Atai Life Sciences Q1 2023 Results, Pipeline Update On DMT And Psilocybin Clinical Trials

Clinical-stage biopharma company atai Life Sciences ATAI reported the financial results for its first quarter ended March 31, 2023, and provided the period’s business highlights.

Consolidated quarterly financials:

• Cash, cash equivalents and short-term investments of a total $249.9 million as of March 31, 2023, compared to $273.1 million in Dec. 31, 2022.

• Net loss of $33.1 million, compared to $36.9 million for the same period in 2022.

• R&D expenses of $19.3 million, compared to $15.5 million for the same prior year period.

• G&A expenses of $14.0 million compared to $18.0 million for the same prior year period.

The company expects its current cash position and committed term loan funding will fund operations into the first half of 2026.

Atai’s clinical pipeline, consisting of six lead drug candidates of which four are psychedelic, has seen some movement over the year’s first quarter:

• Parts 1 (intravenous or IV) and 2 (oral transmucosal film or OTF formulation) of the ongoing Phase 1 trial on DMT drug VLS-01 for Treatment-Resistant Depression (TRD) were completed, with the drug being well-tolerated and holding a favorable safety profile, and now moving on to a Part 3 following an amendment to protocol toward further optimizing PK and PD of atai’s proprietary OTF formulation. Additional clinical data is expected around the third quarter of 2023.

• Partner COMPASS Pathways’ CMPS synthetic psilocybin COMP360 for TRD, anorexia nervosa and PTSD is advancing through the Phase 3 program specifically for TRD, with upcoming topline results sooner than expected, starting in the summer of 2024.

• Phase 2b trial on 20mg and 40mg of RL-007, a pro-cognitive neuromodulator for Cognitive Impairment Associated with Schizophrenia (CIAS), has dosed the first patient. Topline results are expected in the second half of 2024.

• GRX-917, or deuterated etifoxine for anxiety disorders, showed positive outcomes in healthy volunteers earlier in January, being well-tolerated with no dose-limiting toxicities and sedation and an improved PK profile compared to non-deuterated etifoxine and demonstrated PD evidence of GABA receptor target engagement. A Phase 2 study in patients with anxiety disorder is expected soon.

• Photo: Benzinga edit with photo by Pexels.