COMPASS Pathways plc announces first quarter 2022 financial results and business highlights

COMPASS Pathways plc announces first quarter 2022 financial results and business highlights

Highlights:

  • End of phase II meeting held with FDA
  • Award of Innovation Passport as part of the UK MHRA Innovative Licensing and Access Pathway ILAP
  • Finalising phase III in TRD program design to be ready for second half of 2022
  • Pioneering collaboration with King’s College London and South London and Maudsley NHS Foundation Trust, to create The Centre for Mental Health Research and Innovation in the UK
  • Cash position at 31 March 2022 of $243.7 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 first quarter 2022 and gave an update on recent progress across its business.

George Goldsmith, Chairman, CEO and Co-founder, COMPASS Pathways, said, “COMPASS made great progress this quarter including a productive end-of-phase II FDA meeting and we are actively working to finalise our phase III programme,. Moreover, we continue to push the boundaries of brain health research as we broaden our pipeline and partnerships. This includes our clinical trial of COMP360 therapy in post-traumatic stress disorder, or PTSD, a condition of significant unmet need for improved patient outcomes. Our strong cash position enables us to move forward at pace.”

Business highlights

COMP360 psilocybin therapy in treatment-resistant depression (TRD):

  • Positive results from groundbreaking phase IIb clinical trial
  • Positive results from open-label study of 25mg COMP360 psilocybin therapy as adjunct to selective serotonergic reuptake inhibitor, or SSRI, antidepressants
  • End-of-phase II meeting held with FDA in April 2022
  • Award of Innovation Passport as part of the UK MHRA Innovative Licensing and Access Pathway (ILAP).
  • Finalising Phase III in TRD programme to be ready for second half of 2022
  • FDA granted breakthrough therapy designation
  • 10 granted patents issued to date covering composition, formulation and method of use

Additional COMP360 development programmes:

  • Phase II trial in PTSD ongoing at Kings College London
  • Investigator-led study in adults with autism spectrum disorder (ASD) announced, the first ever study of psilocybin in adults with ASD, co-sponsored by Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London and South London and Maudsley NHS Foundation Trust
  • Positive early signals seen in investigator-initiated studies in anorexia nervosa and severe treatment-resistant depression, presented at the Society of Biological Psychiatry Annual Meeting in New Orleans
  • Investigator-initiated studies underway across additional indications including new study in autism sponsored
  • Identification of new potential novel drug candidates through the COMPASS Discovery Center and an exclusive research project with Dr Matthias Grill
  • Strategic partnership formed to launch The Centre for Mental Health Research and Innovation to accelerate research and develop new models of mental healthcare in the UK

Financial highlights

  • Net loss for the three months ended 31 March 2022 was $21.2 million, or $0.50 loss per share (after including non-cash share-based compensation expense of $3.1 million), compared with $12.7 million or $0.35 loss per share, during the same period in 2021 (after including non-cash-share-based compensation expense of $1.7 million).
  • R&D expenses were $15.4 million for the three months ended 31 March 2022, compared with $6.9 million during the same period in 2021. Of this increase, $5.1 million was attributable to increased external development expenses as COMPASS progresses its COMP360 psilocybin therapy in TRD, and continues to explore additional indications and therapeutic approaches. A further $2.6 million and $1.0 million were attributable to personnel expenses and non-cash share-based compensation respectively, due to increased headcount. This was partially offset by a decrease of $0.2 million in other expenses.
  • G&A expenses were $10.1 million for the three months ended 31 March 2022 compared with $6.7 million during the same period in 2021. The increase was attributable to an increase of $1.0 million and $0.5 million in personnel expenses and non-cash share-based compensation respectively, due to increased headcount. There was a further increase of $1.4 million in legal and professional fees and $0.4 million in facilities and other expenses.
  • Cash and cash equivalents were $243.7 million as of 31 March 2022 compared with $273.2 million as of 31 December 2021.

Conference call

The COMPASS Pathways management team will host a conference call at 1.00pm UK (8.00am ET) on 10 May 2022. The call can be accessed by dialing 1-800-926-7358 from the United States, 1-212-231-2914 internationally, and 0800-496-0823 from the UK, followed by the conference ID: 22018578

The call will also be webcast on the COMPASS Pathways website and archived for 30 days. For more information, please visit the COMPASS Pathways website (ir.compasspathways.com).
 

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<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also running a phase II clinical trial of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. 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, COMPASS’s business strategy and goals, and COMPASS’s expectations regarding its ongoing preclinical work and clinical trials, development efforts and innovation labs. 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 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; our development efforts and our business strategy to set up research facilities and innovation labs will involve significant costs and resources and may be unsuccessful; and those risks and uncertainties described under the heading “Risk Factors” in COMPASS’s Annual Report on Form 10-K filed with the US Securities and Exchange Commission (SEC) on 24 February 2022 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.
 

Enquiries

Media: Lindsay Complin, lindsay.complin@compasspathways.com, +44 7702 191328
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324

MindMed to Host Earnings Call to Discuss First Quarter 2022 Financial Results and Provide Business Update

MindMed to Host Earnings Call to Discuss First Quarter 2022 Financial Results and Provide Business Update

NEW YORK, May 9, 2022 — Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel products to treat brain health disorders, today announced that it will host its earnings call on Monday, May 16, 2022, at 8:30 a.m. EDT to discuss its financial results for the quarter ended March 31, 2022 and provide a business update.

Individuals may participate via telephone by dialing (877) 407-0789 (domestic) or (201) 689-8562 (international) and using conference ID 13729397. The webcast can be accessed live here or on MindMed’s Investor Resources webpage. The webcast will be archived on the company’s website for at least 30 days after the conference call. 

About MindMed

MindMed is a clinical stage biopharmaceutical company developing novel products to treat brain health disorders, with a particular focus on psychiatry, addiction, pain and neurology. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative drug candidates, with and without acute perceptual effects, targeting the serotonin, dopamine and acetylcholine systems.

MindMed trades on the NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED.

For Media: media@mindmed.co

For Investors: ir@mindmed.co

CORRECTION – atai Life Sciences to Announce First Quarter 2022 Financial Results and Business Update

CORRECTION – atai Life Sciences to Announce First Quarter 2022 Financial Results and Business Update

NEW YORK, May 05, 2022 (GLOBE NEWSWIRE) — In a release issued yesterday under the headline “atai Life Sciences to Announce First-Quarter 2022 Financial Results” by atai Life Sciences N.V. (Nasdaq: ATAI), please note the first and second paragraphs, which contained statements referencing the 2022 IR financial results posting and executives on the video interview, as well as forward-looking statements, have been modified. The corrected release follows:

atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, plans to announce its first quarter 2022 financial results and business update on Monday, May 16, 2022.

A video interview with atai management will be available at 8:30 a.m. (ET) at https://vimeo.com/atailifesciences. The archived video interview will be available in the “Events” section of the atai website at https://www.atai.life/.

About atai Life Sciences

atai Life Sciences is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. Founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape, atai is dedicated to acquiring, incubating, and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders.

atai’s business model combines funding, technology, scientific, and regulatory expertise with a focus on innovative compounds, including psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies to achieve clinically meaningful and sustained behavioral change in mental health patients.

atai’s vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. atai has offices in New York, San Diego, Boston, London, and Berlin. For more information, please visit https://www.atai.life/.

Contact Information

Investor Contact:
Greg Weaver
Chief Financial Officer
Email: greg.weaver@atai.life

Media Contact:
Maggie Gordon
Senior Manager, Communications
Email: maggie@atai.life

IntelGenx to Report First Quarter 2022 Financial Results on May 12, 2022 – Conference Call to Follow

IntelGenx to Report First Quarter 2022 Financial Results on May 12, 2022 – Conference Call to Follow

SAINT LAURENT, Quebec, May 05, 2022 (GLOBE NEWSWIRE) — IntelGenx Technologies Corp. (TSX:IGX) (OTCQB:IGXT) (“IntelGenx”), a leader in pharmaceutical films, today announced that it will release its first quarter 2022 financial results after market close on Thursday, May 12, 2022.

An accompanying conference call will be hosted by Dr. Horst G. Zerbe, Chief Executive Officer, and Mr. Andre Godin, President and Chief Financial Officer, to discuss the results and provide a business update. Details of the conference call and webcast are below:

First Quarter 2022 Results Conference Call Details:
  
Date:Thursday, May 12, 2022
  
Time:4:30 p.m. ET
  
Live Call:1-888-506-0062 (Canada and the United States)
1-973-528-0011 (International)
  
Access Code:546214
  

The call will also be broadcast live and archived on the Company’s website at www.intelgenx.com under “Webcasts” in the Investors section.

About IntelGenx

IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.

IntelGenx’s superior film technologies, including VersaFilm®, DisinteQ, VetaFilm and transdermal VevaDerm, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offers significant benefits to patients and physicians for many therapeutic conditions.

IntelGenx’s highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx’s state-of-the-art manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit www.intelgenx.com.

Forward-Looking Information and Statements

This document may contain forward-looking information about IntelGenx’s operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx’s plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words “may,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “could,” “would,” and similar expressions. All forward looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx’s actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading “Risk Factors” in IntelGenx’s annual report on Form 10-K, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities at www.sedar.com. IntelGenx assumes no obligation to update any such forward-looking statements.

Source: IntelGenx Technologies Corp.

For IntelGenx:

Stephen Kilmer
Investor Relations
(647) 872-4849
stephen@kilmerlucas.com

Or

Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
andre@intelgenx.com

COMPASS Pathways plc to announce first quarter 2022 financial results on 10 May 2022

COMPASS Pathways plc to announce first quarter 2022 financial results on 10 May 2022

LONDON, May 03, 2022 (GLOBE NEWSWIRE) — 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 first quarter 2022, and provide an update on recent business developments on 10 May 2022.

The management team will host a conference call at 8:00am ET (1:00pm UK) on 10 May. The call can be accessed by dialing (800) 926-7358 from the United States, +1 (212) 231-2914 internationally, and 0800 496 0823 from the UK, followed by the conference ID: 22018578.

The call will also be webcast on the Investors section of the COMPASS Pathways website. The webcast will be archived for 30 days.

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<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also running a phase II clinical trial of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. 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.        

Enquiries

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

Greenbrook TMS Announces Dates for Its First Quarter 2022 Financial Results

Greenbrook TMS Announces Dates for Its First Quarter 2022 Financial Results

TORONTO–(BUSINESS WIRE)–Greenbrook TMS Inc. (TSX: GTMS, NASDAQ: GBNH) (“Greenbrook” or the “Company”), will release its 2022 first quarter operational and financial results after market hours on May 13, 2022.

FIRST QUARTER 2022 CONFERENCE CALL DETAILS:

Bill Leonard, President and Chief Executive Officer, and Erns Loubser, Chief Financial Officer, will host a conference call at 10:00 a.m. (Eastern Time) on May 16, 2022 to discuss the financial results for the quarter.

Dial in Numbers:

Toll Free North America: 1 (866) 521-4909
Toronto: (647) 427-2311

Webcast:

For more information or to listen to the call via webcast, please visit:
www.greenbrooktms.com/investors/events.htm

For those that plan on accessing the conference call or webcast, please allow ample time prior to the call time.

Conference Call Replay:

Toll Free (North America): 1 (800) 585-8367
Toronto: (416) 621-4642
Conference ID: 3459997

The conference call replay will be available from 1:00 p.m. ET on May 16, 2022, until 11:59 p.m. ET on June 16, 2022.

About Greenbrook TMS Inc.

Operating through 149 Company-operated treatment centers, Greenbrook is a leading provider of Transcranial Magnetic Stimulation (“TMS”) therapy, an FDA-cleared, non-invasive therapy for the treatment of Major Depressive Disorder and other mental health disorders, in the United States. TMS therapy provides local electromagnetic stimulation to specific brain regions known to be directly associated with mood regulation. Greenbrook has provided more than 790,000 TMS treatments to over 22,000 patients struggling with depression.

Contacts

For further information please contact:
Glen Akselrod
Investor Relations
Greenbrook TMS Inc.

investorrelations@greenbrooktms.com
1-855-797-4867

Wesana Health Reports Q4 2021 Financial Results and Provides Subsequent Period Highlights

Wesana Health Reports Q4 2021 Financial Results and Provides Subsequent Period Highlights

CHICAGO and TORONTO, May 02, 2022 (GLOBE NEWSWIRE) — Wesana Health Holdings Inc. (“Wesana” or the “Company”) (CSE: WESA; OTCQB: WSNAF), a data-driven life sciences company focused on developing the novel therapies of tomorrow and delivering new care paradigms today, has today announced its fourth quarter and full-year 2021 financial results.

Q4 2021 Highlights and Subsequent Events

  • Exploring broadening SANA-013’s lead indication to treat Major Depressive Disorder (“MDD”)
  • Delivered findings indicating that psilocybin potentiates the impact of an anti-depressant
  • Received positive feedback from pre-IND meeting with FDA on SANA-013
  • Reported positive findings from animal study on novel depression treatment protocol combining psilocybin and cannabidiol
  • Appointed Meghna A. Gaeta as Chief Marketing Officer
  • Completed filing of Patent Cooperation Treaty (“PCT”) Applications for novel drug protocols
  • Record Q4 2021 and Q1 2022 operating results at Wesana Clinics
  • Third Wesana Clinic slated to open May 2022
  • Ended the fourth quarter with US $6.6 million in cash

Daniel Carcillo, Chief Executive Officer of Wesana Health, commented: “The fourth quarter of 2021 and events subsequent to the quarter-end, marked a number of important strategic developments for Wesana Health culminating with the positive feedback from FDA regarding SANA-013 and our strategic decision to explore broadening the lead indication of SANA-013 to MDD. In addition, we are pleased to report that our Care Delivery business segment, Wesana Clinics (the “Clinics”), experienced record-breaking growth in the fourth quarter and subsequently in the first quarter of 2022.

We expect that our ongoing strategic investments in people, assets and capabilities will continue to deliver value to our current and future patients in addition to our broader stakeholders.”

Selected Consolidated Financial Information

The following table sets forth selected financial information derived from the Company’s annual combined and consolidated financial statements for the years ended December 31, 2021 and 2020. The following information should be read in conjunction with the financial statements and the accompanying management’s discussion and analysis (“MD&A”), which are available on the Company’s website at www.wesanahealth.com and under the Company’s SEDAR profile at www.sedar.com.

For the years ended ($USD)Dec 31, 2021Dec 31, 2020Change
Cash Balance6,576,0881,266,7815,309,307
Total Assets9,741,6021,267,2938,474,309
Total Equity7,714,585(63,181)7,777,766
Weighted Average Shares Outstanding23,152,7294,775,99718,376,732
Fully Diluted Shares Outstanding (as converted*)41,387,7434,775,99736,611,746
    

*The number is presented assuming all of the Company’s outstanding Proportionate Subordinate Voting Shares and Super Voting Shares as at December 31, 2021 are converted into Subordinate Voting Shares in accordance with their terms and all of the Company’s other outstanding convertible, exchangeable and exercisable securities as at December 31, 2021 are converted, exchanged or exercised in accordance with their terms.

Business Updates and Highlights

“We are delighted with the progress we have made thus far on SANA-013 and the clear pathway set forth by FDA for the initiation of study in humans,” said Mark Wingertzahn, Wesana Chief Scientific Officer. “As we look into optimizing our drug development program, we are moving forward concurrently with our functional animal studies to broaden and deepen our knowledge of SANA-013.”

Wesana Is Exploring Broadening SANA-013 Lead Indication to Treat Major Depressive Disorder

On April 18, 2022, following the completion of a successful Pre-IND meeting with the United States Food and Drug Administration (“FDA”), the Company announced it is exploring the opportunity to expand its lead indication for SANA-013 to Major Depressive Disorder (“MDD”) following the completion by the Company of the non-brokered private placement (the “Placement”).

Consistent with the positive feedback received from the FDA, Wesana is also exploring the opportunity to accelerate the development of SANA-013 by initiating a Phase 1b/2a human study for MDD in H1 2023. In contrast to the current development pathway for SANA-013 with TBI associated depression as the lead indication, currently targeting the launch of a Phase 1 study in Q4 of 2022 in a healthy human patient population, the revised development pathway would allow the Company to bypass the healthy patient population study and research an MDD affected patient population directly as part of a Phase 1b/2a study.

New Findings Indicating Psilocybin Potentiates Impact of an Anti-Depressant

On March 22, 2022, Wesana delivered data from an animal study, conducted by an independent global laboratory services provider in a validated model of depression.

Results of the study showed that administration of imipramine given three weeks following a psilocybin loading dose provided an additional 39% improvement in depressive behaviors from that of psilocybin loading dose alone. Furthermore, a second administration of imipramine given four weeks after a psilocybin loading dose provided an even greater reduction (45%) in depressive behaviors.

Positive Feedback from Pre-IND Meeting with FDA on SANA-013

On March 14, 2022, Wesana reported that they have received a full written response from the FDA regarding their pre-Investigational New Drug (“IND”) meeting for the novel therapy and proprietary protocol of SANA-013 for the treatment of Traumatic Brain Injury (“TBI”) related MDD.

The Company received positive written responses from the FDA on March 11th outlining the requirements to open the IND and commence clinical studies for SANA-013. The Company believes the written response provides a path to agreements on IND-enabling studies and validates the team’s effort and accomplishments over the past year. The FDA response also provided important insights pertaining to advancing SANA-013 as a potential treatment for TBI-related MDD. Wesana intends to initiate its in-human clinical study program in late 2022.

Positive Findings from Animal Study on Novel Depression Treatment Protocol Combining Psilocybin and Cannabidiol

On January 18, 2022, Wesana shared positive results of an animal study on a novel depression treatment protocol. Combining psilocybin and cannabidiol, the animal study, conducted by an independent global laboratory services provider, demonstrated considerable and sustained improvement in depressive behaviors.

Wesana’s novel and proprietary depression treatment protocol includes a single high dose of psilocybin followed by a maintenance regimen of a microdose of psilocybin combined with cannabidiol. In a validated pre-clinical animal model of depression, the maintenance regimen demonstrated up to 64% further improvement than those observed with a single high dose of psilocybin alone.

Furthermore, the maintenance regimen provided a sustained antidepressant effect after the single high dose of psilocybin. Wesana’s proprietary treatment protocol is currently being evaluated for the treatment of multiple mental health conditions including major depressive disorder associated with traumatic brain injury.

PCT Patent Applications for Novel Drug Protocols

On December 9, 2021, Wesana announced the completion of PCT applications toward securing the exclusive rights to protocols, delivery methods and compositions of matter which includes utilizing a high loading dose of psilocybin-assisted psychotherapy, coupled with non-hallucinogenic, low maintenance doses of psilocybin with and without other evidence-based therapies (plant medicines, fungi and adaptogens) to treat neurological based conditions. These PCT applicationsfiled with the World Intellectual Property Organization, will enable Wesana to file patent applications and seek protection in most major markets throughout the world.

Clinics and Financing Update

Medical billings1 from Wesana Clinics increased 30% in the first quarter of 2022 as compared to the fourth quarter of 2021. In that same period, overall patient volume increased by 4%, led by 95% increase in Spravato appointments.

Wesana is also thrilled to announce the official May 2022 opening of their third facility in Naperville, Illinois. Naperville’s convenient location will complement the existing Wesana Clinics locations in Oak Brook and Chicago, enabling the Clinics to provide high caliber mental healthcare to the growing number of residents in the western suburbs and greater Chicagoland area.

This new 3,000 square-foot facility – located in southwest Naperville – will be overseen by Dr. Abid Nazeer, Naperville native and Wesana’s Chief Medical Officer. The psychiatrist-led clinic will focus on serving the community through the delivery of personalized innovative psychiatric care, inclusive of ketamine therapy, medication management, psychotherapy, cognitive testing, and pharmacogenetic testing. It will also be the first of the Wesana Clinics to offer Deep Transcranial Magnetic Stimulation, which has shown efficacy as a treatment for conditions such as Major Depression, OCD, anxious depression, and more.

Wesana today announced that it has closed an initial tranche of the previously announced non-brokered private placement for aggregate gross proceeds of approximately CAD$1,100,000. The Company intends to use the net proceeds from the Placement towards evaluating the potential expanding of the indication for SANA-013 to MDD and initiating a Phase 1b/2a human study in H1 2023 as an alternative approach to the current development pathway, research and development activities following such evaluation and general working capital and corporate purposes

Pursuant to the initial tranche of the Placement, the Company issued 641,154 Subordinate Voting Share Units (each, an “SVS Unit”) at a price of CAD$0.73 per unit and 17,158 Proportionate Subordinate Voting Share Units (each, a “PVS Unit”) at a price of CAD$36.50 per unit. Each SVS Unit consists of one Subordinate Voting Share and one Subordinate Voting Share purchase warrant (an “SVS Warrant”). Each SVS Warrant is exercisable by the holder thereof to acquire one additional Subordinate Voting Share for a period of 36 months from the date of issue at an exercise price of CAD$0.90 per Subordinate Voting Share. Each PVS Unit consists of one Proportionate Subordinate Voting Share and one Proportionate Subordinate Voting Share purchase warrant (a “PVS Warrant”). Each PVS Warrant is exercisable by the holder thereof to acquire one additional Proportionate Subordinate Voting Share for a period of 36 months from the date of issue at an exercise price of CAD$45.00 per Proportionate Subordinate Voting Share. No subscriptions under the initial tranche of the Placement are subject to finder’s fee.

Securities issued under the Placement are subject to a four-month hold period under applicable Canadian securities laws.

About Wesana Health

Wesana Health helps people transcend barriers in mental health and performance. We innovate in care development through our therapies and patent-pending protocols, and in care delivery through activating a new multidisciplinary, technology-supported clinical model. Learn more at www.wesanahealth.com.

Cautionary Note Regarding Forward-Looking Information

This news release contains “forward-looking information” within the meaning of applicable securities laws with respect to the Company, including, but not limited to: the initiation of Phase 1 clinical trials in Q4 2022, exploration of initiation of a Phase 1b/2a study in H1 2023 as part of a revised accelerated development pathway, exploration of MDD as the lead indication for SANA-013, the use of proceeds of the Placement, the Company’s patent application efforts, information concerning timing for the opening of Wesana’s new clinic located in Naperville, Illinois, and any other statement that may predict, forecast, indicate or imply future plans, intentions, levels of activity, results, financial position, operational or financial performance or achievements. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, “will”, “projects”, or “believes” or variations (including negative variations) of such words and phrases, or statements that certain actions, events, results or conditions “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Except for statements of historical fact, information contained herein constitutes forward-looking information. Forward-looking information is not a guarantee of future performance and is based upon a number of estimates and assumptions of management at the date the statements are made.

Certain assumptions that influence successfully initiating its clinical development program in Q4 2022 include: (i) third parties who assisted the Company with the pre-IND submissions will continue to satisfy deadlines on deliverables within anticipated timeframes; (ii) the pre-IND guidance will continue to support that a drug development plan and future clinical trials are going to be acceptable to the FDA; (iii) the Company and its consultants can efficiently and timely address any additional correspondence, submission of additional materials or information pursuant to any ongoing requests as they may arise during the course of their review following the filing of submissions; (iv) additional pre-clinical studies will be commenced and completed on a timely basis and results will be supportive and as anticipated; (v) the Company’s pre-clinical studies (animal pharmacology and toxicology testing) generate data and analyses to support an FDA decision that it is safe to proceed with human trials of the Company’s formulation; and (vi) the Company is able to maintain a GMP supply source necessary to conduct in-human clinical trials.

Certain assumptions that influence successfully expanding the lead indication for SANA-013 to MDD include all of the assumptions in the above and (i) the board of directors of the Company (the “Board”) makes a determination, based on the readiness of the overall research and development plan, capital resources and internal procedures of the Company, to approve the expansion of the lead indication to MDD; (ii) the Company’s current capital and proceeds from the Placement will be sufficient for developing the updated IND submission package and updated IND enabling studies; (iii) the broadened indication and the future clinical trials are going to be acceptable to the FDA; (iv) the Company and its consultants can efficiently and timely address any additional correspondence, submission of additional materials or information pursuant to any ongoing requests as they may arise resulted from the broaden indication; and (v) additional pre-clinical studies required for MDD will be commenced and completed on a timely basis and results will be supportive and as anticipated.

Certain assumptions that influence the successful initiation of a Phase 1b/2a study in H1 2023 as part of a revised accelerated development pathway include: all assumptions above and (i) the Company’s current capital and proceeds from the Placement will be sufficient for the accelerated study; and (ii) the Board makes a determination, based on the readiness of the overall research and development plan, capital resources and internal procedures of the Company, to approve the revised project objectives.

Certain factors that influence the successfully opening of the Naperville clinic in Q2 2022/Spring 2022 include: (i) the Company has finalized the lease, (ii) renovations and permitting of the property for the purpose of clinic operations have been, and are expected to continue to be, minimal, (iii) the Company has an internal and external team dedicated to addressing issues that may arise during clinic construction; and (iv) there have been no significant delays in the final preparation of the clinic or staffing plans. The timeline for the opening of the third clinic was revised to Q2 2022/Spring 2022 to reflect the delays caused as a result of shipment delays for various furniture and fixtures to be delivered to the third clinic for use in the operations.

Any patent efforts of the Company remain at the application stage and there is no assurance that the Company will file additional patent applications or in what jurisdictions they may be filed, if any. Furthermore, while the PCT application has been filed, there is no assurance that a patent(s) will be granted or will be granted in a form that will be sufficient to protect the Company’s proprietary therapies or protocols or enable it to gain or keep any competitive advantage that it may have.

Although management believes that the anticipated future results, performance or achievements expressed or implied by the forward-looking statements are based upon reasonable assumptions and expectations, the reader should not place undue reliance on forward-looking statements because they involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to differ materially from anticipated future results, performance or achievements expressed or implied by such forward-looking statements. Certain risk factors include but are not limited to there being no assurance as to the Company’s ability to continue as a going concern; there being no assurance that the net proceeds of the Placement will be used as currently contemplated by the Company, the allocation and use of which is at the discretion of the Company, or that the Company will achieve the results from the use of such proceeds as currently targeted; there being no assurance that a further tranche of the Placement will be completed, and if completed, as to the size thereof; the detrimental impact of future losses and negative cash flow from operations; requirements for additional capital; lack of product or service revenue; research and development of drugs targeting the central nervous system being particularly difficult; failure to comply with health and data protection laws and regulations; delays in pre-clinical and clinical testing resulting in delays in commercializing; inability to file investigational new drug applications or clinical trial applications to commence clinical trials in a timely manner; difficulty enrolling patients in clinical trials; competition from other biotechnology and pharmaceutical companies; violations of laws and regulations resulting in repercussions; psychedelic inspired drugs possibly never being approved as medicines; regulatory or political change; reliance on third parties to plan, conduct and monitor preclinical studies and clinical trials; requirements of commercial scale and quality manufactured drug supply; negative results from pre-clinical and clinical trials or studies of others; unfavourable publicity or consumer perception; not achieving publicly announced milestones; reliance on the capabilities and experience of key executives and scientists; disruptions due to acquisitions or collaborations; risk of product liability claims; COVID-19; litigation; conflicts of interest; limited operating history; general economic, market and business conditions and other risk factors including those found in the MD&A and the Company’s annual information form dated September 3, 2021 filed on the Company’s profile on SEDAR at www.sedar.com and discussed in the Company’s other public filings available on SEDAR.

Forward-looking information is provided and made as of the date of this news release and the Company does not undertake any obligation to revise or update any forward-looking information other than as required by applicable law.

Investor Relations:
Keenan Gentry
Email: IR@wesanahealth.com
Phone: 702-329-8038

Media Contacts:
Isadora Forman
Email: media@wesanahealth.com
Phone: 917-653-4613

1 Medical billings is a non-GAAP measure, which includes service fees submitted for payment which are adjusted by the insurance providers based on underlying factors, such as insurance plan, services rendered, and patient deductible limits.

Primary Logo

Source: Wesana Health

Released May 2, 2022

YourWay Cannabis Brands Inc. announces delay in filing 2021 financial results

YourWay Cannabis Brands Inc. announces delay in filing 2021 financial results

VANCOUVER, BRITISH COLUMBIA – May 2, 2022 – YourWay Cannabis Brands Inc. (CSE: YOUR) (the “Company”) announced today that, due to a combination of factors, including (i) the complexity associated with a change of the Company’s auditors which took effect on December 6, 2021; and (ii) changes in the personnel of the Company requiring additional time to support the auditors, the filing of its audited annual financial statements for the year ended December 31, 2021, the related management’s discussion and analysis and CEO and CFO certifications (collectively, the “Annual Filings”) will not be completed by the prescribed deadline of May 2, 2022 (the “Filing Deadline”).

As disclosed in the Company’s news release on April 29, 2022, the Company applied to the British Columbia Securities Commission (the “BCSC”) for the issuance of a management cease trade order in connection with the Company’s anticipated delay in filing the Annual Filings. This application was rejected and as such, the Company expects that a failure to file cease trade order pursuant to National Policy 11-207 – Failure to File Cease Trade Orders and Revocations in Multiple Jurisdictions (a “CTO”) will be imposed against the Company shortly after the Filing Deadline, which will prohibit the trading by any person of any securities of the Company in Canada, including trades in the Company’s common shares made through the Canadian Securities Exchange. Once issued, the CTO will remain in place until such time as the Annual Filings are filed by the Company, currently expected before May 31, 2022. 

The Company confirms as of the date of this news release that there is no insolvency proceeding against it and there is no other material information concerning the affairs of the Company that has not been generally disclosed. 

About YourWay Cannabis Brands Inc.  

YourWay is a publicly traded, multi-state and consumer-centric House of Brands committed to redefining the way consumers and cannabis brands interact, with sales and operations in Arizona and California. Through building their own brands, partnering with others, and supporting retail partners house brand strategy, they are dedicated to expanding their reach; remolding the cannabis industry and ultimately, redefining the way consumers and cannabis brands interact.

YourWay aims to connect with the cannabis consumer on a deeper level, utilizing decades of brand-building expertise and an integral understanding of the customer experience to create an intuitive suite of branded products that closely aligns with consumer need states. The YourWay portfolio is an all-encompassing house of brands designed to create a sense of belonging for every cannabis consumer regardless of their relationship with the plant. Please visit www.yourwaycannabis.com or follow on Twitter at @yourwaycannabis for the latest news and information about YourWay and its brands.

Website:  www.yourwaycannabis.com 

For further information, please contact: 

YourWay Cannabis Brands Inc.

Glen Shear 

Head of Investor Relations

Tel: 437 218-1445

Email: Glen@yourwaycannabis.com

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION: 

This news release includes certain “forward-looking information” as defined under applicable Canadian securities legislation, including statements regarding the plans, intentions, beliefs, and current expectations of the Company with respect to future business activities and operating performance. Forward-looking information is often identified by the words “may”, “would”, “could”, “should”, “will”, “intend”, “plan”, “anticipate”, “believe”, “estimate”, “expect” or similar expressions and includes information regarding: the Annual Filings, including the anticipated delay in filing the Annual Filings, the timing to complete the Company’s audit, the ability of the Company to file the Annual Filings by the timelines set out in this news release, the issuance and duration of a CTO imposed against the Company, andexpectations for other economic, business, and/or competitive factors. Forward-looking information is necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. 

Investors are cautioned that forward-looking information is not based on historical fact but instead reflects management’s expectations, estimates or projections concerning future results or events based on the opinions, assumptions and estimates of management considered reasonable at the date the statements are made. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, such information involves risks and uncertainties, and undue reliance should not be placed on such information, as unknown or unpredictable factors could have material adverse effects on future results, performance, or achievements of the Company. Among the key factors that could cause actual results to differ materially from those projected in the forward-looking information are the following: the Company may not complete its audit and file the Annual Filings as currently anticipated, or at all; the Company will be subject to a general cease trade order in the event that the Annual Filings are not completed and filed; regulatory and licensing risks; changes in consumer demand and preferences; changes in general economic, business and political conditions, including changes in the financial markets; the global regulatory landscape and enforcement related to cannabis, including political risks and risks relating to regulatory change; compliance with extensive government regulation; public opinion and perception of the cannabis industry; the impact of COVID-19; and the risk factors set out in the Company’s annual information form dated August 28, 2020, filed with Canadian securities regulators and available on the Company’s profile on SEDAR at www.sedar.com.

The Company, through several of its subsidiaries, is indirectly involved in the manufacture, possession, use, sale, and distribution of cannabis in the recreational and medicinal cannabis marketplace in the United States. Local state laws where the Company operates permit such activities however, investors should note that there are significant legal restrictions and regulations that govern the cannabis industry in the United States. Cannabis remains a Schedule I drug under the US Controlled Substances Act, making it illegal under federal law in the United States to, among other things, cultivate, distribute or possess cannabis in the United States. Financial transactions involving proceeds generated by, or intended to promote, cannabis-related business activities in the United States may form the basis for prosecution under applicable United States federal money laundering legislation. 

While the approach to enforcement of such laws by the federal government in the United States has trended toward nonenforcement against individuals and businesses that comply with recreational and medicinal cannabis programs in states where such programs are legal, strict compliance with state laws with respect to cannabis will neither absolve the Company of liability under United States federal law, nor will it provide a defense to any federal proceeding which may be brought against the Company. The enforcement of federal laws in the United States is a significant risk to the business of the Company and any proceedings brought against the Company thereunder may adversely affect the Company’s operations and financial performance. 

Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking information prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, believed, estimated, or expected. Although the Company has attempted to identify important risks, uncertainties and factors that could cause actual results to differ materially, there may be others that cause results not to be as anticipated, estimated or intended. Accordingly, readers should not place undue reliance on forward-looking information, which speak only as of the date of this news release. The Company disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by law.

Awakn Life Sciences Reports Fiscal Fourth Quarter And Fiscal Year January 31, 2022, Results

Awakn Life Sciences Reports Fiscal Fourth Quarter And Fiscal Year January 31, 2022, Results

TORONTO, CANADA, April 28, 2022 – Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) (‘Awakn’), a biotechnology company, researching, developing, and delivering combined therapeutics to treat addiction,todayis reporting its financial results and business highlights for the three and twelve months ended January 31, 2022. All results are reported under International Financial Reporting Standards (“IFRS”) and in Canadian dollars, unless otherwise specified.

Anthony Tennyson, Chief Executive Officer of Awakn Life Sciences, stated, “Awakn’s fiscal year 2021 was a foundational year for the Company. We established our business model of researching, developing, and delivering combined therapeutics to treat addiction, with a near term focus on Alcohol Use Disorder (AUD) a condition affecting 400m people globally. This business model enables us to develop new and potentially more effective combined therapeutics for treating addiction and also to gather real world data to support interactions with regulatory agencies prior to commercializing our combined therapeutics at scale.”

“We also acquired clinical stage assets with superior efficacy demonstrated against treatment as usual for our primary indication of AUD. We identified and patented several new chemical series which demonstrated appropriate pharmacological and drug like properties. And we opened three clinics in Europe.”

Looking forward to the rest of calendar year 2022, we plan to progress our AUD Phase II b trial into Phase III, we will complete our early stage basket study in humans for behavioral addictions, which affects several hundred million people globally, we will begin commercial activity in the US by licensing our AUD treatments to clinics in that territory, and we will continue to build and grow our clinics platform,” concluded Anthony Tennyson.

4Q21 Business and Operational Updates, Including Subsequent Updates:

4Q21 Key Corporate Highlights and Developments, Including Subsequent Developments:

Key Financial Highlights:

  • Achieved 12-month revenue of $236,037 via Awakn’s clinics for the fiscal year ended January 31, 2022, compared to $Nil in the prior year. 4Q21 revenue was $204,300 compared to 4Q21 revenue of $31,737, a 544% increase quarter over quarter.
  • Revenue during the 12-month period was primarily driven from the provision of Ketamine assisted therapies at the Oslo clinic in Norway and the Bristol clinic in the UK.
  • As of January 31, 2022, the Company had approximately $1.6 million in cash. Subsequent to year end, the Company closed on a private placement for gross proceeds of $3.25 million.

About Awakn Life Sciences Corp.

Awakn Life Sciences is a biotechnology company, researching, developing, and delivering combined therapeutics to treat addiction. Awakn’s team consists of renowned research and drug development experts, world leading psychiatrists, and psychologists. Addiction is one of the biggest unmet medical needs of our time, affecting over 20% of the global population and is an industry valued at over $100bn per annum. Awakn is disrupting this underperforming industry by rapidly advancing the next generation of drugs and therapies to be used in combination, through preclinical research and clinical stage trials.

www.awaknlifesciences.com  |  Twitter  |  LinkedIn  |  Facebook

Notice Regarding Forward Looking Information

This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as “forward-looking statements”). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company’s future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “continues”, “forecasts”, “projects”, “predicts”, “intends”, “anticipates”, “targets” or “believes”, or variations of, or the negatives of, such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “should”, “might” or “will” be taken, occur or be achieved, including statements relating to the proposed NEO listing, and the business of the Company. All forward-looking statements, including those herein are qualified by this cautionary statement.

Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include: whether conditions to the listing on NEO will be satisfied; the business plans and strategies of the Company, the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.

Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company’s public filings on SEDAR at www.sedar.com. The Company disclaims any intention or obligation to update or revise any forward- looking information, whether as a result of new information, future events or otherwise, other than as required by law.

This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States. The Company’s and Awakn’s securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.

Investor Enquiries:
KCSA Strategic Communications
Valter Pinto / Tim Regan
Phone: +1 (212) 896-1254
Awakn@KCSA.com

Media Enquiries:
America and Canada: KCSA Strategic Communications 
Anne Donohoe
Adonohoe@KCSA.com

Rest of World: ROAD Communications
Paul Jarman / Nora Popova
Awakn@roadcommunications.co.uk

Core One Labs Delay in Filing Audited Consolidated Financial Statements

Core One Labs Delay in Filing Audited Consolidated Financial Statements

Vancouver, British Columbia, Canada – April 25, 2022– Core One Labs Inc. (CSE: COOL), (OTCQB: CLABF), (Frankfurt: LD6, WKN: A3CSSU) (the “Company” or “Core One”).  Core One announces a delay in filing its audited consolidated financial statements for the year ended December 31, 2021, annual management’s discussion and analysis for the same period and management certifications of annual filings (collectively, the “Filings”) beyond the deadline of April 30, 2022 prescribed by Canadian securities laws. The Company now expects to report fourth quarter and full year 2021 results on or before May 15, 2022.
The principal reason for the delay is the significant amount of additional work required to be performed by the Company and its external auditor due to its level of corporate activity over the last year. The Company’s auditor is completing its external audit and will be unable to issue an audit opinion before the end of April 2022, as previously expected.
The Company has informed the staff of the British Columbia Securities Commission (the “BCSC”) about its anticipated delay of the Filings and has applied to the BCSC pursuant to Part 4 of National Policy 12-203 – Management Cease Trade Orders (“NP 12-203”) for a Management Cease Trade Order (“MCTO”) pending the release of the Filings. If an MCTO is issued, the Company intends to satisfy the provisions of the “alternative information guidelines” set out in NP 12-203, including the requirement to file bi-weekly status reports in the form of news releases containing prescribed updating information, until the Filings are made. An MCTO would not generally affect the ability of persons who are not directors, officers, or insiders of the Company to trade in securities of the Company.
 
About Core One Labs Inc.
 
Core One Labs is a life sciences biotechnology research and development company focused on bringing psychedelic medicines to market through the development and production of psychedelic compounds, the advancement of psychedelic assisted treatments, and the integration of novel delivery systems technology
 
The Company has a multi-faceted business approach and incorporates several complementary lines of businesses and units in establishing itself as an industry leader in the rapidly growing and emerging psychedelics market space.
 
Core One, through its wholly owned subsidiary Vocan Biotechnologies Inc., has developed and filed for patent protection of a proprietary psilocybin production system using engineered bacteria. It is also the holder of 4 provisional patents for the development of psychedelic-based pharmaceutical formulations targeting neurological and mental health disorders, under its 100% owned subsidiary Akome Biotech Ltd., and 3 provisional patents under its other 100% owned subsidiary, Awakened Biosciences Inc., for additional synthetic technologies for psilocybin and psilocin production methods.
 
In addition to the development of psychedelics and psychedelic compounds, Core One holds an interest in four medical clinics which maintain a combined database of more than 275,000 patients. Through its clinics the Company intends to integrate a roll out of its intellectual property related to psychedelic technologies and participate in the advancement of psychedelic-based treatments for mental health disorders.
 
Core One Labs Inc.
 
Joel Shacker
Chief Executive Officer
 
FOR MORE INFORMATION, PLEASE CONTACT:
info@core1labs.com
1-866-347-5058
 
Cautionary Disclaimer Statement:
 
The Canadian Securities Exchange does not accept responsibility for the adequacy or accuracy of the content of this news release.
 
Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release, and include the Company’s expectation that it will be able to report fourth quarter and full year 2021 results on or before May 15, 2022. These statements reflect management’s current estimates, beliefs, intentions, and expectations. They are not guarantees of future performance. The Company cautions that all forward-looking statements are inherently uncertain, and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Such factors include, among other things: risks and uncertainties relating to the Company’s limited operating history and the need to comply with strict regulatory regulations.  Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information.
 
In addition, psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (Canada) and it is a criminal offence to possess substances under the Controlled Drugs and Substances Act (Canada) without a prescription or authorization. Health Canada has not approved psilocybin as a drug for any indication. Core One does not have any direct or indirect involvement with illegal selling, production, or distribution of psychedelic substances in jurisdictions in which it operates. While Core One believes psychedelic substances can be used to treat certain medical conditions, it does not advocate for the legalization of psychedelics substances for recreational use. Core One does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within approved regulatory frameworks.