Life Science NewsInvesting News

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the Phase 3 pivotal program design for COMP360 psilocybin therapy in treatment resistant depression (TRD) during a virtual Capital Markets Day. The session, attended by members of COMPASS Pathways' executive leadership and key opinion leaders, included a review of the TRD treatment landscape as well as COMPASS' clinical care and digital strategy, patientmarket access and commercial model, and broader development pipeline (recording available here ) .

COMPASS' program will be the first ever Phase 3 program of psilocybin therapy globally, and follows positive results from its Phase 2b study in treatment-resistant depression, presented at the American Psychiatric Association annual meeting in May 2022 . The Phase 3 program is composed of three clinical trials, two pivotal trials and one long-term follow-up, and is expected to commence by the end of 2022. The pivotal program design is as follows:

  • Pivotal trial 1 (COMP 005) (n=378): a single dose (25mg) monotherapy compared with placebo. This trial is designed to replicate the treatment response seen in the Company's Phase 2b study (n=233).
  • Pivotal trial 2 (COMP 006) (n= 568): a fixed repeat dose monotherapy using three dose arms: 25mg, 10mg and 1mg. This trial is designed to investigate if a second dose can increase the number of responders and/or improve response seen in the Company's Phase 2b study and explore the potential for a meaningful treatment response from repeat administration of COMP360 10mg.
  • The primary endpoint in both pivotal trials is the change from baseline in MADRS total score at Week 6.

COMPASS Pathways' Capital Markets Day featured the following speakers and topics:

Setting the Scene
George Goldsmith: Welcome and introduction to COMPASS
Kabir Nath: Introduction and agenda for the event
Charlie Nemeroff, MD, PhD , The University of Texas at Austin, Dell Medical School: New horizons in neuropsychiatry

TRD and COMPASS' Phase 3 Program
John Rush, MD , Duke University School of Medicine: TRD patient profile review
Guy Goodwin, MD/Trevor Mill: Phase 3 program and pivotal trial design
Sidney Zisook, MD , University of California, San Diego: Perspective on the COMPASS Phase 3 development program

COMP360 Psilocybin Therapy Delivery and Commercialization
Ekaterina Malievskaia, MD & Greg Ryslik: Clinical care innovation and digital tools
Marco Mohwinckel & Steve Levine, MD: Patient/market access and commercial model
Phyllis Foxworth, Depression and Bipolar Support Alliance: Patient perspective on living with TRD and psilocybin therapy

Beyond TRD
Guy Goodwin, MD: COMPASS' Phase 2 study in PTSD and IIS review
Walter Kaye, MD , University of California, San Diego: Unmet need and current treatment paradigm in Anorexia Nervosa
Guy Goodwin, MD: COMPASS' Phase 2 study in Anorexia Nervosa

Closing Remarks
Kabir Nath: Closing remarks

The virtual event was held on October 12 at 8:00 am ET (1 pm UK). The webcast replay is available here .

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

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", "plan", "believe", "estimate", "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, COMPASS's strategic plans or objectives, COMPASS's plans and expected timing for its phase III program in treatment resistant depression and the potential for that or other trials to support regulatory filings and approvals, the future accessibility of COMP360 psilocybin therapy, COMPASS's ability to launch and successfully commercial COMP360 psilocybin therapy, potential revenue streams if COMP360 psilocybin therapy is approved and COMPASS's ability to advance COMP360 psilocybin therapy in other areas of high unmet mental health need and to discover and advance new drug compounds. 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 most recent annual report on Form 10-K or quarterly report on Form 10-Q and in other reports we have filed with the U.S. Securities and Exchange Commission ("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.

Enquiries
Media: Amy Lawrence, amy@compasspathways.com , +44 7813 777 919
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324


Primary Logo

News Provided by GlobeNewswire via QuoteMedia

Compass PathwaysCMPS:USPsychedelics Investing
CMPS:US
Albert Labs

Albert Labs Announces Private Placement

Albert Labs International Corp. (Albert Labs [CSE: ABRT] [FSE: VB50], the "Company"), a biopharmaceutical drug discovery company focused on gaining regulatory approval for active compounds to treat various mental health conditions, has announced a non-brokered private placement for gross proceeds of up to $3,000,000 (the "Offering"), with the first tranche raised at a price of CAD $0.08 per Unit (the "Units"); intermediate closings may take place as determined by the Company.

Each Unit is comprised of one common share (the "Common Share") and one-half of one whole Common Share purchase warrant (each whole warrant, a "Warrant") with each whole Warrant entitling the holder to purchase one additional Common Share of the Company at a price of CAD $0.12 per Share for a period of 12 months from the date of issuance. In the event that the Company's common shares have a closing price on the CSE of greater than CAD $0.15 per common share for a period of 10 consecutive trading days, the Company may accelerate the expiry date of the Warrants by giving notice to the holders thereof and, in such case, the Warrants will expire on the 30th day after the date on which such notice is given to the holder by the Company.

Keep reading...Show less

Seelos Therapeutics to Hold a Research and Development Update Conference Call and Webcast on December 15, 2022

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 hold a research and development update conference call and webcast on Thursday, December 15 th from 1pm to 3pm ET .

(PRNewsfoto/Seelos Therapeutics, Inc.)

"As we approach, what we believe to be, a very important and catalyst heavy 2023 for Seelos, it is important that we update our investors about our progress and strategic plans," said Raj Mehra Ph.D., Chairman and CEO of Seelos. "We have been making great strides with our 3 ongoing registrational studies, completed insightful market research and will release and discuss exciting and encouraging preclinical data."

During the call, members of Seelos' senior management, in conjunction with several Key Opinion Leaders (KOLs), will provide updates to ongoing clinical studies, additional new preclinical data, recently completed market research and an overview of the company's strategic plans across its portfolio of clinical and preclinical stage programs.

Registration is available at https://lifescievents.com/event/seelos-therapeutics-kol-event/ , and an updated call itinerary will be released a few days prior to the call and available at http://seelostherapeutics.com .

About Seelos Therapeutics

Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare diseases. The Company's robust portfolio includes several late-stage clinical assets targeting indications including Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD), amyotrophic lateral sclerosis (ALS) and spinocerebellar ataxia (SCA), as well as early-stage programs in Huntington's disease, Alzheimer's disease, and Parkinson's disease.

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' expected timing to release new preclinical data, the topics expected to be discussed on the call and the expectation that 2023 will be a catalyst-heavy year. 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 clinical results may not be replicated in future studies and trials, the risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval, the risks associated with the implementation of a new business strategy, the risks related to raising capital to fund its development plans and ongoing operations, risks related to Seelos' current stock price, risks related to the global impact of COVID-19, as well as other factors expressed in Seelos' periodic filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact Information:

Anthony Marciano
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue, 2 nd Floor
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos

Mike Moyer
Managing Director
LifeSci Advisors, LLC
250 West 55th St., Suite 3401
New York, NY 10019
(617) 308-4306
mmoyer@lifesciadvisors.com

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/seelos-therapeutics-to-hold-a-research-and-development-update-conference-call-and-webcast-on-december-15-2022-301685770.html

SOURCE Seelos Therapeutics, Inc.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Awakn Life Sciences Announces Location for Larger Oslo Clinic

Awakn Life Sciences Announces Location for Larger Oslo Clinic

Awakn's Nordic expansion begins with new Awakn Clinics Oslo

 Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) ('Awakn'), a revenue-generating biotechnology company researching, developing, and commercializing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announces today the signing of a 5-year lease to open a larger Awakn Clinics Oslo. The move to the new Oslo premises is the first stage of Awakn's Nordic expansion plans.

News Provided by Newsfile via QuoteMedia

Keep reading...Show less
Wonderland 2022 Takeaways: What's After Approvals?

Wonderland 2022 Takeaways: What's After Approvals?

At the largest gathering of stakeholders and enthusiasts in an emerging psychedelics industry, a common thread prevailed — once approvals arrive, where will the industry be heading?

Wonderland offered a preview of what many industry experts see as the future of the nascent industry and how to get through the struggles seen in the stock market during 2022.

Here the Investing News Network (INN) offers a dispatch of highlights from the second edition of the Wonderland psychedelics event held by Microdose for the investors who might have missed out.

Keep reading...Show less
Nirvana Life Sciences Inc. announces agreement to acquire the licensed distributor of a Patented, WHO approved, herbal treatment for opiate addiction

Nirvana Life Sciences Inc. announces agreement to acquire the licensed distributor of a Patented, WHO approved, herbal treatment for opiate addiction

Nirvana Life Sciences Inc. (Nirvana or the "Company") (CSE: NIRV) a western Canadian based life sciences company aimed at developing psychedelic and other natural based medicines, including non-addictive chronic pain and relapse preventing pharmaceutical medicines, is pleased to report that it has entered an agreement to acquire the distributor of a leading addictions focused herbal treatment.

Nirvana Life Sciences Inc. logo (CNW Group/Nirvana Life Sciences Inc.)

Nirvana Life Sciences Inc. is pleased to announce that it has entered into an agreement to purchase Medsmart Dispensary Inc., the exclusive North American licensee for "SOSA", a patented herbal medicine designed to detoxify the human body. Nirvana will commence a formal due diligence process that reviews the clinical studies and scientific claims behind this novel product.

SOSA is a patented, WHO-approved, herbal treatment for opiate addiction that has been administered to more than 30 million patients in Asia . SOSA is registered with the health authorities in China , Indonesia , Thailand , Vietnam , and Cambodia and has been used to safely and effectively treat opiate addictions in these countries for over twenty years. A report from the WHO concluded that SOSA can be used "safely and effectively for heroin and other opiates addiction treatment, detoxification and acute heroin withdrawal symptoms". "In addition, the side effects are minimal and tolerable". SOSA has been proven to be effective at breaking the cycle of addiction to opioids and other opiate-based addictive drugs.

Medsmart holds the exclusive license to distribute SOSA for North America with the right to extend the license to territories including Europe , Oceana, and the balance of the Americas. Nirvana will acquire Medsmart in exchange for 5 million shares of Nirvana. The shares will be subject to certain statutory escrow conditions that may be required by the CSE, the transaction will be subject to regulatory and exchange approval.

The US Council of Economic Advisors estimate the cost of the Opioids Crisis to the US economy at more than $500 billion annually, this equates to almost 4% of GDP. In 2021, more that 75,000 Americans died of drug overdose, with around two-thirds of those deaths linked to opioids. The impact can be measured financially, with massive health care and insurance costs as well as the significant costs of law enforcement. It has been estimated that it will require a large investment, as much as $100 billion , to fully address the crisis. For many years, the pharmaceutical industry has promoted the use of highly addictive pain medications for the management of chronic pain. While these medications have been effective for pain relief, the highly addictive nature of the medications has created a problem with no practical solution. Current solutions proposing free or lower cost opioids are not a solution, society needs practical methods to break addiction, prevent relapse and replace addictive pain management therapies with non-addictive therapies.

Medsmart's Managing Director, Mr. Mahmoud Aziz , states; "We believe that the SOSA product can be a game changer in the effort to help those afflicted with opiates addiction related disorders. For several years, we have been seeking a partner who shares our vision for this product and are pleased to join with the Nirvana team to bring this product to North America . Nirvana's core focus on developing treatments for addictions makes this transaction a strategic one for both of our companies". "We have seen SOSA change lives and free many patients from their addictions, the positive impact has been extraordinary"

Nirvana CEO Bruce Clark stated: "The opportunity to acquire the rights to a therapy that has such a significant track record of success is a rare opportunity." "The Nirvana project was formed with the belief that our innovations can make a difference to people affected by this crisis, the addition of the SOSA product to our program brings the prospect of success much closer." "This acquisition will add a market ready product to our development portfolio and move our revenue generating projection ahead by more than three years."

About Nirvana Life Sciences Inc.

Nirvana Life Sciences Inc. has been founded with a simple objective of researching and developing non-addictive pain management and relapse prevention products that mitigate the symptoms of chronic pain and support patients who battle with addiction. Nirvana believes that pairing naturally sourced psychedelics with modern medicine holds the promise of delivering non-addictive therapeutic solutions. Backed by a team of global leading researchers, Nirvana will develop life changing therapies for those suffering from pain and addiction and consequently alleviate the fiscally strained medical system.

Forward Looking Statements

This news release contains certain forward-looking statements and forward-looking information (collectively referred to herein as forward- looking statements") within the meaning of Canadian securities laws including, without limitation, statements with respect to the future investments by the Company. All statements other than statements of historical fact are forward-looking statements. Undue reliance should not be placed on forward-looking statements, which are inherently uncertain, are based on estimates and assumptions, and are subject to known and unknown risks and uncertainties (both general and specific) that contribute to the possibility that the future events or circumstances contemplated by the forward- looking statements will not occur. Although the Company believes that the expectations reflected in the forward-looking statements contained in this press release, and the assumptions on which such forward- looking statements are made, are reasonable, there can be no assurance that such expectations will prove to be correct. Readers are cautioned not to place undue reliance on forward-looking statements included in this document, as there can be no assurance that the plans, intentions or expectations upon which the forward-looking statements are based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties that contribute to the possibility that the predictions, forecasts, projections and other forward-looking statements will not occur, which may cause the Company's actual performance and results in future periods to differ materially from any estimates or projections of future performance or results expressed or implied by such forward-looking statements. The forward-looking statements contained in this news release are made as of the date hereof and the Company does not undertake any obligation to update publicly or to revise any of the included forward-looking statements, except as required by applicable law. The forward-looking statements contained herein are expressly qualified by this cautionary statement.

SOURCE Nirvana Life Sciences Inc.

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/November2022/21/c1109.html

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less
Silo Wellness Wins Amendment to Proposed Land Use Ordinance for Oregon Psychedelic Ranch; Corporate Update: Shareholder FAQs

Silo Wellness Wins Amendment to Proposed Land Use Ordinance for Oregon Psychedelic Ranch; Corporate Update: Shareholder FAQs

Silo Wellness Inc. (CSE: SILO) (OTCQB: SILFF) (FSE: 3K7A) ("Silo Wellness" or the "Company") is pleased to announce that the Jackson County Planning Commission recommended to the elected commissioners the adoption of an amended land use ordinance that would allow Oregon psilocybin therapy service centers in a nature retreat setting in rural Jackson County. "This is a minor victory for Silo Wellness and for potential patients across the nation," said Silo Wellness founder and CEO Mike Arnold, an Oregon attorney. "As previously drafted, service centers would have been relegated to urban areas. Highway noise and sirens aren't exactly the best setting for psychedelic therapy. But there's still one more vote to go."

News Provided by Newsfile via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×