Ereska (ketamine intranasal) / Seelos Therap - LARVOL DELTA

Department of Defense PTSD Adaptive Platform Trial - Intervention D - SLS-002 (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Global Coalition for Adaptive Research | Initiation date: Nov 2023 ➔ Jun 2025

Trial initiation date • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

Department of Defense PTSD Adaptive Platform Trial - Intervention D - SLS-002 (clinicaltrials.gov) - P2 | N=200 | Active, not recruiting | Sponsor: Global Coalition for Adaptive Research

New P2 trial • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

Department of Defense PTSD Adaptive Platform Trial - Master Protocol (clinicaltrials.gov) - P2 | N=800 | Recruiting | Sponsor: Global Coalition for Adaptive Research | N=600 ➔ 800

Enrollment change • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

A Phase 2 Open Label Study of Efficacy, Safety, and Tolerability of SLS-002 (Intranasal Racemic Ketamine) in Adults with MDD at Imminent Risk of Suicide. (PubMed, Psychopharmacol Bull) - "Spravato® (esketamine) is approved by the FDA for use in treatment-resistant depression and Major Depressive Episodes with Suicidal Ideation based on studies conducted in adults also taking standard antidepressants. The results of this open label study support the continued development of SLS-002. The randomized double-blind placebo-controlled part two of this trial was recently completed."

Journal • P2 data • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • Suicidal Ideation

A Study of SLS-002 (Intranasal Racemic Ketamine) in Adults With Major Depressive Disorder at Imminent Risk of Suicide (clinicaltrials.gov) - P2 | N=164 | Completed | Sponsor: Seelos Therapeutics, Inc. | Recruiting ➔ Completed | N=236 ➔ 164

Enrollment change • Trial completion • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Seelos Therapeutics Announces Top Line Results from SLS-002 Phase II Study in Adults with Major Depressive Disorder at Imminent Risk of Suicide (PRNewswire) - P2 | N=236 | NCT04669665 | Sposnor: Seelos Therapeutics, Inc. | "Seelos Therapeutics, Inc...announced top line data demonstrating clinically meaningful treatment effects across multiple endpoints and a well-tolerated safety profile from the double-blind, placebo-controlled cohort (Part 2) of its Phase II study of SLS-002 (intranasal racemic ketamine) for Acute Suicidal Ideation and Behavior (ASIB) in adults with Major Depressive Disorder (MDD)....MADRS results at 4 hours after dosing demonstrated a statistically significant change relative to placebo (p <0.001, 5.9 point LS2 mean treatment difference); MADRS results at 24 hours after dosing utilizing 2-way ANCOVA3 with baseline MADRS as a covariate (the pre-defined primary endpoint/analysis) demonstrated clinically meaningful results, but did not achieve statistical significance under the methodology used (p=0.069, 3.3 point LS mean treatment difference)."

P2 data • CNS Disorders • Depression • Major Depressive Disorder

Seelos Therapeutics Announces the Close of Enrollment of its Registration Directed Study of SLS-002 (Intranasal Racemic Ketamine) for Acute Suicidal Ideation and Behavior (ASIB) in Adults with Major Depressive Disorder (MDD) (PRNewswire) - "Seelos Therapeutics...today announced the close of enrollment of its registration directed study of SLS-002 (intranasal racemic ketamine) for Acute Suicidal Ideation and Behavior (ASIB) in adults with Major Depressive Disorder (MDD)....We look forward to completing the study and sharing the results in the third quarter of 2023."

Enrollment closed • P2 data • CNS Disorders • Depression • Major Depressive Disorder

Seelos Therapeutics Provides Clinical Update and Reports First Quarter 2023 Financial Results (PRNewswire) - "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 2023. Top-line data from this study is expected to be released in the third quarter of 2023."

P2 data • CNS Disorders • Major Depressive Disorder

A Study of SLS-002 (Intranasal Racemic Ketamine) in Adults With Major Depressive Disorder at Imminent Risk of Suicide (clinicaltrials.gov) - P2 | N=236 | Recruiting | Sponsor: Seelos Therapeutics, Inc. | Trial completion date: Dec 2022 ➔ Jun 2023 | Trial primary completion date: Dec 2022 ➔ Jun 2023

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Assessing SLS-002 (Intranasal Racemic Ketamine) in Adults With Major Depressive Disorder at Imminent Risk of Suicide (clinicaltrials.gov) - P2 | N=10 | Not yet recruiting | Sponsor: Johns Hopkins University

New P2 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • Suicidal Ideation

A Study of SLS-002 (Intranasal Racemic Ketamine) in Adults With Major Depressive Disorder at Imminent Risk of Suicide (clinicaltrials.gov) - P2; N=236; Recruiting; Sponsor: Seelos Therapeutics, Inc.; N=136 ➔ 236

Clinical • Enrollment change • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Seelos Therapeutics Presents a Poster on SLS-002 (Intranasal Racemic Ketamine) at the 2021 IASR/AFSP International Summit on Suicide Research (PRNewswire) - P2, N=136; NCT04669665; Sponsor: Seelos Therapeutics; "Seelos Therapeutics...presented a poster on Part 1, the open-label portion, of the study of SLS-002 (Intranasal Racemic Ketamine) at the IASR/AFSP International Summit on Suicide Research Virtual Conference...Data from the Part 1 open-label portion of the study demonstrated a rapid, robust, and sustained improvement on all 4 scales utilized measuring depression and suicide; Data demonstrated the group mean met the MADRS responder criteria at all times points measured from 24 hours through day 29/30 of the study; Data demonstrated the group mean met the MADRS remission criteria initially at day 6 of the study."

P2 data • CNS Disorders • Depression • Major Depressive Disorder

"$SEEL Seelos Therapeutics Presents a Poster on SLS-002 (Intranasal Racemic Ketamine) at the 2021 IASR/AFSP International Summit on Suicide Research https://t.co/d2GLlksU2m" (@stock_titan)

Novel antidepressant drugs: Beyond monoamine targets. (PubMed, CNS Spectr) - "The recent approval of intranasal Esketamine (glutamatergic agent) in conjunction with an oral antidepressant for the treatment of adult TRD patients was the first step toward expanding beyond the monoamine targets. Several other glutamatergic (AXS-05, REL-1017, AV-101, SLS-002, AGN24175, and PCN-101) and GABAergic (brexanolone, zuranolone, and ganaxolone) drugs are currently in different stages of clinical development for MDD, TRD and other indications. The renaissance of psychedelic drugs and the emergence of preliminary positive clinical trial results with psilocybin, Ayahuasca, 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), and lysergic acid diethylamide (LSD) may pave the way towards establishing this class of drugs as effective therapies for MDD, TRD and other neuropsychiatric disorders. Going beyond the monoamine targets appears to be an effective strategy to develop novel antidepressant drugs with superior efficacy, safety, and tolerability for the improved..."

Journal • Review • CNS Disorders • Depression • Major Depressive Disorder • Mental Retardation • Mood Disorders • Psychiatry

Seelos Therapeutics to Present a Poster on SLS-002 (Intranasal Racemic Ketamine) at the 2021 IASR/AFSP International Summit on Suicide Research (Yahoo Finance) - "Seelos Therapeutics, Inc...announced that it has been selected to present a poster on SLS-002 (Intranasal Racemic Ketamine) at the IASR/AFSP International Summit on Suicide Research Virtual Conference, October 24-27th, 2021."

P2 data • CNS Disorders • Major Depressive Disorder • Suicidal Ideation

Seelos Therapeutics Announces Mid-Year 2021 Business and Clinical Update (PRNewswire) - "On June 15th, Seelos completed a Type C meeting with the FDA to discuss the regulatory pathway for the SLS-002 program. SLS-005 (IV trehalose): In the third quarter, Seelos is expected to commence dosing of a pivotal Phase IIb/III trial in amyotrophic lateral sclerosis (ALS) as part of the HEALEY ALS Platform Trial led by Harvard Medical School at Massachusetts General Hospital at several dozen trial sites across the U.S....Additional studies have commenced to explore efficacy of SLS-004 in the induced Parkinsonism in an in vivo rodent model."

FDA event • New P2/3 trial • Preclinical • Amyotrophic Lateral Sclerosis • CNS Disorders • Depression • Parkinson's Disease

Seelos Therapeutics Doses First Patient in Part 2 of a Registrational Study of SLS-002 (Intranasal Racemic Ketamine) for Acute Suicidal Ideation and Behavior in Patients with Major Depressive Disorder (PRNewswire) - "Subjects will be Enrolled in up to 30 Trial Sites in the North America....Seelos Therapeutics...announced dosing of the first patient in Part 2, the double-blind, placebo-controlled cohort, of its registrational Proof of Concept study of SLS-002 (intranasal racemic ketamine) for Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD)....'We received correspondence from the FDA that Part 2 will serve as a registrational study for the SLS-002 program and we will continue discussions with the FDA on the regulatory pathway going forward.'"

Trial status • CNS Disorders • Depression

Seelos Therapeutics to Participate in Two Investor Conferences in August (PRNewswire) - “Seelos Therapeutics…will participate in two investor conferences: the BTIG Virtual Biotechnology Conference on August 9th and 10th and the Canaccord Growth Conference on August 11th and 12th. Raj Mehra, Ph.D., Chairman and CEO, will present and host one on one meetings to provide a corporate update and overview of the company's programs, specifically Part 2 of the recently initiated registrational study of SLS-002 (intranasal racemic ketamine) in Adults with Major Depressive Disorder at imminent risk of suicide [NCT04669665], the recently released in vivo data utilizing CRISPR-dCas9 gene therapy technology where a single dose of SLS-004 produced therapeutically desirable reductions in SNCA mRNA and SNCA protein expressions...in Parkinson's disease, and the upcoming initiation of the SLS-005 Phase IIb/III pivotal study in amyotrophic lateral sclerosis (ALS) in the Healey ALS Platform Trial.”

Preclinical • Review • Amyotrophic Lateral Sclerosis • CNS Disorders • Depression • Parkinson's Disease

Seelos Therapeutics addressing unmet needs in CNS disorders (BioTuesdays) - "The open-label study was Part 1 of a potentially registrational Phase 2 proof-of-concept trial with SLS-002 in ASIB. The study enrolled 17 patients diagnosed with major depressive disorder requiring psychiatric hospitalization because of a significant risk of suicide. Part 2 of the trial is preparing to enrol 120 patients, with top-line data expected in the first half of 2022."

P2 data • Trial status • CNS Disorders • Depression

Seelos down 20% despite releasing positive data on ketamine depression treatment (SeekingAlpha) - "Shares of Seelos Therapeutics...are down 20.5% to $4.13 in afternoon trading despite releasing positive top-line data from a proof-of-concept study of SLS-002, an intranasal ketamine treatment for major depressive disorder."

P2 data • Stock price • CNS Disorders • Depression

Seelos Therapeutics Announces Positive Topline Data from the Open-Label Study of SLS-002 (Intranasal Racemic Ketamine), Demonstrating a Significant Treatment Effect and a Well Tolerated Safety Profile for Acute Suicidal Ideation and Behavior in Patients with Major Depressive Disorder (PRNewswire) - P2, N=136; NCT04669665; Sponsor: Seelos; "Seelos Therapeutics...announced positive data from Part 1, the open-label cohort, of its potentially registrational Proof-of-Concept study of SLS-002 (intranasal racemic ketamine) demonstrating a significant treatment effect and a well-tolerated safety profile for Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD)....SLS-002 was well tolerated, with 47% of subjects having at least one treatment emergent adverse event."

P2 data • CNS Disorders • Depression • Major Depressive Disorder

Seelos Therapeutics Announces a Strategic Device Partnership with AptarGroup, Inc. (PRNewswire) - "Seelos Therapeutics, Inc....announced today the signing of an agreement between Seelos and AptarGroup, Inc. (NYSE: ATR) for the co-exclusive use and supply of Aptar Pharma's Bidose (BDS) Liquid System device for Seelos' intranasal ketamine product candidate, SLS-002, in the investigational development programs for the treatment of suicidality, depression...Under the terms of the agreement, Seelos has certain rights to add other undisclosed indications to the Strategic Device Partnership....Seelos has completed Part 1, the 16-patient, open-label cohort, of its Proof-of-Concept study, which uses the Aptar BDS Liquid System to deliver 90mg of SLS-002 to patients who are imminently suicidal....The last patient completed Part 1 of the study on March 30, 2021."

Licensing / partnership • Trial completion • CNS Disorders • Depression • Major Depressive Disorder

Seelos Therapeutics Announces Completion of Open-Label Patient Enrollment of Proof of Concept Study of SLS-002 (Intranasal Racemic Ketamine) for Acute Suicidal Ideation and Behavior in Patients with Major Depressive Disorder (PRNewswire) - "Seelos Therapeutics, Inc....announced today the completion of enrollment of patients in Part 1 of its registrational Proof of Concept study of SLS-002 (intranasal racemic ketamine) for Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD)....Seelos expects to release key open-label data in the second quarter of 2021, after analyzing the data received after the last enrolled patient's completion of Part 1 of the study....The last patient is expected to complete Part 1 of the study on April 1, 2021....Part 2 aims to enroll approximately 120 patients to be randomized 1:1 to receive standard of care plus either 90mg doses of SLS-002 or an intranasal placebo."

Enrollment status • P2 data • CNS Disorders • Depression • Major Depressive Disorder

Seelos Therapeutics Announces Amendment of SLS-002 Agreement to Repurchase a Significant Portion of Royalties for SLS-002 (Intranasal Racemic Ketamine Program) (PRNewswire) - "Seelos Therapeutics, Inc....announced today an amendment of the agreement with Vyera Pharmaceuticals AG ('Vyera') for the development of SLS-002 (intranasal racemic ketamine) to repurchase in cash a significant portion of the royalties payable on any future net sales of SLS-002....Under this amendment, for additional cash payments, Seelos has agreed to repurchase 9% of the future royalties and reduce its royalty obligations to a mid-single digit percentage on any future net sales of SLS-002....'We plan to further evaluate ketamine in front-line major depression and other related indications.'"

Commercial • CNS Disorders • Depression • Major Depressive Disorder

"$SEEL to repurchase 9% of the future royalties and reduce its royalty obligations to a mid-single digit percentage on any future net sales of SLS-002." (@BioStocks)