Atai Life Sciences' Q3 Earnings: Near $20M Burned QoQ, Says Funding 'Sufficient' To Streamline 2026

Clinical-stage psychedelics company atai Life Sciences ATAI reported its financial results and corporate updates for the third quarter ended September 30, 2023. 

In numbers:

• Cash, cash equivalents and short-term investments totaled $209.0 million as of Sept. 30, compared to last quarter’s $227.5 million held (ended June 30, 2023) and the $273.1 million held by Dec. 31, 2022.

See full Q2 results.

• Three and nine months R&D expenses of $13.3 million and $48.0 million, vs. $19.0 million and $52.5 million in the same respective periods in 2022.

• Three and nine months G&A expenses of $13.6 million and $44.2 million, vs. $19.4 million and $54.7 million in the same respective periods in 2022.

• Three-month net income loss attributable to shareholders of $44.2 million, vs. $33.9 million in the same period in 2022.

• Long-term debt of $14.96 million by Sept. 30, vs. $14.7 million by Dec. 31, 2022.

The nine-month cash decrease of $64.1 million was mainly due to the $62.2 million net used in operating activities, plus a $5.2 million of funding in strategic investments. 

Still, the company stated it expects its current ”strong” cash position, together with a committed term loan funding, will be sufficient to fund operations into the first half of 2026

CEO and co-founder Florian Brand says the team remains “highly focused” on pioneering the development of novel neuropsychiatric therapies for the growing burden of unmet medical needs in mental health care.

Pipeline News

• Phase 2b study of RL-007, a pro-cognitive neuromodulator for Cognitive Impairment Associated with Schizophrenia, remains “on track.” Topline data is expected for H2 2024.

• Phase 1 study of EMP-01, an oral MDMA derivative targeting PTSD, is anticipated to report data within 2023.

• Phase 1 study data of VLS-01, a new oral transmucosal film formulation of DMT targeting Treatment-Resistant Depression (TRD,) was well tolerated and held a favorable safety profile, further demonstrating that 160mg reached exposure levels comparable to 30mg of intravenous DMT. Preparations underway for a Phase 2 trial in TRD include further optimizations like taste masking, an intrinsic backing layer, and enhancements to increase permeability. A Phase 1b healthy volunteer study was approved and the first participant will be enrolled in H1 2024.

• Phase 1 study data of DMX-1002, an oral formulation of ibogaine targeting Opioid Use Disorder (OUD,) showed 9 mg/kg achieved plasma concentrations and psychedelic experiences, as well as treatment-related adverse events (all mild-to-moderate in severity) and side effects, “consistent with previous studies of Ibogaine.” These results would enable discussions with regulatory authorities toward progressing into a Phase 2a proof-of-concept study in OUD. 

In November 2023 atai acquired all remaining outstanding shares of its subsidiary DemeRx IB Inc., converting DMX-1002 into a wholly-owned atai asset.

• EGX-A and EGX-B, two lead novel 5-HT2A receptor agonists from atai’s internal drug discovery engine, are reportedly “psychedelic-like” with “novel, non-tryptamine structures with differentiated 5-HT receptor pharmacology.” The company will present them at two upcoming scientific events.

• COMP360's partner COMPASS Pathways’ CMPS synthetic psilocybin targeting TRD, PTSD and anorexia nervosa is currently undergoing a major Phase 3 program in TRD patients with topline data expected in summer 2024 and mid-2025; a Phase 2 study for PTSD with topline data expected by end-2023, and a Phase 2 study in anorexia nervosa underway.

• Photo: Benzinga edit with photo by Bacsica, aiyoshi597, Gisele Yashar and metamorworks on Shutterstock.