Psychedelics

Seelos Therapeutics, Inc. a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced its year end 2020 business update. "This past year marked the most significant 12 months in Seelos Therapeutics' history despite being an otherwise challenging year due to the COVID-19 pandemic.  We completed our safety trial for the ...

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 2020 business update.

"This past year marked the most significant 12 months in Seelos Therapeutics' history despite being an otherwise challenging year due to the COVID-19 pandemic.  We completed our safety trial for the intranasal ketamine program and began opening centers for our pivotal trial for Acute Suicidal Ideation and Behavior in patients with major depressive disorder. The trehalose program's pivotal study in ALS was accepted into the HEALEY ALS Platform Trial at Harvard and we began our first in vivo studies of SLS-004 and SLS-007, our gene therapy Parkinson's programs. Seelos received additional patents around the world, orphan drug designations in the US and Europe for various programs plus a Rare Pediatric Disease Designation for SLS-005," remarked Raj Mehra Ph.D., Chairman and CEO of Seelos. "We look forward to 2021 as we embark on clinical studies in two unmet needs, namely imminent suicidality and ALS. We have expanded the Seelos team by adding several experienced industry veterans as full-time Seelos employees to efficiently execute clinical and preclinical programs."

Seelos Team Update

Over the past six months, Seelos expanded its team with the hiring of four full-time employees and the addition of a consultant to aid in the development of key programs.

In addition, Tim Whitaker , MD will now serve as Chief Medical Officer (CMO) for Seelos, formerly serving as Head of Research and Development, and Warren W. Wasiewski , M.D., F.A.A.P. will now serve as Senior Neuro Advisor.

Jessica Kardish , Kimberly Farrand , Lucas Pilipski and Manira Rayamajhi , have all accepted full-time positions at Seelos as follows:

  • Jessica Kardish joined Seelos in January 2021 as Seelos' VP, Clinical Development and Operations. Ms. Kardish has over 25 years of drug development and operations experience in mid-size and small pharma companies, primarily in CNS and rare disease spaces. During her 11 years at Shire Pharmaceuticals, Ms. Kardish had a successful track record which included five global regulatory approvals. She holds a Bachelor of Science from Dickinson College and a Master's in Public Health from The Johns Hopkins University .
  • Kimberly Farrand joined Seelos in July 2020 as Seelos' Senior Director, Clinical Development and Operations. Ms. Farrand possesses over 20 years of experience in the industry and spent over 17 years at Shire Pharmaceuticals prior to its acquisition by Takeda Pharmaceutical Company. She holds a Bachelor of Science in Chemistry from Penn State and a Master's in Public Health in Epidemiology from The George Washington University .
  • Lucas Pilipski joined Seelos in December 2020 as Seelos' Executive Director of Clinical Operations. Mr. Pilipski has over 17 years of industry experience and spent over four years at Sanofi S.A. and eight years at Shire Pharmaceuticals. He holds a Bachelor of Science in Biology from William Patterson University and a Master's of Science in Biology from Villanova University .
  • Manira Rayamajhi , Ph.D.,  joined Seelos in July 2020 as Seelos' Associate Director, Global Regulatory Affairs. She has 10 years of experience spanning multiple therapeutic areas and in all phases of development. She was a Postdoctoral Research Fellow at the University of North Carolina at Chapel Hill for 5 years and previously worked at Carmago Pharmaceutical Services, Syneos Health, and MMS Holdings in various capacities. Dr. Rayamajhi holds a Bachelor of Arts in Biology and Chemistry from Wesleyan College and a Ph.D. in Immunology from the University of Colorado Denver .

David M. Biondi , DO, FAAN has also joined Seelos as a consultant with an extensive background in medical practices and the pharmaceutical industry. Dr. Biondi served as a neurologist in the United States Navy and later in community and academic practice settings. He held medical affairs and clinical development roles at Janssen Pharmaceuticals, Johnson & Johnson, and Alder Biopharmaceuticals. He most recently served as Executive Director for Clinical Programs at Cohen Veterans Bioscience and currently sits on their Board of Directors. Dr. Biondi holds a Bachelor of Science in Pharmacy from Long Island University , a Doctor of Osteopathic Medicine from The University of New England and served his Neurology Residency at the US National Naval Medical Center in Bethesda, MD .

Seelos Business Update

In 2020, Seelos Therapeutics achieved several major milestones and continued to make progress on its multiple clinical stage development programs.

SLS-002 (intranasal racemic ketamine)

  • In March, completed a Type C meeting with the FDA for advice on a regulatory pathway and two-part pivotal trial design
  • In the second quarter, released final safety data of Phase I pharmacokinetics/pharmacodynamics study showing a safe and well tolerated side effect profile at the highest dose levels
  • In the fourth quarter, initiated trial sites in screening and dosing patients for the open-label 16 patient Part A study
  • Received a new patent in Japan for anxiety due to phobic disorders

SLS-005 (IV trehalose)

  • In the third quarter, received a "may proceed" notice from FDA to initiate pivotal Phase IIb/III trial in ALS
  • In December, SLS-005 was selected for the HEALEY ALS Platform Trial led by Harvard Medical School at Massachusetts General Hospital
  • SLS-005 received US Orphan Drug Designation (ODD) in ALS and Sanfilippo syndrome and European ODD for Sanfilippo syndrome
  • Granted Rare Pediatric Disease Designation for SLS-005 in Sanfilippo syndrome
  • Received multiple patents in US and Israel

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

  • In the second quarter, initiated preclinical in vivo studies of both SLS-004 and SLS-007 in Parkinson's disease
  • In September, announced a sponsored research agreement with Duke University for gene therapy studies of SLS-004
  • In October, received a patent covering composition of matter for SLS-007

Upcoming Catalysts

SLS-002 (intranasal racemic ketamine)

  • Potentially pivotal Proof of Concept study commenced in December, and Seelos is continuing to open trial sites for screening and dosing
  • First data readout upon completion of the first 16 patients in the Part A open-label portion

SLS-005 (IV trehalose)

  • Pivotal Phase IIb/III trial in ALS to begin in the first half of 2021 in the HEALEY ALS Platform Trial

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

  • SLS-007 Preclinical data on delivery and target engagement expected in Q1 2021
  • SLS-004 Preclinical data expected mid-2021

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 product candidates for imminent suicidality and ALS, Seelos' ability to efficiently execute clinical and pre-clinical programs, the hiring of certain employees and consultants, including their ability to aid in the development of key programs, the safety profile of SLS-002, the final safety data of SLS-002, the potential pivotal proof of concept study for SLS-002, opening additional trial sites for screening and dosing for the pivotal proof of concept study for SLS-002, the commencement of the pivotal Phase IIb/III trial of SLS-005 for ALS in the HEALEY ALS Platform Trial, the expected timing for preclinical data regarding the delivery and target engagement of SLS-007, and the expected timing for preclinical data for SLS-004. 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 Ave., 12th 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

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SOURCE Seelos Therapeutics, Inc.

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Awakn Life Sciences Files Patent Application for a New Class of Entactogen-Like Molecules to Treat a Broad Range of Addictions

Awakn Life Sciences Files Patent Application for a New Class of Entactogen-Like Molecules to Treat a Broad Range of Addictions

Novel Entactogen NCE Series Enhances the Potential for Improved Treatment of Addiction

Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) ('Awakn'), a biotechnology company, researching, developing and delivering psychedelic therapeutics to treat addiction, announces the filing of a patent application for a new chemical series of entactogen-like molecules, further strengthening Awakn's intellectual property portfolio and pipeline for the treatment of a broad range of addictions including, but not limited to substance addictions such as Alcohol, and behavioural addictions, such as Gambling Disorder and Compulsive Sexual Behaviour.

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Levitee Labs Inc. (CSE: LVT) (OTC: LVTTF) (FSE: 7H7) (the "Company" or "Levitee"), an integrative wellness company with a diversified portfolio of healthcare and wellness assets, is pleased to announce the appointment of David Jenkins and Amin Lahijani to the Board. Mr. Jenkins is a global financier who works with high-net-worth individuals. He has extensive experience in public markets and has helped secure millions of dollars in capital in private and public sectors. He is a highly regarded expert in negotiating, marketing, and advertising. Mr. Jenkins has completed hundreds of multimillion-dollar deals throughout his career, demanding top price for assets in all market conditions. Mr. Jenkins brings in-depth market knowledge and experience to the company.

Mr. Lahijani has a bachelor's from the University of Simon Fraser in Kinesiology. Mr. Lahijani has worked for multiple years as a kinesiologist specializing in injuries and recovery specifically focusing on the lower lumbar. Recently Mr. Lahijani has ventured into entrepreneurship. Mr. Lahijani Holding executive roles for 15 years with a variety of businesses with significant revenues.

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Two thirds of physicians surveyed believe psilocybin therapy has potential benefit for patients with treatment-resistant depression

London, UK and New York, US, 19 January 2022

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, and Sermo, a global leader in physician insights, today announced findings from a survey of Sermo physician members that showed two thirds (66%) of doctors surveyed believe psilocybin therapy has potential therapeutic benefit for patients with treatment-resistant depression (TRD).

More than 320 million people globally suffer with major depressive disorder (MDD) i the leading cause of disability worldwide and one of the fastest growing mental health illnesses ii . About a third of these patients 100 million people aren't helped by existing therapies and suffer with TRD iii .

Psilocybin therapy is an approach being investigated for the treatment of mental health challenges, including TRD. It combines the pharmacological effects of a synthesised version of psilocybin, a psychoactive substance that is an active ingredient in some species of mushrooms, with psychological support iv .

The survey of 259 Sermo member physicians, sponsored by COMPASS, was conducted in November 2021 and completed by participants from the US, the UK, France, Italy, Denmark, Spain and the Netherlands. Doctors were asked their views on the future of psychiatric therapy and the potential role of psilocybin therapy.

Key survey findings:

  • 66% of doctors surveyed believe psilocybin therapy has potential benefit for patients with TRD
  • 50% would prescribe psilocybin therapy, if it was approved; 32% are undecided
  • The greatest potential advantages to psilocybin treatment are believed to be: improved efficacy in treatment-resistant conditions (30%), rapid onset of action (26%), and different mechanism of action from existing therapies (19%)
  • The greatest potential barriers to treatment were cited as: needing a dedicated space for six to eight hours (28%), lack of trained therapists in a new model of psychological support (21%), and office infrastructure (15%)
  • Opinions on the optimal setting for psilocybin administration varied by region: 50% of European respondents said hospital; 42% of US respondents said specialised network of centres
  • Physicians also noted the need to educate healthcare professionals on the potential benefits of psilocybin therapy and on how to incorporate the therapy into their practice, if approved

"Severe mental illnesses, such as treatment-resistant depression, have affected too many people in society for too long. Physicians are looking for new approaches to accelerate the healing process, particularly for patients for whom current therapies have failed," said Murali Doraiswamy MBBS, FRCP, Professor of Psychiatry and Behavioural Sciences at Duke University School of Medicine, and an advisor to Sermo.

Dr Guy Goodwin, Chief Medical Officer, COMPASS Pathways, said: "These findings underline the fact that physicians need more options in helping patients suffering with treatment-resistant depression. COMPASS is developing COMP360 psilocybin therapy through a rigorous programme of research in the hope that we can offer just such an option. It's very encouraging to see that so many doctors see the potential that psilocybin could have and these insights will help us to understand how to introduce COMP360 psilocybin, with psychological support, into medical systems, if approved."

-Ends-

Survey methodology

The survey was designed to assess attitudes towards the use of psilocybin therapy in general, in psychiatry. The survey was conducted online via Sermo's RealTime platform and the random sample of physicians received compensation for their time and expertise. Survey limitations include sampling bias, inability to deduce causality from opinion polls, confounding variables not measured, and other factors.

About COMPASS Pathways

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p www.compasspathways.com


Availability of other information about COMPASS Pathways

Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.


Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as "may", "might", "will", "could", "would", "should", "expect", "intend", "plan", "objective", "anticipate", "believe", "contemplate", "estimate", "predict", "potential", "continue" and "ongoing," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, the safety or efficacy of psilocybin therapy, including COMP360, as a treatment for depression, COMPASS's business strategy and goals, including its ability to launch and commercialise products, COMPASS's expectations for the timing of its pivotal phase III programme and the potential for that or other trials to support regulatory filings and approvals, COMPASS's ability to continue to advance its research or develop plans to bring its product candidates to patients, including COMP360, clinicians' perceptions of the potential advantages and efficacy of COMP360 in relation to other available therapies, including any new therapies that may be approved for the indications we are investigating, and COMPASS's expectations regarding the benefits of psilocybin therapy and the effectiveness of its executive team. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond COMPASS's control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

These risks, uncertainties, and other factors include, among others: preclinical research and clinical development is lengthy and uncertain, and therefore our preclinical studies and clinical trials may be delayed or terminated, or may never advance to or in the clinic; and those risks and uncertainties described under the heading "Risk Factors" in COMPASS's annual report on Form 20-F filed with the US Securities and Exchange Commission (SEC) on 9 March 2021 and in subsequent filings made by COMPASS with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, COMPASS disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on COMPASS's current expectations and speak only as of the date hereof.

About Sermo

Sermo turns physician experience, expertise, and observations into actionable insights for the global healthcare community. Engaging with more than 1.3 million HCPs across 150 countries, the company provides physicians with a social platform and unique community that fosters impactful peer-to-peer collaboration & discussions about issues that are important to them and their patients. Sermo offers on demand access to physicians via a suite of proprietary technology to provide business intelligence that benefits pharmaceutical, healthcare partners, and the medical community at large. To learn more, visit www.sermo.com .


Enquiries

Media: Tracy Cheung, tracy@compasspathways.com, +44 7966 309024
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324


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  • Offering is priced at $0.20 per offered unit, with a full warrant at $0.40 for 24 months
  • Proceeds to be used for organic and inorganic growth initiatives and refocusing the company on clinical healthcare with a focus on addiction services

Levitee Labs Inc. (CSE: LVT) (OTC: LVTTF) (FSE: 7H7) (the " Company " or " Levitee "), an integrative wellness company with a diversified portfolio of healthcare and wellness assets, is pleased to announce that it is proposing to complete a non-brokered private placement (the " Private Placement ") of up to 15,000,000 units (the " Units ") at a price of $0.20 per Unit for aggregate gross proceeds of up to CAD$3,000,000. The Private Placement is subject to approval from the Canadian Securities Exchange.

Each Offered Unit will be composed of one common share of the Corporation (a " Unit Share ") and one common share purchase warrant (each whole warrant, a " Warrant "). Each Warrant will be exercisable at $0.40 per share for a period of 24 months from the date of issuance. The Company will pay a finder's fee of 8% on the gross proceeds of the Private Placement from subscribers introduced by certain finders, and will issue such number of finder's warrants (" Finder's Warrants ") as is equal to 8% of the Units sold to subscribers introduced by certain finders. Each Finder's Warrant will entitle the holder thereof to purchase one common share of the Company (a " Finder's Warrant Share ") at a price of $0.40 per Finder's Warrant Share for a period of twenty-four (24) months from the date of issuance. All securities issued under the Private Placement will be subject to a four month and one day hold period. The Offered Units are expected to be eligible for registered accounts.

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On Wednesday, January 12, 2022, OTC Markets informed the Company that it became aware of certain promotional activities concerning the Company and its common stock traded on the OTCQB Marketplace, specifically the distribution of promotional emails on January 12, 2022, by third-parties discussing the growing ketamine revolution, citing the Company's potential growth in the space. Upon review, the Company determined that a third party, which was not engaged by the Company or any of its officers, directors, controlling shareholders or any third-party service providers distributed promotional emails. The Company had no editorial oversight of the promotional material or any opportunity to review in advance of the distribution; however, the Company has subsequently reviewed the specific details related to the Company that were included in such promotional emails, and has confirmed these details to be factual. The Company wishes to caution readers that the statements made in such promotional emails are speculative in nature. For more complete and specific information regarding the Company, its prospects and the risks associated with those prospects, readers should review the Company's public filings on SEDAR, its website and other reliable sources. The Company encourages investors to contact their investment advisors prior to making any investment.

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