Vancouver, BC – August 27, 2020: Better Plant Sciences Inc. (CSE:PLNT) (OTCQB:BOSQF) (FE:YG3) (“Better”) or (the “Company”)
is pleased to provide an update on the Company’s strategic plan to grow its direct-to-consumer eCommerce sales. This includes the re-launch of the company website, pending acquisition of all JUSU web properties, the launch of an extensive influencer marketing campaign, and a new addition to the team, Gabriel Villablanca, who will serve as the Company’s Director of Ecommerce and Digital Marketing.
“We are thrilled to have launched the Better Plant Sciences website that showcases our new branding and better communicates our strategic direction. Our messaging and mission are in strong alignment, and we believe that this will help to drive interest and loyalty from our target customers,” said Tamara Melck, COO of Better.
The Company is also pleased to welcome Gabriel Villablanca as its new Director of Ecommerce and Digital Marketing. He has over 15 years of experience in digital marketing and has the distinction of having worked very successfully with multiple brands simultaneously under a single parent company. Most recently, he served for 6 years as the digital marketing director for O2E Brands, the umbrella company of 1-800-GOT-JUNK?, WOW 1 DAY PAINTING and Shack Shine.
Gabriel has taken the lead on Urban Juve’s expanded influencer program, in which Urban Juve will partner with skincare and wellness influencers, with a focus on micro-influencers in North America, seeking out a large volume of partnerships. The influence of this group is increasing and tends to show higher conversion rates because these influencers actually act and live like their peers, which creates a more authentic connection than what is possible with those influencers that have followers in the millions. The program is well under development with a combination of affiliate/discount, contesting, and content-based partnerships. Further, following the successful acquisition of JUSU-branded online properties, the Company plans to apply these same strategies to all JUSU branded properties as well to bolster its sales.
“This is the next crucial step in our strategy to drive increased online purchases of our products. The launch of our optimized ecommerce store, urbanjuve.com, was the prerequisite needed to allow for traffic-generation efforts to be put in place, the first of which is a curated influencer program,” said Gabriel Villablanca, Director of Ecommerce at Better. “We plan to employ an ‘always on’ influencer strategy for Urban Juve that is executed continuously throughout the year.”
Authentic content generation by influencers and the sales they drive will complement a digital marketing program inclusive of retargeting and other forms of paid digital media to drive awareness for the brand.
According to Forbes, just 1% of millennials trust classic advertisements; however, 33% of this same group trust blog reviews. Further, 40% of millennials reported that they had purchased a product online after seeing it used by an influencer on YouTube, Instagram or Twitter.
About Better Plant Sciences Inc.
Better develops and acquires intellectual property and other assets related to plant-based products and therapeutics, and develops, manufactures, markets, sells and distributes plant-based products that improve lives. It has 14 patent applications to protect its formulas and over 200 proprietary wellness formulas at various stages of commercialization, including over 20 products that are now for sale via e-commerce or brick and mortar retail stores. It has signed an agreement to acquire JUSU branded plant-based assets from JUSU Bar, JUSU Body and JUSU Cbd, and expects to complete the acquisition this fall. The acquisition includes all inventory, packaging, raw ingredients, and intellectual property related to 300 plant-based products as well as the e-commerce sites where those products are sold. Its majority-owned subsidiary NeonMind Biosciences Inc. is engaged in research into developing a psilocybin (psychedelic mushroom) based product for weight loss and is developing a line of coffees infused with health optimizing medicinal mushrooms including reishi, cordyceps, lion’s mane and turkey tail mushrooms.
This press release includes forward-looking information and statements (collectively, “forward looking statements”) under applicable Canadian securities legislation. Forward-looking statements are necessarily based upon a number of estimates, forecasts, beliefs and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such risks, uncertainties and factors include, but are not limited to: risks related to the development, testing, licensing, brand development, availability of packaging, intellectual property protection, reduced global commerce and reduced access to raw materials and other supplies due to the spread of the Coronavirus, the potential for not acquiring any rights as a result of the patent application and any products making use of the intellectual property may be ineffective or the company may be unsuccessful in commercializing them; and other approvals will be required before commercial exploitation of the intellectual property can happen. Demand for the company’s products, general business, economic, competitive, political and social uncertainties, delay or failure to receive board or regulatory approvals where applicable, and the state of the capital markets. Better cautions readers not to place undue reliance on forward-looking statements provided by Better, as such forward-looking statements are not a guarantee of future results or performance and actual results may differ materially. The forward-looking statements contained in this press release are made as of the date of this press release, and Better expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.
Opioids don’t discriminate—opioid misuse affects all Canadians
On August 12, we wrote about the current opioid crisis and the uptick on opioid-related overdoses and deaths in Canada. This crisis does not discriminate against minority populations and can undoubtedly affect anyone. Indeed, a life-sentence to opioid drug dependency can start with a minor injury, followed by a doctor’s visit. This article addresses how the current medical system disproportionately provides aid to those in the throes of opiate addiction and provides an alternative to the currently available treatment options.
Although the number of Canadians using opioids decreased (from 13% of the population to 11.8% between 2015-2017), hospitalizations for opioid overdose or complications increased to about 17 admissions each day. Between 2016-2019, Canada lost 15,393 lives to the opioid crisis. These are our sisters, fathers, mothers and brothers.
While opioid misuse has affected every region of the country, western Canada (British Columbia and Alberta) and the northern territories (Yukon and Northwest Territories) have experienced the highest devastation levels. Furthermore, in the 2018 National report of the First Nations Regional Health Survey, 24.9% of adults and 10.4% of youth between the ages of 12 and 17 reported opioid-use.
The discrepancies in treatments for opioid dependency
Indeed, the opioid crisis does not discriminate against income, race, gender or cultural influences. There is an opiate out there to accommodate every socio-economic class. However, the treatments available for those seeking to maintain their dependence on opioid-maintenance programs or safe medication-assisted therapy vary from between socio-economic classes.
Medical anthropologist Helena Hansen (2012) describes how methadone clinics were created to serve Black and Latinx urban communities, while buprenorphine clinics concurrently target the growing opioid crisis in white, middle-class communities. She explicitly notes how much more effective buprenorphine is for opiate addiction treatment and discusses how those in minority populations are not receiving equally effective medications.
Compounding the problem is the lack of access to these opioid-maintenance programs during the pandemic. Nick Boyce, of the Ontario Harm Reduction Network, said the dramatic measures adopted to slow the spread of COVID-19 are limiting drug users’ access to support services that prevent overdose deaths. These types of support services are typically in place to aid those who are already at-risk: low-income, reliant on government-assistance programs, living with untreated mental health issues, and with little or no additional support from family.
Thus, those who rely most on government services – people of lower socio-economic populations who have suffered the most during this pandemic – will likely be the ones continuing to suffer long after the peak danger of COVID-19 passes.
Could psychedelic-assisted therapy present a fair, effective and democratic solution?
A recent study published in the PlosOne Journal found that people who use cannabis for therapeutic purposes are less likely to misuse opioids, adding to a growing body of evidence supporting the use of cannabis for pain as a harm reduction strategy. However, not everyone agrees with these findings and research at McMaster University has found that cannabis is not entirely effective in reducing opioid addiction.
At Entheon Biomedical, we believe that it is time to explore new approaches to managing addictive behaviours and addressing the current opioid crisis. We have found that psychedelic substances, mainly DMT, hold much more potential in successfully reducing opioid-dependence.
Our aim at Entheon Biomedical is to demonstrate the efficacy of DMT for the treatment of addiction. We hope to bring psychedelic substances to the biomedical and substance-use treatment market in the most responsible and scientifically-legitimate way.
It is necessary to address the current issue of access in the sphere of psychedelic-assisted therapy. Many important figures in the field, such as Bia Labate, have discussed the problems of privilege and access in psychedelic-assisted treatment. Once these medicines become more regulated, access to them will indeed be minimal as this approach to healing relies on many hours of psychotherapy sessions, which costs a lot of money.
At Entheon Biomedical, we are developing a DMT therapeutic protocol that is much shorter lasting and flexible than established MDMA or psilocybin-assisted therapies. This will ultimately reduce billable hours and decrease associated costs. Ultimately, we hope that these shortened sessions of psychedelic-assisted therapy can increase access to these medicines and reduce the systemic discrepancy found in opiate dependance.
Entheon is optimistic about future findings and is actively working towards addressing the issues in current treatment modalities, access to valuable medicines, and ultimately making a dent in the truly devastating crisis that the opioid epidemic has brought to our communities and families.
For more information on Canada’s current opioid crisis, you can find national data, surveillance, and research here.
Vancouver, British Columbia, Canada – August 27, 2020 – Core One Labs Inc. (CSE: COOL), (OTCQX: CLABD), (Frankfurt: LD62, WKN: A2P8K3) (the “Company”) is pleased to announce that effective August 26, 2020 (the “Effective Date”), the British Columbia Securities Commission (the “BCSC”) has issued an order revoking its cease trade order, originally issued in respect of the securities of the Company on July 15, 2020.
On August 18, 2020, the Company filed (i) its audited annual financial statements, annual management’s discussion and analysis, and related certifications for the years ended December 31, 2019, and on August 24, 2020, the Company filed (ii) its interim financial statements, interim management’s discussion and analysis, and related certifications for the three months ended March 31, 2020 (collectively, the “Financial Disclosure Documents”). The Financial Disclosure Documents are available for review online under the Company’s profile on SEDAR (www.sedar.com). Following the filing of the Financial Disclosure Documents, the Company is up-to-date with its continuous disclosure obligations and has met all conditions required by the BCSC for revocation of the cease trade order.
Interim Financial Statements
The Company also announces that, as a result of the COVID-19 pandemic, it anticipates a delay in the filings of its interim financial statements for the period ended June 30, 2020 (the “Interim Financial Statements”), and accompanying management’s discussion and analysis (“Interim MD&A”), and related CEO and CFO certifications (the “Interim Certifications”, together with the Interim Financial Statements and the Interim MD&A, the “Interim Filings”).
The Company will be relying on BC Instrument 51-517 – Temporary Exemption from Certain Corporate Finance Requirements with Deadlines during the Period of June 2 to August 31, 2020 (“BCI 51-517”) enacted by the BCSC which provides relief consisting of a 45-day extension for certain regulatory filings required to be made during the period June 2, 2020 to August 31, 2020. The Company will be relying on the temporary exemptions pursuant to BCI 51-517 with respect to the following provisions:
the requirement to file the Interim Financial Statements on or before the 60th day after the end of the interim period as required by subsection 4.4(b) of National Instrument 51-102 – Continuous Disclosure Obligations (“NI 51-102”);
the requirement to file its Interim MD&A on or before the earlier of the 60th day after the end of the interim period and the date the Financial Statements are filed as required by subsection 5.1(2) of NI 51-102; and
the requirement to file the Certifications pursuant to Section 5.1 of National Instrument 52-109 – Certification of Disclosure in Issuers’ Annual and Interim Filings.
The Company is continuing to work diligently on the finalization of the Interim Filings and estimates that it will file the Interim Filings on or before October 14, 2020. In connection with utilizing the temporary relief and extensions for issuers provided pursuant to BCI 51-517, the Company confirms that, until such time as the Interim Filings have been filed, the Company’s management and other insiders are subject to an insider trading black-out that reflects the principles of Section 9 of National Policy 11-207 – Failure-to-File Cease Trade Orders and Revocations in Multiple Jurisdictions.
The Company reports that other than as set forth in this news release, since the filing of the Company’s interim financial statements for the three months ended March 31, 2020, there have been no material business developments other than those that have been previously disclosed in the Company’s news releases and filings.
About Core One Labs Inc.
Core One Labs Inc. is a research and technology company with a state-of-the-art cannabis production and packaging facility located in Southern California. The Company’s technology produces infused strips (like breath strips) that are not only a safer, healthier option to other forms of delivery but also superior bioavailability of cannabis constituents. The technology provides a new way to accurately meter the dosage and assure the purity of selected product. The Company holds an interest in walk-in medical clinics located in Vancouver and West Vancouver, British Columbia which maintain a database of over 200,000 patients combined. The Company intends to further develop its product offerings through research and development in these clinics, including the integration of intellectual property related to psychedelic treatments and novel drug therapies.
Core One Labs Inc.
Joel Shacker
Chief Executive Officer
FOR MORE INFORMATION, PLEASE CONTACT:
info@core1labs.com
1-866-347-5058
Cautionary Disclaimer Statement:
The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.
Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management’s current estimates, beliefs, intentions and expectations. They are not guarantees of future performance. The Company cautions that all forward looking statements are inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Such factors include, among other things: risks and uncertainties relating to the Company’s limited operating history and the need to comply with environmental and governmental regulations. In addition, marijuana remains a Schedule I drug under the United States Controlled Substances Act of 1970. Although Congress has prohibited the US Justice Department from spending federal funds to interfere with the implementation of state medical marijuana laws, this prohibition must be renewed each year to remain in effect. Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information.
– Total revenue of $12.2 million increased 70 percent year-over-year –
– Operating cost structure continues to improve in-line with management’s expectations –
– Development project pipeline positions Company for strong performance improvements in FY21 –
MINNEAPOLIS, Aug. 26, 2020 /PRNewswire/ — Vireo Health International, Inc. (“Vireo” or the “Company”) (CNSX: VREO; OTCQX: VREOF), the science-focused, multi-state cannabis company with active operations in exclusively medical-only markets and licenses in nine states and the Commonwealth of Puerto Rico, today reported financial results for its second quarter ended June 30, 2020. All currency figures referenced in this release reflect U.S. dollar amounts.
“Our second-quarter results were in-line with our expectations both in terms of revenue growth and operating expenses,” said Founder & Chief Executive Officer, Kyle Kingsley, M.D. “Furthermore, with the recent closing of the sale of our Pennsylvania manufacturing and processing subsidiary, we are well positioned with a strong balance sheet to execute a strategy that should begin to generate positive cash flow next year as we continue increasing scale in our core markets of Arizona, Maryland, Minnesota, New Mexico, and New York.”
Dr. Kingsley continued, “We believe there is significant potential for Vireo to improve revenue growth and profitability in our core markets, and we’ll be investing in each of these markets through the balance of fiscal year 2020 to increase production capacity and retail store count. We expect the benefits of these investments to begin materializing late this year, and continue to believe that each of these markets has the potential to enact adult-use legislation over the short- to medium-term future, which would present additional opportunity for revenue growth, margin expansion, and value creation for shareholders.”
Second Quarter 2020 Financial Summary
Reported results for the three- and six-month periods ended June 30, 2020 and June 30, 2019 reflect “pro-forma” results, which exclude contributions from the Company’s former Pennsylvania Medical Solutions (“PAMS”) subsidiary, as Vireo announced a planned transaction to divest PAMS on June 22, 2020 and closed the transaction on August 11, 2020. As a result, financial performance of PAMS’ wholesale business and manufacturing operations have been categorized under discontinued operations within the periods referenced in the financial statements accompanying this news release. Vireo continues to own and operate two retail dispensaries in Pennsylvania.
The Company generated revenue in seven states during the second quarter: Arizona, Maryland, Minnesota, New Mexico, New York, Ohio, and Pennsylvania. Total revenue, including contributions from discontinued operations, increased 70 percent year-over-year to $12.2 million versus $7.2 million in the second quarter of 2019. Reported revenue, excluding discontinued operations, was $10.8 million, an increase of 59 percent as compared to $6.7 million in Q2 2019.
Retail revenue was approximately $9.2 million in Q2 2020, an increase of 46 percent compared to $6.3 million in Q2 2019. The increase in retail revenue was principally due to greater patient enrollment and average revenue per patient in Minnesota and New Mexico, as well as contributions from new retail dispensaries in Pennsylvania. Wholesale revenue of $1.6 million increased by $1.1 million or 256 percent, as compared to $444,023 in Q2 2019. The increase in wholesale revenue was primarily due to the growth of wholesale operations in Maryland, New York, and Ohio.
Gross profit before fair value adjustments was $3.5 million, or 32 percent of revenue, as compared to gross profit of $3.0 million or 45 percent, in the same period last year. The variance in gross profit as compared to the prior year was driven primarily by temporary impacts of planned manufacturing downtime and the build-up of inventory in New York, as well as an increase in the mix of sales in wholesale versus retail markets, with a substantial increase in wholesale revenue as compared to last year.
Total operating expenses in the second quarter were $15.4 million, as compared to $5.4 million in the second quarter of 2019, with the increase primarily attributable to increased salaries and wages, as well as an adjustment to share-based compensation related to the vesting of out-of-the-money warrants issued to a former executive upon termination from the Company. Excluding depreciation and share-based compensation, operating expenses in the second quarter of 2020 were $6.0 million, or 55 percent of sales, as compared to $5.0 million or 74 percent of sales in the second quarter of 2019, and $6.2 million or 59 percent of sales in the first quarter of 2020.
Total other expense was $3.4 million during Q2 2020, compared to $1.8 million in Q2 2019. The increase in other expense was primarily attributable to the issuance of warrants in conjunction with the private placement completed in March of 2020, as well as increased interest expense.
Net loss from continuing operations in Q2 2020 was $7.7 million, as compared to a net loss from continuing operations of $593,041 in Q2 2019. Adjusted net loss from continuing operations for Q2 2020, as described in accompanying disclosures and footnotes, was $7.4 million, as compared to a loss of $4.1 million in the prior year quarter. Adjusted EBITDA, as described in accompanying disclosures and footnotes, was a loss of $1.8 million in Q2 2020, as compared to a loss of $1.9 million in Q2 2019. Please refer to the Supplemental Information and Reconciliation of Non-IFRS Financial Measures at the end of this press release for additional information.
Other Developments
Amidst the ongoing coronavirus pandemic, Vireo’s medical cannabis businesses have maintained “essential service” designation in each of their respective states. As a result, to date there has been no material adverse impact on the Company’s financial performance because of the pandemic.
On April 30, 2020, the Company announced the formation of a wholly-owned subsidiary called Resurgent Biosciences, Inc. Resurgent Biosciences is a Delaware corporation that was formed with the intent to commercialize Vireo’s portfolio of intellectual property and related initiatives in a non-plant-touching entity, which may broaden potential partnership opportunities or other strategic outcomes as Vireo seeks to monetize scientific advancements within the cannabis industry and beyond. Vireo currently has several patent applications pending approval by the United States Patent and Trademark Office. Its patent for harm reduction in tobacco products was allowed earlier this year.
On June 19, 2020, the Company announced its planned purchase of 110,000 square foot greenhouse facility in Massey, Maryland for total consideration of $1.3 million. The Company intends to transfer its cultivation license in the state to this newly acquired greenhouse and maintain processing and manufacturing operations at its existing 22,000 square foot facility in Hurlock, Maryland. This transfer is expected to increase Vireo’s biomass cultivation capacity in the state by nearly 12 times once completed.
On June 22, 2020, the Company announced its planned divestiture of its Pennsylvania manufacturing and processing operations (“PAMS”) to a subsidiary of Jushi Holdings, Inc. for total consideration of $37 million, including $13.8 million in cash upon closing. The transaction closed on August 11, 2020.
On July 9, 2020, Vireo announced the formation of an exclusive licensing agreement with eBottles420 to manufacture and distribute Vireo’s patent-pending, terpene-preserving packaging system. This proprietary packaging system preserves cannabis flower by inhibiting the gradual loss of terpenes and other desirable compounds that naturally occur after harvest.
Balance Sheet and Liquidity
As of June 30, 2020, the Company had 37,952,477 equity shares issued and outstanding, and 153,203,217 shares outstanding on an as-converted, fully-diluted basis.
As of June 30, 2020, total current assets were $81.0 million, including cash on hand of $5.7 million. Total current liabilities were $23.2 million, with zero debt currently due within 12 months.
Following the closing of the PAMS transaction on August 11, 2020, the Company had total cash on hand of approximately $21.1 million.
Outlook Commentary
Dr. Kingsley concluded, “As we enter the second half of fiscal year 2020, we plan to leverage the strength of our balance sheet to make several strategic growth investments in our markets in Arizona, Maryland, Minnesota, and New Mexico. We expect to invest approximately $8.0 to $9.0 million in these projects and that they will be completed by the end of the first quarter of fiscal year 2021. Once complete, these investments should help drive stronger revenue growth and profitability, which gives confidence in our ability to begin producing positive cash flow around the mid-point of fiscal year 2021.”
Conference Call and Webcast Information
Vireo Health management will host a conference call with research analysts on Wednesday, August 26, 2020 at 8:30 a.m. ET to discuss its financial results for its second quarter ended June 30, 2020. Interested parties may register to attend the conference call via the following link: http://www.directeventreg.com/registration/event/7027889 . Upon registration, each participant will be provided with call details and a registrant ID for Vireo’s conference ID number 7027889.
Additional information relating to the Company’s first quarter 2020 results is available on SEDAR at www.sedar.com. Vireo Health refers to certain non-IFRS financial measures such as adjusted net income, Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA) and adjusted EBITDA (defined as earnings before interest, taxes, depreciation, amortization, less certain non-cash equity compensation expense, one-time transaction fees, and other non-cash items. These measures do not have any standardized meaning prescribed by IFRS and may not be comparable to similar measures presented by other issuers. Please see the Supplemental Information and Reconciliation of Non-IFRS Financial Measures at the end of this news release for more detailed information regarding non-IFRS financial measures.
About Vireo Health International, Inc.
Vireo Health International, Inc. is a physician-led cannabis company focused on building long-term, sustainable value by bringing the best of medicine, science, and engineering to the cannabis industry. With operations strategically located in early-stage, limited-license medical markets, Vireo manufactures pharmaceutical-grade cannabis products in environmentally-friendly greenhouses and distributes its products through its growing network of Green Goods™ retail dispensaries and hundreds of third-party locations. Its current core medical markets of New York, Minnesota, Pennsylvania, Arizona, New Mexico, and Maryland all have the potential to enact adult-use legalization in the next three to 24 months, and two additional markets in Puerto Rico and Massachusetts also have potential for commercialization. Combined with its teams’ focus on driving scientific innovation within the industry and securing meaningful intellectual property, Vireo believes it is well positioned to become a global market leader in the cannabis industry. Today, eight of its 10 markets are operational with 13 of its 32 total retail dispensary licenses open for business. For more information about the company, please visit www.vireohealth.com.
Forward-Looking Statement Disclosure
This news release contains “forward-looking information” within the meaning of applicable United States and Canadian securities legislation. To the extent any forward-looking information in this news release constitutes “financial outlooks” within the meaning of applicable United States or Canadian securities laws, such information is being provided as preliminary financial results and the reader is cautioned that this information may not be appropriate for any other purpose and the reader should not place undue reliance on such financial outlooks. Forward-looking information contained in this press release may be identified by the use of words such as “plans,” “expects” or “does not expect,” “is expected,” “look forward to,” “budget” “scheduled,” “estimates,” “forecasts,” “will continue,” “intends,” “anticipates,” “does not anticipate,” “believes,” “should,” “should not,” or variations of such words and phrases or indicates that certain actions, events or results “may,” “could,” “would,” “might,” “should,” or “will” “be taken,” “occur,” or “be achieved.” Forward-looking information may include, without limitation, statements regarding the operations, business, financial condition, expected financial results, performance, prospects, opportunities, priorities, targets, goals, ongoing objectives, milestones, strategies and outlook of Vireo, and includes statements about, among other things, the value of assets, the amount of liabilities, the designation of certain businesses or assets as “core” or “non-core,” decisions about allocation of capital and other resources, future developments, the future operations, potential market opportunities including the potential effects of the approval of adult-use cannabis in one or more markets, potential opportunities to monetize assets, strengths and strategy of the Company. Forward-looking information is provided for the purpose of presenting information about management’s current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. These statements should not be read as guarantees of future performance or results. Forward-looking information includes statements with respect to the opportunities for the Company to leverage increasing scale to improve sales growth and operating performance; the anticipation that the medical-only state markets in which the Company’s subsidiaries operate could enact recreational-use legislation over the near-to mid-term future; the anticipated benefits of strategic initiatives; the effects of reduction of corporate overhead and SG&A expenses; improvement to unit economics; expansion of retail dispensaries in key markets; and the expectation that such expansion will drive stronger revenue growth, operating margins and free cash flow. Forward-looking information includes both known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company or its subsidiaries to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements or information contained in this news release including, without limitation, the impact on the Company’s businesses and financial results of epidemics and pandemics, including the COVID-19 pandemic. Financial outlooks, as with forward-looking information generally, are, without limitation, based on the assumptions and subject to various risks as set out herein. Our actual financial position and results of operations may differ materially from management’s current expectations and, as a result, our revenue and cash on hand may differ materially from the revenue and cash values provided in this news release. Forward-looking information is based upon a number of estimates and assumptions of management, believed but not certain to be reasonable, in light of management’s experience and perception of trends, current conditions and expected developments, as well as other factors relevant in the circumstances, including assumptions in respect of current and future market conditions, the current and future regulatory environment; and the availability of licenses, approvals and permits.
Although the Company believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because the Company can give no assurance that they will prove to be correct, including preliminary financial expectations regarding the annualized reduction of corporate overhead and SG&A expenses. Actual results and developments may differ materially from those contemplated by these statements. Forward-looking information is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those projected in the forward-looking information. Such risks and uncertainties include, but are not limited to, risks related to preliminary financial results being subject to the completion of the Company’s financial closing procedures and not being audited or reviewed by the Company’s independent registered public accounting firm; the timing of recreational-use legislation in markets where the Company currently operates; current and future market conditions, including the market price of the subordinate voting shares of the Company; federal, state, local and foreign government laws, rules and regulations, including federal and state laws in the United States relating to cannabis operations in the United States; limited operating history; changes in laws, regulations and guidelines; operational, regulatory and other risks; execution of business strategy; management of growth; difficulty to forecast; conflicts of interest; risks inherent in an agricultural business; liquidity and additional financing; foreign private issuer status and the risk factors set out in the Company’s listing statement dated March 19, 2019, filed with the Canadian securities regulators and available under the Company’s profile on SEDAR at www.sedar.com.
The statements in this news release are made as of the date of this release. The Company disclaims any intent or obligation to update any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws.
Supplemental Information
The financial information reported in this news release is based on audited financial statements for the fiscal year ended December 31, 2019 and unaudited condensed interim consolidated financial statements for the fiscal quarter ended March 31, 2020. All financial information contained in this news release is qualified in its entirety with reference to such financial statements. To the extent that the financial information contained in this news release is inconsistent with the information contained in the Company’s audited financial statements, the financial information contained in this news release shall be deemed to be modified or superseded by the Company’s audited financial statements. The making of a modifying or superseding statement shall not be deemed an admission for any purposes that the modified or superseded statement, when made, constituted a misrepresentation for purposes of applicable securities laws.
VIREO HEALTH INTERNATIONAL, INC. CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION As at June 30, 2020 and December 31, 2019
(Unaudited – Expressed in United States Dollars)
June 30,
2020
December 31,
2019
ASSETS
Current Assets
Cash
$5,726,699
$7,641,673
Restricted Cash
1,592,500
1,592,500
Receivables
706,964
1,025,963
Inventories
38,884,568
32,437,308
Biological Assets
15,694,537
6,134,209
Prepaid Expenses
1,514,635
2,285,548
Deferred acquisition costs
28,136
28,136
Assets Held for Sale
16,854,142
–
81,002,181
51,145,337
Long-Term Assets
Right of Use Assets
21,299,482
25,921,603
Property and Equipment
13,447,308
13,326,337
Deposits
1,915,101
2,651,366
Deferred Loss on Sale Leaseback
–
30,481
Goodwill
3,132,491
3,132,491
Intangible Asset
8,692,856
9,001,237
48,487,238
54,063,515
Total Assets
$129,489,419
$105,208,852
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current Liabilities
Accounts Payable and Accrued Liabilities
$4,747,430
$3,140,086
Current portion of Right of Use Liability
432,616
619,827
Derivative Liability
4,521,230
–
Liabilities Held for Sale
13,506,842
–
23,208,118
3,759,913
Long-Term Liabilities
Deferred Income Taxes
9,090,000
4,528,000
Right of Use Liability
24,118,123
28,665,681
Long-Term Debt
1,110,000
1,110,000
Convertible debt
856,786
817,446
58,383,027
38,881,040
Shareholders’ Equity
Share Capital
122,511,602
118,453,142
Reserves
19,683,869
7,962,509
Deficit
(71,089,079)
(60,087,839)
71,106,392
66,327,812
Total Liabilities and Shareholders’ Equity
$129,489,419
$105,208,852
VIREO HEALTH INTERNATIONAL, INC. CONDENSED CONSOLIDATED INTERIM STATEMENTS OF LOSS AND COMPREHENSIVE LOSS For the Three Months Ended June 30, 2020 and 2019
(Unaudited – Expressed in United States Dollars)
Three Months Ended
June 30,
2020
Three Months Ended
June 30,
2019
REVENUE
10,763,125
6,748,691
Production Costs
(7,283,163)
(3,723,355)
Gross Profit Before Fair Value Adjustments
3,479,962
3,025,336
Realized Fair Value Amounts Included in Inventory Sold
(5,279,567)
(7,627,275)
Unrealized Fair Value Gain on Growth of Biological Assets
16,661,446
11,900,180
Gross Profit
14,861,841
7,298,241
EXPENSES
Depreciation
497,793
168,301
Professional fees
755,244
947,884
Salaries and wages
2,834,481
1,648,858
Selling, general and administrative expenses
2,362,763
2,407,698
Share-Based Compensation
8,985,422
255,765
15,435,703
5,428,506
OTHER INCOME (EXPENSE)
Loss on sale of property and equipment
–
(643)
Interest income (expense), net
(1,206,705)
(721,697)
Accretion expense
(20,142)
(40,591)
Gain (Loss) on derivative liability
(2,292,130)
–
Acquisition related costs
–
(772,110)
Inventory impairment
(89,154)
(479,803)
Other income (expense)
208,388
197,068
Total Other Expense
(3,399,743)
(1,817,776)
INCOME (LOSS) BEFORE INCOME TAXES
(3,973,605)
51,959
Current income taxes
(1,395,000)
(460,000)
Deferred income taxes
(2,323,000)
(185,000)
PROVISION FOR INCOME TAXES
(3,718,000)
(645,000)
LOSS FROM CONTINUING OPERATIONS
(7,691,605)
(593,041)
LOSS FROM DISCONTINUED OPERATIONS
(1,285,856)
(1,279,416)
LOSS AND COMPREHENSIVE LOSS
(8,977,461)
(1,872,457)
Weighted Average Shares Outstanding – basic and diluted
98,871,038
23,272,657
Net Loss Per Share – basic and diluted
– Continuing Operations
(0.08)
(0.03)
– Discontinued Operations
(0.01)
(0.05)
VIREO HEALTH INTERNATIONAL, INC. CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS For the Six Months Ended June 30, 2020 and 2019
(Unaudited – Expressed in United States Dollars)
Six Months Ended
June 30,
2020
Six Months Ended
June 30,
2019
Cash Flows from Operating Activities:
Net income (loss)
(11,001,240)
(5,319,214)
Item not affecting cash:
Depreciation and amortization
1,153,659
1,021,416
Loss on sale of property and equipment
13,800
(1,013)
Share-based compensation
11,721,360
456,952
Loss on derivative liability
966,202
–
Fair value adjustment on sale of inventory
12,962,945
10,589,640
Fair value adjustment on growth of biological assets
(32,113,318)
(19,834,013)
Interest expense
2,355,070
1,448,205
Deferred income taxes
4,562,000
1,652,000
Deferred financing costs
–
448,480
Listing expense
–
2,999,986
Amortization of deferred tenant improvements
–
(652)
Deferred gain/loss on sale leaseback
30,481
(2,846)
Cash flows used in discontinued operations
2,959,190
276,722
Changes in non-cash working capital
2,137,538
(1,312,381)
Cash Flows Used in Operating Activities
(4,252,313)
(7,576,718)
Cash Flows from Investing Activities:
Purchase of property and equipment
(1,249,717)
(3,680,949)
Proceeds on sale of property and equipment
–
974,162
Acquisition costs on business combinations and assets
–
(16,073,617)
Deferred acquisition costs
–
1,816,863
Deposits
16,265
–
Cash flows used in discontinued operations
(152,368)
(247,610)
Cash Flows from Investing Activities
(1,385,820)
(17,211,151)
Cash Flows from Financing Activities:
Proceeds from sale of stock, net of issuance costs
7,613,490
47,542,878
Lease payments
(351,010)
(126,251)
Interest paid
(2,122,422)
(1,356,273)
Cash flows used in discontinued operations
(1,047,414)
(556,139)
Cash Flows from Financing Activities
4,092,644
45,504,215
Net Change in Cash
(1,545,489)
20,716,346
Cash, Beginning of the Period
7,641,673
9,624,110
Cash, End of the Period
6,096,184
30,340,456
Reconciliation of Non-IFRS Financial Measures
Adjusted Net loss, EBITDA, Adjusted EBITDA, and Adjusted Operating Expenses are non-IFRS measures and do not have standardized definitions under IFRS. The following information provides reconciliations of the supplemental non-IFRS financial measures, presented herein to the most directly comparable financial measures calculated and presented in accordance with IFRS. The Company has provided the non-IFRS financial measures, which are not calculated or presented in accordance with IFRS, as supplemental information and in addition to the financial measures that are calculated and presented in accordance with IFRS. These supplemental non-IFRS financial measures are presented because management has evaluated the financial results both including and excluding the adjusted items and believe that the supplemental non-IFRS financial measures presented provide additional perspective and insights when analyzing the core operating performance of the business. These supplemental non-IFRS financial measures should not be considered superior to, as a substitute for or as an alternative to, and should be considered in conjunction with, the IFRS financial measures presented.
Reconciliation of Net Loss to Adjusted Net Loss and Adjusted EBITDA
Three Months Ended
Six Months Ended
June 30,
June 30,
2020
2019
2020
2019
Net loss
(8,977,461)
(1,872,457)
(11,001,240)
(5,319,214)
Net fair value adjustments
(11,381,880)
(4,272,905)
(19,150,373)
(9,244,373)
Listing expense
–
–
–
3,464,613
Gain (Loss) on Derivative Liability
2,292,130
–
966,202
–
Inventory adjustment
89,154
479,803
165,290
752,696
Share-based compensation
8,985,422
255,765
11,721,360
456,952
Severance Expense
339,997
–
339,997
–
Loss from discontinued operations
1,285,856
1,279,416
2,005,773
2,174,418
Adjusted net loss (non-IFRS)
(7,366,782)
(4,130,378)
(14,952,991)
(7,714,908)
Net loss
(8,977,461)
(1,872,457)
(11,001,240)
(5,319,214)
Interest expense, net
1,206,705
721,697
2,355,070
1,390,477
Accretion expense
20,142
40,591
39,340
50,262
Income taxes
3,718,000
645,000
6,462,100
2,857,000
Depreciation
497,793
168,301
845,279
542,080
Amortization
154,190
691,364
308,380
785,044
Loss from discontinued operations
1,285,856
1,279,416
2,005,773
2,174,418
EBITDA (non-IFRS)
(2,094,775)
1,673,912
1,014,702
2,480,067
Net fair value adjustments
(11,381,880)
(4,272,905)
(19,150,373)
(9,244,373)
Listing expense
–
–
–
3,464,613
Gain (Loss) on Derivative Liability
2,292,130
–
966,202
–
Inventory adjustment
89,154
479,803
165,290
752,696
Share-based compensation
8,985,422
255,765
11,721,360
456,952
Severance Expense
339,997
–
339,997
–
Adjusted EBITDA (non-IFRS)
(1,769,952)
(1,863,425)
(4,942,822)
(2,090,045)
Reconciliation of Total Operating Expenses to Adjusted Operating Expenses
Revive to also explore FDA Expanded Access Program (Compassionate Use) for Bucillamine in COVID-19
TORONTO, Aug. 26, 2020- Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce that following the U.S. Food & Drug Administration (“U.S. FDA”) approval to proceed with the Company’s Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19, the Company has submitted its clinical trial protocol for independent Institutional Review Board (“IRB”) approval. Additionally, the Company is exploring the FDA Expanded Access Program, also referred to as the Compassionate Use Program, that can provide access to the Company’s investigational drug, Bucillamine, for people who meet the protocol criteria of the COVID-19 study. Revive expects to have patients enrolled in September 2020.
“We are continuing to make strong progress in our Phase 3 clinical trial in COVID-19 and with the submission of the Phase 3 study protocol to Advarra, a premier IRB services company in North America, for review and approval, it will enable us to select key clinical sites in the U.S. and proceed with site initiation visits to allow for the selected U.S. clinical locations to enroll patients,” said Michael Frank, Revive’s Chief Executive Officer. “We are also exploring the Compassionate Use Program as an alternate option for U.S. licensed physicians to request Bucillamine for their patients who have been diagnosed with COVID-19.”
According to the FDA, expanded access programs provide a way for a patient to receive an investigational drug for a serious disease or condition. These investigational drugs are often made available when there are no comparable or satisfactory alternative therapies to treat the disease or condition, where patient enrollment in clinical trials is not possible, the potential patient benefit justifies the potential risk of treatment and when providing the investigational drug will not interfere with clinical trials that could support the drug’s marketing approval for the treatment indication.
About the Phase 3 Confirmatory Clinical Study
The Phase 3 confirmatory clinical study titled, “A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients with Mild-Moderate COVID-19”, will enroll up to 1,000 patients that will be randomized 1:1:1 to receive Bucillamine 100 mg three times a day (“TID”), Bucillamine 200 mg TID or placebo TID for up to 14 days. The primary objective is to compare the frequency of hospitalization or death in patients with mild-moderate COVID-19 receiving Bucillamine therapy with those receiving placebo. The primary endpoint is the proportion of patients meeting a composite endpoint of hospitalization or death from the time of the first dose through Day 28 following randomization. Efficacy will be assessed by comparing clinical outcomes (death or hospitalization), disease severity using the 8-category NIAID COVID ordinal scale, supplemental oxygen use, and progression of COVID‑19 between patients receiving standard-of-care plus Bucillamine (high dose and/or low dose) and patients receiving standard-of-care plus placebo. Safety will be assessed by reported pre-treatment adverse events and treatment-emergent adverse events (including serious adverse events and adverse events of special interest), laboratory values (hematology and serum chemistry), vital signs (heart rate, respiratory rate, and temperature), and peripheral oxygen saturation.
An interim analysis will be performed by an Independent Data and Safety Monitoring Board (“DSMB”) after 210 patients have been treated and followed up for 28 days after randomization. The better performing Bucillamine dose at the interim analysis will be selected and patients will then be randomized 2:1 to the selected Bucillamine dose or placebo. Additional interim analyses will be performed after 400, 600, and 800 patients have reached this same post-treatment timepoint. The independent DSMB will actively monitor interim data for the ongoing safety of patients and will recommend continuation, stopping or changes to the conduct of the study based on the interim analysis reports.
The Company is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time.
Scientific Rationale of Bucillamine for COVID-19
Preclinical and clinical studies have demonstrated that reactive oxygen species contribute to the destruction and programmed cell death of pulmonary epithelial cells.1 N-acetyl-cysteine (NAC) has been shown to significantly attenuate clinical symptoms in respiratory viral infections in animals and humans, primarily via donation of thiols to increase antioxidant activity of cellular glutathione2,3,4,5. Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine) has a well-known safety profile and is prescribed in the treatment of rheumatoid arthritis in Japan and South Korea for over 30 years. Bucillamine, a cysteine derivative with two thiol groups, has been shown to be 16 times more potent as a thiol donor in vivo than NAC 6. The drug is non-toxic with high cellular permeability. The basis of the clinical study will analyze if Bucillamine has the potential, via increasing glutathione activity and other anti-inflammatory activity, to lessen the destructive consequences of SARS-CoV2 infection in the lungs and attenuate the clinical course of COVID-19.
About Revive Therapeutics Ltd.
Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its recent acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation. For more information, visit www.ReviveThera.com.
Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.
Cautionary Statement
This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Offering, including the intended use of proceeds. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2019, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.
References
1. S Ye et al, Inhibition of Reactive Oxygen Species Production Ameliorates Inflammation Induced by Influenza A Viruses via Upregulation of SOCS1 and SOCS3., American Society for Microbiology. 2015 Mar;89(5):2672-2683).
2. L. Carati et al, Attenuation of influenza-like symptomatology and improvement of cell-mediated immunity with long-term N-acetylcysteine treatment., Eur Respir J. 1997 Jul;10(7):1535-41).
3. M Mata et al, N-acetyl-L-cysteine (NAC) inhibit mucin synthesis and pro-inflammatory mediators in alveolar type II epithelial cells infected with influenza virus A and B and with respiratory syncytial virus (RSV)., Biochem Pharmacol. 2011 Sep;82(5):548-55.
4. D Ungheri et al, Protective effect of n-acetylcysteine in a model of influenza infection in mice., Int J Immunopathol Pharmacol. 2000 Sep-Dec;13(3):123-128.
5. RH Zhang et al, N-acetyl-l-cystine (NAC) protects against H9N2 swine influenza virus-induced acute lung injury., Int Immunopharmacol. 2014 Sep;22(1):1-8).
6. LD Horwitz, Bucillamine: a potent thiol donor with multiple clinical applications, Cardiovasc Drug Rev. 2003 Summer;21(2):77-90).
August 25, 2020 – Vancouver, BC: Better Plant Sciences Inc. (CSE:PLNT) (OTCQB:BOSQF) (FE:YG3) (“Better”) subsidiary Urban Juve Provisions Inc. (“Urban Juve”) announces that it has conducted research and development into plant-based topical products that fight against or prevent infectious diseases leading to the submission of a Natural Health Product (“NHP”) application for a plant-based, antiseptic skin ointment to Health Canada to obtain an NHP number for the product.
“This plant-based skin ointment was developed using the principles of Ayurveda. We have spent the last six months working to identify the plants with the most active compounds with antibacterial and antiviral properties,” says Bhavna Solecki, Director of Research and Product Development at Better Plant Sciences. “We are very pleased with the resulting plant-based antiseptic skin repair and healing ointment formula we have developed to be used to help heal minor skin wounds, cuts, burns, and bruises.”
According to the Natural Health Products Regulations, compendial product license applications such as this are processed within 60-days of receipt.
GM Insights reported that the global wound care biologics market was worth US$ 1.40 Billion in 2018 and is expected to reach a value of US$ 2.5 billion by 2025 with a CAGR of around 9%. Wound care biologics refer to drugs extracted or semi-synthesized from natural sources which are used for controlling and healing infections.
The Better Plant Sciences research and development team focused on using polyherbal combinations, which use a group of plants to achieve an effective therapeutic effect. In Ayurveda, most classical preparations are polyherbal, involving a combination of 3 to 30 plants that are combined in precise ratios to achieve the desired result.
“During the compounding process, one or two of the plants will be active and the others play a supporting role. The supporting herbs have different therapeutic values calculated for different purposes, which act as catalysts to help proper absorption, transportation, and to reduce toxicity,” added Solecki. “We use spices because the phytochemicals within spices are secondary metabolites, which serve to protect against damage by insects, animals, fungi, pathogens, and parasites.”
About Better Plant Sciences Inc.
Better develops and acquires intellectual property and other assets related to plant-based products and therapeutics, and develops, manufactures, markets, sells and distributes plant-based products that improve lives. It has 14 patent applications to protect its formulas and over 200 proprietary wellness formulas at various stages of commercialization, including over 20 products that are now for sale via e-commerce or brick and mortar retail stores. It has signed an agreement to acquire JUSU branded plant-based assets from JUSU Bar, JUSU Body and JUSU Cbd, and expects to complete the acquisition this fall. The acquisition includes all inventory, packaging, raw ingredients, and intellectual property related to 300 plant-based products as well as the e-commerce sites where those products are sold. Its majority-owned subsidiary NeonMind Biosciences Inc. is engaged in research into developing a psilocybin (psychedelic mushroom) based product for weight loss and is developing a line of coffees infused with health optimizing medicinal mushrooms including reishi, cordyceps, lion’s mane and turkey tail mushrooms.
This press release includes forward-looking information and statements (collectively, “forward looking statements”) under applicable Canadian securities legislation. Forward-looking statements are necessarily based upon a number of estimates, forecasts, beliefs and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such risks, uncertainties and factors include, but are not limited to: risks related to the development, testing, licensing, brand development, availability of packaging, intellectual property protection, reduced global commerce and reduced access to raw materials and other supplies due to the spread of the Coronavirus, the potential for not acquiring any rights as a result of the patent application and any products making use of the intellectual property may be ineffective or the company may be unsuccessful in commercializing them; and other approvals will be required before commercial exploitation of the intellectual property can happen. Demand for the company’s products, general business, economic, competitive, political and social uncertainties, delay or failure to receive board or regulatory approvals where applicable, and the state of the capital markets. Better cautions readers not to place undue reliance on forward-looking statements provided by Better, as such forward-looking statements are not a guarantee of future results or performance and actual results may differ materially. The forward-looking statements contained in this press release are made as of the date of this press release, and Better expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.
NEW YORK, Aug. 25, 2020 /PRNewswire/ — Mind Medicine (MindMed) Inc. (NEO: MMED, OTCQB: MMEDF), the leading neuro-pharmaceutical company for psychedelic inspired medicines and the University Hospital Basel’s Liechti Lab are now combining MDMA and LSD in a groundbreaking Phase 1 clinical trial. The Phase 1 MDMA-LSD trial is scheduled to start in Q4 of this year in Basel, Switzerland.
Combined MDMA-LSD treatments have the potential to create next-generation psychedelic assisted therapy paradigms. When added to a psychedelic assisted therapy session, MDMA has the potential to reduce some known rare negative side effects that may occur while using LSD or other classic psychedelics on their own. It has been shown that classic psychedelics such as psilocybin and LSD can sometimes induce short-term unpleasant effects for patients during a psychedelic assisted therapy session. These symptoms may include negative thoughts, rumination, panic and paranoia.
MDMA, an empathogen, is known to acutely induce feelings of increased well-being and trust. By combining LSD and MDMA within the same session, the Liechti Lab and MindMed are evaluating if the combination produces greater overall positive acute effects when compared to LSD or MDMA on their own. MDMA may reduce some of the negative mood effects of LSD and make the patient more comfortable during psychedelic-assisted therapy.
University Hospital Basel’s Liechti Lab’s Dr. Matthias Liechti stated: “The potential of MDMA-LSD is to create a psychological state that may have the benefits of both substances and have longer lasting effects than standalone psilocybin or LSD. Inducing an overall primarily positive acute response during psychedelic assisted therapy is critical because several studies showed that a more positive acute experience is linked to a greater therapeutic long-term effect in patients.”
MindMed is interested in understanding how to balance these compounds in a cohesive way to create better patient outcomes and develop more advanced psychedelic assisted therapies as it expands both its R&D and commercial drug development pipeline.
President of MindMed, Dr. Miri Halperin Wernli added, “A new treatment paradigm combining MDMA and LSD may enhance the positive effects of LSD by inducing a positive psychological state with MDMA which is an empathogen to help counteract some known negative or less positive aspects of LSD or psilocybin. With this innovative treatment paradigm, we are looking to bring the participants outside the bounds of their everyday perceptions, bringing their mind into a very flexible state of mind facilitating new states of consciousness. This will provide the opportunity to step outside their usual sense of self and experience themselves from a radically different and new perspective.”
The Phase 1 Clinical Trial is intended to take around one year to complete. If MindMed finds the results promising, the company may decide to undertake further studies with treatments combining MDMA and LSD, and prepare patient trials for various indications.
Mind Medicine (MindMed) Inc. is a neuro-pharmaceutical company that discovers, develops and deploys psychedelic-inspired medicines to improve health, promote wellness and alleviate suffering. The company has initiated or is initiating studies to evaluate potential treatments to help patients with ADHD, anxiety, cluster headaches and substance abuse. The MindMed executive team brings extensive biopharmaceutical industry experience to this groundbreaking approach to the development of next-generation psychedelic medicines. MindMed trades on the NEO Exchange under the symbol MMED. MindMed can also be traded in the US under the symbolOTCQB: MMEDF and in Germany under the symbol DE:MMQ. For more information: www.mindmed.co.
MindMed Forward-Looking Statements
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and performance of Mind Medicine (MindMed) Inc. (“MindMed”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, MindMed’s and its collaborators’ ability to continue to conduct research and clinical programs, MindMed’s ability to manage its supply chain, product sales of products marketed by MindMed and/or its collaborators (collectively, ” Products”), and the global economy; the nature, timing, and possible success and therapeutic applications of Products and Product candidates and research and clinical programs now underway or planned; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Product candidates and new indications for Products; unforeseen safety issues resulting from the administration of Products and Product candidates in patients, including serious complications or side effects in connection with the use of MindMed’s Products and product candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict MindMed’s ability to continue to develop or commercialize Products; ongoing regulatory obligations and oversight impacting Products, research and clinical programs, and business, including those relating to patient privacy; uncertainty of market acceptance and commercial success of Products and Product candidates and the impact of studies on the commercial success of Products and Product candidates; the availability and extent of reimbursement of Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; competing drugs and product candidates that may be superior to Products and Product candidates; the extent to which the results from the research and development programs conducted by MindMed or its collaborators may be replicated in other studies and lead to therapeutic applications; the ability of MindMed to manufacture and manage supply chains for multiple products and product candidates; the ability of MindMed’s collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labelling, distribution, and other steps related to MindMed’s Products and product candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of MindMed to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement to be cancelled or terminated without any further product success; and risks associated with intellectual property of other parties and pending or future litigation relating thereto, other litigation and other proceedings and government investigations relating to MindMed and its operations, the ultimate outcome of any such proceedings and investigations; and the impact any of the foregoing may have on MindMed’s business, prospects, operating results, and financial condition. Any forward-looking statements are made based on management’s current beliefs and judgment. MindMed does not undertake any obligation to update publicly any forward-looking statement.
NEW YORK, Aug. 24, 2020 /PRNewswire/ — Today, ATAI Life Sciences (“ATAI” or the “Company”), a global biotech developing psychedelic and non-psychedelic compounds for various mental health indications, announced the launch of EmpathBio, a wholly-owned subsidiary developing derivatives of 3,4-methylenedioxy-methamphetamine (MDMA) for the treatment of post-traumatic stress disorder (PTSD) and other indications.
PTSD is a chronic condition characterized by recurring and intrusive thoughts or memories. Often co-occurring with major depression, PTSD has devastating effects on all aspects of an individual’s life. Indeed, one Danish study found that persons with PTSD were 13 times more likely to commit suicide than the general population.
In the US alone, an estimated 13 million people meet the criteria for a PTSD diagnosis. At present, the only FDA approved treatments for PTSD are selective serotonin reuptake inhibitors (SSRIs), namely sertraline hydrochloride (Zoloft) and paroxetine hydrochloride (Paxil). Unfortunately, not only does each come with significant side-effects, two-thirds of patients either do not response or have only a partial response to SSRIs.
MDMA itself is an amphetamine derivative that possesses complex pharmacology and is believed to act by increasing the release of monoamines like serotonin, norepinephrine and dopamine in the brain, as well as stimulating neurohormonal activity. These effects are thought to result in the anxiolytic, prosocial and empathic responses seen with MDMA administration in humans. As a result, MDMA is often classified as an entactogen rather than a typical psychedelic.
MDMA’s entactogenic effects typically last approximately six hours and are hypothesized to promote a sense of psychological safety which may allow patients to more effectively address their individual traumas during psychotherapy. The derivatives of MDMA being developed by EmpathBio are expected to have similar effects.
“PTSD is a debilitating condition which affects millions worldwide,” said Florian Brand, CEO of ATAI Life Sciences. ”Entactogen-assisted psychotherapy promises to fundamentally change how we think about this notoriously difficult to treat disorder.”
The use of MDMA for PTSD has been the subject of extensive research by the Multidisciplinary Association of Psychedelic Research (MAPS) and phase III clinical trials are ongoing. Published results from their phase II clinical trials showed that 56% of participants no longer met the criteria for PTSD two-months after the final MDMA-assisted psychotherapy session. Additionally, researchers followed up with 91 participants twelve months later and found that 67% still did not meet PTSD criteria.
EmpathBio is focused on developing MDMA derivatives with different pharmacological profiles than MDMA. The company believes that such changes may permit the entactogenic effects of MDMA to be separated from some of the known adverse effects. If successful, such an approach could help minimize some of the transient physiological changes caused by MDMA, potentially expanding the pool of PTSD patients who will be medically eligible for the therapy.
“While MDMA-assisted psychotherapy holds great promise for the treatment of PTSD, refinement of MDMA’s entactogenic pharmacology could provide for a greater therapeutic index,” said Glenn Short, CEO of EmpathBio. “We want to ensure that entactogen-assisted psychotherapy is available to all living with PTSD.”
Company Contact:
Allan Malievsky
ATAI Life Sciences
Phone: +1 (917) 974-1371
Email: Allan@ATAI.life
About ATAI Life Sciences
Founded by visionary entrepreneur Christian Angermayer, ATAI Life Sciences AG is a global biotech platform and company builder working to address significant unmet medical needs rooted in a lack of innovation in neuropsychiatry. Based in Berlin, London and New York, its vision is to cure mental health disorders, enabling people to live healthier and happier lives. www.atai.life
Both events important milestones to highly anticipated public listing
TORONTO, Aug. 24, 2020 /PRNewswire/ — Field Trip Psychedelics Inc. (“Field Trip” or the “Company“), the company redefining mental health and well-being through its ground-breaking work in psychedelics and psychedelic-enhanced psychotherapy, today announced it has closed the first tranche of its Series B financing (the “Financing“), raising gross proceeds of $11.0M from a broad base of investors. The Financing was completed through a brokered private placement for which Canaccord Genuity Corp. and Stifel Nicolaus Canada Inc. jointly acted as lead agents.
The proceeds from the Financing will be used to continue Field Trip’s rollout of its Field Trip Health centers across North America, which are providing best-in-class psychedelic assisted psychotherapy, and to further advance its pioneering work with its next generation psychedelic molecule, FT-104, and its advanced research and development on psilocybin producing mushrooms in partnership with the University of West Indies.
The Company recently announced the opening of the New York location of its Field Trip Health centers, following the opening of its Toronto location earlier this year, and will shortly be announcing the opening of its Santa Monica location.
Ronan Levy, Executive Chairman of Field Trip Psychedelics, said, “Our ability to secure this private placement validates the strength of our business strategy, brand and the incredible team of physicians, psychologist, therapists, scientists and employees at Field Trip. It is also reflective of the rapidly increasing interest in the investment community in the science of psychedelics compounds and their incredible potential across a number of applications. Securing these funds strengthens our balance sheet and provides us with capital to execute against these growth plans.”
Sean Trigony, CEO and Founder of Los Angeles-based Seven Hound Ventures, which participated in the financing, said: “Field Trip’s management team has a strong track record of establishing and growing medical clinics, and the science team behind Field Trip Discovery is unparalleled. We are excited to see them applying this experience to the emerging psychedelics industry, building both the infrastructure needed to deliver treatments, as well as the next generation of psychedelic molecules targeting 5HT2A receptors.”
Amalgamation Agreement with Newton Energy Corporation
The Company also announced that it has entered into a definitive agreement dated August 21, 2020 (the “Amalgamation Agreement“) with Newton Energy Corporation (“Newton“) (TSXV: NTN.H) and Newton’s wholly-owned subsidiary, Newton Energy Subco Limited (“Newton Subco“), pursuant to which the parties intend to complete a going-public transaction for Field Trip (the “Transaction“).
The going-public Transaction is structured as a three-cornered amalgamation, which will result in Field Trip becoming a wholly-owned subsidiary of Newton by amalgamating with Newton Subco, and the security holders of Field Trip becoming security holders of Newton. In connection with the completion of the Transaction, it is intended that Newton will change its name to “Field Trip Health Ltd.” (the “Resulting Issuer”). The Amalgamation Agreement will be made available on SEDAR at www.sedar.com.
Field Trip and Newton anticipate the closing of the Transaction (the “Closing”) will occur on or about September 29, 2020. The Transaction is subject to the receipt of all necessary regulatory and shareholder approvals as well as the satisfaction of conditions to the Closing as set out in the Amalgamation Agreement.
“As pioneers in developing an entirely new industry in a profoundly transformative therapeutic modality, access to capital will be one of the key characteristics that distinguishes the leaders in the psychedelics industry,” added Levy. “Our team has demonstrated great success in raising capital to date, and our public listing will provide us with more diverse financing options that will ensure our continued success and further lower our cost of capital.”
About Field Trip Psychedelics Inc.
Field Trip is the world’s first mental wellness company at the forefront of the scientific re-emergence of psychedelics and psychedelic-enhanced therapies. With Field Trip Health centres opening across North America and advanced research on plant-based psychedelics through Field Trip Discovery, we help people from those in treatment to those seeking accelerated personal growth, with a simple, evidence-based way to heal and heighten engagement with the world.
This news release contains projections and forward-looking information that involve various risks and uncertainties regarding future events and are not guarantees of future performance of the Company. These risks and uncertainties could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information. These and all subsequent written and oral forward- looking information are based on estimates and opinions of management on the dates they are made and expressed qualified in their entirety by this notice. The Company assumes no obligation to update forward-looking information should circumstance or management’s estimates or opinions change.
5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) is a psychedelic substance that can be found in plants (Pachter et al. 1959), the secretion of the Incilius Alvarius toad (Weil and Davis 1994), and made synthetically (Hoshino 1936). The substance is well-known for its short-acting properties (depending on the route of administration) with subjective effects summarized in the following soundbite: ‘we are all one.’ This “sense of oneness” is similar to the experiences of ego dissolution (Nour et al. 2016) and mystical experiences (MacLean et al. 2011) evoked by other psychedelics which has been correlated with betterment in mental health-related symptoms (Barsuglia et al. 2017; Griffiths et al. 2006; Uthaug et al. 2019; Uthaug et al. 2018).
Despite being an understudied substance, current research suggests that the use of 5-MeO-DMT can evoke similar (therapeutic) effects as that of longer-acting psychedelics like psilocybin (magic mushrooms) (Barsuglia et al. 2017). Its ability to evoke the aforementioned subjective effects paired with its short-acting properties makes 5-MeO-DMT an attractive substance for Psychedelic Assisted Psychotherapy (PAP) as it could bypass some of the logistical and financial hurdles that stand in the way of individuals getting treatment. This is why I decided to study 5-MeO-DMT’s effects and its implications for aiding in the treatment of various mental health-related disorders, including substance use disorder.
My name is Malin Vedøy Uthaug, and I am currently working as a Postdoctoral Researcher at the Centre for Psychedelic Research at Imperial College in London. I recently joined Entheon Biomedical as a scientific advisor to aid in their quest to develop a treatment for substance use disorder using 5-MeO-DMT. For the past three years, as part of my Ph.D. work at Maastricht University in The Netherlands, I have conducted several studies on both ayahuasca and 5-MeO-DMT to explore their respective effect on mental health. Ayahuasca is a ‘psychedelic tea,’ a plant concoction containing N,N-Dimethyltryptamine (DMT) and monoamine oxidase inhibitors, used historically in a shamanic ceremonial context in the Amazon (Riba et al. 2003). 5-MeO-DMT is a similar substance to DMT known for its fast-acting properties, evoking a psychedelic experience within seconds that can last for 15-40 minutes (depending on the route of administration) (Uthaug et al. 2020; Weil and Davis 1994). I decided to write my Ph.D. on these substances primarily because ayahuasca is used in a ceremonial context, which I believe the scientific and medical communities can learn much from and that it will help us inform the design of PAP moving forward. Secondly, 5-MeO-DMT is a rather understudied substance that appears to have a similar therapeutic potential to longer-acting psychedelics such as ayahuasca and psilocybin (magic mushrooms). The fact that 5-MeO-DMT was and still is an unexplored territory compared to other entices my inner adventuress and fuels my motivation to pursue a career in psychedelic research.
My doctoral dissertation’s main objective was to explore whether the ingestion of ayahuasca and 5-MeO-DMT in a naturalistic setting was related to improvement in mental health-related variables. Those variables could include depression, anxiety, stress, mindfulness, satisfaction with life, creativity, empathy), and whether such an improvement depends on the magnitude of the psychedelic experience (i.e., the experience of ego dissolution). The five original studies I carried out are summarized in my thesis titled; “The Exploration of Naturalistically Used Ayahuasca and 5-MeO-DMT; An assessment of their respective Sub-acute and Long-term effects on Mental Health Related Variables”.
The thesis consists of seven chapters where Chapter 1 assesses the need for a new treatment option or mood-related disorders such as depression, while Chapter 2-3 and Chapter 4-6, summarizes the studies on ayahuasca and 5-MeO-DMT, respectively. Finally, Chapter 7 discusses the key findings of the studies in a broader perspective, explains the implications of the findings, and provides recommendations as we move into PAP’s future.
For all of my studies, I made use of ‘naturalistic observational design.’ This design makes observations and assessments (i.e., questionnaires and computer tasks) in individuals who voluntarily consume psychedelics like ayahuasca and 5-MeO-DMT in a naturalistic setting. There are drawbacks of this design, such as the lack of control for possible influencing non-pharmacological variables (i.e., set and setting, group dynamics, expectation, suggestibility, the potential bias of both researcher and participant). Despite those drawbacks, the design allowed me to collect valuable information that could engender future research and prospective clinical trials.
In a nutshell, my dissertation work suggests that both ayahuasca and 5-MeO-DMT used in a naturalistic setting is associated with persisting betterment (up to 4 weeks) in mental health-related variables (Chapter 2-6) and that this is correlated with the experience of ego dissolution (Uthaug 2020). Furthermore, the research suggests that 5-MeO-DMT may have immunomodulatory potential through the downregulation of cytokine IL-6 (a biomarker for inflammation) (Chapter 5). This echoes the findings of previously reported anti-inflammatory actions of 5-MeO-DMT (Dakic et al. 2017; Szabo et al. 2014) but warrants further longitudinal assessments. Additionally, a retrospective survey-study on the effects of different administration routes of 5-MeO-DMT (Chapter 6) indicated that there was no significant difference in impact and experiences of 5-MeO-DMT when administered through vaporization or intramuscular injection (IM). However, the results revealed that IM evoked the phenomenon of reactivation (defined as flashbacks/re-experiencing [parts of] the experience) less frequently, induces a slower onset of acute effects and had a strong potential to bring about the release of physical tension (somatic release). The results add weight to the clinical considerations of 5-MeO-DMT through IM by Sherwood and colleagues (2019), who identified IM as the most favourable route of administration of 5-MeO-DMT for the following reasons; 1) it avoids the first-pass metabolism; 2) has high bioavailability; 3) it allows for precise control of dosage, and 4) evokes a gentle onset with a slightly longer duration of effects.
Although the current scientific information about 5-MeO-DMT points to a similar (therapeutic) potential as other psychedelics (i.e. psilocybin), the findings from Chapter 3 (manuscript under review) in my dissertation work suggest that non-pharmacological factors such as set and setting may be steering some of the improvement in mental health-related variables. The “naturalistic placebo-control” study on the effects of ayahuasca ingested in a neo-shamanic setting signifies that while improvement in empathy was attributed to ayahuasca’s pharmacological actions, reductions in effect (depression, anxiety and stress) were moderated by non-pharmacological factors such as expectation and learning. Although we did not conduct a similar study on 5-MeO-DMT, it may very well be the case that such non-pharmacological factors played a role in the improvement in mental health-related variables following 5-MeO-DMT use too. Such factors may also include social desirability bias (Grimm 2010) and spiritual bypassing (Fox et al. 2017).
The latter is defined as the tendency to use spiritual ideas and practices to sidestep or avoid facing unresolved emotional issues, psychological wounds, and unfinished developmental tasks. Based on my observations in the field, and by watching over a hundred sessions in the underground, it seems that spiritual bypassing is a common occurrence in the underground where 5-MeO-DMT is used. My reasoning behind that is due to knowledge of the rapid onset and offset of 5-MeO-DMTs effects (through vaporization), and high doses used, which might push an individual to dissociate psychologically. Psychological dissociation is defined in Ralph Metzner’s book as ‘unconsciousness of one’s own bodily postures and gestures, vocalisations and verbalizations, as well as more or less disconnect of total awareness of ones surroundings‘ (2013). If a person dissociates during their experience with 5-MeO-DMT, they will not be ‘online’ to (somewhat) consciously work through material that may be causing them distress. Thus, there will be no resolution of unprocessed, unconscious material, and therefore it is very likely that the same pain will return. As Carl Jung once stated: what you resist persists.
Additionally, from speaking with many participants and facilitators before and after sessions, I became aware of romanticized ideas and expectations that they held about 5-MeO-DMT. Many believed that medicine would somehow set them free from various mental health-related difficulties. In other words, the substance would do the healing work for them. The idea of a “quick fix” is not unusual in our society and is evident in other areas besides mental health. If I go on this vacation, I’ll be happier! If I get this job, I’ll be more satisfied. However, these are nothing but fabricated subjective illusions. The only thing you need is to take full responsibility for yourself and so too for your healing. The solution isn’t externally, but internally. Psychedelics like 5-MeO-DMT may aid in that internal process, but it won’t do the work for you nor anyone else.
I believe it is about time that beliefs about a ‘quick fix’ are reconsidered, not only by participants and facilitators of such ceremonies but also by individuals on a societal level. The reason for this is because healing is hard. If it were easy, we wouldn’t have a worldwide mental health epidemic and an urgent need for a novel treatment option for mental health-related disorders like addiction.
Although more research is needed, there is scientific literature supporting 5-MeO-DMT as an adjunct in therapy for various mental disorders. The idea would be to use it as a catalyst for a therapeutic process (i.e., Psychedelic Assisted Psychotherapy). A person would be supported by a therapist to lean into painful and repressed thoughts. Ideally, the patient undergoes therapeutic sessions before and after to prepare for and integrate the therapy with 5-MeO-DMT. The latter is particularly important, for as the title of the book by Jack Kornfield reads; after the ecstasy, the laundry.
What makes the effects of 5-MeO-DMT any different from the effects of other psychedelics? What does 5-MeO-DMT do that psilocybin or ayahuasca can’t? We do not know yet, but what we do know is this: Previous reports from participants who received ayahuasca-assisted therapy stated that it helped them release the pain or trauma that was being masked by their substance use (Argento et al. 2019). Ayahuasca, it has been suggested, exerts its anti-addictive effect through biochemical, physiological, psychological, and transcendent pathways (Liester and Prickett 2012). Firstly, ayahuasca targets several brain regions associated with addiction, and secondly, reduces dopamine levels in mesolimbic pathways related to the development and maintenance of chronic substance use.
Furthermore, it has shown to help resolve trauma, and finally, induces transcendent experiences pathways (Liester and Prickett 2012).
Additionally, the setting (ritualistic) in which ayahuasca is used and the sense of community it facilitates has also been suggested as an essential factor in addiction cessation (Talin and Sanabria 2017). The latter, a group setting, has shown to be particularly important in the treatment of addiction (Flores 2001). 5-MeO-DMT might hold a similar potential as ayahuasca for the treatment of substance use disorder for similar reasons. Despite not being used in a similar group setting, research has shown that 5-MeO-DMT target several brain areas associated with addiction (Barsuglia et al. 2018; Dakic et al. 2017), and elicit profound mystical experiences akin to that of high-dose psilocybin experiences (Barsuglia et al. 2017). Furthermore, previous research suggests that 5-MeO-DMT has low addiction potential and excellent safety profile (Davis et al. 2018), anti-inflammatory properties through the sigma-1 receptor (Szabo et al. 2014; Uthaug et al. 2019a), the therapeutic potential for various mental health disorders (Davis et al. 2018).
This still doesn’t tap into what makes 5-MeO-DMT so different, but I hope that the following might explain why:
In my opinion, while being mindful of my own bias, it seems to me that 5-MeO-DMT has this unique ability to amplify a person’s interoception (sense of the internal state of the body) to a different, and yet to be understood extent which I think can have important implications for treatment of addiction as well as Post-traumatic Stress Disorder (PTSD). From my perspective, it seems that 5-MeO-DMT can pierce through the dissociative veil that is ‘protecting’ people with addiction or PTSD from unprocessed material like trauma and thus get them in contact with their body. Under the influence of 5-MeO-DMT, while in a supportive therapeutic context, a person could have a chance to get in touch with the reality of the autonomic nervous system and the dysregulation that may be in it. This provides an opportunity to work through material that has been repressed and caused “issues in the tissues” (trauma).
With regards to addiction and based on statements and writings by Dr. Gabor Maté, someone who is misusing a substance (or more) is doing so to dim away or run away from pain. In his view, the place to target in treatment is not the addiction but the illness that is causing it. According to Dr. Maté that pain needs to be felt through to go away for ‘addiction starts and ends with pain.’
Like Dr. Gabor Maté, I also believe that pain needs to be acknowledged and felt. If not, it will continue to return like ‘pop-up notifications’ on a smart-phone as a reminder that something needs attention. I also believe that 5-MeO-DMT may help individuals feel through these things if done in the right setting with proper support from a therapist. The therapeutic relationship is also a key component of treatment success.
That said, it is premature to make conclusions about the place for 5-MeO-DMT in mental health treatments at the current time. There are still many unanswered questions to address, which will require rigorous research designs, testing and analysis. To that end, I am delighted to have joined Entheon Biomedical as an advisor. As we continue to search for, investigate and find the answers to many of these lingering questions, with the ultimate aim of developing therapies that will support those recovering from substance use disorder.
References
Barsuglia J, Davis A, Palmer R (2017a) Characterization of mystical experiences occasioned by 5-MeO-DMT-containing toad bufotoxin and comparison with prior psilocybin studies. Psychedelic Sci 23
Barsuglia JP, Davis AK, Palmer R, Lancelotta R, Windham-Herman M, Peterson K, Polanco M, Grant R, griffiths R (2017b) Characterization of Mystical Experiences Occasioned by 5-MeO-DMT-Containing Toad Bufotoxin and Comparison with Prior Psilocybin Studies 3rd International Psychedelic Science Conference
Barsuglia JP, Polanco M, Palmer R, Malcolm BJ, Kelmendi B, Calvey T (2018) A case report SPECT study and theoretical rationale for the sequential administration of ibogaine and 5-MeO-DMT in the treatment of alcohol use disorder. Progress in brain research 242: 121-158
Dakic V, Nascimento JM, Sartore RC, de Moraes Maciel R, de Araujo DB, Ribeiro S, Martins-de-Souza D, Rehen SK (2017) Short term changes in the proteome of human cerebral organoids induced by 5-MeO-DMT. Scientific reports 7: 12863
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Flores PJ (2001) Addiction as an attachment disorder: Implications for group therapy. International Journal of Group Psychotherapy 51: 63-81
Fox J, Cashwell CS, Picciotto G (2017) The opiate of the masses: Measuring spiritual bypass and its relationship to spirituality, religion, mindfulness, psychological distress, and personality. Spirituality in Clinical Practice 4: 274
Griffiths RR, Richards WA, McCann U, Jesse R (2006) Psilocybin can occasion mystical-type experiences having substantial and sustained personal meaning and spiritual significance. Psychopharmacology 187: 268-283
Grimm P (2010) Social desirability bias. Wiley international encyclopedia of marketing
Hoshino TaS, K. (1936) Über die synthese des bufotenin-methyl-äthers (5-methoxy-n-dimethyl-tryptamin) und bufotenins (synthesen in der indol-gruppe. xv). Bull Chem Soc Jpn 11: 221-224
Liester MB, Prickett JI (2012) Hypotheses regarding the mechanisms of ayahuasca in the treatment of addictions. Journal of psychoactive drugs 44: 200-208
MacLean KA, Johnson MW, Griffiths RR (2011) Mystical experiences occasioned by the hallucinogen psilocybin lead to increases in the personality domain of openness. Journal of Psychopharmacology 25: 1453-1461
Metzner R (2013) The Toad and the Jaguar: a Field Report of Underground Research on a Visionary Medicine: Bufo alvarius and 5-Methoxy-dimethyltryptamine. Regent Press, Regent Press
Nour MM, Evans L, Nutt D, Carhart-Harris RL (2016) Ego-Dissolution and Psychedelics: Validation of the Ego-Dissolution Inventory (EDI). Frontiers in Human Neuroscience 10: 269
Pachter IJ, Zacharias DE, Ribeiro O (1959) Indole alkaloids of Acer saccharinum (the Silver Maple), Dictyoloma incanescens, Piptadenia colubrina, and Mimosa hostilis. The Journal of Organic Chemistry 24: 1285-1287
Sherwood A, Kaylo K, Kargbo R, Davis A, Lancelotta R, Uthaug M, Barrow B (2019) CLINICAL CONSIDERATION OF 5-MeO-DMT International Forum on Consciousness, Madison, Wisconsin
Szabo A, Kovacs A, Frecska E, Rajnavolgyi E (2014) Psychedelic N, N-dimethyltryptamine and 5-methoxy-N, N-dimethyltryptamine modulate innate and adaptive inflammatory responses through the sigma-1 receptor of human monocyte-derived dendritic cells. PloS one 9
Talin P, Sanabria E (2017) Ayahuasca’s entwined efficacy: An ethnographic study of ritual healing from ‘addiction’. International Journal of drug policy 44: 23-30
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Uthaug MV (2020) The Exploration of Naturalistically used Ayahuasca and 5-MeO-DMT; An assessment of their respective Sub-acute and Long-Term effects on Mental Health Related Variables. Maastricht University
Weil AT, Davis W (1994) Bufo alvarius: a potent hallucinogen of animal origin. J Ethnopharmacol 41: 1-8
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