expenses were $12.4 million for the three months ended September 30, 2024, as compared to $13.3 million for the same prior year period. The year-over-year decrease of $0.9 million was primarily attributable to a decrease of $2.7 million in R&D personnel-related expenses, partially offset by an increase of $1.7 million in program-specific expenses. Within program-specific expenses, the increase was primarily driven by additional clinical trial expenses in the current year. The Company is anticipating R&D spend to increase as its R&D programs progress into later stage clinical trials.
General and administrative (G&A) expenses: G&A expenses for the three months ended September 30, 2024, were $10.3 million as compared to $13.6 million in the same prior year period. The year-over-year decrease of $3.3 million was primarily attributable to a $3.5 million decrease in personnel-related expenses and administrative costs. The Company expects the reduction in G&A spend over prior years to continue.
Net income (loss): Net loss attributable to stockholders for the three months ended September 30, 2024, was $26.3 million, which included $2.0 million of non-cash change in fair value of notes receivables and other investments and $5.0 million of non-cash share-based compensation. Net income attributable to stockholders for the three months ended September 30, 2023 was $44.2 million, which included a $69.0 million non-cash change in fair value of other investments related to an accounting change of our Compass Pathways plc investment and $8.3 million of non-cash share-based compensation.
About atai Life Sciences
atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders and was founded as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines to achieve clinically meaningful and sustained behavioral change in mental health patients. atai’s vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. For more information, please visit www.atai.life.
Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “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 business strategy and plans; the potential, success, cost and timing of development of our product candidates, including the progress of preclinical and clinical trials and related milestones; expectations regarding our strategic investment in Beckley Psytech and other investments; expectations regarding our cash runway; and the plans and objectives of management for future operations, research and development and capital expenditures.
Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors described in the section titled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”), as such factors may be updated from time to time in atai’s other filings with the SEC. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by applicable law.
Contact Information
Investor Contact:
IR@atai.life
Media Contact:
PR@atai.life
-- Financial Statements Attached --
ATAI LIFE SCIENCES N.V.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share amounts)
| Three Months Ended | Nine Months Ended | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| September 30, | September 30, | |||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||
| (unaudited) | (unaudited) | |||||||||||
| License revenue | $ | 40 | $ | 87 | $ | 313 | $ | 296 | ||||
| Operating expenses: | ||||||||||||
| Research and development | 12,377 | 13,290 | 36,513 | 48,047 | ||||||||
| General and administrative | 10,265 | 13,631 | 36,226 | 44,159 | ||||||||
| Total operating expenses | 22,642 | 26,921 | 72,739 | 92,206 | ||||||||
| Loss from operations | (22,602 | ) | (26,834 | ) | (72,426 | ) | (91,910 | ) | ||||
| Other income (expense), net | (3,861 | ) | 70,681 | (36,795 | ) | 70,944 | ||||||
| Net income (loss) before income taxes | (26,463 | ) | 43,847 | (109,221 | ) | (20,966 | ) | |||||
| Benefit from (provision for) income taxes | 178 | (238 | ) | 163 | (588 | ) | ||||||
| Losses from investments in equity method investees, net of tax | (26 | ) | (238 | ) | (2,000 | ) | (3,199 | ) | ||||
| Net income (loss) | (26,311 | ) | 43,371 | (111,058 | ) | (24,753 | ) | |||||
| Net loss attributable to noncontrolling interests | (25 | ) | (873 | ) | (747 | ) | (2,821 | ) | ||||
| Net income (loss) attributable to ATAI Life Sciences N.V. stockholders | $ | (26,286 | ) | $ | 44,244 | $ | (110,311 | ) | $ | (21,932 | ) | |
| Net income (loss) per share attributable to ATAI Life Sciences N.V. stockholders — basic | $ | (0.16 | ) | $ | 0.28 | $ | (0.69 | ) | $ | (0.14 | ) | |
| Net income (loss) per share attributable to ATAI Life Sciences N.V. stockholders — diluted | $ | (0.16 | ) | $ | 0.25 | $ | (0.69 | ) | $ | (0.14 | ) | |
| Weighted average common shares outstanding attributable to ATAI Life Sciences N.V. stockholders — basic | 160,621,817 | 155,792,490 | 159,973,201 | 155,793,601 | ||||||||
| Weighted average common shares outstanding attributable to ATAI Life Sciences N.V. stockholders —<br> diluted | 160,621,817 | 177,565,973 | 159,973,201 | 155,793,601 |
ATAI LIFE SCIENCES N.V.
CONDENSED CONSOLIDATED BALANCE SHEET
(Amounts in thousands)
| September 30, | December 31, | |||
|---|---|---|---|---|
| 2024 | 2023 | |||
| (unaudited) | (1) | |||
| Assets | ||||
| Cash and cash equivalents | $ | 29,963 | $ | 45,034 |
| Securities carried at fair value | 55,957 | 109,223 | ||
| Short term restricted cash for other investments | 15,000 | - | ||
| Committed investment funds | - | 25,000 | ||
| Prepaid expenses and other current assets | 7,454 | 5,830 | ||
| Short term notes receivable - related party, net | 5,700 | 505 | ||
| Property and equipment, net | 865 | 981 | ||
| Operating lease right-of-use asset, net | 1,032 | 1,223 | ||
| Other investments held at fair value | 45,227 | 89,825 | ||
| Other investments | 33,893 | 1,838 | ||
| Long term notes receivable - related party, net | - | 97 | ||
| Convertible notes receivable - related party | - | 11,202 | ||
| Other assets | 2,428 | 2,720 | ||
| Total assets | $ | 197,519 | $ | 293,478 |
| Liabilities and Stockholders’ Equity | ||||
| Accounts payable | $ | 4,880 | $ | 4,589 |
| Accrued liabilities | 11,953 | 15,256 | ||
| Current portion of lease liability | 257 | 275 | ||
| Short term convertible promissory notes and derivative liability - related party | 925 | — | ||
| Short term convertible promissory notes and derivative liability | 1,481 | — | ||
| Other current liability | 147 | — | ||
| Contingent consideration liability - related parties | 650 | 620 | ||
| Contingent consideration liability | 1,388 | 1,637 | ||
| Noncurrent portion of lease liability | 808 | 990 | ||
| Convertible promissory notes and derivative liability - related party | — | 164 | ||
| Convertible promissory notes and derivative liability | — | 2,666 | ||
| Long term debt, net | 20,336 | 15,047 | ||
| Other liabilities | 8,378 | 7,918 | ||
| Total stockholders’ equity attributable to ATAI Life Sciences N.V. stockholders | 145,720 | 242,962 | ||
| Noncontrolling interests | 596 | 1,354 | ||
| Total liabilities and stockholders’ equity | $ | 197,519 | $ | 293,478 |
(1) The condensed consolidated financial statements as of and for the year ended December 31, 2023 are derived from the audited consolidated financial statements as of that date.
Exhibit 99.1
Healing mental health disorders so that everyone everywhere can live a more fulfilled life. Company Overview Company Overview – November 2024
All references in this presentation to “we”, “us”, “our”, “atai”, or the “Company” refer to ATAI Life Sciences N.V. and its consolidated subsidiaries, unless the context otherwise requires. This presentation contains forward-looking statements within the meaning of the private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered under by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.” All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, industry dynamics, business strategy and plans, anticipated milestones and timelines for our non-clinical, pre-clinical studies and clinical trials and our objectives for future operations, are forward-looking statements. These statements represent our opinions, expectations, beliefs, intentions, estimates or strategies regarding the future, which may not be realized. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “targets,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions that are intended to identify forward-looking statements. Forward-looking statements are based largely on our current expectations and projections about future events and financial 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 the important factors described in the section titled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”), as updated by our subsequent 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. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this presentation may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. We caution you therefore against relying on these forward-looking statements, and we qualify all of our forward-looking statements by these cautionary statements. The forward-looking statements included in this presentation are made only as of the date hereof. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, neither we nor our advisors nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. Neither we nor our advisors undertake any obligation to update any forward-looking statements for any reason after the date of this presentation to conform these statements to actual results or to changes in our expectations, except as may be required by law. You should read this presentation with the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially different from what we expect. Unless otherwise indicated, information contained in this presentation concerning our industry, competitive position and the markets in which we operate is based on information from independent industry and research organizations, other third-party sources and management estimates. Management estimates are derived from publicly available information released by independent industry analysts and other third-party sources, as well as data from our internal research, and are based on assumptions made by us upon reviewing such data, and our experience in, and knowledge of, such industry and markets, which we believe to be reasonable. In addition, projections, assumptions and estimates of the future performance of the industry in which we operate or of any individual competitor and our future performance are necessarily subject to uncertainty and risk due to a variety of factors, including those described above. These and other factors could cause results to differ materially from those expressed in the estimates made by independent parties and by us. Industry publications, research, surveys and studies generally state that the information they contain has been obtained from sources believed to be reliable, but that the accuracy and completeness of such information is not guaranteed. Forecasts and other forward-looking information obtained from these sources are subject to the same qualifications and uncertainties as the other forward-looking statements in this presentation. This presentation contains excerpts of testimonials from individuals who have been treated with compounds or derivatives of the compounds underlying our product candidates in the context of third-party studies or otherwise that are solely intended to be illustrative and not representative of the potential for beneficial results of such compounds. Our product candidates are in preclinical or clinical stages of development and none of our product candidates have been approved by the FDA or any other regulatory agency. When discussing patents in this presentation, “issued” is to be understood to mean one or more issued or granted claims in one or more country, and “pending” is understood to mean one or more claims pending in a patent application in one or more country. Patent protection is a highly fact-sensitive inquiry, varying from country-to-country, and provides for enforceable protection to the extent (a) covered by a given claim, and (b) issued in such country or countries. No generalized descriptions of patents made herein should be relied upon; rather, a detailed discussion of our intellectual property and related risk factors can be found in our most recently filed Annual Report on Form 10-K, available on the SEC’s website at www.sec.gov. Any trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construed as an endorsement of the products or services of the Company. Disclaimer 02
atai Life Sciences: addressing significant unmet patient needs in mental health disorders so that everyone, everywhere can live a more fulfilled life Executive Summary and Key Highlights 03 1 Significant unmet need: mental health disorders are one of the largest global health burdens; it is estimated that one out of every two people in the world will develop a mental health disorder in their lifetime.1 3 7 clinical-stage programs: seven active clinical-stage psychedelic and non-psychedelic programs, each with a robust package of prior clinical evidence. 2 Novel approach: our objective is to enable patients to achieve clinically meaningful improvements by developing innovative therapeutics with rapid-onset, durable effects and a focus on interventional treatment approaches. 4 5+ clinical readouts expected over the next 18 months: several anticipated clinical trial readouts across our drug development programs and strategic investments through 2024 and 2025. 5 Runway into 2026: cash and cash equivalents, marketable securities, and committed term loan funding expected to provide funding into 2026.2 McGrath et al, “Age of onset and cumulative risk of mental disorders: a cross-national analysis of population surveys from 29 countries”, The Lancet Psychiatry, 2023, Marketable securities includes money market funds, U.S. Treasury securities, commercial paper, corporate notes/bonds, U.S. government agencies securities, and public equities; term loan funding from Hercules Capital of up to $175M includes $45M capital that can be drawn not subject to milestones
Our vision is being delivered through a robust pipeline of development programs and strategic investments across a range of compounds and psychiatric indications Programs Overview Abbreviations: DMT = N,N-Dimethyltryptamine; R-MDMA = R enantiomer of 3,4-Methylenedioxymethamphetamine; 5-MeO-DMT = 5-methoxy-N,N-dimethyltryptamine Majority ownership stake in Recognify Life Sciences Strategic Investment in Compass Pathways Strategic Investment in Beckley Psytech All dates provided are as estimated Trial initiation defined as central regulatory and ethics approval 04 Programs Primary Indication Preclin Phase 1 Phase 2 Phase 3 Next anticipated milestone4,5 RL-0071 Pro-cognitive neuromodulator Cognitive Impairment Associated with Schizophrenia Ph2b results(mid’25) VLS-01 DMT Treatment Resistant Depression Ph2 initiation (around YE’24) EMP-01 R-MDMA Social Anxiety Disorder Ph2 initiation (around YE’24) IBX-210 Ibogaine Opioid Use Disorder Novel 5-HT2A Receptor Agonists(incl. non-hallucinogenic neuroplastogens) Undisclosed Undisclosed COMP3602 Psilocybin Treatment Resistant Depression Ph3 Pivotal Trial 1 results (Q2’25) BPL-0033 5-MeO-DMT Treatment Resistant Depression Ph2b topline data(Q2’25) ELE-1013 Psilocin Major Depressive Disorder Ph2a results(H2’24) STRATEGIC INVESTMENTS Undisclosed
We are funded through all expected milestones across our drug development programs and strategic investments for 2024 and 2025 Upcoming Catalysts Abbreviations: OL = Open-label; TRD = Treatment Resistant Depression; MDD = Major Depressive Disorder; PTSD = Post Traumatic Stress Disorder; AUD = Alcohol Use Disorder; YE = Year-end; CIAS = Cognitive Impairment in Schizophrenia All dates provided are as estimated Trial initiation defined as central regulatory and ethics approval 05 Achieved and anticipated milestones1,2(2024-25) BPL-003Ph 2a (TRD) OL Part 1 data 2025 H2’24 H1’24 VLS-01Ph 1b first participant dosed ELE-101Ph 1 topline data COMP360Ph 2 (PTSD) topline data BPL-003Ph 2a (AUD) topline OL data RL-007Ph 2b (CIAS) topline data (mid’25) VLS-01Ph 1b topline data BPL-003Ph 2b topline data (Q2’25) VLS-01Ph 2 (TRD) initiation (around YE’24) ELE-101 Ph 2a (MDD) topline OL data VLS-01Ph 2 (TRD) topline data (around YE’25) EMP-01Ph 2 (SAD) topline data (around YE’25) EMP-01Ph 2 (SAD) initiation (around YE’24)
RL-007 for Cognitive Impairment
Note: CIAS = Cognitive impairment associated with schizophrenia All dates provided for expected milestones are estimated SUMMARY: RL-007 RL-007 is a potential pro-cognitive neuromodulator, investigated in >500 participants and demonstrating consistent cognitive effects and good tolerability (2R, 3S)-2-amino-3-hydroxy-3-pyridin-4-yl-1-pyrrolidin-1-yl-propan-1-one(L)-(+) tartrate salt oral capsules (RL-007) GABA/nicotinic modulator Primary: CIAS Potential: Cognitive disorders including Alzheimer’s dementia and/or Autism Adjunctive treatment to standard of care for schizophrenia patients with cognitive impairment Phase 2a CIAS trial completed in H2’21Phase 2b first patient dosed in 1Q’23 Phase 2b topline data in mid’25 Issued composition of matter, formulation and method of use patents PRODUCT PHARMA-COLOGY INDICATIONS TARGET POSITION ACHIEVED & EXPECTED MILESTONES1 INTELLECTUAL PROPERTY Significant unmet need: no currently approved treatments for lead CIAS indication Reproducibility of effect: Pro-cognitive effects demonstrated in two Phase 1 and two Phase 2 trials Tolerability: No drug-related serious adverse events in over 500 study participant exposures and minimal potential for drug-drug interactions (DDIs) Add-on therapy to standard of care: clean DDI profile means it can likely be administered as an adjunctive to standard of care atypical antipsychotics 07
World Health Organization Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016 Cloutier et al, The economic burden of schizophrenia in the United States in 2013. J Clin Psychiatry 2016;77(6):764-771 Bora et al, Cognitive Impairment in Schizophrenia and Affective Psychoses: Implications for DSM-V Criteria and Beyond Holm M et al, Employment among people with schizophrenia or bipolar disorder: 2021 GlobalData (as of 11/15/2022) Cognitive impairment is very common4 Cognitive impairment is a common and major cause of disability in schizophrenia, with more than 80% of patients showing significant impairment ~80% ~24m Global sufferers of Schizophrenia¹ ~$155bn U.S. economic burden from adults with CIAS or Schizophrenia(direct + indirect costs)³ 15th Leading cause of disability worldwide (2016)² 0 FDA approvals for CIAS As of November 2022, there are no FDA approved treatments for CIAS6 Schizophrenia patient employment rate Five years following diagnosis, only 10% of schizophrenia patients have employment; being unemployed is primarily related to lower cognitive and social functioning5 ~10% CIAS & Schizophrenia in numbers 08 URGENT NEED FOR INNOVATION Cognitive impairment associated with schizophrenia (CIAS) is a core feature of schizophrenia, accounts for much of the impaired functioning associated with the disorder and is not responsive to existing treatments CIAS & Schizophrenia RL-007: Disease Overview
atai’s Phase 2a study in CIAS demonstrated RL-007’s potential to improve cognitive signals on a subset of MCCB neurocognitive endpoints RL-007: Phase 2a Results 09 Day 2 “pre-RL-007” was compared to Day 4 “post-RL-007” Abbreviations: MCCB = MATRICS™ Consensus Cognitive Battery PHASE 2A TRIAL - EFFICACY DATA ON COMPONENTS MCCB COMPOSITE Signal of improvement1 n=7 n=8 n=8 n=8 Cohen’s d* (Symbol Coding): 20 mg: 0.79 40 mg: 0.56 *Active vs pbo T-Scores (Normalized for age, gender, and education level) Key Takeaways 1 2 4 Study demonstrated dose-related trends for improvements on each MCCB sub-component neurocognitive test completed: Hopkins Verbal Learning Test, BACS Symbol Coding & Category Fluency On the BACS Symbol Coding test, the best correlate of the MCCB total score, a Cohen’s d effect size of 0.79 and 0.56 was seen at the 20mg and 40mg doses respectively versus placebo qEEG data also demonstrated increases in amplitude in the alpha band and in the alpha-slow wave index, markers of alertness believed to correlate with aspects of cognition. Cognitive function was assessed in 31 patients with CIAS across four cohorts (10, 20, 40 & 80mg). Patients received four doses of placebo followed by six doses of RL-007 over 4-days1 3 Key Takeaways
A randomized, placebo-controlled study of RL-007 is currently underway in ~234 patients with CIAS with topline data anticipated in mid’2025 RL-007: Phase 2b Study Design 10 Abbreviations: MCCB = MATRICS™ Consensus Cognitive Battery, TID = 3x/day dosing, Trial status: First patient dosed in 1Q’23, Topline data anticipated mid’25 RL-007 TID 40mg (n=78) RL-007 TID 20mg (n=78) Placebo (n=78) R Randomized 1:1:1 Primary Endpoint: MCCB neurocognitive composite score at Week 6 Other Secondary Endpoints: Select Individual Components of MCCB, including BACS Symbol Coding Clinical Global Impression Score Week 6 Day 1 Total N = ~234 patients PHASE 2B STUDY DESIGN
VLS-01 (DMT) for TRD
SUMMARY: VLS-01 Abbreviations: DMT = N,N-Dimethyltryptamine; TRD= Treatment Resistant Depression; GAD = Generalized Anxiety Disorder; AUD = Alcohol Use Disorder; PK/PD = Pharmacokinetic/Pharmacodynamic; PCT = Patent Cooperation Treaty; OTF = Oral Transmucosal Film All dates provided for expected milestones are estimated. Trial initiation defined as central regulatory and ethics approval Palhano-Fontes F et al, Rapid antidepressant effects of the psychedelic ayahuasca in treatment-resistant depression: a randomized placebo-controlled trial. Psychol Med. 2019 Exclusive of possible patent term adjustments or extensions or other forms of exclusivity. For additional detail please see the most recent 10-K filing 13 Rapid onset and durable efficacy: based on prior clinical evidence with DMT, VLS-01 has potential to generate sustained, clinically meaningful improvement on depressive symptoms2 Short duration of psychedelic effect: Phase 1 data suggests subjective effects experienced for ~2 hours, potentially enabling VLS-01 to fit around interventional psychiatry paradigm established by Spravato® Optimized OTF formulation: favorable safety & tolerability and an IV-like PK profile were demonstrated in Phase 1 with this OTF approach, which may support a more scalable patient / provider experience N,N-Dimethyltryptamine (DMT) in an oral transmucosal film (VLS-01) DMT is the active psychedelic moiety in ayahuasca 5-HT2A receptor agonist Primary: TRD Potential: GAD, AUD Short-duration psychedelic treatment with the potential to have a best-in-class route of administration and tolerability Phase 1b last participant completed 1H’24 Phase 1b trial results in 2H’24 IND approved by U.S. FDA in 2H'24 Phase 2 (TRD) study initiation around YE’24 Issued patent covering oral transmucosal films of DMT, supported by several pending and PCT patent applications PRODUCT PHARMA-COLOGY INDICATIONS TARGET POSITION ACHIEVED & EXPECTED MILESTONES1 INTELLECTUAL PROPERTY VLS-01 has potential for rapid onset and durable efficacy in treating TRD patients, and has been designed to fit around a 2-hour in-clinic treatment protocol Patent protected formulation: Issued and pending patents covering oral transmucosal films of DMT expected to expire in 20423
World Health Organization (2020) World Health Organization – Disease Burden 2000-2019 (2020) Greenberg et al., “The Economic Burden of Adults with Major Depressive Disorder in the United States (2010 and 2018)” (2021) Salzer, “National Estimates of Recovery-Remission From Serious Mental Illness”, Psychiatry Online (2018) Tew et al., “Impact of prior treatment exposure on response to antidepressant treatment in late life” Am J Geriatr Psychiatry (2006) Cascade et al., ”Real-World Data on SSRI Antidepressant Side Effects” Psychiatry MMC (2009) Treatment resistant depression (TRD) is diagnosed after two failed courses of antidepressants First onset depression (MDD) Persistent depression (MDD) Treatment resistant depression (TRD) Inadequate response rate A third of patients with depression respond inadequately or relapse with current treatments4 Severe side effects common with SSRIs 25% of patients on SSRIs report “very bothersome” or “extremely bothersome” side effects. Most common long term side effects with SSRI/SNRIs are sexual dysfunction, sleepiness, and weight gain6 Slow onset of treatment effect Frontline SSRI treatments for depression have slow onset (4-12w)5 Depression in numbers ~300m Global sufferers of depression1 ~$300Bn U.S. economic burden from adults with MDD (direct + indirect costs)3 2nd Leading cause of disability worldwide (2019)2 Depression is a mood disorder that affects the thoughts and behavior of an individual, leading to psychological, physical, and social problems 14 URGENT NEED FOR INNOVATION ~33% ~25% 4-12 weeks Depression VLS-01: Disease Overview
A key differentiator for VLS-01 from other psychedelic-like compounds could be its potential to leverage the 2-hour in-clinic treatment paradigm established by Spravato® VLS-01: Commercial Potential 15 ANTICIPATED TIME TO RESOLUTION OF SUBJECTIVE EFFECTS1 (in hours) Illustrative Spravato® VLS-01 BPL-003 / ELE-101 Multi-dose 5-MeO-DMT Psilocybin + analogs MDMA LSD Average workday(8 hours) ~2 ~2 ~2 ~2 to 6* ~6 ~8 ~8 to 12 VLS-01 has the potential to offer a predictable dosing model administered around the 2-hour in-clinic treatment paradigm established by Spravato® 1 Shorter duration of subjective effects could facilitate scalable adoption, enabling clinics to accommodate more patients daily compared to longer-duration psychedelics 2 Key Takeaways Could enhance patient convenience and treatment access in over 4,500 certified Spravato® clinics2 with established reimbursement and logistics pathways 3 1. Subject to further validation through future clinical studies and real-world evidence 2. https://www.spravatohcp.com/#find-a-center * If multi-dose required
We have completed dosing in a Phase 1b trial investigating the PK, PD, safety and tolerability of an optimized buccal formulation of VLS-01 compared to DMT IV VLS-01: Phase 1b Clinical Trial Design Abbreviations: IV = Intravenous; OTF = Oral Transmucosal Film; PK / PD = Pharmacokinetic / Pharmacodynamic VLS-01 PHASE 1B STUDY DESIGN 16 Treatment Period 1: Single dose DMT IV Day 1 SCREENING Dose 1: 57-min 30mg IV infusion Dose 1: 57-min 30mg IV infusion Dose 1: 160mg OTF Dose 2: 60mg OTF Dose 3: 120mg OTF Dose 1: 160mg OTF Dose 2: 120mg OTF Dose 3: 60 or 20mg OTF Treatment Period 2: Repeated dosing VLS-01 Day 29 Day 57 Day 85 END OF STUDY Day 99 Cohort 1 (n=8) Cohort 2 (n=9) Design: Open-label, dose ranging study of an optimized OTF formulation of VLS-01 in healthy volunteers Enrolled 17 healthy participants Tested 160mg, 120mg, 60mg or 20mg of VLS-01 Primary Endpoint: Plasma and urine PK characteristics Key Secondary Endpoints: Safety and tolerability Subjective acute PD drug effects
Higher doses of VLS-01 demonstrated a plasma concentration (C-Max) comparable to DMT IV and robust subjective effects that resolved in ~2 hours VLS-01: Phase 1b Results 17 Pharmacokinetics (PK) C-Max was dose-proportional and comparable between the higher VLS-01 doses (120mg and 160mg) and the 30mg DMT IV dose VLS-01 rapidly reached peak plasma concentration (T-Max) within 30-45 minutes Pharmacodynamics (PD) Dose-dependent effects, with robust subjective effects seen at the VLS-01 120mg and 160mg doses 13/14 participants in the 120mg cohort achieved SIRS scores greater than 7 Perceptual effects generally fully resolved within 90-120 mins VLS-01 PHASE 1B – PRELIMINARY PK/PD RESULTS1 DMT plasma concentration over time (ng/ml) post administration Time post administration (minutes) Dose range: 30mg (n=17) 160mg (n=16) 120mg (n=14) 60mg (n=6) 20mg (n=8) Subjective Intensity Rating Scale (SIRS) scores (0 to 10) post administration Time post administration (minutes) Dose range: Abbreviations: IV = Intravenous; OTF = Oral Transmucosal Film; PK / PD = Pharmacokinetic / Pharmacodynamic; C-Max = maximum (or peak) serum concentration; T-Max =time it takes for a drug to reach the maximum concentration (C-Max) Draft Delivery Version 0.1 [Data cut-off: 2024-06-17]. Study data has been source data verified by the study monitor and queries resolved prior to creating the draft tables but the database is not yet locked and results may change 30mg (n=17) 160mg (n=16) 120mg (n=14) 60mg (n=6) 20mg (n=8) DMT IV doses VLS-01 OTF doses Key Takeaways DMT IV doses VLS-01 OTF doses
Optimized VLS-01 OTF had a favourable safety profile in Ph1b study with most adverse events classified as either mild or moderate, and most resolving on the day of dosing VLS-01: Phase 1b Results 18 1 Blood pressure and heart rate increases were transient and mostly resolved within 90 min without intervention. None were considered clinically significant. Overall impressions from healthy volunteers in the 120mg group was that VLS-01 was well-tolerated and psychologically meaningful with reports of increased self-reflection The most common TEAEs were headache, dissociation, euphoric mood and nausea; adverse events were transient with most resolving on the day of dosing No. of participants with drug-related TEAE (>10%): DMT IV VLS-01 GRX-917 150 mg N=9 Total (N=62) 30mg (N=17) 160mg (N=16) 120mg (N=14) 60mg (N=7) 20mg (N=8) Headache 1 (6%) 5 (31%) 4 (29%) 1 (13%) 11 (18%) Dissociation 1 (6%) 5 (31%) 3 (21%) 9 (15%) Euphoric mood 1 (6%) 3 (19%) 3 (21%) 7 (11%) Nausea 5 (31%) 1 (7%) 1 (14%) 7 (11%) Emotional distress 1 (6%) 3 (19%) 4 (6%) Feeling drunk 2 (14%) 1 (13%) 3 (5%) Feeling hot 2 (12% 2 (3%) Anxiety 2 (12%) 2 (3%) Dizziness 1 (6%) 1 (14%) 2 (3%) Vomiting 2 (13%) 2 (3%) Abdominal pain 1 (14%) 1 (2%) At least one severe TEAE 0 At least one serious TEAE1 01 At least one TEAE leading to discontinuation 1 (6%) 1 (2%) 1. Please note one (1) SAE as per feedback from the FDA, of unknown origin and subject to ongoing, collaborative discussion with the agency Abbreviations: OTF = Oral Transmucosal Film a. Treatment Emergent Adverse Events (TEAEs) are defined as adverse events that occurred following the first administration of study medication b. Draft Delivery Version 0.1 [Data cut-off: 2024-06-17]. Study data has been source data verified by the study monitor and queries resolved prior to creating the draft tables but the database is not yet locked and results may change VLS-01 PHASE 1B PRELIMINARY SAFETY RESULTSa,b 3 Key Takeaways 2 Results from the C-SSRS showed participants experienced no increase in suicidal thoughts, intentions or behaviours 4
We are now initiating a randomized, double-blind, placebo-controlled, Phase 2 study to assess the efficacy of repeated doses of VLS-01 in ~142 participants with TRD VLS-01: Phase 2 Study Design 19 VLS-01 PHASE 2 STUDY DESIGN (PRELIMINARY) Treatment Period 1 Dose 1: VLS-01 120mg R Randomized 1:1 Total N = 142 patients Dose 2: VLS-01 120mg Dose 1: Placebo Dose 2: Placebo Day 1 Day -1 Week 2 Week 4 Primary endpoint Week 14 Last visit (Period 1) END OF PERIOD 1 Treatment Period 2 R 3rd dose Randomized 1:1 Dose 3: VLS-01 120mg Week 14 Dose 3: VLS-01 60mg Week 16 Last visit (Period 2) Study design: Moderate to severe TRD Patient must be willing to discontinue current antidepressants No use of psychedelics within 6 months of screening1 Psychological support pre-and post-dose Primary Endpoint: Change from Baseline in MADRS total score at Week 4 Other Secondary Endpoints: Change from Baseline in MADRS total score at Week 6 and Week 14 Response and remission rates Safety and tolerability Abbreviations: MADRS = Montgomery-Asberg Depression Rating Scale Patients are also excluded if they report any lifetime use of DMT or DMT-containing drugs, or report a history of > 2 lifetime administrations of any other psychedelic drug Trial initiation defined as central regulatory and ethics approval END OF PERIOD 2 Trial status: Trial initiation expected around year-end 20242 Topline data anticipated around year-end 2025
EMP-01 (R-MDMA) for Social Anxiety Disorder
SUMMARY: EMP-01 EMP-01 is an oral formulation of R-MDMA, a moiety that is pharmacologically distinct from both racemic MDMA and S-MDMA Oral formulation of the R-enantiomer of MDMA (EMP-01) Monoamine releaser and reuptake inhibitor with prominent effects on serotonin (5-HT) First-in-class psychedelic-like compound for treatment of Social Anxiety Disorder (SAD) Primary: SAD Potential: Other anxiety disorders, autism spectrum disorders, PTSD Phase 1 study completed in Q1 2024 Phase 2 trial initiation around YE’24 Phase 2 study results around YE’25 Issued patent covering MDMA enantiomers and processes for their preparation, supported by several pending patent applications PRODUCT PHARMA-COLOGY TARGET POSITION INDICATIONS ACHIEVED & EXPECTED MILESTONES1 INTELLECTUAL PROPERTY Beneficial psychological effects: EMP-01 administration in healthy volunteers resulted in dose-dependent increases in emotional breakthroughs and measures of self-compassion, both factors associated with reduction in anxiety symptoms. Well tolerated: EMP-01 was generally well tolerated, with no severe or serious adverse events observed. Third-party animal studies indicate that R-MDMA may have fewer adverse effects compared to racemic MDMA2. First-to-market potential: no other companies in the psychedelic or psychedelic-like space are targeting the SAD indication. 20 Abbreviations: SAD = Social Anxiety Disorder; PTSD = Post Traumatic Stress Disorder; PCT = Patent Cooperation Treaty All dates provided for expected milestones are estimated. Trial initiation defined as central regulatory and ethics approval Curry DW, Young MB, Tran AN, Daoud GE, Howell LL. Separating the agony from ecstasy: R(-)-3,4-methylenedioxymethamphetamine has prosocial and therapeutic-like effects without signs of neurotoxicity in mice. Neuropharmacology. 2018 Jan Unexpected subjective effects: in a phase 1 trial, EMP-01 was found to be significantly more psychedelic-like than MDMA, with a more "inward focused" experience.
Schizophrenia SAD patients in the US Approximately 7.1% of US adults, or ~18 million individuals, suffered from Social Anxiety Disorder (SAD) in the past year4 ~18m Anxiety in numbers ~40m Suffer from anxiety disorders in the US1 ~$42bn Annual societal cost of anxiety disorders in the US3 #1 Most common mental health disorder in the US2 Anxiety disorders develop when feelings of apprehension and unease persist over an extended period and potentially worsen over time 0 No novel molecules approved for SAD in over 20 years Most recent FDA approvals of novel molecules for SAD were Effexor (2003), Zoloft (2002) and Paxil (1999)6 35% Low recovery rate Only 35% of patients with SAD recovered after 10 years of prospective follow-up5 Moderate to severe impairment is common Of adults with SAD in the past year, 30% had serious impairment, 39% had moderate impairment, and 31% had mild impairment4 69% Generalized Anxiety Disorder (GAD) Social Anxiety Disorder (SAD) Panic Disorder Anxiety and Depression Association of America (2021) National Alliance on Mental Illness (2021) DeVane et al., “Anxiety Disorders in the 21st Century: Status, Challenges, Opportunities, and Comorbidity With Depression”, AJMC (2005) National Institute of Mental Health Keller MB. Social anxiety disorder clinical course and outcome: review of Harvard/Brown Anxiety Research Project (HARP) findings. J Clin Psychiatry. 2006 GlobalData (as of 06.26.2024). 21 URGENT NEED FOR INNOVATION Anxiety Disorders EMP-01: Disease Overview atai Life Sciences | Strictly confidential
Our findings present the possibility that R-MDMA may offer unique pharmacological benefits to racemic MDMA, and with a lower risk for adverse effects EMP-01: Unique Profile of R-MDMA 22 Curry DW, Young MB, Tran AN, Daoud GE, Howell LL. Separating the agony from ecstasy: R(-)-3,4-methylenedioxymethamphetamine has prosocial and therapeutic-like effects without signs of neurotoxicity in mice. Neuropharmacology. 2018 Jan Danforth AL, Grob CS, Struble C, Feduccia AA, Walker N, Jerome L, Yazar-Klosinski B, Emerson A. Reduction in social anxiety after MDMA-assisted psychotherapy with autistic adults: a randomized, double-blind, placebo-controlled pilot study. Psychopharmacology (Berl). 2018 CHO-K1 overexpressing human 5-HT2a receptors are incubated with test compound for 1 hour at 37*C, with lithium chloride causing IP1 accumulation upon 5-HT2a agonism Fear extinction test models the ability of the compound to facilitate the therapeutic effect of exposure-based therapy; exposure-based therapy is sometimes used in the clinical management of social anxiety disorder Human 5-H2TA receptor activation study3 Efficacy signals with fewer adverse effects Validated unique pharmacology R-MDMA S-MDMA MDMA (racemate) Similar to the racemic MDMA, R-MDMA has been shown to significantly increase social interaction in both animal models and exploratory human studies1, 2 Yet, unlike racemic MDMA, it does not appear to increase locomotor activity, produce signs of neurotoxicity, or increase body temperature in animal models1 Differences are hypothesized to arise from: R-MDMA has reduced amphetamine-like pharmacology than S-MDMA R-MDMA is a partial agonist at 5-HT2A receptors Profile of R- vs. racemic MDMA R-MDMA (EMP-01) shows significantly greater activity at the 5-HT2a receptor compared to racemic MDMA and S-MDMA EMP-01 also demonstrated inducement of a mouse head twitch response, suggesting R-MDMA may generate a more psychedelic-like, internal subjective experience Fear Extinction Mice model4 Effects of racemic MDMA and R-MDMA on body temp1 (Third party study) 0 36 38 40 42 MDMA (20mg/kg) Saline R-MDMA (50mg/kg) Temperature °C Time (mins) Pre conditionstimulus (CS) Day 1 after dose Day 9 after dose ** * Vehicle (saline) MDMA (7.8 mg/kg) EMP-01 (10mg/kg) EMP-01 (30 mg/kg) Freezing (%) * p<0.01 ** p<0.0001 Dosing and condition stimulus
In a completed Phase 1 study, EMP-01 was generally well tolerated, with no severe or serious adverse events observed EMP-01: Phase 1 Results 23 1 2 5 Only 1/24 participants (4%) experienced bruxism, grinding of teeth, which is a common side effect of racemic MDMA Observed changes in both pulse and blood pressure were in the expected range and were only slightly dose dependent Body temperature remained in the normal range across all cohorts (hyperthermia is a known side effect of racemic MDMA) Single-ascending dose, double-blinded, placebo-controlled Phase 1 study enrolling 32 healthy participants and testing EMP-01 or placebo in a 6+2 design 3 Placebo N=8 EMP-01 dose (N=24) GRX-917 150 mg N=9 GRX-917 200 mg N=9 Total N=32 75mg (N=6) 125mg (N=6) 175mg (N=6) 225mg (N=6) Participants with at least one drug-related TEAEs2 1 2 1 4 6 14 Nausea 1 1 3 3 8 Headache 1 1 2 Vomiting 1 1 2 Fatigue 1 1 2 Pain in jaw 1 1 Dizziness 1 1 Tremor 1 1 Chills 1 1 Feeling hot 1 1 Palpitations 1 1 Bruxism 1 1 Treatment Emergent Adverse Events (TEAEs) are defined as adverse events that occurred following the first administration of study medication. If a participant has multiple occurrences of a TEAE, the participant is presented only once in the Participant count (n) column for a given Preferred Term. Drug related TEAEs defined as any TEAE that was deemed to have either a “possible”, “probable” or “definite” relationship to the study drug EMP-01 PHASE 1 SAFETY RESULTS1 Key Takeaways Results from the C-SSRS showed participants experienced no increase in suicidal thoughts, intentions or behaviours 4
In Phase 1 study, dose-dependent increases in acute emotional breakthroughs and increased measures of self-compassion observed 1 week post EMP-01 dose EMP-01: Phase 1 Results 24 1 Some measures of self-compassion also significantly increased with the 225mg dose of EMP-01 at the 1-week follow-up visit SAD patients report lower levels of self-compassion than healthy controls and social anxiety symptom severity is correlated with lower self-compassion2 225mg dose of EMP-01 showed statistically significant increases in emotional breakthroughs. Emotional breakthroughs have been shown to mediate efficacy in depression and anxiety studies involving classical psychedelics1 2 GM Goodwin et al, 2022, Roseman et al, 2019, https://med.uth.edu/psychiatry/2024/04/01/fda-grants-breakthrough-status-to-lsd-formula-and-opens-a-new-frontier-in-the-generalized-anxiety-disorder-gad-treatment/ Werner et al, 2012, Blackie and Kovovski, 2018, Madaki and Koszychi, 2020 P<0.05 Placebo 75mg 125mg 175mg 225mg EMP-01 PHASE 1 PHARMACODYNAMIC (PD) RESULTS “I had an emotional breakthrough.” P<0.05 “I faced emotionally difficult feelings that I usually push aside.” P<0.05 “I was able to get a sense of closure on an emotional problem.” P<0.05 “I experienced a resolution of a personal conflict/trauma.” EMP-01 dose levels: Average Emotional Breakthrough Inventory (EBI) scoring on Day 2 after EMP-01 dosing Key Takeaways
In Phase 1 study, EMP-01 also demonstrated a dose-dependent, psychedelic-like experience with a subjective effect profile more like classical psychedelics than MDMA EMP-01: Phase 1 Results 25 Oceanic Boundlesness Vigilance Reduction Visionary Restructuazilation Dread of Ego Dissolution Auditory Alterations Average score on 5D-ASC psychedelic experience questionnaire per dimension Psilocybin 20-30mg1 EMP-01 225mg MDMA 125mg2 Hasler et al, 2004, Vollenweider et al, 2007 Holze et al., 2020; Schmid et al., 2021; Angerer et al., 2023; Hysek et al., 2011; Hysek et al., 2012; Hysek et al., 2012 Vollenweider FX, Smallridge JW. Classic Psychedelic Drugs: Update on Biological Mechanisms. Pharmacopsychiatry. 2022 Danforth AL, Grob CS, Struble C, Feduccia AA, Walker N, Jerome L, Yazar-Klosinski B, Emerson A. Reduction in social anxiety after MDMA-assisted psychotherapy with autistic adults: a randomized, double-blind, placebo-controlled pilot study. Psychopharmacology (Berl). 2018 EMP-01 demonstrated a unique, dose-dependent subjective effect profile Placebo(n=8) 75mg(n=6) 125mg(n=6) 175mg(n=6) 225mg(n=6) Total score on 5D-ASC psychedelic experience questionnaire per dose level EMP-01 PHASE 1 PHARMACODYNAMIC (PD) RESULTS 1 The qualitative profile of the effects (based on 5D-ASC questionnaire were generally found to be more like classical psychedelics (i.e., psilocybin or LSD) than MDMA Classic psychedelics have also been shown to be effective in treating the symptoms of anxiety3, as has MDMA4 2 Study facilitators reported that EMP-01 appeared to produce a more inward-focused and "peaceful" experience in participants compared to their experience facilitating MDMA therapies 3 Key Takeaways
We are initiating an exploratory Phase 2a, placebo-controlled study to assess the safety and efficacy of two 225 mg doses of EMP-01 versus placebo in adults with SAD EMP-01: Phase 2 Study Design 26 Design: Phase 2a, randomized, double-blind, placebo-controlled study Adult participants diagnosed with Social Anxiety Disorder (SAD) Liebowitz Social Anxiety Scale (LSAS) total score ≥60 at screening Primary Endpoint: Safety and tolerability Other Secondary Endpoints: LSAS total score (Baseline to Day 43 Visit) Change from Baseline in mean Clinical Global Impression (CGI) severity scores Trial status: Trial initiation expected around year-end 20241 Topline data anticipated around year-end 2025 EMP-01 225mg R Randomized 1:1 Day 43 Day 1 Total N = 60 patients Placebo EMP-01 225mg Placebo Dose 1 Dose 2 Day 0 Day 29 Final visit EMP-01 PHASE 2A STUDY DESIGN (PRELIMINARY) Abbreviations: LSAS = Liebowitz Social Anxiety Scale Trial initiation defined as central regulatory and ethics approval
IBX-210 (IV-Ibogaine) for Opioid Use Disorder
Post traumatic stress disorder and traumatic brain injury, respectively World Health Organization Salzer, “National Estimates of Recovery-Remission From Serious Mental Illness”, Psychiatry Online (2018) A single dose of ibogaine may support withdrawal and long-term relapse prevention in OUD patients Product Overview: IBX-210 for Opioid Use Disorder Lead indication overview ~3m US OUD Incidence in 20202 >100k Opioid-related deaths in US in 2022 Substance use disorders are highly prevalent and characterized by an inability to control the use of a legal or illegal drugs, such as opioids (including prescription opioids) or alcohol. Current standard of care for OUD primarily consists of psychosocial support and synthetic full and partial opioid receptor agonists (methadone & buprenorphine), where approximately 30% of patients achieve treatment success (defined as >80% illicit opioid free weeks). In addition, long-acting opioid antagonists (naltrexone) lead to a proportion of patients achieving treatment success. Global disease burden IBX-210 Key Product Features A single dose of ibogaine delivered in a monitored setting may support withdrawal and long-term relapse prevention in Opioid Use Disorder patients Prior clinical evidence: In third-party open label studies, oral ibogaine was associated with significantly reduced opioid cravings, both at discharge and at one month post treatment, as well as improved mood in patients with OUD In addition, a double-blind, placebo-controlled study in subjects with cocaine use disorder demonstrated a statistically significant benefit on urine confirmed relapse of a single administration of oral ibogaine compared to placebo Lead: Opioid Use Disorder (“OUD”)Potential expansions: Add’l Substance Use Disorders, PTSD, TBI1 Phase 1 oral ibogaine study completed in 3Q 23 PRODUCT INDICATIONS CURRENT STATUS INTELLECTUAL PROPERTY Issued and pending method of treatment claims for OUD IBX-210 is a novel IV formulation of ibogaine, which is an indole alkaloid with potential for clinical benefit through oneirophrenic effects 28
Results from an open-label study of 8-12 mg/kg of ibogaine in patients seeking detoxification from opioids and cocaine Clinical Evidence: Efficacy & safety of oral ibogaine in open-label study PRIOR CLINICAL EVIDENCE (THIRD PARTY STUDY1) Note: TRD = Treatment Resistant Depression; DMT = N,N-Dimethyltryptamine; HCQ = Heroin Craving Questionnaire 1 Mash et al., “Ibogaine Detoxification Transitions Opioid and Cocaine Abusers Between Dependence and Abstinence: Clinical Observations and Treatment Outcomes” (2018) 1 2 Safety: Ibogaine was reported to be well tolerated with no serious adverse events. 4 Key Takeaways HCQ-29 Subscale Pre-dose (N=75) 5 4 3 2 1 0 Discharge (N=74) 1 Month (N=37) Emotionality(negative mood state) Compulsivity(lack of confidence in ability to quit) Purposefulness(desire of intent to use) Expectancy(expected positive benefits of drug use) Self-reported dimensions of craving Efficacy – Post-Acute Withdrawal Syndrome: signs and symptoms at post dose assessments were reduced compared to pre-dose baseline withdrawal severity measures. Objective signs of opioid withdrawal were mild and none were exacerbated at later time points. 3 Efficacy – Relapse Prevention (shown left): Opioid dependent patients had significant reductions in the mean scores of four HCQ-29 domains of craving measured at program discharge and out to 1 month for patients continuing through study completion. Cravings are an important mediator of relapse. Summary: A single-dose of oral ibogaine showed reductions in self-reported opioid cravings in 74 opioid dependent patients. 29
IBX-210 has the potential to become the first & best in-class treatment for OUD, minimizing risk of relapse SUMMARY IBX-210 could potentially become a paradigm-shifting therapy for Opioid Use Disorder (OUD) Current standard of care for OUD is medication therapy, requiring opioid substitutes that carry significant side effects Sustained relapse prevention Single dose administered in monitored setting, providing both withdrawal support and oneiric experience driving sustained remission Single Therapeutic Episode Minimal Abuse Potential No Opioid Side Effects High Adherence / Low Risk of Relapse Cholinergic, glutamatergic and monoaminergic receptor modulator Mechanism of Action Ibogaine (IBX-210) Therapy Medication Assisted Therapy1 Daily therapy given in substitution of opioid in outpatient setting in attempt to wean off from opioid Mu-agonist Partial Mu-agonist Mu-antagonist Methadone Buprenorphine Naltrexone Withdrawal Support2 Therapies given for symptomatic management during supervised withdrawal (detoxification) Alpha-2 agonist Alpha-2 agonist Clonidine Lofexidine Current strategies for withdrawal support have high rates of relapse Note: OUD = Opioid Use Disorder Source: Publicly available information, including company websites and clinicaltrials.gov, GlobalData, Evaluate Pharma (both as of 2022) Current Standard of Care Rarely used given high rates of relapse. Used primarily in institutional or penitentiary settings 30
BPL-003 (5-MeO-DMT) for TRD & AUD Strategic Investment into Beckley Psytech
SUMMARY: BPL-003 Abbreviations: TRD = Treatment Resistant Depression, AUD = Alcohol Use Disorder As of January 4th 2024. Terms of the strategic investment also included a 1:1 warrant coverage on the Primary Investment. atai also holds a time-limited right of first refusal on a future sale of the company and an indefinite right of first negotiation for BPL-003 and ELE-101 All dates provided for expected milestones are estimated Short duration of subjective effects: BPL-003 is a short duration psychedelic, with acute effects resolving in ~2 hours, supporting greater commercial scalability vs other psychedelics Rapid & durable efficacy after a single dose: in an exploratory Phase 2a study, 55% of patients achieved clinical response on Day 2 after a single dose, and this rate of response was maintained at Week 12 First to market potential: first short-duration psychedelic to receive FDA Investigational New Drug (IND) approval for a Phase 2 clinical trial 35.5% ownership1 of Beckley Psytech 5-HT2A / 5-HT1A Receptor agonist Primary: TRD Potential: AUD First-to-market with 5-MeO-DMT Ph2b (TRD) topline data in Q2’25 Ph2a open-label (AUD) data in H2’24 Granted composition of matter and methods of use patents; numerous pending claims STRATEGIC INVESTMENT PHARMA-COLOGY INDICATIONS TARGET POSITION ACHIEVED & EXPECTED MILESTONES2 INTELLECTUAL PROPERTY BPL-003 has the potential to become a first-in-class short-duration psychedelic treatment with rapid acting and durable antidepressant effects 5-MeO-DMT salt form in dry powder nasal spray device PRODUCT 32
BPL-003 had a favorable safety profile and was well tolerated in a Phase 1 study, with no observed serious or severe adverse events BPL-003: Phase 1 Results 1 n = number of partcipants reporting at least one TEAE in that category, % - rounded proportion of cohort total Abbreviations: TEAE = Treatment Emergent Adverse Events, ECG = Electrocardiogram, C-SSRS = Columbia-suicide severity rating scale 33 Placebo N=13 BPL-003 dose (N=31) GRX-917 150 mg N=9 GRX-917 200 mg N=9 GRX-917 300 mg N=8 All GRX-917 N=43 Total N=44 1 mg N=4 2.5 mg N=4 4mg N=4 6 mg N=4 8 mg N=5 10mg N=5 12 mg N=5 Any TEAEs1 2 1 1 4 3 4 2 4 21 Nasal discomfort 1 2 2 2 3 10 Nausea 2 1 2 1 1 7 Vomiting 2 1 2 5 Headache 1 1 2 4 Administration site pain 1 1 2 Chest discomfort 1 1 Dizziness 1 1 Pyrexia 1 1 Gastroenteritis 1 1 Back pain 1 1 Hypoesthesia 1 1 Limb discomfort 1 1 Tremor 1 1 Lacrimation Increased 1 1 Restlessness 1 1 BPL-003 PHASE 1 SAFETY DATA Results from the C-SSRS showed participants experienced no increase in suicidal thoughts, intentions or behavior There were no severe or serious adverse events observed, and 89.5% TEAEs were mild and 10.5% were moderate in severity 1 2 4 3 5 Blood pressure and heart rate increases were transient and resolved within 90 min without intervention. None were considered clinically significant. Most common TEAEs (>10%) were nasal discomfort, nausea, vomiting, and headache. TEAEs did not appear to correlate with dose There were no clinically significant findings for laboratory parameters, vital signs, ECGs or physical examinations Key Takeaways
12mg (n=5) 10mg (n=5) 8mg (n=5) 6mg (n=4) 4mg (n=4) 2.5mg (n=4) 1mg (n=4) Mean plasma concentration levels (ng/ml) Time post-dose (minutes) BPL-003 Phase 1 Pharmacokinetic Profile Pharmacokinetics (PK) Exposure was dose-proportional Rapid onset with mean Tmax of 6-17 min Mean half life of 15-30 min Pharmacodynamics (PD) Participants were psychedelic naive All participants on doses ≥6mg achieved intensity scores ≥7 Perceptual effects generally fully resolved within 60 - 90 mins BPL-003 Phase 1 Subjective Drug Intensity (SDI) rating 0 12 30 60 90 12mg (n=5) 10mg (n=5) 8mg (n=5) 6mg (n=4) Time post-dose (minutes) Mean subjective drug intensity (SDI) Results from the completed BPL-003 Phase 1 study demonstrated a dose proportional PK/PD profile with perceptual effects generally resolving within 90 min BPL-003: Phase 1 Results 0 12 30 60 90 Source: internal Beckley Psytech data Abbreviations: SAD = Single Ascending Dose; PK = Pharmacokinetic; PD = Pharmacodynamic 34 Dose range taken forward to Phase 2 Key Takeaways BPL-003 PHASE 1 RESULTS
Completed Part 1 of an open-label Phase 2a study investigating BPL-003 as a therapy for patients with TRD BPL-003: Phase 2a Clinical Trial Design Abbreviations: MADRS = Montgomery–Åsberg Depression Rating Scale Screening Part 1: Monotherapy Open label Day 2 85 Completed Q1 2024 BPL-003 PHASE 2A STUDY DESIGN Single dose of BPL-003 29 STUDY DETAILS Open-label study evaluating a single dose of BPL-003 nasal spray, in patients with moderate-to-severe TRD Parts 1 & 3 are in patients not on anti-depressants, Part 2 is in patients who are also taking select SSRIs to explore effects of co-administration Psychological support during preparation, dosing and integration KEY INCLUSION CRITERIA Montgomery-Asberg Depression Rating Scale (MADRS) score ≥24 Part 1 & 3: willing and able to discontinue current antidepressants Part 2: on current stable dose of antidepressant SSRI therapy KEY OBJECTIVES Primary Endpoint: Safety and tolerability of BPL-003 Other Secondary Endpoints: MADRS change through Week 12 Remission and response rates through Week 12 35 Part 2: Adjunct to SSRIs Initiated Q1 2024 Part 3: Two-dose induction model Initiated Q3 2024
BPL-003 produced meaningful clinical response and durable remission rates after just a single dose, and was generally well tolerated with no serious adverse events BPL-003: Phase 2a TRD Results Source: internal Beckley Psytech data Response rate defined as ≥50% reduction in MADRS score and Remission rate defined as MADRS score ≤10 * Prior to data analysis, one participant (from total of 12 patients) was determined not to meet multiple per protocol eligibility criteria and was excluded from the efficacy analysis. 36 BPL-003 PHASE 2A INITIAL RESULTS Response and remission rate1 in TRD patients after a single dose of BPL-003 Response and Remission rate1,2 Time post-dose 55% of patients achieved clinical response on Day 2 and this rate of response was maintained at Week 12 1 At Week 4, 55% of patients achieved both clinical remission and response 2 Day 2 Week 4 Week 12 45% Response Rate (n = 11*) Remission Rate (n = 11*) 3 4 Acute effects resolved within an average time of less than 2 hours Most common AEs (>10%) were nasal discomfort, headaches, nausea and vomiting, broadly consistent with Phase 1 findings Key Takeaways
BPL-003 is actively recruiting for its ongoing Phase 2b study, a randomized, quadruple-masked, monotherapy study in moderate to severe TRD patients BPL-003: Phase 2b TRD Clinical Trial Design 1 Patients entering the open-label extension are randomized to receive either a single 12mg dose or a biphasic 4mg and 8mg dose approximately 10 minutes apart. 2Total N changed due to an adjustment in the randomization ratio and lower then anticipated dropout rate. Abbreviations: MADRS = Montgomery–Åsberg Depression Rating Scale; CGI-S = Clinical Global Impressions-Severity; PGIC = Patient's Global Impression of Change; EQ-5D = EuroQol-5D Randomization (n=~1852) Day 0 2 29 57 Wk-8 Washout 12 mg1 Core Study (8 weeks) Primary Analysis 29 57 Topline data anticipated in Q2’25 (first patient dosed Oct 2023) Open label extension (8 weeks) 0.3 mg (n=~70) 8 mg (n=~45) 12 mg (n=~70) 1st Dose 2nd Dose KEY INCLUSION CRITERIA Patients with moderate to severe TRD Hamilton Depression Scale (HAM-D) >= 19 Willing and able to discontinue current antidepressants KEY OBJECTIVES Primary Endpoint: MADRS change from baseline at Week 4, 12mg vs. 0.3mg Other Secondary Endpoints: MADRS change from baseline at Day 2, Week 1 and Week 8 CGI-S, PGIC, EQ-5D 8 37 1 1 2
ELE-101 (Psilocin) for MDD Strategic Investment into Beckley Psytech
SUMMARY: ELE-101 Abbreviations: TRD = Treatment Resistant Depression; PTSD = Post Traumatic Stress Disorder As of January 4th Goodwin et al, 2022; Raison et al, 2023 All dates provided for expected milestones are estimated Optimized formulation: intravenous formulation enables an improved PK profile, reducing inter-subject variability and more reliably inducing a psychedelic experience Patent protected: patent-protected intravenous formulation of a psilocin benzoate salt 35.5% ownership1 of Beckley Psytech 5-HT2A Receptor agonist Primary: TRD Potential: Anorexia Nervosa, PTSD Best-in-class psilocin formulation with significantly shorter treatment duration, and reduced inter-subject variability compared to oral formulations of psilocybin Phase 1 topline data announced in H1 2024 Phase 2a OL (MDD) data in H2 2024 Granted composition of matter and methods of use patents; numerous pending claims STRATEGIC INVESTMENT PHARMA-COLOGY INDICATIONS TARGET POSITION ACHIEVED & EXPECTED MILESTONES3 INTELLECTUAL PROPERTY ELE-101 could offer the therapeutic benefits of psilocybin in a more consistent, controllable, and shorter treatment paradigm of approximately two hours Psilocin salt form administered via IV infusion PRODUCT Short duration of subjective effects: compared to psilocybin, IV psilocin produces a much shorter duration of psychedelic effects resolving in ~2 hours Proven therapeutic potential: psilocin is the active metabolite of psilocybin which has already demonstrated a strong antidepressant effect in several studies2 39
ELE-101 is design to demonstrate potential benefits of psilocybin’s active moiety in an optimized delivery and treatment model ELE-01: IV Psilocin 1 Psilocin simulations based on primary data from Brown et al. 2017, Madsen et al . 2019, Hasler et al. 1997, and Carhart-Harris et al. 2011. 2 Holze F. et al (2023). Pharmacokinetics and Pharmacodynamics of Oral Psilocybin Administration in Healthy Participants. Clin Pharmacol Ther. Psilocin pharmacokinetics for IV psilocin (simulated) vs. oral psilocybin1 Typical plasma psilocin concentrations at effective dose of 25mg psilocybin1 Perceptual threshold2 Anticipate benefits of IV psilocin vs oral psilocybin: Reduced variability Shorter-half life = shorter duration of psychedelic effect, anticipated to be <2 hours 40
A Phase 1/2a study is currently underway: Part A, a dose-escalation study in healthy volunteers, is complete and dosing has initiated for Part B, an open-label study in MDD ELE-101: Phase 1/2a Clinical Trial Design ELE-101 Phase 1/2a – Part A Topline data1: Well-tolerated with no serious or severe adverse events (AE) Demonstrated a dose-proportional PK profile, leading to reduced inter-subject variability compared to oral psilocybin Induced high-intensity, short-duration psychedelic experiences, suggesting a potential treatment time of ~two hours in the clinic Key Objectives: Safety and tolerability of ELE-101 in patients with moderate to severe MDD Key Secondary Endpoints: Assessment of MADRS change (Day 2, 4, 6, 15, 29) CGI-S, PGIC Single Ascending Dose ELE-101 Phase 1/2a – Part B Open-label MDD cohort Ph1 Part A results announced in H1 2024; Ph2a Part B data expected in H2 2024 Screening Dose to be selected Open label Day 1 Day 29 Dose 1 Placebo Dose 2 Placebo Dose 3 Placebo Dose 4 Placebo Day 1 Day 7 Full data from the Phase 1 study is expected to be published at a later date Abbreviations: MADRS = Montgomery–Åsberg Depression Rating Scale; PK = Pharmacokinetics; PD = Pharmacodynamics; CGI-S = Clinical Global Impressions-Severity; PGIC = Patient's Global Impression of Change; MDD = Major Depressive Disorder 41
Nasdaq: ATAI