Atai's Q2 2023 Plus Clinical Data On Ibogaine-Opioid Study, Pipeline's Psilocybin, DMT, Ketamine & MDMA

Atai Life Sciences ATAI reported its consolidated, unaudited financial results for the second quarter 2023 ended June 30. Numbers show:

• Cash, cash equivalents and short-term investments for $227.5 million, a 6-month $46.5 million operating activities disbursement considering the $273.1 million held in Dec. 31, 2022.

• Three and six-month R&D expenses of $15.5 million and $34.8 million vs. $17.9 million and $33.4 million spent in the same periods in 2022.

• Three and six-month G&A expenses of $16.6 million and $30.5 million vs. $17.2 million and $35.2 million in the same 2022 periods.

• Three and six-month net loss attributable to shareholders of $33.1 million and $66.2 million vs. $36.6 million and $73.5 million for the same 2022 periods.

Ibogaine Phase 1 Trial Results, Business & Pipeline Highlights

Management expects the current cash position and committed term loan funding will allow for the funding of operations into the first half of 2026. 

See Also: Atai Life Sciences Hopes Hercules Can Help 'Sustain' Operations Until 2026

The company’s pipeline is currently advancing 8 programs with its affiliated companies, six of which are psychedelic-based substances.

Done in conjunction with DemeRx IB, oral ibogaine DMX-1002 for the potential treatment of Opioid Use Disorder (OUD) has delivered new clinical results: 

• The small Phase 1 study on safety, tolerability and pharmacokinetics of single-ascending doses of either 3 mg/kg, 6 mg/kg and 9 mg/kg showed the 9 mg/kg dose plasma concentrations were consistent with previous studies, subjects reporting psychedelic experiences and obtaining therapeutic benefit in OUD.

• Related adverse events also reflected on prior DMX-1002 trials, 94% rated as mild-to-moderate with no serious ones reported.

• One participant who received 9 mg/kg showed QTc prolongation levels near those seen at the 10 mg/kg dose, though the patient was asymptomatic with no cardiac arrythmias and the QTc change resolved without intervention or sequelae.

• ICL Professor Emeritus and DMX-1002 program advisor cardiologist Dr. Marek Malik said the results are consistent with ibogaine’s known side-effect profile. “Ibogaine is known to cause prolongation of the electrocardiographic QT interval. Drug-induced prolongation of the QT interval is a phenomenon that has been, with many but not all drugs, associated with cardiac arrhythmias. The QT-related side effect of ibogaine is anticipated to be manageable in a controlled setting with appropriate cardiac monitoring and safety protocols.” 

• The benefit of the drug will need to be defined in further efficacy trials and weighed against the defined risks, something the company is planning on filing a regulatory assessment for soon.

Other program updates include RL-007 (pro-cognitive neuromodulator for cognitive impairment associated with schizophrenia) which would report topline Phase 2b trial results in H2 2024; VLS-01 (DMT for Treatment-Resistant Depression) already showing promising Phase 1 results and of which additional data is expected Q3 2023; PCN-101’s (R-Ketamine also for TRD) fresh Phase 1 results; EMP-01 (MDMA derivative for PTSD) and its soon-to-commence Phase 1 trial which would report initial data in Q4 2023; and COMPASS Pathways' CMPS COMP360 (psilocybin therapy for TRD, anorexia nervosa and PTSD), with Phase 3 program’s long-term topline data expected by summer 2024.

CEO Florian Brand says the team is “especially encouraged” by the progress of the ongoing trials on RL-007 and VLS-01, and CSO Srinivas Rao sees DMX-1002’s potential to become “a disease modifying treatment for this vulnerable patient population seeking to end their intractable cycle of drug dependence.”

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