NEW YORK and BERLIN, March 28, 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 fourth quarter and full year 2023 financial results and provided corporate and clinical highlights.
“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
Cash, cash equivalents, and short-term investments: Cash and cash equivalents and short-term investments were $154.2 million as of December 31, 2023, as compared to $273.1 million as of December 31, 2022. The decrease of $118.9 million was primarily driven by $84.1 million net cash used in operating activities, $25.0 million designated for the Beckley Psytech investment and $15.0 million of additional investments to advance our programs. The Company expects its cash, marketable securities and committed term loan facility with Hercules Capital, Inc. will be sufficient to fund operations into 2026.
Research and development (R&D) expenses: R&D expenses were $14.2 million and $62.2 million for the three and twelve months ended December 31, 2023, respectively, as compared to $21.9 million and $74.3 million for the same prior year periods. The year-over-year full-year decrease of $12.1 million was primarily attributable to a decrease of $10.1 million of contract research organization expenses and $2.1 million in R&D personnel costs as a result of the deprioritization of certain programs.
General and administrative (G&A) expenses: G&A expenses for the three and twelve months ended December 31, 2023 were $19.4 million and $63.6 million, respectively, as compared to $15.7 million and $70.4 million in the same prior year periods. The year-over-year decrease of $6.8 million was primarily attributable to a $8.1 million decrease in personnel expenses, $2.0 million net decrease of professional services and other administrative expenses, partially offset by a $3.3 million increase related to a prior year non-income tax refund.
Net loss: Net loss attributable to shareholders for the three and twelve months ended December 31, 2023 was $18.3 million and $40.2 million, respectively, as compared to $45.0 million and $152.4 million for the comparable prior year periods.
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:
IR@atai.life
Media Contact:
PR@atai.life
ATAI LIFE SCIENCES N.V. | |||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||
(Amounts in thousands, except share and per share amounts) | |||||||||||||||
(unaudited) | |||||||||||||||
Three Months Ended | Years Ended | ||||||||||||||
December 31, | 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 |
ATAI LIFE SCIENCES N.V. | |||||||
CONDENSED CONSOLIDATED BALANCE SHEET | |||||||
(Amounts in thousands) | |||||||
December 31, | December 31, | ||||||
2023 | 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 |
NEWTOWN, Pa., Dec. 22, 2024 /PRNewswire/ -- The law firm of Edelson Lechtzin LLP is…
Miami, Florida--(Newsfile Corp. - December 21, 2024) - Amid the vibrant backdrop of Art Basel…
Daily Fit Notes, founded by Justin Brey in New York, launches a text-based subscription fitness…
MT. STERLING, Ohio, Dec. 20, 2024 /PRNewswire/ -- WillowWood, a global leader in prosthetic solutions,…
TORONTO, ON / ACCESSWIRE / December 20, 2024 / Quantum BioPharma Ltd. (NASDAQ:QNTM)(CSE:QNTM)(FRA:0K91) ("Quantum BioPharma"…
Toronto, Ontario--(Newsfile Corp. - December 20, 2024) - Glow Lifetech Corp. (CSE: GLOW) (OTC Pink:…