Announcement • Mar 20

Seelos Therapeutics, Inc. Provides Update on Top-Line Results from its Amyotrophic Lateral Sclerosis Study with SLS-005 (IV Trehalose)

Seelos Therapeutics, Inc. provided an update on top-line data of the Phase 2/3 HEALEY ALS Platform trial. This study was performed in collaboration with The Sean M. Healey and AMG Center, which is viewed as an influential force in ALS research and in caring for the ALS community. Their unique and innovative approach continues to be a benefit to the ALS community and its contributions have helped bring the last two FDA approved therapies for ALS to market. The study was designed to evaluate SLS-005 (IV trehalose), a low molecular weight disaccharide that stabilizes misfolded proteins and activates autophagy, in decreasing the slope of the ALS Functional Rating Scale (ALSFRS-R) and separation from placebo in Function and Mortality in an all-comers population of Persons with ALS (PALS). While the study did not meet statistical significance in the primary and secondary endpoint in the Full Analysis Set (FAS)2, by showing a 13% improvement in Function and Mortality with an 88% success probability (versus the pre-specified 98%), it showed a potential signal of efficacy in a pre-specified subgroup (ERF). In the pre-specified subgroup of PALS treated with SLS-005, without RELYVRIO®, the top-line data favored SLS-005 versus placebo in efficacy measures in the Efficacy RELYVRIO® Free (ERF)1 data set (n=130), including: a 22% improvement in slope of change in ALSFRS-R assessment adjusted for mortality, with an 89% success probability, at 24 weeks, the rate of decline in ALSFRS-R slope (points per month) also favored the SLS-005 treatment group versus placebo over 6 months (-0.80 and -1.07 points per month, respectively), a 25% slowing of Slow Vital Capacity (SVC) decline versus placebo (-11.5% for SLS-005 and -15.4% for placebo) at 24 weeks. Seelos has not yet received the full dataset and upon receiving it in the near future, Seelos plans to run additional analyses, including biomarkers of neurodegeneration, neurofilament light chain (NfL), exploratory efficacy results, subgroups and post-hoc analyses. SLS-005 was generally well-tolerated and comparable to placebo in safety. There was an imbalance of deaths/death equivalents observed in the study, with more events seen in the SLS-005 group compared to placebo, all were considered unrelated to the study drug. Seelos received top-line results for Regimen E (RGE). This included a Full Analysis Set (FAS), an Efficacy Regimen Only (ERO) population and an Efficacy RELYVRIO® Free (ERF) population. FAS includes shared placebo from all regimens, including RGE (n=204) and the RGE SLS-005 participants (n=120). The Efficacy Regimen Only (ERO) population includes 120 RGE SLS-005 and 41 RGE placebo participants. 31 participants in the ERO population received RELYVRIO® during the SLS-005 RGE study, thus confounding results from this population. The ERF analyses exclude participants who initiated RELYVRIO® during the study. ERF represents the participants who followed the protocol as envisioned (n=130, i.e., the ERF population comprises 81% of ERO/RGE participants). SLS-005 is a low molecular weight disaccharide (0.342 kDa) that crosses the blood brain barrier and is thought to stabilize proteins and activate autophagy through the activation of Transcription Factor EB (TFEB), a key factor in lysosomal and autophagy gene expression. The activation of TFEB is an emerging therapeutic target for a number of diseases with pathologic accumulation of storage material. In animal models of several diseases associated with abnormal cellular protein aggregation or storage of pathologic material, SLS-005 has been shown to reduce aggregation of misfolded proteins and reduce accumulation of pathologic material. SLS-005 has previously received Orphan Drug Designation for the treatment of ALS from the U.S. Food and Drug Administration and from the European Medicines Agency in the EU. SLS-005 is an investigational treatment and is not currently approved by any health authority for medicinal use. According to the National Institute of Neurological Disorders and Stroke, amyotrophic lateral sclerosis (ALS) is a group of rare neurological diseases that mainly involve the nerve cells (neurons) responsible for controlling voluntary muscle movement. In ALS, both the upper motor neurons and the lower motor neurons degenerate or die and stop sending messages to the muscles. Unable to function, the muscles gradually weaken, start to twitch (called fasciculations), and waste away (called atrophy). Eventually, the brain loses its ability to initiate and control voluntary movements. The disease is progressive, meaning the symptoms get worse over time. The majority of ALS cases (90% or more) are considered sporadic. This means the disease seems to occur at random with no clearly associated risk factors and no family history of the disease. Although family members of people with sporadic ALS are at an increased risk for the disease, the overall risk is very low, and most will not develop ALS. Most people with ALS eventually die from respiratory failure, usually within 3 to 5 years from when the symptoms first appear. However, about 10% of people with ALS survive for 10 or more years. Currently, there is no cure for ALS and no effective treatment to halt or reverse the progression of the disease. A 1-point change in the ALSFRS-R score can indicate a meaningful difference in a person's ability to function independently with activities of daily living (ADL's), including eating, bathing, dressing or walking.

Announcement • Sep 21

Seelos Therapeutics, Inc. Announces Top Line Results from SLS-002 Phase II Study in Adults with Major Depressive Disorder at Imminent Risk of Suicide

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). SLS-002 versus placebo demonstrated early and persistent reductions in symptoms of depression as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS). The graph presents results from the mixed model for repeated measures (MMRM) analysis of change from baseline in MADRS total score. Target enrollment of this study was 220 patients, however, due to financial constraints, only 147 patients diagnosed with MDD requiring psychiatric hospitalization due to significant risk of suicide were randomized. The data from the 147 subjects (67% of target enrollment) were evaluated using the protocol-defined methods of analysis. Due to the limited sample size, the study did not meet the pre-defined primary endpoint (MADRS ANCOVA at 24 hours post dosing). However, assuming the same treatment difference and standard deviation, analyses showed that the study would have achieved statistical significance for the primary endpoint, had the study reached full enrollment (220 patients). Detailed Summary of Key Efficacy Endpoints: MADRS results at 4 hours after dosing demonstrated a statistically significant change relative to placebo (p <0.001, 5.9 point LS 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); MADRS results at 24 hours after dosing utilizing an exploratory ANOVA (t-test) analysis demonstrated statistically significant change relative to placebo (p=0.049, 3.6 point mean treatment difference); MADRS results at Day 16 demonstrated a statistically significant change relative to placebo (p=0.012, 4.4 point LS mean treatment difference) – demonstrating persistence of effect; Meaningful results further supported by (proportion of SLS-002 subjects versus placebo, respectively): MADRS Response Rate, defined as = 50% reduction from baseline, at Day 16 (75.7% versus 47.9%) p<0.001; MADRS Remission Rate, defined as a total score = 12, at Day 16 (62.2% versus 32.9%) p<0.001; MADRS at end of 2-week safety follow up (Day 29/30) revealed continued improvement, demonstrating no evidence of return of symptoms. Clinically meaningful reduction in acute suicidality was demonstrated with SLS-002 over placebo. Both groups continued to improve over time. Sheehan-Suicidality Tracking Scale (S-STS) Total Score: (Mean baseline total scores were 21.4 for SLS-002 and 21.0 for placebo): 4 hour change from baseline was -15.1 for SLS-002 and -12.0 for placebo (p=0.022); 24 hour change from baseline was -15.5 for SLS-002 and -12.1 for placebo (p=0.008); Clinical Global Impression of Severity for Suicidal Ideation and Behavior (CGIS-S/IB)5: (Mean baseline scores were 4.0 for both SLS-002 and placebo): 4 hour change from baseline was -1.5 for SLS-002 and -1.1 for placebo (p=0.011); 24 hour change from baseline was -1.7 for SLS-002 and -1.4 for placebo (p=0.102); Detailed Summary of Safety Results: SLS-002 was well-tolerated with no new or unique safety signals identified and there were no deaths reported in the study. At least one treatment-emergent adverse event was reported in 52.7% of subjects treated with SLS-002 versus 39.7% treated with placebo; the majority of adverse events were mild or moderate and transient in nature. The most common treatment-emergent adverse events (=5% and >placebo) were dizziness (18.9% versus 2.7%), euphoric mood (6.8% versus 0%) and suicidal ideation (5.4% versus 2.7%). There were 5 serious adverse events (3 with SLS-002, 2 with placebo), all for suicidality, all judged unrelated to the study drug, and all resolved. Specific scales were utilized to measure the three most common known adverse events associated with ketamine treatments, which are dissociation, hemodynamic effects and sedation. The data below support that SLS-002 may reduce the frequency and severity of these most common effects compared to what is reported with other ketamine treatments. Clinician-Administered Dissociative States Scale (CADSS): At no point did the placebo-adjusted mean change from pre-dose baseline exceed the threshold of clinically meaningful dissociation (>4); Placebo-adjusted mean change from pre-dose baseline (at 40 minutes – correlating roughly with maximum plasma concentrations) = 3.9 after first dose and 1.8 at 1 hour post first dose; Placebo-adjusted mean change from pre-dose baseline 2.5 on Day 4 (at 40 minutes) after second dose and 1.4 on Day 8 (at 40 minutes) after third dose. Hemodynamic Effects: 6 subjects who received SLS-002 had an adverse event reported of either increased blood pressure or hypertension, all events were mild (except 1 moderate), all were transient and resolved; In review of mean vital sign data for SLS-002, minimal changes were observed; Systolic blood pressure at Baseline was 122.7 mmHg, with maximum mean values of 126.7 mmHg on days 1 and 11 (1 hour post dose); Diastolic blood pressure at Baseline was 77.7 mmHg, with maximum mean values of 81.1 mmHg on Day 8 (1 hour post dose). Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S): Maximum sedation (MOAA/S score < 5) occurred approximately 15 minutes after dosing on day 1 (placebo adjusted % of subjects 25.5%) with attenuation over time.

Pharmaceuticals Industry Growth	5.95%
Revenue growth rate	n/a
Return on equity	n/a
Net Margin	n/a
Last Earnings Update	30 Jun 2024

Date	Revenue	Earnings	G+A Expenses	R&D Expenses
30 Jun 24	2	4	11	0
31 Mar 24	2	-27	12	0
31 Dec 23	2	-38	13	0
30 Sep 23	2	-51	13	-33
30 Jun 23	1	-81	12	1
31 Mar 23	1	-73	12	0
31 Dec 22	0	-74	12	0
30 Sep 22	0	-82	17	63
30 Jun 22	0	-73	17	28
31 Mar 22	0	-61	17	33
31 Dec 21	0	-66	15	47
30 Sep 21	0	-45	9	38
30 Jun 21	0	-39	9	29
31 Mar 21	0	-33	8	25
31 Dec 20	0	-19	8	11
30 Sep 20	0	-23	7	0
30 Jun 20	0	-22	6	-9
31 Mar 20	0	-21	6	-7
31 Dec 19	0	-51	6	0
30 Sep 19	0	-42	5	0
30 Jun 19	0	-40	5	9
31 Mar 19	0	-38	4	7
31 Dec 18	0	-3	3	1
30 Sep 18	0	-3	2	1
30 Jun 18	0	-2	1	1
31 Mar 18	0	-2	1	1
31 Dec 17	0	-12	7	3

Data	Last Updated (UTC time)
Company Analysis	2026/07/19 05:10
End of Day Share Price	2026/06/01 00:00
Earnings	2024/06/30
Annual Earnings	2023/12/31

Package	Data	Timeframe	Example US Source ^*
Company Financials	10 years	Income statement Cash flow statement Balance sheet	SEC Form 10-K SEC Form 10-Q
Analyst Consensus Estimates	+3 years	Forecast financials Analyst price targets	Analyst Research Reports Blue Matrix
Market Prices	30 years	Stock prices Dividends, Splits and Actions	ICE Market Data SEC Form S-1
Ownership	10 years	Top shareholders Insider trading	SEC Form 4 SEC Form 13D
Management	10 years	Leadership team Board of directors	SEC Form 10-K SEC Form DEF 14A
Key Developments	10 years	Company announcements	SEC Form 8-K

Analyst	Institution
Bruce Jackson	Benchmark Company
Mayank Mamtani	B. Riley Securities, Inc.
Thomas Shrader	BTIG

Seelos Therapeutics Past Earnings Performance

Past criteria checks 0/6

Key information

Recent past performance updates

Recent updates

Seelos Therapeutics, Inc. announced delayed 10-Q filing

Seelos Therapeutics, Inc. Filed for Bankruptcy

Seelos Therapeutics, Inc.(OTCPK:SEEL) dropped from S&P TMI Index

Seelos Therapeutics, Inc.(OTCPK:SEEL) dropped from NASDAQ Composite Index

Seelos Therapeutics Announces Notice of Delisting from Nasdaq and Transfer of Listing to Over-the-Counter Market

Seelos Therapeutics, Inc. has filed a Follow-on Equity Offering.

Seelos Therapeutics, Inc., Annual General Meeting, Sep 27, 2024

Seelos Therapeutics, Inc. has filed a Follow-on Equity Offering in the amount of $1.136948 million.

Seelos Therapeutics Announces 1-for-8 Reverse Stock Split to Regain Compliance with the Minimum Bid Price Requirement of $1.00 Per Share of Common Stock for Continued Listing on the Nasdaq Capital Market

Nasdaq to Delist Common Stock of Seelos Therapeutics

Seelos Therapeutics, Inc. Announces Appointment of Richard Pascoe as Chairman of the Board of Directors

New major risk - Market cap size

Seelos Therapeutics, Inc. Provides Update on Top-Line Results from its Amyotrophic Lateral Sclerosis Study with SLS-005 (IV Trehalose)

New major risk - Revenue and earnings growth

New major risk - Market cap size

Seelos Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $4.000001 million.

Seelos Therapeutics, Inc. has filed a Follow-on Equity Offering in the amount of $4.000001 million.

Consensus EPS estimates upgraded to US$0.41 loss

Seelos Therapeutics, Inc. Announces Receipt of Minutes from its End of Phase II Meeting with the United States Food and Drug Administration Highlighting Modifications to the Primary and Secondary Endpoints of its Phase II Study of SLS-002

Chief Financial Officer recently bought US$100k worth of stock

New major risk - Market cap size

Seelos Therapeutics, Inc. has completed a Follow-on Equity Offering.

Seelos Therapeutics, Inc. has filed a Follow-on Equity Offering.

New major risk - Shareholder dilution

New major risk - Revenue and earnings growth

Consensus EPS estimates upgraded to US$0.34 loss

Seelos Therapeutics Receives Non-Compliance Notice from Nasdaq Regarding Non-Compliance with Minimum Bid Price Requirement for Continued Listing on the Nasdaq Capital Market Under Nasdaq Listing Rule 5550(a)(2)

New major risk - Revenue and earnings growth

Consensus revenue estimates decrease by 26%

Seelos Therapeutics, Inc. Announces Top Line Results from SLS-002 Phase II Study in Adults with Major Depressive Disorder at Imminent Risk of Suicide

Consensus revenue estimates increase by 80%, EPS downgraded

Seelos Therapeutics, Inc. 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)

Listing Qualifications Staff of Nasdaq Provides Notice to Seelos Therapeutics for Not Regain Compliance with Rule 5550(a)(2) and Not Eligible for Second 180 Calendar Day Compliance Period

Price target decreased by 12% to US$5.50

No longer forecast to breakeven

Seelos Therapeutics Announces Completion of Enrollment of its Phase II/III Trial of SLS-005 in Amyotrophic Lateral Sclerosis on the HEALEY ALS Platform

Seelos Therapeutics Doses First Patients in an Ethnobridging Study with Sls-002 (Intranasal Racemic Ketamine)

Price target decreased to US$5.80

Seelos: Data This Year Is Critical

Seelos wins Parkinson’s research grant for gene therapy program

Price target decreased to US$4.25

Founder recently bought US$57k worth of stock

Price target decreased to US$6.83

Seelos: FDA Action Makes It Highly Attractive

High number of new and inexperienced directors

High number of new and inexperienced directors

Seelos Therapeutics: Shares Have Finally Found A Floor But Risk Remains

High number of new and inexperienced directors

High number of new and inexperienced directors

High number of new and inexperienced directors

Director Judith Dunn has left the company

Price target decreased to US$8.58

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