NEW YORK - Seelos Therapeutics, Inc. (NASDAQ:SEEL), a clinical-stage biopharmaceutical company, has entered into a Material Transfer Agreement with the U.S. Army Medical Materiel Development Activity (USAMMDA) to provide its investigational therapy, SLS-002, for a Department of Defense-funded clinical trial. The study, named Military and Veterans Adaptive Platform Clinical Trial (M-PACT), aims to assess the efficacy of SLS-002, an intranasal form of racemic ketamine, in treating post-traumatic stress disorder (PTSD) among military personnel.
The M-PACT trial, which is a Phase II randomized, double-blinded, placebo-controlled study, will commence dosing of the SLS-002 cohort before the end of 2024. It is the sole ketamine-based therapy included in the study, which is supported by the Defense Health Agency and executed by USAMMDA's Warfighter Readiness, Performance, and Brain Health Project Management Office.
Raj Mehra, Ph.D., CEO of Seelos, highlighted the absence of new drugs approved for PTSD in the last two decades, mentioning that around 13 million people in the U.S. live with PTSD. He expressed optimism about SLS-002 being part of the trial due to anecdotal evidence suggesting that ketamine could be an effective treatment for PTSD symptoms. The intranasal formulation of SLS-002 is expected to offer rapid onset of benefits while minimizing side effects associated with other methods of ketamine administration.
The M-PACT trial will evaluate safety, tolerability, and efficacy over a 12-week treatment period with a 30-day screening and a 4-week safety follow-up. It will use the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) and other clinical endpoints to measure changes in PTSD symptom severity. The trial will also monitor suicidal thoughts or behaviors using the Columbia Suicide Severity Rating Scale (C-SSRS) and assess several biomarkers associated with PTSD.
SLS-002 has two investigational new drug applications for the treatment of acute suicidal ideation and behavior in major depressive disorder and PTSD. Seelos aims to address the unmet need for rapid and effective treatment options for suicidality in the United States.
This collaboration with USAMMDA represents a significant step for Seelos in advancing its therapeutic pipeline and potentially providing a new treatment option for PTSD. The company's participation in the M-PACT trial is based on a press release statement and reflects the ongoing efforts to explore innovative treatments for central nervous system disorders and rare diseases.
In other recent news, Seelos Therapeutics has been granted an extension by the Nasdaq Hearings Panel to meet the exchange's minimum listing requirements. The pharmaceutical company was previously notified for not meeting the minimum bid price and market value of listed securities. The Panel has now extended the deadline for compliance with the market value requirement to August 30, 2024, and the bid price requirement to September 30, 2024.
Seelos Therapeutics has also amended its financial agreement with Lind Global Asset Management V, LLC, modifying the terms of a Convertible Promissory Note. The amendment stipulates that Seelos is not required to maintain a minimum cash balance until October 31, 2024.
In another development, the company implemented a 1-for-8 reverse stock split, converting every eight existing shares of common stock into one. This reduces the number of authorized shares from 400 million to 50 million and the number of issued and outstanding shares from approximately 17.4 million to roughly 2.2 million.
Lastly, Seelos Therapeutics has appointed Richard Pascoe as Chairman of the Board of Directors. These are all recent developments as Seelos continues to navigate its financial obligations and corporate governance responsibilities.
InvestingPro Insights
As Seelos Therapeutics, Inc. (NASDAQ:SEEL) embarks on a pivotal Phase II trial for its PTSD treatment, SLS-002, the company's financial metrics reflect both challenges and growth potential. According to InvestingPro data, Seelos has experienced a significant revenue growth of 76.05% over the last twelve months as of Q2 2024, indicating an upward trajectory in its financial performance. This may be a reflection of the company's strategic initiatives and potential market for its PTSD therapy.
Despite this revenue growth, Seelos faces financial headwinds, as evidenced by a gross profit margin of -915.34% for the same period. This suggests that the company's cost of goods sold significantly exceeds its revenue, which could be attributed to high research and development costs associated with its clinical trials. Additionally, the company's market capitalization stands at a modest 1.33 million USD, underscoring its status as a small-cap company in the biopharmaceutical industry.
InvestingPro Tips also highlight that Seelos' stock price has been subject to considerable volatility. The stock has taken a significant hit over the last week, with a price total return of -15.56%. Over the last year, the decline has been even more pronounced, with a price total return of -99.51%. This volatility is a critical factor for investors to consider, especially those looking for stability in their investment portfolios.
For those interested in a deeper analysis, InvestingPro offers additional tips that could provide further insights into Seelos' financial health and stock performance. These include the company's short-term obligations in relation to its liquid assets, and the absence of dividend payments to shareholders, which may influence investment decisions. There are a total of 16 additional InvestingPro Tips available for Seelos, which can be found at https://www.investing.com/pro/SEEL.
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