MindMed Closes Upsized Financing of CAD $34.5m, Gross Proceeds Raised Since Company Founding Now Total CAD $121.4m (USD $94.8m)

Post-Financing Cash Reserves of CAD $85m (USD $66.4m) to Enable Advancement of Digital Therapeutics Division and Growing Clinical Trial Pipeline

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES

TORONTODec. 11, 2020 /CNW/ — Mind Medicine (MindMed) Inc. (NEO: MMED, OTCQB: MMEDF) (“MindMed” or the “Company”) is pleased to announce that it has closed its previously announced bought deal short form prospectus offering, including the exercise in full of the underwriter’s over-allotment option (the “Offering”). In connection with the Offering, the Company issued 18,170,000 units of the Company (the “Units”) at a price per Unit of CAD $1.90 (the “Issue Price”) for gross proceeds of CAD $34,523,000. The Offering was conducted by Canaccord Genuity Corp., as lead underwriter, and Eight Capital.

Each Unit comprises one subordinate voting share of the Company (a “Subordinate Voting Share”) and one-half of one Subordinate Voting Share purchase warrant (each whole warrant, a “Warrant”). Each Warrant entitles the holder thereof to purchase one Subordinate Voting Share at an exercise price of CAD $2.45 until December 11, 2023. If, at any time following the closing of the Offering, the daily volume weighted average trading price of the Subordinate Voting Shares on the NEO Exchange Inc. is greater than CAD $4.00 per Subordinate Voting Share for the preceding 10 consecutive trading days, the Company may, upon providing written notice to the holders of Warrants, accelerate the expiry date of the Warrants to the date that is at least 30 days following the date of such written notice. The Warrants will be listed for trading on the facilities of the NEO Exchange Inc. (the “NEO”) under the symbol “MMED.WA”, subject to the final approval of the NEO.

Since the founding of Mind Medicine Inc. in May 2019, MindMed has now raised a total of CAD $121.4m (USD$94.8m) in investment capital before fundraising and deal expenses.

MindMed Co-Founder & Co-CEO, J.R. Rahn said, “The COVID-19 pandemic has made it clearer than ever that the current global mental healthcare system demands more comprehensive solutions to address multiple mental health and addiction crises around the world. This successful upsized financing from investors offers further validation that psychedelic medicines are being viewed as a promising new frontier in mental health treatments. As we advance and design this new treatment paradigm in mental health and addiction, we believe that interlacing digital therapeutics alongside regulated psychedelic drug development through rigorous science at the FDA and other regulatory bodies will be integral to advancing the potential healing of millions of patients globally.”

The Company intends to use the net proceeds of the Offering for investment in its digital medicine division, additional microdosing research and development as well as general working capital and corporate purposes, including to further fund its ongoing programs.

Post-financing, the Company now has cash reserves of CAD $85m (USD $66.4m) to enable development of its digital medical division Albert and continued progress of its clinical trial pipeline of psychedelic inspired medicines and experiential therapies.

With Albert, the Company aims to build an integrated digital platform to improve patient safety, outcomes, and clinical trial design. By pairing digital tools, such as wearables and the latest in machine learning, with psychedelic assisted therapies, MindMed can optimize and better understand the patient journey and therapeutic outcomes from pre-care through to after-care.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the United States Securities Act of 1933, as amended, and applicable state securities laws.

About MindMed

MindMed is a psychedelic medicine biotech company that discovers, develops and deploys psychedelic inspired medicines and experiential therapies to address addiction and mental illness. The Company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including Psilocybin, LSD, MDMA, DMT and an Ibogaine derivative, 18-MC. The MindMed team brings extensive biopharmaceutical experience to the Company’s groundbreaking approach to developing the next generation of psychedelic inspired medicines and experiential therapies.

MindMed trades on the Canadian NEO Exchange under the symbol MMED. MindMed is also traded in the United States under the symbol MMEDF and in Germany under the symbol MMQ. For more information: http://www.mindmed.co/

Forward-Looking Statements

Certain statements in this news release related to the Company are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the intended use of proceeds of the Offering, the listing of the Warrants on the NEO,  the Company’s cash reserves and the effects thereof, and the Company’s intended future business plans and operations, including the development of psychedelic inspired medicines and experiential therapies. There are numerous risks and uncertainties that could cause actual results and MindMed’s plans and objectives to differ materially from those expressed in the forward-looking information. Actual results and future events could differ materially from those anticipated in such 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 are expressly qualified in their entirety by this notice. Except as required by law, the Company does not intend to update these forward-looking statements.

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Spotlight: Dr. Denton Hoyer, Scientific Advisor, Mydecine

Published at PsychedelicFinance.com

Dr. Denton Hoyer has been involved in drug discovery at leading pharmaceutical companies and research institutions for the last 30 years. He holds numerous patents and has been published extensively in the field of medicinal chemistry and drug research. Dr. Hoyer has unparalleled expertise in computational chemistry enabled probe molecule design, drug design and optimization, synthetic planning and execution, evaluation of chemical novelty and intellectual property assessment and strategies. Dr. Hoyer is currently on the scientific advisory board at Mydecine Innovations Group.

______________________________________

You have been involved in pharmaceutical ventures and drug discovery for multiple decades. Can you tell us what first drew you into psychedelics as a potential therapeutic area?

This is an area of research with research barriers imposed for quite some time. We see now changes in policy and attitudes, which will enable us to bring modern drug discovery into the field and move it forward with exciting discoveries and new therapies.

On a personal level, what have you found most exciting about psychedelics derived medicines and the impact they could have on mental healthcare, addiction and trauma?

It has been disappointing to see the slow progress in traditional CNS (Central Nervous System) therapeutics approaches as practiced in pharma. The psychedelic natural products give us alternative approaches and can address unmet needs that have stymied CNS therapeutics. I’m very optimistic with the progress that has been made in psychedelics and anticipate incredible growth in this area.

You have experience with some of the largest Pharma companies on the planet, including Pfizer and Novartis. What did you learn there about novel drug discovery that you are now able to bring in to the world of psychedelics?

Adapting any compound for clinical use requires one to understand the drug on a molecular level and anticipate development issues such as manufacture, stability, formulation, off-target effects and safety. Through the application of the principles of medicinal chemistry, we can address these issues and develop a product clinicians can use confidently.

You have joined the team at Mydecine. What drew you to the opportunity and what are you spending your time on building with them?

I was impressed with the competence and depth of the Mydecine team and my working with them has been completely enjoyable.  They are working with major players in the field of psychedelics research and the team is able to identify new opportunities for collaboration and engagement. Currently, I am taking a deep look at psychedelics of interest to Mydecine, identifying new opportunities, developing intellectual property and setting research strategies.

Can you share some of the obstacles that you’ll have to overcome working with new types of psychedelics and new molecules?

As anyone in research will tell you, the efficacy of an agent can be complex on a receptor level and deciphering mechanisms of action responsible for any therapeutic effect challenging. Fortunately, the psychedelics have a deep history of past anecdotal use that informs more rigorous studies. This is a key advantage in providing strong proof of concept for particular indications.

What do you think most people still don’t understand about psychedelics and their therapeutic potential?

Past policy on the utility of psychedelics has been confused with dirty drugs, recreational abuse and unscientific conclusions made for political and societal reasons. Bringing serious study with well characterized agents is needed to make progress in identifying the appropriate illnesses and clinical environments in which effective treatments can be developed.

From a drug discovery perspective, what are you most excited about right now in your collaboration with Mydecine and what impact could it have long term?

The psychedelics we are currently focusing on have clear indications for specific illnesses and that provides our short term focus and growth. However, we believe there are many new opportunities to expand the use of psychedelics and the time is ripe to begin the research. We are able to anticipate potential issues that can hinder the development of psychedelics and find solutions. This includes the invention of new molecular entities  and is the long view. Taking this long view will drive new discoveries and open up the field of CNS research.

 

Always do your own research and make your own investment decisions. This is not a solicitation to purchase or sell securities .Psychedelic Finance is not a registered investment advisor and does not purport to provide investment advice, whether implied or otherwise. Psychedelic Finance does not independently verify the accuracy or the truth of the statements or representations made by issuers. This message is meant for information and educational purposes only and Psychedelic Finance does not intend for this information to be used to inform an investment decision.

HAVN LIFE SCIENCES TO SUPPLY PSYCHEDELIC COMPOUNDS TO CLINICAL STUDIES FOCUSED ON VETERANS AND PTSD

Havn Life will collaborate on future clinical studies in the U.S. and Canada with Heroic Hearts to investigate effects of low-dosage psychoactive compounds on veterans the post-traumatic stress disorder (PTSD).


Vancouver, BC – Havn Life Sciences Inc. (CSE : HAVN) (FSE : 5NP(the “Company” or “Havn Life”), a Canadian biotechnology company pursuing standardized extraction of psychoactive compounds, the development of natural healthcare products, and innovative mental health treatment to support brain health and enhance the capabilities of the mind, is pleased to announce it has signed a Memorandum of Agreement (“MOA”) with the international veterans organization, Heroic Hearts Project (“Heroic Hearts”).

Heroic Hearts is a registered 501(c)(3) non profit organization in the United States that connects military veterans struggling with mental trauma, to psychedelic therapy options including ayahuasca, psilocybin, and ketamine. Heroic Hearts also provides support and professional counseling to these veterans throughout the process. These veterans typically have tried all the available resources offered by the Department of Veteran Affairs with limited success leaving them with very few options.

“This collaboration between Havn Life and Heroic Hearts has the potential to make an extraordinary impact of the mental health and wellness of military veterans,” said Susan Chapelle, EVP of Research and Development at Havn Life. “Under the agreement, Havn Life will supply products and compounds to be used in Heroic Hearts’ future clinical studies that will investigate the effects of low-dosage psychedelic compounds on veterans suffering from emotional trauma and PTSD. This progressive research will help develop clinical trial formulations to aid in the recovery of PTSD and other trauma-related disorders. We look forward to working closely with veterans and others with military backgrounds.”

Heroic Hearts is also working to advance the body of scientific evidence around psychedelic compounds through approved research studies with the University of Georgia and the University of Colorado Boulder.

“We are laying the groundwork to lead  standardization of the psychedelic supply chain and the development of IP while also contributing to the limited research on PTSD, human performance optimization and cutting-edge mental health paradigms” Chapelle added.

Two-thirds of Canadian military personnel with PTSD do not respond completely to the best available evidence-based therapies, according to a 2018 study that examined recovery, rehabilitation and reintegration of injured service members and veterans. Further, suicide risk is higher in Canadian Armed Forces (CAF) Veterans than the Canadian general population, found a “Life After Service” study published in 2016.

As part of the agreement, Havn Life will supply products for any future U.S. and Canadian studies, upon approval of  its Licensed Dealer application. Havn Life scientists will provide support for Heroic Heart’s current studies and aid in the development of research protocols. The collaboration will also explore the use of mental health and pharmacology management platforms to collect baseline and usage data from veterans.

Havn Life is also providing funding to launch a Heroic Hearts division in Canada, to help expand support to Canadian Veterans.

On Behalf of The Board of Directors
Tim Moore
Chief Executive Officer


About Havn Life Sciences Inc.

Havn Life Sciences is a Canadian biotechnology company pursuing standardized extraction of psychoactive compounds, the development of natural healthcare products, and innovative mental health treatment to support brain health and enhance the capabilities of the mind. Learn more at: havnlife.com and follow us on FacebookTwitter and Instagram.

Connect

Investor Relations
ir@havnlife.com
604 (687)-7130

Facebook: @havnlife
Twitter: @havnlife
Insta: @havn.life
LinkedIn: @Havn Life

Media Contact
Brittany@exvera.com
778-238-6096

Field Trip Health Ltd. Reports Second Fiscal Quarter 2021 Financial Results, Announces Two New Field Trip Health Center Locations

  • Pre-clinical studies demonstrate potential of FT-104, its novel psychedelic molecule, as preferable option for psychedelic therapies, with comparable potency to psilocybin and shorter duration
  • 4 Field Trip Health centers are in operation, with Amsterdam and newly announced locations in Atlanta, GA and Houston, TX under construction
  • Digital applications Trip and Portal providing people with new tools for tele-therapy
  • Strong cash position of $14.0M to advance development of FT-104 and continue expansion of Field Trip Health Centers in North America and Europe

TORONTO, Nov. 30, 2020 (GLOBE NEWSWIRE) — Field Trip Health Ltd. (CSE: FTRP) (OTCBB: FTRPF) (“Field Trip”), a leader in the development and delivery of psychedelic therapies, reported its second fiscal quarter results for the three and six months ended September 30, 2020. All results are reported under International Financial Reporting Standards (“IFRS”) and in Canadian dollars, unless otherwise specified.

Key Highlights and Recent Developments

During fiscal Q2 of 2021, Field Trip completed brokered and non-brokered private placements of an aggregate of 6,333,656 Class A shares in the capital of Field Trip, at a price of $2.00 per Field Trip Share, for aggregate gross proceeds of $12,667,312 (the “Financing”). Funds for these private placements were received in two tranches.

As at September 30, 2020, Field Trip reported cash and cash equivalents of $14,042,025 which included $11,033448 gross proceeds from the first tranche of financing and $1,638,670 in other receivables, which primarily related to the second tranche funds from the Financing held in escrow and released in October.

On October 1, 2020, Field Trip completed its previously announced going public transaction via a reverse takeover and began trading on the Canadian Securities Exchange (the “CSE”) under the stock symbol “FTRP”, as well as the OTCBB under the symbol “FTRPF”.

With its strong cash position and recent listing, Field Trip is well-positioned to execute on its corporate strategy of building an integrated psychedelics company through its Field Trip Discovery and Field Trip Health Divisions. Field Trip Discovery’s focus includes: (i) continued development of FT-104, its first drug candidate, which is a novel synthetic psychedelic molecule; and (ii) advanced research and cultivation on psilocybin producing fungi at its research facility (the “Jamaica Facility”) at The University of West Indies (Mona) in Jamaica (“UWI”). Field Trip Health’s focus is on: (i) building out the clinical infrastructure needed to deliver psychedelic therapies at scale, with current and announced locations in Toronto, New York, Los Angeles, Chicago, Amsterdam, Atlanta, GA and Houston, TX; and (ii) developing digital tools to enhance and optimize the therapeutic experience in its Field Trip Health Centers and beyond, including Trip, its mobile application supporting consciousness expansion and Portal, its tools to support people participating in psychedelic therapies at Field Trip Health centers.

FT-104

FT-104 is a next-generation, synthetic psychedelic molecule whose design is, in part, based on classical serotonin 2A psychedelics. Patents are pending on FT-104’s structure, formulation and use in treating a variety of central nervous system disorders. Preliminary results for FT-104 demonstrate that FT-104 is similar in potency to psilocybin, but may provide a significantly shorter duration of psychedelic experience relative to psilocybin (in the range of two to four hours, which is approximately half the duration of psilocybin), making it a more convenient and potentially preferable option for psychedelic therapy. FT-104 is concurrently undergoing optimization and cGMP scale-up, as well as pre-clinical evaluation, both of which are expected to be completed by June 2021. Field Trip anticipates that FT-104 will enter into Phase 1, clinical trials in the second half of calendar year 2021.

Psilocybin-producing Fungi Research and Cultivation

Since January 2020, Field Trip has successfully cultivated 24 varieties (from 13 different species) of psilocybin-producing fungi and truffles in a temporary facility at UWI’s Mona Campus, and in October 2020, Field Trip substantially completed construction of a 2,072 sq. ft. custom-built research and cultivation facility situated on UWI’s Mona campus. The purpose of the Jamaica Facility is to optimize the cultivation techniques and operating procedures for psilocybin-producing fungi and develop the analytical tools and techniques to ensure the safe use of domesticated species in psychedelic therapy in legal jurisdictions (states or countries) as markets for psilocybin-producing fungi continue to emerge. Field Trip anticipates utilizing such techniques and operating procedures at Field Trip Health’s Amsterdam location, as well expected operations in the State of Oregon, following the passage of Measure 109, which will effectively create the first legal market for psilocybin therapies in North America.

In addition, Field Trip will seek to identify and quantify total tryptamine content, including psilocybin and other tryptamine analogues that may play a role in the psychedelic experience, and use this knowledge to optimize production of reproducible and well-characterized psychedelic botanical medicines. Further, any new substances identified during these efforts, may lead to promising new candidates for drug development.

Field Trip Health Centers

Field Trip Health centers are primarily dedicated to the treatment of depression and other mental health conditions using proprietary protocols and settings within a framework of ketamine-assisted therapies but will offer therapies using other psychedelic molecules where and when permitted, including in The Netherlands and the State of Oregon.

During the second fiscal quarter, following the successful opening of its Toronto location in March 2020, Field Trip opened Field Trip Health centers in the United States with locations in New York and Los Angeles. In October 2020, Field Trip completed construction at its Chicago location and expects to begin providing therapies to people in December.

Field Trip also announced that it has entered into a lease to build a Field Trip Health center in Amsterdam, Netherlands, which will provide programs utilizing truffles containing psilocybin, which are legal in The Netherlands. Field Trip has also entered into two additional leases in Atlanta, GA and Houston, TX, respectively bringing the total number of Field Trip Health centers to a total of seven, ahead of schedule. The Field Trip Health center in Atlanta, GA will be a 5,189 sq. ft. facility located at Building 200, 750 Glenwood Avenue and is a part of the redevelopment of GlenCastle, which is Atlanta’s historic city stockade, stables and farm, that is being restored and repurposed into Atlanta’s most unique and creative office campus. The Houston center is a 4,600 sq. ft. facility located at Suite 4310 Westheimer Road, Suite 220 in Houston’s River Oaks neighborhood and will offer seven treatment rooms and a large group therapy room.

Digital Teletherapy Tools: Trip and Portal

During the second fiscal quarter, Field Trip also launched the Trip, a mobile app that provides users with a framework and tools to make the most of self-directed consciousness-expanding activities such as meditation and breathwork. Trip was released to users on Apple and Android platforms and has over 3,600 active users.

Field Trip also launched Portal, a proprietary digital tool designed to complement its in-person therapeutic experience. Portal provides users with content, information, meditations, and synchronous and asynchronous communication tools for people in its psychedelic therapies and programs.

Effects of COVID-19 Pandemic on Operations

Overall, Field Trip was not significantly affected by the COVID-19 pandemic. Although restrictions delayed construction on the New York and Los Angeles Field Trip Health centers, the delays were not significant and operations in its existing and planned Field Trip Health centers continue in earnest. As the COVID-19 pandemic has resulted in an estimated 300% increase in the incidence of depression in the US1, Field Trip anticipates that it will see an increase in expected long-term demand for its depression-related psychedelic therapies, particularly as case counts start to diminish in the future. However, Field Trip anticipates that financial results and operations for the forthcoming fiscal quarters may be negatively impacted by the COVID-19 pandemic as restrictions limit people’s ability to seek non-essential health services.

Financial Highlights

For the second fiscal quarter, Field Trip reported patient services revenues of $94,532 from its Toronto and New York Field Trip Health centers, which began continuous operations in June and August, respectively.

Net loss for the second fiscal quarter of $3,932,444 was primarily due to general and administration expenses of $2,182,144, research and development expenses of $745,989, sales & marketing expenses of $268,475, patient services expenses of $232,114, occupancy costs of $111,877 and realized foreign exchange loss of $196,288. Net loss for the second fiscal quarter of 2020 of $514,643 was primarily due to general and administration expenses of $411,686, occupancy costs of $59,342 and sales and marketing expenses of $43,582.

For the six months ended September 30, 2020, the Company reported patient services revenues of $118,131 from our Toronto and New York clinics. Net loss of $6,891,348 was primarily due to general and administration expenses of $3,536,064, research and development expenses of $1,480,991, sales & marketing expenses of $420,307, patient services expenses of $289,089, occupancy costs of $175,660 and realized foreign exchange loss of $591,010. Net loss for the period from April 2 (date of incorporation) to September 30, 2019 of $681,418 was primarily due to general and administration expenses of $564,331, occupancy costs of $73,472 and sales and marketing expenses of $43,582.

Selected Consolidated Financial Information

The following table sets forth selected financial information derived from the Company’s unaudited condensed interim financial statements for the three and six months ended September 30, 2020 and periods ended September 30, 2019, prepared in accordance with IAS 34 in a manner consistent with the Company’s annual audited financial statements. The following information should be read in conjunction with the financial statements and management’s discussion and analysis, which are available on the Company’s website at www.fieldtriphealth.com and under the Company’s SEDAR profile at www.sedar.com.

(unaudited) 3 months ended
September 30, 2020
3 months ended
September 30, 2019
6 months ended
September 30, 2020
Period from April 2,
2019 (Date of
Incorporation) to
September 30, 2019
$ $ $ $
Revenue 94,532 118,131
Operating Expenses
General and administration 2,182,144 411,686 3,536,064 564,331
Occupancy costs 111,877 59,342 175,660 73,472
Sales and marketing 268,475 43,582 420,307 43,582
Research and development 745,989 1,480,991
Depreciation and amortization 269,578 33 479,338 33
Patient services 232,114 289,089
3,810,177 514,643 6,381,449 681,418
Other Income (Expenses)
Finance expense (58,373) (93,357)
Other expense (158,426) (534,673)
Net Loss (3,932,444) (514,643) (6,891,348) (681,418)
Net Loss per Share – Basic and Diluted (0.16) (0.08) (0.28) (0.11)
Cash (including Restricted Cash) 14,042,025 1,057,334 14,042,025 1,057,334
Other Receivables 1,984,044 7,297 1,984,044 7,297
Total Assets 22,468,694 1,175,561 22,468,694 1,175,561
Total Non-Current Financial Liabilities 2,976,316 2,976,316
Distributions 13,596 13,596

Conference Call

The Company will conduct a conference call and webcast to review its results the following day, Tuesday, December 1, 2020 at 8:00 am ET. To access the call, please dial 1-877-407-9716 or 1-201-493-6779 and provide conference ID 13713475. A live webcast of the conference call can be accessed via the Events and Presentations section of the Field Trip Health Investor Relations website or via the following link: http://public.viavid.com/index.php?id=142525.

For those unable to attend the live call, a telephonic replay will be available until December 15, 2020. To access the replay of the call dial 1-844-512-2921 or 1-412-317-6671 and provide conference ID 13713475. An archived copy of the webcast will be available on the Events and Presentations section of the Field Trip Health Investor Relations website after the conclusion of the call.

______________________________________

1Ettman CK, Abdalla SM, Cohen GH, Sampson L, Vivier PM, Galea S. Prevalence of Depression Symptoms in US Adults Before and During the COVID-19 Pandemic. JAMA Network Open. 2020;3(9):e2019686. doi:10.1001/jamanetworkopen.2020.19686

About Field Trip Health Ltd.

Field Trip is the global leader in the development and delivery of psychedelic therapies. With our Field Trip Discovery division leading the development of the next generation of psychedelic molecules and conducting advanced research on plant-based psychedelics including psilocybin-producing fungi and our Field Trip Health division building centers for psychedelic therapies opening across North America and Europe along with the digital and technological tools that will enable massive scale 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.

Learn more at https://www.meetfieldtrip.comhttps://www.fieldtriphealth.com and https://www.fieldtriphealth.nl.

Follow us on Twitter and Instagram: @fieldtriphealth

To receive company updates about Field Trip and to be added to the email distribution list please sign up here.

For further information, contact Ronan Levy, Executive Chairman, and a Director at Field Trip, at 1 (833) 833-1967.

Cautionary Note Regarding Forward-Looking Information

This release includes forward-looking information within the meaning of Canadian securities laws regarding Field Trip and its business, which may include, but are not limited to, statements with respect to the listing of the common shares of Field Trip on the Canadian Securities Exchange, and the timing of such events. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such statements are based on the current expectations and views of future events of the management of Field Trip and are based on assumptions and subject to risks and uncertainties. Although the management of Field Trip believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the companies, including risks regarding the COVID-19 epidemic, the medical clinic industry, market conditions, economic factors, management’s ability to manage and to operate the business and the equity markets generally. Although Field Trip has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Field Trip does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

The CSE has neither approved nor disapproved the contents of this news release.

Media contacts:
Paige Tatulli
Autumn Communications
212-206-9780
paiget@autumncommunications.com / fieldtrip@autumncommunications.com

Investor contacts:
Elizabeth Barker
KCSA Strategic Communications
212-896-1203
ebarker@kcsa.com

SOURCE Field Trip Health Ltd.

Vireo Health Announces Third Quarter 2020 Financial Results

— Total revenue of $13.4 million increased 68 percent year-over-year —
— Gross margin of 42.7% reflects improving manufacturing efficiencies in core markets —
— Christian Gonzalez promoted to role of COO; Patrick Peters promoted to EVP of Retail —
— Revenue growth catalysts and cost discipline position Company for future margin improvement —

MINNEAPOLIS, Nov. 25, 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 six states and the Commonwealth of Puerto Rico, today reported financial results for its third quarter ended September 30, 2020. All currency figures referenced in this press release reflect U.S. dollar amounts.

Vireo Logo (PRNewsfoto/Vireo Health, Inc.)

“Our third-quarter results demonstrate the improving nature of our business and success of recent initiatives to improve operating and financial performance,” said Chairman and Chief Executive Officer, Kyle Kingsley, M.D. “For the past several quarters we’ve been focused on positioning our vertically-integrated portfolio of assets to produce sustained and profitable growth, and we believe today’s results are an encouraging indicator that we’re nearing a critical inflection point in cash flow generation from operations.”

Dr. Kingsley continued, “Thanks to the hard work of our teams improving costs and manufacturing efficiencies, Vireo is positioned to improve margins as we continue growing our Green Goods™ retail dispensary footprint and benefit from likely tailwinds of regulatory changes. Each of our current development projects remain on time and budget, and with seven new dispensaries expected to open before the end of Q1 2021 and the potential for a majority of our state-based markets to pass adult-use legislation within the next year, we believe Vireo is poised for strong improvements in revenue growth and profitability.”

Summary of Key Financial Metrics

Three Months Ended

Nine Months Ended

September 30,

September 30,

US $ in millions

2020

2019

Variance

2020

2019

Variance

Total Revenue, Including Disc. Ops

$13.4

$8.0

67.6%

$36.8

$21.0

75.6%

Reported Results

Revenue1

$11.9

$7.1

67.4%

$33.3

$19.1

74.5%

Gross Profit (Before Fair Value Adjustments)

$5.1

$1.8

190.5%

$11.9

$7.5

57.8%

Gross Profit Margin (Before Fair Value Adjustments)

42.7%

24.6%

1,809 bps

35.7%

39.5%

-380 bps

Adjusted Operating Expenses2(non-IFRS)

$6.1

$7.5

-19.2%

$18.2

$15.4

17.9%

Adjusted Operating Expenses (% of Sales) (non-IFRS)

50.8%

105.1%

-5,436 bps

54.7%

81.0%

-2,627 bps

SG&A Expenses

$2.2

$4.1

-46.5%

$6.8

$7.8

-13.0%

SG&A (% of sales)

18.2%

56.9%

-3,869 bps

20.3%

40.8%

-2,044 bps

Adjusted EBITDA (non-IFRS)

($0.7)

($5.2)

-87.1%

($5.6)

($6.6)

-14.4%

Adjusted EBITDA Margin (non-IFRS)

-5.7%

-73.5%

6,788 bps

-16.9%

-34.4%

1,755 bps

1 Reported revenue figures exclude contributions from Vireo’s former Pennsylvania cultivation and processing operations

2 Excludes depreciation and share-based compensation expenses

 

Third Quarter 2020 Financial Highlights

The Company generated revenue in seven states during the third quarter: Arizona, Maryland, Minnesota, New Mexico, New York, Ohio, and Pennsylvania. Total revenue, including contributions from discontinued operations, increased 68 percent year-over-year to $13.4 million. Reported revenue, excluding discontinued operations, was $11.9 million or an increase of 67 percent as compared to Q3 2019.

Retail revenue was approximately $9.9 million in Q3 2020, an increase of 61 percent compared to $6.2 million in Q3 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 retail dispensaries in Pennsylvania. Wholesale revenue of $2.0 million increased by $1.1 million as compared to $980,921 in Q3 2019, with the increase primarily driven by the growth of wholesale operations in Maryland.

Gross profit before biological asset adjustments was $5.1 million, or 43 percent of revenue, as compared to gross profit of $1.8 million or 25 percent of revenue in the same period last year. The improvement in gross profit compared to the prior year was the result of operational efficiency gains in several markets, improved operating leverage through higher sales volumes and production facility upgrades completed last year.

Total operating expenses in the third quarter were $6.9 million, an improvement of $1.3 million or 16 percent as compared to $8.2 million in the third quarter of 2019. The reduction in operating expenses was attributable to lower professional fees and selling, general and administrative expenses including start-up expenses related to buildout and pre-revenue operations in some markets. Excluding depreciation and share-based compensation, operating expenses in the third quarter of 2020 were $6.1 million, or 51 percent of sales, as compared to $7.5 million or 105 percent of sales in the third quarter of 2019.

Total other income was $10.5 million during Q3 2020, compared to an expense of $825,868 in Q3 2019. The significant variance in other income as compared to the prior year quarter was primarily attributable to a one-time gain on the divestiture of the Company’s former Pennsylvania manufacturing and processing operations (“PAMS”) of $16.4 million. This transaction closed on August 11, 2020.

EBITDA, as described in accompanying disclosures and footnotes, was $8.1 million during Q3 2020, compared to a loss of $15.9 million in Q3 2019. Adjusted EBITDA was a loss of $675,808 in Q3 2020, as compared to a loss of $5.2 million in Q3 2019. Please refer to the Supplemental Information and Reconciliation of Non-IFRS Financial Measures at the end of this press release for additional information.

Net income in Q3 2020 was $122,252, as compared to a net loss of $14.6 million in Q3 2019.  The favorable improvement in net income was primarily driven by the one-time gain of $16.4 million on the divestiture of the Company’s former PAMS subsidiary.

Subsequent Events

On October 1, 2020, Vireo announced that it reached a definitive agreement with Ayr Strategies Inc., to sell all the assets and liabilities of its affiliate, Ohio Medical Solutions, Inc. (“OMS”), for total consideration of $4.85 million, including $1.2 million in cash. This transaction is expected to close early next year.

On November 5, 2020, the Company announced that it entered into a non-binding term sheet with Green Ivy Capital and its affiliates for a proposed senior secured, delayed draw term loan with an aggregate principal amount of up to $46,000,000. Vireo management expects definitive loan documents for the funding of the first tranche to be executed in December 2020.

On November 9, 2020, the Company announced that it secured a purchase option on an additional 96 acres of land adjacent to its existing facilities in Fulton County, NY for a total purchase price of approximately US $1.3 million. This option could enable the Company to significantly expand its cultivation and processing capacity in the state in the event of favorable regulatory changes.

On November 13, 2020, a subsidiary of Jushi Holdings, Inc. notified Vireo of its intent to exercise its purchase option on Vireo’s subsidiary, Pennsylvania Dispensary Solutions (“PDS”) for $5.0 million cash. Vireo believes the closing of this transaction will occur in December 2020.

On November 16, 2020, the Company announced that it had exercised its right to force the redemption of all subordinate voting share purchase warrants issued to participants in the Company’s private placement offering which closed on March 10, 2020. This forced redemption is expected to result in the issuance of 13,651,574 additional subordinate voting shares and cash proceeds of approximately $10.0 million.

On November 23, 2020, the Company filed a preliminary base shelf prospectus with the securities regulators in each province of Canada, except for the Province of Quebec. The preliminary base shelf prospectus has not yet become final for the purpose of the sale of securities. The intention of the base shelf prospectus is to allow the Company to more efficiently access capital when market opportunities permit. The Company wishes to correct that the base shelf prospectus is for an amount of up to C$200 million not C$260 million as disclosed in the Company’s news release dated November 23, 2020.

This news release does not constitute an offer to sell or the solicitation of an offer to buy in the United States and the securities referred to in this news release may not be offered or sold in the United States absent registration under the U.S. Securities Act of 1933 or pursuant to an applicable exemption from the registration requirements under the U.S. Securities Act of 1933 and applicable state securities laws. A copy of the preliminary base shelf prospectus can be found on SEDAR at www.sedar.com.

Leadership Update

Today the Company also announced the promotions of Christian Gonzalez to the role of Chief Operating Officer and Patrick Peters to the role of Executive Vice President of Retail.

As Chief Operating Officer, Mr. Gonzalez will lead the Company’s nationwide manufacturing, retail, and product development teams. Christian joined Vireo in 2018 as General Manager in Pennsylvania and since then has overseen major capacity expansion projects and helped optimized manufacturing efficiencies at Vireo’s cultivation and processing facilities in Minnesota, New York, Maryland, Arizona, and New Mexico. He is an engineer and entrepreneur with over 15 years of manufacturing experience in the medical device, pharmaceutical and aerospace/defense industries.

As Executive Vice President of Retail, Mr. Peters’ responsibilities include the complete oversight of Vireo’s retail, ecommerce, and wholesale sales channels. Mr. Peters joined Vireo in 2019 to lead the Company’s retail growth initiatives which focused on the expansion of Green Goods™ retail store openings and re-brandings nationwide. He has over 20 years of retail marketing experience as an executive leader at brands such as Calvin Klein, Kate Spade, and Juicy Couture.

Planned Transition from IFRS to U.S. GAAP Reporting

The Company is currently in the process of transitioning to becoming a U.S. domestic registrant, and plans to begin presenting its financial statements in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”), rather than International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board. Beginning in 2021, the Company expects to file Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K with the U.S. Securities and Exchange Commission. The Company anticipates incurring one-time expenses and professional fees related to this transition of approximately $0.5 million during the fourth quarter.

Balance Sheet and Liquidity

As of September 30, 2020, the Company had 37,337,138 equity shares issued and outstanding, and 155,376,287 shares outstanding on an as-converted, fully-diluted basis.

As of September 30, 2020, total current assets were $81.3 million, including cash on hand of $16.3 million, which does not include approximately $16.0 million in expected cash proceeds resulting from the redemption of warrants and divestitures of PDS and OMS. Total current liabilities were $20.7 million, with zero debt currently due within 12 months.

Outlook Commentary

Dr. Kingsley concluded, “As we exit fiscal year 2020, we’re focused on successfully completing our capacity expansion projects in Arizona, Maryland, and New Mexico, as well as our planned dispensary openings in Maryland, Minnesota and New Mexico. However, cash inflows from the forced redemption of warrants and exercise of the PDS purchase option materialized sooner than we anticipated, and our improving liquidity position has enabled us to begin evaluating additional investment opportunities. We expect to provide the investment community with an update on development initiatives and their potential impacts to our long-term operating and financial outlook in the spring of next year.”

Conference Call and Webcast Information

Vireo Health management will host a conference call with research analysts on Wednesday, November 25, 2020 at 8:30 a.m. ET (7:30 a.m. CT) to discuss its financial results for its third quarter ended September 30, 2020. Interested parties may register to attend the conference call via the following link:  http://www.directeventreg.com/registration/event/8084816. Upon registration, each participant will be provided with call details and a registrant ID for Vireo’s conference ID number 8084816.

A live audio webcast of this event will also be available in the Events & Presentations section of the Company’s Investor Relations website at https://investors.vireohealth.com/events-and-presentations/default.aspx and will be archived for one year.

About Vireo Health International, Inc.

Vireo Health International, Inc. (“Vireo” or the “Company”) is a physician-led cannabis company focused on bringing the best of technology, science, and engineering to the cannabis industry. Vireo manufactures proprietary, branded cannabis products in environmentally-friendly, state-of-the-art greenhouses and other facilities and distributes its products through its growing network of Green GoodsTM retail dispensaries and through hundreds of third-party dispensaries in seven states. Vireo’s team of more than 425 employees, led by scientists, engineers, and cultivation experts, is focused on efficiency and the creation of best-in-class products, while driving scientific innovation within the cannabis industry and developing meaningful intellectual property. Today, Vireo is licensed to grow and/or process cannabis in seven markets. The Company is operational in six of those markets – including the core markets of Arizona, Maryland, Minnesota, New Mexico, and New York. The Company holds 29 total retail dispensary licenses, of which 11 are currently open for business. For more information about Vireo, please visit www.vireohealth.com.

Additional Information

Additional information relating to the Company’s third quarter 2020 results is available on SEDAR at www.sedar.com. Vireo 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.

Contact Information

Investor Inquiries:
Sam Gibbons
Vice President, Investor Relations
samgibbons@vireohealth.com 
(612) 314-8995

Media Inquiries:
Albe Zakes
Vice President, Corporate Communications
albezakes@vireohealth.com  
(267) 221-4800

Forward-Looking Statement Disclosure

This press 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 press 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; the expectation that such expansion will drive stronger revenue growth, operating margins and free cash flow; the anticipated closing of certain divestitures and the timing thereof; the anticipated benefits of the land purchase option acquired by the Company in New York; the Company’s anticipation that it will enter into definitive loan documents with Green Ivy Capital and receive proceeds from a resultant loan; the expectation that a preliminary base shelf prospectus will become final or that any securities will be sold under a base shelf prospectus; the anticipated share issuance and proceeds related to the Company’s redemption of all subordinate voting share purchase warrants issued to participants in the March 10, 2020, private placement; the transition of the Company’s financial reporting from IFRS to U.S. GAAP; and updates on actual and proposed development initiatives, including estimates of the timing of completion of such initiatives. 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 press release. 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 press 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; risks related to the COVID-19 pandemic; 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 and in the Company’s registration statement on Form 10, filed November 5, 2020 on EDGAR with the U.S. Securities and Exchange Commission.

The statements in this press 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 press release is based on audited financial statements for the fiscal year ended December 31, 2019 and unaudited condensed interim consolidated financial statements for the third quarter ended September 30, 2020. All financial information contained in this press release is qualified in its entirety with reference to such financial statements. To the extent that the financial information contained in this press release is inconsistent with the information contained in the Company’s audited financial statements, the financial information contained in this press 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 September 30, 2020 and December 31, 2019

September 30,

December 31,

(Unaudited – Expressed in United States Dollars)

2020

2019

ASSETS

Current Assets

Cash

$                16,281,768

$                  7,641,673

Restricted Cash

1,592,500

1,592,500

Note Receivable

3,750,000

Receivables

619,491

1,025,963

Inventories

38,343,055

32,437,308

Biological Assets

13,513,582

6,134,209

Prepaid Expenses

2,365,580

2,285,548

Deferred acquisition costs

28,136

28,136

Assets Held for Sale

4,787,026

81,281,138

51,145,337

Non-Current Assets

Right of Use Asset

19,369,077

25,921,603

Property and Equipment

15,155,239

13,326,337

Deposits

1,648,423

2,651,366

Deferred Loss on Sale Leaseback

30,481

Goodwill

3,132,491

3,132,491

Intangible Asset

8,562,776

9,001,237

47,868,006

54,063,515

Total Assets

$            129,149,144

$            105,208,852

LIABILITIES AND SHAREHOLDERS’ EQUITY

Current Liabilities

Accounts Payable and Accrued Liabilities

$                7,725,246

$                3,140,086

Current portion of Right of Use Liability

776,541

619,827

Warrant Liability

8,587,565

Liabilities Held for Sale

3,637,026

20,726,378

3,759,913

Long-Term Liabilities

Deferred Income Taxes

12,715,000

4,528,000

Right of Use Liability

22,011,662

28,665,681

Long-Term Debt

1,110,000

1,110,000

Convertible debt

833,408

817,446

57,396,448

38,881,040

Shareholders’ Equity

Share Capital

122,511,602

118,453,142

Reserves

20,207,921

7,962,509

Retained Earnings

(70,966,827)

(60,087,839)

71,752,696

66,327,812

Total Liabilities and Equity

$            129,149,144

$            105,208,852

 

 

VIREO HEALTH INTERNATIONAL, INC. 

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF LOSS AND COMPREHENSIVE LOSS

 Three Month 

 Three Month 

 Period Ended 

 Period Ended 

For the Three Months Ended September 30, 2020 and 2019

September 30,

September 30,

(Unaudited – Expressed in United States Dollars)

2020

2019

REVENUE

$             11,942,640

$                           7,136,222

Production Costs

(6,846,390)

(5,381,906)

Gross Profit Before Fair Value Adjustments

5,096,250

1,754,316

Realized Fair Value Amounts Included in Inventory Sold

(5,879,438)

(844,142)

Unrealized Fair Value Gain on Growth of Biological Assets

2,908,834

(7,839,571)

Gross Profit

2,125,646

(6,929,397)

EXPENSES

Depreciation

355,450

515,486

Professional fees

546,128

1,421,033

Salaries and wages

3,347,061

2,023,027

Selling, general and administrative expenses

2,170,871

4,058,524

Share Based Compensation

524,052

229,916

6,943,562

8,247,986

OTHER INCOME (EXPENSE)

Loss on sale of property and equipment

(4,752)

Gain on disposal of assets

16,437,897

Loss on assets held for sale

(446,544)

Interest expense, net

(1,356,834)

(871,781)

Accretion expense

(19,669)

(72,976)

Gain (Loss) on Derivative Liability

(4,066,335)

Inventory adjustment

(151,328)

346,493

Other income (expense)

138,645

(222,852)

Total Other Income (Expense)

10,535,832

(825,868)

 INCOME (LOSS) BEFORE INCOME TAXES 

5,717,916

(16,003,251)

Current income taxes

(2,674,900)

346,000

Deferred income taxes

(3,390,000)

3,160,000

PROVISION FOR INCOME TAXES

(6,064,900)

3,506,000

LOSS AND COMPREHENSIVE LOSS FROM CONTINUING OPERATIONS

(346,984)

(12,497,251)

LOSS AND COMPREHENSIVE LOSS FROM DISCONTINUED OPERATIONS

469,236

(2,068,255)

TOTAL LOSS AND COMPREHENSIVE LOSS

$                  122,252

$                       (14,565,506)

Weighted Average Shares Outstanding – basic and diluted

98,871,038

24,299,953

Net Loss Per Share – basic and diluted

 – Continuing Operations

(0.00)

(0.51)

 – Discontinued Operations

0.00

(0.09)

 

 

VIREO HEALTH INTERNATIONAL, INC.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS

Nine Months
Ended

Nine Months

Ended

For the Nine Months Ended September 30, 2020 and 2019

September 30,

September 30,

(Unaudited – Expressed in United States Dollars)

2020

2019

Cash Flows from Operating Activities:

Net Loss

$           (10,878,988)

$        (19,884,720)

Items Not Affecting Cash:

Depreciation and Amortization

1,607,649

2,101,142

Loss on Sale of Property and Equipment

35,449

(5,652)

Share Based Compensation

12,245,412

686,868

Gain on disposal of business

(16,437,897)

Loss on assets held for sale

446,544

Loss on derivative liability

5,032,537

Fair Value Adjustment on Sale of Inventory

18,842,382

11,433,782

Fair Value Adjustment on Growth of Biological Assets

(35,022,153)

(11,994,442)

Interest Expense

3,805,740

1,694,898

Deferred Income Taxes

7,952,000

(1,508,000)

Deferred financing and acquisition costs

1,836,750

Listing expense

2,994,606

Amortization of deferred tenant improvements

(175,341)

Deferred gain/loss on sale leaseback

30,481

1,906

Cash flows used in discontinued Operations

2,363,077

1,624,119

Changes in non-cash working capital

3,889,776

(5,174,015)

Cash Flows Used in Operating Activities

(6,087,991)

(16,368,099)

Cash Flows from Investing Activities:

Purchase of Property and Equipment

(4,017,205)

(6,188,681)

Proceeds on sale of Property and Equipment

982,391

Acquisition Costs

(15,937,223)

Divestitures

16,637,489

Deposits

30,943

(15,222)

Cash flows used in discontinued Operations

(188,718)

(240,910)

Cash Flows from ( Used in) Investing Activities

12,462,509

(21,399,645)

Cash Flows from Financing Activities:

Proceeds from private placement, net of issuance costs

7,613,490

47,542,878

Lease payments

(479,504)

(73,972)

Interest Paid

(3,423,454)

(1,398,298)

Cash flows used in discontinued Operations

(1,291,809)

(1,564,266)

Cash Flows from Financing Activities

2,418,723

44,506,342

Net Change in Cash

$               8,793,241

$            6,738,598

Cash, Beginning of the Period

7,641,673

9,624,110

Cash, End of the Period

$             16,434,914

$          16,362,708

 

Reconciliation of Non-IFRS Financial Measures

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 EBITDA

Three Months Ended

September 30,

2020

2019

Net income (loss)

$            122,252

$    (14,565,506)

Interest expense, net

1,356,834

871,781

Accretion expense

19,669

72,976

Income taxes

6,064,900

(3,506,000)

Depreciation

355,450

515,486

Amortization

153,357

727,731

EBITDA (non-IFRS)

$          8,072,462

$    (15,883,532)

Net fair value adjustments

2,970,604

8,683,713

Gain (Loss) on Derivative Liability

4,066,335

Inventory adjustment

151,328

(346,493)

Share-based compensation

524,052

229,916

(Gain)/Loss from discontinued operations

(469,236)

2,068,255

Loss on assets held for sale

446,544

Gain on sale of discontinued operations

(16,437,897)

Adjusted EBITDA (non-IFRS)

$          (675,808)

$     (5,248,141)

Net Loss Per Share – basic and diluted for the nine months ended September 30, 2020 and 2019 was $(0.12) and $(0.00), respectively.

 

 

Reconciliation of Total Operating Expenses to Adjusted Operating Expenses

Three Months Ended

Nine Months Ended

September 30,

September 30,

2020

2019

2020

2019

Total Operating Expenses

$    6,943,562

8,247,986

$  31,663,589

17,193,745

Depreciation

-355,450

-515,486

-1,200,729

-1,057,566

Share-based compensation

-524,052

-229,916

-12,245,412

-686,868

Adjusted Operating Expenses

6,064,060

7,502,584

18,217,448

15,449,311

% of Revenue

50.8%

105.1%

54.7%

90.1%

 

 

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SOURCE Vireo Health International, Inc.

MindMed to Launch Albert, A Digital Medicine Division for Psychedelic Medicines

NEW YORKNov. 24, 2020 /PRNewswire/ — MindMed (NEO: MMED) (OTCQB: MMEDF) (DE: MMQ), a leading psychedelic medicine biotech company, is establishing a digital medicine division known as AlbertAlbert is in the process of assembling and recruiting a leading team of technologists, therapists, and clinical drug development experts to help the company research, develop and build an integrated technical platform and comprehensive toolset aimed at delivering psychedelic inspired medicines and experiential therapies combined with digital therapeutics.

Digital therapeutics are defined as evidence-based therapeutic interventions for patients to prevent, manage, or treat a mental disorder or disease. Pairing digital tools, such as wearables and the latest in machine learning, with psychedelic assisted therapies, can give healthcare providers the ability to optimize and better understand the patient journey and therapeutic outcomes from pre-care through to after-care.

MindMed Co-Founder and Co-CEO J.R. Rahn said, “We believe that the next frontier in psychedelic medicine will be to quantify with great precision psychedelic assisted therapy’s impact on patient populations. This new division will not only build apps, technologies and other platforms to help the patient, but hopefully also make the medical community comfortable with this novel treatment paradigm for mental health and addiction by measuring the potential value to their patient populations and ultimate savings to insurers.”

Recent advancements in digital therapeutics have the potential to enable a real time assessment of efficacy in both clinical trials and real-world settings leading to a more robust understanding of the value of a treatment and long-term impact on patient outcomes.

MindMed’s clinical team under the leadership of President and Head of Clinical Dr. Miri Halperin Wernli is designing an experimental clinical trial that pairs non-hallucinogenic psychedelic inspired medicines such as microdoses of LSD with digital therapeutics to track, engage and influence patient behavior. MindMed intends to announce full details of this clinical trial once MindMed and its scientific collaborators finalize the protocol design for submission to relevant health regulators.

Dr. Miri Halperin Wernli said, “This is a perfect moment for digital medicine solutions to come to patients to help support behavioral change, measure and enhance psychiatric care and health outcomes. Our intention is to use digital therapeutics alongside pharmaceutical medicines to maximize one another’s value to the patient and for the healthcare system. The two classes of medicine, along with psychotherapy and various forms of cognitive behavioral therapies, must be regarded as complementary to enhance outcomes, which will create new opportunities to improve quality of care and patient outcomes and drive behavior change at scale.”

About MindMed

MindMed is a psychedelic medicine biotech company that discovers, develops and deploys psychedelic inspired medicines and therapies to address addiction and mental illness. The company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including Psilocybin, LSD, MDMA, DMT and an Ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to the company’s groundbreaking approach to developing the next-generation of psychedelic inspired medicines and therapies.

MindMed trades on the Canadian exchange NEO under the symbol MMED. MindMed is also traded in the United States under the symbol MMEDF and in Germany under the symbol 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.

Media Contact: mindmed@crosscutstrategies.com

BETTER PLANT LAUNCHES URBAN JUVE LOYALTY PROGRAM WITH LOYALTYLION

Vancouver, B.C. – November 24, 2020: Better Plant Sciences Inc. (CSE: PLNT) (OTCQB: VEGGF) (FSE: YG3) (“Better Plant”) or (the “Company”) is pleased to announce the launch of  a customer rewards program called “Insider Rewards” for its Urban Juve skin care line.

“Insider Rewards will give our customers the opportunity to collect points to earn free products and also provide access to exclusive promotions,” said Gabriel Villablanca, Director of eCommerce for Better Plant. “Our objective is to turn customers into repeat and loyal customers, and ultimate advocates of the brand and our products.”

LoyaltyLion is a loyalty program platform that supports eCommerce growth by unlocking insights that make it possible to amplify marketing efforts while making customers feel valued. LoyaltyLion has a track record of producing higher customer spend and increasing repeat purchase rates.

“Customers who are members are more likely to purchase more items than nonmember customers without an account,” added Villablanca. “So offering a wide range of rewards in exchange for brand engagement, can pay dividends. Brand engagement activities could include signing up for Urban Juve emails, leaving product reviews, and following Urban Juve on social media platforms.”

The loyalty program also offers a mobile-optimized referral tool to help gain new high value customers at a low acquisition cost. The Company plans to offer Insider Rewards across all brands and will leverage the LoyaltyLion platform for the program.

A 2019 KPMG survey reported that 81% of millennial consumers say they spend more with a company when they are a member of a loyalty program, and 78% say they would switch to a company that offered a better program.

 

About Better Plant Sciences Inc.

Better Plant offers plant-based products for optimum health and wellness. It is a vertically integrated company with a team whose complementary experience enables acquisition, development, manufacturing, and direct-to-consumer distribution of our products. Its  all-natural products vary in use from pain treatment to disease prevention to skin care, all without chemicals or harmful ingredients.  It has an extensive catalogue of over 400 proprietary product formulas.  Better Plant currently has over 60 plant-based products for sale through eCommerce or in retail stores under the brands Jusu, Urban Juve, and Wright & Well. Better Plant also owns approximately 52% of NeonMind Biosciences Inc. NeonMind Biosciences Inc. has manufactured a line of coffees infused with medicinal mushrooms including reishi, cordyceps, lion’s mane and turkey tail mushrooms. NeonMind is also engaged in research into developing a psilocybin (psychedelic mushroom) based product to aid in or cause weight loss and treat obesity and related illnesses.

Health Canada has approved NeonMind’s preclinical trial for research into using psilocybin as a treatment to promote and cause weight loss and NeonMind is currently developing protocols for Phase II human trials to be submitted for approval in early 2021.

NeonMind’s product candidates with psychedelic compounds will not be commercialized prior to applicable regulatory approval, which will only be granted if clinical evidence of safety and efficacy for the intended uses is successfully developed. Psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (CDSA) and it is a criminal offence to possess substances under the CDSA without a prescription. Health Canada has not approved psilocybin as a drug.

For more information about Better Plant, visit betterplantsciences.com or follow @betterplantsciences on Instagram.

Go to urbanjuve.com to join the customer rewards program and to buy Urban Juve products.

 

Investor Relations Contact

Penny White, President & CEO

Ali Dumanski, Investor Relations

invest@betterplantsciences.com 

1-833-514-2677

The Canadian Securities Exchange has not reviewed, approved or disapproved the contents of this news release.

 

Cautionary Statement Regarding Forward-Looking Statements

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 COVID-19, 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.

Field Trip Health Ltd. and WHOOP announce partnership to measure effect of psychedelic therapies on physiology and mental health

Collaboration will initially focus on special operations veterans through Field Trip’s Basecamp division, and then expand to general population seeking treatment with psychedelic therapies

TORONTO, Nov. 19, 2020 (GLOBE NEWSWIRE) — Field Trip Health Ltd. (CSE: FTRP, OTCBB: FTRPF) (“Field Trip”), a global leader in the development and delivery of psychedelic therapies, and WHOOP, the human performance company, today announced a partnership whereby Field Trip will be using WHOOP Strap 3.0 to measure the biometric effects of Field Trip’s psychedelic therapies.

Field Trip, which is opening Field Trip Health centers across North America and Europe for the delivery of psychedelic therapies, plans to conduct an observational study to assess whether Field Trip’s ketamine-assisted therapies, which have demonstrated significant efficacy in treating mental health conditions such as depression, anxiety and PTSD, translate into improvements in physical health through a variety of biometric measures collected via WHOOP Strap 3.0 including heart rate variability (HRV), resting heart rate, and overall sleep quality. Field Trip procured WHOOP products and access to additional data insights via a research partnership and enterprise program.

“The clinical results from our first three centers in Toronto, New York and Los Angeles, as determined by validated mental health measures, have been extremely positive. We have noted a significant reduction in depressive symptoms from severe or moderately severe to mild or non-existent, along with reduction in anxiety and trauma related symptoms,” said Dr. Ryan Yermus, Field Trip’s Chief Clinical Officer. “Through this partnership with WHOOP and the observational study we will be conducting, we expect to find that these improvements in mental health correlate strongly to improvements in a person’s biometrics as well.”

The initial focus of the study will be on military veterans who seek ketamine-assisted therapies through Field Trip’s Basecamp program, a treatment program designed specifically for military veterans and people in high-intensity professions such as front line medical workers, police and firefighters. Military veterans experience post-traumatic stress at significantly higher rates than the general population, which may be a result of traumatic brain injury (TBI) and chronic traumatic encephalopathy (CTE) from exposure to blast waves from explosives.

“In their continual search for a persistent, unfair advantage on the battlefield, Special Operations veterans are highly attuned to their physical and mental performance and well-being,” said Adam Wright, Director of Field Trip Basecamp. “Deploying WHOOP as part of their treatment program is consistent with this natural disposition of veterans. We not only expect veterans to be eager to participate in a study that will help future veterans, we also anticipate they will optimize their performance and experience additional health improvements through actionable insights from WHOOP across sleep, recovery, and strain.”

Studies have demonstrated that physiological metrics such as HRV and slow wave sleep patterns are correlated with improved health outcomes. The parties anticipate that the effects of Field Trip’s psychedelic therapies will improve these key metrics and this study is expected to advance the understanding of correlation between mental health and physiology.

Kristen Holmes, Vice President of Performance Science at WHOOP, commented: “Through our initial work with SEAL Future Foundation, we were able to show that psilocybin and ayahuasca therapies had profoundly positive effects on the physiology of veteran SEALs. With this program at Field Trip, which is offering legal treatment with psychedelic therapies across North America and Europe, we hope to be part of the healing of a much larger group of people, and further show that 24/7 health monitoring by WHOOP technology can help people take control of their overall well-being when used in association with new mental and emotional health therapies.”

“At Field Trip, our mission is to bring the world to life through psychedelics and psychedelic-enhanced therapies,” said Ronan Levy, Field Trip’s Executive Chairman. “Through this partnership with WHOOP, we hope to demonstrate that our work not only changes the mental and emotional well-being of people, it also tangible and meaningfully gets expressed through their physical well-being as well.”

About Field Trip Health Ltd.

Field Trip is the global leader in the development and delivery of psychedelic therapies. With our Field Trip Discovery division leading the development of the next generation of psychedelic molecules and conducting advanced research on plant-based psychedelics including psilocybin-producing fungi and our Field Trip Health division building centers for psychedelic therapies across North America and Europe along with the digital and technological tools that will enable massive scale, 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.

Learn more at https://www.meetfieldtrip.comhttps://www.fieldtriphealth.com and https://www.fieldtriphealth.nl.

Follow us on Twitter and Instagram: @fieldtriphealth

To receive company updates about Field Trip and to be added to the email distribution list please sign up here.

For further information, contact Ronan Levy, Executive Chairman and a Director at Field Trip, at 1 (833) 833-1967.

About WHOOP
WHOOP, the human performance company, provides a membership for 24/7 coaching to improve health. The WHOOP membership comes with free hardware (the new Whoop Strap 3.0), a coaching platform designed to optimize your behavior, and a community of high performers. WHOOP members range from professional athletes and Fortune 500 CEOs to fitness enthusiasts, frontline workers, and military personnel. Studies show WHOOP can positively change behavior, increase sleep, and improve physiological biomarkers. Founded in 2012, WHOOP is based in Boston and has raised more than $200 million in venture capital. Visit whoop.com for the latest company news and connect with WHOOP on InstagramTwitterFacebook, and YouTube.

Cautionary Note Regarding Forward-Looking Information
This release includes forward-looking information within the meaning of Canadian securities laws regarding Field Trip and its business, which may include, but are not limited to, statements with respect to the listing of the common shares of Field Trip on the Canadian Securities Exchange, and the timing of such events. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such statements are based on the current expectations and views of future events of the management of Field Trip, an d are based on assumptions and subject to risks and uncertainties. Although the management of Field Trip believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the companies, including risks regarding the COVID-19 epidemic, the medical clinic industry, market conditions, ec onomic factors, management’s ability to manage and to operate the business and the equity markets generally. Although Field Trip has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or inf ormation. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Field Trip does not undertake any obligation to publicly update or r evise any forward-looking statement, whether as a result of new information, future events, or otherwise.

The CSE has neither approved nor disapproved the contents of this news release.

Media contacts:
Paige Tatulli
Autumn Communications
212-206-9780
paiget@autumncommunications.com / fieldtrip@autumncommunications.com

Investor contacts:
Elizabeth Barker
KCSA Strategic Communications
212-896-1203
ebarker@kcsa.com

SOURCE Field Trip Health Ltd.

COMPASS Pathways plc announces financial results for third quarter 2020

Highlights include $146.6 million IPO, continued progress with phase IIb psilocybin therapy clinical trial, strengthened board and leadership team, and launch of Drug Discovery Center


Third quarter and post-period highlights:

  • Completed upsized initial public offering (IPO) on Nasdaq, raising $146.6 million
  • Continued to progress phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression
  • Strengthened board and leadership team with appointments of Linda McGoldrick as non-Executive Director; Greg Ryslik as Senior Vice President, Data Science, Machine Learning and Digital Health Research; and Stephen Schultz as Senior Vice President, Investor Relations
  • Established Drug Discovery Center with the University of the Sciences in Philadelphia, PA

Conference call today at 1.00pm GMT (8.00am ET)

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the third quarter of 2020 and gave an update on recent progress across its business.

George Goldsmith, Chairman, CEO and Co-founder, COMPASS Pathways, said, “This has been a significant quarter, with an IPO that gives us the funds needed to advance our mission and transform mental health care. Recent hires for the company build further important expertise within our strong leadership team, including in data science and digital health, which will be core to the future of mental health care. We remain fully focused on execution of our phase IIb trial investigating our COMP360 psilocybin therapy for treatment-resistant depression and, with scientific partners in our recently established Drug Discovery Center, are also evaluating the potential of early stage compounds to address mental health challenges.”

Corporate highlights

In September 2020, we completed our IPO of 8,625,000 American Depositary Shares (ADSs) representing 8,625,000 ordinary shares at a price of $17.00 per ADS. This included 1,125,000 additional ADSs issued upon the exercise in full by the underwriters of their option to purchase additional ADSs. The total gross proceeds from the offering were $146.6 million. All ADSs sold in the offering were offered by COMPASS. The ADSs began trading on the Nasdaq Global Select Market on 18 September 2020.

Business highlights

We have continued to make steady progress with our phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression. We are opening a new trial site in Berlin, Germany, this month, bringing our trial to 21 sites in 10 countries. While the COVID-19 pandemic has impacted our trial, our plan to report data from this trial in late 2021 remains unchanged. We are working closely with our trial sites to carefully assess the ongoing COVID-19 situation and will always put the safety of patients and our teams above everything else.

Our team has continued to expand and we have been pleased to welcome several new colleagues to our leadership team during the quarter and post-period. Linda McGoldrick joined our board of directors in September 2020, bringing healthcare and life sciences experience from a range of public and private companies, and non-profit organisations, including Financial Health Associates International, Zillion Inc, Veos plc, and Kaiser Permanente International. In 2018, Linda was appointed by the Governor of Massachusetts to serve on the state’s Health Information Technology Commission. Greg Ryslik PhD joined us on 9 November 2020 as Senior Vice President, Data Science, Machine Learning and Digital Health Research, and Stephen Schultz will join us on 1 December 2020 as Senior Vice President, Investor Relations. Greg is a data scientist and AI (artificial intelligence) executive; he is an instructor at Stanford Continuing Studies and has held senior positions at Mindstrong and at Tesla Inc. Stephen has more than 30 years’ experience in investor relations and joins us from GW Pharmaceuticals; he has previously held senior roles at Amarin Corporation, Acusphere, and Shareholder.com. Earlier in the quarter, Steve Levine MD joined us as Vice President, Patient Access; Steve was formerly Founder and CEO at Actify Neurotherapies. Sarah Bateup was appointed Head of Therapy Research and Training, having previously been Chief Clinical Officer at Ieso Digital Health.

On 5 August 2020, we entered into a sponsored research agreement with the University of the Sciences in Philadelphia, PA, to establish a Drug Discovery Center. The Center is exploring and developing optimised psychedelic and other early stage compounds targeting the 5HT2A receptor, a receptor in the brain that is recognised as a promising target in the treatment of mental health illnesses.

In July 2020, we were granted our second UK patent, adding to our US patent and German utility model, and including claims covering crystalline psilocybin, pharmaceutical formulations, medical uses, and a method of manufacturing. Our US patent, granted in December 2019, was the subject of a petition for post grant review, filed on 21 February 2020; the petition was dismissed on the merits on 20 August 2020.

We continue to work with a number of academic and other partners to accelerate research or to provide our COMP360 psilocybin for use in their independent studies. We are providing funding and support to the Aquilino Cancer Center at Adventist HealthCare Shady Grove Medical Center, in Rockville, MD, which recently launched the first clinical trial of psilocybin therapy with simultaneous administration and one-on-one patient support to treat depression in cancer patients.

Earlier this month, we joined the Psychiatry Consortium, an international collaboration of medical research charities and pharmaceutical companies focused on the challenge of identifying and validating novel drug targets to address the unmet therapeutic needs of people living with mental health conditions. We will work alongside Psychiatry Consortium members and academic partners to advance research projects, providing support through access to funding, expertise, and commercialisation know-how. The Psychiatry Consortium seeks project proposals from the global psychiatric research community via biannual open calls for applications – the next call for applications will open in January 2021.

Financial highlights

Cash position: We held cash and cash equivalents of $196.5 million as of 30 September 2020, compared with $67.6 million at 30 June 2020. This is expected to fund operations into 2023.

Research & development expenses: R&D expenses were $6.9 million for the three months ended 30 September 2020, compared with $3.1 million during the same period in 2019. The change was primarily related to increased activities associated with our ongoing development of COMP360, increased share-based compensation, and other increases in personnel costs to support the development of COMP360.

R&D expenses were $18.8 million for the nine months ended 30 September 2020, compared with $8.0 million during the same period in 2019. The change was primarily related to increased activities associated with our ongoing development of COMP360, increased share-based compensation, and other increases in personnel costs to support the development of COMP360.

General and administrative expenses: G&A expenses were $6.6 million for the three months ended 30 September 2020, compared with $3.1 million during the same period in 2019. $2.1 million of the increase was related to share-based compensation expenses, and there were also increases in legal and professional fees, personnel and consulting expenses, and facilities costs.

G&A expenses were $21.1 million for the nine months ended 30 September 2020, compared with $5.9 million during the same period in 2019. $9.7 million of the increase was related to share-based compensation expenses, and there were also increases in legal and professional fees, personnel and consulting expenses, and facilities costs.

Other income (expense), net: Other income (expense), net was a net expense of $3.1 million for the three months ended 30 September 2020, compared with a net income of $0.6 million during the same period in 2019. $4.3 million of the increase in net expense related to foreign exchange losses.

Other income (expense), net was a net expense of $1.5 million for the nine months ended 30 September 2020, compared with a net income of $1.9 million during the same period in 2019. $3.3 million of the increase in net expense related to foreign exchange losses.

Net loss: The net loss for the three months ended 30 September 2020 was $16.7 million, or $1.30 loss per share, (after including non-cash share-based compensation expense of $5.2 million), compared with $5.7 million, or $0.73 loss per share, during the same period in 2019 (after including non-cash share-based compensation expense of $1.8 million).

The net loss for the nine months ended 30 September 2020 was $41.5 million, or $3.90 loss per share, (after including non-cash share-based compensation expense of $16.6 million), compared with $12.0 million, or $1.68 loss per share, during the same period in 2019, (after including non-cash share-based compensation expense of $2.5 million).

Conference call

The COMPASS Pathways management team will host a conference call at 1.00pm GMT (8.00am ET) on 12 November 2020. The call can be accessed by dialling (833) 665-0659 from the United States, +1 (914) 987-7313 internationally, and 0800 028 8438 from the UK, followed by the conference ID: 9377988.

The call will also be webcast live on the investors section of the COMPASS Pathways website (ir.compasspathways.com). The webcast will be archived for 30 days.

 

About COMPASS Pathways

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we are currently conducting a phase IIb clinical trial of psilocybin therapy for TRD, in 21 sites across Europe and North America. We are headquartered in London, UK, with offices in New York, USA. Our vision is a world of mental wellbeing. www.compasspathways.com

 

Availability of other information about COMPASS Pathways

Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (Linkedin), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

 

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond COMPASS’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

These risks, uncertainties, and other factors include, among others: preclinical and clinical development is lengthy and uncertain, and therefore our preclinical studies and clinical trials may be delayed or terminated, or may never advance to or in the clinic; and those risks and uncertainties described under the heading “Risk Factors” in COMPASS’s Prospectus filed with the US Securities and Exchange Commission (SEC) on 21 September 2020 and in subsequent filings made by COMPASS with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, COMPASS disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on COMPASS’s current expectations and speak only as of the date hereof.

 

Enquiries

COMPASS Pathways
Tracy Cheung, tracy@compasspathways.com, +44 7966 309024
Amy Lawrence, amy@compasspathways.com, +44 7813 777919

Westwicke (for investor enquiries)
Stephanie Carrington, stephanie.carrington@westwicke.com, +1 646 277 1282

NEONMIND OBTAINS HEALTH CANADA APPROVAL TO ADVANCE PSILOCYBIN RESEARCH

Vancouver, B.C. – November 12, 2020: Better Plant Sciences Inc. (CSE: PLNT) (OTCQB: VEGGF) (FSE: YG3) (“Better Plant”) is pleased to announce that its majority owned subsidiary NeonMind Biosciences Inc. (“NeonMind”) has obtained Health Canada approval to advance its preclinical trial on psilocybin-based research (the “Trial”).

The Trial is intended to determine the capacity of psilocybin to dose-dependently cause weight loss and prevent weight gain, measuring glucose metabolism, weight loss and effect on food cravings.

NeonMind has engaged the University of British Columbia (the “University”) to conduct the Trial. The services are provided by the University under the supervision of Dr. Alasdair Barr, Department of Anesthesiology, Pharmacology & Therapeutics, Faculty of Medicine, who is authorized by Health Canada to act as the Principal Investigator for the Trial (the “Principal Investigator”).

Dr. Barr is a tenured faculty member at the University and has extensive experience working with controlled substances as part of his research. His doctoral and post-doctoral research involved a significant body of work using controlled substances.

Before psilocybin, a restricted substance, can be used for a scientific purpose in Canada, the Canadian Minister of Health must grant authority or an exemption pursuant to Subsection 56 of the Controlled Drugs and Substances Act, S.C. 1996, c. 19.

On July 27, 2020, an application regarding the NeonMind Trial was submitted to Health Canada and on October 7, 2020, pursuant to section J.01.059 of Part J of the Food and Drug Regulations (FDR), Health Canada granted authorization to the Principal Investigator to carry out the Trial using psilocybin at UBC.

 

About NeonMind Biosciences Inc.

The NeonMind team marries ancient Ayurvedic wisdom with modern science, delivering high quality formulations that put health and wellness at the forefront for each of its unique coffee blends. In addition to its medicinal mushroom products, NeonMind is developing patent pending intellectual property for therapeutic uses of psilocybin, the psychedelic substance in magic mushrooms. Health Canada has approved NeonMind’s preclinical trial for research into using  psilocybin as a treatment for weight loss and NeonMind is currently developing protocols for Phase II human trials to be submitted for approval in early 2021.

NeonMind’s product candidates with psychedelic compounds will not be commercialized prior to applicable regulatory approval, which will only be granted if clinical evidence of safety and efficacy for the intended uses is successfully developed. Psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (CDSA) and it is a criminal offence to possess substances under the CDSA without a prescription. Health Canada has not approved psilocybin as a drug.

 

About Better Plant Sciences Inc.

Better Plant Sciences Inc. offers a collection of high-efficacy, plant-based products for optimum health and wellness.  We are a vertically-integrated company with a team whose complementary experience enables acquisition, development, manufacturing, and direct-to-consumer distribution of our products.  We are committed to staying at the forefront of plant-science research and development, and are constantly engaged in research to further expand our portfolio of proprietary formulations and pending patents. Our all natural products vary in use from pain treatment to disease prevention to health optimization, all without chemicals or harmful ingredients.  We have an extensive catalogue of over 400 proprietary product formulas.  We currently have over 80 plant-based products for body, baby, and home for sale through e-commerce or in retail stores under the brands JUSU, Urban Juve, and Wright & Well. Better Plant owns approximately 52% of NeonMind’s issued and outstanding shares.

For more information about Better Plant, visit www.betterplantsciences.com or follow @betterplantsciences on Instagram.

 

Investor Relations Contact:

Penny White, President & CEO

Ali Dumanski, Investor Relations

invest@betterplantsciences.com

1-833-514-2677

The Canadian Securities Exchange has not reviewed, approved or disapproved the contents of this news release.

 

Cautionary Statement Regarding Forward-Looking Statements

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 COVID-19, 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 Better Plant’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 Plant cautions readers not to place undue reliance on forward-looking statements provided by Better Plant, 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 Plant 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.