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Highlights:
Optimi Health (CSE:OPTI,OTC:OPTHF,FRA:8BN) is focused on becoming the leading global supplier of GMP-grade psilocybin and functional mushrooms for health and wellness markets. Capitalizing on the projected 6.41 percent market growth by 2026 for the psychedelic mushroom market, the company is anticipating the opening of its specially designed facility for GMP-grade psilocybin cultivation.
The facility is already licensed by Health Canada for psilocybin manufacturing and has the capacity to produce 2,000 kilograms per month. Optimi Health’s cultivation process has a six-week growth cycle while maintaining the standards and quality of GMP guidelines.
Company Highlights
- Optimi Health aims to become a global leader in GMP-certified psilocybin and functional mushroom products to cater to the emerging psychedelic segment of the wellness industry.
- Three revenue streams are in the works to fully capitalize on the diverse needs of the growing market: Optimi Labs, Optimi Farms and Optimi Products. Optimi Products is already generating revenue, while Optimi Farms is slated to become the primary revenue driver.
This Optimi Health profile is part of a paid investor education campaign.*
OPTI:CC
Optimi Health Announces Closing of Strategic Non-Brokered Private Placement
- $1.85 million in proceeds received through a strategic offering of units at $0.325 per unit with each unit comprised of one common share and one-half of one (1/2) Common Share purchase warrant exercisable at $0.50, for total potential proceeds of $3.27 million.
- Financing will fuel Optimi's ongoing commercialization efforts, support new product development and provide necessary working capital to be strategic in the marketplace, with opportunities being explored in Oregon and Alberta.
- Chip Wilson, founder of lululemon athletica inc., is an advisor to the Company and health and wellness advocate.
- The Private Placement increases Chip's ownership to 9.5% on a fully diluted basis.
Optimi Health Corp. ( CSE: OPTI ) (OTCQX: OPTHF) (FRA: 8BN) (" Optimi " or the " Company "), a leading GMP producer and safe supply advocate licensed by Health Canada to produce and distribute natural, EU-GMP grade psilocybin and other psychedelic substances, most notably MDMA, is pleased to announce it has closed a non-brokered private placement of 5,692,308 units of the Company (each a " Unit ") at a price of $0.325 per Unit (the " Private Placement ") for gross proceeds of $1,850,000 with Wilson Capital, the Private Equity Division Chip Wilson's ( "Chip" ) family office. The Company intends to use the proceeds from the issuance of the Units to support its psychedelic product commercialization efforts, ongoing psilocybin and MDMA research and clinical trial initiatives, in-house drug development, and for general working capital.
Each Unit consists of one (1) common share of the Company (a " Common Share ") and one-half of one (1/2) Common Share purchase warrant (each whole warrant, a " Warrant "). Each Warrant is exercisable at $0.50 for a period of two (2) years from the date of issuance. The Common Shares and Warrants comprising the Units and any Common Shares issued upon exercise of the Warrants are subject to a statutory hold period of four months plus a day from the date of issuance in accordance with applicable securities laws.
Optimi welcomes this strategic investment led by the family office of Chip Wilson, founder of lululemon athletica inc., who also serves on the Advisory Board of Optimi. Mr. Wilson, stated, "Our participation in the placement speaks to our belief that the Company can achieve its plan to be a world leader in psychedelic product development and global distribution."
Optimi CEO, Bill Ciprick, commented, "It is important to demonstrate both to our existing shareholders and the market at large that Optimi's leadership is taking an active role in raising smart capital. When looking at a variety of potential funding options to lead this round of financing, apart from ensuring the terms of the financing were highly competitive, expanding its relationship with Chip through this investment was the preferred scenario given Chip's familiarity with the operational business, his ongoing support to Optimi in an advisory capacity, and understanding of management and the Board's track record and commitment to achieving its near and long-term corporate milestones."
The private placement increases the amount of the Company's Common Shares owned by Founders, members of the Advisory Board, Directors, and Officers.
Optimi co-founder, director and CFO, Jacob Safarik, says, "This pivotal financing puts the Company in the enviable position of being backed by one of the most trusted family offices in Canada. In a time of market instability, Optimi has maintained the necessary flexibility to execute on its path to profitability while strengthening its working capital position to continue pursuing important product development and research initiatives that support Optimi's position as a leading safe supply advocate," said Safarik. "It is crucial to our continued success that Optimi be ready for opportunities including the implementation of legal psychedelic therapy in new markets taking shape, such as Oregon and Alberta, and that we have a variety of safe, lab tested, EU-GMP psilocybin and MDMA products available to patients around the world as the global regulatory markets continue to evolve."
The strategic offering sets the foundation for the Company's upcoming expansion milestones, including Phase I and II psilocybin and MDMA clinical trials with ATMA Journey Centers, the rollout and expansion of Optimi's functional mushroom and psychedelic product catalogues, and establishing an operational footprint in Oregon's regulated psilocybin market.
Optimi co-founder, director and CMO, Dane Stevens, stated, "This sends the right message at the right time to investors paying close attention to the psychedelics market. When an investor like Chip Wilson offers to increase his position and back the future of Optimi, you find a way to get a deal done. Optimi would not exist without the vision and commitment of JJ and Chip Wilson, the Safarik family, and the shared belief that the work we are doing today will improve the health of so many in need for many years to come. With this strategic raise, we are building trust with shareholders and operations team alike, and demonstrating that the Company's Founders and leadership team are committed to the long-term success and growth of Optimi."
The Wilson family recently made news for their $100,000,000 donation, the largest in history, to the B.C. Parks Foundation — as well as the establishment of Solve FSHD (a foundation to research into a cure for facioscapulohumeral muscular dystrophy) with an additional $100 million, in September and March of 2022, respectively. These were facilitated by the Wilson 5 Foundation, the family's private foundation.
FOR INTERVIEW REQUESTS OR FURTHER INFORMATION PLEASE CONTACT:
Michael Kydd
Investor Relations
Email: investors@optimihealth.ca
Phone: +1 (902) 880 6121
ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)
Optimi Health Corp. is a Canadian-based company licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and synthetic psychedelic substances, as well as functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable psychedelic formulations for transformational human experiences, the Company's goal is to be the number one trusted, compassionate supplier of safe drug products throughout the world. Optimi's products are produced at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia, making it the largest psilocybin and MDMA producer in North America.
FORWARD‐LOOKING STATEMENTS
This news release contains forward‐looking statements and forward‐looking information within the meaning of Canadian securities legislation (collectively, "forward‐looking statements") that relate to Optimi's current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as "will likely result," "are expected to," "expects," "will continue," "is anticipated," "anticipates," "believes," "estimated," "intends," "plans," "forecast," "projection," "strategy," "objective," and "outlook") are not historical facts and may be forward‐looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward‐looking statements. No assurance can be given that these expectations will prove to be correct and such forward‐looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release. In particular and without limitation, this news release contains forward‐looking statements pertaining to the Private Placement, including with respect to the use of proceeds, the future success of Optimi, activities proposed to be conducted under the Company's approved Health Canada dealer's licence and associated business related to Psilocybin, Psilocin, other psychedelic substances, some being synthetically formulated, and Optimi's plans, focus and objectives.
Forward‐looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi's control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward‐looking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID‐19 pandemic and other factors set forth under "Forward‐Looking Statements" and "Risk Factors" in the Company's Annual information Form dated January 12, 2022, and other continuous disclosure filings available under Optimi's profile at www.sedar.com. Optimi undertakes no obligation to update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward‐looking statement.
Any forward‐looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.
Neither the Canadian Securities Exchange nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.
News Provided by GlobeNewswire via QuoteMedia
Alberta Puts Patients First By Regulating Psychedelic Therapy: Optimi Health
Highlights:
- The safe supply of psychedelic drug products manufactured at a GMP-level is critical in treating serious mental health issues. Minister of Mental Health and Addictions, the Honourable Carolyn Bennett, has publicly stated that safe drug supply is paramount to reducing overdose deaths.
- Optimi Health is the largest cultivator of natural EU-GMP psilocybin and MDMA in North America.
- Optimi Health is licensed by Health Canada to supply clinical trials and patients approved under the Special Access Program.
Optimi Health Corp . ( CSE: OPTI ) (OTCQX: OPTHF) (FRA: 8BN) ("Optimi" or the "Company"), a leading Canadian-based company licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and other psychedelic substances, most notably MDMA, is applauding the government of Alberta's decision to regulate some psychedelics for therapeutic use in the province.
The proposed framework as stated by the Government of Alberta comes into effect on January 16, 2023. It would give a physician, psychiatrist, or doctor the ability to prescribe and administer psilocybin, MDMA, or other psychedelics produced by Optimi to patients under the Mental Health Services Protection Act.
Optimi CEO, Bill Ciprick, made the following statement on behalf of the Company:
"Yesterday, the Government of Alberta made a bold and politically courageous decision to regulate the use of psychedelic therapy for patients suffering from a variety of treatment-resistant conditions. They have accepted the substantial body of research, including the completion of a growing number of randomized clinical trials, which highlight psilocybin (the active ingredient in "magic" mushrooms) when paired with psychotherapy as an emerging and novel approach for the treatment of a host of mental health conditions, including treatment-resistant depression, substance-use disorder, and severe anxiety associated with a terminal diagnosis.
Thanks to Optimi's existing partnerships and supply agreements with clinics, therapists, and researchers within the Province of Alberta — including ATMA Journey Centers, Bloom Psychedelic Therapy and Research Centre, and SABI Mind — the Company is uniquely positioned to support the development of Alberta's regulated psychedelic therapy infrastructure.
The increasing evidence supporting the benefits of psilocybin-containing mushrooms when used as part of psychotherapy has resulted in growing international interest in moving quickly to increase patient access to this treatment given the impressive and growing track records of safety in both the therapeutic and naturalistic use contexts.
We have seen widespread, bi-partisan support for psilocybin and MDMA Bills introduced in State legislatures across the United States; the Biden Administration has appointed a special task force to understand and prepare for the regulation of psychedelics in the U.S; and recently, Canadian Minister of Mental Health and Addictions, the Honourable Carolyn Bennett, admitted that Canada needs a safe supply of drugs to fight the spiraling opioid crisis.
While we await further details on Alberta's regulatory framework, we encourage other provincial health ministries to start asking the right questions about psychedelic therapy, and to seek further guidance from the Psychedelic Association of Canada's Memorandum of Regulatory Analysis (MORA) which provides a step-by-step regulatory framework for end-of-life and palliative Canadians.
As a Health Canada licensed supplier of EU-GMP natural psilocybin and synthetic psychedelics, Optimi Health is committed to working with the Government of Alberta to supply the therapeutic psychedelics they need to treat those who are suffering."
Optimi's state-of-the-art EU-GMP cultivation and analytical facilities in Princeton, British Columbia are now fully operational. After completing the largest legal grow of natural psilocybin in Canada's history, the Company is aiming for first-mover advantage in Oregon as the demand for natural product intensifies in the legalized State and will be contacting the government of Alberta in the coming days to discuss supply.
"We believe a key differentiator in the psychedelics space is that Optimi is commercializing and ready to go now," said Dane Stevens, Optimi Co-Founder and Chief Marketing Officer. "While we eagerly wait for Health Canada to regulate access for something we believe to be a safe and efficacious medicine when delivered with therapy, this announcement by the Government of Alberta can help patients today. Optimi's timeline is now, and we are excited to be one of the first company's supplying tested, EU-GMP psychedelic products to regulated jurisdictions such as Oregon and Alberta," added Stevens.
More information on the regulatory administrative and service requirements proposed under Alberta's Mental Health Services Protection Act can be found here .
FOR INTERVIEW REQUESTS OR FURTHER INFORMATION PLEASE CONTACT:
Michael Kydd
Investor Relations
Email: investors@optimihealth.ca
Phone: +1 (902) 880 6121
ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)
Optimi Health Corp. is a Canadian-based company licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and synthetic psychedelic substances, as well as functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable psychedelic formulations for transformational human experiences, the Company's goal is to be the number one trusted, compassionate supplier of safe drug products throughout the world. Optimi's products are grown at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia, making it the largest psilocybin and MDMA cultivator in North America.
FORWARD‐LOOKING STATEMENTS
This news release contains forward‐looking statements and forward‐looking information within the meaning of Canadian securities legislation (collectively, "forward‐looking statements") that relate to Optimi's current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as "will likely result," "are expected to," "expects," "will continue," "is anticipated," "anticipates," "believes," "estimated," "intends," "plans," "forecast," "projection," "strategy," "objective," and "outlook") are not historical facts and may be forward‐looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward‐looking statements. No assurance can be given that these expectations will prove to be correct and such forward‐looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release. In particular and without limitation, this news release contains forward‐ looking statements pertaining to activities proposed to be conducted under the Company's approved Health Canada dealer's licence and associated business related to Psilocybin, Psilocin, other psychedelic substances, some being synthetically formulated, and Optimi's plans, focus and objectives.
Forward‐looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi's control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward‐looking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID‐19 pandemic and other factors set forth under "Forward‐Looking Statements" and "Risk Factors" in the Company's Annual information Form dated January 12, 2022, and other continuous disclosure filings available under Optimi's profile at www.sedar.com . Optimi undertakes no obligation to update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward‐looking statement.
Any forward‐looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.
News Provided by GlobeNewswire via QuoteMedia
Optimi Health, ATMA Journey Centers To Proceed With Phase I Natural Psilocybin and MDMA Clinical Trial Application to Health Canada
Optimi Health Corp . ( CSE: OPTI ) (OTCQX: OPTHF) (FRA: 8BN) ("Optimi" or the "Company"), a Canadian-based company licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and other psychedelic substances, most notably MDMA, is pleased to announce that in conjunction with ATMA Journey Centers ("ATMA"), the companies have confirmed their intent to proceed with a Phase I clinical trial application (CTA) that will document the safety of the Optimi's natural psilocybin biomass and 3,4-methylenedioxy-methamphetamine (MDMA) in healthy patients.
Upon Health Canada approval, it would be the first trial to assess both safety and additional markers, such as the mystical experience questionnaire in healthy subjects that have consumed MDMA.
Optimi CEO, Bill Ciprick, says the goal of the clinical trial is to acquire data, including blood pressure, temperature, heart rate, and ECG readings, for Optimi's proprietary formulation using natural EU-GMP psilocybin and MDMA. These products are being produced and tested in-house at Optimi's 20,000 square foot facilities in Princeton, British Columbia.
"The clinical validation of our products on healthy subjects brings us one-step closer to commercialization," said Ciprick. "Coming off the success of ATMA's recently completed Phase I psilocybin trial and a No Objection Letter to conduct its N-500 Phase II psilocybin clinical trial on frontline healthcare professionals, we're excited to officially begin the process," he added. "For the thousands of trained professionals waiting to experience natural, EU-GMP psilocybin and MDMA, we share their enthusiasm and believe we have an ethical responsibility to supply them with a life-changing product that is receiving considerable attention from regulatory bodies across the world."
ATMA is currently the only Canadian organization that has received approval from Health Canada to conduct a Phase I safety trial with psilocybin in healthy therapists, which it completed last month. Health Canada recently provided ATMA with a No Objection Letter to conduct an N-500 psilocybin Phase II clinical trial aimed at studying the potential relief of COVID-19-associated mental health concerns in frontline healthcare providers, in addition to documenting the healthcare providers' firsthand evaluation of the potential effectiveness of psilocybin psychotherapy in the application.
ATMA CEO, David Harder, recognizes the historical context of the CTA and says his team is committed to building on the success of his company's leadership in therapist-centred and therapist-driven support and training.
"Securing a clinical trial using natural EU-GMP psilocybin and MDMA is key to the growth of training and providing for experiential learning with both of these molecules, and others, as they are developed by Optimi," said Harder. "This is critical in providing a solid training program for therapists to prepare for the need that is already at our doorstep," he added.
In August, psychedelic pioneer and industry stalwart, Rick Doblin, outlined his organization's (the Multidisciplinary Association for Psychedelic Studies – MAPS) goal to train 25,000 therapists in MDMA-assisted therapy for PTSD before 2030.
He added that a further 100,000 therapists could be "kept busy" through potential clinical indications for MDMA and psilocybin such as alcohol and substance abuse, social anxiety, and phobias.
In 2017, the Food and Drug Administration (FDA) granted Breakthrough Therapy designation to MDMA-assisted psychotherapy for the treatment of PTSD.
Optimi's plan for commercialization involves the Company being an active leader in meeting therapist demand for natural EU-GMP psilocybin and MDMA.
Both Ciprick and Harder have confirmed that Optimi will serve as the official clinical trial sponsor while ATMA delivers clinical research expertise through its medical advisory team led by Dr. Michael Blough. Details of the CTA protocol will be released upon receipt of a No Objection Letter from Health Canada.
The Optimi-ATMA partnership is intended as an expansion of the scope of the relationship which began with the signing of an initial psilocybin supply agreement in June 2022 and will serve as the basis for the further development of the Company's commercial pipeline.
FOR INTERVIEW REQUESTS OR FURTHER INFORMATION PLEASE CONTACT:
Michael Kydd
Investor Relations
Email: investors@optimihealth.ca
Phone: +1 (902) 880 6121
ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)
Optimi Health Corp. is a Canadian-based company licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and synthetic psychedelic substances, as well as functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable psychedelic formulations for transformational human experiences, the Company's goal is to be the number one trusted, compassionate supplier of safe drug products throughout the world. Optimi's products are grown at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia, making it the largest psilocybin and MDMA cultivator in North America.
ABOUT ATMA JOURNEY CENTERS
ATMA is pioneering a therapist-centered and therapist-driven business model for the psychedelic industry, by building the largest online community platform for psychedelic practitioners. Education, training, and business support services will all be accessible on one user friendly technology platform. ATMA's philosophy of inclusivity will encourage more participation from healthcare professionals, which will in turn yield more data and experiences. Overall, this will lead to increased effectiveness and accessibility of psychedelic-assisted therapy. Beginning with a clear focus on psilocybin-assisted therapy, ATMA will be able to expand to other psychedelics as the regulatory environment also expands. ATMA provides a clear, guided path for healthcare professionals and clinics to build psychedelic-assisted therapies into their current practices.
FORWARD‐LOOKING STATEMENTS
This news release contains forward‐looking statements and forward‐looking information within the meaning of Canadian securities legislation (collectively, "forward‐looking statements") that relate to Optimi's current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as "will likely result," "are expected to," "expects," "will continue," "is anticipated," "anticipates," "believes," "estimated," "intends," "plans," "forecast," "projection," "strategy," "objective," and "outlook") are not historical facts and may be forward‐looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward‐looking statements. No assurance can be given that these expectations will prove to be correct and such forward‐looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release. In particular and without limitation, this news release contains forward‐ looking statements pertaining to activities proposed to be conducted under the Company's approved Health Canada dealer's licence and associated business related to Psilocybin, Psilocin, other psychedelic substances, some being synthetically formulated, and Optimi's plans, focus and objectives.
Forward‐looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi's control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward‐looking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID‐19 pandemic and other factors set forth under "Forward‐Looking Statements" and "Risk Factors" in the Company's Annual information Form dated January 12, 2022, and other continuous disclosure filings available under Optimi's profile at www.sedar.com. Optimi undertakes no obligation to update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward‐looking statement.
Any forward‐looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.
News Provided by GlobeNewswire via QuoteMedia
Optimi Health Completes Largest Legal Natural Psilocybin Harvest in Canadian History
Optimi Health Corp. ( CSE: OPTI ) (OTCQX: OPTHF) (FRA: 8BN) ("Optimi" or the "Company"), is pleased to announce that it has completed what it believes to be the largest legal natural psilocybin harvest in Canadian history. The Company is licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and other psychedelic substances, most notably MDMA, as well as functional mushrooms that focus on the health and wellness markets.
Building off its first official harvest on May 27 th , which produced various strains of psilocybin for lab analysis and early-stage supply agreements, the Company is pleased to report that its investment in state-of-the art environmental controls and facility cultivation operations have resulted in a commercially harvested yield of more than 150 kg of Panaeolus cyanescens and Psilocybe cubensis.
All Optimi mushroom products are grown from the Company's world-leading psilocybin genetic bank and are grown in EU-GMP compliant clean rooms that ensure sterile cultivation and undergo almost 300 different analytical tests post-harvest.
"Our mushrooms are some of the most tested products on the planet as we cross the lines between Pharmaceutical, Agriculture, Botanical, and Food testing quality assays," said Optimi Chief Science Officer, Justin Kirkland. "This yield gives us the capacity and scale we need to advance our analytical schedule while also developing our product pipeline," he added.
Once analyzed and tested, both in-house and then by a licensed third-party lab according to Optimi's strict product specification and quality assurance standards, the Company will commence distribution of the harvested quantities to fulfill supply agreements signed in recent months with various industry partners and licensed research entities across the globe.
Optimi Chief Operations Officer, Bryan Safarik, says the yield exceeded expectations in terms of quality and quantity.
"By controlling and tracking all of the inputs digitally, we are able to consistently grow psilocybin-containing mushrooms at a much higher potency to maximize the amount of naturally occurring psilocybin within the mushroom," said Safarik. "These state-of-the-art controls are a key differentiator for what we offer the global market. The higher the potency, the less biomass you need to achieve the desired amount of pure psilocybin API, which means we can create considerably more natural psilocybin per square foot than a typical black market grow. More psilocybin in less space achieves more revenue per square foot," he added.
All surplus inventory from the harvest will be safely stored in Optimi's Level 8 Security Vault to ensure minimal degradation of the natural psilocybin.
Optimi will also be using the mushrooms to further develop its on-site extraction methods and will use the product to finalize its naturally derived psilocybin offerings this fall. The Company is working to supply various upcoming phase 1 & 2 clinical trials to build out the required human safety data in healthy Canadians, and eventually patients suffering from depression, anxiety, and PTSD.
Bringing a safe and federally licensed supply of psilocybin products to market beyond encapsulated biomass is integral to the Company's global innovation strategy.
On May 11 th , Optimi Labs announced the expansion of its on-site analytical laboratory, which allows the company to measure consistency in its product while it begins to build out proprietary formulations, extracts, and its product catalogue — beginning with the recently launched BLUE SERENITY . Biomass derived from this harvest is likewise intended for use in showcasing the stability and accuracy of dosing for patients who request access to natural psilocybin mushrooms via the Special Access Program and clinical trials.
The harvest includes the following psilocybin-containing mushroom strains:
Koh Samui
B Plus
Malabar
Penis Envy
Burma
Blue Pulaski
To access a complete photo gallery of this historic grow, please click here .
Authorized parties interested in purchasing or distributing Optimi psilocybin and functional mushroom products, MDMA, or other synthetic psychedelics are invited to contact sales@optimihealth.ca where a member of the sales team will respond within 24 hours.
ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)
Optimi Health Corp. is a Canadian-based company licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and synthetic psychedelic substances, as well as functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable psychedelic formulations for transformational human experiences, the Company's goal is to be the number one trusted, compassionate supplier of safe drug products throughout the world. Optimi's products are grown at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia, making it the largest psilocybin and MDMA cultivator in North America.
FOR INTERVIEW REQUESTS OR FURTHER INFORMATION PLEASE CONTACT:
Investor Relations
Michael Kydd
investors@optimihealth.ca
+1 (902) 880 6121
www.optimihealth.ca
FORWARD‐LOOKING STATEMENTS
This news release contains forward‐looking statements and forward‐looking information within the meaning of Canadian securities legislation (collectively, "forward‐looking statements") that relate to Optimi's current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as "will likely result," "are expected to," "expects," "will continue," "is anticipated," "anticipates," "believes," "estimated," "intends," "plans," "forecast," "projection," "strategy," "objective," and "outlook") are not historical facts and may be forward‐looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward‐looking statements. No assurance can be given that these expectations will prove to be correct and such forward‐looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release. In particular and without limitation, this news release contains forward‐ looking statements pertaining to activities proposed to be conducted under the Company's approved Health Canada dealer's licence and associated business related to Psilocybin, Psilocin, other psychedelic substances, some being synthetically formulated, and Optimi's plans, focus and objectives.
Forward‐looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi's control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward‐looking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID‐19 pandemic and other factors set forth under "Forward‐Looking Statements" and "Risk Factors" in the Company's Annual information Form dated January 12, 2022, and other continuous disclosure filings available under Optimi's profile at www.sedar.com. Optimi undertakes no obligation to update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward‐looking statement.
Any forward‐looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.
News Provided by GlobeNewswire via QuoteMedia
Optimi Health Signs First International Mushroom Supply Agreement with UK-based Avida Global
Optimi Health Corp. ( CSE: OPTI ) (OTCQX: OPTHF) (FRA: 8BN) ("Optimi" or the "Company"), a Canadian-based company licensed by Health Canada to produce natural, scalable, and accessible psychedelic and functional mushroom products for transformational human experiences, is pleased to announce that it has entered into an agreement with Avida Global ("Avida"), a privately-held UK-based producer of high-quality wellness products, including nutraceuticals and medicinal cannabis oils, for the global well-being and medical markets.
In its first large-scale international distribution agreement, Optimi will supply Avida with an extensive catalog of Optimi Life functional mushroom supplement formulations. The supplements will be available for distribution to clients and partners worldwide via Avida Labs, Avida's white-labelling and manufacturing business.
Avida will function as the exclusive distributor for Optimi's line of functional mushroom products in the United Kingdom, the European Union, Switzerland, India, Japan, Indonesia, Thailand, and Israel.
The Europe functional mushroom market is expected to grow at a Compound Annual Growth Rate (CAGR) of 5.6 percent in the forecast period (2021 to 2028) and reach USD $107 million by 2028. The UK market is forecast to grow at a CAGR of 7.5 percent between 2021 - 2027.
Optimi CEO, Bill Ciprick, says the partnership unlocks a significant market opportunity to synergize Avida's impressive worldwide distribution network with Optimi's position as the top functional and psychedelic mushroom producer in North America.
"Optimi's objective has consistently been to become the world's number one supplier of functional and psychedelic mushroom products, bar none," said Ciprick. "We are now significantly closer to achieving that goal by globally elevating our Optimi Life functional mushroom brand with an industry-leading, EU-GMP partner such as Avida," he added. "This is directly in line with our goal to commercialize and generate revenue."
The terms of the agreement further stipulate the potential for the sale of psilocybin mushrooms via the same distribution networks in response to the still-evolving demands of international markets.
With operations in the UK and North-East Colombia, Avida Global Managing Director and Head of UK Operations, Paul Parkinson, says the international agreement with Optimi marks a significant expansion for Avida in the plant-based medicines category and will bring mutual benefits and exposure for both companies.
"Both Avida and Optimi share similar synergies putting quality and science at the heart of everything we do," said Parkinson. "Our partnership with Optimi complements the increasing global demand for natural, organic mushroom products and presents a unique opportunity for Avida Global in this nascent category. We are pleased to be building a strong and innovative product pipeline backed by exemplary service delivery and some of the most rigorous and stringent operational standards in the world," he added.
Ciprick and Parkinson jointly expressed their agreement that new generation, health-smart mushroom enthusiasts are reshaping the whole functional mind and body experience.
"Great products are supported by consumers who investigate the experience as much as the science behind these formulations," they added. "The unique thing about this partnership is that we are aligned and driven to meet those expectations as we further develop our product and service footprint in emerging health markets across the world."
Optimi recently announced the signing of a retail and e-commerce distribution agreement for Optimi Life nutraceutical products with Canadian outlets Well.ca, Vitasave, and Healthy Planet.
FOR INTERVIEW REQUESTS OR FURTHER INFORMATION, PLEASE CONTACT:
Michael Kydd
Investor Relations
Email: investors@optimihealth.ca
Phone: +1 (902) 880 6121
Web: www.optimihealth.ca
Avida Global
Poppy Butcher
PR & Communications Director
poppy.butcher@avidaglobal.com
+44 7956 169209
ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)
Optimi Health Corp. is a Canadian-based company licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and synthetic psychedelic substances, as well as functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable psychedelic formulations for transformational human experiences, the Company's goal is to be the number one trusted, compassionate supplier of safe drug products throughout the world. Optimi's products are grown at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia, making it the largest psilocybin and MDMA cultivator in North America.
ABOUT AVIDA GLOBAL
Avida Global is a vertically integrated Global cannabis business headquartered in Surrey, UK, with a dedicated cultivation and production facility in North-East Colombia. The company was founded in 2018 with the vision of providing the highest quality medicinal cannabis products to patients and consumers around the world in order to bring quality to life. The Avida Global Group consists of Avida Global SAS, Avida Labs UK and Green Stem CBD.
Avida Labs is Avida Global's white-labelling and manufacturing business. Based in Surrey, UK, the company formulates and manufactures bespoke topical and ingestible white-label products, from plant to product, using the highest quality ingredients and latest manufacturing processes.
FORWARD‐LOOKING STATEMENTS
This news release contains forward‐looking statements and forward‐looking information within the meaning of Canadian securities legislation (collectively, "forward‐looking statements") that relate to Optimi's current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as "will likely result," "are expected to," "expects," "will continue," "is anticipated," "anticipates," "believes," "estimated," "intends," "plans," "forecast," "projection," "strategy," "objective," and "outlook") are not historical facts and may be forward‐looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward‐looking statements. No assurance can be given that these expectations will prove to be correct and such forward‐looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release. In particular and without limitation, this news release contains forward‐ looking statements pertaining to activities proposed to be conducted under the Company's approved Health Canada dealer's licence and associated business related to Psilocybin, Psilocin, other psychedelic substances, some being synthetically formulated, and Optimi's plans, focus and objectives.
Forward‐looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi's control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward‐looking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID‐19 pandemic and other factors set forth under "Forward‐Looking Statements" and "Risk Factors" in the Company's Annual information Form dated January 12, 2022, and other continuous disclosure filings available under Optimi's profile at www.sedar.com . Optimi undertakes no obligation to update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward‐looking statement.
Any forward‐looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.
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Compass Pathways to Participate in December Investor Conferences
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that members of the executive management team will participate in the following investor conferences in addition to hosting investor meetings:
- 7 th Annual Evercore ISI HealthCONx Conference: Fireside chat at 10:25am ET on December 3, 2024
- Piper Sandler 36 th Annual Healthcare Conference: Fireside chat at 3:30pm ET on December 4, 2024
A live audio webcast of these events will be accessible here for 30 days following the events.
About Compass Pathways
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are living with mental health challenges and who are not helped by existing standards of care. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).
We have commenced a phase 3 clinical program of COMP360 psilocybin treatment in TRD, the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p
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.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241125241648/en/
Enquiries
Media: Sally Bain, sally.bain@compasspathways.com , + 1 781 458 0443
Investors: Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324
News Provided by Business Wire via QuoteMedia
Compass Pathways to participate in Stifel 2024 Healthcare Conference
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that management will present at the Stifel 2024 Healthcare Conference at 10:55 am ET on November 19, 2024.
A live audio webcast of the presentation will be accessible from the "Events" page of the Investors section of the Compass website. A replay of the webcast will be accessible for 30 days following each event.
About Compass Pathways
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are living with mental health challenges and who are not helped by existing standards of care. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).
We have commenced a phase 3 clinical program of COMP360 psilocybin treatment in TRD, the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p
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.
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: Sally Bain, media@compasspathways.com , + 1 781 458 0443
Investors: Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324
News Provided by GlobeNewswire via QuoteMedia
Compass Pathways Announces Third Quarter 2024 Financial Results and Business Updates
- Top-line COMP005 data for COMP360 phase 3 pivotal program in treatment-resistant depression now expected in second quarter 2025
- COMP006 data will now be announced after 26-week time point, expected in the second half of 2026
- Strategic reorganization to focus all efforts on COMP360 program resulting in reduction of workforce of approximately 30%
- Cash position of $207 million
- Conference call October 31 at 8:00 am ET (12:00 pm UK)
Compass Pathways plc (Nasdaq: CMPS) ("Compass"), a biotechnology company dedicated to accelerating access to evidence-based innovation in mental health, today reported its financial results for the third quarter 2024 and an update on recent business progress.
"Ensuring the success of our lead COMP360 program is our absolute priority. We remain confident that COMP360 can be an effective therapy for patients with serious mental illness and our focus on delivering new treatment options for patients living with treatment-resistant depression remains paramount," said Kabir Nath, Chief Executive Officer of Compass Pathways. "The shift in the phase 3 pivotal program timeline has forced us to look carefully at our operations and ensure that every resource is focused on this goal. As such, we have made the difficult decision to reduce our workforce and exit activities that are not directly tied to the completion of the trials, regulatory filing and commercialization if approved. These are necessary strategic decisions that we believe will position the COMP360 program for success."
Business highlights
COMP360 psilocybin treatment in TRD
The phase 3 clinical program of COMP360 psilocybin treatment in TRD is the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted. Top-line pivotal COMP005 trial data is expected in the second quarter 2025. In addition, as a result of the increased regulatory scrutiny on functional unblinding, the company has decided to shift the data release for COMP006 until after the 26-week time point and the completion of the blinded portion has been reached for all patients to protect against the risk of unblinding. With this change, Compass now expects data for COMP006 in the second half of 2026.
Prioritization of resources
As a result of changing timelines for the phase 3 trials, we will be reducing our workforce by approximately 30%, including eliminating some senior management positions, to further focus the organization and its capital resources on successfully delivering the COMP360 program. Our non-COMP360 preclinical efforts will be stopped and we are exploring a potential externalization for our digital health tools.
Financial highlights
- Net loss for the three months ended September 30, 2024, was $38.5 million, or $0.56 loss per share (including non-cash share-based compensation expense of $5.0 million), compared with $33.4 million, or $0.67 loss per share, during the same period in 2023 (including non-cash-share-based compensation expense of $4.4 million).
- Net loss for the nine months ended September 30, 2024, was $111.8 million, or $1.67 loss per share (including non-cash share-based compensation expense of $15 million), compared with $85.9 million, or $1.81 loss per share, during the same period in 2023 (including non-cash-share-based compensation expense of $13.1 million).
- Research and development expenses were $32.9 million for the three months ended September 30, 2024, compared with $21.5 million during the same period in 2023. The increase was primarily attributable to development expenses associated with advancing our late-stage COMP360 phase 3 clinical trials and increased personnel expenses due to increased R&D headcount.
- Research and development expenses were $86.9 million for the nine months ended September 30, 2024, compared with $60.4 million during the same period in 2023. The increase was primarily attributable to development expenses associated with advancing our late-stage COMP360 phase 3 clinical trials and increased personnel expenses due to increased R&D headcount.
- General and administrative expenses were $15.0 million for the three months ended September 30, 2024, compared with $12.5 million during the same period in 2023. The increase was primarily attributable to increased personnel expenses due to increased headcount supporting our corporate functions and increased legal and professional fees due to consulting, legal advice and patent applications.
- General and administrative expenses were $42.9 million for the nine months ended September 30, 2024, compared with $38.1 million during the same period in 2023. The increase was primarily attributable to increased personnel expenses due to increased headcount supporting our corporate functions and increased legal and professional fees due to consulting, legal advice and patent applications.
- Cash and cash equivalents were $207 million as of September 30, 2024, compared with $220.2 million as of December 31, 2023.
- Debt was $29.8 million as of September 30, 2024, compared with $28.8 million as of December 31, 2023.
Financial Guidance
Fourth quarter 2024 net cash used in operating activities is expected to be in the range of $37 million to $43 million. The full-year 2024 net cash used in operating activities is expected to be in the range of $114 million to $120 million. The cash position at September 30, 2024, is expected to be sufficient to fund operating expenses and capital expenditure requirements at least into 2026.
Conference call
The management team will host a conference call at 8:00 am ET (12:00 pm UK) on October 31, 2024. A live webcast of the call will be available on the Compass Pathways website at Third Quarter 2024 Financial Results. The webcast will also be on the Investors section of the Compass Pathways website for 30 days.
About Compass Pathways
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are living with mental health challenges and who are not helped by existing standards of care. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).
We have commenced a phase 3 clinical program of COMP360 psilocybin treatment in TRD, the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p
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.
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", "will", "could", "would", "expect", "intend", "plan", "anticipate", "believe", "potential" and "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, our financial guidance; our business strategy and goals, our expectations and projections about the company's future cash needs and financial results; our plans for a strategic reorganization, including a reduction in workforce, and our expectations regarding impact and cost savings from our planned reduction in workforce; our plans and expectations regarding our phase 3 trials in TRD, including our expectations regarding the time periods during which the results of the two Phase 3 trials will become available; the potential for the pivotal phase 3 program in TRD, any future trials in PTSD, or other trials to support regulatory filings and approvals; our expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment, including as a treatment for treatment of TRD, PTSD, and anorexia nervosa; our expectations regarding the benefits of our investigational COMP360 psilocybin treatment; and our plans, expectations and ability to achieve our goals related to the research collaboration agreements. 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 our 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: we will require substantial additional funding to achieve our business goals, including to repay the term loan facility, and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our clinical trials and research and development efforts; the availability of future tranches under the term loan facility is dependent, in part, on the approval of the lender, achievement of certain milestones and other factors; clinical development is lengthy and outcomes are uncertain, and therefore our phase 3 clinical trials in TRD and our other clinical trials may be delayed or terminated; the results of early-stage clinical trials of our investigational COMP360 psilocybin treatment may not be predictive of the results of later stage clinical trials; our efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for COMP360 or any of future product candidates may be unsuccessful; the risk that our research collaborations will not continue or will not be successful; and our efforts to obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; and those risks and uncertainties described under the heading "Risk Factors" in our most recent annual report on Form 10-K or quarterly report on Form 10-Q and in other reports we have filed with the U.S. Securities and Exchange Commission ("SEC") , which are available on the SEC's website at www.sec . Except as required by law, we disclaim 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 our current expectations and speak only as of the date hereof.
COMPASS PATHWAYS PLC Condensed Consolidated Balance Sheets (unaudited) (in thousands, except share and per share amounts) (expressed in U.S. Dollars, unless otherwise stated) | |||||||
September 30, | December 31, | ||||||
2024 | 2023 | ||||||
ASSETS | |||||||
CURRENT ASSETS: | |||||||
Cash and cash equivalents | $ | 206,953 | $ | 220,198 | |||
Restricted cash | 389 | 440 | |||||
Prepaid expenses and other current assets | 26,319 | 40,658 | |||||
Total current assets | 233,661 | 261,296 | |||||
NON-CURRENT ASSETS: | |||||||
Operating lease right-of-use assets | 2,745 | 4,306 | |||||
Deferred tax assets | 4,414 | 3,336 | |||||
Long-term prepaid expenses and other assets | 6,518 | 7,049 | |||||
Total assets | $ | 247,338 | $ | 275,987 | |||
LIABILITIES AND SHAREHOLDERS' EQUITY | |||||||
CURRENT LIABILITIES: | |||||||
Accounts payable | $ | 8,233 | $ | 5,892 | |||
Accrued expenses and other liabilities | 13,522 | 11,301 | |||||
Debt, current portion | 2,156 | — | |||||
Operating lease liabilities - current | 2,300 | 2,411 | |||||
Total current liabilities | 26,211 | 19,604 | |||||
NON-CURRENT LIABILITIES | |||||||
Debt, non-current portion | 27,638 | 28,757 | |||||
Operating lease liabilities - non-current | 459 | 1,882 | |||||
Total liabilities | $ | 54,308 | $ | 50,243 | |||
SHAREHOLDERS' EQUITY: | |||||||
Ordinary shares, £0.008 par value; 68,409,068 and 61,943,471 shares authorized, issued and outstanding at September 30, 2024 and December 31, 2023, respectively | 699 | 635 | |||||
Additional paid-in capital | 700,273 | 621,645 | |||||
Accumulated other comprehensive loss | (16,542 | ) | (16,926 | ) | |||
Accumulated deficit | (491,400 | ) | (379,610 | ) | |||
Total shareholders' equity | 193,030 | 225,744 | |||||
Total liabilities and shareholders' equity | $ | 247,338 | $ | 275,987 | |||
COMPASS PATHWAYS PLC Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) (in thousands, except share and per share amounts) (expressed in U.S. Dollars, unless otherwise stated) | |||||||||||||||
Three Months ended September 30, | Nine Months ended September 30, | ||||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||||
OPERATING EXPENSES: | |||||||||||||||
Research and development | $ | 32,928 | $ | 21,526 | $ | 86,898 | $ | 60,379 | |||||||
General and administrative | 14,968 | 12,536 | 42,893 | 38,135 | |||||||||||
Total operating expenses | 47,896 | 34,062 | 129,791 | 98,514 | |||||||||||
Loss from operations: | (47,896 | ) | (34,062 | ) | (129,791 | ) | (98,514 | ) | |||||||
OTHER INCOME (EXPENSE), NET: | |||||||||||||||
Benefit from R&D tax credit | 4,084 | 2,685 | 10,894 | 9,521 | |||||||||||
Interest income | 1,977 | 1,015 | 6,645 | 2,357 | |||||||||||
Interest expense | (1,137 | ) | (1,080 | ) | (3,347 | ) | (1,080 | ) | |||||||
Foreign exchange gains (losses) | 4,452 | (1,997 | ) | 3,894 | 2,064 | ||||||||||
Other income | 191 | 112 | 486 | 106 | |||||||||||
Total other income, net | 9,567 | 735 | 18,572 | 12,968 | |||||||||||
Loss before income taxes | (38,329 | ) | (33,327 | ) | (111,219 | ) | (85,546 | ) | |||||||
Income tax expense | (173 | ) | (62 | ) | (571 | ) | (386 | ) | |||||||
Net loss | $ | (38,502 | ) | $ | (33,389 | ) | $ | (111,790 | ) | $ | (85,932 | ) | |||
Net loss per share attributable to ordinary shareholders—basic and diluted | $ | (0.56 | ) | $ | (0.67 | ) | $ | (1.67 | ) | $ | (1.81 | ) | |||
Weighted average ordinary shares outstanding—basic and diluted | 68,395,343 | 49,633,104 | 67,001,326 | 47,355,992 | |||||||||||
Net loss | $ | (38,502 | ) | $ | (33,389 | ) | $ | (111,790 | ) | $ | (85,932 | ) | |||
Other comprehensive gain (loss): | |||||||||||||||
Foreign exchange translation adjustment | 339 | (738 | ) | 384 | (599 | ) | |||||||||
Comprehensive loss | $ | (38,163 | ) | $ | (34,127 | ) | $ | (111,406 | ) | $ | (86,531 | ) | |||
View source version on businesswire.com: https://www.businesswire.com/news/home/20241031740397/en/
Enquiries
Media: Sally Bain, sally.bain@compasspathways.com , + 1 781 458 0443
Investors: Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324
News Provided by Business Wire via QuoteMedia
Seelos Announces Second Postponement of its Annual Meeting of Stockholders
Seelos Therapeutics, Inc. (OTCQB: SEEL) ("Seelos"), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced that its 2024 Annual Meeting of Stockholders (the "Annual Meeting"), which was previously postponed to Friday, October 25, 2024 from its originally scheduled date of Friday, September 27, 2024 has been further postponed. The Annual Meeting is now scheduled to be held virtually, via live webcast at www.virtualshareholdermeeting.comSEEL2024 on Monday, November 25, 2024 at 8:00 a.m., Eastern Time . The record date for the Annual Meeting, August 19, 2024 is unchanged and applies to the postponed Annual Meeting.
The Annual Meeting has been postponed due to an anticipated lack of quorum, and to provide further time to solicit proxies from the Company's stockholders. Seelos' Board of Directors unanimously recommends that you vote FOR the Board of Director nominees and FOR all other proposals identified in the Company's proxy statement for the Annual Meeting. Stockholders who have already cast their votes do not need to take any action, unless they wish to change or revoke their prior proxy or voting instructions, and their votes will be counted at the postponed Annual Meeting. For stockholders who have not yet cast their votes, we urge them to vote their shares now, so they can be tabulated prior to the postponed Annual Meeting.
About Seelos Therapeutics
Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare diseases.
For more information, please visit our website: https://seelostherapeutics.com , the content of which is not incorporated herein by reference.
IMPORTANT ADDITIONAL INFORMATION
Seelos has filed a definitive proxy statement with the Securities and Exchange Commission (the "SEC") on August 20, 2024 . STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) FILED BY SEELOS AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT ANY SOLICITATION. Stockholders may obtain a free copy of the proxy statement and the other relevant materials, and any other documents filed by Seelos with the SEC, at the SEC's web site at http://www.sec.gov or on the "SEC Filings" section of Seelos' website at https://seelostherapeutics.com .
Participants in the Solicitation
Seelos, its directors and executive officers and other members of management and employees will be participants in the solicitation of proxies with respect to a solicitation by Seelos. Information about Seelos' executive officers and directors, including information regarding the direct or indirect interests, by security holdings or otherwise, is available in Seelos' definitive proxy statement for its Annual Meeting, which was filed with the SEC on August 20, 2024 . To the extent holdings by our directors and executive officers of Seelos securities reported in the proxy statement for the Annual Meeting have changed, such changes have been or will be reflected on Statements of Change in Ownership on Forms 3, 4 or 5 filed with the SEC. These documents are or will be available free of charge at the SEC's website at http://www.sec.gov .
Forward-Looking Statements
Statements made in this press release, which are not historical in nature, constitute forward-looking statements related to Seelos for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements are based on Seelos' current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos' business and plans described herein include, but are not limited to, the risk of not receiving stockholder approval of any of the proposals to be presented at the Annual Meeting, the risks related to raising capital to fund its development plans and ongoing operations and risks related to Seelos' current stock price, as well as other risk factors and matters set forth in our periodic filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2023 , subsequent Quarterly Reports on Form 10-Q, including Seelos' Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 . Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
Contact Information:
Mike Moyer
Managing Director
LifeSci Advisors, LLC
250 West 55th St., Suite 3401
New York , NY 10019
(617) 308-4306
mmoyer@lifesciadvisors.com
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SOURCE Seelos Therapeutics, Inc.
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Compass Pathways to Announce Third Quarter Financial Results on October 31, 2024
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that it will release financial results for the third quarter 2024 ending September 30, 2024, and provide an update on recent business developments, on October 31, 2024.
The management team will host a conference call at 8:00 am ET (12:00 pm UK) on October 31, 2024. To access the call, please register in advance here to obtain a local or toll-free phone number and your personal pin.
A live webcast of the call will be available on the Compass Pathways website at: Third Quarter 2024 Financial Results
The webcast will also be available 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 biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are living with mental health challenges and who are not helped by existing standards of care. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).
We have commenced a phase 3 clinical program of COMP360 psilocybin treatment in TRD, the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p
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.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241024060255/en/
Enquiries
Media: Sally Bain, sally.bain@compasspathways.com , + 1 781 458 0443
Investors: Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324
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