Company Overview - March 2024
02
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.
Any trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construed as an endorsement of the products or services of the Company.
Highlights
03
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
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.
Eight clinical-stage psychedelic and non-psychedelic programs and strategic investments, each with a robust package of prior clinical evidence.
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.
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
04
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 |
DMX-1002 / Ibogaine | Opioid Use Disorder |
VLS-01 / DMT | Treatment-Resistant Depression |
ELE-1012 / Psilocin | Major Depressive Disorder |
EMP-01 /R-MDMA | Post-Traumatic Stress Disorder & others |
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 |
atai Life Sciences: Operational Focus & Program Guidance
05
PSYCHEDELIC PROGRAMS & STRATEGIC INVESTMENTS
NON-PSYCHEDELICPROGRAMS
COMP3601
(Psilocybin)
✓❑ Successful outcome of Ph 2b trial in TRD
- Ph 2 (PTSD) - data Spring '24
-
Ph 3 (TRD) - Pivotal Trial 1 topline data 4Q
'24 - Ph 3 (TRD) - Pivotal Trial 2 topline data mid-
'25
BPL-0032
(5-MEO-DMT)
✓❑ Successful outcome of Ph 1 trial
- Ph 2a OL (TRD) data in 1H'24
- Ph 2a OL (AUD) data in mid-'24
- Ph 2b (TRD) data in 2H'24
VLS-01
(DMT)
✓❑ Initial Ph 1 results in 2Q'23
✓❑ Additional Ph 1 data in 3Q'23
❑✓ Ph 1b first participant
dosed in 1H'24
- Ph 1b topline results in 2H'24
DMX-1002
(Ibogaine)
✓❑ Initial Phase 1
results in 3Q '23
- Submit FDA meeting request in 1H'24
ELE-1012
(Psilocin)
- Ph 1/2a OL (MDD) - data in 1H'24
EMP-01
(R-MDMA)
✓❑ Ph 1 trial initiated in 3Q'22
✓❑ Ph 1 results in 4Q '23
RL-007
(Pro-Cognitive
Neuromodulator)
✓❑ Successful outcome of Ph 2a trial in CIAS
✓❑ Ph 2b first patient dosed in
1Q'23
- Topline Ph 2b data mid-'25
GRX-917
(Deuterated
etifoxine)
✓❑ Ph 1 topline results in 1Q'23
✓❑ Late breaking presentation at 2023 SOBP annual meeting
1 Strategic Investment in Compass Pathways | Abbreviations: PTSD = Post-Traumatic Stress Disorder; CIAS = Cognitive Impairment Associated with Schizophrenia; | Strategic Investment | ||
2 | Strategic Investment in Beckley PsyTech | TRD = Treatment Resistant Depression; AUD = Alcohol Use Disorder; MDD = Major Depressive Disorder | ||
3 | All dates provided are as estimated |
06
atai's Depression Portfolio Comparison
07
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 | ~6 h |
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
08
BPL-003: Intranasal 5-MeO-DMT
09
(ng/ml) | 12mg (n=5) |
10mg (n=5) | |
levels | |
8mg (n=5) | |
concentration | 6mg (n=4) |
4mg (n=4) | |
2.5mg (n=4) | |
1mg (n=4) | |
Mean plasma | |
Time post-dose (minutes)
(SDI) | 12mg (n=5) |
10mg (n=5) | |
intensity | |
8mg (n=5) | |
6mg (n=4) | |
Mean subjective drug | |
Time post-dose (minutes)
Safety
- All adverse events (AEs) were mild (89.5%) or moderate (10.5%); no Serious AEs occurred
- Most common AEs (>10%) : nasal discomfort, nausea, vomiting, and headache
Pharmacokinetics (PK)
- Exposure was dose-proportionate
- Rapid onset: mean Tmax of 6-17 min
- Short duration: mean t1/2 of 15-30 min
Pharmacodynamics (PD)
- Subjects were psychedelic naive
- All subjects on doses ≥6mg achieved intensity scores ≥7
- Perceptual effects generally fully resolved within 60 - 90 mins
Abbreviations: SAD = Single Ascending Dose; PK = Pharmacokinetic; PD = Pharmacodynamic
BPL-003 Phase 2a Clinical Trial Design
10
Core Study (12 weeks)
Open | 10mg (n=12) | ||||||
label | |||||||
Screening | Day 2 8 | 29 | 57 | 85 | |||
- Patients with moderate-severe treatment resistant depression
- Montgomery-AsbergDepression Rating Scale (MADRS) score ≥24
- Willing and able to discontinue current antidepressants
Primary Endpoint: | |
» Safety and tolerability of BPL-003 monotherapy | |
Key Secondary Endpoints: | |
Data expected for Ph 2a (TRD) in 1H24 | |
» MADRS change at Day 2, 8, 29, 57 and 85 | |
» CGI-S, PGIC, EQ-5D | |
Abbreviations: MADRS = Montgomery-Åsberg Depression Rating Scale; CGI-S = Clinical Global Impressions-Severity; PGIC = Patient's Global Impression of Change; EQ-5D = EuroQol-5D
Attachments
- Original Link
- Original Document
- Permalink
Disclaimer
ATAI Life Sciences NV published this content on 04 March 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 04 March 2024 13:27:09 UTC.