SEEL Seelos Therapeutics Inc

 

 

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): September 24, 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 September 24, 2024, Seelos Therapeutics, Inc. (the "Company") issued a press release titled “Seelos Therapeutics announces the signing of a Material Transfer Agreement with U.S. Army Medical Materiel Development Activity (USAMMDA) to evaluate SLS-002 for treatment of PTSD.” A copy of the press release is filed herewith as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

Forward-Looking Statements

 

The press release contains 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 and the subsequent Quarterly Reports on Form 10-Q, including the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024.

 

Item 9.01 Financial Statements and Exhibits

 

(d) Exhibits.

 

Number		Description
99.1		Press Release, dated September 24, 2024.
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: September 24, 2024	By:	/s/ Raj Mehra, Ph.D.
		Name:	Raj Mehra, Ph.D.
		Title:	Chief Executive Officer and President

  

 

Exhibit 99.1

 

 

Seelos Therapeutics announces the signing of a Material Transfer Agreement with U.S. Army Medical Materiel Development Activity (USAMMDA) to evaluate SLS-002 for treatment of PTSD

 

-Dosing of the SLS-002 cohort is expected to commence in 4Q2024

 

NEW YORK, September 24, 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 announced the signing of a Material Transfer Agreement (MTA) with the U.S. Army Medical Materiel Development Activity (USAMMDA) to supply SLS-002 (intranasal racemic ketamine) for the U.S. Department of Defense's (DOD) Military and Veterans Adaptive Platform Clinical Trial (“M-PACT”) to evaluate its potential for treatment of post-traumatic stress disorder (PTSD).

 

Dosing of the SLS-002 cohort is expected to commence prior to the end of 2024 and it is the only ketamine-based therapy selected for inclusion in this study. The trial is funded by the DOD’s Defense Health Agency and led by USAMMDA’s Warfighter Readiness, Performance, and Brain Health Project Management Office.

 

“Approximately 13 million people in the U.S. live with PTSD and there have been no new drugs approved in the last two decades for people suffering the effects of PTSD,” said Raj Mehra, Ph.D., Chief Executive Officer of Seelos. “I believe that the inclusion of SLS-002 in this study is due to the robust amount of anecdotal evidence that ketamine has the potential to be an effective therapeutic for the symptoms of PTSD and other related conditions. Our data to date with SLS-002 suggest that its intranasal formulation could provide a rapid onset of benefit while mitigating the side effects seen through the other routes of administration of ketamine. We are proud to be included in this study and look forward to commencing the dosing of SLS-002.”

 

The DOD M-PACT (NCT05422612) is a Phase II randomized, double-blinded, placebo-controlled study that will evaluate the safety, tolerability, and efficacy of multiple pharmacotherapeutic interventions in active-duty service members and veterans with PTSD. The trial utilizes an adaptive platform design that randomizes participants among the multiple treatment cohorts selected for inclusion in the study and enables sharing of control participants to increase study efficiency. The trial design entails a 30-day screening period, a 12-week treatment period, and a 4-week safety follow-up. Data will be collected to measure changes in PTSD symptom severity, as measured by the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) and other clinically relevant endpoints. These include the incidence of new or worsening suicidal thoughts or behaviors, as measured by changes in the Columbia Suicide Severity Rating Scale (C-SSRS) score. In addition, the trial is evaluating several biomarkers associated with PTSD and assessing treatment safety and tolerability.

 

 

For more information about the M-PACT trial can be found at: https://ptsdclinicaltrial.org/.

 

About SLS-002

 

SLS-002 is intranasal racemic ketamine with two investigational new drug applications for the treatment of Acute Suicidal Ideation and Behavior in Major Depressive Disorder and in Post-Traumatic Stress Disorder (PTSD). SLS-002 was originally derived from a Javelin Pharmaceuticals, Inc./Hospira, Inc. program with 16 clinical studies involving approximately 500 subjects. Seelos looks to address an unmet need for a therapy to treat suicidality in the U.S. with SLS-002. Traditionally, anti-depressants have been used in this setting but many of the existing treatments are known to contribute to an increased risk of suicidal thoughts in some circumstances, and if they are effective, it often takes weeks for the full therapeutic effect to be manifested. Based on information gathered from the databases of the Agency for Healthcare Research and Quality, there were more than 1,000,000 visits to emergency rooms for suicide attempts in 2019 in the U.S. alone. Experimental studies suggest ketamine has the potential to be a rapid, effective treatment for refractory depression, suicidality and PTSD.

 

About USAMMDA

 

The U.S. Army Medical Materiel Development Activity develops, delivers, and fields critical drugs, vaccines, biologics, devices, and medical support equipment to protect and preserve the lives of Warfighters across the globe. USAMMDA project managers guide the development of medical products for the U.S. Army Medical Department, other U.S. military services, the Joint Staff, the Defense Health Agency, and the U.S. Special Operations community. The process takes promising technology from the Department of Defense, industry, and academia to U.S. Forces, from the testing required for U.S. Food and Drug Administration approval or licensing to fielding and sustainment of the finished product. USAMMDA Project Management Offices will transition to a Program Executive Office under the Defense Health Agency, Deputy Assistant Director for Acquisition and Sustainment.

 

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

 

 

No official endorsement of third parties or their products is made or inferred.

 

Forward Looking Statements

 

Statements made in this press release, which are not historical in nature, constitute forward-looking statements related to Seelos for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, statements regarding the completion of the offering, the anticipated proceeds from the offering and the use of such proceeds. For example, the Company is using forward looking statements in this press release when it discusses the expected timing of the dosing of the study and the study parameters, as well as the belief that the inclusion of SLS-002 in this study is due to the robust amount of anecdotal evidence that ketamine has the potential to be an effective therapeutic for the symptoms of PTSD and other related conditions. These statements are based on our current expectations and beliefs and are subject to a number of factors, risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The risks and uncertainties involved include those associated with general economic and market conditions and our ability to satisfy closing conditions applicable to the offering, our intended use of proceeds from the offering, as well as other risk factors and matters set forth in our periodic filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2023, subsequent Quarterly Reports on Form 10-Q, including Seelos' Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, and the prospectus supplement and the accompanying prospectus related to the public offering to be filed with the SEC. 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

 

 

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