Seelos Therapeutics Positive Q1 Financials Make For 'The Most Important Year' In Company's History

Clinical-stage biopharma company Seelos Therapeutics Inc. SEEL reported financial results and clinical updates corresponding to the first quarter ended March 31, 2023.

Quarterly numbers show:

• Total cash and cash equivalents of $14.1 million as of March 31, 2023, compared to the $15.5 million held in Dec. 31, 2022.

• R&D expenses totaled $5.7 million compared to $10.0 million in the same period in 2022.

• G&A expenses of $4.1 million compared to $4.0 million in 2022’s same period, plus other expenses of $4.5 million as compared to income of $9,000 in 2022’s same period.

• Net loss of $13.4 million or $0.12 per basic and diluted share, compared to $14.0 million or $0.13 per basic and diluted share for the same period in 2022.

• Net revenue of $808,000 compared to zero during the same period in 2022, reportedly attributed to a federal research grant from Mass General Brigham Research Management under the Expanded Access Program.

Pipeline Update And Yearly Outlook

The company’s assets portfolio includes two psychedelic-based compounds and several non-psychedelic ones.

During this year’s first quarter, two programs saw clinical advancement:

• Proprietary intranasal racemic ketamine SLS-002, currently under study for Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD,) expects to complete patient enrollment by the end of June and release topline study data during the third quarter of 2023.

• SLS-005 (IV trehalose) for Amyotrophic Lateral Sclerosis (ALS) is advancing a Phase 2/3 trial led by Harvard Medical School at MGH, with enrollment completion in February and topline data expected in the fourth quarter. In March, the company temporarily paused additional enrollment in the study on Spinocerebellar Ataxia type 3 (SCA3) following financial considerations, and in April it announced it has dosed the first patient in an Expanded Access Program fully funded by NINDS for patients with ALS who do not qualify for existing clinical trials.

Chairman and CEO Dr. Raj Mehra called 2023 "the most important year in Seelos' history” thus far: “Our experienced team feels confident that the design and execution of this trial will allow SLS-002 to demonstrate its true potential of efficacy, safety, and tolerability in patients with MDD at imminent risk of suicide. We strongly believe that this therapeutic, if successful, may help the large number of people with suicidal ideation globally."

Mehra further highlighted the completion of enrollment of the SLS-005 study in ALS and upcoming topline Phase 2/3 data later this year, as well as the R&D team’s efforts on putting forth the company’s first internally-created gene therapy program, SLS-009, “focusing on one-time treatment of neurodegenerative disorders such as Huntington's disease, by permanently activating the autophagy-lysosomal pathways."

Photo: Benzinga edit with photo by Zita and canadastock on Shutterstock.