SEEL Seelos Therapeutics Inc.

5.45
-0.02  -0%
Previous Close 5.47
Open 5.54
52 Week Low 0.4426
52 Week High 6.16
Market Cap $399,210,069
Shares 73,249,554
Float 70,029,495
Enterprise Value $394,737,060
Volume 4,189,225
Av. Daily Volume 11,543,630
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Upcoming Catalysts

Drug Stage Catalyst Date
SLS-002
Acute Suicidal Ideation and Behavior in patients with Major Depressive Disorder (ASIB in MDD)
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Trehalose (SLS-005)
Sanfilippo syndrome/MPS III
Phase 2
Phase 2
Phase 2b/3 open-label trial planned.
Vitaros
Erectile dysfunction
CRL
CRL
CRL issued to Apricus (pre-reverse merger) for NDA resubmission - February 16, 2018.
SLS-002-102
Healthy volunteers
Phase 1
Phase 1
Phase 1 proof of concept trial commenced December 2020.
SLS-005 (IV trehalose) - HEALEY ALS Platform Trial
Amyotrophic lateral sclerosis
Phase 2/3
Phase 2/3
Phase 2/3 trial to commence 1H 2021.
SLS-002-101
Healthy volunteers
Phase 1
Phase 1
Phase 1 DDI initial data released January 10, 2020 - generally safe and well-tolerated.

Latest News

  1. NEW YORK, April 6, 2021 /PRNewswire/ -- Seelos Therapeutics, Inc. (NASDAQ:SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system (CNS) disorders and rare diseases, 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, and Post-Traumatic Stress Disorder (PTSD). Under the terms of the agreement, Seelos has certain rights to add other undisclosed indications to the Strategic Device Partnership.

    NEW YORK, April 6, 2021 /PRNewswire/ -- Seelos Therapeutics, Inc. (NASDAQ:SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system (CNS) disorders and rare diseases, 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, and Post-Traumatic Stress Disorder (PTSD). Under the terms of the agreement, Seelos has certain rights to add other undisclosed indications to the Strategic Device Partnership.

    Aptar's patented BDS Liquid System has been approved by the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) for the delivery of other therapeutics and, to date, millions of the Bidose and Unidose (UDS) Systems have been sold and are used daily by thousands of patients worldwide. Aptar's BDS Liquid System is ideal for intranasal therapies, like SLS-002, where a precise delivery of active CNS drug formulations is required. The BDS Liquid System is ready-to-use, requiring no priming or shaking, making the device ideal for use in a crisis situation.

    "Aptar is a world-class organization and has been an integral partner for our intranasal ketamine program since our inception," said Raj Mehra Ph.D., Chairman and CEO of Seelos. "This partnership strengthens the collaboration between Seelos and Aptar, and further protects the SLS-002 franchise."

    The Strategic Device Partnership covers Seelos' use of Aptar's BDS Liquid System with its SLS-002 program, which is currently in development for the treatment of Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD).

    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. Part 1 of the Proof-of-Concept study precedes Part 2, which is a registrational double blind placebo-controlled trial.

    Seelos expects to release key open-label data in the second quarter of 2021, after analyzing the data received from Part 1 of the study. The last patient completed Part 1 of the study on March 30, 2021.

    If you or a loved one are having thoughts of suicide, please seek immediate medical help, go to your nearest emergency room, or call the National Suicide Prevention Lifeline at 1-800-273-8255.

    About Aptar

    Aptar is a global leader in the design and manufacturing of a broad range of drug delivery, consumer product dispensing and active material solutions. Aptar's innovative solutions and services serve a variety of end markets including pharmaceutical, beauty, personal care, home, food and beverage. Using insights, design, engineering and science to create dosing, dispensing and protective packaging technologies for the world's leading brands, Aptar in turn making a meaningful difference in the lives, looks, health and homes of millions of patients and consumers around the world. The company is headquartered in Crystal Lake, Illinois and has 13,000 dedicated employees in 20 countries. For more information, visit www.aptar.com.

    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 or Post-Traumatic Stress Disorder. SLS-002 was originally derived from a Javelin Pharmaceuticals, Inc./Hospira, Inc. program with 16 clinical studies involving approximately 500 subjects. SLS-002 is being developed to address an unmet need for a therapy to treat suicidality in the U.S. 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. The clinical development program for SLS-002 included two parallel healthy volunteer studies (Phase I), and is being followed by pivotal registration studies after meeting with the FDA. 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 depression and suicidality.

    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) or Post-Traumatic Stress Disorder (PTSD), amyotrophic lateral sclerosis (ALS), Sanfilippo syndrome, Parkinson's Disease, other psychiatric and movement disorders plus orphan diseases.

    For more information, please visit our website: http://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 Strategic Device Partnership between Seelos and Aptar, the benefits of Aptar's BDS Liquid System, Seelos' expectation that Aptar's BDS Liquid System is ideal for delivery of SLS-002 in crisis situations, the ability of the collaboration between Seelos and Aptar to protect the SLS-002 franchise, commencement of Part 2 of the Proof-of-Concept study, Seelos' expected timing for key open-label data from Part 1 of the Proof-of-Concept study and for the last patient's completion of Part 1 of the Proof-of-Concept study, and the potential for ketamine to be a rapid, effective treatment for refractory depression and suicidality. These statements are based on Seelos' current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos' business include, but are not limited to, the risk that Seelos' agreement with Aptar does not produce the benefits expected, the risk of not successfully executing its preclinical and clinical studies, including the Proof-of-Concept study of SLS-002, and not gaining marketing approvals for its product candidates, the risk that prior test results may not be replicated in future studies and trials, 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 a new business strategy, the risks related to raising capital to fund its development plans and ongoing operations, risks related to Seelos' current stock price, risks related to the global impact of COVID-19, as well as other factors expressed in Seelos' periodic filings with the U.S. Securities and Exchange Commission, including its 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

    Head of Corporate Communications

    Seelos Therapeutics, Inc. (NASDAQ:SEEL)

    300 Park Avenue

    New York, NY 10022

    (646) 293-2136

     

    http://seelostherapeutics.com

    https://twitter.com/seelostx


    https://www.linkedin.com/company/seelos

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/seelos-therapeutics-announces-a-strategic-device-partnership-with-aptargroup-inc-301262259.html

    SOURCE Seelos Therapeutics, Inc.

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  2. NEW YORK, March 5, 2021 /PRNewswire/ -- Seelos Therapeutics, Inc. (NASDAQ:SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, 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. Part 1 of the study has a 16-day treatment period followed by a safety follow-up period to day 30. The last patient is expected to complete Part 1 of the study on April 1, 2021.

    "Our first look at the potential efficacy of SLS-002 in depressed and imminently suicidal patients should provide valuable insights in this large unmet need. We look forward to initiating Part 2 of this study and are continuing to identify more trial sites," said Raj Mehra Ph.D., Chairman and CEO of Seelos. 

    The Proof of Concept study is a multicenter, two-part clinical trial, comprised of an open-label cohort (Part 1) followed by a randomized, double-blind, placebo-controlled study (Part 2). Part 1 is an open-label, non-placebo study of 16 patients receiving standard of care plus 90mg doses of SLS-002, and 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.

    If you or a loved one are having thoughts of suicide, please seek immediate medical help, go to your nearest emergency room, or call the National Suicide Prevention Lifeline at 1-800-273-8255.

    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 or Post-Traumatic Stress Disorder. SLS-002 was originally derived from a Javelin Pharmaceuticals, Inc./Hospira, Inc. program with 16 clinical studies involving approximately 500 subjects. SLS-002 is being developed to address an unmet need for a therapy to treat suicidality in the U.S. 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 depression and suicidality.

    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) or Post-Traumatic Stress Disorder (PTSD), amyotrophic lateral sclerosis (ALS), Sanfilippo syndrome, Parkinson's Disease, other psychiatric and movement disorders plus orphan diseases.

    For more information, please visit our website: http://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 expected timing for efficacy and safety data from Part 1 of the Proof of Concept study, the expected timing for the last patient's completion of Part 1 of the Proof of Concept study, the potential for information regarding the efficacy of SLS-002 to provide insights for the treatment of ASIB in patients with MDD, Seelos' expectations around the addition of further trial sites for the Proof of Concept study, commencement of Part 2 of the Proof of Concept study, the design of the Proof of Concept study and the potential for ketamine to be a rapid, effective treatment for refractory depression and suicidality. These statements are based on Seelos' current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated to Seelos' business include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies, including the Proof of Concept study of SLS-002, and not gaining marketing approvals for its product candidates, the risk that prior test results may not be replicated in future studies and trials, 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 a new business strategy, the risks related to raising capital to fund its development plans and ongoing operations, risks related to Seelos' current stock price, risks related to the global impact of COVID-19, as well as other factors expressed in Seelos' periodic filings with the U.S. Securities and Exchange Commission, including its 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

    Head of Corporate Communications

    Seelos Therapeutics, Inc. (NASDAQ:SEEL)

    300 Park Ave., 12th Fl

    New York, NY 10022

    (646) 293-2136

     

    www.seelostherapeutics.com

    https://twitter.com/seelostx

    https://www.linkedin.com/company/seelos

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/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-301241165.html

    SOURCE Seelos Therapeutics, Inc.

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  3. NEW YORK, Feb. 18, 2021 /PRNewswire/ -- Seelos Therapeutics, Inc. (NASDAQ:SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, 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.

    On March 6, 2018, Seelos entered into an asset purchase agreement with Vyera, currently known as Phoenixus AG, to acquire the assets and liabilities of Vyera's intranasal racemic ketamine program, which Seelos now calls SLS-002. As additional consideration to certain upfront cash and equity payments and success-based milestone payments contemplated under the prior agreement, Seelos agreed to pay a mid-teens percentage royalty 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 believe this repurchase of a significant portion of royalties due on SLS-002 has the potential to return meaningful future value to Seelos stockholders, assuming we are successful in the clinical development, FDA approval process, and commercialization of the intranasal ketamine program," said Raj Mehra Ph.D., Chairman and CEO of Seelos. "The current study of SLS-002 is dosing patients with major depressive disorder who are at imminent risk of suicide. We plan to further evaluate ketamine in front-line major depression and other related indications."

    Seelos has begun dosing patients in Part A of its Proof-of-Concept study, which is a 16-patient, open-label cohort, using 90mg of SLS-002 in patients who are imminently suicidal. Part A of the Proof-of-Concept study precedes Part B, which is a registrational double blind placebo-controlled trial. 

    If you or a loved one are having thoughts of suicide, please seek immediate medical help, go to your nearest emergency room, or call the National Suicide Prevention Lifeline at 1-800-273-8255.

    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 or Post-Traumatic Stress Disorder. SLS-002 was originally derived from a Javelin Pharmaceuticals, Inc./Hospira, Inc. program with 16 clinical studies involving approximately 500 subjects. SLS-002 addresses an unmet need for a therapy to treat suicidality in the U.S. 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. The clinical development program for SLS-002 included two parallel healthy volunteer studies (Phase I) and is being followed by pivotal registration studies after meeting with the FDA. 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 depression and suicidality.

    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) or Post-Traumatic Stress Disorder (PTSD), amyotrophic lateral sclerosis (ALS), Sanfilippo syndrome, Parkinson's Disease, other psychiatric and movement disorders plus orphan diseases.

    For more information, please visit our website: http://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 Seelos' ability to repurchase future royalties under the asset purchase agreement with Vyera, the ability of the royalty repurchase to return meaningful future value to Seelos stockholders, Seelos' ability to succeed in the clinical development, FDA approval process and commercialization of its intranasal ketamine program (SLS-002), Seelos' plans to evaluate ketamine in front-line major depression and other related indications, the design of the Proof of Concept study, the expected timing for commencing Part B of the Proof of Concept study and the potential for ketamine to be a rapid, effective treatment for refractory depression and suicidality. These statements are based on Seelos' current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated to Seelos' business include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies, including the Proof of Concept study of SLS-002, and not gaining marketing approvals for its product candidates, the risk that prior test results may not be replicated in future studies and trials, 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 a new business strategy, the risks related to raising capital to fund its development plans and ongoing operations, risks related to Seelos' current stock price, risks related to the global impact of COVID-19, as well as other factors expressed in Seelos' periodic filings with the U.S. Securities and Exchange Commission, including its 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

    Head of Corporate Communications

    Seelos Therapeutics, Inc. (NASDAQ:SEEL)

    300 Park Ave., 12th Fl

    New York, NY 10022

    (646) 293-2136



    www.seelostherapeutics.com

    https://twitter.com/seelostx

    https://www.linkedin.com/company/seelos

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/seelos-therapeutics-announces-amendment-of-sls-002-agreement-to-repurchase-a-significant-portion-of-royalties-for-sls-002-intranasal-racemic-ketamine-program-301229821.html

    SOURCE Seelos Therapeutics, Inc.

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  4. NEW YORK, Feb. 17, 2021 /PRNewswire/ -- Seelos Therapeutics, Inc. (NASDAQ:SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced that it will participate in the 33rd Annual Roth Conference, which will be held virtually on March 15-17, 2021.

    Raj Mehra, Ph.D., Chairman and CEO, will host 1x1 meetings via conference calls on March 16th and 17th.

    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) or Post-Traumatic Stress Disorder (PTSD), amyotrophic lateral sclerosis (ALS), Sanfilippo syndrome, Parkinson's disease, other psychiatric and movement disorders plus orphan diseases.

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

    Contact Information:

    Anthony Marciano

    Head of Corporate Communications

    Seelos Therapeutics, Inc. (NASDAQ:SEEL)

    300 Park Ave., 12th Fl

    New York, NY 10022

    (646) 293-2136

     

    https://seelostherapeutics.com/ 

    https://twitter.com/seelostx 

    https://www.linkedin.com/company/seelos

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/seelos-therapeutics-to-participate-in-the-33rd-annual-roth-conference-301229245.html

    SOURCE Seelos Therapeutics, Inc.

    View Full Article Hide Full Article
  5. NEW YORK, Feb. 1, 2021 /PRNewswire/ -- Seelos Therapeutics, Inc. (NASDAQ:SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced that it will participate in Canaccord Genuity's New Paradigms and Treatment Approaches in Mental Health virtual conference, Wednesday, February 3rd and Thursday, February 4th, 2021.

    Raj Mehra, Ph.D., Chairman and CEO, will present on Wednesday, February 3rd at 11:30am ET, and host one on one meetings, to discuss SLS-002, Seelos' intranasal racemic ketamine program which has begun its registrational proof of concept study for Acute Suicidal Ideation and Behavior in patients with Major Depressive Disorder.

    The study is a multicenter, two-part clinical trial, comprised of an open-label cohort followed by a randomized, double-blind, placebo-controlled study. The purpose of the study is to evaluate the efficacy, safety, and tolerability of repeat doses of SLS-002 in addition to standard of care on the symptoms of Major Depressive Disorder and suicidality in patients who are assessed to be at imminent risk of suicide.

    If you or a loved one are having thoughts of suicide, please seek immediate medical help, go to your nearest emergency room, or call the National Suicide Prevention Lifeline at 1-800-273-8255.

    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 or Post-Traumatic Stress Disorder. SLS-002 was originally derived from a Javelin Pharmaceuticals, Inc./Hospira, Inc. program with 16 clinical studies involving approximately 500 subjects. SLS-002 addresses an unmet need for a therapy to treat suicidality in the U.S. 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. The clinical development program for SLS-002 included two parallel healthy volunteer studies (Phase I), followed by pivotal registration studies after meeting with the FDA. 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 and suicidality.

    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) or Post-Traumatic Stress Disorder (PTSD), amyotrophic lateral sclerosis (ALS), Sanfilippo syndrome, Parkinson's disease, other psychiatric and movement disorders, and orphan diseases.

    For more information, please visit our website: http://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 potential for ketamine to be a rapid, effective treatment for refractory depression and suicidality, the design of the proof of concept study, and the characteristics of SLS-002 to be evaluated in the proof of concept study. These statements are based on Seelos' current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated to Seelos' business include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies, including the proof of concept study of SLS-002, and not gaining marketing approvals for its product candidates, the risk that prior test results may not be replicated in future studies and trials, 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 a new business strategy, the risks related to raising capital to fund its development plans and ongoing operations, risks related to Seelos' current stock price, risks related to the global impact of COVID-19, as well as other factors expressed in Seelos' periodic filings with the U.S. Securities and Exchange Commission, including its 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

    Head of Corporate Communications

    Seelos Therapeutics, Inc. (NASDAQ:SEEL)

    300 Park Ave., 12th Fl

    New York, NY 10022

    (646) 293-2136



    https://seelostherapeutics.com/

    https://twitter.com/seelostx

    https://www.linkedin.com/company/seelos

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/seelos-therapeutics-to-participate-in-canaccord-genuitys-new-paradigms-and-treatment-approaches-in-mental-health-conference-february-3-4-301218823.html

    SOURCE Seelos Therapeutics, Inc.

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