Seelos Therapeutics, Inc. 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 has accepted Seelos' Investigation New Drug application to study SLS-005 for the treatment of spinocerebellar ataxia . The FDA has also granted the program Fast Track designation in the U.S. for ...

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 mgmL 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.

For more information on NAF: https://www.ataxia.org/

About Trehalose

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.

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
www.seelostherapeutics.com
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos

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Gwella logo

Gwella Mushrooms


Overview

As one of the most prominent rising stars of the psychedelic and wellness space, functional mushrooms present an immense market potential set to reach into the billions.

Global market research projects the market for functional mushrooms could grow to a CAGR of 8.0 percent by 2024 from US$5.8 billion in 2018. More impressively, analysts report that the global wellness economy is valued at US$4.5 trillion, with estimates trending upward. With margins like these and shifting legal frameworks surrounding the recreational use of psychedelic medicines, investors can't ignore the economic upside and shifting tides that this emerging industry and market could have in the coming years.

Gwella is a Canadian-based psychedelic wellness company focused on building an accessible, original and scalable over-the-counter portfolio of functional and psychedelic mushroom products that enhance individual and community wellness. The company's advanced direct-to-consumer platform combines an innovative mix of wellness, mushrooms and psychedelics with a modern twist in an integration of media and technology.



Each element of its ecosystem works together in a flywheel to build loyalty, engagement and appeal to consumer desires influenced by purchasing behaviors. Gwella Media, Wellness and Technology work together to create a leading hub of psychedelic Consumer Packaged Goods (CPG), curated media content and B2B and B2C technology IP. The expertly crafted platform drives Gwella closer to becoming a household name in psychedelics and wellness for the modern, technological age.

Driven by a consumer-first approach, the company has built a robust portfolio of products and continues to drive its dual focus for wellness and psychedelic balance and appeal to consumers looking to explore both spaces. Gwella's proprietary elements, including exclusive access to highly valued ingredients, create a perfect harmony of branding and product design and delivery.

Gwella Wellness is the company's purpose-built consumer product vertical. Using exclusive ingredients, formulations, delivery systems, testing and research, Gwella Branded CPG tackles health and wellness through high volume avenues in retail, e-commerce and clinical, retreat and legal jurisdictions. Its product pipeline includes Gwella's flagship Mojo, Journey, and incoming MYMYCO, Yugen and Anxiety Strips, with more products in development.

Mojo, the company's first psychedelic asset is the world's first psilocybin-free Microdose product with a provisional patent filed and clinical trials underway. Mojo Microdose was hailed as Consumer Product of the Year during the 1st Annual Microdose Awards. The psychedelic-based gummy edible utilizes proprietary elements, exclusive and premium ingredients and is engineered over 12 months of R&D. Likewise, the flagship product contains proprietary IP, including high Bioactive Cordyceps concentrate and 14 different bioactives.

Gwella has also made strides to disrupt the psychedelic media space. Its content platforms cover an intersection of psychedelics and wellness, providing resources and tools for responsible usage and updates on the latest trends. Combining commerce and content, the company hopes to work in community creation, branding building, data monetization and affliction through ad revenue.

Unlike other major players in the wellness and psychedelic space, Gwella occupies unique positioning with its development of technological tool suite and IP. Its CAPture app, the company's first proprietary B2B and B2C tools are currently live and in private beta. The one-of-a-kind platform works to process real-time data of consumption and behavior habits to forecast trends for the psychedelic consumer market.

The next steps for Gwella include delivering its much-anticipated Yugen, MYMYCO and Anxiety Strips in 2022. The company also intends to launch innovative psychedelic nutraceutical products by 2023. With an emphasis on perfecting its proprietary delivery systems, novel stacks and developing daily product and subscription services, Gwella has given investors a lot to be excited about.

Gwella's management team brings together scientists, mushroom experts and brand builders with over 50 years of combined CPG experience and a proven track record in launching and driving over C$100 million in sales for some of the top brands in the world, including the Body Shop, Dermalogica and Starbucks. Likewise, the company has an award-winning creative marketing team to bring its vision to new heights and growing markets. Together, this leadership team primes Gwella for exceptional growth and expansive economic potential across emerging psychedelic markets.

Company Highlights

  • Gwella is building a leading brand and modern alternative wellness platform that exists at the intersection of three megatrends: functional health, mushrooms and psychedelics.
  • Gwella aims to curate an ecosystem of products, content and tools that work together as a flywheel and central hub for the mainstream audience interested in psychedelics and wellness.
  • Gwella's flagship product, Mojo, is the world's first psilocybin-free Microdose product with a provisional patent filed and clinical trials underway.
  • Gwella Technology involves the company's first proprietary B2B and B2C tool suite, CAPture app, which processes real-time data consumption and market intelligence to forecast current trends in psychedelic consumer markets.
  • The company's content platform covers an intersection of psychedelics and wellness through a media IP and emphasis on community creation.
  • The next steps for Gwella include focusing on developing its technology and media channels as well as its robust R&D pipeline with six further products in development.
  • The company leverages advantageous positioning with its proprietary IP, including high Bioactive Cordyceps concentrate
  • The company is backed by some of the top funds in the psychedelic and CPG space, including Vine Ventures, Ambria, Vice Ventures, The Conscious Fund, Palo Santo and JLS Fund.
  • The company has a top-tier management team with over 50 years of CPG experience and a proven track record of success across multiple industries and big brand exposure.

Key Products

Mojo

Mojo contains a complex blend of 14 active ingredients including their proprietary full-spectrum Cordyceps Sinensis (CS-4) mushroom concentrate. Gwella's patented thin layer technology compounds novel stacks, delivering powerful benefits to consumers in more concentrated margins that are naturally derived.

Mojo simulates the reported pharmacological effects of microdosing psilocybin and is designed to optimize performance by harnessing the power of fully legal mushrooms and botanicals.

Gwella has begun clinical trials for Mojo and commenced sales for the product, which is already generating revenue. The combination of unique and premium ingredients, proprietary elements and well-engineered R&D prime Mojo for exceptional scalability and economic growth potential.

MYMYCO: Mushroom Grow-Kit

MyMyco is an easy-to-set-up mushroom grow-kit supported by educational resources and expertly curated community information. Intended mushroom types in the kit include Lion's Mane, Grey or Pink Oyster and Reishi. MyMyco is projected to launch in 2022.

Yugen: Wellness Beverage

Yugen is a one-of-a-kind drink that supports people who are intermittent fasting, on the keto diet or simply trying to maintain their weight through alternative wellness means. The drink contains a proprietary stack of functional ingredients and adaptogens, primarily derived from the fungi family. Gwella expects to launch Yugen in 2023.

Gwella Technology: CAPture App

Gwella Technology involves the exciting next steps in the company's journey to becoming a household name in the psychedelic and wellness space. Its first-ever CAPture App platform processes real-time consumer data and consumption habits to compile forecasted data of the next best trends for the psychedelic consumer market. The company is currently developing a suite of B2B and B2C tools, which helps better grasp consumer demographics, purchase data and trending updates to gain a competitive edge in this ever-evolving market.

Gwella Media

Gwella's media IP and content platform combine the perfect storm of psychedelics and wellness. The intersection of commerce, social media and content provides resources and tools for responsible usage and keeps up with the latest trends consumers want to know. Emphasizing community, brand recognition, market research and e-commerce, the company utilizes major media avenues like blogs, podcasting and video content under one cohesive brand.

Management Team

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Peter Reitano - Founder & CEO

Peter Reitano is an entrepreneur and investor with over a decade of experience in scaling some of the world's top brands. Reitano has built, advised, raised for, and sold multiple ventures and is an active participant and early adopter in the wellness and 'vice' space. He is especially interested in the transformational potential of psychedelics and the evidence-backed use of entheogens and is currently working on improving access to these substances. Reitano is also the co-founder of Abacus Agency and has held multiple advisor roles for several companies.

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Stefany Nieto - Co-founder & COO

As COO, Stefany Nieto engineers the execution of strategic goals for Gwella while fostering a collaborative team culture and building customer-centric partnerships. She previously founded Green Iglu, an award-winning food sovereignty start-up that builds food production facilities in remote communities across Canada, including the Arctic. As Executive Director within Green Iglu, she oversaw operations and led corporate partnerships including Google, Ernst and Young, and the Government of Canada.

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Vinay Sharma - CDO

Vinay Sharma has earned over ten years of experience delivering growth via digital marketing for over 100 brands serving clients ranging from CPG, B2B, travel, fashion, automotive, and health sector with a focus on high measurable growth. He has led 100 percent of YoY growth for eCommerce clients for the past few years consecutively in revenue. Recently, Sharma has worked with a FinTech start-up and led their user acquisition, where we have gathered over 20k users in just four months since releasing a public beta.

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Erin Cochrane - Co-Founder & Director of Product

Erin Cochrane is the co-founder and director of Product at Gwella and co-founder & facilitator of Healing While Healing community support network. She is passionate about individual and collective empowerment towards well-being and regeneration of the natural world. In pursuing this passion she has held multiple positions across sustainability-focused companies and has held the operations & development director position at Regenesis.

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Daniel Sanders - CSO

Daniel Sanders has held multiple positions across the biotechnology sector including research technician, CRO, research coordinator, director and more. Sanders currently is the president of ARextracts and director of research and business development at MaryGold Laboratories, LLC.

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