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Seelos Therapeutics Announces Data Demonstrating Statistically Significant Downregulation of mRNA and Reduction of Alpha Synuclein in an In Vitro Gene Therapy Study of SLS-004 Utilizing CRISPR-dCas9 in Dementia with Lewy Bodies

Seelos Therapeutics Announces Data Demonstrating Statistically Significant Downregulation of mRNA and Reduction of Alpha Synuclein in an In Vitro Gene Therapy Study of SLS-004 Utilizing CRISPR-dCas9 in Dementia with Lewy Bodies

– A Single Dose of SLS-004 Produced 19% Downregulation of mRNA and ~40% Reduction of Alpha-Synuclein Compared to the Control Group

– These Results Support Advancing SLS-004 into Additional Preclinical Studies in Dementia with Lewy Bodies

NEW YORK, June 9, 2022 /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 data demonstrating a statistically significant (p<0.01) 19% downregulation of mRNA and a ~40% reduction of alpha synuclein (α-synuclein) in an in vitro study of SLS-004, its gene therapy program utilizing CRISPR-dCas9, in dementia with Lewy bodies (DLB).

DLB is characterized by the accumulation of aggregated α-synuclein protein in Lewy bodies and Lewy neurites. In DLB, the pathological changes are observed in the neocortex and limbic systems with a distinguishing feature of cholinergic dysfunction, which is different from other Lewy body disorders such as Parkinson’s disease. Cholinergic neurons are differentially vulnerable in various neuropathologic entities that cause dementia, including DLB. Available evidence points to early and substantial degeneration of these neurons in DLB.

“This current in vitro study extends the existing CRISPR program for Parkinson’s disease to DLB as both disorders are synucleinopathies although affecting different neurons in separate regions of the brain. Our team’s observation of a meaningful efficacy with a new CRISPR technology focused on cholinergic neurons in striatum for DLB is exciting indeed, as it reinforces our earlier findings in a Parkinson’s disease model,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos. “Results producing statistically significant reductions in mRNA and α-synuclein are clinically meaningful. We plan to advance into additional preclinical studies in DLB and Parkinson’s and expect additional data in the second half of this year.” Preliminary Findings of In Vitro Study

The goal of this in vitro study was to extend the existing SNCA-targeted epigenome therapy system (SLS-004) by modifying the viral vector to target specific cholinergic neurons in the cortex that are afflicted in DLB and validate the specificity and efficacy in human-induced pluripotent stem cells (hiPSC) derived neuronal systems.

The parental line SNCA-Tri hiPSC-derived system for the proof-of-concept model was utilized for the current study. hiPSC were differentiated utilizing earlier protocols used in SLS-004. Multiple batches of each differentiated neuronal type were evaluated, and successful differentiation of each batch was established.

The preliminary findings showed that following two weeks of differentiation into cholinergic neurons, there was a statistically significant (p<0.01) 19% downregulation of mRNA and a ~40% reduction of α-synuclein protein compared to the no treatment/repressor groups.

Seelos plans to advance the study of SLS-004 in DLB in additional preclinical studies and disclose further developments of this new CRISPR-based therapeutic technology in the future.

In July 2021, Seelos released positive preclinical in vivo data with SLS-004 in downregulation of overexpressed α-synuclein in a Parkinson’s disease model and plans to release additional data in the second half of 2022.

About Dementia with Lewy Bodies

Dementia with Lewy bodies (DLB) is one of the two types of dementia that has Lewy body inclusions as hallmarks of pathology, the other being Parkinson’s disease dementia. DLB’s initial symptoms of decreased mental functioning in patients often appear similar to the onset of Alzheimer’s disease. However, unlike Alzheimer’s, progression of DLB can cause various movement issues as well as visual and auditory hallucinations.

DLB a progressive neurodegenerative disorder in which cognition, behavioral symptoms, and Parkinsonian symptoms worsen over time, shortening life expectancy and often requiring nursing home placement. There are currently no treatments with evidence of disease-modifying effects in DLB. Current treatment options are primarily symptomatic and targeted toward specific disease manifestations, including cognitive or behavioral symptoms, disabling Parkinson’s symptoms, sleep behavior disorder and other symptoms. 

About SLS-004

SLS-004 is a novel epigenome-editing approach to modulate expression of SNCA gene mediated by modification of DNA-methylation. SLS-004 utilizes an all-in-one lentiviral vector harboring dCas9-DNA methyltransferase 3A (DNMT3A) to enrich DNA-methylation within CpGs island at the SNCA intron 1 region. The system resulted in a precise and fine-tuned downregulation (30%) of SNCA overexpression in hiPSC-derived dopaminergic neurons from a PD patient with the triplication of the SNCA locus (SNCA-Tri). Most importantly, the reduction of SNCA expression mediated by the developed system was sufficient to ameliorate disease related cellular phenotypes. The in vitro studies achieved several key milestones including the establishment that DNA hypermethylation at SNCA intron 1 allows an effective and sufficient tight downregulation of SNCA expression levels and suggests the potential of this target sequence combined with the CRISPR-dCas9 technology as a novel epigenetic-based therapeutic approach for PD.

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 Company’s plans to advance into additional pre-clinical studies in DLB and Parkinson’s, its expectations to disclose additional developments and data, including its plans to release data for a Parkinson’s disease model in the second half of this year, the safety and efficacy of SLS-004 and its ability to downregulate or reduce SNCA mRNA and SNCA protein expression. 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 include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies and not gaining marketing approvals for its 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 preclinical study of SLS-004 are not replicated or are materially different from the results of 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 Seelos’ 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 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
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

SOURCE Seelos Therapeutics, Inc.

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Seelos Therapeutics Receives a Notice of Allowance in the U.S. for an Additional Patent for SLS-007

Seelos Therapeutics Receives a Notice of Allowance in the U.S. for an Additional Patent for SLS-007

NEW YORK, May 18, 2022 /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 it has received a Notice of Allowance for U.S. patent application number 16/833,515 from the United States Patent and Trademark Office (USPTO) covering SLS-007 titled: “Structure-Based Peptide Inhibitors of Alpha-Synuclein Aggregation”.

This Notice of Allowance covers the method of treating several neurodegenerative diseases such as Alzheimer’s disease, Parkinson’s disease (PD), Lewy body dementia and multiple system atrophy, through contacting alpha-synuclein (α-synuclein) protofilaments with an effective amount of SLS-007.

Seelos is currently delivering SLS-007 via an adeno-associated virus (AAV) in a preclinical study designed to establish the in vivo pharmacokinetic and pharmacodynamic profiles and target engagement. SLS-007 is comprised of endogenously available amino acids and thus is expected to be a novel approach to target prevention of α-synuclein aggregation and slow disease progression in synucleinopathy diseases. Preliminary data from the study is expected in the second half of 2022.

About SLS-007

SLS-007 is a family of rationally designed peptide inhibitors that target the non-amyloid component core (NACore) of α-synuclein to inhibit protein aggregation in patients with PD. The overexpression of α-synuclein leads to the formation of α-synuclein aggregates which comprise Lewy bodies and Lewy neurites which are the hallmarks of the pathology in brains of patients with PD. Recent in vitro and cell culture research have shown that SLS-007 has the potential to stop the propagation and seeding of α-synuclein aggregates.

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), spinocerebellar ataxia (SCA), 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 potential for SLS-007 to be a disease-modifying gene focused on intracellular α-synuclein aggregates in PD, the initiation and completion of the preclinical study of SLS-007, the ability of SLS-007 and related peptides to slow the progression of PD by stopping the seeding and potential propagation of α-synuclein aggregates, the ability of SLS-007 delivered via an AAV to target the NACore, expectations regarding the results of the study, including the establishment of the in vivo pharmacokinetic and pharmacodynamics profiles and target engagement parameters of SLS-007 and the expected timing for releasing preliminary data regarding the 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 with Seelos’ business include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies 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
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

SOURCE Seelos Therapeutics, Inc.

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Seelos Therapeutics to Participate in the 2022 Jefferies Global Healthcare Conference

Seelos Therapeutics to Participate in the 2022 Jefferies Global Healthcare Conference

NEW YORK, May 12, 2022 /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 2022 Jefferies Global Healthcare Conference, June 8-10, 2022.

Raj Mehra, Ph.D., Chairman and CEO and Michael Golembiewski, CFO, will present on Friday, June 10th  at 12:00 PM ET and host 1×1 meetings.

The 2022 Jefferies Global Healthcare Conference is an annual gathering where over 500 public & private healthcare companies and 3,000 leading executives, institutional investors, private equity investors & VCs will address near-term and long-term investment opportunities and discuss the current trends driving healthcare in the U.S. and internationally.

Presentation webcast registration may be accessed here.

For questions about the conference, please email healthcareconference@jefferies.com.

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), spinocerebellar ataxia (SCA), 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 Avenue
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

SOURCE Seelos Therapeutics, Inc.

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Seelos Therapeutics to Participate in the B. Riley Securities’ Virtual Neuro and Ophthalmology Conference

Seelos Therapeutics to Participate in the B. Riley Securities’ Virtual Neuro and Ophthalmology Conference

NEW YORK, April 22, 2022 /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 B. Riley Securities’ Virtual Neuro and Ophthalmology Conference, April 27-28, 2022.

Raj Mehra, Ph.D., Chairman and CEO and Tim Whitaker, MD, Chief Medical Officer, will participate in a fireside chat on Wednesday, April 27th at 12:00 PM ET.

For registration: B. Riley Securities’ Virtual Neuro and Ophthalmology ConferenceAbout 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), spinocerebellar ataxia (SCA), 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
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue, 2nd 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

SOURCE Seelos Therapeutics, Inc.

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Seelos Therapeutics Announces Amendment of SLS-002 Agreement to Repurchase the Remaining Royalties Payable to Phoenixus AG for SLS-002 (Intranasal Racemic Ketamine Program), All Future Success and Commercial Based Milestones and the Change of Control Fee

Seelos Therapeutics Announces Amendment of SLS-002 Agreement to Repurchase the Remaining Royalties Payable to Phoenixus AG for SLS-002 (Intranasal Racemic Ketamine Program), All Future Success and Commercial Based Milestones and the Change of Control Fee

NEW YORK, April 11, 2022 /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 Phoenixus AG, formerly known as Vyera Pharmaceuticals AG (“Vyera”), for the development of SLS-002 (intranasal racemic ketamine) to repurchase in cash and stock the remaining royalties payable on any future net sales of SLS-002, all future success and commercial based milestones and the change of control fee in the event SLS-002 is acquired.  

On March 6, 2018, Seelos entered into an asset purchase agreement (the “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. In February 2021, Seelos amended the asset purchase agreement, for three additional cash payments, agreeing 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. Seelos completed those payments in February, June, and September of 2021. Under the amendment entered into on April 8, 2022, for additional cash and stock payments due by April 2022, July 2022 and January 2023, the parties have agreed to terminate in full all contingent payment obligations to Vyera and its related entities under the Purchase Agreement, effective upon the payment and issuance of all cash and stock payments.

“We believe this repurchase of the remaining financial obligations owed or that may become payable on SLS-002 has the potential to return meaningful future value to Seelos’ stockholders, assuming we are successful in the clinical development, regulatory approval processes, and commercialization of the intranasal ketamine program,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos.

“This amendment removes all future royalties due to Vyera, nearly $100 million of potential future milestones and a change of control fee in the event this program were to be acquired as a standalone transaction or as part of a larger transaction,” said Michael Golembiewski, CFO of Seelos.

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 looks 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), spinocerebellar ataxia (SCA), 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 ability of the royalty repurchase to return meaningful future value to Seelos stockholders, and Seelos’ ability to succeed in the clinical development, regulatory approval processes and commercialization of its intranasal ketamine program (SLS-002). 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, and not gaining marketing approvals for its product candidates, the risk that prior clinical 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
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue, 2nd Floor
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com 
www.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

SOURCE Seelos Therapeutics, Inc.

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Seelos Therapeutics Receives an Acknowledgement Letter of a Clinical Trial Notification from the Australian Government Department of Health Therapeutic Goods Administration for a Pilot Study of SLS-005 in Alzheimer’s Disease

Seelos Therapeutics Receives an Acknowledgement Letter of a Clinical Trial Notification from the Australian Government Department of Health Therapeutic Goods Administration for a Pilot Study of SLS-005 in Alzheimer’s Disease

NEW YORK, March 8, 2022 /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 it has received an acknowledgement letter of a Clinical Trial Notification (CTN) from the Australian Government Department of Health Therapeutic Goods Administration (TGA) for a pilot study of SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion) for the treatment of patients with Alzheimer’s disease.  

“Trehalose’s activity in Alzheimer’s disease is unique as it inhibits both the beta-amyloid pathology and tau aggregates in preclinical rodent models. This activity appears to be intraneuronal, occurring within the cell, which differs from the antibody-focused therapies. Both amyloid precursor protein and tau oligomers are cytoplasmic within the cell and can be acted upon by Trehalose by inducing autophagy and proteasomal systems. Autophagy has been implicated in degradation of other misfolded protein aggregates as well,” said Raj Mehra Ph.D., Chairman and CEO of Seelos. “We expect to gain evidence and important insights into the suitability of SLS-005 in the treatment of these neurological conditions, which are so physically, emotionally and financially devastating to patients and their families.”

In addition, Seelos received authorization to conduct a separate open-label basket study (ACTRN: 12621001755820) in Australia to evaluate the effectiveness of SLS-005 on disease progression and severity, as well as its safety and tolerability, in participants with selected neurodegenerative diseases including Huntington’s disease.

Australia’s regulatory body for clinical trials, the TGA, and the Australian Government’s Research and Development Tax Incentive provide a very attractive opportunity for small US biotech companies to initiate clinical trials in Australia in an effort to expedite the initiation of studies and utilize the country’s strong clinical trial capabilities.

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.  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 is an investigational treatment and is not currently approved by any health authority for medicinal use.

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’ pilot study of SLS-005 for the treatment of Alzheimer’s disease, statements regarding Seelos’ plan to conduct a separate open-label basket study, statements regarding SLS-005’s prospects and expected insights, and statements regarding the Company’s potential market opportunity. 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, and not gaining marketing approvals for its product candidates, the risk that prior clinical 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 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 Ave., 2nd Fl.  
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

SOURCE Seelos Therapeutics, Inc.

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Seelos Therapeutics Announces Year-End 2021 Business and Clinical Update

Seelos Therapeutics Announces Year-End 2021 Business and Clinical Update

NEW YORK, March 7, 2022 /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 its year-end 2021 business and clinical update.

“In the second half of 2021, we continued to accomplish several significant milestones and continued to execute in the face of one of the most difficult environments for publicly-traded biotech companies that I’ve seen in my career,” said Raj Mehra Ph.D., Chairman and CEO of Seelos. “We began the placebo-controlled Part 2 of the registration directed study of SLS-002 and plan to enroll in over 30 sites. The SLS-005 IV trehalose program’s registrational study in ALS, which was accepted into the HEALEY ALS Platform Trial at Harvard, commenced dosing participants in February 2022 and our IND was accepted to study SLS-005 in spinocerebellar ataxia and its Phase IIb/III pivotal study should begin dosing in Q2 2022. We have begun additional in vivo studies with our Parkinson’s disease focused gene therapy program SLS-004 after demonstrating its capability of reducing alpha-synuclein expression. We look forward to continuing to provide meaningful updates on the current state of progress on all of our programs as well as additional initiatives.”

Seelos Clinical Update

SLS-002 (intranasal racemic ketamine)

  • In July, Seelos began dosing patients in Part 2 of the registration directed, double-blind, placebo-controlled cohort in Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD).  
  • In June, based on feedback from a Type C meeting with the FDA, Seelos is planning to expand the size of the trial and number of sites now that this trial has been labeled registration directed.
  • In October, Seelos presented a poster titled “A Phase 2 Open Label Study of Efficacy, Safety, and Tolerability of SLS-002 (Intranasal Racemic Ketamine) in Adults with Major Depressive Disorder at Imminent Risk of Suicide“, at the 2021 IASR/AFSP International Summit on Suicide Research Virtual Conference. SLS-002 demonstrated rapid, robust and sustained reductions on the Montgomery-Åsberg Depression Rating Scale (MADRS), the Clinical Global Impression of Severity for Suicidal Ideation and Behavior, the Patient Global Impression of severity for Suicidal Ideation and Behavior, and the Sheehan-Suicidality Tracking Scale. Additionally, the group mean met the MADRS remission criteria initially on day 6 after only 2 doses of SLS-002.

SLS-005 (IV Trehalose)

  • In November, the FDA accepted Seelos’ Investigational New Drug (IND) application to study SLS-005 for the treatment of spinocerebellar ataxia (SCA). Seelos plans to initiate a Phase IIb/III registrational study in the first half of 2022.
  • The FDA granted the program Fast Track designation in the U.S. for SCA, and SLS-005 has previously received Orphan Drug designation for spinocerebellar ataxia type 3 (SCA3) from the FDA and from the European Medicines Agency in the EU.
  • Also in November, Seelos was an Emerald Sponsor of the 4th Annual ALS ONE Research Symposium where Dr. Mehra presented an update of the program.
  • In February 2022, Seelos commenced dosing of the first participants in a registrational Phase II/III trial in amyotrophic lateral sclerosis (ALS) as part of the HEALEY ALS Platform Trial led by Harvard Medical School at Massachusetts General Hospital at several dozen trial sites across the U.S.

SLS-004 and SLS-007 (Parkinson’s disease gene therapy programs)

  • In early July, Seelos released in vivo data demonstrating down-regulation of SNCA mRNA and protein-expression from a study of SLS-004 in an in-vivo rodent model utilizing CRISPR-dCas9 gene therapy technology.
  • Additional studies have commenced to explore efficacy of SLS-004 in the induced Parkinsonism in an in-vivo rodent model.
  • Seelos was issued a patent covering the composition of matter for SLS-007, a potentially disease-modifying gene therapy focused on intracellular alpha-synuclein (α-synuclein) aggregation in Parkinson’s disease (PD).

Seelos Business Update

  • In the second half of 2021, Seelos achieved several major clinical and financial milestones and continued to make progress on its multiple clinical stage development programs.
  • As of year-end 2021, Seelos had $78.7mm of cash.
  • Between August and December, Seelos presented at 8 investor conferences, multiple fireside chat format video calls for investors and 2 industry events for the scientific community.
  • In September, Seelos announced the promotions of Michael Golembiewski to Chief Financial Officer and Anthony Marciano to Chief Communications Officer.
  • Also in September, Seelos appointed Margaret Dalesandro, Ph.D., an accomplished biopharmaceutical executive with over 30 years of experience in drug development and commercialization, to its Board of Directors.
  • In October, Seelos was the platinum level sponsor of the American Foundation for Suicide Prevention’s Out of the Darkness Westchester County Walk in Mamaroneck, NY.
  • In November and December, Seelos raised $20.2 million in a private placement of senior secured convertible notes. Seelos will use the proceeds for general corporate purposes and to advance the development of its product candidates.
  • Also in November, Seelos acquired a worldwide license (excluding China, Taiwan, Macau and Hong Kong) from iX Biopharma Europe Ltd for Wafermine™, a sublingual racemic ketamine wafer, and a worldwide license for other sublingual ketamine wafers, delivered using a proprietary fast-dissolving wafer-based drug delivery platform technology known as WaferiX™.

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 complete clinical studies for its product candidates, Seelos’ ability to efficiently execute clinical and pre-clinical programs, opening additional trial sites for screening and dosing for the pivotal SLS-002 registration directed study (the “SLS-002 Study”), Seelos’ plan to initiate the SLS-005 Phase IIb/III registrational study for the treatment of SCA (with SLS-002 Study, the “Studies”). 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, or continuing or initiating the Studies, and not gaining marketing approvals for its product candidates, the risk that prior clinical results may not be replicated in future studies and trials (including the risk that the clinical results from the Studies are not replicated, or the risk that the clinical results from the SLS-002 Study are materially different from the topline clinical results of Part I of the SLS-002 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 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 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
Head of Corporate Communications
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue, 2nd 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

SOURCE Seelos Therapeutics, Inc.

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Seelos Therapeutics Announces Dosing of the First Participants in a Registrational Phase II/III Trial of SLS-005 in Amyotrophic Lateral Sclerosis on the HEALEY ALS Platform

Seelos Therapeutics Announces Dosing of the First Participants in a Registrational Phase II/III Trial of SLS-005 in Amyotrophic Lateral Sclerosis on the HEALEY ALS Platform

NEW YORK, Feb. 28, 2022 /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 the dosing of the first participants in its registrational Phase II/III trial studying the investigational treatment SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion) for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease) on the HEALEY ALS Platform Trial.

“Initiating this trial is a major achievement for Seelos and we are honored to be part of the HEALEY ALS Platform Trial. We look forward to offering this investigational therapy to people suffering with this debilitating disease,” said Raj Mehra Ph.D., Chairman and CEO of Seelos.  

“We are thankful to all the patients with ALS who participate in the HEALEY ALS Platform Trial and help develop new treatments in a much faster and more efficient approach.  Partnering with Seelos to determine the efficacy of SLS-005 in this platform trial will give answers sooner because of the sharing of data and infrastructure with other regimens in the platform trial,” added Merit Cudkowicz, MD, director of the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital, Chief of the Department of Neurology, and Principal Investigator of the HEALEY ALS Platform Trial.

Seelos’ Phase II/III trial (NCT05136885) plans to enroll 160 participants with either familial or sporadic ALS in a double-blind placebo-controlled trial. Participants will be randomized 3:1 (drug: placebo) and studied with a primary endpoint measuring change from baseline on Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) score at 24 weeks. Secondary endpoints will also be measured at 24 weeks, including change from baseline in slow vital capacity, muscle strength, quality of life measurements as well as additional signs of disease progression. 

If you are a patient (PALS) or caregiver of someone with ALS (CALS) and would like more information, please visit: https://seelostherapeutics.com/patients-and-caregivers/

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.  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.

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’ Registrational Phase II/III Trial of SLS-005 treatment of ALS  (the “Trial”), the number of patients to be enrolled in the Trial, the expected duration of the Trial, the primary and secondary endpoints to be evaluated in the Trial and statements regarding SLS-005’s prospects and statements regarding the Company’s potential market opportunity. 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, or continuing its Trial, and not gaining marketing approvals for its 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 Trial or other future trails and studies of SLS-005), 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 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 Ave., 2nd 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

SOURCE Seelos Therapeutics, Inc.

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Seelos Therapeutics Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

Seelos Therapeutics Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

NEW YORK, Dec. 21, 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 that it has granted a stock option to purchase 75,000 shares of common stock to one new employee. The stock option was granted pursuant to the Seelos Therapeutics, Inc. 2019 Inducement Plan and granted as an inducement material to the new employee entering into employment with Seelos in accordance with Nasdaq Listing Rule 5635(c)(4).

The stock option has an exercise price equal to $1.65, the closing price per share of Seelos’ common stock, as reported by Nasdaq, on December 20, 2021, the date of grant. The option is a non-qualified stock option and 1/4th of the shares vest on the one-year anniversary of the new employee’s commencement of employment and an additional 1/48th of the shares vest monthly thereafter over the next three years, in each case provided that the new employee remains continuously employed by Seelos through the applicable vesting date, inclusive.

Seelos is providing this information in accordance with Nasdaq Listing Rule 5635(c)(4).

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

This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about the employees and equity plans. Risks and uncertainties include risks associated with the Company’s employees and equity plans, and additional risks set forth in the Company’s filings with the Securities and Exchange Commission. These forward-looking statements represent the Company’s judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.  

Contact Information:
Anthony Marciano
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Ave., 2nd Fl.
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
www.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

SOURCE Seelos Therapeutics, Inc.

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Seelos Therapeutics to Participate in the 11th Annual LifeSci Partners Corporate Access Event

Seelos Therapeutics to Participate in the 11th Annual LifeSci Partners Corporate Access Event


NEW YORK, Dec. 16, 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 11th Annual LifeSci Partners Corporate Access Event, January 5-7th, 2022.Raj Mehra, Ph.D., Chairman and CEO will host 1×1 meetings virtually on Wednesday-Friday, January 5-7th, 2022.For information and registration: LifeSci Partners Corporate Access Event 2022About the 11th Annual LifeSci Partners Corporate Access EventThe LifeSci Partners 11th Annual Corporate Access Event will feature more than 200 innovative publicly traded and privately held biotechnology, medical technology, pharmaceutical, life sciences, and digital health companies from across the globe.This event will include 1×1 meetings with company senior management teams and panel discussions featuring KOLs, CEOs, specialized investors, and healthcare experts highlighting the most relevant topics impacting the life sciences industry today.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), Spinocerebellar ataxia (SCA), 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
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Ave., 2nd Floor
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com 
https://seelostherapeutics.com/ 
https://twitter.com/seelostx 
https://www.linkedin.com/company/seelosMike Moyer
Managing Director
LifeSci Advisors, LLC
250 West 55th St., Suite 3401 
New York, NY 10019
(617) 308-4306
mmoyer@lifesciadvisors.com Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/seelos-therapeutics-to-participate-in-the-11th-annual-lifesci-partners-corporate-access-event-301445887.htmlSOURCE Seelos Therapeutics, Inc.