The |
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(State or other jurisdiction of incorporation or organization)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Title of each class
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Trading
Symbol(s)
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Name of each exchange
on which registered
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||
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(Nasdaq Global Market)
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Item 2.02. |
Results of Operations and Financial Condition.
|
Item 9.01. |
Financial Statements and Exhibits.
|
Exhibit
No.
|
Description
|
|
Press Release of ATAI Life Sciences N.V., dated May 11, 2023.
|
||
104
|
Cover Page Interactive Data File (embedded within the inline XBRL document).
|
|
* |
Furnished herewith
|
ATAI LIFE SCIENCES N.V.
|
||
Date: May 11, 2023
|
By:
|
/s/ Florian Brand
|
Name:
|
Florian Brand
|
|
Title:
|
Chief Executive Officer
|
- |
RL-007: First patient dosed in the Phase 2b study of RL-007 in Cognitive Impairment Associated with Schizophrenia.
|
- |
GRX-917: Presented PD data from the completed Phase 1 study, which suggest the potential for anxiolytic effects without the significant sedative effects seen
with benzodiazepines.
|
- |
VLS-01: Well-tolerated in Parts 1 (IV) and 2 (OTF) of the on-going Phase 1 study. Amended protocol to expand study into Part 3, which is expected to further
optimize the PK and PD of our proprietary OTF formulation.
|
- |
COMP360: Acceleration of the Pivotal Trial 1 (COMP 005) part of the Phase 3 program in TRD, with topline data from Pivotal Trial 1 now expected in the summer
of 2024.
|
- |
The Company’s $250M cash position and committed term loan funding is expected to fund operations into 1H 2026.
|
- |
In the first quarter of 2023, the first patient was dosed in the Phase 2b study of RL-007 in patients with Cognitive Impairment Associated with Schizophrenia (CIAS).
|
- |
The Phase 2b study is a randomized, placebo-controlled, double-blind, study of 6 weeks duration evaluating 20mg and 40mg of RL-007 vs placebo.
|
- |
The primary endpoint of the study is the change from baseline in the MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite score, a well-established regulatory
endpoint.
|
- |
Topline results from this study are expected in the 2nd half of 2024.
|
- |
In January 2023, Phase 1 results were announced from the study of GRX-917 in healthy volunteers.
|
o |
GRX-917 was well-tolerated, with no dose-limiting toxicities and sedation comparable to placebo.
|
o |
GRX-917 had an improved pharmacokinetic (PK) profile relative to non-deuterated etifoxine and demonstrated pharmacodynamic (PD) evidence of GABA receptor target engagement.
|
- |
In April 2023, the company detailed PD data from the Phase 1 study in a poster presentation at the Society for Biological Psychiatry (SOBP) Annual Meeting.
|
o |
As measured by EEG, GRX-917 demonstrated a statistically significant increase in beta power, a marker of potential anxiolytic effects, comparable to what is seen with exogenous
neurosteroids and benzodiazepines.
|
o |
Unlike benzodiazepines, however, GRX-917 was found to not reduce alpha power, a marker of potential sedative effects.
|
- |
The company expects to proceed GRX-917 into a Phase 2 study in patients living with anxiety disorder. More details of the Phase 2 clinical development plan will be provided upon
study initiation.
|
- |
The company recently completed Part 1 and Part 2 of an ongoing Phase 1 open-label, single-ascending dose study of VLS-01 in healthy adult participants.
|
- |
The Phase 1 study is designed to evaluate the safety, tolerability, PK and PD of VLS-01 delivered by intravenous (IV) infusion and using our proprietary oral transmucosal film
(OTF) formulation.
|
o |
In Part 1 (IV) and Part 2 (OTF), VLS-01 was well-tolerated, with no dose-limiting toxicity and a favorable safety profile.
|
o |
VLS-01 IV was consistent with the known pharmacological profile of DMT, producing robust exposure-dependent increases in the subjective intensity of psychedelic experience.
|
o |
VLS-01 OTF produced generally dose-dependent increases in exposure, approaching that seen with IV administration. In addition, VLS-01 OTF administration resulted in subjective
psychedelic experiences in the majority of subjects.
|
- |
To further optimize the PK and PD of our proprietary OTF formulation, a protocol amendment was implemented to add Part 3, which will explore further dose ranging.
|
- |
The company expects to report additional clinical data in Q3 2023.
|
- |
COMPASS Pathways announced an acceleration of the Pivotal Trial 1 (COMP 005) part of the Phase 3 program in TRD, with topline data from Pivotal Trial 1 now expected in the summer
of 2024.
|
- |
The on-going Phase 3 program is composed of two pivotal trials, each of which will have a long-term follow-up component. The primary endpoint in both pivotal trials is the change
from baseline in MADRS total score at week 6.
|
Three Months Ended
March 31,
|
||||||||
2023
|
2022
|
|||||||
License revenue
|
$
|
37
|
$
|
—
|
||||
Operating expenses:
|
||||||||
Research and development
|
19,281
|
15,460
|
||||||
General and administrative
|
13,970
|
17,982
|
||||||
Total operating expenses
|
33,251
|
33,442
|
||||||
Loss from operations
|
(33,214
|
)
|
(33,442
|
)
|
||||
Other income (expense), net
|
58
|
1,521
|
||||||
Loss before income taxes
|
(33,156
|
)
|
(31,921
|
)
|
||||
Provision for income taxes
|
(165
|
)
|
(41
|
)
|
||||
Losses from investments in equity method investees, net of tax
|
(1,033
|
)
|
(5,596
|
)
|
||||
Net loss
|
(34,354
|
)
|
(37,558
|
)
|
||||
Net loss attributable to noncontrolling interests
|
(1,219
|
)
|
(689
|
)
|
||||
Net loss attributable to ATAI Life Sciences N.V. stockholders
|
$
|
(33,135
|
)
|
$
|
(36,869
|
)
|
||
Net loss per share attributable to ATAI Life Sciences N.V.
stockholders — basic and diluted
|
$
|
(0.21
|
)
|
$
|
(0.24
|
)
|
||
Weighted average common shares outstanding attributable to ATAI Life Sciences N.V. stockholders — basic
and diluted
|
155,792,490
|
153,529,268
|
March 31
2023
|
December 31,
2022
|
|||||||
(unaudited)
|
(1)
|
|
||||||
Assets
|
||||||||
Cash and cash equivalents
|
$
|
185,885
|
$
|
190,613
|
||||
Securities carried at fair value
|
63,998
|
82,496
|
||||||
Prepaid expenses and other current assets
|
9,199
|
14,036
|
||||||
Short term notes receivable - related parties, net
|
8,851
|
—
|
||||||
Property and equipment, net
|
1,114
|
928
|
||||||
Operating lease right-of-use asset, net
|
1,489
|
226
|
||||||
Other investments
|
5,846
|
6,755
|
||||||
Long term notes receivable - related parties, net
|
1,155
|
7,262
|
||||||
Other assets
|
3,180
|
3,125
|
||||||
Total assets
|
$
|
280,717
|
$
|
305,441
|
||||
Liabilities and Stockholders' Equity
|
||||||||
Accounts payable
|
4,915
|
2,399
|
||||||
Accrued liabilities
|
13,819
|
17,306
|
||||||
Current portion of lease liability
|
317
|
180
|
||||||
Other current liabilities
|
902
|
12
|
||||||
Non-current portion of contingent consideration liability - related parties
|
918
|
953
|
||||||
Non-current portion of lease liability
|
1,185
|
44
|
||||||
Convertible promissory notes - related parties, net of discounts and deferred issuance costs
|
422
|
415
|
||||||
Long-term debt, net
|
14,783
|
14,702
|
||||||
Other liabilities
|
2,816
|
3,664
|
||||||
Total stockholders' equity attributable to ATAI Life Sciences N.V. stockholders
|
236,825
|
260,740
|
||||||
Noncontrolling interests
|
3,815
|
5,026
|
||||||
Total liabilities and stockholders' equity
|
$
|
280,717
|
$
|
305,441
|
Document and Entity Information |
May 11, 2023 |
---|---|
Cover [Abstract] | |
Document Type | 8-K |
Amendment Flag | false |
Document Period End Date | May 11, 2023 |
Entity File Number | 001-40493 |
Entity Registrant Name | ATAI LIFE SCIENCES N.V. |
Entity Central Index Key | 0001840904 |
Entity Incorporation, State or Country Code | P7 |
Entity Tax Identification Number | 00-0000000 |
Entity Address, Address Line One | Wallstraße 16 |
Entity Address, City or Town | Berlin |
Entity Address, Country | DE |
Entity Address, Postal Zip Code | 10179 |
City Area Code | +49 89 |
Local Phone Number | 2153 9035 |
Title of 12(b) Security | Common shares, €0.10 par value per share |
Trading Symbol | ATAI |
Security Exchange Name | NASDAQ |
Entity Emerging Growth Company | true |
Entity Ex Transition Period | false |
Written Communications | false |
Soliciting Material | false |
Pre-commencement Tender Offer | false |
Pre-commencement Issuer Tender Offer | false |
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