Life Science News

Albert Labs Validates Global Supply Chain for Controlled Substances

Albert Labs Validates Global Supply Chain for Controlled Substances

Albert Labs International Corp. (CSE: ABRT) (FSE: VB50), the "Company" or "Albert Labs"), a fully-integrated biopharmaceutical company bringing innovative prescription medicines to patients with unmet mental health needs, is pleased to announce the validation of their controlled substance supply chain through the successful global distribution of its psilocybin-based KRN Active Pharmaceutical Ingredient (API).

Albert Labs Logo, Validates Global Supply Chain for Controlled Substances (CNW Group/Albert Labs International Corp.)

Albert Labs have successfully distributed their proprietary KRN API from their Health Canada licensed laboratory in Vancouver . Only very few companies have the ability to globally distribute controlled substances of this classification, Schedule 1. This now enables the API to be used as part of their pre-clinical studies at its Infarmed licensed laboratory in Porto, Portugal . This distribution follows an extensive research and development programme allowing for the production and scaling of highly potent yields of its KRN API, for which IP protection has been achieved, using bioreactor technology to ensure the efficient and economical manufacture of its mycelium derived pharmaceutical product.

The company is nearing completion of their KRN-101 pre-clinical studies, which includes full analytical profiling, in-vivo, and in-vitro studies, allowing the medicine to be used in its first, in-human studies in Melbourne, Australia due to begin in Q2 2023 .

Dr. Michael Raymont , CEO of Albert Labs : "Validating our supply chain across two of our jurisdictions, North America and Europe , marks a valuable milestone in our operational program. We have demonstrated our ability to distribute KRN-101, a schedule 1 substance, to global, licensed facilities, and this achievement advances our progress by establishing the viability of our supply chain as we prepare for our first-in-human studies."

Business of Albert Labs International Corp.

Albert Labs is a fully-integrated biopharmaceutical company bringing innovative prescription medicines to patients with unmet mental health needs. Its team of experts leverage advanced culture technology and natural extraction, coupled with a comprehensive regulatory approach, to accelerate the development of mental health drugs, for which the needs are both urgent and unmet. Albert Labs looks to develop solutions through an approved, fast track clinical pathway focusing on Real World Evidence (RWE). RWE studies are an increasingly recognised clinical route, heavily used in oncology and recently, in the successful development of COVID-19 vaccines.

Through collaborations with research institutions, hospital centres and government agencies, Albert Labs uses existing clinical infrastructure to deliver and improve patient access to its treatment. Albert Labs' first drug target, KRN-101, is a potential solution for cancer-related anxiety, a market of over 15 million people with roughly 1 million new sufferers each year. From this initial focus, Albert Labs will address broader mental health concerns, reported to affect over a billion people worldwide.

The company's goal is to deliver effective medicines to those who suffer with their mental health in the shortest possible time without compromising safety and/or quality, while also providing significant returns to shareholders.

Albert Labs (CSE: ABRT) (FSE: VB50) is publicly listed on the Canadian Securities Exchange (CSE) .

You can find more details about Albert Labs on our website here .

ON BEHALF OF THE BOARD OF DIRECTORS

Albert Labs International Corp.

Dr. Michael Raymont

Chief Executive Officer, Chairman

Cautionary Statement

This news release includes forward-looking statements that are subject to assumptions, risks, and uncertainties. Statements in this news release that are not purely historical are forward-looking statements, including without limitation any statements concerning the Company's intentions, plans, estimates, beliefs, or expectations regarding the future. Although the Company believes that any such intentions, plans, estimates, beliefs, and expectations in this news release are reasonable, there can be no assurance that any such intentions, plans, beliefs, and expectations will prove to be accurate.

The Company cautions readers that all forward-looking statements, including without limitation those relating to the Company's future operations and business prospects, are based on assumptions none of which can be assured, and are subject to certain risks and uncertainties that could cause actual events or results to differ materially from those indicated in the forward-looking statements. Readers are advised to rely on their evaluation of such risks and uncertainties and should not place undue reliance on forward-looking statements.

Any forward-looking statements are made as of the date of this news release, and the Company assumes no obligation to update the forward-looking statements or to update the reasons why actual events or results could or do differ from those projected in the forward-looking statements. The Company assumes no obligations to update any forward-looking statements, whether as a result of new information, future events, or otherwise unless required by the applicable securities laws.

SOURCE Albert Labs International Corp.

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Albert Labs

Albert Labs Recognition of the TGA's Rescheduling of Psilocybin

Albert Labs International Corp. ([CSE: ABRT] [FSE: VB50], the "Company" or "Albert Labs"), a fully-integrated biopharmaceutical company bringing innovative prescription medicines to patients with unmet mental health needs, is delighted to recognise the decision of Australia's medicinal regulatory authority, the Therapeutic Goods Administration, to reschedule psilocybin and officially recognise its medical potential.

Last week the Australian Medicines Authority, the Therapeutic Goods Administration (TGA), announced their ground-breaking decision to officially recognise the potential clinical benefit of psilocybin as a medicine, becoming the first to do so. A key factor referenced in this decision being a lack of effective medicinal options currently available to patients, as well as the large and growing amount of highly promising research in the field.

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Albert Labs

Albert Labs Announces Private Placement

Albert Labs International Corp. (Albert Labs [CSE: ABRT] [FSE: VB50], the "Company"), a biopharmaceutical drug discovery company focussed 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 $300,000 (the "Offering"), at a price of CAD $0.048 per Unit (the "Units").

Each Unit is comprised of one common share of Albert Labs (the "Common Share") and one non-transferable Common Share purchase warrant (the "Warrant"). Each full Warrant will be exercisable to acquire one common share of Albert Labs at an exercise price of CAD $0.07 for 24 months from the date of the closing of the Private Placement. The Company may decrease the size of the Private Placement.

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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.

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Albert Labs signs Letter of Intent  with iNGEN? CRO for First In-Human Clinical Studies

Albert Labs signs Letter of Intent with iNGEN? CRO for First In-Human Clinical Studies

Albert Labs International Corp. ( Albert Labs (CSE: ABRT) (FSE: VB50), the "Company"), a pharmaceutical drug development company focused on gaining regulatory approval for novel medicines to treat various mental health conditions, signs a Letter of Intent (LOI) with full-service Contract-Research Organisation (CRO), iNGENū, to carry out the Company's first in-human study of its primary drug target, KRN-101.

Albert Labs Inc. logo (CNW Group/Albert Labs International Corp.)

This randomised, double-blind study will evaluate the safety and tolerability of KRN-101 in study participants and determine its full pharmacokinetic characterization. As a unique, natural medicine containing a range of bioactives, KRN-101 is required to have its own pharmacokinetic profile despite an extensive background of safety data to support psilocybin-based medicines. Profiling KRN-101 through this study will allow the Company to reap the long-term potential of having a differentiated product through extensive opportunities for intellectual property protection.

This study will take place in Melbourne, Australia , and including the collection of all clinical outputs, will be carried out over 8 weeks with an expected completion in Q3 2023. Upon completion, KRN-101 will be available for use in late-stage clinical trials, allowing the Company to proceed with its Real World Evidence trial in the United Kingdom , which will establish the efficacy of the treatment for cancer-related distress. This first in-human study also allows the Company to collect valuable data which will enable a future Investigational New Drug (IND) Application to be filed with the FDA, thus taking KRN-101 to the largest pharmaceutical market in the world.

The Company will also benefit from the Australian Federal Government's Research & Development incentive programme which will provide cash rebates for 43.5% of all eligible costs relating to the study.

The study will be carried out by iNGENū, a full-service CRO specialising in clinical trials for psychoactive pharmaceuticals, who work with a network of specialist consultants and research facilities across the South-East Pacific region to facilitate high quality and cost-effective research.

Dr. Sud Agarwal , CEO of iNGENū: "It's a privilege to have been selected as the CRO by Albert Labs' team of highly credentialed research experts to take the KRN-101 investigational product into first-in-human studies in Australia ."

"This study will be conducted by iNGENū CRO at a globally renowned research unit in Melbourne , and will yield critical data to help characterise the pharmacokinetics of KRN-101 and establish a recommended late-stage dose for future clinical trials."

Dr. Michael Raymont , CEO of Albert Labs : "We have carefully considered a range of partners for our first in-human study and are delighted to come to this agreement with iNGENū. We have been impressed by their capabilities and see a strong alignment with our core values as a company. We also greatly appreciate the assistance of the Australian Government for carrying out this research.  Through this partnership we will provide the highest standard of clinical due diligence, and risk mitigation for planned late-stage trials in the UK through expansion into the United States . We feel that this is a significant step forward in value creation for our shareholders."

Business of Albert Labs International Corp.

Albert Labs is a pharmaceutical drug development company, focused on gaining regulatory approval for novel medicines for the treatment of mental health, and providing rapid access to effective prescription medicines for people suffering from mental health disorders. Its team of experts leverage advanced culture technology and natural extraction, coupled with a comprehensive regulatory approach, to accelerate the development of mental health drugs, for which the needs are both urgent and unmet. Albert Labs looks to develop solutions through an approved, fast track clinical pathway focusing on Real World Evidence (RWE). RWE studies are an increasingly recognized clinical route, heavily used in oncology and recently, in the successful development of COVID-19 vaccines.

Through collaborations with research institutions, hospital centres and government agencies, Albert Labs uses existing clinical infrastructure to deliver and improve patient access to its treatment. Albert Labs' first drug target, KRN-101, is a potential solution for cancer-related anxiety, a market of over 15 million people with roughly 1 million new sufferers each year. From this initial focus, Albert Labs will address broader mental health concerns, reported to affect over a billion people worldwide.

Albert Labs (CSE: ABRT) (FSE: VB50) is publicly listed on the Canadian Securities Exchange (CSE) .

You can find more details about Albert Labs on our website here .

ON BEHALF OF THE BOARD OF DIRECTORS

Albert Labs International Corp.

Dr. Michael Raymont

Chief Executive Officer & Chairman

Cautionary Statement

This news release includes forward-looking statements that are subject to assumptions, risks, and uncertainties. Statements in this news release that are not purely historical are forward-looking statements, including without limitation any statements concerning the Company's intentions, plans, estimates, beliefs, or expectations regarding the future. Although the Company believes that any such intentions, plans, estimates, beliefs, and expectations in this news release are reasonable, there can be no assurance that any such intentions, plans, beliefs, and expectations will prove to be accurate.

The Company cautions readers that all forward-looking statements, including without limitation those relating to the Company's future operations and business prospects, are based on assumptions none of which can be assured, and are subject to certain risks and uncertainties that could cause actual events or results to differ materially from those indicated in the forward-looking statements. Readers are advised to rely on their evaluation of such risks and uncertainties and should not place undue reliance on forward-looking statements.

Any forward-looking statements are made as of the date of this news release, and the Company assumes no obligation to update the forward-looking statements or to update the reasons why actual events or results could or do differ from those projected in the forward-looking statements. The Company assumes no obligations to update any forward-looking statements, whether as a result of new information, future events, or otherwise unless required by the applicable securities laws.

SOURCE Albert Labs International Corp.

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Albert Labs provides Corporate Update

Albert Labs provides Corporate Update

Albert Labs International Corp. ( Albert Labs (CSE: ABRT) (FSE: VB50), the "Company"), a pharmaceutical drug development company focussed on gaining regulatory approval for active compounds to treat various mental health conditions, has published a corporate update highlighting the progress that has been made since closing its Series A private placement and some information on its future plans and activities.

Albert Labs, press release, psilocybin, mental health, cancer, pharma, biotech (CNW Group/Albert Labs International Corp.)

Overview – Series A Private Placement

Albert Labs completed its Series A private placement in tranches between February 2021 and March 2022 , an offering of 18,947,500 shares and gross proceeds of CAD$4,736,875 , with senior management investing CAD$2,690,215 and the balance of CAD$2,690,215 coordinated with support from Chrystal Capital Partners. This placement took place concurrently with a reverse take-over transaction that would see Albert Labs' shares trade on the Canadian Securities Exchange (CSE), subject to restrictions with a large proportion of shares held under escrow terms.

The Company's key strategies were, and remain as follows: (i) to manufacture and deliver natural psilocybin in the form of a prescription drug known as KRN-101 to trial centres, and (ii) to initiate Real World Evidence (RWE) trials, including all necessary partnerships, to lead to a regulatory approved medication for treating anxiety and depression, initially in cancer patients.

Operational Progress – 6-month Update

The Company has made substantial progress, in spite of an economic environment that has presented widespread challenges to financial markets and business operations across all sectors.

Some of the most significant milestones that have been achieved by the Company over the last 6-months include:

March 2022 :

  • Albert Labs International Corp. listing on Canadian Securities Exchange (CSE)
  • Filing US Provisional Patent for standardised and scalable manufacturing of natural pharmaceuticals, including KRN-101

April 2022 :

  • Established Pre-Clinical Advisory Board, chaired by globally-renowned toxicology expert, Dr Ricardo Dinis-Oliveira

May 2022 :

  • Granted Health Canada Licence for production, sale (through the Special Access Programme) and export of Schedule 1 substances
  • Successful technology transfer, procurement and implementation of pre-clinical programme at Schedule 1 analytical and toxicological laboratory in Porto, Portugal
  • RWE Clinical Trial protocols written (with partners at the University of Manchester , Christie Hospital, and National Cancer Research Institute) for the study of KRN-101 as a treatment for cancer-related distress, including Albert Labs' psychotherapy protocols

June 2022 :

  • Ethical approval received for Albert Labs' pre-clinical programme for KRN-101 toxicology studies at laboratory in Porto
  • Professor Sara Tai appointed as Lead Clinical Researcher for RWE Clinical Trial, Senior Clinical Psychology Professor at the University of Manchester

July 2022 :

  • Mike Thompson MBE, former CEO of the Association for the British Pharmaceutical Industry (ABPI) and Senior Vice-President of Commercial Strategy at GSK Global, and Katie Shelton-Innes , experienced UK growth company finance expert, appointed to Board of Directors

August 2022 :

  • New International PCT Patent Application (No. PCT/CA2022/051281) filed for proprietary manufacturing method, providing industry-leading levels of scalable and consistent natural Psilocybin-based pharmaceuticals

September 2022 :

  • Successful technology transfer and implementation of KRN-101 manufacturing process and quality assurance procedures ready for pre-clinical studies at laboratory in Porto

October 2022:

  • Received Good Laboratory Practice (GLP) accreditation for pre-clinical programme allowing for submission of pre-clinical data to global regulatory authorities (including MHRA, EMA and FDA)

In the near future, the Company will continue work on:

  • The completion of KRN-101 toxicology studies to GLP standards, ready for CTA, and available for licensing and Special Access Programmes;
  • Third-party validation (to Good Manufacturing Practice standard) of KRN-101 data for Clinical Trial Application (CTA);
  • Pre-CTA MHRA Scientific Advice Meeting
  • Partnership negotiations to extend clinical research into further regulatory jurisdictions

Dr. Michael Raymont , CEO of Albert Labs : "We have made significant progress over the last 6-months, establishing our pharmaceutical operations across three jurisdictions, the United Kingdom , European Union and North America . As is inevitable with an early-stage company, especially in the drug development R&D area, some milestones are achieved as planned, while others require "workarounds" or extensions."

A key differentiator for Albert Labs is the growth, extraction and use of a mycelium extract, which includes a spectrum of key bio-actives present in its natural form. Mycelium is a complex, living organism and there may be therapeutic value from the combination of key bio-actives present in our primary drug target, KRN-101. Using patent-pending, bioreactor-based manufacturing technology, the Company has been able to produce consistent, standardised, and pharmacologically valuable APIs'; KRN-101 is a unique asset that meets the highest product requirements for global regulatory standards. Most importantly, KRN-101 strengthens the long-term value of the company, not only as a potential therapeutic to treat millions but also offers potential for extensive intellectual property protection.

"Developing and refining our standardised, "quality-regulated" API production process is a major accomplishment, and the additional time we took resulted in a robust production process with additional intellectual property potential," said Dr. Raymont.

The Company has also been working on expanding its market access programme. Albert Labs primary focus is still the treatment of patients in the United Kingdom , by aiming for the execution of a Real World Evidence clinical trial and pursuing all corresponding reimbursement mechanisms. In addition, however, the Company is now in a position to start the process to pursue, in parallel, an Investigational New Drug (IND) Application in the US.  If successful, this would take KRN-101 directly into the largest pharmaceutical market in the world, the United States.

"We feel that the strategy of parallel tracking work toward both UK and US regulatory approval reduces risk as compared to the single-track approach, while at the same time, increasing and accelerating our developments over the longer term.  We will need to augment our resources to allow for the increased scope of work", said Dr. Raymont, adding, "Over the next few months, we will be working on some key milestones, which we need to reach in order to deliver our treatment in the clinical setting."

Business of Albert Labs International Corp.

Albert Labs is a pharmaceutical drug development company, focussed on gaining regulatory approval for active compounds in the treatment of mental health, and providing rapid access to effective prescription medicines for people suffering from mental health disorders. Its team of experts leverage advanced culture technology and natural extraction, coupled with a comprehensive regulatory approach, to accelerate the development of mental health drugs, for which the needs are both urgent and unmet. Albert Labs looks to develop solutions through an approved, fast track clinical pathway focusing on Real World Evidence (RWE). RWE studies are an increasingly recognised clinical route, heavily used in oncology and recently, in the successful development of COVID-19 vaccines.

Through collaborations with research institutions, hospital centres and government agencies, Albert Labs uses existing clinical infrastructure to deliver and improve patient access to its treatment. Albert Labs' first drug target, KRN-101, is a potential solution for cancer-related anxiety, a market of over 15 million people with roughly 1 million new sufferers each year. From this initial focus, Albert Labs will address broader mental health concerns, reported to affect over a billion people worldwide.

The company's goal is to deliver effective medicines to suffers with mental health concerns in the shortest possible time without compromising safety and/or quality, while also providing significant returns to shareholders.

Albert Labs (CSE: ABRT) (FSE: VB50) is publicly listed on the Canadian Securities Exchange (CSE) .

You can find more details about Albert Labs on our website here .

ON BEHALF OF THE BOARD OF DIRECTORS

Albert Labs International Corp.

Dr. Michael Raymont

Chief Executive Officer, Chairman

Cautionary Statement

This news release includes forward-looking statements that are subject to assumptions, risks, and uncertainties. Statements in this news release that are not purely historical are forward-looking statements, including without limitation any statements concerning the Company's intentions, plans, estimates, beliefs, or expectations regarding the future. Although the Company believes that any such intentions, plans, estimates, beliefs, and expectations in this news release are reasonable, there can be no assurance that any such intentions, plans, beliefs, and expectations will prove to be accurate.

The Company cautions readers that all forward-looking statements, including without limitation those relating to the Company's future operations and business prospects, are based on assumptions none of which can be assured, and are subject to certain risks and uncertainties that could cause actual events or results to differ materially from those indicated in the forward-looking statements. Readers are advised to rely on their evaluation of such risks and uncertainties and should not place undue reliance on forward-looking statements.

Any forward-looking statements are made as of the date of this news release, and the Company assumes no obligation to update the forward-looking statements or to update the reasons why actual events or results could or do differ from those projected in the forward-looking statements. The Company assumes no obligations to update any forward-looking statements, whether as a result of new information, future events, or otherwise unless required by the applicable securities laws.

SOURCE Albert Labs International Corp.

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Seelos Therapeutics Announces Registered Direct Offering of Common Stock and Warrants to Purchase Common Stock

Seelos Therapeutics, Inc. (Nasdaq: SEEL) ("Seelos"), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system (CNS) disorders and rare diseases, announced today it has entered into an agreement with a life sciences-focused investment fund for the sale of 12,059,298 shares of its common stock, pre-funded warrants exercisable for an aggregate of 9,340,702 shares of common stock and common warrants exercisable for an aggregate of 26,750,000 shares of common stock. The shares of common stock and accompanying common warrants are being sold at a combined offering price of $0.525 per share, and the pre-funded warrants and accompanying common warrants are being sold at a combined offering price of $0.524 per pre-funded warrant. All of the shares of common stock, pre-funded warrants and accompanying warrants to be sold in the offering will be sold by Seelos. The pre-funded warrants will be immediately exercisable following the closing of the offering and will have an exercise price of $0.001 per share. The common warrants will not be exercisable until after the six-month anniversary of the closing of the offering, will have an exercise price of $0.60 per share and will expire on the date that is five and a half years following the closing of the offering.

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COMPASS Pathways to participate in upcoming Cowen 43rd Annual Health Care Conference, Oppenheimer 33rd Annual Healthcare Conference, and Loop Capital Investor Conference

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that management will participate in three upcoming events as follows:

  • Cowen 43 rd Annual Health Care Conference: ‘Neuropsych Panel' at 12:50pm ET on March 6, 2023 and host investor meetings
  • Oppenheimer 33 rd Annual Healthcare Conference: presentation at 10:00am ET on March 13, 2023 and host investor meetings
  • Loop Capital Conference: host investor meetings on March 14, 2023

Live audio webcast of the panel and presentation will be accessible from the "Events" page of the Investors section of the COMPASS website. Each replay of the webcast will be accessible for 30 days following each event. For more information, please visit ir.compasspathways.com.

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Chronic Cluster Headaches No More: The Promise Of Lobe Sciences' At-Home Psychedelic Treatments Without The Trip!

Chronic Cluster Headaches No More: The Promise Of Lobe Sciences' At-Home Psychedelic Treatments Without The Trip!

(NewsDirect)

By Richard Dal Monte

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COMPASS Pathways Announces Fourth Quarter and Year-End 2022 Financial Results and Business Highlights

Highlights:
  • Phase 3 pivotal program underway - important updates announced
  • Phase 3 long term follow up defined
  • Cash position at 31 December 2022 of $143.2 million
  • Conference call today at 8:00am ET (1:00pm UK)

COMPASS Pathways plc (Nasdaq: CMPS) ("COMPASS"), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the fourth quarter and year-end 2022 and gave an update on recent progress across its business.

Kabir Nath, Chief Executive Officer, said, "During this past quarter, we commenced our COMP360 phase 3 pivotal program in treatment-resistant depression, a significant milestone for our area of science as these are the first ever phase 3 trials of psilocybin. We have also announced important updates to this program that accelerate the placebo-controlled trial pivotal data read out and streamline the long-term follow up as an integrated component of the pivotal trials. We are confident that this phase 3 program should generate the evidence to support a regulatory filing and to support broad patient access through integration into healthcare systems."

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COMPASS Pathways plc to announce fourth quarter and year-end 2022 financial results on 28 February 2023

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that it will release financial results for the fourth quarter and year-end 2022, and provide an update on recent business developments on 28 February 2023.

The management team will host a conference call at 8:00am ET (1:00pm UK) on 28 February. To access the call, please register in advance here to obtain a local or toll-free phone number and your personal pin.

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Nirvana Life Sciences

Nirvana Life Director Hoffmeister Resigns

Nirvana Life Sciences Inc., (CSE:NIRV) ("Nirvana" or the "Company") a Canadian based life sciences company aimed at developing non-addictive chronic pain and addiction treatment products announces that Mr. Chris Hoffmeister has resigned from the Company's Board of Directors. The Company thanks Mr. Hoffmeister for his service over the last 4 years.

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