Silo Wellness (CSE:SILO, OTCQB:SILFF) is pursuing two parallel tracks to capitalize on the growing market fully. First, biotech research represents its long-term track, with the second track focusing on providing services in jurisdictions where legal barriers have been removed. The company, which was founded in Oregon by an Oregon lawyer, has previously launched Oregon’s first legal psychedelic retreats via ketamine (also a U.S. legal first).
Silo Wellness is pursuing treatment programs in Oregon under Ballot Measure 109, and has a proof of concept center in Jamaica. Combined, the company has a unique combination of business lines for both near-term and long-term revenue.
This Silo Wellness profile is part of a paid investor education campaign.*
Click here to connect with Silo Wellness (CSE:SILO, OTCQB:SILFF) to receive an Investor Presentation
Silo Wellness, Inc. (CSE: SILO) (OTCQB: SILFF) (FSE: 3K7A) ("SILO") has confirmed its intention to acquire all of the issued and outstanding securities of NUGL Inc. (OTC Pink: NUGL) ("NUGL" or "TargetCo") in a transaction valued at CAD $43,289,624.60, subject to the terms and conditions set forth in the binding Letter of Intent executed on August 28, 2023 in an arms-length transaction.
Terms of the Transaction:
SILO shall hold an annual and general special shareholders meeting to obtain approval for the acquisition of NUGL/Kaya, to elect a new board that would result in a change of control of the resulting issuer, and for a potential share consolidation and potential name change.
SILO will acquire 100% of the issued and outstanding shares of NUGL in exchange for 2,010,000,000 shares from treasury (all shares herein are pre-consolidation), for a purchase price of CAD $40,200,000.00.
NUGL stock options, warrants, and other convertible securities will be adjusted to receive SILO Common Shares on an economically equivalent basis.
Silo Wellness will issue common shares in a best-efforts private placement financing to raise gross proceeds of CAD $250,000.00 to $2M at 2 cents per share to validate the purchase price and cover costs to close the transaction, as well as provide additional capital for strategic growth post-merger.
Finder's fee of 3% of the transaction shall be paid to NUGL board member Benjamin Kaplan and 3% to Silo CEO Mike Arnold for a total of 64,934,437 shares issued each.
The final structure of the Transaction is subject to receipt of final tax, corporate, and securities law advice and securities regulatory and CSE approval for both SILO and NUGL.
The combined market cap of the two companies at the CAD $0.02/share valuation would be CAD $43,289,624.60. NUGL shares are valued at CAD $0.0461 (USD $0.0344). Silo shares are valued at CAD $0.02. The effective time of the transaction will result in the listing of the shares of the combined company on the Canadian Securities Exchange ("CSE"). The CSE is likely to keep the stock halted until such shareholder decision due to the size of the transaction, the change of control, and the definition of fundamental change under the rules.
Audited financial information about NUGL Inc. will be provided to shareholders prior to the special shareholders meeting to vote on this acquisition. This information will also be included in the press release announcing the signing of the definitive agreement.
Contact Silo Wellness:
Mike Arnold, CEO
541-900-5871
IR at Silo Wellness dot com
For more information about Silo Wellness or to book a Jamaican psychedelic retreat, please visit www.silowellness.com.
For NUGL Media and Investor Relations, please contact:
David L. Kugelman
(866) 692-6847 Toll Free - U.S. & Canada
(404) 281-8556 Mobile and WhatsApp
dk@atlcp.com
Skype: kugsusa
About Silo Wellness
Silo Wellness Inc., founded in Oregon and a leader in psilocybin wellness retreats, is unwavering in its dedication to destigmatize and democratize transformative psychedelic experiences. Oregon trial lawyer and entrepreneur Mike Arnold founded Silo Wellness in 2018, and it stands as the state's only publicly traded company actively providing psilocybin experiences to clients. The company's retreats, currently set in the breathtaking landscapes of Jamaica with expansion plans in Oregon, facilitate personal healing journeys.
Silo Wellness has received significant media recognition for its groundbreaking work, notably including a feature in Anderson Cooper's CNN documentary, 'Magic Mushrooms: Can They Change Your Mind?' During this documentary (now on HBO Max), CNN Correspondent David Culver experiences on-camera psilocybin therapy, illuminating the transformative power of these experiences. It further emphasizes Silo Wellness's ambitious plans for a rural psilocybin service center in the Portland area, complete with overnight accommodations, pending land use permits. Acknowledging potential challenges and competition in this emergent field, Silo Wellness remains resolute in its mission to bring the healing power of psilocybin to those in need.
Please share and comment on Silo's posts on social media:
About Kaya Group and NUGL Inc.
Kaya is a leader in Jamaica's fast-growing hospitality and tourism industry through its three Kaya Herb House retail locations and Gap Café wellness center. Kaya Herb House Drax Hall near Ocho Rios is Jamaica's first legal Medical Marijuana dispensary and the company's flagship retail complex. It is also the base for Kaya's cultivation and processing operations. The second Kaya Herb House in Kingston is minutes from the Bob Marley Museum, Jamaica House, the Office of the Prime Minister, and the French Embassy in the heart of Kingston within the golden triangle. Kaya's third retail location in the historic town of Falmouth is minutes from the cruise ship terminal and about 30 minutes from Montego Bay. Kaya recently opened the first phase of its Wellness Center at The Gap Café, located in the pristine hills of the Jamaican Blue Mountains, approximately 21 miles from Kingston outside the entrance to Holywell Recreation Park. The Gap Café has been a Jamaican treasure for nearly a century. Kaya has operated it as a wellness center since December 2022.
Kaya offers tours of Kaya Farm at its Drax Hall location, with more than 45 different genetics being cultivated and processed. All of our Kaya Herb House retail locations include:
A Dab Bar Consumption Lounge.
An authentic Italian thin-crust pizzeria.
Our world-renowned Square Grouper bar.
Kaya targets the potential multibillion-dollar industry for developing, marketing, and distributing psilocybin mushrooms, which are legal in Jamaica, through its Kaya Extracts division. For more information about Kaya, please visit https://kayaherbhouse.com.
Follow Kaya on social media using the links below:
The NUGL platform provides companies in the cannabis industry with targeted networking and advertising opportunities to expand their reach by connecting with consumers where cannabis is legal.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/178740
News Provided by Newsfile via QuoteMedia
Kaya Group ("Kaya" or "the Company") (OTC: NUGL), the first medicinal Ganja herb house in the Caribbean and holistic, wellness-focused ecosystem, announced today a strategic partnership with Silo Wellness Inc. (CSE: SILO) (OTCQB: SILFF) (FSE: 3K7A) ("Silo"), a pioneer in the psychedelic and wellness space, to offer a comprehensive range of incomparable psychedelic wellness experiences and retreats in Jamaica. The partnership combines Kaya's three Kaya Herb House retail locations and Gap Café wellness center with Silo's expertise in managing psilocybin wellness retreats in Jamaica's legal psilocybin market.
Key Highlights of the Transaction
Under the terms of the agreement, Silo Wellness acquired 25,081,369 shares of NUGL in exchange for the issuance of 15,293,640 shares of Class A common stock in Silo in this arms-length transaction. In accordance with the agreement, both Silo Wellness and NUGL are bound by conditions that prohibit the transfer or sale of purchased shares for a minimum period of 12 months, unless the shares have been properly registered under the Securities Act or are exempt from registration. Pursuant to CSE Policy 6.2(5), the shares will be issued after five business days (see the Form 9 filed on the CSE website) with price protection at the 20-day VWAP of CAD$0.012. There is no finder's fee and shareholder approval is not required due to the size of the transaction.
Enhanced Retreat Experiences and Market Presence
Silo Wellness intends to incorporate Kaya's psilocybin offerings to provide holistic and diversified experiences at their wellness retreats, enabling participants to explore alternative healing and mental health treatments that harness the potential synergies between cannabis and psilocybin.
In light of the recent financial successes of NUGL/Kaya, with top-line revenue hitting $2.2M USD in 2022 ($1.5M gross profit; $2.7M net loss), an increase in revenue from $1.8M USD in 2021, Silo Wellness' partnership with NUGL/Kaya Group brings even more opportunity for expansion and solidifies the company's presence in Jamaica, a region championing the burgeoning psychedelics industry. With the market projected to be worth $5.7 billion globally by 2027 (per the " Psychedelic Drugs: Global Market Outlook "), Silo Wellness attempts to strategically places itself for substantial growth.
Mike Arnold , founder and CEO of Silo Wellness and an Oregon attorney, asserts, "Our collaboration with Kaya is a monumental stride in realizing our vision to offer holistic treatments that combine the best of and broaden our international footprint. We're committed to providing transformative plant medicine wellness experiences."
Echoing this sentiment, Bali Vaswani , CEO of NUGL and Founder of Kaya, adds, "Jamaica is a perfect market for psilocybin offerings, and together with Silo Wellness, we will contribute to the evolving conversation around the potential benefits of these natural compounds."
About Kaya Group and NUGL Inc.
Kaya is a leader in Jamaica's fast-growing hospitality and tourism industry through its three Kaya Herb House retail locations and Gap Café wellness center. Kaya Herb House Drax Hall near Ocho Rios is Jamaica's first legal Medical Marijuana dispensary and the company's flagship retail complex. It is also the base for Kaya's cultivation and processing operations. The second Kaya Herb House in Kingston is minutes from the Bob Marley Museum, Jamaica House, the Office of the Prime Minister, and the French Embassy in the heart of Kingston within the golden triangle. Kaya's third retail location in the historic town of Falmouth is minutes from the cruise ship terminal and about 30 minutes from Montego Bay. Kaya recently opened the first phase of its Wellness Center at The Gap Café, located in the pristine hills of the Jamaican Blue Mountains, approximately 21 miles from Kingston outside the entrance to Holywell Recreation Park. The Gap Café has been a Jamaican treasure for nearly a century. Kaya has operated it as a wellness center since December 2022.
Kaya offers tours of Kaya Farm at its Drax Hall location, with more than 45 different genetics being cultivated and processed. All of our Kaya Herb House retail locations include:
Kaya targets the potential multibillion-dollar industry for developing, marketing, and distributing psilocybin mushrooms, which are legal in Jamaica, through its Kaya Extracts division. For more information about Kaya, please visit https://kayaherbhouse.com .
Follow Kaya on social media using the links below:
The NUGL platform provides companies in the cannabis industry with targeted networking and advertising opportunities to expand their reach by connecting with consumers where cannabis is legal.
About Silo Wellness
Silo Wellness Inc., founded in Oregon and a leader in psilocybin wellness retreats, is unwavering in its dedication to destigmatize and democratize transformative psychedelic experiences. Oregon trial lawyer and entrepreneur Mike Arnold founded Silo Wellness in 2018, and it stands as the state's only publicly traded company actively providing psilocybin experiences to clients. The company's retreats, currently set in the breathtaking landscapes of Jamaica with expansion plans in Oregon, facilitate personal healing journeys. Silo Wellness has received significant media recognition for its groundbreaking work, notably including a feature in Anderon Cooper's CNN documentary, 'Magic Mushrooms: Can They Change Your Mind?' During this documentary (now on HBO Max), CNN Correspondent David Culver experiences on-camera psilocybin therapy, illuminating the transformative power of these experiences. It further emphasizes Silo Wellness's ambitious plans for a rural psilocybin service center in the Portland area, complete with overnight accommodations, pending land use permits. Acknowledging potential challenges and competition in this emergent field, Silo Wellness remains resolute in its mission to bring the healing power of psilocybin to those in need
Forward-Looking Statements
Certain statements in this press release may be considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include projections of matters that affect revenue, operating expenses, or net earnings; projections of growth; and assumptions relating to the preceding. Such forward-looking statements generally start with the "plans," "anticipates," "expects," "believes," or similar words of like kind. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or qualified. Future events and actual results could differ materially from those outlined in, contemplated by, or underlying the forward-looking information. The company's business plan addresses these factors in greater detail, along with NUGL's current financial filings with the OTC Markets Group.
For Media and Investor Relations, please contact:
David L. Kugelman
(866) 692-6847 Toll Free - U.S. & Canada
(404) 281-8556 Mobile and WhatsApp
dk@atlcp.com
Skype: kugsusa
News Provided by GlobeNewswire via QuoteMedia
Silo Wellness Inc. (CSE: SILO) (OTCQB: SILFF) (FSE: 3K7A) ("Silo" or "the Company"), a pioneer in the psychedelic and wellness space, and NUGL Inc. (OTC Pink: NUGL), a multifaceted Jamaican cannabis and psychedelics lifestyle company, are thrilled to announce a strategic partnership through Kaya Group to bring a comprehensive range of psychedelic wellness experiences and retreats in Jamaica. This partnership, executed August 2, 2023, entails a significant transaction that underscores the strategic value of this collaboration.
Key Highlights of the Transaction
Under the terms of the agreement, Silo Wellness acquired 25,081,369 shares of NUGL in exchange for the issuance of 15,293,640 shares of Class A common stock in Silo in this arms-length transaction. In accordance with the agreement, both Silo Wellness and NUGL are bound by conditions that prohibit the transfer or sale of purchased shares for a minimum period of 12 months, unless the shares have been properly registered under the Securities Act or are exempt from registration. Pursuant to CSE Policy 6.2(5), the shares will be issued after five business days (see the Form 9 filed on the CSE website) with price protection at the 20-day VWAP of CAD$0.012. There is no finder's fee, and shareholder approval is not required due to the size of the transaction.
Enhanced Retreat Experiences and Market Presence
Silo Wellness intends to incorporate Kaya's psilocybin offerings to provide holistic and diversified experiences at their wellness retreats, enabling participants to explore alternative healing and mental health treatments that harness the potential synergies between cannabis and psilocybin.
In light of the recent financial successes of NUGL/Kaya, with top-line revenue hitting $2.2M USD in 2022 ($1.5M gross profit; $2.7M net loss), an increase in revenue from $1.8M USD in 2021, Silo Wellness' partnership with NUGL/Kaya Group brings even more opportunity for expansion and solidifies the company's presence in Jamaica, a region championing the burgeoning psychedelics industry. With the market projected to be worth $5.7 billion globally by 2027 (per the "Psychedelic Drugs: Global Market Outlook"), Silo Wellness attempts to strategically place itself for substantial growth.
Mike Arnold, founder and CEO of Silo Wellness and an Oregon attorney, asserts, "Our collaboration with Kaya is a monumental stride in realizing our vision to offer holistic treatments and broaden our international footprint. We're committed to providing transformative plant medicine wellness experiences."
Echoing this sentiment, Bali Vaswani, CEO of NUGL and Founder of Kaya, adds, "Jamaica is a perfect market for psilocybin offerings, and together with Silo Wellness, we will contribute to the evolving conversation around the potential benefits of these natural compounds."
Other Corporate Updates
The Company is excited to announce the appointment of Michael Hartman as its new Chief Operating Officer (COO). Mr. Hartman developed the intellectual property portfolio that helped launch Silo in 2018 and is a major shareholder and current board member.
In other corporate developments, Silo Wellness has terminated the previously announced transaction with BitGift (OTC Pink: MONI) due to a lack of responses to repeated attempts to engage and conduct due diligence.
Contact:
Mike Arnold, CEO
541-900-5871
IR at Silo Wellness dot com
For more information about Silo Wellness or to book a Jamaican psychedelic retreat, please visit www.silowellness.com.
About Silo Wellness
Silo Wellness Inc., founded in Oregon and a leader in psilocybin wellness retreats, is unwavering in its dedication to destigmatize and democratize transformative psychedelic experiences. Oregon trial lawyer and entrepreneur Mike Arnold founded Silo Wellness in 2018, and it stands as the state's only publicly traded company actively providing psilocybin experiences to clients. The company's retreats, currently set in the breathtaking landscapes of Jamaica with expansion plans in Oregon, facilitate personal healing journeys.
Silo Wellness has received significant media recognition for its groundbreaking work, notably including a feature in Anderson Cooper's CNN documentary, 'Magic Mushrooms: Can They Change Your Mind?' During this documentary (now on HBO Max), CNN Correspondent David Culver experiences on-camera psilocybin therapy, illuminating the transformative power of these experiences. It further emphasizes Silo Wellness's ambitious plans for a rural psilocybin service center in the Portland area, complete with overnight accommodations, pending land use permits. Acknowledging potential challenges and competition in this emergent field, Silo Wellness remains resolute in its mission to bring the healing power of psilocybin to those in need.
Please share and comment on Silo's posts on social media:
About Kaya Group and NUGL Inc.
Kaya is a leader in Jamaica's fast-growing hospitality and tourism industry through its three Kaya Herb House retail locations and Gap Café wellness center. Kaya Herb House Drax Hall near Ocho Rios is Jamaica's first legal Medical Marijuana dispensary and the company's flagship retail complex. It is also the base for Kaya's cultivation and processing operations. The second Kaya Herb House in Kingston is minutes from the Bob Marley Museum, Jamaica House, the Office of the Prime Minister, and the French Embassy in the heart of Kingston within the golden triangle. Kaya's third retail location in the historic town of Falmouth is minutes from the cruise ship terminal and about 30 minutes from Montego Bay. Kaya recently opened the first phase of its Wellness Center at The Gap Café, located in the pristine hills of the Jamaican Blue Mountains, approximately 21 miles from Kingston outside the entrance to Holywell Recreation Park. The Gap Café has been a Jamaican treasure for nearly a century. Kaya has operated it as a wellness center since December 2022.
Kaya offers tours of Kaya Farm at its Drax Hall location, with more than 45 different genetics being cultivated and processed. All of our Kaya Herb House retail locations include:
A Dab Bar Consumption Lounge.
An authentic Italian thin-crust pizzeria.
Our world-renowned Square Grouper bar.
Kaya targets the potential multibillion-dollar industry for developing, marketing, and distributing psilocybin mushrooms, which are legal in Jamaica, through its Kaya Extracts division. For more information about Kaya, please visit https://kayaherbhouse.com.
Follow Kaya on social media using the links below:
The NUGL platform provides companies in the cannabis industry with targeted networking and advertising opportunities to expand their reach by connecting with consumers where cannabis is legal.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/175978
News Provided by Newsfile via QuoteMedia
Silo Wellness Inc. (CSE: SILO) (OTCQB: SILFF) (FSE: 3K7A) ("Silo" or "the Company"), a pioneer in psilocybin wellness retreats, is excited to announce its feature this Sunday on a groundbreaking CNN documentary episode of The Whole Story with Anderson Cooper.
The episode, entitled 'Magic Mushrooms: Can They Change Your Mind?' takes an unprecedented step in mainstream media coverage of psychedelic therapies: CNN Correspondent David Culver undergoes psilocybin therapy on camera, providing viewers with a firsthand perspective on the transformative journey. This is a follow-up on Mr. Culver's CNN story featuring Silo Wellness last November.
"We're honored to be part of this monumental moment in mainstream media," said Oregon attorney Mike Arnold, CEO of Silo Wellness. "This isn't just a milestone for Silo Wellness, but for the entire field of psychedelic therapy. It's a significant step towards greater understanding and acceptance."
Silo Wellness, known for its distinctive retreats in the beautiful landscapes of Jamaica with plans in Oregon, is proud to have facilitated this transformative experience. The episode gives the public an intimate view of participants' personal healing journeys under the guidance of Silo's experienced team.
The episode is set to premiere this Sunday, June 18 at 8pm ET/PT. This represents a prime opportunity for potential investors, current shareholders, and the general public to gain an inside look at the innovative work being done at Silo Wellness.
"By showcasing our approach to psilocybin therapy and its profound potential on a platform like CNN, we're playing a part in normalizing and destigmatizing these treatments, creating value for our shareholders and improving the narrative around mental health care," added Arnold.
Other Corporate Updates - Debt Settlement
Silo Wellness intends to issue 11,078,959 shares of its common stock to settle the CAD$166,184.38 account payable debt in an arm's length transaction subject to the statutory four-month hold. The number of shares is determined based on CAD$0.015 per share, the 20-day volume-weighted average price (VWAP) as of Monday, June 12, 2023. Pursuant to CSE Policy 6.2(5) (adopted April 3, 2023), the Company intends to close on the share issuance no sooner than five days. The price protection expires July 22, 2023. In accordance with the previously announced debt restructuring plan, the Company intends to issue shares to settle additional accounts payable and other debt.
Regarding the intended shares for debt announced on April 24, 2023, the Company no longer intends to settle that debt at this time. The parties have agreed to extend the closing of that transaction to contemplate additional opportunities.
For more information about Silo Wellness or to book a Jamaican psychedelic retreat, please visit www.silowellness.com.
Contact:
Mike Arnold, CEO
541-900-5871
IR at Silo Wellness dot com
About Silo Wellness
Silo Wellness's mission is to provide psychedelics to those suffering as quickly and inexpensively as possible. Silo is currently Oregon's only publicly traded company actively providing psychedelics to clients. The Company was founded in 2018 by an Oregon trial lawyer in anticipation of Oregon legalizing psilocybin on January 1, 2023, and currently offers Jamaica psilocybin retreats at an all-inclusive seafront resort. The Company has a right of first refusal on all psilocybin mushrooms with Oregon first-mover cultivator Satya, Inc., and announced in January its intended Portland-area rural psilocybin service center with overnight dorm room accommodations (if land use permits are granted).
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION: This news release contains "forward-looking information" and "forward-looking statements" (collectively, "forward-looking statements") within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates, and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as "expects", or "does not expect", "is expected", "anticipates" or "does not anticipate", "plans", "budget", "scheduled", "forecasts", "estimates", "believes" or "intends" or variations of such words and phrases or stating that certain actions, events or results "may" or "could", "would", "might" or "will" be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements.
In this news release, forward-looking statements relate to, among other things, the ability of Silo Wellness to actually increase or maintain revenue and even stay viable as a public company given the capital and revenue deficiencies previously announced. Obtaining profitability and scaling in Jamaica continues to be an uncertain risk along with accomplishing anything licenses in Oregon and then becoming profitable. Forward-looking statements are 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 statements.
Such factors include, but are not limited to: general business, economic, competitive, regulatory, political and social uncertainties, potential impacts of COVID-19, uncertainties regarding the finalization of definitive agreements with the property owner, and the risk of commoditization in the psychedelic market. Such risks and uncertainties include, among others, the risk factors included in Silo Wellness's continuous disclosure documents available on www.sedar.com. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.
Readers should not place undue reliance on the forward-looking statements and information contained in this news release. Silo Wellness assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.
NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/169986
News Provided by Newsfile via QuoteMedia
Via NewMediaWire Moon Equity Holdings Corp. ("MONI" or "the Company") (OTC: MONI) has signed a binding letter of intent ("LOI") to divest its BitGift asset to Silo Wellness Inc. (CSE: SILO) (OTCQB: SILFF) (FSE: 3K7A), an Oregon-based psychedelics company, for a sum up to CAD$500,000. At closing, MONI plans to allocate the Silo shares as a dividend to MONI existing shareholders, based on a record date to be determined by FINRA.
Moon Equity Holdings CEO, Frank Ottaviani, stated, "We are pleased to have entered into this agreement with Silo Wellness, and we are looking forward to integrating the BitGift platform into Oregon's psilocybin market and beyond. This technology will provide significant value to Silo and its clients. This transaction is timely for MONI as we've been working to finalize our previously announced acquisition of MONI by an aviation company."
BitGift®, recently signed a Partnership Agreement with MoonPay. BitGift's platform is designed to make the crypto experience more accessible and provide users with greater flexibility. Catering to both beginners and experienced users, the platform enables users to be able to provide its customers the use of Visa Debit Cards, as well as Onramp and Offramp services. Existing BitGift® users have already been able to open a cryptocurrency wallet to buy, store, send, or receive a crypto gift; now, with the help of MoonPay, BitGift® users will be able to sell their crypto, convert their crypto into cash, and send/transfer funds to a bank account of their choice.
This new partnership with MoonPay comes with great quality and magnitude. In November 2021, MoonPay completed a round of Series A funding in the amount of $555 million. This brought the valuation of MoonPay to $3.4 billion, which in turn placed MoonPay as the largest and highest-valued Series A for any bootstrapped crypto company having over five million customers. MoonPay ensures that compliance with their over 5 million customers will never be an issue as it provides top notch KYC and onboarding services.
https://www.moonpay.com/about-us
When this transaction is completed, Silo Wellness will utilize the platform as a solution for addressing the challenges faced by licensed psilocybin operators in Oregon when complying with banking and anti-money laundering regulations. To ensure adherence to these laws, Silo Wellness and BitGift plan to collaborate with other providers and industry experts to establish and implement strong Know Your Customer (KYC) and Anti-Money Laundering (AML) procedures, encompassing identity verification, transaction monitoring, risk assessment, and regulatory reporting.
According to the terms, MONI would transfer the BitGift asset to Silo Wellness in exchange for 5,050,505 Common Shares of Silo (currently valued at CAD$100,000 as per the 20-day VWAP). Additional consideration of up to CAD$400,000 would be payable upon reaching specific revenue milestones. The shares would be subject to a 6-month contractual hold. We plan on executing a definitive agreement within the next 30 days.
When this transaction is completed, MONI will distribute the Silo shares as a dividend to its shareholders, introducing approximately 2,000 new US-based shareholders to the Oregon psilocybin market.
Mike Arnold, CEO of Silo Wellness, commented, "We see BitGift as a catalyst to swiftly move Oregon psilocybin away from a cash-only system. We're enthusiastic about further exploring this opportunity and collaborating with MONI to finalize the transaction terms. As per the agreement, MONI would distribute the Silo shares as a dividend to its shareholders. We will be welcoming up to 2,000 new US-based shareholders into the Silo family and sharing our revenue strategy for psilocybin programming in Oregon and Jamaica. We encourage all our new shareholders to contact us through social media and investor relations to inquire about shareholder discounts for Oregon and Jamaica psilocybin retreats.
About Moon Equity Holdings Corp.
MONI was created with a focus on acquiring companies in Fintech. MONI recently acquired the BitGift platform, which is focused on Crypto, Blockchain Technology, and DeFi (Decentralized Finance). Its goal is to offer services and products globally to capture total market share and increase company stock value for its shareholders.
About Silo Wellness
Silo Wellness's mission is to provide psychedelics to those suffering as quickly and as inexpensively as possible. Silo is currently Oregon's only publicly traded company actively providing psychedelics to clients. The Company was founded in 2018 by an Oregon trial lawyer in anticipation of Oregon legalizing psilocybin on January 1, 2023, and currently offers Jamaica psilocybin retreats at an all-inclusive seafront resort. The Company has a right of first refusal on all psilocybin mushrooms with Oregon first-mover cultivator Satya, Inc., and announced in January its intended Portland-area rural psilocybin service center with overnight dorm room accommodations (if land use permits are granted).
Forward-Looking Statements This press release contains forward-looking statements. Readers are cautioned that any such statements are not guarantees of future performance and that actual developments or results may vary materially from those projected in the forward-looking statements. The company disclaims any obligation to update any forward-looking statements made in this press release.
Contact us at: Info@moonequityholdings.com
News Provided by GlobeNewswire via QuoteMedia
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“Participants and analysts have known that the psychedelic opportunity is ultimately a long game that requires public policy progression alongside pharmaceutical advancement and innovation. Ultimately, a watershed moment could lead to a waterfall effect across the industry."
— Naseem Husain, Horizons ETFs
"I see the US Food and Drug Administration approving one or both of these compounds (psilocybin and MDMA) and a new medical model and industry will be birthed in 2024 and 2025."
— Andrew DeAngelo, Forbes
The Investing News Network is a growing network of authoritative publications delivering independent, unbiased news and education for investors. We deliver knowledgeable, carefully curated coverage of a variety of markets including gold, cannabis, biotech and many others. This means you read nothing but the best from the entire world of investing advice, and never have to waste your valuable time doing hours, days or weeks of research yourself.
At the same time, not a single word of the content we choose for you is paid for by any company or investment advisor: We choose our content based solely on its informational and educational value to you, the investor.
So if you are looking for a way to diversify your portfolio amidst political and financial instability, this is the place to start. Right now.
Psychedelics Market 2023 Year-End Review
Psychedelics Market Forecast: Top Trends That Will Affect Psychedelics in 2024
The psychedelics industry is maturing after the investment boom of 2020 and 2021, and patient long-term investors looking for opportunities to diversify their portfolios have options when it comes to exposure.
As clinical trials and research continue to demonstrate the potential benefits of psychedelic-assisted therapy (PAT), companies in the space are attracting more attention. The Investing News Network (INN) spoke with Naseem Husain, senior vice president and exchange-traded fund (ETF) strategist at Horizons ETFs, to get his thoughts on 2023.
"Compared to the market fervor in 2020/2021, like (2022), 2023 was a quieter and colder year in the psychedelics marketplace. This past year, no major catalysts emerged and there was continued consolidation in the industry — a trend that will likely continue," the expert said during the interview, emphasizing the period's slowness.
"That being said, clinical trials take time, and participants and analysts have known that the psychedelic opportunity is ultimately a long game that requires public policy progression, alongside pharmaceutical advancement and innovation. Ultimately, a watershed moment could lead to a waterfall effect across the industry," Husain added.
According to Research Nester, the psychedelic drug market was worth US$3 billion in 2022. If it grows at the firm's estimated compound annual growth rate of 14 percent, the market will be worth more than US$12 billion by 2035.
“There are 22 million American adults suffering from depression, 300 million people worldwide. So unfortunately, there's a very large unmet need and a massive market opportunity,” Cybin (NYSEAMERICAN:CYBN) CEO Doug Drysdale explained in an end-of-year conversation with INN. “The (depression and anxiety) market is maybe around a US$40 billion potential. If you add in other potential indications … like postpartum depression, alcohol use disorder or eating disorders, you're looking at a total addressable market of maybe US$100 billion annually.”
Here INN looks back on the psychedelics space in 2023 and highlights key developments and trends.
As more people struggle with mental health and the addiction crisis worsens, a growing body of evidence suggests that psychedelic substances may offer much-needed relief. Researchers have continued to demonstrate that these treatments can be used to treat a variety of mental health disorders, and may reduce healthcare costs as well.
This has sparked a shift in the US legislative landscape, with increasing bipartisan support for psychedelic drug reform. At the federal level, President Joe Biden has expressed his expectation that psychedelic therapies will be approved in specific circumstances, and in 2023, the Food and Drug Administration (FDA) took steps to facilitate the development of psychedelic therapies when it released a comprehensive guide for clinical investigations.
At the state level, Oregon and Colorado have emerged as pioneers in the regulated use of psychedelics, with Oregon granting its first license for a healing center in March after officially legalizing PAT in January. Likewise, Colorado passed its Regulated Natural Medicine and Legalization Act in July, and will progressively implement various PATs.
While some states have introduced legislation to legalize or decriminalize psychedelics, the legislative process can be slow and outcomes uncertain. For example, while Oklahoma has approved HB 3414 to increase research, other legislation is still working its way through the system, such as New York's Psychedelic Law Enforcement Reform Act.
In October, California Governor Gavin Newsom signed a bill to immediately allow doctors to prescribe psychedelic treatments if the substances are rescheduled. However, he vetoed SB 58, which sought to decriminalize the possession and personal use of a selected group of psychedelics, after it had already passed through the Senate and Assembly. Newsom said his reason for vetoing the bill was that it failed to meet guidelines that would criminalize possession outside of medical clearance. It also didn’t satisfy the criteria for treatment guidelines, such as dose information.
Outside the US, other countries have also been taking steps to regulate and explore the therapeutic potential of psychedelics. Canada, the US' northern neighbor, is one example — on a provincial level, Alberta enacted a new policy at the start of 2023 that regulates psychedelic drugs for mental health treatment.
Federally, most psychedelic therapies remain illegal. However, Canadians continue to lobby for increased access to these treatments, and in rare cases can be approved for PATs that are undergoing clinical trials through the country’s Special Access Program. Last year, the Senate’s Subcommittee on Veteran Affairs published a report calling on governments at all levels to perform a large-scale research program on PATs, as the treatments have the potential to greatly help military veterans, an underserved demographic for which mental health struggles are common.
One company making this a focus is the veteran-founded Apex Labs, whose psilocybin product APEX-90 was recently approved for a 160 macro-dose clinical trial starting in the first quarter of 2024. However, ahead of the trial, a Canadian military veteran with treatment-resistant depression was approved for the treatment through the Special Access Program; they received a dose on November 2 in Vancouver accompanied by psychotherapy.
For its part, Australia has taken a different approach. On July 1, legalization took effect for MDMA and psilocybin for the medical treatment of post-traumatic stress disorder (PTSD) and depression, respectively, in tandem with therapy.
“Time will tell, but the Australian announcement is likely the biggest ‘positive’ event for the space and could provide a model for other jurisdictions to emulate,” Husain said. “If a major country like Australia is able to successfully administer psychedelic medicines, that could prove a catalyst for Canada and other Commonwealth nations.”
The use of psychedelics for therapeutic purposes continued building momentum in 2023 as clinical trials investigating the efficacy of these substances for treating a range of mental health conditions reached new milestones.
One of the more notable trials of 2023 was Compass Pathways' (NASDAQ:CMPS) investigation of the effectiveness of its product, COMP360, in treating bipolar II depression. This was the first study of PAT on bipolar disorder. The results, which were published in JAMA Psychiatry on December 6, suggest that psilocybin combined with psychotherapy could be an effective and safe treatment for bipolar II depression. The company is also studying the use of COMP360 to treat mental health disorders such as anorexia, PTSD and treatment-resistant depression, among others.
Another significant development in the field of psychedelic therapies was the publication of positive results from MindMed’s (NASDAQ:MNMD,NEO:MMED) Phase 2b trial of its LSD-based product MM-120, which was being investigated as a potential treatment for generalized anxiety disorder. According to the company’s website, there is also evidence to suggest that MM-120 could be effective for treating chronic pain and substance use disorders. MindMed’s share price rose by 7 percent following the news. The company plans to move on to Phase 3 trials in 2024.
Cybin, another player in the psychedelics industry, reported positive topline data from Phase 2 clinical trials of CYB003 for major depressive disorder. “(It’s) really unprecedented to see 80 percent of patients in remission after two doses. I don't think we've ever seen anything like that in depression, ever,” Cybin’s Drysdale commented to INN about the results. The US Patent and Trademark Office granted the company a patent for its product on December 6.
Finally, MAPS Public Benefit, a subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), submitted a new drug application to the FDA in December following positive results from Phase 3 trials that studied the efficacy of its MDMA-assisted therapy for treating PTSD. On January 5, MAPS Public Benefit announced it was changing its name to Lykos Therapeutics as it begins to focus on product commercialization pending FDA approval of its treatment.
The market for psychedelic therapies is evolving, and with the changing landscape there will be challenges that must be addressed. In a December 2022 research paper, experts explored the economic considerations surrounding PAT, including market dynamics and the potential for growth and consolidation in the space.
Bruce Campbell, president and portfolio manager at StoneCastle Investment Management, discussed MindMed in a market call with BNN Bloomberg: “One of the risks they obviously have with a company like (MindMed), they're going to need to continually raise money over time, much like the cannabis sector has done, to kind of build out their operations. So they're nowhere near the point where they're going to be cashflow positive. So you do have to be aware that if the stock runs up it could pull back on financing, and it's probably a position that you want to trade around.”
Campbell’s comments specifically address MindMed, but they also speak to the broader challenges and risks associated with investing in the psychedelics industry, including the need for ongoing funding and the potential volatility.
While some clinical trials have yielded promising results, companies must still overcome the complexities of patenting and commercializing their products. One issue that could hinder profitability is that psychedelic compounds are naturally occurring substances that may be difficult to protect under existing intellectual property laws.
To address this challenge, companies in the psychedelics industry are exploring a range of strategies, including developing novel formulations of compounds, combining them with other ingredients to create proprietary products and leveraging their expertise and data to establish a competitive advantage.
For example, Numinus Wellness (TSX:NUMI,OTCQX:NUMIF) made significant changes to its business in 2023 in order to increase its revenue, including launching a clinic licensing platform called Numinus Network, expanding its practitioner training programs and partnering with Healing Commercial Real Estate to find more clinics for its services. The company also closed operations at its non-revenue-producing Numinus Bioscience research lab.
After turning its focus to revenue-generating activities, Numinus reported significant growth in revenue in the fourth quarter of 2023, including US$5 million from the company’s wellness clinics.
As part of its focus on practitioner training, Numinus announced a partnership with MAPS in June, for which it submitted a clinical trial application to Health Canada. The purpose of the trial is to study how healthcare practitioners could establish protocols and procedures for MAPS’ MDMA-assisted therapy and identify any potential challenges. If successful, Numinus has plans to incorporate the therapy into its repertoire of PAT education and training programs.
While regulatory considerations are an important factor in the growth and development of the PAT industry, another trend affecting the sector is the increasing consolidation of the market through mergers and acquisitions.
“We've seen a huge amount of consolidation over the last couple of years, down from maybe 60 reported psychedelic companies to frankly only about a half a dozen now that are really focused on drug development,” Drysdale noted. Two such examples in 2023 were Cybin’s acquisition of Small Pharma and Otsuka’s (TSE:4578) acquisition of Mindset.
As the PAT sector develops, concerns are also arising, especially when it comes to the need for companies to balance affordable and equitable access to treatment as they pursue growth and expansion.
To this end, Beckley Waves, a venture studio that works exclusively with practitioners in the psychedelics space, established the New Ethics Council in June. The council is composed of experts who will be able to provide guidance on best practices. Among them is Beckley Waves founder Amanda Fielding, who has been an influential presence in the industry for generations, pouring over 55 years of research into the benefits of psychedelic experiences.
Looking back on recent developments in the psychedelics industry, it’s clear that in 2023 the field made significant strides in terms of clinical research, as well as some regulatory progress.
Of course, uncertainties still lie ahead in this young sector. “Despite positive broader market performance across other major indices, risk-off sentiment from 2022 persisted throughout 2023, which has led to a greater gulf between the psychedelic and biotech industries and other sectors,” said Husain.
Don’t forget to follow us @INN_LifeScience for real-time news updates!
Securities Disclosure: I, Meagen Seatter, hold no direct investment interest in any company mentioned in this article.
Editorial Disclosure: The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.
Additional information on investing in psychedelics stocks — FREE
As research into psychedelic drugs continues to produce positive results, policymakers are taking note.
With promising clinical trials, increasing public acceptance and a growing desire for psychedelic-assisted therapies (PATs), the sector seems to be poised for significant growth in the coming years.
Heading into 2024, the Investing News Network (INN) turned to industry insiders to dig into what might be in store for the psychedelics market. Read on to learn what they had to say.
Psychedelics companies are seeing a growing influx of funding and support thanks to positive clinical trial results.
“I think we've seen a shift in the last maybe three or four months of the year where more institutions are starting to look back at the psychedelic space again,” Cybin (NYSEAMERICAN:CYBN) CEO Doug Drysdale said in an interview with INN. “We had Steven Cohen's fund, Point72, make a significant investment in Cybin. They came in on our (at-the-market offering), and a number of other institutions are paying attention now as the sector is maturing.”
In addition, Lykos Therapeutics, which just changed its name from MAPS Public Benefit, secured US$100 million in Series A funding from a group of private investors in January 2024.
Lykos was previously focused on developing PATs for a range of mental health disorders, but after completing Phase III trials for its MDMA-assisted therapy for post-traumatic stress disorder in 2023, and then submitting a new drug application (NDA) to the US Food and Drugs Administration (FDA) in December, the company has changed its focus to bringing its MDMA treatment to market. The funding will be used to support these ongoing efforts.
Several of the same investors also recently contributed to a US$3.3 million funding round for Beckley Waves, a venture studio formed exclusively for the development of the psychedelics industry.
The regulatory landscape for these psychedelic substances will play a crucial role in shaping the market, with drug reform and decriminalization efforts having the potential to unlock significant growth opportunities.
While the current legislative landscape for psychedelics bears some similarities to that of the cannabis industry, there are also key differences, namely psychedelics companies' sole focus on therapeutic applications.
“In my opinion, the psychedelics industry is completely different than the cannabis market,” said Naseem Husain, senior vice president and exchange-traded fund (ETF) strategist at Horizons ETFs. “One is a medical and biotechnology opportunity, while another is primarily focused on retail, at least in the North American market. While both have legal barriers to overcome that could result in growth, the psychedelic pipeline is about pharmaceutical and regulatory development and less so about marketing and distribution like we’ve seen in the hyper-competitive cannabis sector.”
This crucial distinction could create greater accessibility for the patients who need these treatments. More and more practitioners are being allowed to administer psychedelic drugs via trials, and certain US states and Canadian provinces have legalized PATs or developed regulatory mechanisms to make them accessible, such as Health Canada’s Special Access Program. Even Australia, a country that has maintained a strict stance on cannabis, has approved the legal therapeutic use of MDMA and psilocybin, although some scientists have called the decision rushed.
In some cases, patients are circumventing federal roadblocks either by procuring illicit substances on their own, or by seeking treatment through private institutions. For example, psychedelic integration therapy, which helps individuals process and integrate insights gained during a psychedelic experience, is available in Vancouver, BC, but often at an exorbitant cost, and patients are left to source psychedelic compounds on their own.
What Drysdale and other market participants hope to achieve through their therapies is affordable and effective treatment, which needs Health Canada or FDA approval to be accessible.
“What we're doing is we are creating and producing synthetic, modified molecules, GMP manufactured, hoping to be FDA approved, prescribed by a doctor, reimbursed by your insurance company,” he said. “And I think that's what you need to attract the attention of patients who are already depressed and dealing with stuff. I think that some may go seek natural mushrooms, but if we can make these treatments really accessible through this regulated route first, then I think that's the most reliable and less risky way of providing really significant access.”
Could 2024 be the year for psychedelic drug reform? Some experts think the answer could be yes.
“I see the FDA approving one or both of these compounds (psilocybin and MDMA) and a new medical model and industry will be birthed in 2024 and 2025,” Andrew DeAngelo said in a Forbes article on cannabis and psychedelics market predictions for 2024. However, he also acknowledged that the industry is often unpredictable.
That said, there has been some progress on that front.
As mentioned, Lykos has now submitted an NDA to the FDA for its MDMA treatment, and the company requested a priority review because of the FDA’s designation of MDMA as a breakthrough therapy. If the FDA accepts the application, the process will take six months with a priority review or 10 months with a regular review.
If the FDA ultimately approves the treatment, MDMA would need to be moved from Schedule I to Schedule II, opening the door for other practitioners who have potential therapies in their pipelines.
While legalization is widely expected in the future, opinions vary on how quickly it will come. For instance, the American Medical Association predicts that most states will have legalized psychedelics by 2037 — that means current investors might still need to wait a while before they start seeing high returns on investment.
“Participants and analysts have known that the psychedelic opportunity is ultimately a long game that requires public policy progression alongside pharmaceutical advancement and innovation. Ultimately, a watershed moment could lead to a waterfall effect across the industry,” Husain said.
The evidence suggests that the psychedelics industry could be on the brink of significant growth in the coming years, but with some caveats. While clinical trial results have been promising and public acceptance is growing, the regulatory landscape will play a critical role in shaping the future of the market.
With the right regulations and approvals in place, psychedelics could revolutionize mental health treatments by offering affordable and effective therapies to those who need them.
Don’t forget to follow us @INN_LifeScience for real-time news updates!
Securities Disclosure: I, Meagen Seatter, hold no direct investment interest in any company mentioned in this article.
Editorial Disclosure: The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.
Additional information on investing in psychedelics stocks — FREE
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 23 rd Annual Needham Virtual Healthcare Conference at 8:00am ET on April 9, 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 such event. For more information, please visit investor section of compasspathways.com.
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 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 U.S. 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 COMP 360 psilocybin therapy in TRD, the largest randomized, controlled, double-blind psilocybin therapy clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p www.compasspathways.com .
Availability of other information about Compass Pathways
Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including, but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
Enquiries
Media: Amy Lawrence, amy@compasspathways.com , +44 7813 777 919
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324
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Compass Pathways plc (Nasdaq: CMPS) ("Compass"), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced that Board Chair and co-founder George Goldsmith and fellow co-founder Ekaterina Malievskaia have resigned their seats on the company's board of directors, effective March 29, 2024.
David Norton, lead independent director on the Compass board of directors, will become interim chair. Compass is running a global search for a permanent board chair, focused on recruiting a leader with a strong background in the biotechnology sector and broad strategic experience across the product lifecycle.
"When we started Compass eight years ago, we could not have imagined how the company would grow and mature," said George Goldsmith, outgoing board chair of Compass Pathways. "The company is on a strong, positive trajectory to develop psilocybin treatment under Kabir Nath's principled leadership. My commitment to transforming mental health care is unwavering. It is time to turn my attention to the next phase of making this vision a reality for patients, providers and health systems independent of any particular treatment modality."
"Everyone has a story, and too often this story includes the shortcomings of existing treatments and the pain and frustration of navigating the system," said Ekaterina Malievskaia. "I step down from the board convinced that the company is in good hands and on the right track financially, in its programs, and in preparation for a potential commercial launch to bring treatments to those in need. Innovation in mental health care remains as important to me as it was ten years ago, and I plan to continue to apply my experience and knowledge to the field."
"George and Katya leave an enduring legacy at Compass Pathways and across the field of mental health care," said David Norton. "Their leadership and compassion for people living with difficult-to-treat mental health conditions, their commitment to rigor and evidence, and their focus on ensuring broad and equitable access to innovation in mental health have moved us closer to achieving the vision they set when they launched the company: a world of mental wellbeing. Thanks to their leadership, Compass is in a strong position as it continues to execute its phase 3 program in treatment-resistant depression. We wish them all the best as they move into the next phase of their careers and continue their efforts to transform mental health care."
George and Ekaterina co-founded Compass Pathways in 2016. George served as Chief Executive Officer of the company from its founding until August 1, 2022, when Kabir Nath assumed the role. Ekaterina served as Chief Innovation Officer until she stepped down from her executive role in June 2023. This transition is a natural evolution as Compass has matured as a public company and progresses through late-stage clinical development and into commercial preparations.
Key accomplishments of their tenure at the company and on the board include:
David Norton is a former Company Group Chairman of Global Pharmaceuticals for Johnson & Johnson. He began his career with J&J in 1979 and held several positions across the company, including Company Group Chairman, Worldwide Commercial and Operations for the CNS/internal medicine franchise, Company Group Chairman for the pharmaceutical businesses in Europe, the Middle East and Africa, and Company Group Chairman for the pharmaceutical businesses in North America. He has been a member of the Compass board of directors since 2018, serving as lead independent director. He also serves on the board of directors of Forepont Capital.
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 current treatments. 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 been designated a Breakthrough Therapy by the U.S. 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 United States. Our vision is a world of mental wellbeing. www.compasspathways.com
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 "will", "may", "might", "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 expectations regarding its plans for a new board chair and Compass's expectations regarding its pivotal phase 3 program or other trials to support regulatory filings and approvals. 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: market risks and other market conditions; the timing and outcome of the Company's search for a new board chair; clinical development is lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; we will require substantial additional funding to achieve our business goals 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 product development efforts; our efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for COMP360 or any future product candidates may be unsuccessful; establishing, maintaining, defending and enforcing our patents and other intellectual property rights covering our investigational COMP360 psilocybin treatment may be challenging and costly and our efforts to protect our patents and other intellectual property rights may be unsuccessful; our efforts to commercialize and to obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; our ability to successfully manage leadership changes; economic and geopolitical uncertainties and those risks and uncertainties described under the heading "Risk Factors" in Compass's most recent annual report on Form 10-K or quarterly report on Form 10-Q and in other reports we have filed with the U.S. Securities and Exchange Commission ("SEC"), which are available on the SEC's website at www.sec.gov . Except as required by law, Compass disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Compass's current expectations and speak only as of the date hereof.
Enquiries
Media: Amy Lawrence, amy@compasspathways.com , +44 7813 777 919
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324
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