atai Life Sciences Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate and Clinical Highlights
- Strategic investment in Beckley Psytech to enhance psychedelic therapy development
- Positive Phase 2a results for BPL-003 in TRD patients with rapid and lasting effects
- Commencement of dosing for VLS-01 in a Phase 1b study for TRD
- Financially stable with funding anticipated to support operations until 2026
- None.
Insights
The strategic investment in Beckley Psytech by atai Life Sciences represents a significant move within the biopharmaceutical industry, particularly in the burgeoning field of psychedelic-based therapies. The investment highlights a trend towards therapies that can be administered within a short time frame in a clinical setting, which could lead to increased patient throughput and potentially lower costs for healthcare providers. The focus on treatment-resistant depression (TRD) is noteworthy given the high unmet need in mental health care and the potential market size. The financial commitment, with operations funded into 2026, indicates a robust runway for atai, which is reassuring to investors concerned about the burn rate typical of clinical-stage companies.
From a financial perspective, the decrease in R&D and G&A expenses suggests effective cost management, although it's important to consider whether this could impact the pace or quality of clinical trials. The net loss reduction is a positive sign, but it's essential to monitor how these savings are achieved and how they correlate with the progress of the clinical programs. The cash position and the strategic investment in Beckley Psytech may provide atai with leverage in future negotiations and collaborations, potentially enhancing shareholder value.
atai Life Sciences' investment in Beckley Psytech and the progress of its clinical programs, including BPL-003 and VLS-01, are significant for the field of mental health treatment. The reported efficacy of BPL-003 in TRD patients, with 45% in remission after three months, is promising considering the challenge of treating this patient population. The safety profile, with no serious adverse events, is also notable. The controlled Phase 2b study's outcomes will be critical in validating these findings and could have a substantial impact on the company's valuation and the future of psychedelic-based therapies.
The initiation of the Phase 1b study of VLS-01, with an optimized formulation for improved pharmacokinetics, suggests a strategic focus on enhancing patient experience, which is important for the adoption of these treatments. The Phase 2 trial anticipation for both BPL-003 and VLS-01 in TRD, along with the ongoing COMP360 Phase 3 program, positions atai as a leader in this novel therapeutic area. The implications for patients with TRD could be far-reaching if these treatments prove to be effective and manageable within the clinical setting.
The investment and clinical advancements reported by atai Life Sciences indicate a strategic positioning within the mental health treatment market. The emphasis on in-clinic, short-duration treatments aligns with current healthcare trends towards outpatient care and could open up new market segments. The potential scalability of these therapies, if successful, could disrupt the current treatment paradigm for mental health disorders, particularly for TRD which has a significant patient population that is not well-served by existing treatments.
Investor sentiment is likely to be influenced by the top-line results from the Phase 2b TRD study expected in the second half of 2024, as well as the results from other ongoing trials. Positive outcomes could lead to increased investor confidence and a reevaluation of atai's market potential. The company's cash position and expected operational funding into 2026 provide a buffer against market volatility and R&D investment risks. However, the success of atai's strategic investments and clinical outcomes will ultimately determine the long-term impact on the company's stock performance and market share within the mental health sector.
- Strategic investment in Beckley Psytech to accelerate the development of psychedelic-based therapies that fit within the two hour in-clinic treatment paradigm established by Spravato®
- Initial BPL-003 (intranasal 5-MeO-DMT) Phase 2a open-label results demonstrated a rapid and durable antidepressant effect through three months in TRD patients; top-line results from a controlled Phase 2b TRD study anticipated in 2H 2024
- Dosing commenced in VLS-01 (oral transmucosal DMT) Phase 1b study, with optimized formulation designed to improve pharmacokinetics and patient experience ahead of anticipated Phase 2 trial in TRD
- Cash, marketable securities, and committed term loan funding expected to fund operations into 2026
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
- In January 2024, atai made a strategic investment in Beckley Psytech, a private clinical-stage biotechnology company. The transaction added two clinical-stage assets, BPL-003 and ELE-101 to atai’s programs. Atai owns
35.5% of Beckley Psytech and holds a time-limited right of first refusal on a future sale of the company, asset sales or other transfer of commercial rights, as well as an indefinite right of first negotiation for BPL-003 and ELE-101. - In November 2023, atai acquired all remaining outstanding shares of its subsidiary, DemeRx IB, Inc., streamlining clinical, general and administrative operations.
- atai realized operational efficiencies by simplifying and optimizing its organizational structure in line with its revised business and pipeline priorities.
Clinical Highlights
BPL-003: 5-MeO-DMT for Treatment-Resistant Depression (TRD)
- BPL-003 is an intranasal formulation of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) designed to fit within a two hour in-clinic treatment paradigm.
- In March 2024, a Phase 2a open-label study showed that a single administration of BPL-003 resulted in rapid and durable antidepressant effects, with
45% of patients in remission three months after dosing. The acute effects of BPL-003 resolved on average in less than two hours, and it was found to be safe and well-tolerated in this trial population, with no serious adverse events (SAEs) reported. - A controlled Phase 2b study of BPL-003 in 225 TRD patients is underway across multiple sites, including the United States, Australia and Europe, with topline data expected in 2H 2024.
- Data from a Phase 2a open-label study in Alcohol Use Disorder patients is expected mid-2024.
VLS-01: N,N-dimethyltryptamine (DMT) for TRD
- VLS-01 is an oral transmucosal film (OTF) formulation of DMT designed to fit within a two-hour treatment paradigm.
- In March 2024, we announced the initiation of dosing in a Phase 1b study that is designed to evaluate the relative safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of an optimized OTF formulation of VLS-01, compared to intravenous (IV) DMT.
- The optimized formulation is designed to improve the PK and the patient and provider experience ahead of moving into an anticipated Phase 2 trial in TRD.
- Results of the Phase 1b trial are anticipated in 2H 2024.
ELE-101: Psilocin for Major Depressive Disorder (MDD)
- ELE-101 is an IV formulation of psilocin, the active moiety of psilocybin.
- ELE-101 has the potential to offer the therapeutic benefits of psilocybin in a more consistent, controllable, and shorter treatment paradigm of approx. 2 hours.
- Initial results from the ELE-01 Phase 1/2a study are anticipated in H1 2024.
COMP360: Psilocybin Therapy for TRD
- COMP360 is a formulation of synthetic psilocybin.
- COMP360 is currently being evaluated in a Phase 3 program in TRD patients composed of two pivotal trials, each of which will have a long-term follow-up component.
- Pivotal Trial 1 (COMP005) top-line data is expected in the fourth quarter of 2024 and Pivotal Trial 2 (COMP006) top-line data is anticipated mid-2025.
- Phase 2 open-label efficacy data in PTSD is expected in Spring 2024.
IBX-210: Ibogaine for Opioid Use Disorder (OUD)
- IBX-210 is an IV formulation of semi-synthetic ibogaine.
- In August 2023, the Phase 1 study results demonstrated that 9 mg/kg of oral ibogaine leads to robust psychedelic experiences. However, a high degree of inter-individual PK variability and significant QT prolongation were noted across all doses. While deemed to be clinically manageable, both factors have the potential to increase site burden and limit scalability.
- atai has developed a novel IV formulation of ibogaine. The objective is to improve safety, reduce PK variability and achieve a shorter and more predictable in-clinic time.
- A Phase 1/2a study of IBX-210 for the treatment of OUD is anticipated to initiate in the second half of this year.
RL-007: Pro-Cognitive Neuromodulator for Cognitive Impairment Associated with Schizophrenia (CIAS)
- RL-007 is an orally bioavailable compound that has demonstrated pro-cognitive effects in multiple pre-clinical and clinical studies, including two Phase 1 and two Phase 2 trials.
- The ongoing Phase 2b study will evaluate 20mg and 40mg of RL-007 vs. placebo in patients living with CIAS. Topline results are expected mid-2025.
- The Company will deliver a presentation at the 2024 Congress of the Schizophrenia International Research Society in Florence (Italy) on April 4, 2024 from 10:00 AM – 12:00 PM CET.
Consolidated Financial Results
Cash, cash equivalents, and short-term investments: Cash and cash equivalents and short-term investments were
Research and development (R&D) expenses: R&D expenses were
General and administrative (G&A) expenses: G&A expenses for the three and twelve months ended December 31, 2023 were
Net loss: Net loss attributable to shareholders for the three and twelve months ended December 31, 2023 was
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 | |||
FAQ
What is the strategic investment made by ATAI?
What were the results of the Phase 2a study for BPL-003 in TRD patients?
Which study has dosing commenced for VLS-01?
How long is the funding expected to last for ATAI?
