– Strong execution across atai’s three strategic pillars: rapid acting pharmacological intervention, ongoing digital support and biomarker-driven precision mental health
– Key milestones include first subject dosed in Phase 1 KUR-101, launch of drug discovery engine Invyxis, initiation of Psyber usability study in patients and COMPASS’ end of Phase 2 FDA meeting
– Ended the first quarter with
Video interview with Management to be posted today at
“We made great progress in the first quarter on our mission to achieve clinically meaningful behavioral change in people living with mental health disorders – seeing strong momentum across our three strategic pillars. We dosed the first subject in our Phase 1 KUR-101 trial and launched our fourth drug discovery program, Invyxis. In addition, we initiated a usability study of Psyber in patients receiving ketamine treatment, further advancing our ongoing digital support programs,” said
“The first quarter of 2022 continued with strong execution of our clinical pipeline. We anticipate several clinical milestones in 2022 and beyond, including data from the Phase 2 proof-of-concept study of PCN-101 as a potential at-home-use therapy in treatment resistant depression (TRD). We also anticipate results from a relative bioavailability study comparing subcutaneous formulation of PCN-101 to existing IV formulation, and additional Phase 1 readouts, including GRX-917, DMX-1002, and KUR-101. Finally, we expect Phase 2 trial initiations for GRX-917 and RL-007, as well as Phase 1 initiations for EMP-01 and VLS-101 during 2022 and RLS-01 in the first half of 2023. It’s a testament to our phenomenal team that we anticipate to have 10 compounds in the clinic.” said
Video Interview with Management
A video interview with
The interview will also be accessible for replay in the “Events” section of the Company’s website at www.atai.life. The archived copy of the interview will be available on the Company’s website for at least 30 days.
Pipeline Highlights
The Company continued to execute in the first quarter advancing many of its programs and is looking forward to additional clinical milestones for the remainder of 2022 and beyond. The Company anticipates 10 compounds in clinical development. atai’s development pipeline of pharmaceuticals, digital therapeutics, and precision mental health are supported by a total of 171 issued patents and 49 pending non-provisional patents.
Treatment Resistant Depression (TRD)
Perception Neuroscience – PCN-101: After receiving FDA IND Clearance in
COMPASS Pathways – COMP-360: COMPASS held a productive end-of-Phase 2 meeting with the FDA in
Cognitive Impairment Associated with Schizophrenia (CIAS)
Recognify Life Sciences – RL-007: Recognify is expected to initiate a Phase 2a proof-of concept trial in CIAS in the second half of 2022, with the goal of demonstrating the pro-cognitive benefit of RL-007 in CIAS.
Generalized Anxiety Disorder (GAD)
GABA Therapeutics – GRX-917: In
Opioid Use Disorder (OUD)
Kures – KUR-101: Kures initiated a Phase 1 trial in
Drug Discovery
Further strengthening atai’s commitment to next-generation treatments, atai launched Invyxis in late
Team Expansion
atai continued to strengthen its team in the first quarter by securing key hires. At GABA Therapeutics
Consolidated Financial Results
atai ended the first quarter of 2022 with a cash position of
Cash, Cash Equivalents, and Short-term investments
Cash, cash equivalents and short-term investments totaled
Operating Costs and Expenses
Research and development expenses were
There was no acquisition of in-process R&D expense for the three months ended
General and administrative expenses for the three months ended
Net loss attributable to shareholders for the three months ended
About
atai's business model combines funding, technology, scientific, and regulatory expertise with a focus on innovative compounds, including psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies 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. All statements contained in this press release other than statements of historical fact, including statements regarding our future operating results and financial position, the success, cost, and timing of development of our product candidates, including the progress of preclinical studies and clinical trials and related milestones, the commercialization of our current product candidates and any other product candidates we may identify and pursue, if approved, including our ability to successfully build a specialty sales force and commercial infrastructure to market our current product candidates and any other product candidates we may identify and pursue, the timing of and our ability to obtain and maintain regulatory approvals, our business strategy and plans, potential acquisitions, and the plans and objectives of management for future operations and capital expenditures, are forward-looking statements. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond our control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.
We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including without limitation: statements regarding our future operating results and financial position, the success, cost and timing of development of our product candidates, including the progress of preclinical studies and clinical trials and related milestones, the commercialization of our current product candidates and any other product candidates we may identify and pursue, if approved, including our ability to successfully build a specialty sales force and commercial infrastructure to market our current product candidates and any other product candidates we may identify and pursue, the timing of and our ability to obtain and maintain regulatory approvals, our business strategy and plans, potential acquisitions, and the plans and objectives of management for future operations and capital expenditures. Other risk factors include the important factors described in the section titled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the
Any forward-looking statements made herein speak only as of the date of this press release, and you should not rely on forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, performance, or achievements reflected in the forward-looking statements will be achieved or will occur. Except as required by applicable law, we undertake no obligation to update any of these forward-looking statements for any reason after the date of this press release or to conform these statements to actual results or revised expectations.
Contact Information
Investor Contact:
Chief Financial Officer
greg.weaver@atai.life
Media Contact:
Senior Manager of Communications
maggie@atai.life
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
(Amounts in thousands, except share and per share amounts) | ||||||||
(unaudited) | ||||||||
Three Months Ended | ||||||||
2022 | 2021 | |||||||
License revenue | $ | — | $ | 19,880 | ||||
Operating expenses: | ||||||||
Research and development | 15,460 | 5,585 | ||||||
Acquisition of in-process research and development | — | 972 | ||||||
General and administrative | 17,982 | 9,273 | ||||||
Total operating expenses | 33,442 | 15,830 | ||||||
Income (loss) from operations | (33,442 | ) | 4,050 | |||||
Other income (expense), net | 1,521 | 1,703 | ||||||
Net income (loss) before income taxes | (31,921 | ) | 5,753 | |||||
Provision for income taxes | (41 | ) | (6 | ) | ||||
Losses from investments in equity method investees, net of tax | (5,596 | ) | (1,703 | ) | ||||
Net income (loss) | (37,558 | ) | 4,044 | |||||
Net income (loss) attributable to redeemable noncontrolling interests and noncontrolling interests | (689 | ) | 3,356 | |||||
Net income (loss) attributable to | $ | (36,869 | ) | $ | 688 | |||
Net income (loss) per share attributable to | $ | (0.24 | ) | $ | 0.01 | |||
Net income (loss) per share attributable to | $ | (0.24 | ) | $ | 0.01 | |||
Weighted average common shares outstanding attributable to | 153,529,268 | 119,258,529 | ||||||
Weighted average common shares outstanding attributable to | 153,529,268 | 121,374,430 | ||||||
CONDENSED CONSOLIDATED BALANCE SHEET | ||||||
(Amounts in thousands) | ||||||
2022 | 2021 | |||||
(unaudited) | (1) | |||||
Assets | ||||||
Cash and cash equivalents | $ | 123,975 | $ | 362,266 | ||
Debt securities carried at fair value | 210,939 | — | ||||
Prepaid expenses and other current assets | 12,985 | 11,903 | ||||
Short term notes receivable | 887 | 913 | ||||
Property and equipment, net | 178 | 149 | ||||
Equity method investments | 9,749 | 16,131 | ||||
Other investments | 10,587 | 11,628 | ||||
Long term notes receivable - related parties | 6,928 | 3,835 | ||||
Other assets | 7,504 | 7,341 | ||||
Total assets | $ | 383,732 | $ | 414,166 | ||
Liabilities and Stockholders' Equity | ||||||
Accounts payable | 3,612 | 6,004 | ||||
Accrued liabilities | 18,252 | 14,829 | ||||
Current portion of contingent consideration liability - related parties | — | 51 | ||||
Other current liabilities | 227 | 51 | ||||
Non-current portion of contingent consideration liability - related parties | 2,433 | 2,432 | ||||
Convertible promissory notes - related parties, net of discounts and deferred issuance costs | 725 | 743 | ||||
Other liabilities | 4,126 | 4,097 | ||||
Total stockholders' equity attributable to | 346,006 | 376,908 | ||||
Noncontrolling interests | 8,351 | 9,051 | ||||
Total liabilities and stockholders' equity | $ | 383,732 | $ | 414,166 | ||
(1) The condensed consolidated financial statements as of and for the year ended | ||||||
Source:
2022 GlobeNewswire, Inc., source