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

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

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

Jackson County recently voted 52.7% against a psilocybin "opt out." Next up in the saga is the land use hearing before the Jackson County Commissioners next Wednesday, November 23rd at 1:30 p.m. They can choose to accept the ordinance or amend it in any fashion, including adopting its original form, which continues to be a risk factor of the Company's Jackson County plans. Advocates are invited to testify remotely or in person: https://jacksoncountyor.zoom.us/j/89523141457.

Psilocybin Home Occupations?

The new proposed ordinance, which can be downloaded here, would not only allow Oregon psilocybin therapy retreats at existing lodging locations, such as New Frontier Ranch, with whom Silo has an LOI, but also in enclosed outbuildings on residential farmland under statutory "home occupation" exemptions. "At the hearing I advocated that the county shouldn't just allow for commercial lodging locations for companies like us but should also allow for home occupations," stated Arnold. "This is a matter of fairness for Jackson County entrepreneurs but also is a matter of patient access. The more options for care and the more competition, the lower the price and the better the quality of services. A rising tide lifts all ships. Let's hope the commissioners agree."

What happens if the Oregon psychedelic ranch LOI is terminated due to next week's vote?

"I have been in Oregon for 24 years and a trial lawyer for most of my time here," stated Arnold. "Consequently, our network runs deep and so do our legal options.

"I chose New Frontier Ranch for several reasons. First, the property is amazing. Second, the property owner is a dear friend whom I trust. Third, the likely capital expenditures are low due to the potential joint venture. Fourth, it is already operating in a commercial capacity with lodging and event hosting. However, it's the court judgment that makes this property one of a kind because of the pre-code grandfather rights there. If the commissioners revert back to 'general commercial' zoning only for psilocybin, we will confer with the county for an exemption under the prior judgment. If they do not acquiesce, we intend to litigate.

"That would push out any potential launch down there for a longer period of time, if at all, due to the adversarial process but could potentially make us the only psilocybin service center in rural Jackson County. In the meantime, I will simply plan to move on to my second or third property options and begin to negotiate terms there.

"We remain undeterred in our plans to be a market leader in Oregon. I founded Silo in 2018, anticipating filing an Oregon license application in 2023. It's been a long road. To get to this point, we had to first cultivate mushrooms in Jamaica, then operate retreats there, but also raise capital and complete a public listing. But now here we are on the cusp of what we believe to be the last chance to be first to market in the plant medicine space. It's a very exciting time."

Other Corporate Updates - Shareholder/Investor FAQs

Silo Wellness receives many investor relations questions. Given the frequency of some of these questions, Silo Wellness will update its Investor FAQ page as follows:

How do retreats scale? Do you lease or own the locations where retreats are located?

In Jamaica, we neither own nor lease the space. As mentioned in previous MD&As, the Company uses agreements with third-party resorts. These agreements are non-material.

Booking different locations as we went along initially allowed the Company to build out the business model without having the capital risk associated with purchasing, running, and operating a resort. By not leasing the resorts, we do not take on the long-term risk of vacancies.

This booking model was very efficient during COVID when the supply of vacancies far exceeded demand for Jamaica resorts. However, with the rise of digital nomadism and increased tourism abroad, quality locations with the proper setting for psychedelics are rarer. Additionally, the previous model still had risk by booking an entire resort per retreat: If bookings don't meet the breakeven threshold, then a retreat could be operated at a loss.

This is a great deal for the resort but not so much for the Company. Yes, we get some economies of scale through discounts by booking an entire resort or block of rooms. However, those aren't the sort of collaborators we are looking for in the space. We are looking for friends and partners, not looking to be someone's customer. The resorts received all of the publicity of being associated with their customer (Silo) in a cutting-edge sector and thus received all of the earned media coverage that being a pubco and early mover leveraged. They also received the other marketing - with none of the cost. Then, the resort could turn around and market their resort to other psychedelic operators who would come to them thanks to us raising their profile. Exclusivity was not negotiated by previous leadership, nor was it even likely to be granted without considerable financial commitments by us given our smaller scale at that time. Essentially the Company was a glorified booking/marketing agency for the resorts with none of the risks shared by the resorts.

Property Collaborations. Consequently, since June 2022, under the new Silo Wellness leadership, the Company embarked to leverage relationships on the island to minimize risk by collaborating with other operators. On August 22, 2022, the Company announced the first of those collaborations involving Go Natural Jamaica. In that collaboration we book as we go with the risk shared by the operator. This is a fair deal for the resort in that they get the momentum of the psilocybin industry with the Silo Wellness psychedelic brand and risk mitigation process that invokes trust and safety. Additionally, they can still fill up their resorts with non-psychedelic customers when we are not hosting and thus do not have to share that revenue with us.

There are two things that clients are looking for when booking a retreat: cost and safety. They are afraid that they might break their brain. That's a horrible mindset to have when trying psychedelics for the first time. Most people are coming to fight fear (fear of the future and fear of what happens due to the regrets of the past), so introducing a new form of fear due to the medicine itself or the providers of the medicine is not necessarily very helpful.

We mitigate that fear by focusing on client safety. Clients come to us knowing that we have the intake team, protocols, and procedures in place to keep them safe.

Clients also know that we are a US and Canada-based company and not some perceived fly-by-night foreign operator. They have read the testimonials and watched TV interviews of past participants, and have seen the third-party validation from independent journalists (CNN, Outside Magazine, Bloomberg, Forbes, Fodor's Travel, Men's Health, Evening Standard, Washington Post, etc.). There's also the feeling of safety by booking with a Company that has the regulations and transparency that surround a publicly traded company. That's another layer of trust. They know that the buck stops somewhere.

We market, intake, prepare clients, administer the medicine, risk mitigate the ceremonies, and integrate clients. The resort operators do what they do best: run the hospitality side of resort accommodations (transportation to/from the airport, lodging, food, etc.).

The Hilton Hotel Model. This of course is all a short-term model. As we grow, this model scales similar to the hotel industry. If someone wants to book a stay anywhere in the world, they can always trust a minimum level of care by booking with someone like Hilton. The brand invokes trust and consistency of lodging and services. The local entrepreneurs and property owners can focus on the on-site client care and get the economies of scale that come with booking, protocols, procedures, etc. that the brand brings to the table.

So that begs the question: If psychedelic medicine is potentially a hotel-type model, then why isn't Hilton branding psychedelic retreats? Because it's federally illegal in the United States and traditional banks can't touch the space for now. This means capital is scarce and this is why the psychedelic industry (the cannabis industry before it) was funded by speculative private investors. They get the greater potential returns that come with a successful revenue-generating business that banks can't finance, but they can exit at any time due to having invested in a public stock. This may slightly cover their downside if they are good at predicting the future.

The long-term vision of Silo Wellness is to scale and enter markets one molecule and one jurisdiction at a time. The bigger you are, the easier it is to negotiate favorable contracts.

We started out with one person with a dream and a vision. That led to relationships with others who share the vision. That led to collaborations. This vision led to revenue. Competition leads to slim margins. New collaborators may see the upside with a recognized and experienced brand and terms may get better over time; and the cycle continues. The more you can offer a property owner or operator, the better the terms get. This is a long game for sure with a lot of risk, but the model was built out on an island off the coast of the greatest market and the greatest country on earth. Persistence, preserving capital, smart collaborations, and keeping the eye on revenue is the key.

Oregon Real Estate. The Company intends to scale where it is legal and where capital and relationships permit. Oregon differs from Jamaica in that the barrier to entry is the license which must be associated with a given location. We can't just bounce around to different resorts depending on terms. That makes the relationships or the capital (which of course come from relationships) ever more important. It also creates a lot of risk in the short term as local jurisdictions come up with their land use regulations. See the previous press releases relating to Oregon property risks.

Future Markets. The Company expects that legislation of similar design may be introduced in other jurisdictions in the coming years, such as Colorado, as well as additional ballot measures similar to Measure 109. The Company cannot comment on the regulatory framework in any such jurisdiction as it has not been created. The Company will assess its options to conduct legal business in such jurisdictions when State or Provincial, as applicable, and Federal regulations are established and may seek any required licenses or approvals at that time.

What happens to the retreat industry if the FDA reschedules and approves psychedelics such as psilocybin for prescriptions?

In the end, we contend that this is still a services industry, not a products industry. For the healing, you have to put in the work, and consumers are still going to want safety in a psychedelic experience. We believe that the brand that is in Oregon, Jamaica, Colorado, and wherever is next will be able to have some insurance coverage once it is rescheduled and will be immediately able to expand nationwide with the existing brand, processes, protocols, people and procedures. This has been our vision since 2018 and the voters haven't let us down yet.

ABOUT Silo Wellness

Silo Wellness is a growth-oriented holding company focused on psychedelic opportunities that benefit from a unified ecosystem and exceptional leadership. Founded in 2018 in Oregon and headquartered in Toronto, Silo Wellness has a presence in both Jamaica and Oregon. Silo Wellness is a publicly traded on the Canadian (CSE: SILO) and Frankfurt (FSE: 3K7A) exchanges and listed on the OTCQB Venture Market (OTCQB: SILFF).

For more information about Silo Wellness or to book a Jamaican psychedelic retreat, please visit www.silowellness.com. For more information about Silo's recent acquisition, Dyscovry Science, visit www.Dyscovry.com.

Silo Wellness Company Contact:

Mike Arnold, President
541-900-5871
IR at Silo Wellness dot com

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. Forward-looking information may relate to anticipated events or results including, but not limited to the ability of the Company to finalize definitive documents and close on the potential retreat center property partnership; the Company's ability to satisfy the Oregon licensing requirements and achieve a license in Oregon; the Company's ability to successful launch an Oregon operation, including hiring of qualified staff and getting access to mushrooms to sustain operations; and the Company's ability to fund operations as well as the company's pre-existing capital requirements. 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 and the potential impact of COVID-19. 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/144752

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Silo Wellness Announces LOI to Acquire NUGL/Kaya in a Transaction Valued at CAD $43,289,624.60; CSE to Halt Trading Until Shareholder Approval

Silo Wellness Announces LOI to Acquire NUGL/Kaya in a Transaction Valued at CAD $43,289,624.60; CSE to Halt Trading Until Shareholder Approval

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:

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Milestone in Psychedelic Wellness: Silo Wellness and NUGL's  Share Exchange Paves Way for Expansion and Collaboration

Milestone in Psychedelic Wellness: Silo Wellness and NUGL's Share Exchange Paves Way for Expansion and Collaboration

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

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Jamaica Based Kaya Group Forges Partnership with Silo Wellness for Psychedelic Wellness Experiences and Retreats; Announces Share Exchange Agreement

Jamaica Based Kaya Group Forges Partnership with Silo Wellness for Psychedelic Wellness Experiences and Retreats; Announces Share Exchange Agreement

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.

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Can Psilocybin / Oregon's Silo Wellness "Change your Mind?" - Anderson Cooper's CNN Documentary with Journalist Tripping on Camera this Sunday; Debt Settlement Updates

Can Psilocybin / Oregon's Silo Wellness "Change your Mind?" - Anderson Cooper's CNN Documentary with Journalist Tripping on Camera this Sunday; Debt Settlement Updates

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.

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Moon Equity Holdings to Sell BitGift Asset to Silo Wellness in Exchange for a Dividend

Moon Equity Holdings to Sell BitGift Asset to Silo Wellness in Exchange for a Dividend

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."

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Melodiol Global Health Limited

Melodiol Q2 Revenue and Updates

Melodiol Global Health Limited (ASX:ME1) (‘Melodiol’ or ‘the Company’) is pleased to advise that it has delivered another strong revenue quarter. During Q2 of 2024, Melodiol generated unaudited revenue of$4.8m, a 9% increase on Q1 2024 ($4.4m). H2 2024 unaudited revenues now total $9.2m, a 31% increase on H1 2023 ($7.0m).
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Melodiol Global Health Limited

Corporate Update

Melodiol Global Health Limited (ASX:ME1) (‘Melodiol’ or ‘the Company’) is pleased to provide the following corporate update.

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Seelos Therapeutics Announces 1-for-8 Reverse Stock Split

Seelos Therapeutics, Inc. (Nasdaq: SEEL) ("Seelos" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced that its Board of Directors approved a 1-for-8 reverse stock split of its outstanding shares of common stock, to be effective as of 12:01 a.m. Eastern Time on Thursday May 16, 2024.

(PRNewsfoto/Seelos Therapeutics, Inc.)

The Company's common stock will begin trading on a reverse stock split-adjusted basis at the opening of the market on Thursday, May 16, 2024 . Following the reverse stock split, the Company's common stock will continue to trade on the Nasdaq Capital Market under the symbol "SEEL" with the new CUSIP number, 81577F307. The reverse stock split is intended for the Company to regain compliance with the minimum bid price requirement of $1.00 per share of common stock for continued listing on the Nasdaq Capital Market.

At the effective time of the reverse split, every 8 issued and outstanding shares of the Company's common stock will be converted automatically into one share of the Company's common stock without any change in the par value per share. No fractional shares will be issued in connection with the reverse stock split, and fractional shares resulting from the reverse stock split will be rounded up to the nearest whole share. The reverse stock split will reduce the number of authorized shares of the Company's common stock from 400,000,000 shares to 50,000,000 shares and the ownership percentage of each stockholder will remain unchanged other than as a result of fractional shares. In addition, the reverse stock split will apply to the Company's common stock issuable upon the exercise of the Company's outstanding warrants and stock options, with proportionate adjustments to be made to the exercise prices thereof and under the Company's equity incentive plans, as applicable.

The reverse stock split will reduce the number of issued and outstanding shares of the Company's common stock from approximately 17.4 million to approximately 2.2 million.

About Seelos Therapeutics:

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

Forward-Looking Statements:

Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding the reverse stock split and the timing thereof, the potential impact of the reverse split on the bid price of the Company's common stock, the potential for the Company to regain compliance with the minimum bid price requirement of $1.00 per share of common stock for continued listing on the Nasdaq Capital Market and the expected number of shares of common stock to be outstanding following the reverse stock split. These statements are based on our current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The risks and uncertainties involved include those associated with general economic and market conditions, as well as other risk factors and matters set forth in our periodic filings with the SEC, including our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q . Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact Information

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

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

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/seelos-therapeutics-announces-1-for-8-reverse-stock-split-302144966.html

SOURCE Seelos Therapeutics, Inc.

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Melodiol Global Health Limited

Mernova’s Strong Progress Continues

Melodiol Global Health Limited (ASX:ME1) (‘Melodiol’ or ‘the Company’) is pleased to advise that its wholly owned Canadian subsidiary, Mernova, continues to make strong operational progress.

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Compass Pathways Announces First Quarter 2024 Financial Results and Business Highlights

  • COMP360 phase 3 pivotal program in treatment-resistant depression (TRD) on track for top-line COMP005 trial data in fourth quarter 2024, COMP006 trial top-line data expected mid-2025
  • Compass announces positive phase 2 COMP360 data in post-traumatic stress disorder (PTSD)
  • Michael Gold to join Compass as Head of R&D
  • Compass enters into additional commercial collaborations, including with Reliant Medical Group, part of Optum Care
  • Cash position of $262.9 million at March 31, 2024
  • Conference call May 8 at 8:00 am ET (1:00 pm UK)

Compass Pathways plc (Nasdaq: CMPS) ("Compass"), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the first quarter 2024 and provided an update on recent business progress.

Kabir Nath, Chief Executive Officer, said, "We were pleased to see the positive results from the phase 2 PTSD study, a condition with significant unmet need and limited therapeutic options for the people who live with it. PTSD is a logical extension for COMP360 psilocybin treatment as there is significant overlap in patients living with treatment-resistant depression and PTSD. These strong data enable us to explore the optimal path forward to advance clinical development in PTSD alongside our phase 3 pivotal program in TRD, which is on track for initial data this year. We also continue to prepare for commercialization of COMP360 in TRD if approved by the FDA and have established collaborations with important mental health providers in the US to investigate models for the delivery of COMP360 psilocybin treatment at scale in diverse care settings."

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Compass Pathways announces durable improvement in symptoms through 12 weeks in open-label phase 2 study of COMP360 psilocybin in post-traumatic stress disorder

  • Study met primary safety endpoint; administration was well tolerated, with no serious adverse events observed
  • Early and clinically meaningful improvement from baseline in mean CAPS-5 total score (29.5 point reduction at week 12), with change from baseline in mean SDS total score (14.4 point reduction at week 12)
  • 81.8% response (reduction of ≥ 15 points in CAPS-5 score), 63.6% remission (total CAPS-5 ≤ 20) rates at week 4 with 77.3% response and 54.5% remission at week 12
  • Measures of symptom scores relative to baseline improved following a single 25mg dose administered with psychological support (n=22)

Compass Pathways plc (Nasdaq: CMPS) ("Compass"), a biotechnology company dedicated to accelerating access to evidence-based innovation in mental health, today announced top-line results from an open-label phase 2 study evaluating the safety and tolerability of investigational COMP360 psilocybin treatment in 22 patients with post-traumatic stress disorder (PTSD). The study met its primary safety endpoint and available secondary efficacy endpoints. Study observations included meaningful and sustained symptom improvement from baseline in mean CAPS-5 total score, a measure of disease severity, and in Sheehan Disability Scale (SDS) score, a measure of functional impairment in daily life. Administration of COMP360 was well-tolerated, with a safety profile consistent with previous studies.

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