atai Life Sciences Provides First Quarter 2024 Financial Results and Company Updates

May 15, 2024 by No Comments

First participant dosed in Phase 1b trial of VLS-01 with data expected in 2H’24; Phase 2 study in TRD patients anticipated to initiate around YE’24Beckley Psytech’s Phase 2a study of BPL-003 in TRD patients showed rapid and durable antidepressant effects; Phase 2b topline data expected in 2H’24Compass Pathways’ Phase 2 study of COMP360 in PTSD patients demonstrated durable improvement in symptoms; Phase 3 data of COMP360 in TRD patients expected in 4Q’24 Co-Founder Florian Brand to step down as CEO as part of a planned transition by YE’24 and to be succeeded by Co-Founder and current Chief Scientific Officer Srinivas Rao, M.D., Ph.D. Cash, marketable securities, and committed term loan funding expected to fund operations into 2026 NEW YORK and BERLIN, May 15, 2024 — (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced first quarter 2024 financial results, provided corporate updates and announced a transition in its leadership. Florian Brand (“Mr. Brand”), Co-Founder and current CEO, will step down as CEO by the end of this year. Co-Founder Srinivas Rao, M.D., Ph.D. (“Dr. Rao”), currently the Chief Scientific Officer, will be promoted to Co-CEO effective June 1, 2024 and intends to assume the role of CEO by the end of the year subject to appointment as required by local law. “I co-founded atai in 2018 with the bold mission to transform mental health care, and I am immensely proud of our accomplishments and continuous progress made across our R&D programs over the last six years. To that end, looking at the recent months, we have achieved many clinical milestones, with dosing in our VLS-01 Phase 1b program well underway and encouraging Phase 2 data readouts from both BPL-003 and COMP360,” said Mr. Brand. “As I prepare to turn my focus to new entrepreneurial ventures in other areas of significant unmet medical needs, I am confident in passing the torch to my Co-Founder Srini by year-end. His exceptional leadership and deep expertise in neuropsychiatric drug development have been pivotal to our success, and I am delighted that he will be leading atai into its next phase, where his experience in late stage clinical development will be especially relevant and impactful.” Dr. Rao brings over 24 years of knowledge and experience from diverse biotechnology and pharmaceutical roles, having held the titles of Chief Scientific, Medical, or Executive Officer at companies ranging from venture-backed startups to vertically integrated, publicly traded pharmaceutical companies. “It is an honor to follow in the footsteps of my dear friend and Co-Founder, Florian. I am deeply grateful for the opportunity to continue to work with him as Co-CEOs until the end of the year and build upon our shared vision, ensuring atai’s continued success in addressing challenging mental health conditions,” said Dr. Rao. “In the near-term this year, I look forward to several data milestones, including the Phase 2b readout of BPL-003 in TRD, Phase 3 data of COMP360 in TRD and the VLS-01 Phase 1b readout.” Founder and Chairman Christian Angermayer commented: “Since its inception in 2018, atai has been at the forefront of mental health innovation, driven by a commitment to deliver ground-breaking therapies to those in need, with a special focus on psychedelic substances. Florian successfully led the company from its early days through numerous R&D, business development and financing milestones, including an IPO in 2021. Florian’s leadership and execution focus have been foundational to the success of atai. We look forward to seeing the new heights he will achieve. As Florian transitions, we are deeply grateful for the enduring impact he made on our company, and while he will leave as CEO at the end of this year, he will always be part of the atai family and our success story. With his extensive experience in late stage drug development, Srini has the right profile and skillset to lead atai into its next evolutionary phase.” Corporate Updates Florian Brand, Co-Founder and current CEO of atai, will assume the role of Co-CEO effective June 1, 2024 and will step down as CEO by the end of this year.Co-Founder Srinivas Rao, currently the Chief Scientific Officer of atai, will be promoted to Co-CEO effective June 1, 2024, and intends to assume the role of CEO by the end of the year subject to appointment as required by local law. Clinical Highlights VLS-01: N,N-dimethyltryptamine (DMT) for Treatment-Resistant Depression (TRD) VLS-01 is an oral transmucosal film (OTF) formulation of DMT designed to fit within the two-hour in-clinic treatment paradigm successfully established by Spravato®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.Results of the Phase 1b study are anticipated in 2H 2024.The Company plans to initiate a randomized, placebo-controlled Phase 2 trial of VLS-01 in TRD patients around YE’24. BPL-003: 5-MeO-DMT for TRD as primary indication Beckley Psytech’s BPL-003 is an intranasal formulation of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) designed to fit within an approximately two hour in-clinic treatment paradigm.In March 2024, Part 1 of a Phase 2a open-label (OL) 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. Acute effects resolved on average in less than two hours, and BPL-003 was found to be well-tolerated, with no serious adverse events reported.In April 2024, Part 2 of the Phase 2a OL study initiated to investigate BPL-003 as an adjunctive therapy to Selective Serotonin Reuptake Inhibitors in TRD patients.A randomized, controlled Phase 2b study of BPL-003 in TRD patients is underway with topline data expected in 2H 2024. COMP360: Psilocybin Therapy for TRD as primary indication Compass Pathways’ COMP360 is an oral formulation of synthetic psilocybin that is currently being evaluated in multiple clinical studies.In May 2024, results from an OL Phase 2 study in 22 patients with PTSD showed that COMP360 met its primary safety endpoint and was well tolerated, with no serious adverse events. COMP360 demonstrated a rapid and durable improvement in PTSD symptoms. Week 4 and 12 reductions in the CAPS-5 total score of 29.9 and 29.5, respectively, were observed.The response rate, as defined by patients experiencing a ≥ 15-point improvement on CAPS-5 score, was 81.8% at week 4 and 77.3% at week 12.The remission rate, as defined by CAPS-5 total score of ≤ 20, was 63.6% at week 4 and 54.5% at week 12. The Phase 3 program of COMP360 in TRD patients is composed of two pivotal trials, each with a long-term follow-up component. Pivotal Trial 1 (COMP005) topline data is expected in the fourth quarter of 2024 and Pivotal Trial 2 (COMP006) topline data is anticipated mid-2025. Upcoming R&D Catalysts 1H’24 ELE-101 MDD Phase 1/2a initial data 2H’24 VLS-01 Phase 1b topline data