8-K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 19, 2024

Seelos Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

Nevada	000-22245	87-0449967
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

300 Park Avenue, 2nd Floor, New York, NY	10022
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: (646) 293-2100

Not Applicable
(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities Registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.001 par value	SEEL	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 8.01. Other Events.

On March 19, 2024, Seelos Therapeutics, Inc. (the "Company") issued a press release (the “Press Release”) providing an update on top-line results from its Amyotrophic Lateral Sclerosis (ALS) study with SLS-005 (IV Trehalose) (the “Data”). A copy of the Press Release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The Press Release references a presentation (the “Presentation”) that provides any additional analysis and information from the Data, which the Company made available on its website on March 19, 2024. A copy of the Presentation is attached as Exhibit 99.2 to this Current Report on Form 8-K. The Presentation is current as of March 19, 2024, and the Company expressly disclaims any obligation to update this material in the future.

Forward-Looking Statements

The Press Release and Presentation contain forward-looking statements that involve future risks and uncertainties as contemplated by the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in the Press Release and Presentation should be regarded as “forward-looking statements.” These forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These forward-looking statements are based on the expectations, estimates, projections, beliefs and assumptions of the Company based on information currently available to it, all of which are subject to change. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from the results contemplated by the forward-looking statements. Many of the important factors that will determine these results and values are beyond the Company’s ability to control or predict. Except as otherwise required by law, the Company does not assume any obligation to update any forward-looking statements.

For additional information about factors that could cause actual results to differ materially from those described in the forward-looking statements, please refer to the Company’s filings with the Securities and Exchange Commission, including the risk factors contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits.

Number	Description
99.1	Press Release, dated March 19, 2024.
99.2	Presentation regarding top-line results from ALS Study with SLS-005 (IV Trehalose).
104	Cover Page Interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL).

*             *             *

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	Seelos Therapeutics, Inc.
Date: March 19, 2024	By:	/s/ Raj Mehra, Ph.D.
		Name:	Raj Mehra, Ph.D.
		Title:	Chief Executive Officer and President

EX-99.1

Exhibit 99.1

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

NEW YORK, March 19, 2024 /PRNewswire/ -- Seelos Therapeutics, Inc. (Nasdaq: SEEL) (“Seelos”), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today 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)¹.

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

Additional analysis and information from these data accessible here.

“The HEALEY platform is designed to detect signals of efficacy and we believe the observed signal and success probability is competitive to other recently FDA-approved therapies for ALS which also failed to achieve statistical significance when measured for function and mortality on similar primary and efficacy endpoints,” said Raj Mehra Ph.D., Chairman and Chief Executive Officer of Seelos. “We plan to request a meeting with the FDA to discuss potential next steps for the program and will continue our potential partner discussions.”

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.

Populations – ERF¹, FAS² and ERO³:

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).

About SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion)

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.

About Amyotrophic Lateral Sclerosis (ALS)

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 percent 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 percent 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.⁴

^4. FDA Center for Drug Evaluation and Research, Application Number 209176Orig1s000, Office Director Memo, Ellis F. Unger, MD, May 4, 2017. Paganoni S, et al. New Eng J Med. 2020.

About Seelos Therapeutics

Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare diseases. The Company's robust portfolio includes several late-stage clinical assets targeting indications including Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD), amyotrophic lateral sclerosis (ALS) and spinocerebellar ataxia (SCA), as well as early-stage programs in Huntington's disease, Alzheimer's disease, and Parkinson's disease.

For more information, please visit our website: https://seelostherapeutics.com, the content of which is not incorporated herein by reference.

Forward Looking Statements

Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding the Phase 2/3 study of SLS-005, statements regarding the competitiveness of the results to recently approved FDA therapies for ALS, statements regarding any planned meetings and discussions with the FDA, statements regarding The Sean M. Healey and AMG Center’s contributions to the ALS community, statements regarding the timing of Seelos’s receipt of the full dataset for the trial, statements regarding additional analyses to be run by Seelos and statements regarding SLS-005's prospects and any future analyses that may be conducted. These statements are based on Seelos' current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos' business and plans described herein include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies, not being able to move forward with the development of SLS-005, and not gaining marketing approvals for SLS-005 and/or its other product candidates; the risk that prior clinical results may not be replicated in future studies and trials (including the risk that the results from the prior studies of SLS-005 may not be replicated or may be materially different from the results of the top-line data from the SLS-005 study); the risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval; the risks associated with the implementation of Seelos' business strategy; the risks related to raising capital to fund its development plans and ongoing operations; the risks related to Seelos' current stock price; as well as other factors expressed in Seelos' periodic filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact Information:

Anthony Marciano
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue, 2^nd Floor
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos

Mike Moyer
Managing Director
LifeSci Advisors, LLC
250 West 55th St., Suite 3401
New York, NY 10019
(617) 308-4306
mmoyer@lifesciadvisors.com

EX-99.2

Exhibit 99.2

SEELOS THERAPEUTICS SLS - 005 ALS Top - Line Data March 2024 “We are a company focused on achieving the most efficient development of products that address significant unmet needs in CNS disorders and in rare diseases”

FORWARD - LOOKING STATEMENTS This corporate presentation includes certain forward - looking statements within the meaning of Section 21E of the Securities Exch ange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These forward - looking statements include, but are not limited to, statements r egarding the intent, belief or current expectations of Seelos Therapeutics, Inc. ("we," "us," "our," the "Company" or "Seelos") and our management team. These forwa rd - looking statements involve known and unknown risks, uncertainties and other important factors that may cause the actual results, performance or achievements of th e C ompany to be materially different from any future results, performance or achievements expressed or implied by the forward - looking statements. Words such as “anticipates,” “believes,” “forecasts,” “potential,” “goal,” “contemplates,” “expects,” “intends,” “plans,” “pr oje cts,” “hopes,” “seeks,” “estimates,” “strategy,” “continues,” “ongoing,” “opportunity,” “could,” “would,” “should,” “likely,” “will,” “may,” “can,” “designed to,” “future,” “ for eseeable future” and similar expressions and variations, and negatives of these words, identify forward - looking statements. These forward - looking statements are based on the expectations, estimates, projections, beliefs and assumptions of our management based on information currently available to us, all of which are subject to change. Th ese forward - looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materia lly from the results contemplated by the forward - looking statements. Many of the important factors that will determine these results and values are beyond our ability to control or predict. You are cautioned not to put undue reliance on any forward - looking statements. Except as otherwise required by law, we do not assume any obligation to up date any forward - looking statements. For additional information about factors that could cause actual results to differ materially from those described in the for war d - looking statements, please refer to the Company’s filings with the Securities and Exchange Commission (the “SEC”), including the risk factors contained in the Compan y’s Annual Report on Form 10 - K for the year ended December 31, 2023, subsequent Quarterly Reports on Form 10 - Q and in the company’s other filings with the SEC. This corporate presentation is for informational purposes only and is neither an offer to purchase, nor solicitation of an of fer to sell, subscribe for or buy any securities or the solicitation of any vote in any jurisdiction pursuant to the proposed transaction, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirement s o f Section 10 of the Securities Act of 1933, as amended. 2

3 ALS Prevalence and Approved Therapies Edaravone (RADICAVA ® ) Approved after running a second Phase 3 study utilizing post - hoc analysis https://pubmed.ncbi.nlm.nih.gov/28522181/ ALS has a global prevalence of at least 200,000 people • 30,000 in US 1 and 30,000 in EU and UK 2 1. https://www.cdc.gov/als/dashboard/index.html 2. Brown CA, et al. Neuroepidemiology. 2021;55(5):342 - 353 Approved: 2017 ( IV) 2022 (Oral) Approved:1995 Riluzole (RILUTEK ® ) FDA approved after two Phase 3 studies measuring time to tracheostomy or death. Neither study showed a statistically significant difference in mortality at the end of the study . https ://www.accessdata.fda.gov/drugsatfda_docs/ label/2009/020599s011s012lbl.pdf Prevalence Earliest Approved Therapies QALSODY ® (tofersen) is a prescription medicine used to treat adults with amyotrophic lateral sclerosis (ALS) who have a mutation, or change, in the superoxide dismutase 1 (SOD1) gene. QALSODY received accelerated approval based on reduction in neurofilament light chain ( NfL ) in the blood observed in patients treated with QALSODY. https://www.qalsody.com/ Approved: 2023 Approved: 2022 The FDA approved RELYVRIO ® based on safety and efficacy data from a single clinical trial (Study 1) of 137 adult patients with ALS . https://www.fda.gov/drugs/drug - approvals - and - databases/drug - trials - snapshots - relyvrio Recently Approved Therapies “Definite/Probable” ALS patients “Definite” ALS patients “Definite/Probable” ALS patients March 8, 2024: Did not meet prespecified primary or secondary endpoints, n=664

4 SLS - 005 (IV Trehalose) is Regimen E (RGE) – Three Datasets Prespecified for analysis Primary Analysis Prespecified Dataset SLS - 005 IV Trehalose Placebo Limitation(s) Full Analysis Set (FAS) n= 120 n=41 + n=163 (shared placebo) 1. Regimen Placebo ~ Shared placebo 2. Primary Analysis ~ Sensitivity Analysis Efficacy Regimen Only (ERO) ITT (intent - to - treat) n= 120 n=41 Protocol violation by introducing RELYVRIO mid - study (n=31) Efficacy RELYVRIO Free (ERF) mITT (modified ITT) (as envisioned) n= 99 n=31 Cleanest Dataset

5 Sensitivity of primary analysis result to each dataset in Regimen E (RGE) SLS - 005 IV Trehalose Consistency: Primary ≠ Sensitivity Analysis 22% Slowing of Function and Mortality Primary Analysis Model Full Analysis Set (FAS) SLS - 005 IV Trehalose (as envisioned) ERF Set – Sensitivity Analysis Pooled Placebo n=204 RGE Active n=120 RGE Placebo n=31 RGE Active n=99 - 6.42 - 4.80 Δ = 1.62 ~ 6 months 25% benefit in Function Alone 13% Slowing of Function and Mortality

6 - 5.01 - 7.00 - 6.70 - 4.80 - 7.50 - 8.10 - 9.62 - 6.42 -10.00 -9.00 -8.00 -7.00 -6.00 -5.00 -4.00 -3.00 -2.00 -1.00 0.00 RADICAVA QALSODY RELYVRIO SLS-005 (IV Trehalose) ALSFRS - R Change from Baseline SLS - 005 vs Approved ALS Treatments For illustrative purposes only. No head - to - head trials with Relyvrio ® and/or Qalsody ® have been conducted. Data from FDA briefing book and AdCom meetings and comparison based upon a review of published literature and internal clinical tr ial data on SLS - 005. Approved: 2022 Definite ALS patients Approved: 2023 Definite/Probable ALS patients All comers : Possible/ Definite/Probable ALS patients Increased Treatment Benefit Approved: 2017/2022 Definite/Probable ALS patients N=135 Active: 87 Placebo: 48 N=60 Active: 39 Placebo: 21 N=130 Active: 99 Placebo: 31 N=134 Active: 68 Placebo: 66 Active Active Placebo

7 Safety Endpoints • Safety Endpoints – TEAE • Analysis set – STF

8 - 8% 2% 2% 1% 13% 22% -12% -7% -2% 3% 8% 13% 18% 23% A B C D E ERF Healey Platform Trial Regimens SLS - 005 Trehalose has the best data of all regimens (A to E) completed so far Head - to - Head Healey Platform Trial Data % Change vs Placebo Function & Mortality Increased Treatment Benefit SLS - 005 – Trehalose only (ERF) 22 % Slowing of Function and Mortality

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Cover	Mar. 19, 2024
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Document Type	8-K
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Entity File Number	000-22245
Entity Registrant Name	Seelos Therapeutics, Inc.
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Entity Tax Identification Number	87-0449967
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Entity Address, Address Line One	300 Park Avenue
Entity Address, Address Line Two	2nd Floor
Entity Address, City or Town	New York
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Entity Emerging Growth Company	false