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Pure Extracts Provides Q3 Corporate Update

Pure Extracts Provides Q3 Corporate Update

Vancouver, B.C. (July 7, 2022) – Pure Extracts Technologies Corp. (CSE: PULL) (OTC: PRXTF) (XFRA: A2QJAJ) (“Pure Extracts” or the “Company”), a plant-based extraction company focused on cannabis, hemp and the rapidly emerging psychedelic sector, is pleased to provide a brief summary of recent activities.

The Summer season has arrived, and with it a pickup in cannabis sales activity across Canada. Fortunately, despite the continuing oversupply of dry flower in the marketplace, the extraction sector is now experiencing increasing demand and continues to present new and innovative products to consumers as they expand their appetites beyond dry flower.

In fact, we have received purchase orders (POs) from 6 provinces within the last 2 months, including our largest PO received to-date for a mid-six figure amount. Since our last update, our continued expansion across Canada positions the Company to report on several positive activities we can offer our growing base of partners, stakeholders and shareholders alike.

Ontario Market Penetration

In Ontario, Canada’s most populous province, we have expanded our SKU count to 8 products encompassing both THC and CBD vapes as well as THC edibles and ultra-high potency CBD edibles.

Medical Cannabis by Shoppers Drug Mart

We recently signed a listing agreement with Shoppers Drug Mart for medical cannabis products and received our first PO. Largest provider of medical cannabis in Canada covering all provinces and two territories, Shoppers Drug Mart represents an opportunity for Pure Extracts to increase its brand awareness nationwide and to expand its product offerings a with a leading health and wellness provider in the country.

Pivot Financial Credit Facility

We recently entered into a one year credit agreement with Pivot Financial I Limited Partnership for a non-revolving term loan in the aggregate amount of $1,225,000 (the “Credit Facility”). In connection with the Credit Facility, Pure Extracts has entered into a general security agreement in favour of Pivot on terms and conditions customary in such transactions. The Credit Facility shall be used by Pure Extracts for: (i) re-financing 2 equipment leases, (ii) the purchase of biomass for extraction, (iii) building finished product inventory, and (iv) general working capital purposes.

Market Awareness and Product Distribution

Pure Extracts’ products are now listed for sale at licensed outlets throughout British Columbia (BC), Alberta (AB), Saskatchewan (SK), Ontario (ON), New Brunswick (NB) and Nova Scotia.

The product mix encompasses 38 SKUs currently available in respective provincial recreational cannabis market, and further offers 16 SKUs specifically targeting the medical cannabis supply chain, representing over 54 listings nation-wide.

The product lineup has been increased to include 2 important additions: a Pure Pulls branded one-gram, high-potency (90%), botanical terpene infused, THC distillate vape cart called 9 lb Hammer and a Pure Pulls branded one-gram cured resin called Durga Mata. Demand for our 9 lb Hammer is strong and will be our first SKU that is listed in all 6 provinces that our products are sold in. Cured resin has long been popular in the United States and we expect that it will be met with positive consumer uptake here in Canada.

Pure Extracts’ CBD gummies, offered in their unique blister packaging, continue to report growing market share across the country. Our new large pack format of ultra-high potency CBD gummies offers both 600 mg and 1,000 mg quantities. Medical sales continue to expand through the Abba Medix sales platform, notably in the THC vape and CBD gummie product lineup.

Our in-house services continue to see demand from other licensed producers. The two most active services include our white label and tolling business development for industrial-scale customers. We are pleased to have signed one new white label program for the production of vape cartridges with an initial PO for 10,000 units.

New Product Development

Pure Extracts’ development team sourced a new vape cart manufacturer that provides both cost effective pricing and higher quality than our previous supplier and we are in the midst of switching over to the new carts. The manufacturer has a robust supply chain, meets the highest global manufacturing standards and carries inventory in Canada, thus providing reliable and timely shipping to our Pemberton facility. They also offer bespoke testing at their Canadian lab for new product development and optimization of vape cart configuration.

Our development team is working on a new infused-product and is expected to be executing an unveiling and product launch aimed at new product SKU’s targeting the Canadian marketplace within the next quarter. Until then, we are keeping details to a minimum as we hope to earn marketing leverage of a very underserved product mix that we believe will position well with our brand identity and distribution ability.

We also have 2 new SKUs in development to compliment our recently launched high potency vape carts and cured resin products. This will provide additional flavour profiles for consumers to choose from.

Sales & Marketing

Enhanced social media & sales support strategy:

  • Our dedicated Pure Extracts social strategy (Pure Pulls and Pure Chews) now includes daily posting of a curated feed promoting organic engagement across Instagram, Twitter, Facebook and LinkedIn.
  • A full complement of sales material has been developed to support sales activities in the field.
  • Product knowledge training is actively underway for field sales reps and budtenders (both on-site and virtually).
  • Acquiring timely data directly from dispensaries in order to strengthen our direct dialogue and manage production in-line with demand.

Near Term Summary

We completed our first product delivery to Nova Scotia at the end of June and we will make our first product delivery to Medical Cannabis by Shoppers Drug Mart this month. Our popular new, high potency distillate vape product, 9 Pound Hammer, also launches across select markets / provinces this month. Next month we will commence deliveries for our expanded listings in Ontario with 6 SKUs currently available throughout the province plus 2 more SKUs coming in October. We continue to develop additional medical SKUs for our two medical cannabis channel partners, Medical Cannabis by Shoppers Drug Mart and Abba Medix, with product availability planned for later this year.

In Conclusion

With the closing of our financing with Pivot Financial, the signing of the listing agreement with Medical Cannabis by Shoppers Drug Mart and the expansion of our product line in Ontario, we have generated positive momentum for the key summer months. We remain focused on growth, innovation, and value generation.

With regards to expansion, we have decided not to proceed with Michigan as a result of declining extract prices in the state and a significant rise in estimated build-out costs and now it appears that other states offer more compelling opportunities which we are continuing to evaluate.

We invite everyone to stay engaged with us, either through social media or by signing up on our website for regular news alerts, because we will have much more to talk about in the months ahead.

ON BEHALF OF THE BOARD

“Ben Nikolaevsky”
Ben Nikolaevsky
CEO and Director

About Pure Extracts (CSE: PULL) (OTC: PRXTF) (XFRA: A2QJAJ)

Pure Extracts Technology Corp. features an all-new, state-of-the-art processing facility located just 20 minutes north of world-famous Whistler, British Columbia. The bespoke facility has been constructed to European Union GMP standards aiming towards export sales of products and formulations, including those currently restricted in Canada, into European jurisdictions where they are legally available. Pure Extracts was granted its Standard Processing License by Health Canada under the Cannabis Act on September 25, 2020, and its Sales Amendment on July 19, 2021. The Company’s stock began trading on the Canadian Securities Exchange (CSE) on November 5, 2020.

Find out more at https://pureextractscorp.com/

Or contact:
Pure Extracts Investor Relations
Tel: +1 604 493 2052
info@pureextractscorp.com    

This news release contains forward-looking statements relating to the future operations of Pure Extracts,

and the other statements are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release, including, without limitation, statements regarding the future plans and objectives of Pure Extracts’, are forward-looking statements and involve risks and uncertainties. A number of factors could cause actual events, performance or results to differ materially from what is projected in forward looking statements. Although we believe that the assumptions underlying these statements are reasonable, they may prove to be incorrect, and we cannot assure that actual results will be consistent with these forward-looking statements. Given these risks, uncertainties and assumptions, investors should not place undue reliance on these forward-looking statements. Whether actual results, performance or achievements will conform to the Company’s expectations and predictions is subject to a number of known and unknown risks, uncertainties, assumptions and other factors, including those listed under “Risk Factors” in the Company’s Annual Information Form. The Company does not undertake to update any forward-looking information, except as, and to the extent required by, applicable securities laws.

This news release contains information about potential sales revenue from supply agreements, which may be considered as disclosure of financial outlook under applicable securities laws. Such information is subject to the same assumptions, risk factors, limitations, and qualifications as set forth in the above paragraph. Specifically, estimated sales revenue which may be derived from supply contracts has been calculated based on current wholesale prices and assume, among other things, that the Company will be able to find buyers for its products. The financial outlook contained in this news release was made by management as of the date of this news release and was provided for the purpose of providing readers with an understanding of the potential revenue which may be derived from any agreements recently entered into by the Company, and are not an estimate of profitability or any other measure of financial performance. Readers are cautioned that the financial outlook contained in this document should not be used for purposes other than for which it is disclosed herein.

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

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Wellbeing Digital Sciences Provides Commercial and Corporate Updates for KGK Science

Wellbeing Digital Sciences Provides Commercial and Corporate Updates for KGK Science

The Company’s Wholly Owned Contract Research Organization has Recently Signed a Number of New Contracts, Completed Clinical Research Reports and Obtained Regulatory Approvals, Among Other Achievements by its Staff

‍Vancouver, British Columbia, April 19, 2022 / Globe Newswire / – Wellbeing Digital Sciences Inc. (“Wellbeing” or the “Company”) (NEO: MEDI) (OTC: KONEF) (FRA: SQ2), an evidence-based mental healthcare company focused on the development and implementation of innovative clinical solutions, including psychedelic medicine and digital therapeutics, as supported by clinical research is pleased to provide a commercial and corporate update regarding the recent achievements of its wholly owned subsidiary, KGK Science Inc., (“KGK” or the “CRO”). The first quarter of 2022 has delivered significant opportunities for KGK as new contracts have been signed, clinical research reports have been completed, regulatory approvals have been obtained and other honours have been bestowed upon the CRO. 

During the first quarter of 2022, KGK’s research team finalized two clinical study reports – a COVID-19 virtual study and an immune function study. Its regulatory team was able to complete gap analysis for a propriety delivery system in March and obtained regulatory approvals for two clinical trials that include a mood and an immune health clinical trial. The CRO’s regulatory team also conducted claims reviews for two dietary supplement companies and one food company, as well as a label review for a dietary supplement. Regarding new business, KGK signed six contracts over the last month including an Ames study, three claims reviews, two path-to-market and gap analysis engagements, two product licence applications, a consulting project for claims regarding a supplement and a manuscript. 

Dr. Mal Evans, Chief Scientific Officer of KGK, will be serving as a judge for the 2022 Nutraingredients Awards (the “Awards”), which will be her second year as a judge for these prestigious awards. The Awards honour the best and brightest ingredients, products, companies, people and initiatives in the nutrition and dietary supplements industry. This is the eighth year that the Awards will be held, with the winners being announced during a presentation ceremony on May 4, 2022. More information on the 2022 Nutraingredient Awards can be found on its website: https://nutraingredients-awards.com/live/en/page/home

Andrew Charrette, Director of Regulatory Affairs and Psychedelic Advisor at KGK, has been invited to be a panellist at Lift&Co. Expo (the “Expo”) in Toronto, Canada. He will guide a session on New Psychedelics Data: The Latest Industry Analysis for Canadian Psychedelics. The Expo will take place from May 12- 15, 2022 at the Metro Toronto Convention Centre in Toronto, Canada. The Expo is known for being the number one cannabis conference and trade show in Canada.More information on the Lift&Co. Expo can be found on its Twitter page: https://twitter.com/liftandco

KGK has also been invited to present virtually at Nutrition 2022 Live Online (“Nutrition 2022”), the American Society for Nutrition’s annual flagship meeting, on June 14 – 16, 2022. Nutrition 2022 is an event that addresses scientific and clinical topics while offering scientific presentations, live Q&A, small group discussions and networking opportunities The meeting will allow KGK the opportunity to showcase its successful findings of a clinical trial that examined the use of natural health products to support immunity during flu season. KGK submitted an abstract that it authored, for “A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial Investigating Two Dietary Supplements on Supporting Immune Function in Healthy Adults in a Flu Vaccine Model”. More information about Nutrition 2022 can be found on its website: https://nutrition.org/nutrition-2022-live-online/

Management Commentary

“The team at KGK has been busy to start 2022 and I would like to commend them on their successes this year to date. I am grateful for all the hard work that has been expended by my colleagues and staff in order to have the privilege of providing this strong update. Also, I am proud of Dr. Mal Evans and Mr. Andrew Charrette for being asked to represent KGK at the 2022 Nutraingredients Awards and the Lift&Co. Expo, respectively,” said Najla Guthrie, CEO of Wellbeing. “KGK, as a core component of Wellbeing and its comprehensive strategy to re-conceptualize mental health care service offerings to patients, continues to strengthen as a business. We are confident in our plan to foster innovation in mental health services through contract research support, innovative solutions and digital therapeutics backed by scientific evidence, for Wellbeing’s expanding North American footprint and clinical expert network,” added Ms. Guthrie.

ABOUT KGK SCIENCE

Founded in 1997, KGK is a leading North American contract research organization based in London, Ontario that primarily provides high-quality clinical research trials with a focus on nutraceutical and emerging health care products. The business has successfully helped hundreds of companies with custom-designed clinical trials and claim substantiation strategies to move products into global markets. KGK’s other existing service lines include expert regulatory support and compliance solutions, participant recruitment, research support services and consulting services. On an approximate basis, the business to date has produced 150 publications, executed over 400 clinical trials across more than 40 indications, amassed 25,000 participants in its database and collected 10 million data points.

‍

ABOUT WELLBEING DIGITAL SCIENCES

Wellbeing Digital Sciences Inc. is an evidence-based mental healthcare company focused on the development and implementation of innovative clinical solutions, including psychedelic medicine and digital therapeutics, as supported by clinical research. Its mission is supported by a network of North American clinics that provide forward-thinking therapies and other types of treatment to patients as well as through a contract research organization that offers clinical trials services to clients pursuing drug development. In essence, the Company exists to make breakthrough treatments more accessible and to offer patients transformational experiences.

On behalf of:

WELLBEING DIGITAL SCIENCES INC.

“Najla Guthrie“

Najla Guthrie, CEO

For further information, please contact:

Nick Kuzyk, Investor Relations

Tel: 1-844-746-6351

Email: ir@wellbeingdigital.co 

Web: www.wellbeingdigital.co

Twitter: @Wellbeing_IR

Notice Regarding Forward-Looking Information:

This news release contains forward-looking statements including but not limited to statements regarding the Company’s business, assets or investments, as well other statements that are not historical facts. Readers are cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties, both general and specific, that contribute to the possibility that the predictions, forecasts, projections and other forward-looking statements will not occur, which may cause actual performance and results in future periods to differ materially from any estimates or projections of future performance or results expressed or implied by such forward-looking statements. These assumptions, risks and uncertainties include, among other things, the state of the economy in general and capital markets in particular, investor interest in the business and prospects of the Company.

The forward-looking statements contained in this news release are made as of the date of this news release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities law. Additionally, the Company undertakes no obligation to comment on the expectations of, or statements made, by third parties in respect of the matters discussed above.

Endnotes

  1. “The 2022 Nutraingredients Awards”, NUTRAingredients, 2022, https://nutraingredients-awards.com/live/en/page/home
  2. “Lift & Co. Expo 2022 Toronto”, CBS trade shows global, 2022,  https://www.cantonfair.net/event/11780-lift-co-expo
  3. “Non-Stop Learning and Engagement”, American Society for Nutrition, 2022, https://nutrition.org/nutrition-2022-live-online/
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Psilocybin works twice as well as nicotine patches!

Mydecine Secures Financing and Provides Company Update on Clinical Trials, Drug Development and Technology Initiatives

Dr. Matthew Johnson’s research found that 59% of nicotine-addicted patients remained abstinent from smoking for 12 months after receiving a single macrodose of psilocybin. Only 28% of patients on a nicotine patch remained abstinent for the same time period.

His other research shows that multiple psilocybin doses can have an 80% success rate!

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Field Trip Health Ltd. Reports Second Fiscal Quarter 2022 Financial Results and Provides Business Update

Field Trip Health Ltd. Reports Second Fiscal Quarter 2022 Financial Results and Provides Business Update

  • Announced plans to advance FT-104, its novel psychedelic compound, to clinic for Treatment-Resistant Depression and Postpartum Depression as the lead indications.
  • Initiated a new pipeline research program focused on discovering novel psychedelics with a reduced cardiovascular risk profile compared to classic psychedelics (the “FT-200 Group”) and filed a provisional patent in connection to the composition of matter for the first molecule identified in the FT-200 Group.
  • Continued to invest in best-in-class clinical infrastructure, with nine clinics currently in operation and nine locations under construction or about to commence construction.
  • Commenced trading on the NASDAQ Global Select Market (“NASDAQ”) under the ticker symbol “FTRP”.
  • As at September 30, 2021, Field Trip had approximately $88 million in unrestricted cash and cash equivalents and short-term investments.
  • Commenced a strategic review of the current corporate structure to assess options to maximize the value of the drug development and therapy delivery business units.

TORONTO, Nov. 15, 2021 (GLOBE NEWSWIRE) — Field Trip Health Ltd. (TSX: FTRP; FTRP.WT; NASDAQ: FTRP) (“FieldTrip“), a leader in the development and delivery of psychedelic therapies, reported its second fiscal quarter 2022 results for the three months ended September 30, 2021 and provided a business update. All results are reported under International Financial Reporting Standards (“IFRS“) and in Canadian dollars, unless otherwise specified.

Key Highlights and Recent Developments

During the quarter, Field Trip progressed its strategy of building a leading psychedelic therapy company (Field Trip Health) and continued to invest in its drug development pipeline and program expansion (Field Trip Discovery).

Field Trip Discovery

FT-104

During the quarter, it was announced that the lead indications for FT-104, Field Trip’s lead novel psychedelic compound in development (patent pending), will be Treatment Resistant Depression and Postpartum Depression. FT-104 is a novel, synthetic 5HT2A receptor agonist compound. It is currently advancing through preclinical studies with the in vivo portion completed, and final results from safety pharmacology and GLP toxicology are expected in calendar Q4 2021. To date, GLP toxicology, cardiovascular, pulmonary, and neurological safety pharmacology studies, as well as genotoxicity potential, all continue to be encouraging. In addition, final manufacturing of clinical trial material is scheduled for production to enable FT-104 to move into Phase 1 clinical trials in the first half of calendar 2022. The Company has experienced, and may continue to experience, delays in initiating Phase 1 clinical trials due to the ongoing COVID pandemic and delays at its contract manufacturing organization.

FT-200 Group: Introducing Field Trip’s Second Novel Psychedelic Program

The Company also announced the discovery of a novel molecule that, based on in vivo assay details, has the structure of classical psychedelics and has demonstrated improved selectivity for the target serotonin 2A receptor (5HT2A) relative to FT-104 and psilocybin versus off target serotonin, 5HT1A, 5HT2B and 5HT2C receptors. This is meaningful because off-target 5HT2B activity has been associated with increased risk of cardiovascular toxicity. Based on this discovery, the Company is expanding the scope of its development pipeline to focus on a new group of molecules termed the FT-200 Group, (which includes the molecule mentioned above), that have the structure of classical psychedelics, with similar potency at the 5HT2A receptor as FT-104 and psilocybin, but with reduced or the absence of activity at the off-target 5HT2B receptor. The aim of the work is that by reducing or eliminating 5HT2B activity it may allow molecules like those in the FT-200 Group to be administered more frequently, such as more chronic or chronic intermittent administration or ‘microdosing’ strategies.

“The first molecule identified in the FT-200 Group demonstrates significant promise to maintain 5HT2A activity while reducing off-target serotonin receptor activity. We are continuing to conduct preclinical work on this molecule and will explore structural analogs within the FT-200 Group to better refine and optimize this new family of substances, understand their properties better and work towards identifying a lead candidate”, said Joseph del Moral, Field Trip’s Co-founder and CEO.

On October 29, 2021 the Company filed a provisional patent application in the United States to protect the composition, as well as potential formulations and uses of the first molecule in the FT-200 group.

Field Trip Health Centres

Leveraging the growing awareness of Field Trip’s psychedelic-assisted therapy clinics, Field Trip announced on August 31, 2021 the launch of the KAP Co-operative Program (“KAP Co-op”), a program that enables eligible independent psychedelic therapists to provide ketamine-assisted psychotherapy (and, in the future, other legal, psychedelic-assisted therapies) at its Field Trip Health Centres. Field Trip also announced the launch of training programs designed to provide interested psychotherapists or other qualified mental health professionals and clinicians with access to best-in-class training on KAP.

The Company continues to invest in its clinics and during the quarter, entered into lease agreements for locations in Dallas, TX, Miami, FL and Scottsdale, AZ. Subsequent to the quarter end, the Company announced the opening of the Seattle, WA clinic, its sixth in the United States and ninth overall, along with the recent opening of a location in Fredericton, NB, and the imminent opening of a location in Vancouver, BC.

Hannan Fleiman, Field Trip’s Co-Founder and President, said, “We continue to see strong growth in our clinic business and our team is proud of the outcomes we are helping our patients achieve. We have continued to make significant investments in building out the leading platform for the delivery of psychedelic therapies and to position our clinics to be at the absolute forefront of our industry in establishing the critical infrastructure for the current and emerging psychedelic therapies with 9 clinics now in operation and 9 locations under construction or about to commence construction. Importantly, the clinics enable Field Trip to capture significant amounts of patient data on clinical outcomes which we expect to help inform future clinical development and treatment strategies.”

From a brand perspective, Field Trip continues to be a globally recognized company in the industry. During the quarter, the Company was featured in many top-tier print and broadcast media outlets, including Forbes, Vox Media, Insider, People and others, generating nearly 2 billion total potential media impressions. Field Trip’s brand presence and reach continues to generate strong website traffic and patient interest in the KAP treatments offered by the Company.

NASDAQ Listing

On July 29, 2021, Field Trip’s Common Shares commenced trading on the NASDAQ Global Select Market (“NASDAQ”) under the ticker symbol “FTRP”, providing the Company with greater access to capital. The Common Shares continue to trade in Canada on the TSX under its current symbol FTRP. Concurrent with the NASDAQ listing, Field Trip’s Common Shares ceased to be quoted on the OTCQX. The Company previously completed the process to ensure its shares are eligible for electronic clearing and settlement through the Depository Trust Company (DTC). In addition, Ronan Levy and Ellen Lubman joined the Compensation Committee and Mujeeb Jafferi and Dr. Ryan Yermus resigned as directors of the Company. Mr. Jafferi and Dr. Yermus continue to serve as Field Trip’s Chief Operating Officer and Chief Clinical Officer, respectively.

Mr. del Moral, continued, “The milestone of listing on NASDAQ during the quarter was testament to the rapid progress we have made and increased our visibility in the marketplace, improving trading liquidity and ultimately enhancing long term shareholder value as we further strengthen our leadership position in the psychedelic medicine industry.”

Strategic Review of Corporate Structure

The Company has commenced a strategic review designed to ensure that each operating unit is best positioned, optimally resourced, and focused to provide maximum long-term value to all stakeholders.

Mr. Joseph del Moral, said, “With the FT-104 nearing the clinic, the expansion of discovery efforts around our FT-200 Group, and the growing number of opportunities for Field Trip Health Centers we believe it is the correct time to review all strategic options to ensure we continue to maximize the growth potential and value of each business unit.”

The Company has engaged Bloom Burton Securities Inc. as its financial advisor in connection with the strategic review.

Financial Highlights

For the second fiscal quarter ended September 30, 2021, the Company earned patient services revenues of $907,816 from its Toronto, New York, Santa Monica, Chicago, Atlanta, Houston and Amsterdam clinics, an increase of $813,284 or 860% over the comparative quarter ended September 30, 2020 of $94,532 and an increase of $40,416 or 5% over the prior fiscal first quarter. The Amsterdam clinic began generating revenues in September 2021. Second fiscal quarter 2021 patient services revenues were generated from only two clinics, Toronto and New York. The modest quarter over quarter revenue increase was in part due to the COVID-19 Delta variant and seasonality associated with the slower summer months. Revenues in the first part of the third quarter indicate a clear upward trend as a result of recent process optimizations to accelerate patient on-boarding and increase clinic capacity.

Net loss for the second fiscal quarter of $13,019,280 was primarily due to total operating costs of $15,638,596, of which $2,055,890 was related to non-cash share-based compensation and $848,712 was related to non-cash depreciation and amortization. This was partially offset by a foreign exchange gain of $1,856,088. This compares with a net loss of $3,932,444 in the second fiscal quarter of 2021. The increase from the prior year primarily reflects the Company’s focus on growing the business and continued investment in its drug development pipeline and best-in-class clinic infrastructure. As the Company continues to scale, it is optimizing and streamlining the development of its psychedelic-assisted therapies.

Total operating costs in the second fiscal quarter were $15,638,596 and were comprised of the following: general and administration expenses of $8,917,717, research and development expenses of $2,102,787, patient services expenses of $1,917,451, sales and marketing expenses of $1,315,434, depreciation and amortization of $848,712 and occupancy costs of $536,495. This compares with total operating costs of $3,810,177 in the second fiscal quarter of 2021.

The difference in general and administrative expenses in the second fiscal quarter also included $596,055 in non-recurring expenses primarily related to the NASDAQ uplisting, $1,330,847 in recurring public company costs as well as non-cash share-based payments of $1,380,398.

Balance Sheet

As of September 30, 2021 Field Trip had unrestricted cash and cash equivalents, funds held in trust and short-term investments of $87,526,034.

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 months and six months ended September 30, 2021 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.

FIELD TRIP HEALTH LTD

STATEMENTS OF LOSS AND COMPREHENSIVE LOSS

3 months ended 3 months ended 6 months ended 6 months ended
September 30,
2021		 September 30,
2020		 September 30,
2021		 September 30,
2020
$ $ $ $
Revenue
Patient services 907,816 94,532 1,775,216 118,131
907,816 94,532 1,775,216 118,131
Operating Expenses
General and administration 8,917,717 2,092,593 16,260,688 3,366,948
Occupancy costs 536,495 111,877 913,110 175,660
Sales and marketing 1,315,434 281,185 2,379,561 435,940
Research and development 2,102,787 806,536 3,555,901 1,601,898
Depreciation and amortization 848,712 269,578 1,464,195 479,338
Patient services 1,917,451 248,408 3,375,272 321,665
Total Operating Expenses 15,638,596 3,810,177 27,948,727 6,381,449
Other Income (Expenses)
Interest income 111,934 2,589 243,549 4,838
Interest expense (256,522 ) (60,962 ) (403,109 ) (98,195 )
Other income (expense) 1,856,088 (158,426 ) 783,396 (534,673 )
Net Loss (13,019,280 ) (3,932,444 ) (25,549,675 ) (6,891,348 )
Net Loss per Share – Basic and Diluted (0.23 ) (0.16 ) (0.44 ) (0.28 )

 

As at
September 30,
2021
$		 As at
March  31,
2021
$
Cash and cash equivalents 22,388,946 38,469,057
Funds held in trust – 795,516
Restricted cash 619,127 588,041
Short-term investments 65,137,088 72,552,870
Accounts receivable 2,464,223 813,761
Total Assets 119,912,854 126,450,005
Total Non-Current Financial Liabilities 18,102,184 6,426,484

Certain comparative figures have been reclassified where necessary to conform with current period presentation.

Conference Call

The Company will conduct a conference call and webcast to discuss its results the following morning, Tuesday, November 16 at 8:30 am ET. To access the call, please dial 1-877-407-9716 (within the U.S.) or 1-201-493-6779 (outside the U.S.) and provide conference ID 13724604. A live webcast of the conference call can be accessed via the Events and Presentations section of the Field Trip Health Investor Relations website here.

For those unable to attend the live call, a telephonic replay will be available until 11:59 pm ET on Tuesday, November 30, 2021. To access the replay of the call dial 1-844-512-2921 (within the U.S.) or 1-412-317-6671 (outside the U.S.) and provide conference ID 13724604. 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.

About Field Trip Health Ltd.

Field Trip is a 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 and our Field Trip Health division building centres for psychedelic therapies opening across North America and Europe along with the digital and technological tools that will enable massive scale, we help people in need with a simple, evidence-based way to heal and heighten engagement with the world.

Learn more at https://www.meetfieldtrip.com, https://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.

Cautionary Note Regarding Forward-Looking Information  

This release includes forward-looking information (within the meaning of Canadian securities laws and within the meaning of the United States Private Securities Litigation Reform Act of 1995) regarding Field Trip and its business. 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 the timing, completion and potential outcomes of the Strategic Review, the funds available to Field Trip and the use of such funds, the ability of Field Trip to operate its clinics, the construction and commencement of construction of additional clinics, the development, patentability and viability of FT-104 and the FT-200 Group, the ability of Field Trip to complete an investigational new drug application and obtain regulatory approvals, as required, prior to initiating clinical trials for FT-104 and molecules within the FT-200 Group, the ability of Field Trip to meet eligibility requirements for clinical testing and through to more complex clinical trials, the ability of Field Trip to obtain regulatory approvals prior to each clinical trial and the ability of Field Trip to generate patient member growth, interest in the training program, interest in the KAP Co-Op Program, uptake of the KAP Co-Op Program by therapists and patients, the ability of management to sustain and continue optimization of its clinical operations, the timing and results of its research and development programs, approval of phase 1 human trials, if any, the risk that future clinical studies may not proceed as expected or may produce unfavorable results, the opening of additional clinics, 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. Additional information relating to Field Trip, including its Annual Information Form, can be located on the SEDAR website at www.sedar.com and on the EDGAR section of the SEC’s website at www.sec.gov.

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities.

Neither the Toronto Stock Exchange, nor its Regulation Services Provider, have approved the contents of this release or accept responsibility for the adequacy or accuracy of this release.

CONTACTS:

Media contacts:
Rachel Moskowitz
Autumn Communications
202-276-7881
press@fieldtriphealth.com

Nick Opich / McKenna Miller
KCSA Strategic Communications
212-896-1206 / 347-487-6197
press@fieldtriphealth.com

Investor contacts:
Kathleen Heaney / Tim Regan
KCSA Strategic Communications
fieldtripIR@kcsa.com

SOURCE Field Trip Health Ltd.

Posted on

MindMed Announces Financial Results for the Third Quarter 2021 and Business Highlights; Cash Balance of $145.9 USD ($185.4 CAD) to Execute on Diverse Clinical Pipeline

MindMed Announces Financial Results for the Third Quarter 2021 and Business Highlights; Cash Balance of $145.9 USD ($185.4 CAD) to Execute on Diverse Clinical Pipeline

MindMed (Nasdaq: MNMD, NEO: MMED, DE: MMQ), a leading biotech company developing psychedelic-inspired therapies, has announced its quarterly financial results for the quarter ended September 30, 2021.

Third Quarter 2021 Financial Highlights (in USD)

  • Cash Balance. Total assets as of September 30, 2021 were $178.6 million, including $145.9 million in cash, as compared to $85.6 million, including $80.1 million in cash, as of December 31, 2020
  • Net Cash Used in Operating Activities. Net Cash Used in Operating Activities of $10.8 million and $31.9 million for the three and nine months ended September 30, 2021, as compared to $5.8 million and $16.5 million for the three and nine months ended September 30, 2020, respectively
  • Net Loss. Net and comprehensive loss of $24.3 million and $74.6 million for the three and nine months ended September 30, 2021, as compared to $8.6 million and $21.4 million for the three and nine months ended September 30, 2020

Third Quarter 2021 Business Highlights

  • Announced the Appointment of Andreas Krebs and Carol Vallone as Board Directors and the Transition of Bruce Linton
  • Appointed three new members to its Scientific Advisory Board: Dr. Maria Oquendo, Ruth Meltzer Professor and Chairman of Psychiatry at University of Pennsylvania and Psychiatrist-in-Chief at the Hospital of the University of Pennsylvania; Dr. Bob Dworkin, Professor of Anesthesiology and Perioperative Medicine, Neurology, and Psychiatry, and Professor in the Center for Health + Technology, at the University of Rochester School of Medicine and Dentistry; and Dr. Bryan Roth, University of North Carolina Psychiatrist and Pharmacologist
  • MindMed and Liechti Lab Provided Results from the Psilocybin Research and Development (R&D) Collaboration
  • Joined the Clinical Trials Transformation Initiative and Critical Path Institute’s Patient-Reported Outcome Consortium
  • Announced a Strategic Research Collaboration with Sphere Health
  • MindMed and BioXcel Therapeutics Published an International Patent Application Describing a System for Identifying Agitation Episodes
  • Announced Collaboration with Forian to Advance Development of Personalized Psychiatry for Anxiety Disorders

Management Update & Earnings Call

Management will host an earnings call to review the third quarter financials and business developments on Wednesday, November 17th, 2021, at 8:00 am EST. Details are below:

https://mindmed-co.zoom.us/webinar/register/WN_Tp–QUSPS9u17HCQwxlc4Q

Complete financial statements along with related management’s discussion and analysis can be found in the System for Electronic Document Analysis and Retrieval (SEDAR), the electronic filing system for the disclosure documents of issuers across Canada at www.SEDAR.com and on the Electronic Data Gathering, Analysis, and Retrieval system (EDGAR), the electronic filing system for the disclosure of documents of issuers in the United States at www.sec.gov.

About MindMed

MindMed is a clinical-stage 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 MindMed’s approach to developing the next generation of psychedelic inspired medicines and therapies.

MindMed trades on the NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED. MindMed is also traded in Germany under the symbol MMQ. For more information: www.mindmed.co

Forward-Looking Statements

Certain statements in this news release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is 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 “will”, “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe”, “potential” or “continue”, or the negative thereof or similar variations. Forward-looking information in this news release include, but are not limited to, statements regarding the start of MindMed’s Phase 1 clinical trial of dimethyltryptamine (DMT), the business and the therapeutic potential of MindMed’s product candidates, the ability to successfully execute and delivery on the R(-)-MDMA Program, the ability to achieve success with our collaborations with Sphere Health and Forian, the successful outcome of the Phase 1 clinical trial of DMT, the ability to initiate a Phase 2 clinical trial of DMT, regulatory approvals, the effects of DMT, subject enrollment and the administration method of DMT. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, such information involves risks and uncertainties, and undue reliance should not be placed on such information, as unknown or unpredictable factors could have material adverse effects on future results, performance or achievements of the Company. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; lack of product revenue; compliance with laws and regulations; difficulty associated with research and development; risks associated with clinical trials or studies; heightened regulatory scrutiny; early stage product development; clinical trial risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; as well as those risk factors discussed or referred to herein and the risks described under the headings “Risk Factors” in the Company’s filings with the securities regulatory authorities in all provinces and territories of Canada which are available under the Company’s profile on SEDAR at www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking information prove incorrect, actual results and future events could differ materially from those anticipated in such information. Although the Company has attempted to identify important risks, uncertainties and factors that could cause actual results to differ materially, there may be others that cause results not to be as anticipated, estimated or intended. 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 and does not assume any obligation to update this forward-looking information.

Media Contact: mindmed@150bond.com

Posted on

Cybin Inc. Reports its Second Quarter Financial Results and Recent Business Highlights

Cybin Inc. Reports its Second Quarter Financial Results and Recent Business Highlights

– Company to host conference call at 4:30pm EST today –

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing “Psychedelics to TherapeuticsTM”, today reported unaudited financial results for its second quarter ended September 30, 2021.

“The first half of the year has been a transformative period for Cybin that included significant and swift advancements in our research and development pipeline and overall business. Through CYB003, we believe that we have identified a potentially safer treatment option for patients with depression and addiction disorders that we expect to have strong intellectual property protection and a positive pharmacokinetic profile for patients, providers and payers. We plan to move through the ongoing, remaining preclinical studies quickly and submit an investigational new drug application and clinical trial application in the second quarter of 20221, in the U.S. and the U.K., respectively,” said Doug Drysdale, Chief Executive Officer of Cybin.

Drysdale continued, “In addition, we continue to evolve our value-driving, patient-centered approach to potential treatments for mental health and addiction through our commitment to advancing programs such as EMBARK, that aims to facilitate psilocybin-assisted psychotherapy for frontline workers impacted by the COVID-19 pandemic, as well as targeted research using the Kernel Flow neuroimaging technology that we expect will allow us to quantitively understand the psychedelic experience in the brain as it is happening. We believe these programs combined with our proprietary psychedelic new chemical entities have the potential to transform the treatment landscape for various psychiatric and neurological conditions.”

Recent Business and Pipeline Highlights:

  • Announced preclinical data for its novel deuterated psilocybin analog, CYB003, for the potential treatment of major depressive disorder and alcohol use disorder. The data demonstrated that CYB003 may provide significant treatment benefits to address the challenges and limitations of oral psilocybin, including improved safety through less patient variability, reduced clinic times through faster onset of action and shorter duration of effect, and lower dosing through improved brain penetration, which may result in fewer side effects, ultimately offering an improved patient experience. Cybin expects to complete the ongoing preclinical studies of CYB003 in Q1 2022 and submit an investigational new drug application (“IND”) to the U.S. Food and Drug Administration (the “FDA”), and a clinical trial application with the U.K. Medicines and Healthcare Products Regulatory Agency in Q2 20222.
  • Granted a Schedule I manufacturing license from the U.S. Drug Enforcement Agency for the Company’s Boston-area research lab that is expected to allow the Company to expand its internal research and development capabilities.
  • Received approval from the FDA for its IND application to proceed with a Company-sponsored feasibility study using the Kernel Flow quantitative neuroimaging technology to measure ketamine’s psychedelic effect on cerebral cortex hemodynamics.
  • Launched the EMBARK Psychedelic Facilitator Training Program in collaboration with the University of Washington in preparation for the first clinical trial of psilocybin-assisted psychotherapy to address COVID-19 related distress in frontline healthcare professionals.
  • Welcomed Dr. Amir Inamdar as Chief Medical Officer for European Operations; Dr. Geoff Varty as Head of Research and Development; and Leah Gibson as Vice President of Investor Relations.

Second-Quarter Financial Highlights

  • Cash and cash equivalents totaled to C$75.2 million as of September 30, 2021.
  • Net loss was C$17.6 million for the quarter ended September 30, 2021 of which non-cash expenses totaled C$6.0 million and cash-based operating expenses totaled C$11.6 million.

Conference Call and Webcast Details

DATE:

Monday, November 15, 2021

TIME:

4:30 p.m. (EST)

DIAL-IN

1-844-200-6205 (U.S. toll free) or 1-833-950-0062 (Canada toll free)

CODE

727873

WEBCAST

https://events.q4inc.com/attendee/747515026

The live and archived webcast will also be available on the Company’s Investor Relations site under the Events & Presentations page.

Business Update

Cybin has decided not to proceed with its nutraceutical product line in order to focus its efforts on the research and development of its psychedelic molecules. Further, the Company no longer anticipates conducting business activities in Jamaica, as the Company focuses on the new Deuterated Psilocybin Analog Program. The Company intends to complete future clinical trials in the U.S. and the U.K.

About Cybin

Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in the United States, United Kingdom and Ireland. The Company is focused on progressing psychedelics to therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

Cautionary Notes and 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 Company’s development of innovative drug delivery systems, statements regarding the potential benefits of the Company’s novel deuterated psilocybin analog, CYB003, statements regarding the Company’s completion of preclinical studies of CYB003 in Q1 20223 and the submission of a new drug application and clinical trial application in Q2 20224, statements regarding the Company’s EMBARK Psychedelic Facilitator Training Program, statements regarding the anticipated results of using Kernel Flow technology in the Company’s research, and statements regarding the expansions of the Company’s internal research and development capabilities under its Schedule I manufacturing license.

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Company’s operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in each of the Company’s management’s discussion and analysis for the three and six month periods ended September 30, 2021, the Company’s annua l information form for the year ended March 31, 2021, and the Company’s listing statement dated November 9, 2020, which are available under the Company’s profile on www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Although the forward- looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward- looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds or can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations.

Neither the Neo Exchange Inc. nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

_________________

1 Based on a calendar year-end.

2 Based on a calendar year-end.

3 Based on a calendar year-end.

4 Based on a calendar year-end.

 

Investor & Media Contact:
Leah Gibson
Vice President, Investor Relations
Cybin Inc.
leah@cybin.com

Source: Cybin Inc.

Posted on

atai Life Sciences Reports Third Quarter 2021 Financial Results and Corporate Update

atai Life Sciences Reports Third Quarter 2021 Financial Results and Corporate Update

-Positive topline results from COMP360’s Phase 2b study-

-RL-007 Phase 2a topline data in cognitive impairment associated with schizophrenia expected end of Q4-

-Continued progress across 11 therapeutic programs, including initiation of Perception’s Phase 2a and DemeRx’s Phase 1/2 trials as well as interim Phase 2a RL-007 readout of first cohort-

-Launch of atai Impact, a philanthropic program to harness the power of innovative mental health approaches for social change-

-Company to host a webcast and conference call today at 08:30am EST-

BERLIN and NEW YORK, Nov. 15, 2021 (GLOBE NEWSWIRE) — atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today reported its financial results for the third quarter ended September 30, 2021, and provided its corporate update.

“Following our IPO in June, we continue to see positive momentum. We have 11 therapeutic programs underway and each clinical development milestone marks progress towards achieving our vision to heal mental health disorders so that everyone, everywhere can live a more fulfilled life,” said Florian Brand, CEO and Co-Founder.

“In response to the heterogeneity of the mental health patient population, we are developing a pharmacologically diverse array of treatments. We intend to support these treatments with innovative digital therapeutics and robust insights from our multi-modal data approach. Our ultimate goal is to tailor our treatments to individual patient needs by using a diverse set of biomarkers. We anticipate further growth of our drug development pipeline and our enabling technologies through our ‘buy and build’ approach and will remain highly active in business development.

“We recently initiated two new clinical trials: a Phase 2a trial with PCN-101 (R-ketamine) for treatment-resistant depression and a Phase 1/2 trial with DMX-1002 (ibogaine) in opioid use disorder. In terms of clinical readouts, just last week we saw positive Phase 2b data from COMPASS Pathways, the first company we funded to rigorously research the potential of psychedelics. This clinical trial demonstrated the rapid onset of effect, large effect size, and durability of COMP360 (a proprietary synthetic formulation of psilocybin) in treatment-resistant depression. We expect another important clinical readout before the end of the year for RL-007 in cognitive impairment associated with schizophrenia.

“The narrow focus on mental health treatments means that every single trial result offers important insights not only for the program in question but for all our programs, allowing us to accelerate the development of novel treatments for patients in need.”

Program Updates

COMP360 (psilocybin):
Program Details: COMP360 is a proprietary formulation of synthetic psilocybin, a 5-HT2A-R agonist being developed as an oral, potentially rapid-acting antidepressant.

Recent Advancements:

  • In November, COMPASS announced positive topline results from its Phase 2b randomized, controlled, double-blind, dose-controlled trial of COMP360 psilocybin therapy for treatment-resistant depression.
  • The 233-patient study met its primary endpoint, showing a 6.6-point reduction on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to 3 weeks when comparing the 25mg dose to the 1mg dose.
  • COMP360 also showed both rapid response and durability of efficacy. Rapid onset of action with statistically significant treatment differences between the 25mg vs 1mg groups were apparent the day after COMP360 psilocybin administration. Responder rates at week 12 based upon a ≥50% decrease in MADRS total score from baseline were 32.9% and 16.4% for psilocybin doses of 25mg and 1mg respectively. Remitter rates at week 12 based upon a MADRS total score ≤10 were 26.6% and 11.4% for psilocybin doses of 25mg and 1mg respectively.
  • COMP360 was generally well tolerated.

Upcoming Milestones:

  • A pivotal Phase 3 study is anticipated to launch in 2022.

Affiliate: COMPASS Pathways

PCN-101 (R-ketamine):
Program Details: PCN-101 is a parenteral formulation of R-ketamine, a glutamatergic modulator being developed as a potentially rapid-acting antidepressant, with the potential for at-home treatment.

Recent Advancements:

  • In September 2021, Perception Neuroscience initiated the Phase 2 trial of PCN-101 (R-ketamine) for TRD. This randomized, double blind, placebo-controlled trial is designed to assess the efficacy, safety, dose response and duration of action in patients with TRD.

Upcoming Milestones: 

  • Topline data are expected at the end of 2022.

Affiliate: Perception Neuroscience

RL-007:
Program Details: RL-007, a cholinergic, glutamatergic and GABA-B receptor modulator, is an orally available compound that is being developed for the treatment of cognitive impairments associated with schizophrenia (CIAS). The currently active open-label, multi-dose, biomarker-focused Phase 2a trial of RL-007 in patients with CIAS is designed to evaluate the compound’s safety, tolerability and its impact on electroencephalogram-based biomarkers.

Recent Advancements:

  • Following the encouraging results of a recently completed interim analysis of Quantitative Electroencephalogram (qEEG) data from the eight patients in the first cohort, atai advanced a portion of a future milestone payment aiming to accelerate initiation of the subsequent trial, which, broadly, will be a double-blind, placebo controlled, proof-of-concept study focused on more traditional cognitive endpoints, including subsets of the MATRICS battery.

Upcoming Milestones: 

  • Topline data are expected by the end of 2021.

Affiliate: Recognify Life Sciences

GRX-917 (deuterated etifoxine):
Program Details: GRX-917 is an oral formulation of a deuterated version of etifoxine, a mitochondrial translocator protein agonist, designed to provide potentially rapid anxiolytic activity with improved tolerability compared to current treatments for anxiety in the United States.

Recent Advancements:

  • The Phase 1 randomized, double blind, placebo-controlled trial of GRX-917 is designed to evaluate the compound’s safety, tolerability, pharmacokinetics, as well as pharmacodynamics using qEEG. We have recently completed the single ascending dose (SAD) component of the trial, and dosing in the multiple ascending dose (MAD) component is ongoing.

Upcoming Milestones:

  • Topline data are expected in mid-2022.

Affiliate: GABA Therapeutics

DMX-1002 (ibogaine):
Program Details: DMX-1002 is an oral formulation of ibogaine, a cholinergic, glutamatergic and monoaminergic receptor modulator being developed for the treatment of opioid use disorder (OUD).

Recent Advancements:

  • In September 2021, DemeRx IB dosed the first subject in a Phase 1/2a trial of DMX-1002. This trial is designed to assess the safety, tolerability, pharmacokinetics, and efficacy of DMX-1002 and will inform future studies in patients with OUD.

Upcoming Milestones

  • Topline safety data are expected in early 2022.

Affiliate: DemeRx IB

Q3 and Recent Corporate Updates
Discovery Programs

  • Launched PsyProtix, a precision psychiatry company creating new chemical entities targeting mitochondrial dysfunction related to TRD and other mental health conditions. PsyProtix is currently engaged in discovery and preclinical development and expects to launch clinical trials in 2023.
  • Created and pharmacologically tested over 250 novel compounds at EntheogeniX based upon structures generated using computational chemistry approach. Lead candidate selection is currently ongoing.

Formulation Technologies

  • Entered into an expanded agreement with strategic partner IntelGenx, building on positive early feasibility data, to support IntelGenx’s graduation from the TSX Venture Exchange to the Toronto Stock Exchange. As part of the strategic partnership, IntelGenx has exclusively partnered with atai to develop formulations of compounds for the prevention or treatment of mental health disorders.
  • Completed a proof-of-principle study demonstrating that InnarisBio’s sol-gel based excipient technology can effectively transport compounds from the nose directly to the brain in an animal model. InnarisBio is developing its nose-to-brain excipient technology to facilitate potentially rapid, non-invasive entry into the brain for use across various drug candidates in atai’s pipeline, including Revixia, Neuronasal, and DemeRx.

Digital Therapeutics

  • Initiated a user acceptability testing of our digital therapeutics (DTx) app, one of our key enabling technologies, in patients with TRD receiving ketamine treatment.
  • In addition, we have assembled a proof-of-concept, EEG- and VR-based digital therapeutic device to support patients undergoing psychedelic therapy, and we have kicked off user feedback testing to optimize across product parameters.
  • Both technologies are expected to be implemented in Viridia and Revixia Phase 1 trials and DemeRx IB Phase 2 trial starting next year.

New Initiatives

  • Launched atai Impact, atai’s philanthropic program, established to support and collaborate with nonprofits and institutions that share atai Life Sciences’ vision, with the key pillars of: advancing education, expanding access, and supporting the wider ecosystem of mental health care. atai Impact has an initial focus on the psychedelics sector, given its emerging potential in tackling the growing mental health crisis. Its formation is underpinned by atai’s belief that harmonization across commercial and non-profit entities represents the best path forward to harness the power of innovative mental health approaches for positive social change. The atai Impact program will be initially funded by 1% of the gross proceeds from our June 2021 IPO and founders’ and shareholders’ contributions.

Third Quarter 2021 Financial Results

Cash and Cash Equivalents
Cash and cash equivalents totaled $430.3 million as of September 30, 2021, compared to $97.2 million as of December 31, 2020. The nine month increase of $333.1 million is attributed to net proceeds of $231.6 million from atai’s IPO, net proceeds of $166.4 million from Series C and Series D and common stock issuances, $20.0 million of license revenue proceeds, and $10.1 million proceeds from the sale of investments and issuance and conversion of convertible notes. Offsetting were cash payments of $32.6 million for investments in platform companies and other assets, and $62.4 million in net operating expenses and effect of foreign exchange rate changes.

Operating Costs and Expenses
Research and development (R&D) expenses were $13.4 million and $35.0 million for the three and nine months ended September 30, 2021, respectively, as compared to $3.1 million and $8.1 million for the same prior year periods. The increase of $10.3 million and $26.9 million, respectively, were attributable to personnel costs, including stock-based compensation expense, and increased contract research organization expenses related to advancements in atai’s R&D programs.

atai recorded acquisition of in-process R&D expense of $9.0 million for the nine months ended September 30, 2021, relating to its investments in Neuronasal and InnarisBio.

General and administrative expenses for the three and nine months ended September 30, 2021 were $20.3 million and $66.9 million, respectively, as compared to $4.3 million and $8.7 million in the same prior year periods. The increases of $16.0 million and $58.2 million, respectively, were attributable to personnel costs, including stock-based compensation expense, professional fees, and other costs related to support of atai’s platform growth and public company requirements.

Total stock-based compensation expense for the three and nine months ended September 30, 2021 was $12.2 million and $50.0 million, respectively, as compared to $2.1 and $2.2 for the comparable prior year periods, reflecting the recognition of expense related to the achievement of IPO performance-based partial vesting conditions.

Net loss attributable to atai shareholders for the three and nine months ended September 30, 2021 was $31.2 million and $78.9 million, respectively, as compared to $83.2 million and $83.2 million for the comparable prior year periods.

Conference Call Information
atai will host a conference call and live audio webcast today at 08:30am EST to discuss its financial results and provide a corporate update. To access the live conference call, please dial 877-407-3982 from the United States, or +1 (201) 493-6780 internationally, using the conference ID: 13724750. The live and archived webcast of this call will be available in the “Events” section of the atai Life Sciences website at ir.atai.life. An archived copy of the webcast will be available on the atai website for at least 30 days after the conference call.

About atai Life Sciences
atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to acquiring, incubating and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders.

atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders.

atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai is headquartered in Berlin, with offices in New York and London. For more information, please visit www.atai.life.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “anticipate,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, our future operating results and financial position; the success, cost and timing of development of our product candidates, including the progress of preclinical and clinical trials and related milestones; the commercialization of our current product candidates and any other product candidates we may identify and pursue, if approved, including our ability to successfully build a specialty sales force and commercial infrastructure to market our current product candidates and any other product candidates we may identify and pursue; the timing of and our ability to obtain and maintain regulatory approvals; our business strategy and plans; potential acquisitions; and the plans and objectives of management for future operations and capital expenditures. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond our control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including without limitation: we are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception, and we anticipate that we will continue to incur significant losses for the foreseeable future; we will require substantial additional funding to achieve our business goals, and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our product development efforts; our limited operating history may make it difficult to evaluate the success of our business and to assess our future viability; we have never generated revenue and may never be profitable; our product candidates contain controlled substances, the use of which may generate public controversy; clinical and preclinical development is uncertain, and our preclinical programs may experience delays or may never advance to clinical trials; we rely on third parties to assist in conducting our clinical trials and some aspects of our research and preclinical testing, and those clinical trials, including progress and related milestones, may be impacted by several factors including the failure by such third parties to meet deadlines for the completion of such trials, research, or testing, changes to trial sites and other circumstances; we currently rely on qualified therapists working at third-party clinical trial sites to administer certain of our product candidates in our clinical trials and we expect this to continue upon approval, if any, of our current or future product candidates; if third-party sites fail to recruit and retain a sufficient number of therapists or effectively manage their therapists, our business, financial condition and results of operations would be materially harmed; we cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized; research and development of drugs targeting the central nervous system, or CNS, is particularly difficult, and it can be difficult to predict and understand why a drug has a positive effect on some patients but not others; we face significant competition in an environment of rapid technological and scientific change; third parties may claim that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and may prevent or delay our development and commercialization efforts; a change in our effective place of management may increase our aggregate tax burden; we identified material weaknesses in connection with our internal control over financial reporting; and a pandemic, epidemic, or outbreak of an infectious disease, such as the COVID-19 pandemic, may materially and adversely affect our business, including our preclinical studies, clinical trials, third parties on whom we rely, our supply chain, our ability to raise capital, our ability to conduct regular business and our financial results. Other risk factors include the important factors described in the section titled “Risk Factors” in our final prospectus, dated June 17, 2021, filed with the Securities and Exchange Commission (“SEC”) pursuant to Rule 424(b) under the Securities Act, and in our other filings with the SEC, that may cause our actual results, performance or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements.

Any forward-looking statements made herein speak only as of the date of this press release, and you should not rely on forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, performance, or achievements reflected in the forward-looking statements will be achieved or will occur. Except as required by applicable law, we undertake no obligation to update any of these forward-looking statements for any reason after the date of this press release or to conform these statements to actual results or revised expectations.

Contact Information

Media Contact:
Camilla Dormer
VP, Communications, atai Life Sciences
Email: camilla@atai.life

Investor Contact:
Chad Messer
VP, Investor Relations, atai Life Sciences
Email: chad@atai.life

 

ATAI LIFE SCIENCES N.V.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share amounts)
(unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
2021 2020 2021 2020
License revenue $ 266 $ – $ 20,146 $ –
Operating expenses:
Research and development 13,363 3,058 34,974 8,056
Acquisition of in-process research and development – – 8,934 120
General and administrative 20,264 4,328 66,868 8,749
Total operating expenses 33,627 7,386 110,776 16,925
Loss from operations (33,361 ) (7,386 ) (90,630 ) (16,925 )
Other income (expense), net 6,887 (13,942 ) 2,608 6,352
Net loss before income taxes (26,474 ) (21,328 ) (88,022 ) (10,573 )
Provision for income taxes (368 ) (4 ) (432 ) (4 )
Gain on investment dilution – – 16,923 –
Losses from investments in equity method investees, net of tax (4,800 ) (61,862 ) (9,440 ) (73,693 )
Net loss (31,642 ) (83,194 ) (80,971 ) (84,270 )
Net income (loss) attributable to redeemable noncontrolling
interests and noncontrolling interests (484 ) 1 (2,040 ) (1,021 )
Net loss attributable to ATAI Life Sciences N.V. stockholders $ (31,158 ) $ (83,195 ) $ (78,931 ) $ (83,249 )
Net loss per share attributable to ATAI Life Sciences N.V. stockholders– basic and diluted $ (0.21 ) $ (0.92 ) $ (0.59 ) $ (0.92 )
Weighted average common shares outstanding attributable to ATAI Life Sciences N.V.
stockholders — basic and diluted		 151,130,212 90,709,312 134,334,685 90,709,312

 

ATAI LIFE SCIENCES N.V.
CONDENSED CONSOLIDATED BALANCE SHEET
(Amounts in thousands)
September 30, December 31,
2021 2020
(unaudited) (1)
Assets
Cash and cash equivalents $ 430,308 $ 97,246
Prepaid expenses and other current assets 11,551 2,076
Short term notes receivable – related party – 226
Property and equipment, net 138 71
Deferred offering costs – 1,575
Equity method investments 15,086 –
Other investments held at fair value 6,816 –
Other investments 14,256 8,044
Long term notes receivable 908 911
Long term notes receivable – related parties 3,784 1,060
Other assets 1,262 339
Total assets $ 484,109 $ 111,548
Liabilities and Stockholders’ Equity
Accounts payable $ 1,974 $ 3,083
Accrued liabilities 13,075 9,215
Current portion of contingent consideration liability – related parties 50 –
Deferred revenue 180 –
Short-term notes payable 38 –
Non-current portion of contingent consideration liability – related parties 1,947 1,705
Convertible promissory notes – related parties, net of discounts and deferred issuance costs 800 1,199
Convertible promissory notes and derivative liability – 978
Other liabilities 3,285 –
Total stockholders’ equity attributable to ATAI Life Sciences N.V. stockholders 453,186 90,822
Noncontrolling interests 9,574 4,546
Total liabilities and stockholders’ equity $ 484,109 $ 111,548
(1) The condensed consolidated financial statements as of and for the year ended December 31, 2020 are derived from the audited consolidated financial statements as of that date.
Posted on

Silo Pharma Reports Third Quarter Results and Operating Highlights

Silo Pharma Reports Third Quarter Results and Operating Highlights

Englewood Cliffs, NJ, Nov. 11, 2021 (GLOBE NEWSWIRE) — Silo Pharma, Inc. (OTCQB: SILO), a development-stage biopharmaceutical company focused on the use of psychedelics as a therapeutic, today reported its financial results for the third quarter 2021 and gave an update on recent progress in its business.

Operating Highlights

  • Entered sponsored research agreement with Columbia University to develop psychedelic therapeutics for Alzheimer’s Disease and received an option to license assets currently under development
  • UMB awarded notice of allowance from the U.S. Patent and Trademark Office for central nervous system homing peptide patent on Silo’s licensed technology
  • Zylo Therapeutics and Silo Pharma’s joint venture received DEA Approval to advance the Patented Z-Pod technology to deliver ketamine
  • Advancement of sponsored research and option agreement with The University of Maryland, Baltimore for novel joint homing peptide for rheumatoid arthritis
  • Advancing with up-listing plan to the Nasdaq Stock Market
  • Total working capital approximately $11.0 million

Mr. Eric Weisblum, Chief Executive Officer of Silo Pharma, commented, “We are making progress in our efforts to advance research in psychedelics as a therapeutic and achieved several key milestones in the third quarter of 2021. We materially strengthened our balance sheet to advance our platform and accelerate our development plans. Additionally, we remain focused on our goal to uplist our shares to the Nasdaq, and believe the uplisting will strengthen long term shareholder value and serve as a catalyst to further diversify our shareholder base.”

About Silo Pharma

Silo Pharma is a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research for people suffering from indications such as depression, PTSD, Alzheimer’s, Parkinson’s, and other rare neurological disorders. Silo’s mission is to identify assets to license and fund the research which we believe will be transformative to the well-being of patients and the health care industry. For more information, visit www.silopharma.com

Safe Harbor and Forward-Looking Statements
This news release contains “forward-looking statements” within the meaning of the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified by the use of words “could”, “believe”, “anticipate”, “intend”, “estimate”, “expect”, “may”, “continue”, “predict”, “potential” and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Silo Pharma, Inc. (“Silo” or “the Company”) to differ materially from the results expressed or implied by such statements, including changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company’s technology platforms, retaining and expanding the Company’s customer base, fluctuations in consumer spending on the Company’s products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this presentation, whether as a result of new information, future events, or otherwise, after the date of this presentation or to reflect the occurrence of unanticipated events except as required by law.

Investor Relations Contact:
Hayden IR
Brett Maas
646-536-7331
Email: brett@haydenir.com

Posted on

Lobe Sciences Provides Corporate Update to Investors and Stakeholders

Lobe Sciences Provides Corporate Update to Investors and Stakeholders

Vancouver, British Columbia–(Newsfile Corp. – September 13, 2021) – Lobe Sciences Ltd. (CSE: LOBE) (OTC Pink: GTSIF) (“Lobe” or the “Company“) is pleased to provide the following corporate update by CEO Philip Young, addressed to shareholders, investors and other stakeholders of the Company:

Dear Fellow Shareholders and Psychedelic Medicine Enthusiasts,

We are pleased to say that 2021 has been a busy and transformative year for the Company. During 2021, we have made significant progress on several fronts, and completed our transition to an integrated pharmaceutical development company. We have built the foundation of a drug development company and we are now following a path for the development of therapeutics for which we intend to seek FDA approval in the United States, and similar approvals internationally. Millions of people are experiencing the devastating, often long-term effects of mTBI (mild traumatic brain injury) and PTSD (post-traumatic stress disorder), with few, if any, effective treatments available. Our goal is to change that fact. We believe that psychedelic based therapeutics will bring a new era of treatment for many illnesses where current therapies are insufficient or unavailable. As such, we believe the Company is poised to lead the way in developing treatments for mTBI and PTSD, while altering the perception of psychedelic medicine as a treatment modality. Our entire team is dedicated to making a significant impact in this rapidly growing industry as we differentiate ourselves from other psychedelic medicine companies by executing our strategic plans and vision. The following is a brief review of the achievements we have made, laying the foundation for continued progress and milestones, which we believe will position the Company for long-term growth and success.

2021 Business Developments – the building blocks for our future

Our 2021 accomplishments spanned every aspect of our business as we executed our multi-prong strategy and vision for future developments. These accomplishments included: streamlining operations, enhancing our balance sheet, strengthening our intellectual property portfolio, further developing our medical devices, increasing our scientific breadth and reach by forming a world class scientific advisory board and entering into relationships with key organizations that promote mental health and wellness. Key accomplishments include:

Clinical and Scientific Developments and Operations:

Our pre-clinical study involving psilocybin and NAC (N-Acetylcysteine) led by Principal Investigator, Dr. Michael Hoffer of the University of Miami is progressing and in the process of analyzing the data. The Company continued to strengthen its overall product, device and intellectual property (“IP“) portfolio through acquisitions and our development efforts. Other key highlights include:

  • On February 18, 2021 we announced the successful completion and testing of the proof of concept prototype of its proprietary nasal mist device;
  • On April 27, 2021 we announced the Company entered into a joint venture agreement with Virtual Psychedelics Incorporated to design, develop and commercialize the Krysalis Pod, a state-of-the-art media device that will deliver immersive virtual experiences without a headset. (the “JV”);
  • On April 29, 2021 we announced the filing of a PCT application entitled “Methods, Compositions and Devices for Treating Mild Traumatic Brain Injury”;
  • On May 4, 2021 we announced the acquisition of the Vitamind line of functional mushroom wellness products; and
  • On May 19, 2021 we announced entering into a production and supply agreement with HAVN Life Sciences Inc.

As announced on March 8, 2021, the Company completed the divestiture of the Washington State cannabis asset to Ionic Brands Corp. (“Ionic“), strengthening our balance sheet with a cash payment to the Company of $1,750,000, and receipt of 100,406,701 Series E shares of Ionic and 4,000,000 Ionic warrants.

Executive Team, Advisors and Industry Relationships:

In 2021, in addition to myself as CEO, we added Michael Petter, an accomplished businessman to our board of directors. We also assembled an accomplished Scientific Advisory Board (“SAB”), led by our CSO, Maghsoud Dariani, including Dr. Mark Geyer, Dr. Charles Grob, Dr. Benjamin Kelmendi, Dr. Michael Hoffer and Dr. Skip Rizzo, all regarded as leaders and innovators in their respective psychedelic and medical communities. We also leveraged our advisor network and partnered with the NFL Alumni Association and the World Boxing Association to investigate and develop plans for monitoring, mitigating and managing the consequences of mTBI and PTSD.

Looking Ahead: on-going corporate initiatives

The Company intends to leverage its 2021 accomplishments achieved to-date. Key milestones we anticipate working towards include the following items. The Company plans on completing these items by the end of calendar 2022, barring any unforeseen delays.

Clinical and Scientific Development and Regulatory

  • Announce the results of the University of Miami Pre Clinical Study of the treatment of mTBI and PTSD
  • Submit Pre Investigational New Drug (“IND“) meeting request to FDA
  • Announce contract research organization (“CRO“) partner, finalize study protocol, select sites for first-in-man study with our combination therapeutics
  • Finalize agreement with a cGMP manufacturing partner for clinical trial and commercial supplies of psilocybin and NAC (N-Acetylcysteine)
  • Initiate the first human study with Lobe’s patent pending combination therapeutics of psilocybin and NAC (N-Acetylcysteine)
  • Update on cGMP psilocybin production timing and availability
  • File IND with FDA
  • Update clinical trial enrolment progress
  • Update IND plans based on feedback from FDA
  • Finalize specifications for and design plan for nasal mist delivery device

Collaborations and Partnerships

  • Update on Krysalis Pod design team and progress
  • Launch the first products in the Vitamind product portfolio, subject to regulatory approval
  • Update on Krysalis Pod design and tech stack development
  • Expand Vitamind product offerings and launch in USA, subject to regulatory approval

Investment Conference Schedule:

The Company will be sharing its vision and plans with investors as we attend several leading investment conferences and trade conventions including:

  • HC Wainwright 23rd Global Investment Conference, September 13-15, 2021
  • Maxim Group, Advances in Mental Health – Psychedelics and Non-Psychedelics Conference, September 22, 2021
  • Benzinga Healthcare Small Cap Conference, September 29, 2021
  • MoneyShow Virtual Expo, October 5-7, 2021
  • BioFuture 2021, October 5-7, 2021
  • LD Micro Main Event, October 12-14, 2021
  • Q4 Investor Summit Virtual Conference, November 16-17, 2021
  • JP Morgan Healthcare Conference, January 10-13, 2022

In summary, we believe the balance of 2021 and 2022 will bring exciting developments as we build on the foundation of our accomplishments. We are committed to creating effective therapies and treatments to better the lives of millions of people. We believe we have built a solid foundation and strategy that incorporates strong partnerships with recognized industry leaders, a world-class Scientific Advisory Board, a growing intellectual property portfolio, along with multiple products and devices under development.

Thank you for your continued commitment and support as we continue to execute our strategy to position the Company for long-term growth and success.

Philip Young
CEO and Director

* * *

About Lobe Sciences Ltd.

Lobe Sciences is a life sciences company focused on psychedelic medicines. The Company, through collaborations with industry-leading partners, is engaged in drug research and development using psychedelic compounds and the development of innovative devices and delivery mechanisms to improve mental health and wellness.

For further information please contact:

Lobe Sciences Ltd.
Philip J Young, CEO
info@lobesciences.com
Tel: (949) 505-5623

THE CSE HAS NOT REVIEWED AND DOES NOT ACCEPT RESPONSIBILITY FOR THE ACCURACY OR ADEQUACY OF THIS RELEASE.

Disclaimer for Forward-Looking Statements

This news release contains forward-looking statements relating to the future operations of the Company and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact included in this release, including statements made by our Chief Executive Officer and regarding the future plans and objectives of the Company; progression with nasal mist device engineering and commercialization; the pursuit of M&A initiatives, and the expected benefits to be derived from previous M&A initiatives; the development of effective delivery methods and commercialization potential of the nasal mist device, research and development using NAC and psilocybin and growth of the business; the Company’s expected attendance at various industry conferences; the timing of and results from the University of Miami pre-clinical study; expected timing to submit a pre IND meeting request to the FDA (and statements regarding FDA approvals generally); expected announcement and timing of a CRO partner, finalizing study protocol, and statements regarding a first-in-man study with our combination therapeutics; statements regarding expected development of the Krysalis Pod; anticipated timing and announcement of initiation of the first human study with Lobe’s patent pending combination therapeutics of psilocybin and NAC (N-Acetylcysteine); expected timing and occurrence of the launch of products in the Vitamind product portfolio, expansion of the Vitamind product line and receipt of regulatory approvals required for product launches; expected statements and timing regarding cGMP psilocybin production and availability; and the expected timing for the launch of new products and revenue-generating activities and expected completion of milestones by the end of calendar 2022, are all forward looking statements that involve risks and uncertainties. Forward-looking statements, by their very nature, require management to make assumptions and are subject to inherent risks and uncertainties, and while management of the Company believes the forward-looking statements contained herein have a reasonable basis, the possibility exists that our predictions, forecasts, projections, expectations or conclusions will not prove to be accurate. Material assumptions that underlie the forward-looking statements included in this news release include, without limitation, assumptions regarding: the outcomes of scientific studies showing the efficacy of psychedelic therapies on mTBI and PTSD, increasing acceptance in the medical community and among consumers for psychedelic therapies as an effective treatment modality; the Company having access to sufficient capital needed to support its various milestone objectives, expected synergies from M&A transactions and the timing of various milestone objectives, regulatory approvals and our ability to capitalize on business opportunities and develop revenue-generating activities; and the impact of COVID-19 on our business plans. Readers are cautioned that assumptions used in the preparation of the forward-looking statements may prove to be incorrect. As a result of the inherent uncertainty of forward-looking statements, there can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements, whether as a result of known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. Important risks and uncertainties that could cause actual results to differ materially from the Company’s expectations include without limitation risks relating to: that we may not have the capital needed or will not be able to raise sufficient capital to support our business activities or achieve our anticipated milestones; delays or stoppages in the Company’s business activities resulting from the COVID-19 pandemic; adverse or unexpected findings in scientific research; adverse changes to the regulatory environment in which we operate; regulatory delays or the failure to obtain required regulatory approvals; failure to capitalize on business opportunities and develop revenue-generating activities; contract counterparty risks; key personnel risk; business integration risks; risks inherent to equity and debt markets and their effects on our share price, and such other risks as may be detailed from time to time in the filings made by the Company pursuant to securities regulations, as well as other risks that may presently be unknown to us or which we consider to be immaterial at the time such forward-looking statements are made. As a result of these risks and uncertainties, the Company cannot guarantee that any forward-looking statement will materialize as expected, and the reader is therefore cautioned not to place undue reliance on any forward-looking statements contained in this news release. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement, are made only as of the date of this news release and the Company does not intend to update any of the forward-looking statements contained in this news release except as expressly required by applicable securities laws.