NEW YORK, Dec. 6, 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 received an issued patent from the Japanese Patent Office (Japanese patent number 6968839, titled: STRUCTURE-BASED PEPTIDE INHIBITORS OF ALPHA-SYNUCLEIN AGGREGATION), 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 is currently conducting in vivo pre-clinical studies delivering SLS-007 via an adeno-associated virus (AAV) that is designed to target the non-amyloid component core (NACore) of α-synuclein to inhibit abnormal aggregation and accumulation of the α-synuclein protein in the brains of patients with Parkinson’s Disease (PD). The preclinical studies are designed to establish the in vivo pharmacokinetic and pharmacodynamic profiles and target engagement parameters of SLS-007.
As previously announced, Seelos was issued a composition of matter patent for SLS-007 in the U.S. in October 2020.
About SLS-007
SLS-007 is a family of rationally designed peptidic inhibitors that target the NACore of α-synuclein to inhibit abnormal aggregation and accumulation of this protein in the brains of patients with PD. The overexpression of α-synuclein leads to the formation of α-synuclein aggregates which comprise Lewy bodies and neurites which are the hallmarks of the pathogenesis of 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.
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 aggregation 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, 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. 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.
– New SLS-003 Program Extends Seelos’ Ketamine Franchise into Additional Indications Including Chronic Neuropathic Pain and Additional Psychiatric Disorders
– Program has been Granted Orphan Drug Designation in the US for the Treatment of Complex Regional Pain Syndrome
NEW YORK, Nov. 24, 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 it has entered into an exclusive license agreement (License Agreement), whereby it acquired a worldwide license (excluding China, Taiwan, Macau and Hong Kong) from iX Biopharma Ltd (iX Biopharma) 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™.
Seelos plans to evaluate sublingual ketamine, now named SLS-003, in pain indications such as chronic neuropathic pain and Complex Regional Pain Syndrome (CRPS) and in additional psychiatric disorders, including post-traumatic stress disorder (PTSD).
The US Food and Drug Administration (FDA) has granted Wafermine™ Orphan Drug designation for the treatment of CRPS.
“Our licensing of this new program broadens Seelos’ ketamine franchise with a formulation that we believe will be more suitable for chronic dosing in indications like CRPS and PTSD, which are both very difficult indications to treat effectively,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos. “The pharmacokinetic, pharmacodynamic and safety profiles of SLS-003 that have been demonstrated to date suggest a formulation with the potential of being prescribed with less restrictions than current formulations. Our team is very excited to be developing both acute, in SLS-002, and a potentially chronic, in SLS-003, ketamine-based therapy programs. We look forward to initiating studies with SLS-003 in 2022 and our recent capital raises have accounted for the expected development costs for initiating studies.”
“We are delighted to collaborate with Seelos Therapeutics, whose deep insights in ketamine drug development make them an ideal partner to further the development of Wafermine™ and the other sublingual ketamine products,” said Eddy Lee, Chairman and CEO of iX Biopharma. “Licensing our WaferiX™-based pharmaceutical drugs to suitable third parties for development and commercialization is a core strategy to unlock the value of our assets. We are therefore excited that this commercially significant agreement with Seelos is a validation of our ability to deliver on this strategy.”
Pursuant to the License Agreement, Seelos will pay iX Biopharma a one-time, upfront fee of $9,000,000, comprised of $3,500,000 in cash and $5,500,000 in restricted shares of Seelos’ common stock for the worldwide license for Wafermine™ (excluding China, Taiwan, Macau and Hong Kong), the worldwide license for WaferiX™ in other ketamine formulations, and clinical supplies. Seelos will also pay iX Biopharma certain milestone payments contingent on achievement by Seelos of certain development, regulatory and commercial milestones and a low double-digit royalty on future net sales of certain licensed products.
About iX Biopharma LTD
iX Biopharma is a specialty pharmaceutical and nutraceutical company listed on the Catalist board of the Singapore Exchange Securities Trading Limited (SGX-ST), operating a fully integrated business model from drug development to manufacturing and supply, with facilities in Australia. The Group is focused on the development and commercialization of therapies for diseases of the central nervous system using novel, patent-protected formulations for sublingual delivery.
The licensed products utilize iX Biopharma’s patented sublingual wafer technology, known as WaferiX™, to disintegrate under the tongue rapidly for faster therapeutic action and predictable dosing. In pharmacokinetic studies, sublingual delivery using WaferiX™ increased bioavailability of active compounds when compared to oral administration, while avoiding excessively high peak plasma concentrations typical of IV bolus dosing.
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 disorders. The Company’s robust portfolio includes several late-stage clinical assets targeting psychiatric and movement disorders, including orphan diseases. Seelos is based in New York, New York.
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 related to the efficacy and potential applications for the Licensed Products and associated Wafermine technology; the satisfaction of the conditions related to any contingent milestone or royalty payments; and the funding of all future development, manufacturing and commercialization of the Licensed Products. 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 risks that Seelos will not realize the expected benefits from the license with iX Biopharma, 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.
NEW YORK, Nov. 24, 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 the placement of a $22.0 million senior secured convertible note (the “Note”) and shares of Seelos common stock (the “Closing Shares”) to Lind Global Asset Management V, LLC, managed by The Lind Partners, a New York institutional fund manager and an existing investor in Seelos. Seelos will receive $20.0 million in gross proceeds.
Seelos intends to use the proceeds for general corporate purposes and to advance the development of its product candidates.
“2021 has been a volatile year for the biotech sector and this financial commitment from the team at Lind further strengthens our balance sheet and provides for additional future funding,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos. “The team at Lind has been a terrific partner for us and their creative and innovative funding solutions are thoughtfully and strategically designed to fit the needs of their partners. We are proud to once again work together, and we look forward to the continued execution of our ongoing and future studies.”
The following are some of the key features of the Note:
36-month maturity with a 0% coupon for the first year
After the first anniversary, the Note shall bear interest at an annual rate of 5% per annum and interest payments will be required monthly thereafter
Repayment of principal in 24 monthly payments beginning in November 2022 equal to the then-outstanding principal amount of the Note, divided by the number of months remaining until the Note’s maturity date
Any principal and interest repayments may be made, at the Company’s sole discretion, in cash, common stock, or a combination of both
Starting 9 months after the date of issuance of the Note, convertible at Lind’s option into shares of Seelos common stock at a fixed conversion price of $6.00 per share
Seelos has the right to prepay (i) up to 66 2/3% of the outstanding principal amount of the Note prior to the nine-month anniversary of the issuance date of the Note, and (ii) up to the entire outstanding principal amount of the Note on or after the nine-month anniversary (or, if Seelos prepays any amount of the Note during the first nine months, the 12 month anniversary) of the issuance date of the Note, subject to Lind’s right to convert a portion of the Note at $6.00 per share in certain circumstances
The agreement includes up to an additional $30.0 million of funding in senior secured convertible notes based on achievement of certain future milestones, which may be either at the option of Seelos or with the mutual agreement of Seelos and Lind depending on the milestone
“Lind is once again pleased to increase our investment in Seelos to help fund multiple registrational studies,” said Phillip Valliere, Managing Director at The Lind Partners. “Raj and the Seelos team have continued to execute at a very high level since our initial funding last December and we are glad to re-invest to fund further development of their pipeline.”
The Note and the Closing Shares were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the Note, have not been registered under the Act or applicable state securities laws. Accordingly, the Note, the Closing Shares and the underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.
This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.
About The Lind Partners
The Lind Partners manages institutional funds that are leaders in providing growth capital to small- and mid-cap companies publicly traded in the US, Canada, Australia and the UK. Lind’s funds make direct investments ranging from US$1 to US$30 million, invest in syndicated equity offerings and selectively buy on market. Having completed more than 100 direct investments totaling over US$1 Billion in transaction value, Lind’s funds have been flexible and supportive capital partners to investee companies since 2011.
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 disorders. The Company’s robust portfolio includes several late-stage clinical assets targeting psychiatric and movement disorders, including orphan diseases. Seelos is based in New York, New York. 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 related to Seelos’ expectations on the anticipated use of proceeds from the financing and the additional potential $30.0 million of funding and achievement of milestones thereunder. 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 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 and general market conditions, 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
NEW YORK, Nov. 10, 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 has been selected to present at the 4th Annual ALS ONE Research Symposium, November 29-30th, 2021.
Raj Mehra, Ph.D., Chairman and CEO will present as part of the industry updates on Tuesday, November 30th from 2:00-3:00pm ET to discuss SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion) for the treatment of amyotrophic lateral sclerosis (ALS) which is the most recent regimen to be added on the HEALEY ALS Platform Trial.
The HEALEY ALS Platform Trial is designed to evaluate multiple investigational treatments simultaneously, thus accelerating the development of effective and breakthrough treatments for people living with ALS. Trehalose would be the fifth regimen in the Platform Trial. The Sean M. Healey & AMG Center for ALS works closely with the Northeast ALS Consortium (NEALS) and industry partners to tailor the Platform Trial arm to their experimental study drugs.
About ALS ONE
ALS ONE is a collaboration bringing together world-leading ALS researchers, doctors, and care practitioners focused on finding treatments for ALS and novel approaches to improve care and quality of life for individuals currently living with the disease. The unprecedented linking of minds and resources from Massachusetts General Hospital (MGH), University of Massachusetts Medical Center, ALS Therapy Development Institute (ALS TDI), and Compassionate Care ALS (CCALS) is unique for its leadership in efficiency, dedication to innovative research, and commitment to increasing access to care and treatment.
ALS ONE’s collaboration includes Dr. Merit Cudkowicz, MD, MSc, Chief of Neurology, Massachusetts General Hospital (MGH); Dr. Robert Brown Jr., MD, DPhil, Chief of Neurology, UMass Medical Center; Dr. James Berry, MD, Co-Director of the MGH Neuromuscular Division and of the MGH ALS Unit; Dr. Fernando Vieira, MD, Chief Executive Officer, ALS Therapy Development Institute; and Ron Hoffman, Founder and Director Compassionate Care ALS (CCALS).
The Sean M. Healey & AMG Center at Massachusetts General Hospital, in collaboration with the Northeast ALS Consortium (NEALS), has launched the first ever platform trial for ALS. This project aims to greatly accelerate the timelines towards effective ALS treatments and to provide greater trial access for patients affected by this devastating disease.
The HEALEY ALS Platform Trial’s investigational new drug application (IND) was approved by the FDA in January 2020 and is a collaborative effort with the initial goal of 54 clinical trial sites prepared to enroll patients this year across the U.S. to provide greater access to patients wishing to participate.
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.
NEW YORK, Nov. 8, 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 the U.S. Food and Drug Administration (FDA) has accepted Seelos’ Investigation New Drug (IND) application to study SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion) for the treatment of spinocerebellar ataxia (SCA). The FDA has also 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.
“SCA is a highly debilitating neurodegenerative disease that currently lacks a cure or an approved therapeutic and as such, patients manage symptoms through physical therapy and other symptomatic treatments,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos. “SLS-005 has already displayed encouraging open label human data in SCA3, the most common type of SCA, and our team has taken that experience and knowledge into the design and plans for our global Phase IIb/III placebo-controlled study. We look forward to initiating this study in early 2022 and our recent capital raises have accounted for the expected development costs for initiating this study.”
Prior to Seelos acquiring the program, SLS-005 had already been studied in a six-month open label Phase IIa study that also included an additional six-month follow up in patients with SCA3, also known as Machado-Joseph Disease (Zaltzman 2020). The open label study evaluated 14 patients with SCA3 over a six-month period and found the average score on the Scale for Assessment and Rating of Ataxia (SARA), a well-recognized clinical tool for measuring functional impairment associated with the disease, remained stable. Six patients received treatment for as long as 12 months and continued to maintain stable SARA scores. In comparison, natural history data suggests that individuals with SCA3 would be expected to show a measurable increase on SARA within a 12-month period, which is indicative of disease progression and worsening of symptoms.
Additionally, Seelos was named as one of the initial members of the National Ataxia Foundation (NAF) Drug Development Collaborative, an industry consortium that has the principal goal of accelerating the development of treatments for Ataxia.
“On behalf of the National Ataxia Foundation and the ataxia community we represent, we’re thrilled that Seelos Therapeutics has received both IND acceptance and Fast Track designation from the FDA,” said Andrew Rosen, NAF Executive Director. “Seelos is a founding member of the NAF Drug Development Collaborative and NAF looks forward to working closely with Seelos to support the company as its program progresses.”
About Spinocerebellar Ataxia
Spinocerebellar Ataxia is a serious disease caused by degeneration of the cerebellum with an onset usually in adult life. Clinically, it is characterized by progressive unsteadiness of gait and stance, impaired coordination of limb movements, slurred speech, and abnormal eye movements. Spinocerebellar ataxia type 3, also known as Machado-Joseph disease (MJD), is characterized by progressive cerebellar ataxia and is known to cause progressively severe disability and often premature death approximately 10-20 years from onset of symptoms.
About the National Ataxia Foundation (NAF) and the NAF Drug Development Collaborative
NAF is a nonprofit organization established in 1957 to help persons with ataxia and their families. The Foundation’s mission is to accelerate the development of treatments and a cure while working to improve the lives of those affected by ataxia. NAF is the only organization in the United States dedicated to the disease that serves all types of ataxias. NAF works closely with the world’s leading ataxia researchers, promoting exchanges of ideas and innovation in ataxia discovery.
The NAF Drug Development Collaborative provides a centralized source for access to resources needed to support research and development of ataxia therapies. Members will benefit from the integration of the patient experience with sound ataxia scientific and clinical expertise. NAF brings more than 60 years of experience in supporting patients and caregivers and connecting them with research and clinical trial opportunities. NAF has also funded a network of ataxia clinicians at sites around the US that will be a critical component of the Collaborative’s work. Specific objectives of the Collaborative include natural history and biosample data collection, development of biomarkers, validation of rating scales, clinical trial design, patient-reported outcomes, and other data necessary for the development and approval of safe and effective therapies.
Trehalose is a low molecular weight disaccharide (0.342 kDa) that crosses the blood brain barrier, stabilizes proteins, and importantly activates autophagy, which is the process that clears material from cells. In several animal models of diseases, associated with abnormal cellular protein aggregation or storage of pathologic material, it has been shown to reduce aggregation of misfolded proteins and reduce accumulation of pathologic material. Trehalose activates 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.
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 design and plans for the global Phase IIB/III placebo-controlled study of SLS-005 in SCA (the “Study”), the expected timeline for commencing the Study and Seelos’ available capital and expected development costs to initiate the Study. 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 initiating the Study, 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 Study or other future trials 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.
_____________________
Zaltzman R, Elyoseph Z, Lev N, Gordon CR. Trehalose in Machado-Joseph Disease: Safety, Tolerability, and Efficacy. Cerebellum. 2020 Oct; 19(5):672-679. doi: 10.1007/s12311-020-01150-6. PMID: 32514820.
NEW YORK, Nov. 2, 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 Guggenheim Healthcare Talks, Idea Forum, 3rd Annual Neuro/Immunology Day on November 15-16th and in The Benchmark Company 10th Annual Discovery One on One Investor Conference on December 2nd, 2021.
Guggenheim Healthcare Talks, Idea Forum, 3rd Annual Neuro/Immunology Day
Raj Mehra, Ph.D., Chairman and CEO, will host 1×1 meetings virtually on Monday and Tuesday, November 15-16th
Yatin Suneja, Senior Biotechnology Analyst at Guggenheim Securities, LLC will host a fireside chat with Dr. Mehra on Tuesday, Nov. 16th at 2:20pm ET
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.
– Data from the Part 1 Open-Label Portion of the Study Demonstrated a Rapid, Robust, and Sustained Improvement on all 4 Scales Utilized Measuring Depression and Suicide
– Data Demonstrated the Group Mean Met the MADRS Responder Criteria at All Times Points Measured from 24 Hours Through Day 29/30 of the Study
– Data Demonstrated the Group Mean Met the MADRS Remission Criteria Initially at Day 6 of the Study
NEW YORK, Oct. 25, 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 presented a poster on Part 1, the open-label portion, of the study of SLS-002 (Intranasal Racemic Ketamine) at the IASR/AFSP International Summit on Suicide Research Virtual Conference.
Clinical Improvements in Four Scales over Study Duration in 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
The 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, 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 (CGIS-SI/B), the Patient Global Impression of severity for Suicidal Ideation and Behavior (PGIS-SI/B), and the Sheehan-Suicidality Tracking Scale (S-STS).
“SLS-002 demonstrated a rapid onset of action, impressive efficacy and a sustained improvement from the first dose through the end of the study, including the group mean meeting the MADRS remission criteria initially on Day 6 after only 2 doses,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos. “Meeting these early criteria for response and remission is highly encouraging considering that these patients were not only severely depressed but also acutely suicidal.”
This open-label portion of the study enrolled 17 subjects diagnosed with major depressive disorder (MDD) requiring psychiatric hospitalization due to significant risk of suicide with a baseline score of > 28 points on the MADRS, a score of 5 or 6 on MADRS Item-10, a score of > 15 points on the S-STS total score and a history of previous suicide attempt(s), as confirmed on the Columbia Suicide Severity Rating Scale (C-SSRS) with a history of at least one actual attempt, or if the attempt was interrupted or aborted, is judged to have been serious in intent.
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 (“INDs”). The lead program is focused on the treatment of ASIB in MDD. 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 an efficacious drug to treat suicidality in the United States. 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 and when they are effective, it often takes weeks for the full therapeutic effect to be manifested. We believe there is a large opportunity in the United States and European markets for products in this space. Based on information gathered from the databases of the Agency for Healthcare Research and Quality, there were approximately 1,000,000 visits to emergency rooms for suicide attempts in 2013 in the United States 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 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’ 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 (the “Study”), statements regarding SLS-002’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 the Study, 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 Study are not replicated), 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.
NEW YORK, Sept. 9, 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 M-Vest Advances in Mental Health, Psychedelic and Non-Psychedelic Virtual Conference on September 22nd and the Cantor Virtual Global Healthcare Conference, September 27th-30th, 2021.
(PRNewsfoto/Seelos Therapeutics, Inc.)
M-Vest Advances in Mental Health, Psychedelic and Non-Psychedelic Virtual Conference
Raj Mehra, Ph.D., Chairman and CEO will participate in a Depression Panel titled: “Spravato opened the door, what comes next?”, on Wednesday, September 22nd at 2:00pm ET.
The panel discussion will be moderated by Jason McCarthy, Ph.D., Head of Biotechnology Research at Maxim Group.
Raj Mehra, Ph.D., Chairman and CEO, will participate in a fireside chat on Wednesday, September 29th at 10:00am ET and host 1×1 meetings via conference calls.
The fireside chat will be moderated by Charles C. Duncan, Ph.D., Senior Biotechnology Analyst at Cantor Fitzgerald.
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.
NEW YORK, Sept. 2, 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 appointment of Margaret Dalesandro, Ph.D. to its Board of Directors.
Dr. Margaret Dalesandro is an accomplished biopharmaceutical executive with over 30 years of experience in drug development and commercialization. She held senior executive leadership positions at ImClone Systems, Inc. and in her role as Vice President of Project, Portfolio and Alliance Management, she managed the successful development of ERBITUX (cetuximab), which contributed significantly to the $6.5 billion sale of ImClone to Eli Lilly and Company in 2008. Prior to ImClone Systems Inc., Dr. Dalesandro served as an Executive Director of Cardiovascular/Oncology Project/Portfolio/Alliance Management at GlaxoSmithKline plc. Earlier in her career, she was Director of Cardiovascular Research and Assistant Director of Immunobiology Research and Development, Pharmaceutical Division, at Centocor, Inc. where her research contributed to the successful development of REMICADE (Infliximab).
“Margaret brings an enormous amount of drug development and commercialization experience to Seelos,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos. “We expect significant contributions from her as we proceed with late-stage development of several of our assets in the clinic.”
She is the founder and currently president of Brecon Pharma Consulting LLC, a full-service pharmaceutical and biotechnology consultancy focused on identifying and obtaining critical information early in product development.
Dr. Dalesandro holds M.A. and Ph.D. degrees in Biochemistry from Bryn Mawr College and completed an NIH Postdoctoral fellowship in Molecular Immunology at Wake Forest University. Dr. Dalesandro is Chair of the Board of Directors of OncoSec Medical Incorporated and a member of the Board of Directors of Skye Bioscience, Inc.
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: https://seelostherapeutics.com, the content of which is not incorporated herein by reference.
Forward Looking Statements
Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements are based on management’s 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. All information in this press release is as of September 1, 2021 and we undertake no duty to update this information. A more complete description of these risks can be found in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year-ended December 31, 2020 and our Quarterly Report on Form 10-Q for the quarter-ended June 30, 2021.
NEW YORK, Sept. 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 the promotions of Michael Golembiewski to Chief Financial Officer and Anthony Marciano to Chief Communications Officer, each effective September 1, 2021.
“I congratulate Michael and Anthony on their promotions, which are a testament to their abilities, hard work and dedication to Seelos,” said Raj Mehra Ph.D., Chairman and CEO of Seelos.
Mr. Golembiewski joined Seelos in January 2019 as Vice President, Finance. Previously, he was Vice President of Finance at Agile Therapeutics, Inc., a pre-commercial biotechnology company. He was also Vice President of Finance, Principal Accounting Officer and Corporate Controller at Pernix Therapeutics Holdings, Inc., a global commercial life sciences company. He was also Executive Director, Corporate Controller at NPS Pharmaceuticals, Inc., a global commercial life sciences company that was sold to Shire plc in 2015 for $5.2 billion. Mr. Golembiewski began his career in the biotechnology field with ImClone Systems Incorporated. He is a Certified Public Accountant (not in public practice) and obtained his Bachelor of Science degree in accounting from Rider University.
Mr. Marciano began his work with Seelos as a consultant in August 2017 and was appointed Head of Corporate Communications in January 2019. His role at Seelos will continue to be spearheading investor and media relations, introductions to advocacy groups, investment bank interactions and general corporate communications strategies. Mr. Marciano began as a healthcare-dedicated institutional equity salesman at Leerink, Swann and Company (currently Leerink Partners, LLC) in 2000 and immediately prior to Seelos served as a Senior Vice President at Jefferies. He has extensive experience interacting with the hedge fund and mutual fund communities and deep knowledge of the investment banking process including the structuring and placement of equity and debt transactions. Mr. Marciano holds a Bachelor of Science degree in Finance and Marketing from Manhattan College and a Master of Business Administration from the O’Malley School of Business at Manhattan College.
Also, during the month of August, several Seelos employees, including certain members of senior management, purchased shares of Seelos stock in the open market.
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 are based on management’s 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. All information in this press release is as of September 1, 2021 and we undertake no duty to update this information. A more complete description of these risks can be found in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year-ended December 31, 2020 and our Quarterly Report on Form 10-Q for the quarter-ended June 30, 2021.
We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept”, you consent to the use of ALL the cookies.
This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
Cookie
Duration
Description
cookielawinfo-checkbox-analytics
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional
11 months
The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy
11 months
The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
