Seelos has Big Hopes in 2023 for Ketamine Drug

CEO: "2023 is the most important year in Seelos' history thus far."

Before the markets opened on Monday, Seelos Therapeutics Inc. (Nasdaq: SEEL) provided a clinical update and reported its financial results for the first quarter ending March 31. Net revenue for the quarter was $808,000 versus last year’s net revenue of zero.

The revenue was mostly due to a grant from Mass General Brigham Research Management under the Expanded Access Program, which is funded by a grant from the national Institute of Neurological Disorders and Stroke.

Net loss for the quarter was ($13.4) million, or ($0.12) per basic and diluted share versus a net loss of ($14.0) million, or ($0.13) per basic and diluted share for the same period in 2022. Total operating expenses for the quarter were $8.9 million.

As of March 31, total cash and cash equivalents were $14.1 million, a decrease of $1.5 million compared to $15.5 million as of Dec. 31, 2022. The company has an accumulated deficit of $228.2 million.

“2023 is the most important year in Seelos’ history thus far. Our team has been diligently working to complete the registration directed study of our intranasal ketamine program, SLS-002, and we have notified our trial sites that enrollment will conclude by the end of June 2023. We expect to release top-line data in the third quarter of 2023,” said Raj Mehra, chairman and CEO.

“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 also highlighted the completion of enrollment for the company’s ALS study of SLS-005, with data expected from the Phase II/III student in late 2023.

Seelos’ R&D team also internally created SLS-009, a gene therapy focused on the “one-time treatment of neurodegenerative disorders, such as Huntington’s disease, by permanently activating the autophagy-lysosomal pathways,” Mehra said.

Nasdaq Pressures

Seelos told investors in the its latest regulatory filing that it has been under the Nasdaq share price requirement of $1 per share and that if it didn’t get the price higher by May 22, 2023, it would possibly engage in a reverse stock split.

Even if it still can get the price over $1 for 10 days, the Nasdaq may give the company another 180 days to regain compliance with this requirement.

The stock was lately selling at 89 cents per share.

Pipeline

On March 29, the company announced that it planned to focus the majority of its resources on the ongoing registration directed study of SLS-002 for the potential treatment of acute suicidal ideation and behavior in patients with major depressive disorder and the fully enrolled Phase II/III study of SLS-005 in ALS.

“We further announced that we have temporarily paused additional enrollment of patients in the SLS-005-302 study in Spinocerebellar Ataxia (SCA). Patients already enrolled will continue in the study and data will continue to be collected in order to make decisions for resuming enrollment in the future. We also announced that we are pausing all non-essential preclinical work,” the company said in its filing.

The company outlined its plans as follows:

SLS-002 (intranasal racemic ketamine)

Seelos plans to complete enrollment of the registration directed, double-blind, placebo-controlled study in acute suicidal ideation and behavior (ASIB) in patients with major depressive disorder (MDD) by the end of June.

Top-line data from this study is expected to be released in the third quarter of 2023.

LS-005 (IV trehalose)

In February, Seelos completed enrollment of its registrational Phase II/III trial in ALS as part of the HEALEY ALS Platform Trial led by Harvard Medical School at Massachusetts General Hospital.

Top-line data from this study is expected to be released in the fourth quarter of 2023.

In March, Seelos temporarily paused additional enrollment of patients in the SLS-005-302 study in spinocerebellar ataxia type 3 (SCA3). Patients already enrolled will continue in the study and data will continue to be collected in order to make decisions for resuming enrollment in the future.

This temporary pause has been implemented as a business decision due to financial considerations, and is not based on any data related to safety or therapeutic effects.

In April, Seelos announced it has dosed the first patient in an expanded access program (EAP) for patients with ALS who do not qualify for existing clinical trials and that the EAP will be fully funded by a grant from the NINDS under the ACT for ALS.

SLS-004 (Parkinson’s disease gene therapy programs)

At the Annual Alzheimer’s & Parkinson’s Drug Development Summit in February, Seelos presented a poster on quantitative increase in SNpc TH+ neuronal count and neuronal density compared to control hemisphere.

Debra Borchardt

Debra Borchardt is the Co-Founder, and Executive Editor of GMR. She has covered the cannabis industry for several years at Forbes, Seeking Alpha and TheStreet. Prior to becoming a financial journalist, Debra was a Vice President at Bear Stearns where she held a Series 7 and Registered Investment Advisor license. Debra has a Master's degree in Business Journalism from New York University.


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