EMP-01

• Reported positive Phase 1b results of VLS-01 (buccal film DMT); expect to initiate a Phase 2 study in treatment-resistant depression patients around YE’24 • Announced clinical development plans for EMP-01 (oral R-MDMA); expect to initiate a Phase 2 study of EMP-01 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, Aug. 13, 2024 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced second quarter 2024 financial results and provided corporate updates. “Over the past quarter, we've made significant strides to advance our pipeline, with key updates from our VLS-01 and EMP-01 programs,” stated Dr. Srinivas Rao, Co-Chief Executive Officer and Co-founder of atai. “Our positive Phase 1b results for VLS-01 underscore its potential as a best-in-class oral treatment for patients suffering from treatment-resistant depression, and we look forward to initiating the Phase 2 study around year-end. Clinical development plans for EMP-01 are advancing with a Phase 2 study in Social Anxiety Disorder (SAD) set to begin around year-end. This follows encouraging Phase 1 results, where EMP-01 demonstrated a unique subjective profile compared to racemic MDMA and classical psychedelics. With no novel molecules approved for SAD in over 20 years, it remains an area of critical unmet need. Looking ahead, our team is focused on several important readouts and study initiations in the second half of the year. As such, we continue to establish our position as a leader in mental health innovation, with a robust set of high potential programs aimed at addressing the areas of most significant unmet need.” Recent Clinical HighlightsVLS-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.Recently, atai announced positive topline data from the Phase 1b trial of VLS-01 buccal film in 17 healthy participants. Peak plasma concentration of VLS-01 occurred within 30-45 minutes. VLS-01 was shown to induce a short psychedelic experience, with subjective effects generally resolving within 90-120 minutes.VLS-01 demonstrated a favorable safety profile and was well tolerated, with all adverse events classified as either mild or moderate, most resolving on the day of dosing, and none related to blood pressure, heart rate, or suicidality.The Company expects to initiate a 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 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 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 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. Anticipated Upcoming R&D Catalysts H2’24 VLS-01 TRD: Phase 2 initiation (around YE’24)EMP-01 SAD: Phase 2 initiation (around YE’24)IBX-210 opioid use disorder (OUD): Phase 1b/2a initiationBPL-003 TRD: Phase 2b complete patient enrollmentBPL-003 alcohol use disorder (AUD): Phase 2a topline open-label dataELE-101 major depressive disorder (MDD): Phase 2a topline open-label dataCOMP360 TRD: Phase 3 Pivotal Trial 1 topline data 2025 RL-007 cognitive impairment associated with schizophrenia (CIAS): Phase 2b topline data (mid’25)COMP360 TRD: Phase 3 Pivotal Trial 2 topline data (mid’25) Consolidated Financial ResultsCash, cash equivalents, and short-term securities (primarily US treasuries and government agency securities): As of June 30, 2024, the Company had cash, cash equivalents, restricted cash and short-term securities of $103.3 million compared to $154.2 million as of December 31, 2023. The decrease of $50.9 million was primarily driven by $38.8 million net cash used in operating activities, $10 million for the Beckley Psytech investment, and $3.9 million funding of strategic investments. The Company expects its cash, short-term securities, public equity holdings, and committed term loan facility with Hercules Capital, Inc. to be sufficient to fund operations into 2026. Research and development (R&D) expenses: R&D expenses were $12.6 million for the three months ended June 30, 2024, as compared to $15.5 million for the same prior year period. The year-over-year decrease of $2.9 million was primarily attributable to a decrease of $1.0 million in program-specific expenses and $1.9 million in R&D personnel. Within program-specific expenses, the decrease was primarily driven by more clinical trial and discovery expenses in prior 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 June 30, 2024, were $13.4 million as compared to $16.6 million in the same prior year period. The year-over-year decrease of $3.2 million was primarily attributable to a $1.9 million decrease in personnel related expenses, $1.8 million net decrease of professional services and other administrative expenses, partially offset by a $0.5 million increase in public company and investor relations expense. The Company expects the reduction in G&A spend over prior years to continue. Other income (expense), net. Other expense for the three months ended June 30, 2024, was $31.3 million as compared to $0.2 million income in the same prior year period. Other expense for the 2024 second quarter includes a $30.6 million reduction in the fair value of our assets and liabilities, net. This primarily consists of a $29.1 million reduction in investments held at fair value, $7.5 million reduction in the fair value of related party notes receivable, and $4.8 million decrease in fair value of convertible note liability. Net loss: Net loss attributable to stockholders for the three months ended June 30, 2024, was $57.3 million as compared to $33.0 million for the three months ended June 30, 2023. About atai Life Sciencesatai 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,” “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 InformationInvestor 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 Six Months Ended June 30, June 30, 2024 2023 2024 2023 (unaudited) (unaudited)License revenue $273 $172 $273 $209 Operating expenses: Research and development 12,605 15,476 24,136 34,757 General and administrative 13,397 16,558 25,952 30,529 Total operating expenses 26,002 32,034 50,088 65,286 Loss from operations (25,729) (31,862) (49,815) (65,077)Other income (expense), net (31,348) 204 (32,943) 263 Loss before income taxes (57,077) (31,658) (82,758) (64,814)Provision for income taxes (19) (185) (15) (351)Losses from investments in equity method investees, net of tax (273) (1,928) (1,974) (2,961)Net loss (57,369) (33,771) (84,747) (68,126)Net loss attributable to noncontrolling interests (57) (729) (722) (1,948)Net loss attributable to ATAI Life Sciences N.V. stockholders $(57,312) $(33,042) $(84,025) $(66,178)Net loss per share attributable to ATAI Life Sciences N.V. stockholders — basic and diluted $(0.36) $(0.21) $(0.53) $(0.42)Weighted average common shares outstanding attributable to ATAI Life Sciences N.V. stockholders — basic and diluted 160,387,701 155,792,490 159,643,518 155,793,323 ATAI LIFE SCIENCES N.V.CONDENSED CONSOLIDATED BALANCE SHEET(Amounts in thousands) June 30, December 31, 2024 2023 (unaudited) (1) Assets Cash and cash equivalents $19,333 $45,034 Securities carried at fair value 69,013 109,223 Short term restricted cash for other investments 15,000 - Committed investment funds - 25,000 Prepaid expenses and other current assets 4,690 5,830 Short term convertible notes receivable - related party 7,976 - Short term notes receivable - related party, net 1,896 505 Property and equipment, net 873 981 Operating lease right-of-use asset, net 1,043 1,223 Other investments held at fair value 61,141 89,825 Other investments 32,381 1,838 Long term notes receivable - related party, net - 97 Convertible notes receivable - related party - 11,202 Other assets 2,432 2,720 Total assets $215,778 $293,478 Liabilities and Stockholders' Equity Accounts payable 3,814 4,589 Accrued liabilities 12,911 15,256 Current portion of lease liability 239 275 Other current liability 680 — Contingent consideration liability - related parties 580 620 Contingent consideration liability 1,373 1,637 Noncurrent portion of lease liability 838 990 Convertible promissory notes and derivative liability - related party 1,270 164 Convertible promissory notes and derivative liability 2,049 2,666 Long term debt, net 15,236 15,047 Other liabilities 8,255 7,918 Total stockholders' equity attributable to ATAI Life Sciences N.V. stockholders 167,890 242,962 Noncontrolling interests 643 1,354 Total liabilities and stockholders' equity $215,778 $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.

Novel Composition of MDMA Enantiomers leading to next-generation MDMA possibilitiesTORONTO, March 27, 2024 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is extremely pleased to announce that the US Patent and Trademark Office (USPTO) has indicated it is issuing an allowance for the granting of a patent for ALA-002, the company’s lead investigational MDXX Novel Chemical Entity (NCE). This provides the Company a strong basis for ongoing protection of this intellectual property (IP). ALA-002 is a novel mixture of MDMA enantiomers, consisting of 70-80% R-MDMA and 20-30% S-MDMA. Preclinical testing has shown that the administration of ALA-002 results in significantly lowered incidence of hyperthermia, the major adverse event elicited by racemic generic MDMA. The Composition also showed improved indication of pro-social effect in both C57 (General Population) and BTBR (Autism-Like) mouse models, and a reduced “abuse liability” (addiction) potential. PharmAla’s patent application included in-vivo experimental animal data, which is generally held to be stronger evidence than computational, or in-silico, modeling. “MDMA is relatively unique in that it has two enantiomers that are active, but are active in dramatically different ways. In the brain, these two variants of the molecule have a synergistic effect. In short, the sum of these parts is greater than the whole,” said Dr. Harpreet Kaur, Vice President of Research at PharmAla Biotech. “Viewed this way, it becomes obvious that the effects of racemic MDMA should be viewed not as one active, but as a combination effect – and as such, it is open to optimization. With ALA-002, we believe we have done that difficult work, and have created an improved, novel, next generation MDMA drug substance formulation.” ALA-002 is considered by the US Food and Drug Administration (FDA) to be a Novel Chemical Entity (NCE), and in the opinion of the Company it is a different Active Moiety than racemic MDMA. As such, the Company believes that should it be approved by the FDA for use as a treatment for any disorder, it should be granted its own Data Exclusivity period. The Company intends to pursue its own clinical research with the novel composition, either alone or with an out-licensing partner. It has completed a Phase 2 protocol for the research of ALA-002 as a treatment for Social Anxiety symptoms in patients with Autism Spectrum Disorder (ASD) in conjunction with researchers at the University of Sydney. The Company believes that this is an Orphan Indication, in that there are no FDA-approved treatments currently available for social anxiety in autistic patients. However, the Company also believes that ALA-002 could be useful in the treatment of a number of neurological and neuropsychiatric disorders. “We are incredibly pleased that USPTO has issued an allowance for the granting of the Composition of Matter patent for ALA-002. This is the culmination of years of pre-clinical and intellectual property work, and represents a significant achievement in a relatively crowded IP environment,” said Nick Kadysh, Founding CEO, PharmAla Biotech. “PharmAla’s IP team has already begun working towards patenting this composition in a number of relevant global markets, with the support of Intellectual Property Ontario (IPON), and we are excited to both defend and build on what we believe is an exceptionally valuable piece of intellectual property.” PharmAla intends to use this landmark USPTO allowance to accelerate allowance in other jurisdictions through all practicable means. About PharmAla PharmAla Biotech Holdings Inc. (CSE: MDMA)(OTCQB: MDXXF) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials as well as commercial sales in selected jurisdictions, and to develop novel drugs in the same class. PharmAla is the only company currently provisioning clinical-grade MDMA for patient treatments outside of clinical trials. PharmAla’s research and development unit has completed proof-of-concept research into several IP families, including ALA-002, its lead drug candidate. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. For more information, please contact:Nicholas KadyshChief Executive OfficerPharmAla Biotech Holdings Inc.Email: press@PharmAla.caPhone: 1-855-444-6362Website: www.PharmAla.ca Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release. Cautionary Statement This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmAla’s current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by PharmAla at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. The forward-looking information contained in this press release is made as of the date hereof, and PharmAla is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in PharmAla’s management’s discussion and analysis which is available on PharmAla’s profile at www.sedar.com. This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction