Healingmental health disorders so that everyone everywhere can live a more fulfilled life.
Company Overview - June 2024
02
Disclaimer
All references in this presentation to "we", "us", "our", "atai", or the
"Company" refer to ATAI Life Sciences N.V. and its consolidated
subsidiaries, unless the context otherwise requires. This presentation
contains forward-looking statements within the meaning of the private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered under by the safe harbor provisions for forward- looking statements contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended." All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, industry dynamics, business strategy and plans and our objectives for future operations, are forward- looking statements. These statements represent our opinions, expectations, beliefs, intentions, estimates or strategies regarding the future, which may not be realized. In some cases, you can identify forward- looking statements by terms such as "may," "will," "should," "expects," "plans," "anticipates," "could," "intends," "targets," "projects," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions that are intended to identify forward-looking statements. Forward-looking statements are based largely on our current expectations and projections about future events and financial 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 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 updated by our subsequent filings with the SEC, that may cause our actual results, performance or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements. Moreover, we operate in a very competitive and rapidly
changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our businessor the extent towhich any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this presentation may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. We caution you therefore against relying on these forward-looking statements, and we qualify all of our forward-looking statements by these cautionary statements.
The forward-looking statements included in this presentation are made only as of the date hereof. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, neither we nor our advisors nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. Neither we nor our advisors undertake any obligation to update any forward-looking statements for any reason after the date of this presentation to conform these statements to actual results or to changes in our expectations, except as may be required by law. You should read this presentation with the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially different from what we expect.
Unless otherwise indicated, information contained in this presentation concerning our industry, competitive position and the markets in which we operate is based on information from independent industry and research organizations, other third-party sources and management estimates. Management estimates are derived from publicly available information
released by independent industry analysts and other third-party sources, as well as data from our internal research, and are based on assumptions made by usupon reviewing such data, and our experience in, and knowledgeof, such industry and markets, which we believe to be reasonable. In addition, projections, assumptions and estimates of the future performance of the industry in which we operate or of any individual competitor and our future performance are necessarily subject to uncertainty and risk due to a variety of factors, including those described above. These and other factors could cause results to differ materially from those expressed in the estimates made by independent parties and by us. Industry publications, research, surveys and studies generally state that the information they contain has been obtained from sources believed to be reliable, but that the accuracy and completeness of such information is not guaranteed. Forecasts and other forward-looking information obtained from these sources are subject to the same qualifications and uncertainties as the other forward-looking statements in this presentation.
This presentation contains excerpts of testimonials from individuals who have been treated with compounds or derivatives of the compounds underlying our product candidates in the context of third-party studies or otherwise that are solely intended to be illustrative and not representative of the potential for beneficial results of such compounds. Our product candidates are in preclinical or clinical stages of development and none of our product candidates have been approved by the FDA or any other regulatory agency.
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Highlights
03
atai Life Sciences: Healing mental health disorders so that everyone everywhere can live a more fulfilled life
1 | Mental health disorders are one of the largest global health burdens; in 2019, 1 in every 8 people, or approx. 1 |
billion people around the world, were living with a mental disorder.1 |
2 | atai's objective is to enable mental health patients to achieve clinically meaningful and sustained behavioral |
change through developing innovative, rapid-acting and durable therapeutics. |
3 | Eight clinical-stage psychedelic and non-psychedelic programs and strategic investments, each with a |
robust package of prior clinical evidence. | |
4 | Validated operating model and ability to capture value: IPO of COMPASS Pathways in 2020 and |
licensing deal between Otsuka and atai subsidiary Perception Neuroscience in 2021. | |
5 | Cash, marketable securities, and committed term loan funding expected to provide runway into 2026.2 |
- World Health Organization
- Committed term loan funding includes $45M of additional capital that can be drawn not subject to milestones under the facility with Hercules Capital; marketable securities includes money market funds, U.S. Treasury securities, commercial paper, corporate notes/bonds, U.S. government agencies securities, and public equities
Drug Development Programs and Strategic Investments
Our strategy will be delivered through a robust portfolio of psychedelic and non- psychedelic drug development programs and strategic investments
Programs / Investments | Primary Indication | Preclin | Phase 1 | Phase 2 | Phase 3 | |||||
PSYCHEDELIC PROGRAMS & STRATEGIC INVESTMENTS
COMP3601 / Psilocybin | Treatment-Resistant Depression |
BPL-0032 /5-MEO-DMT | Treatment-Resistant Depression |
VLS-01 / DMT | Treatment-Resistant Depression |
ELE-1012 / Psilocin | Major Depressive Disorder |
IBX-210 / Ibogaine | Opioid Use Disorder |
EMP-01 /R-MDMA | Undisclosed |
EGX-A & EGX-B / Novel 5-HT2A Receptor Agonists | Undisclosed |
NON-PSYCHEDELICPROGRAMS
RL-007 /Pro-cognitive neuromodulator3 | Cognitive Impairment Associated | |||
with Schizophrenia | ||||
GRX-917 / Deuterated etifoxine | Generalized Anxiety Disorder | |||
1 Strategic Investment in Compass Pathways | 3 RL-007 compound is (2R, 3S)-2-amino-3-hydroxy-3-pyridin-4-yl1-pyrrolidin-1-yl-propan-1-one(L)-(+) tartrate salts | Strategic Investment | ||
2 Strategic Investment in Beckley PsyTech | ||||
Upcoming Catalysts
05
We expect to deliver several meaningful R&D milestones anticipated across our key programs and strategic investments through 2024 and 20251
Achieved and expected milestones1
(2024-25)
H1'24
o VLSPh 1b-01first participant dosed
o BPL-003
Ph 2a OL (TRD) Part 1 data
-
ELE-101
Ph 1/2a OL (MDD) initial data
o COMP360Ph 2 (PTSD) data (Spring '24)
1. All dates provided are as estimated
H2'24
-
VLS-01
Ph 1b topline data
- BPL-003
Ph 2a OL (AUD) data (mid'24)
- COMP360
Ph 3 (TRD) Pivotal Trial 1 topline data
- BPL-003
Ph 2b (TRD) patient recruitment completed
- IBX-210
Ph 1/2a initiation
- VLS-01
Ph 2 initiation (around YE'24)
2025
-
RL-007
Ph 2b (CIAS) topline data (mid'25)
- COMP360
Ph 3 (TRD) Pivotal Trial 2 topline data (mid'25)
06
Programs in
Depression
BPL-003,VLS-01, COMP360, ELE-101
atai's Depression Portfolio Comparison
07
A diverse portfolio of differentiated psychedelic assets to address the heterogeneity of patients who suffer from depression
Route of | Receptor binding affinity | Rapid Onset | Appr. | |||||||||
Associated | Primary | of Treatment | Duration | |||||||||
Program | Compound | Indication | Administration | (5-HT2A :5-HT1A )1 | Effect | in clinic | ||||||
BPL-003 5-MeO-DMT | TRD | Intranasal | 0.01 | ~2h |
VLS-01 | DMT | TRD | Oral | 3.4 | ~2h |
transmucosal film | |||||
COMP360 Psilocybin2 | TRD | Oral | 2.0 | ~6h |
ELE-101 | Psilocin | MDD | Intravenous | 2.0 | ~2h |
1 Besnard et al. 2012 // 2 Psilocybin is not present in the body in meaningful concentrations after oral consumption // Abbreviations: TRD = Treatment Resistant Depression; MDD = Major Depressive Disorder
Commercial Positioning
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atai's focus is on psychedelics with the potential to leverage the 2-hour interventional psychiatry treatment paradigm successfully established by Spravato®
Anticipated hours in-clinic1
Anticipated in-clinic time based on duration of subjective effects1
(in hours) Illustrative
12
~8 to 12
8 | ~6 to 8 | |
~2 to 6* | ~6 | |
4 | ||
~2 | ~2 |
0 | |||
Spravato® BPL-003 | Multi-dose Psilocybin MDMA | LSD | |
/ VLS-01 | 5-MeO- + analogs | ||
/ ELE-101 | DMT |
1
2
3
Key Takeaways
BPL-003,VLS-01 and ELE-101 have the potential in depression to offer a predictable, single-dose model administered within the 2-hour in-clinictreatment paradigm established by Spravato®
We anticipate this facilitates more scalable adoption and allows clinics to accommodate a greater number of patients daily, compared to psychedelics with longer duration subjective effects
This may ultimately drive improved patient convenience and treatment access in the >4,000 certified delivery clinics2 for Spravato® with proven reimbursement and logistics pathways
- Subject to further validation through future clinical studies and real-world evidence
- https://www.spravatohcp.com/#find-a-center
- If multi-dose required
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BPL-003
(5-MeO-DMT) for TRD & AUD
Strategic Investment into Beckley Psytech
BPL-003: Phase 1 Results
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Beckley Psytech's BPL-003 had a favorable safety profile and was well tolerated in the Phase 1 SAD study, with no observed serious or severe adverse events
BPL-003 Phase 1 Treatment-Emergent Adverse Events (TEAEs)1
Placebo | BPL-003 dose (N=31) | Total | |||||||||
1 mg | 2.5 mg | 4mg | 6 mg | 8 mg | 10mg | 12 mg | |||||
N=13 | N=44 | ||||||||||
N=4 | N=4 | N=4 | N=4 | N=5 | N=5 | N=5 | |||||
Any TEAEs | 2 | 1 | 1 | 4 | 3 | 4 | 2 | 4 | 21 | ||
Nasal discomfort | 1 | 2 | 2 | 2 | 3 | 10 | |||||
Nausea | 2 | 1 | 2 | 1 | 1 | 7 | |||||
Vomiting | 2 | 1 | 2 | 5 | |||||||
Headache | 1 | 1 | 2 | 4 | |||||||
Administration | 1 | 1 | 2 | ||||||||
site pain | |||||||||||
Chest discomfort | 1 | 1 | |||||||||
Dizziness | 1 | 1 | |||||||||
Pyrexia | 1 | 1 | |||||||||
Gastroenteritis | 1 | 1 | |||||||||
Back pain | 1 | 1 | |||||||||
Hypoesthesia | 1 | 1 | |||||||||
Limb discomfort | 1 | 1 | |||||||||
Tremor | 1 | 1 | |||||||||
Lacrimation | 1 | 1 | |||||||||
Increased | |||||||||||
Restlessness | 1 | 1 | |||||||||
1 n = number of subjects reporting at least one TEAE in that category, % - rounded proportion of cohort total
Key Takeaways
There were no severe or serious adverse events
1 observed, and 89.5% TEAEs were mild and
10.5% were moderate in severity.
Most common TEAEs (>10%) were nasal
2 discomfort, nausea, vomiting, and headache. TEAEs did not appear to correlate with dose.
There were no clinically significant findings for
3 laboratory parameters, vital signs, ECGs or physical examinations.
Blood pressure and heart rate increases were
4 transient and resolved within 90 min without intervention. None were considered clinically significant.
5 | Results from the C-SSRS showed participants |
experienced no increase in suicidal thoughts, | |
intentions or behavior. |
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ATAI Life Sciences NV published this content on 05 June 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 05 June 2024 12:13:05 UTC.