Exhibit 99.1

atai Life Sciences Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate and Clinical Highlights

 

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Strategic investment in Beckley Psytech to accelerate the development of psychedelic-based therapies that fit within the two hour in-clinic treatment paradigm established by Spravato®

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Initial BPL-003 (intranasal 5-MeO-DMT) Phase 2a open-label results demonstrated a rapid and durable antidepressant effect through three months in TRD patients; top-line results from a controlled Phase 2b TRD study anticipated in 2H 2024

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Dosing commenced in VLS-01 (oral transmucosal DMT) Phase 1b study, with optimized formulation designed to improve pharmacokinetics and patient experience ahead of anticipated Phase 2 trial in TRD

 

“In 2023, we demonstrated our continued commitment to transforming mental health care for those most in need. Much of our recent focus has centred on psychedelic-based therapies for depression - such as BPL-003, an intranasal formulation of 5-MeO-DMT - that require two hours or less in a clinic. We believe that the combination of a short treatment time and durable efficacy has the potential to enable accessible and convenient interventional treatments at scale. The recent BPL-003 Phase 2a data from Beckley Psytech are encouraging in anticipation of the larger Phase 2b results in the second half of this year. The data showed that acute effects resolved on average in less than two hours, the antidepressant effect was rapid, and was sustained for three months,” said Florian Brand, atai Chief Executive Officer and Co-founder.

 

Mr. Brand continued, “Another asset designed as a two hour in-clinic treatment is VLS-01, an oral transmucosal formulation of N,N-DMT, which recently started dosing in a Phase 1b trial. Looking ahead, we anticipate several important milestones throughout the next year, including the Phase 2b readout from BPL-003.”

 

Corporate Highlights

 

 

 

 

Clinical Highlights

 

BPL-003: 5-MeO-DMT for Treatment-Resistant Depression (TRD)

 

 

 

 

 

VLS-01: N,N-dimethyltryptamine (DMT) for TRD

 

 

 

 

 

ELE-101: Psilocin for Major Depressive Disorder (MDD)

 

 

 

 

COMP360: Psilocybin Therapy for TRD

 

 

 

 

 

IBX-210: Ibogaine for Opioid Use Disorder (OUD)

 

 

 

 

 

RL-007: Pro-Cognitive Neuromodulator for Cognitive Impairment Associated with Schizophrenia (CIAS)

 

 

 

 

Consolidated Financial Results

 

 

 

 

 

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 the plans and objectives of management for future operations 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:

 

 

Media Contact:

 

 

		Three Months Ended December 31,								Years Ended December 31,
		2023				2022				2023				2022
		(unaudited)
License revenue		$	18			$	38			$	314			$	233
Operating expenses:
Research and development			14,156				21,876				62,203				74,313
Acquisition of in-process research and development			—				—				—				357
General and administrative			19,423				15,727				63,582				70,350
Total operating expenses			33,579				37,603				125,785				145,020
Loss from operations			(33,561	)			(37,565	)			(125,471	)			(144,787	)
Other income (expense), net			15,241				(1,756	)			86,185				9,605
Loss before income taxes			(18,320	)			(39,321	)			(39,286	)			(135,182	)
Provision for income taxes			(428	)			(6,002	)			(1,016	)			(6,229	)
Losses from investments in equity method investees, net of tax			(394	)			(1,326	)			(3,593	)			(16,006	)
Net loss			(19,142	)			(46,649	)			(43,895	)			(157,417	)
Net loss attributable to noncontrolling interests			(850	)			(1,638	)			(3,671	)			(5,032	)
Net loss attributable to ATAI Life Sciences N.V. stockholders		$	(18,292	)		$	(45,011	)		$	(40,224	)		$	(152,385	)
Net loss per share attributable to ATAI Life Sciences N.V. stockholders — basic and diluted		$	(0.12	)		$	(0.28	)		$	(0.25	)		$	(0.98	)
Weighted average common shares outstanding attributable to ATAI Life Sciences N.V. stockholders — basic and diluted			158,842,995				158,703,781				158,833,785				155,719,585

		December 31, 2023				December 31, 2022
Assets
Cash and cash equivalents		$	45,034			$	190,613
Securities carried at fair value			109,223				82,496
Committed Investment Funds			25,000				—
Prepaid expenses and other current assets			5,830				14,036
Short term notes receivable			505				—
Property and equipment, net			981				928
Operating lease right-of-use asset, net			1,223				226
Other investments held at fair value			89,825				—
Other investments			1,838				6,755
Long term notes receivable - related parties, net			97				7,262
Convertible notes receivable - related party			11,202				—
Other assets			2,720				3,125
Total assets		$	293,478			$	305,441
Liabilities and Stockholders' Equity
Accounts payable			4,589				2,399
Accrued liabilities			15,256				17,306
Current portion of contingent consideration liability - related parties			275				180
Other current liabilities			—				12
Contingent consideration liability - related parties			620				953
Contingent consideration liability			1,637				—
Noncurrent portion of lease liability			990				44
Convertible promissory notes - related parties			164				415
Convertible promissory notes			2,666				—
Long term debt, net			15,047				14,702
Other liabilities			7,918				3,664
Total stockholders' equity attributable to ATAI Life Sciences N.V. stockholders			242,962				260,740
Noncontrolling interests			1,354				5,026
Total liabilities and stockholders' equity		$	293,478			$	305,441

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