– Robust execution throughout atai’s three strategic pillars: speedy appearing pharmacological intervention, ongoing digital help and biomarker-driven precision psychological well being
– Key milestones embrace first topic dosed in Part 1 KUR-101, launch of drug discovery engine Invyxis, initiation of Psyber usability research in sufferers and COMPASS’ finish of Part 2 FDA assembly
– Ended the primary quarter with $335 million money, sustaining atai’s place as a well-funded, main psychological well being firm
Video interview with Administration to be posted immediately at 8:30 a.m. EDT
NEW YORK and BERLIN, Could 16, 2022 (GLOBE NEWSWIRE) — atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical firm aiming to remodel the therapy of psychological well being issues, immediately reported monetary outcomes for the quarter ended March 31, 2022 and supplied a enterprise replace.
“We made nice progress within the first quarter on our mission to realize clinically significant behavioral change in folks dwelling with psychological well being issues – seeing robust momentum throughout our three strategic pillars. We dosed the primary topic in our Part 1 KUR-101 trial and launched our fourth drug discovery program, Invyxis. As well as, we initiated a usability research of Psyber in sufferers receiving ketamine therapy, additional advancing our ongoing digital help packages,” stated Florian Model, Chief Government Officer & Co-Founding father of atai.
“The primary quarter of 2022 continued with robust execution of our medical pipeline. We anticipate a number of medical milestones in 2022 and past, together with data from the Part 2 proof-of-concept research of PCN-101 as a possible at-home-use remedy in therapy resistant melancholy (TRD). We additionally anticipate outcomes from a relative bioavailability research evaluating subcutaneous formulation of PCN-101 to present IV formulation, and extra Part 1 readouts, together with GRX-917, DMX-1002, and KUR-101. Lastly, we count on Part 2 trial initiations for GRX-917 and RL-007, in addition to Part 1 initiations for EMP-01 and VLS-101 throughout 2022 and RLS-01 within the first half of 2023. It’s a testomony to our phenomenal workforce that we anticipate to have 10 compounds within the clinic.” stated Srinivas Rao, Chief Scientific Officer & Co-Founding father of atai.
Video Interview with Administration
A video interview with atai Life Sciences CEO & Co-Founder Florian Model, CSO & Co-Founder Srinivas Rao, and CFO Greg Weaver can be accessible immediately at 8:30 a.m. Jap Time at https://vimeo.com/atailifesciences.
The interview can even be accessible for replay within the “Occasions” part of the Firm’s web site at www.atai.life. The archived copy of the interview can be accessible on the Firm’s web site for not less than 30 days.
Pipeline Highlights
The Firm continued to execute within the first quarter advancing lots of its packages and is wanting ahead to further medical milestones for the rest of 2022 and past. The Firm anticipates 10 compounds in medical improvement. atai’s improvement pipeline of prescribed drugs, digital therapeutics, and precision psychological well being are supported by a complete of 171 issued patents and 49 pending non-provisional patents.
Therapy Resistant Despair (TRD)
Notion Neuroscience – PCN-101: After receiving FDA IND Clearance in December 2021, Notion has reached settlement with the FDA to maneuver ahead to broaden its PCN-101 Part 2a medical research initiated final September in Europe to the US. Notion has additionally initiated enrollment in a medical drug-drug interplay research in April 2022 to evaluate the pharmacokinetics of PCN-101 when used concurrently with different medicine. As well as, a relative bioavailability research evaluating the subcutaneous formulation to the prevailing IV formulation is anticipated to be initiated later this yr.
COMPASS Pathways – COMP-360: COMPASS held a productive end-of-Part 2 assembly with the FDA in April 2022.
Cognitive Impairment Related to Schizophrenia (CIAS)
Recognify Life Sciences – RL-007: Recognify is anticipated to provoke a Part 2a proof-of idea trial in CIAS within the second half of 2022, with the purpose of demonstrating the pro-cognitive advantage of RL-007 in CIAS.
Generalized Nervousness Dysfunction (GAD)
GABA Therapeutics – GRX-917: In June 2021, GABA initiated a Part 1 single and a number of ascending dose trial of GRX-917. Topline data for this trial is anticipated by mid of this yr and the initiation of a Part 2a proof-of-concept trial is anticipated to observe within the second half of this yr.
Opioid Use Dysfunction (OUD)
Kures – KUR-101: Kures initiated a Part 1 trial in March 2022. The trial is a randomized, double-blind, two-part research of the protection, tolerability, pharmacokinetics, analgesic and respiratory results of KUR-101 in wholesome volunteers. Half 1 is a five-cohort, single ascending dose research of KUR-101. Half 2 is a three-period crossover research to check the analgesic and respiratory results of a single oral dose of KUR-101, a single oral dose of fast launch oxycodone (OxyNorm™) and a single oral dose of placebo in wholesome male volunteers. Topline outcomes are anticipated within the second half of 2022.
Drug Discovery
Additional strengthening atai’s dedication to next-generation therapies, atai launched Invyxis in late January 2022 to speed up discovery of subsequent technology psychological well being therapies. Invyxis will add confirmed medicinal chemistry and complete organic analysis capabilities to develop atai’s portfolio of recent chemical entities. The early focus can be on designing distinctive, novel compounds focusing on the serotonin 5-HT2A receptor with different central nervous system receptor targets to observe. This new platform firm enhances atai’s machine learning-powered computational chemistry with EntheogeniX and biosynthesis-based drug discovery approaches with TryptageniX.
Crew Growth
atai continued to strengthen its workforce within the first quarter by securing key hires. At GABA Therapeutics Mario David Saltarelli, M.D., Ph.D., was appointed as Chief Government Officer and Chief Medical Officer. Maju Mathews, M.D., and Cedric Burg had been appointed as CMO and SVP of Medical Operations, respectively, at Notion Neuroscience.
Consolidated Monetary Outcomes
atai ended the primary quarter of 2022 with a money place of $335 million which it anticipates can be ample to supply a money runway via yr finish 2023.
Money, Money Equivalents, and Brief-term investments
Money, money equivalents and short-term investments totaled $335 million as of March 31, 2022, in comparison with $362 million as of December 31, 2021. The three-month web use of money of $27 million was primarily attributable to web money utilized in working actions of $24.0 million and $3 million of further investments within the platform firms.
Working Prices and Bills
Analysis and improvement bills had been $15.5 million for the three months ended March 31, 2022, as in comparison with $5.6 million for a similar prior yr interval. The rise of $9.9 million was primarily attributable to a rise of $4.8 million of personnel prices, which included a $3.6 million enhance in stock-based compensation expense and $4.9 million of elevated contract analysis group bills associated to the development of R&D packages.
There was no acquisition of in-process R&D expense for the three months ended March 31, 2022. Acquisition of in-process R&D expense for a similar prior yr interval was $1.0 million, which was primarily associated to IPR&D acquired from InnarisBio.
Normal and administrative bills for the three months ended March 31, 2022, had been $18.0 million, as in comparison with $9.3 million in the identical prior yr interval. The rise of $8.7 million was primarily attributable to a $6.4 million enhance in stock-based compensation expense, a $1.7 million enhance in insurance coverage prices, and a $0.7 million enhance in personnel and amenities prices.
Internet loss attributable to shareholders for the three months ended March 31, 2022, was $36.9 million. For the three months ended March 31, 2021, the Firm acknowledged $0.7 million in web revenue attributable to shareholders, primarily because of the recognition of $19.9 million of license income associated to the Otsuka Settlement throughout the interval.
About atai Life Sciences
atai Life Sciences is a clinical-stage biopharmaceutical firm aiming to remodel the therapy of psychological well being issues. Based in 2018 as a response to the numerous unmet want and lack of innovation within the psychological well being therapy panorama, atai is devoted to buying, incubating, and effectively creating modern therapeutics to deal with melancholy, nervousness, dependancy, and different psychological well being issues.
atai’s enterprise mannequin combines funding, expertise, scientific, and regulatory experience with a concentrate on modern compounds, together with psychedelic remedy and different medicine with differentiated security profiles and therapeutic potential. By pooling sources and finest practices, atai goals to responsibly speed up the event of recent medicines throughout its firms to realize clinically significant and sustained behavioral change in psychological well being sufferers.
atai’s imaginative and prescient is to heal psychological well being issues so that everybody, in every single place can reside a extra fulfilled life. For extra data, please go to www.atai.life.
Ahead-Wanting Statements
This press launch comprises forward-looking statements throughout the which means of the Non-public Securities Litigation Reform Act of 1995, as amended. We intend such forward-looking statements to be coated by the protected harbor provisions for forward-looking statements contained in Part 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Part 21E of the Securities Trade Act of 1934, as amended (the “Trade Act”). The phrases “imagine,” “could,” “will,” “estimate,” “proceed,” “anticipate,” “intend,” “count on,” “anticipate,” “provoke,” “might,” “would,” “undertaking,” “plan,” “probably,” “preliminary,” “seemingly,” and related expressions are supposed to establish forward-looking statements, though not all forward-looking statements include these phrases. All statements contained on this press launch aside from statements of historic truth, together with statements relating to our future working outcomes and monetary place, the success, price, and timing of improvement of our product candidates, together with the progress of preclinical research and medical trials and associated milestones, the commercialization of our present product candidates and some other product candidates we could establish and pursue, if accredited, together with our means to efficiently construct a specialty gross sales pressure and industrial infrastructure to market our present product candidates and some other product candidates we could establish and pursue, the timing of and our means to acquire and preserve regulatory approvals, our enterprise technique and plans, potential acquisitions, and the plans and goals of administration for future operations and capital expenditures, are forward-looking statements. The forward-looking statements on this press launch are neither guarantees nor ensures, and you shouldn’t place undue reliance on these forward-looking statements as a result of they contain recognized and unknown dangers, uncertainties, and different elements, lots of that are past our management and which might trigger precise outcomes, ranges of exercise, efficiency or achievements to vary materially from these expressed or implied by these forward-looking statements.
We now have primarily based these forward-looking statements largely on our present expectations and projections about future occasions and developments that we imagine could have an effect on our monetary situation, outcomes of operations, enterprise technique, short-term and long-term enterprise operations and goals, and monetary wants. These forward-looking statements are topic to various dangers, uncertainties, and assumptions, together with with out limitation: statements relating to our future working outcomes and monetary place, the success, price and timing of improvement of our product candidates, together with the progress of preclinical research and medical trials and associated milestones, the commercialization of our present product candidates and some other product candidates we could establish and pursue, if accredited, together with our means to efficiently construct a specialty gross sales pressure and industrial infrastructure to market our present product candidates and some other product candidates we could establish and pursue, the timing of and our means to acquire and preserve regulatory approvals, our enterprise technique and plans, potential acquisitions, and the plans and goals of administration for future operations and capital expenditures. Different danger elements embrace the vital elements described within the part titled “Danger Components” in our most up-to-date Annual Report on Kind 10-Ok filed with the Securities and Trade Fee (“SEC”), as up to date by our subsequent filings with the SEC, that will trigger our precise outcomes, efficiency, or achievements to vary materially and adversely from these expressed or implied by the forward-looking statements.
Any forward-looking statements made herein communicate solely as of the date of this press launch, and you shouldn’t depend on forward-looking statements as predictions of future occasions. Though we imagine that the expectations mirrored within the forward-looking statements are affordable, we can not assure that the longer term outcomes, efficiency, or achievements mirrored within the forward-looking statements can be achieved or will happen. Besides as required by relevant legislation, we undertake no obligation to replace any of those forward-looking statements for any purpose after the date of this press launch or to adapt these statements to precise outcomes or revised expectations.
Contact Data
Investor Contact:
Greg Weaver
Chief Monetary Officer
[email protected]
Media Contact:
Maggie Gordon
Senior Supervisor of Communications
[email protected]
| ATAI LIFE SCIENCES N.V. | ||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
| (Quantities in hundreds, besides share and per share quantities) | ||||||||
| (unaudited) | ||||||||
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2022 | 2021 | |||||||
| License income | $ | — | $ | 19,880 | ||||
| Working bills: | ||||||||
| Analysis and improvement | 15,460 | 5,585 | ||||||
| Acquisition of in-process analysis and improvement | — | 972 | ||||||
| Normal and administrative | 17,982 | 9,273 | ||||||
| Whole working bills | 33,442 | 15,830 | ||||||
| Earnings (loss) from operations | (33,442 | ) | 4,050 | |||||
| Different revenue (expense), web | 1,521 | 1,703 | ||||||
| Internet revenue (loss) earlier than revenue taxes | (31,921 | ) | 5,753 | |||||
| Provision for revenue taxes | (41 | ) | (6 | ) | ||||
| Losses from investments in fairness methodology investees, web of tax | (5,596 | ) | (1,703 | ) | ||||
| Internet revenue (loss) | (37,558 | ) | 4,044 | |||||
| Internet revenue (loss) attributable to redeemable noncontrolling pursuits and noncontrolling pursuits | (689 | ) | 3,356 | |||||
| Internet revenue (loss) attributable to ATAI Life Sciences N.V. stockholders | $ | (36,869 | ) | $ | 688 | |||
| Internet revenue (loss) per share attributable to ATAI Life Sciences N.V. stockholders– primary | $ | (0.24 | ) | $ | 0.01 | |||
| Internet revenue (loss) per share attributable to ATAI Life Sciences N.V. stockholders– diluted | $ | (0.24 | ) | $ | 0.01 | |||
| Weighted common widespread shares excellent attributable to ATAI Life Sciences N.V. stockholders — primary | 153,529,268 | 119,258,529 | ||||||
| Weighted common widespread shares excellent attributable to ATAI Life Sciences N.V. stockholders — diluted | 153,529,268 | 121,374,430 | ||||||
| ATAI LIFE SCIENCES N.V. | ||||||
| CONDENSED CONSOLIDATED BALANCE SHEET | ||||||
| (Quantities in hundreds) | ||||||
| March 31, | December 31, | |||||
| 2022 | 2021 | |||||
| (unaudited) | (1) | |||||
| Belongings | ||||||
| Money and money equivalents | $ | 123,975 | $ | 362,266 | ||
| Debt securities carried at honest worth | 210,939 | — | ||||
| Pay as you go bills and different present property | 12,985 | 11,903 | ||||
| Brief time period notes receivable | 887 | 913 | ||||
| Property and gear, web | 178 | 149 | ||||
| Fairness methodology investments | 9,749 | 16,131 | ||||
| Different investments | 10,587 | 11,628 | ||||
| Long run notes receivable – associated events | 6,928 | 3,835 | ||||
| Different property | 7,504 | 7,341 | ||||
| Whole property | $ | 383,732 | $ | 414,166 | ||
| Liabilities and Stockholders’ Fairness | ||||||
| Accounts payable | 3,612 | 6,004 | ||||
| Accrued liabilities | 18,252 | 14,829 | ||||
| Present portion of contingent consideration legal responsibility – associated events | — | 51 | ||||
| Different present liabilities | 227 | 51 | ||||
| Non-current portion of contingent consideration legal responsibility – associated events | 2,433 | 2,432 | ||||
| Convertible promissory notes – associated events, web of reductions and deferred issuance prices | 725 | 743 | ||||
| Different liabilities | 4,126 | 4,097 | ||||
| Whole stockholders’ fairness attributable to ATAI Life Sciences N.V. stockholders | 346,006 | 376,908 | ||||
| Noncontrolling pursuits | 8,351 | 9,051 | ||||
| Whole liabilities and stockholders’ fairness | $ | 383,732 | $ | 414,166 | ||
| (1) The condensed consolidated monetary statements as of and for the yr ended December 31, 2021 are derived from the audited consolidated monetary statements as of that date. | ||||||
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