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Wesana Health Reports Q3 2021 Financial Results

Wesana Health Reports Q3 2021 Financial Results

CHICAGO and TORONTO, Nov. 29, 2021 (GLOBE NEWSWIRE) — Wesana Health Holdings Inc. (“Wesana” or the “Company”) (CSE: WESA; OTCQB: WSNAF), a data driven life sciences company, has announced its quarterly financial results for the three- and nine-month period ending September 30, 2021.

Q3 2021 Highlights

  • Ended the third quarter with US$11,266,187 in cash
  • Completed the acquisition of PsyTech and related transactions, launching Care Delivery as a new business segment consisting of Wesana Solutions, Wesana Clinics and PsyTech Connect
  • Committed US$1.5mm in funding to Multidisciplinary Association for Psychedelic Studies (“MAPS”) to work towards developing a partnership agreement on the research of the application of MAPS’ psychedelic-assisted therapy programs towards the treatment of Traumatic Brain Injury (“TBI”)
  • Wesana was included as a core component of the AdvisorShares Psychedelics ETF

Chad Bronstein, Executive Chairman of Wesana Health Commented: “The third quarter marked a number of important strategic developments for Wesana Health, including the PsyTech acquisition. Through the acquisition of PsyTech we have been able to expand our patient reach and overall patient impact through the addition of Care Delivery as a business segment. Notably, the Care Delivery segment, highlighted by the two flagship clinics in Chicago, provides key clinical protocols for Wesana to use as a base for greenfield expansion in addition to a network of acquisition targets through PsyTech Connect. The Care Delivery segment also provides an important future conduit to test Wesana’s psychedelic drug development program having recently surpassed 4,000 administered ketamine treatments at the clinics level since inception.

Additionally, we are incredibly pleased with our funding commitment to MAPS to work towards a partnership agreement. Assuming we can achieve successful partnership discussions, a research collaboration with MAPS could accelerate Wesana’s timing to market on MDMA therapy for the treatment of TBI.

We believe Wesana is ending the most recent quarter in a position of strength and expect that our continuous strategic investments in people, assets and capabilities will continue to deliver value to our expanding patient base.”

Selected Consolidated Financial Information

The following table sets forth selected financial information derived from the Company’s unaudited condensed interim combined and consolidated financial statements for the three- and nine-months ended September 30, 2021. The following information should be read in conjunction with the financial statements and the accompanying management’s discussion and analysis (“MD&A”), which are available on the Company’s website at www.wesanahealth.com and under the Company’s SEDAR profile at www.sedar.com.

For the three months ended ($USD) Sept 30, 2021 Dec 31, 2020 Change
Cash Balance 11,266,187 1,266,781 9,999,406
Total Assets 36,284,015 1,267,293 31,016,722
Total Equity 33,671,164 63,181 33,607,983
Weighted Average Shares Outstanding 14,394,323 4,775,997 9,618,326
Fully Diluted Shares Outstanding (as converted*) 39,919,613 4,775,997 35,143,616

*The number is presented assuming all of the Company’s outstanding Proportionate Subordinate Voting Shares and Super Voting Shares as at September 30, 2021 are converted into Subordinate Voting Shares and all of the Company’s other outstanding convertible, exchangeable and exercisable securities as at September 30, 2021 are converted, exchanged or exercised in accordance with their terms.

PsyTech Acquisition and Launch of the Care Delivery Segment

On September 8, 2021, the Company completed the acquisition (the “PsyTech Acquisition”) of Psychedelitech Inc. (“PsyTech”) and the acquisition of Advanced Psychiatric Management LLC. Such acquisitions added three components that expanded the Company’s business into Care Delivery:

•       Wesana Clinics – Wesana Clinics is a chain of psychiatrist-led mental health clinics focused on delivering psychiatric care, inclusive of ketamine therapy, while also preparing for the delivery of other psychedelic therapies as they become available. The Wesana clinical network currently includes two flagship clinics located in Illinois with another under development contemplated to open in the first quarter of 2022. See “Cautionary Note Regarding Forward-Looking Information” below.

•       Wesana Solutions – Wesana Solutions is a clinical software platform focused on improving mental healthcare through facilitating access to clinical protocols and tracking their efficacy. In concert with electronic medical records and practice management systems, Wesana Solutions is intended to be used in clinics delivering psychedelics and related therapies, targeting the developing international psychiatric clinic and research market, with initial clinical deployment to be focused on the United States. Wesana Solutions is contemplated to begin clinical deployment in the first quarter 2022 and will help Wesana gather and process neurological data about patient response to various compounds and protocols under investigation. See “Cautionary Note Regarding Forward-Looking Information” below.

•        PsyTech Connect – PsyTech Connect is a community for the clinical use of psychedelics with over 8,000 actively engaged professionals and has become a resource for psychedelic therapy protocols and clinical best practices. PsyTech Connect also features the annual PsyTech Summit, a premier psychedelic conference that averages over 2,200 attendees. Through PsyTech Connect, Wesana will be able to develop relationships with leading edge psychiatric practitioners and provide them with tools for managing, understanding, and personalizing care for their patients.

US$1.5 Million Funding of MAPS Research
On September 14, 2021, the Company announced its commitment pursuant to a memorandum of understanding to fund an initial US$1.5 million to MAPS with the aggregate amount expected to be used in part by MAPS to finance the evaluation of legal, scientific and operational elements of a proposed partnership. In connection with the investment, MAPS Public Benefit Corporation (“MAPS PBC”), a wholly-owned subsidiary of MAPS, is expected to activate a team to carry out such an assessment.

The partnership between MAPS and the Company is contemplated to accelerate MAPS PBC’s research timelines and provide additional support to MAPS for further research, advocacy, education, and equitable access to MDMA-assisted therapy treatments. Under the terms of the partnership, Wesana is contemplated to, among other things: (i) gain expertise and information to design psychedelic-assisted therapy programs for TBI and improve the Company’s timeline and path to market for its treatments, (ii) explore obtaining an exclusive commercial license to use MDMA for the treatment of TBI, (iii) evaluate the viability of, and enter into, revenue share agreements between the organizations, (iv) adapt MAPS’ equitable access research projects to develop a meaningful patient access program, and (v) fund associated research, administered by MAPS PBC, with additional capital.

The formation of a partnership between the Company and MAPS remains subject to, among other things, negotiation and execution of definitive documentation and satisfaction of the conditions precedent negotiated therein. There is no assurance that any such definitive documentation will be settled and entered into by the parties nor that any such conditions precedent will be met. Overall, any direct or indirect research and development efforts of the Company related to MDMA remain at a preliminary stage. Please refer to the MD&A for additional details.

Inclusion in the AdvisorShares Psychedelics ETF

On October 1, 2021 the Company announced that its shares were included in the AdvisorShares Psychedelics ETF (the “Fund”), currently trading under the ticker symbol “PSIL” on the NYSE Arca exchange. The recently launched Fund primarily focuses its strategy on investing in publicly traded companies in the life sciences, biotechnology and pharmaceuticals sectors that derive at least 50% of their net revenue or devote 50% of their assets to the advancement of psychedelic compounds. The Fund looks to highlight the leaders in the psychedelics sector as its core holdings.

Continuous Disclosure

Further to a review by the Ontario Securities Commission (the “OSC”) of the Company’s continuous disclosure in connection with the Company’s filing of its preliminary base shelf prospectus dated September 15, 2021, the Q3 MD&A includes amended disclosure pertaining to the Company’s management’s discussion and analysis for the quarter ended June 30, 2021 (the “Q2 MD&A”). Such amended disclosure (the “Amended Q2 MD&A Information”) is being included in the MD&A to address comments received from the OSC and to improve the Company’s disclosure. In particular, the Company has included additional disclosure regarding the Q2 MD&A as follows:

  • The Company has provided additional disclosure regarding the Company’s active projects that have not yet generated revenue, broken down by business segments, including the status thereof, the expenditures made in respect of such projects and how such expenditures relate to anticipated timing and costs to take each such project to the next stage of the project plan;
  • The Company has provided additional disclosure regarding an update to the Company’s previously disclosed milestones and how the Company has allocated, re-allocated and used the proceeds from certain prior financings in relation to such milestones;
  • The Company has provided additional disclosure regarding the Company’s results of operations, including the material components of research and development and general and administration expenses for the three and six-month periods ended;
  • The Company has provided additional disclosure regarding an analysis of the Company’s liquidity, including the primary need for liquidity to fund the development of its business segments to meet the Company’s planned growth and development activities and that the primary source of liquidity has been, and is expected to continue to be, through reliance on capital markets until commercialization of projects or until cash flow positive status is achieved;
  • The Company has provided additional disclosure regarding the Company’s capital resources, including the extent to which such resources have been committed towards capital expenditures, disclosures on cash held, available working capital and cash burn rate as at and for the quarter ended June 30, 2021 in addition to anticipated cash flow requirements for the 12 months following the quarter ended; and
  • The Company has provided additional disclosure regarding the material factors and assumptions underlying previously disclosed forward-looking information, as well as updates to, or withdrawals of, previously disclosed forward-looking statements.

As a result of having to include such enhanced disclosure within the MD&A as a corrective matter, the Company will be placed on the public list of Refiling and Errors in accordance with OSC Staff Notice 51-711 (Revised) – Refilings and Corrections of Errors.

About Wesana Health
Wesana Health is an emerging life sciences company championing the development of innovative approaches for better understanding, protecting, and improving neurological health and performance. Through extensive clinical research and academic partnerships, Wesana Health is developing evidence-based formulations and protocols, including psilocybin-based therapies, that empower patients to overcome neurological, psychological, and mental health ailments. In order to comply with applicable corporate practice of medicine laws, the Wesana Clinics are solely licensed physician owned and are organized as physician practices, with the Company providing management services to the Wesana Clinics. Learn more at www.wesanahealth.com.

Cautionary Note Regarding Forward-Looking Information
This press release contains “forward-looking information” within the meaning of applicable securities laws with respect to the Company, including, but not limited to: the beta testing results for, the completion of product development and timing for clinic deployment of, Wesana Solutions, the opening of a third Wesana Clinic in the first quarter of 2022, the completion and timing of entering into a partnership with MAPS and information concerning the expected benefits thereof; and any other statement that may predict, forecast, indicate or imply future plans, intentions, levels of activity, results, financial position, operational or financial performance or achievements. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, “will”, “projects”, or “believes” or variations (including negative variations) of such words and phrases, or statements that certain actions, events, results or conditions “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Except for statements of historical fact, information contained herein constitutes forward-looking information. Forward-looking information is not a guarantee of future performance and is based upon a number of estimates and assumptions of management at the date the statements are made.

Wesana Solutions remains in the beta testing phase. While there is no assurance that product development will be completed and clinical deployment will be achieved nor the extent to which the Company will secure clinical customers for Wesana Solutions once it completes product development and initiates the clinical deployment, the clinic deployment of Wesana Solutions is contemplated to begin in the first quarter of 2022. Certain factors that influence successfully completing beta testing and product development and achieving clinical deployment within such timeline include: (i) the development of this software platform was subcontracted out by the Company and the beta testing phase has been initiated; (ii) third parties and internal product leads have met expected deliverable timelines to date; (iii) to date the Company has not identified any significant issues regarding functionality of the software; (iv) the Company has allocated sufficient funds and resources to complete final product development and marketing plans; and (v) the Company has engaged regulatory and data consultants to monitor regulations impacting commercialization of the software.

Certain assumptions that influence successfully completing beta testing and product development and achieving clinical deployment within such timeline include: (i) there are no significant delays in the final development and testing schedule and staffing plans; (ii) beta testing results are positive and supportive of the software being deployed in a clinical setting; (iii) development and marketing costs remaining consistent with the Company’s budgeting; and (iv) the Company will be able to secure future relationships and establish commercial agreements for the software with third party clinics.

Certain factors that influence successfully opening a third Wesana Clinic in the first quarter of 2022 include: (i) the Company has identified a third clinic location and property and is currently in lease negotiations; (ii) should the Company procure additional capital and proceed with a lease in connection with the identified third property, renovations and permitting of the property for the purpose of clinic operations are expected to be minimal; (iii) the Company has an internal team dedicated to identifying potential target clinics and locations and evaluating and addressing issues that may arise during due diligence of any potential targets.

Certain assumptions that influence successfully opening a third Wesana Clinic in the first quarter of 2022 include: (i) there are no significant delays in executing the third property lease in the fourth quarter of 2021 or shortly thereafter, if additional capital is raised; (ii) additional capital is raised during the fourth quarter of 2021 or shortly thereafter for the third location; and (iii) there are no significant delays in renovation/permitting if the third property lease is executed.

The formation of a partnership between the Company and MAPS remains at a preliminary stage. Certain assumptions that influence successfully forming such a partnership include: (i) the ability of the Company to successfully negotiate and enter into definitive documentation in respect of the contemplated partnership with MAPS and satisfy any related conditions precedent; and (ii) the ability of the Company to raise sufficient additional capital to be able to fund such potential partnership with MAPS.

Other general assumptions include, operating conditions remaining favorable, including sustained availability of third-party service providers and other inputs for the Company’s operations; sustained political and regulatory stability; and sustained stability in capital goods markets.

While the Company considers the foregoing assumptions to be reasonable, the assumptions are inherently subject to significant business, economic, social, political, regulatory, competitive, and other risks and uncertainties, contingencies and other factors that could cause actual performance, achievements, actions, events, results or conditions to be materially different from those projected in the forward-looking information. Many assumptions are based on factors and events that are not within the control of the Company and there is no assurance they will prove to be correct.

Furthermore, such forward-looking information involves known and unknown risks, uncertainties and other factors which may cause the actual performance, achievements, actions, events, results, or conditions of the Company to be materially different from any future performance, achievements, actions, events, results or conditions expressed or implied by such forward-looking information. Such factors include, among others: delays in beta clinical testing resulting in delays in commercializing; the Company does not remain within its development and marketing costs for Wesana Solutions, requiring the Company to reallocate existing capital away from other projects and/or raise additional capital; reliance on third parties to plan, conduct and monitor beta clinical testing, product development and clinical deployment of technology; the Company does not secure future relationships and establish commercial agreements for Wesana Solutions with third party clinics; inability to raise sufficient additional capital to fund the opening of the third Wesana Clinic; inability to receive any applicable governmental approvals and permits to advance the business of the Company, including to open the third Wesana Clinic, should additional capital to fund its opening be raised; inability to negotiate, settle, enter into or execute upon a definitive partnership arrangement with MAPS; inability to raise sufficient additional capital to fund such potential partnership with MAPS; research and development of drugs targeting the central nervous system being particularly difficult; failure to comply with health and data protection laws and regulations; violations of laws and regulations resulting in repercussions; regulatory or political change; changes to applicable corporate practice of medicine laws and regulations; delays in pre-clinical and clinical testing resulting in delays in commercializing; inability to file investigational new drug applications or clinical trial applications to commence clinical trials in a timely manner; difficulty enrolling patients in clinical trials; reliance on third parties to plan, conduct and monitor preclinical studies and clinical trials; competition from other biotechnology and pharmaceutical companies; maintaining and enhancing reputation and brand recognition; ability to protect intellectual property; requirements to share intellectual property with service providers; negative operating cash flow and going concern; the detrimental impact of future losses and negative cash flow from operations; unfavorable publicity or consumer perception; not achieving publicly announced milestones; psychedelic inspired drugs possibly never being approved as medicines; reliance on the capabilities and experience of key executives and scientists; disruptions due to acquisitions or collaborations; risk of product liability claims; COVID-19; litigation; conflicts of interest; limited operating history; exposure to the fluctuation of foreign exchange rates; enforcement of judgments and effecting service of process on directors and officers; general economic, market and business conditions, and other risks factors including those found in the MD&A and the Company’s annual information form dated September 3, 2021 filed on the Company’s profile on SEDAR at www.sedar.com and discussed in the Company’s other public filings available on SEDAR.

Although the Company has attempted to identify important factors that could cause actual results to differ materially, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such forward-looking information will prove to be accurate as actual results and future events could differ materially from those anticipated in such information. Accordingly, readers should not place undue reliance on forward-looking information. Forward-looking information is provided and made as of the date of this news release and the Company does not undertake any obligation to revise or update any forward-looking information other than as required by applicable law.

For more information, please contact:

Investor Contact:
Keenan Gentry
Email: IR@wesanahealth.com
Phone: 773-236-7972

Media Contacts:
Nick Opich / Fallon Carter
KCSA Strategic Communications
Email: Wesana@kcsa.com
Phone: 212-896-1206

On behalf of the Board of Directors:
Daniel Carcillo, Chief Executive Officer
Phone: 773-236-7972


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Source: Wesana Health

Released November 29, 2021

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Red Light Holland Reports Second Quarter 2021 Results

Red Light Holland Reports Second Quarter 2021 Results

Company announces 56% increase in the number of stores selling its iMicrodose products in the Netherlands

Six-month revenues of $1,080,875

Toronto, Ontario–(Newsfile Corp. – November 29, 2021) – Red Light Holland Corp. (CSE: TRIP) (FSE: 4YX) (OTC Pink: TRUFF) (“Red Light Holland” or the “Company”), an Ontario-based corporation engaged in the production, growth, and sale of a premium brand of magic truffles, today reported its financial results for the three and six months ended September 30, 2021. Unless otherwise stated, all amounts are expressed in Canadian dollars. The Company is also pleased to announce a significant increase in the number of Smart Shop retail stores selling its iMicrodose products in the Netherlands.

Commenting on Red Light Holland’s second quarter performance, Todd Shapiro, Chief Executive Officer stated, “I am pleased with the progress that we have made during the second quarter. We were focused on iMicrodose and Maka product development with the goal of increasing future revenues and related margins. The quarter saw us close two important strategic acquisitions and continue to realize revenues and gross profit from our existing operations. Our acquisition of a majority interest in Acadian Exotic Mushrooms (AEM) is expected to commence significant revenue generation in March 2022. Increasing our revenue is a core focus and we continue to identify and analyze merger and acquisition transactions while remaining cautious with our spending habits.”

With regards to the increased store presence in the Netherlands, Hans Derix, Red Light Holland President, added “We have increased the number of stores that sell our iMicrodose psychedelic products from 25 to 39 (a 56% increase) in the Netherlands. This is a significant increase in market presence that was completed under the backdrop of retail pressure attributed to the continuing global pandemic. We have also developed and launched a newly branded Maka line of products. As a result of these efforts, we expect increased revenue related to psychedelic products and functional mushroom products in the coming quarters.”

Sarah Hashkes, Red Light Holland’s CTIO added, “Rec and Tech is Red Light Holland’s core focus. We have seen a strong increase in privacy first data collection with our iMicrodose end consumers in the Netherlands via our iMicro App. Our Tele-counseling support remains a phenomenal option and we are also thrilled to have entered into a ‘mold making stage agreement’ with Hotopfun factory in China to continue to build out Wisdom smart home devices, inspired by the mycelium network, in preparation for mass manufacturing Q1 of 2022. Red Light Holland continues to execute its strategic initiatives and we are proud of our unique and innovative technology and their alternative revenue streams.”

SUMMARY OF THE QUARTER ENDED SEPTEMBER 30, 2021

  • Completed the acquisition of a 51% interest in Acadian Exotic Mushrooms Ltd (AEM), a Canadian gourmet mushroom production facility co-owned by leading Canadian mushroom farming groups.
  • Completed the acquisition to acquire 100% of the issued and outstanding shares of Mera Life Sciences LLC, a company permitted to perform research, cultivation, production, development, extraction, import and export, and clinical treatment facilities with prescribed patient access in St. Vincent and the Grenadines.
  • Completed Canada’s largest legal sale and import of psilocybe truffles into Canada under a Health Canada approved Psilocybin Import Permit. The Company sold 1.5 kg to CCrest Laboratories Inc., a cGMP pharmaceutical laboratory in Montreal, Canada.
  • Generated revenues of $485,738 for the three months ended September 30, 2021 resulting in gross profit of $156,970, an increase of $61,240 (or 64.0%) over the previously reported quarter.
  • Continued balance sheet strength including cash in the amount of $29.1 million.

Both the Financial Statements and Management’s Discussion and Analysis for the three and six months ended September 30, 2021 are now available on SEDAR.

About Red Light Holland

The Company is an Ontario-based corporation engaged in the production, growth and sale (through existing Smart Shops operators and an advanced e-commerce platform) of a premium brand of magic truffles to the legal market within the Netherlands.

For additional information on the Company:

Todd Shapiro
Chief Executive Officer & Director
Tel: 647-643-8747 (TRIP)
Email: todd@redlighttruffles.com
Website: https://redlighttruffles.com/

Forward-Looking Statements

This press release contains certain “forward-looking information” within the meaning of applicable Canadian securities legislation. Such forward-looking information and forward-looking statements are not representative of historical facts or information or current condition, but instead represent only the Company’s beliefs regarding future events, plans or objectives, many of which, by their nature, are inherently uncertain and outside of the Company’s control. Often, but not always, forward-looking statements and information can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward-looking information involves known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company, or their respective subsidiaries to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information contained in this news release. Examples of such information include statements with respect to: Acadian Exotic Mushrooms Ltd and its ability to commence revenue generating deliveries by March 2022; the Company’s ability to close merger and acquisition transactions in both the psychedelic and exotic farm industries; the increase in Smart Shop retail store presence translating into increased sales of the Company’s psychedelic products; the Company’s plans to begin mass manufacturing of the Wisdom smart home devices in Q1 of 2022; and expectations for other economic, business, and/or competitive factors.

Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information, expectations regarding future growth and expansion of the operations of the business; regulatory and licensing risks; changes in general economic, business and political conditions, including changes in the financial and stock markets; changes in demand for the Company’s product offerings; risks related to infectious diseases, including the impacts of the COVID-19 pandemic; legal and regulatory risks inherent in the psychedelics industry, including the global regulatory landscape and enforcement related to psychedelics; political risks and risks relating to regulatory change; risks relating to anti-money laundering laws; compliance with extensive government regulation and the interpretation of various laws regulations and policies; public opinion and perception of the psychedelics industry; and such other risks contained in the public filings of the Company filed with Canadian securities regulators and available under the Company’s profile on SEDAR at www.sedar.com, including the Company’s annual information form for the year ended March 31, 2020.

Although the Company believes that the assumptions and factors used in preparing, and the expectations contained in, the forward-looking information and statements are reasonable, undue reliance should not be placed on such information and statements, and no assurance or guarantee can be given that such forward-looking information and statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information and statements. The forward-looking information and forward-looking statements contained in this press release are made as of the date of this press release, and the Company does not undertake to update any forward-looking information and/or forward-looking statements that are contained or referenced herein, except in accordance with applicable securities laws

The forward-looking information and forward-looking statements contained in this press release are made as of the date of this press release, and the Company does not undertake to update any forward-looking information and/or forward-looking statements that are contained or referenced herein, except in accordance with applicable securities laws.

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Hollister Biosciences Announces Third Quarter Fiscal 2021 Financial Results Including Revenue of USD $14.5M and Adjusted Ebitda of USD $1.2M

Hollister Biosciences Announces Third Quarter Fiscal 2021 Financial Results Including Revenue of USD $14.5M and Adjusted Ebitda of USD $1.2M

Revenue of $14.5 million increased 53% from prior year period

Gross profit income of $3.5 million increased 151% from prior year period

Net income was $0.4 million versus a loss of $0.6 million in prior year period

Adjusted EBITDA was $1.2 million, versus a loss of $0.6 million in prior year period 

Maintained a strong liquidity position, including a cash & cash equivalents balance of $7.6 million, an increase of 300% from prior year quarter

VANCOUVER, BC, Nov. 29, 2021 /CNW/ – Hollister Biosciences Inc. (CSE: HOLL) (OTC: HSTRF) (FRANKFURT: HOB) (the “Company” or “Hollister“) today announced its financial results for the third quarter fiscal 2021 ended September 30, 2021. All financial information is presented in U.S. dollars unless otherwise indicated.

Hollister Biosciences Inc. Logo (CNW Group/Hollister Biosciences Inc.)
Hollister Biosciences Inc. Logo (CNW Group/Hollister Biosciences Inc.)

“We delivered another solid quarter, continuing to drive year-over-year growth. Our performance in this quarter was driven by organic growth of our core business, Venom Extracts. As we approach the end of our final quarter and the beginning of a period of transformation, our strengthened and experienced leadership team is laser focused on creating shareholder value, delivering sustainable profitable growth, keeping operating costs low, and scaling the Company for optimal global success.”
–          Jake Cohen, Chief Executive Officer, Hollister

“Hollister’s third quarter results demonstrate the strength of our business and commitment to executing against our strategy. With its strong balance sheet, we believe the Company is well positioned and prepared for growth as it continues on its strategic transformation.”
–          Eula Adams, Chief Financial Officer, Hollister

Third Quarter 2021 Financial Results

  • Total revenue was $14.5 million, an increase of $5 million or 53% compared to the prior year period.
  • Gross profit was $3.5 million compared to $1.4 million for the prior year period.
  • Net income was $0.4 million versus a loss of $0.6 million in the prior year period.
  • Adjusted EBITDA was $1.2 million compared to a loss of $0.6 million in the prior year period.
  • Cash and cash equivalents was $7.6 million, a 300% increase as compared to $1.9 million at June 30, 2020.

Third Quarter 2021 Business Highlights

  • On July 13th, 2021, the Company announced it was added as an index constituent in the Solactive US Marijuana Companies Index (the “Index“) as part of the Index’s June 2021 quarterly rebalancing and as a result is now a holding in the Horizons US Marijuana Index ETF (NEO: HMUS).
  • On August 25th, 2021, the Company announced ‘Hollister Brand Campus‘ (the “Campus“) a 30-Acre Arizona Brand Campus with planned 700,000 square feet of cultivation area and an existing 28,500-square-foot processing and manufacturing facility.
  • On August 31st, 2021, the Company announced two new board members, Mr. Kevin Harrington, an original “Shark” from the NBC hit TV series “Shark Tank” and Mr. Jakob Ripshtein, the former CFO of Diageo North America and President of Aphria Inc.

Recent Events

  • On October 18th, 2021, the Company announced a series of operational and strategic updates to create shareholder value, enhance governance, operations and market positioning while preparing the Company for the next phase of its growth, including:
    • Appointment of:
      • Jacob Cohen as Chief Executive Officer
      • Eula Adams as Chief Financial Officer
      • Chris Lund as Chief Commercial Officer
      • Jill Karpe as Senior Vice President of Admin and Finance;
    • Refocused business strategy to develop a “house of brands” focused on cannabis consumer packaged goods;
    • Initiated rebranding corporate identity and name of the company; and
    • Reduction of expenses and resource allocation on non-core business activities.
  • On November 2nd, 2021, the Company announced it received an order from the Ontario Securities Commission granting Hollister an exemption from certain provisions governing disclosure and other matters applicable to issuers with outstanding “restricted securities”.
  • On November 23rd, 2021, all matters put forward before the Company’s shareholders for consideration and approval, as listed in the management information circular of the Company dated October 18, 2021 (the “Circular“), were approved by the requisite majority of votes cast at the Company’s Annual General and Special Shareholder Meeting. This includes the election of all six (6) Board of Director nominees listed in the Circular: Jakob Ripshtein, Jacob Cohen, Eula Adams, Lily Dash, Kevin Harrington, and Brett Mecum.

Outlook
The Company believes the outlook is strong and has developed a solid strategy supported by strong operational, financial and leadership capabilities. In January 2021, the state of Arizona enacted sales of adult-use cannabis ahead of industry expectations. The Company recognized a substantial increase in demand for its branded goods and bulk wholesale products, creating a larger volume of sales in the first half of the year as dispensaries and brands readied for inventory for the market change. During Q3 2021 and beyond the Company focused its efforts on improving sales of higher margin products and aligning supply and demand to flow with the seasonality of the Arizona and cannabis markets at large. Management reports that January through November sales are estimated to exceed $64.5 million. Management believes the previously forecasted guidance of $70 million is achievable and driven by sales of finished and bulk products in the company’s core market of Arizona. Historically, fourth quarter sales in Arizona improved versus summer months due to local population increases from seasonal residents returning and holiday visitors. The overall Arizona market demand has seen improvements in the categories that the company operates and is expected to continue.

Sales through the end of November are preliminary and are unaudited and subject to change and adjustment when the Company prepares its audited consolidated financial statements for the year ended December 31, 2021. Accordingly, investors are cautioned not to place undue reliance on the foregoing information. The preliminary results provided in this news release constitute “forward-looking information” within the meaning of applicable Canadian securities laws, are based on several assumptions and are subject to a number of risks and uncertainties. Actual results may differ materially. See “Cautionary Statement Regarding Forward-Looking Information”.

The Company will continue optimizing its platform in Arizona through improved same-store sales, loyalty, and expanding its product portfolio and market penetration. The recently announced Campus project is progressing and once production has commenced it is expected to provide the Company with substantially reduced direct material costs, resulting in improved gross margin. The Campus also has ample space to expand production of higher margin finished products. 

As previously announced, the Company is moving forward, implementing  its “house of brands” cannabis consumer packaged goods strategy which includes manufacturing and distribution of owned and partner branded cannabis products in chosen markets. Additionally, the Company is planning to rationalize its existing brand and product portfolio, dedicating efforts towards new, highly targeted brand partnerships and the acquisition or development of owned brands.

On the corporate development front, the process to rebrand the Company and to align it with its refined strategy has commenced. Campaigns to improve awareness and broaden the shareholder base are being developed.

The Company has placed certain non-core assets including its California operations in a care and maintenance program to reduce expenses and improve overall financial and operational performance.

In addition to operational, financial, governance and strategy improvements, the Company has also been dedicating efforts to enter new markets with its existing brands.

USE OF NON-IFRS FINANCIAL MEASURES
This press release includes certain non-IFRS financial measures. Reconciliations of these non-IFRS financial measures to the most directly comparable financial measure calculated and presented in accordance with IFRS are included below. This information should be considered as supplemental in nature and not as a substitute for, or superior to, any measure of performance prepared in accordance with IFRS. The Company’s management team uses adjusted EBITDA to evaluate operating performance and trends and to make planning decisions. The Company’s management team believes adjusted EBITDA helps identify underlying trends in the business that could otherwise be masked by the effect of the items that are excluded. Accordingly, the Company believes that adjusted EBITDA provides useful information to investors and others in understanding and evaluating the operating results, enhancing the overall understanding of past performance and future prospects, and allowing for greater transparency with respect to key financial metrics used by management in its financial and operational decision-making.

The table below reconciles net income (loss) and comprehensive income (loss) to Adjusted EBITDA (Loss for the three and nine months ended September 30, 2021 and 2020:

Three months ended
September 30,		Nine months ended
September 30,
2021202020212020
$$$$
Net income (loss) and comprehensive income (loss)457,148(649,095)4,040,649(2,584,259)
Add (deduct) impact of:
Accretion–3,150–9,451
Depreciation333,739445,045964,861574,098
Finance costs123,300107,274332,905327,135
Foreign exchange gain(29,665)–(57,961)–
Interest expense34237,75020,35687,750
Transaction costs–––379,684
Acquisition expense–––535,478
Interest income(46,802)–(112,890)–
Gain on sublease––262,015–
Gain on lease extinguishment19,951–19,951–
Lease renegotiation costs(252,036)–(252,036)–
Income tax expense617,000(8,400)2,438,000(8,400)
Deferred income tax recovery(3,000)–(131,000)–
Foreign currency translation adjustment22,8663,9027,05581,642
Adjusted EBITDA (Loss)1,242,843(60,374)7,531,905(597,421)

The live audio earnings conference call may be accessed online and by phone using the link: https://www.renmarkfinancial.com/events/third-quarter-2021-results-cse-holl-2021-11-30-160000. Investors may pre-register for the call by navigating to the same link provided. The conference call will be archived for replay and accessible at https://hollisterbiosciences.co/investors/.

About Hollister
Hollister is a multi-state company with a portfolio of innovative, high-quality cannabis & hemp branded consumer products and white-labeling manufacturing. The Company’s products are sold in 370 dispensaries across Arizona and California. Hollister’s wholly-owned brand, Venom Extracts, is a category-leading brand that sold more than 4 million grams in 2020, accounting for up to 30% of category sales in Arizona.

Products from Hollister include HashBone, the brand’s premier artisanal hash-infused pre-roll, along with concentrates (shatter, budder, crumble), distillates, solvent-free bubble hash, pre-packaged flower, pre-rolls, tinctures, vape products and full-spectrum high CBD pet tinctures. The Company’s wholly-owned California subsidiary Hollister Cannabis Co is the 1st state and locally licensed cannabis company in the city of Hollister, CA, birthplace of the “American Biker”.

Website:  www.hollisterbiosciences.co

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION:

This news release includes certain “forward-looking information” as defined under applicable Canadian securities legislation, including statements regarding the plans, intentions, beliefs, and current expectations of the Company with respect to future business activities and operating performance. To the extent any forward-looking information in this news release constitutes “financial outlooks” within the meaning of applicable Canadian securities laws, such information is being provided as preliminary financial and operational results and the reader is cautioned that this information may not be appropriate for any other purpose and the reader should not place undue reliance on such financial outlooks. Forward-looking information is often identified by the words “may”, “would”, “could”, “should”, “will”, “intend”, “plan”, “anticipate”, “believe”, “estimate”, “expect” or similar expressions and includes information regarding: the impacts of the Campus; the implementation of the Company’s “house of brands” cannabis consumer packaged goods strategy; the Company’s rebranding; and expectations for other economic, business, and/or competitive factors. Forward-looking information is necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Financial outlooks, as with forward-looking information generally, are, without limitation, based on the assumptions and subject to various risks as set out herein. The Company’s actual financial position and results of operations may differ materially from management’s current expectations and, as a result, the Company’s revenue may differ materially from the estimated revenue provided in this news release.

Investors are cautioned that forward-looking information is not based on historical fact but instead reflects management’s expectations, estimates or projections concerning future results or events based on the opinions, assumptions and estimates of management considered reasonable at the date the statements are made. 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. Among the key factors that could cause actual results to differ materially from those projected in the forward-looking information are the following: the Company’s financial results, including the Company’s revenue for the year to date will be as projected; regulatory and licensing risks; changes in consumer demand and preferences; changes in general economic, business and political conditions, including changes in the financial markets; the global regulatory landscape and enforcement related to cannabis, including political risks and risks relating to regulatory change; compliance with extensive government regulation; public opinion and perception of the cannabis industry; the impact of COVID-19; and the risk factors set out in the Company’s annual information form dated August 28, 2020, filed with Canadian securities regulators and available on the Company’s profile on SEDAR at www.sedar.com.

The Company, through several of its subsidiaries, is indirectly involved in the manufacture, possession, use, sale, and distribution of cannabis in the recreational and medicinal cannabis marketplace in the United States. Local state laws where the Company operates permit such activities however, investors should note that there are significant legal restrictions and regulations that govern the cannabis industry in the United States. Cannabis remains a Schedule I drug under the US Controlled Substances Act, making it illegal under federal law in the United States to, among other things, cultivate, distribute or possess cannabis in the United States. Financial transactions involving proceeds generated by, or intended to promote, cannabis-related business activities in the United States may form the basis for prosecution under applicable United States federal money laundering legislation.

While the approach to enforcement of such laws by the federal government in the United States has trended toward nonenforcement against individuals and businesses that comply with recreational and medicinal cannabis programs in states where such programs are legal, strict compliance with state laws with respect to cannabis will neither absolve the Company of liability under United States federal law, nor will it provide a defense to any federal proceeding which may be brought against the Company. The enforcement of federal laws in the United States is a significant risk to the business of the Company and any proceedings brought against the Company thereunder may adversely affect the Company’s operations and financial performance.

Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking information prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, believed, estimated, or expected. 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. Accordingly, readers should not place undue reliance on forward-looking information, which speak only as of the date of this news release. The Company disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by law.

SOURCE Hollister Biosciences Inc.

For further information: Company Contact: Joshua Lavers: ir@hollisterbiosciences.co, Tel: (416) 644-2020 or (212) 812-7680

Posted on

atai Life Sciences Increases its Ownership Position in COMPASS Pathways

atai Life Sciences Increases its Ownership Position in COMPASS Pathways

Demonstrates atai’s confidence in COMPASS’ Phase 2b data and its potential for patients with treatment-resistant depression

Reinforces COMPASS as highly complementary to atai’s diversified approach to innovation in mental health

NEW YORK, Nov. 29, 2021 (GLOBE NEWSWIRE) — atai Life Sciences (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced that it has increased its ownership interest in COMPASS Pathways (“COMPASS”), from 19.4% to 20.8%.

This equity stake increase is a demonstration of atai’s confidence in COMPASS Pathways and in the potential of COMP360 in mental health care, following the recent COMP360 data in treatment-resistant depression (TRD). This solidifies atai’s position as COMPASS’ largest shareholder.

“We’ve supported COMPASS Pathways since the early days, when they were our very first psychedelic initiative, as part of our quest for more effective solutions for mental health patients. We believe this month’s Phase 2b data was a true milestone for innovation in mental health and COMP360 shows strong potential as a future treatment for patients with TRD,” said Florian Brand, Co-Founder and Chief Executive Officer of atai Life Sciences. “This further confirms our belief in COMPASS’ psilocybin-assisted psychotherapy as a valued part of our diversified approach to develop novel solutions for patients with unmet needs in mental health.”

“Today’s announcement underscores our belief in the potential of COMPASS and COMP360 in the future of mental health care. In my personal opinion, the market doesn’t seem to appreciate the full upside potential given these impressive COMP360 data, the size of the unmet patient need and the potential of COMPASS’ broad patent portfolio,” said Christian Angermayer, Founder and Chairman of atai Life Sciences.

Over 300 million people worldwide live with depression and, of these, a third struggle with TRD that cannot be managed by currently available options.1,2

COMPASS’s Phase 2b trial of COMP360 psilocybin in TRD is the largest and most robust trial ever to be conducted with psilocybin. Participants in this COMPASS trial had previously failed on two to four antidepressants. The 233-patient, 22-site, randomized, controlled, double-blind dose-controlled trial with COMP360 reported rapid and durable results in reducing depression, when combined with psychological support, and was generally well tolerated. A single 25mg dose achieved a 6.6 point reduction (vs 1mg), from baseline to week three, on the Montgomery-Åsberg Depression Rating Scale (MADRS) (p<0.001), successfully meeting the primary endpoint.

Most standard selective serotonin reuptake inhibitor (SSRI) antidepressants were approved on just a 2-3 MADRS point reduction in a general major depressive disorder patient population, and several weeks are typically required to show a significant benefit. Another comparable, intranasal esketamine has demonstrated only a 4 MADRS point reduction at 28 days vs. placebo in TRD (in third party studies), thus highlighting the potential of COMP360 in this challenging patient population.3-5

Despite the mounting problem of mental health in recent years, further compounded by the pandemic, innovation has been sorely lacking; only seven new treatments have been approved by the FDA for psychiatric disorders since 2015.6,7

In 2018, COMP360 received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for TRD.8 COMPASS has recently expanded the indications of interest to post-traumatic stress disorder and initiated an additional Phase 2 study. COMPASS also reported positive signals from an open-label investigator-initiated study in the U.S. of COMP360 for depression in cancer.9,10 COMPASS’ Phase 3 study of psilocybin in TRD is anticipated to launch in 2022. Furthermore, COMPASS is exploring the potential of COMP360 towards several further potential indications including type 2 bipolar disorder depression, anorexia nervosa, body dysmorphia, suicidal ideation and autism.

As we ultimately believe there is no one-size-fits-all solution in the treatment of mental health conditions, atai is progressing a pharmacologically-diverse array of programs, spanning psychedelics, non-psychedelics, and is developing innovative digital therapeutics to address the areas of highest unmet need in mental health. By developing COMP360 and other novel 5-HT2a agonists, COMPASS is highly complementary to our diversified platform and fully aligns with our vision to heal mental health disorders, so that everyone, everywhere can live a more fulfilled life.

References

1. World Health Organization. Depression. Published September 13, 2021. Accessed November 24, 2021. https://www.who.int/news-room/fact-sheets/detail/depression.
2. Pandarakalam JP. Challenges of Treatment-resistant Depression. Psychiatr Danub. 2018;30(3):273-284.
3. Kennedy SH, Andersen HF, Lam RW. Efficacy of escitalopram in the treatment of major depressive disorder compared with conventional selective serotonin reuptake inhibitors and venlafaxine XR: a meta-analysis [published correction appears in J Psychiatry Neurosci. 2006 Jul;31(4):228]. J Psychiatry Neurosci. 2006;31(2):122-131.
4. Mayo Clinic. Selective serotonin reuptake inhibitors (SSRIs). September 17, 2019. Accessed November 24, 2021. https://www.mayoclinic.org/diseases-conditions/depression/in-depth/ssris/art-20044825.
5. SPRAVATO (esketamine) nasal spray [Prescribing Information]. Titusville, NJ. Janssen Pharmaceuticals, Inc.
6. Abbott A. COVID’s mental-health toll: how scientists are tracking a surge in depression. Nature. 2021;590(7845):194-195.
7. EvaluatePharma (as of March 19, 2021). New drugs include new molecular entities or new active ingredients.
8. COMPASS Pathways receives FDA Breakthrough Therapy designation for psilocybin therapy for treatment-resistant depression. [Press Release] https://ir.compasspathways.com/news-events/news-releases. Published October 23, 2018. Accessed November 24, 2021.
9. COMPASS Pathways to launch phase II trial of COMP360 psilocybin therapy for post-traumatic stress disorder. [Press release] https://ir.compasspathways.com/news-releases/news-release-details/compass-pathways-launch-phase-ii-trial-comp360-psilocybin. Published November 3, 2021. Accessed November 24, 2021.
10. Open-label study of COMP360 psilocybin therapy for depression in cancer patients demonstrates feasibility of simultaneous psilocybin administration in small groups. [Press Release] https://ir.compasspathways.com/news-releases/news-release-details/open-label-study-comp360-psilocybin-therapy-depression-cancer. Published October 20, 2021. Accessed November 24, 2021.

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 has offices in New York, London, and Berlin. 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,” “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: the success, cost and timing of development of our product candidates and COMPASS Pathways’ COMP360, including the progress of preclinical and clinical trials and related milestones; 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

For atai:

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

Posted on

atai Life Sciences Increases its Ownership Position in COMPASS Pathways

Demonstrates atai’s confidence in COMPASS’ Phase 2b data and its potential for patients with treatment-resistant depression

Reinforces COMPASS as highly complementary to atai’s diversified approach to innovation in mental health

NEW YORK, Nov. 29, 2021 (GLOBE NEWSWIRE) — atai Life Sciences (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced that it has increased its ownership interest in COMPASS Pathways (“COMPASS”), from 19.4% to 20.8%.

This equity stake increase is a demonstration of atai’s confidence in COMPASS Pathways and in the potential of COMP360 in mental health care, following the recent COMP360 data in treatment-resistant depression (TRD). This solidifies atai’s position as COMPASS’ largest shareholder.

“We’ve supported COMPASS Pathways since the early days, when they were our very first psychedelic initiative, as part of our quest for more effective solutions for mental health patients. We believe this month’s Phase 2b data was a true milestone for innovation in mental health and COMP360 shows strong potential as a future treatment for patients with TRD,” said Florian Brand, Co-Founder and Chief Executive Officer of atai Life Sciences. “This further confirms our belief in COMPASS’ psilocybin-assisted psychotherapy as a valued part of our diversified approach to develop novel solutions for patients with unmet needs in mental health.”

“Today’s announcement underscores our belief in the potential of COMPASS and COMP360 in the future of mental health care. In my personal opinion, the market doesn’t seem to appreciate the full upside potential given these impressive COMP360 data, the size of the unmet patient need and the potential of COMPASS’ broad patent portfolio,” said Christian Angermayer, Founder and Chairman of atai Life Sciences.

Over 300 million people worldwide live with depression and, of these, a third struggle with TRD that cannot be managed by currently available options.1,2

COMPASS’s Phase 2b trial of COMP360 psilocybin in TRD is the largest and most robust trial ever to be conducted with psilocybin. Participants in this COMPASS trial had previously failed on two to four antidepressants. The 233-patient, 22-site, randomized, controlled, double-blind dose-controlled trial with COMP360 reported rapid and durable results in reducing depression, when combined with psychological support, and was generally well tolerated. A single 25mg dose achieved a 6.6 point reduction (vs 1mg), from baseline to week three, on the Montgomery-Åsberg Depression Rating Scale (MADRS) (p<0.001), successfully meeting the primary endpoint.

Most standard selective serotonin reuptake inhibitor (SSRI) antidepressants were approved on just a 2-3 MADRS point reduction in a general major depressive disorder patient population, and several weeks are typically required to show a significant benefit. Another comparable, intranasal esketamine has demonstrated only a 4 MADRS point reduction at 28 days vs. placebo in TRD (in third party studies), thus highlighting the potential of COMP360 in this challenging patient population.3-5

Despite the mounting problem of mental health in recent years, further compounded by the pandemic, innovation has been sorely lacking; only seven new treatments have been approved by the FDA for psychiatric disorders since 2015.6,7

In 2018, COMP360 received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for TRD.8 COMPASS has recently expanded the indications of interest to post-traumatic stress disorder and initiated an additional Phase 2 study. COMPASS also reported positive signals from an open-label investigator-initiated study in the U.S. of COMP360 for depression in cancer.9,10 COMPASS’ Phase 3 study of psilocybin in TRD is anticipated to launch in 2022. Furthermore, COMPASS is exploring the potential of COMP360 towards several further potential indications including type 2 bipolar disorder depression, anorexia nervosa, body dysmorphia, suicidal ideation and autism.

As we ultimately believe there is no one-size-fits-all solution in the treatment of mental health conditions, atai is progressing a pharmacologically-diverse array of programs, spanning psychedelics, non-psychedelics, and is developing innovative digital therapeutics to address the areas of highest unmet need in mental health. By developing COMP360 and other novel 5-HT2a agonists, COMPASS is highly complementary to our diversified platform and fully aligns with our vision to heal mental health disorders, so that everyone, everywhere can live a more fulfilled life.

References

1. World Health Organization. Depression. Published September 13, 2021. Accessed November 24, 2021. https://www.who.int/news-room/fact-sheets/detail/depression.
2. Pandarakalam JP. Challenges of Treatment-resistant Depression. Psychiatr Danub. 2018;30(3):273-284.
3. Kennedy SH, Andersen HF, Lam RW. Efficacy of escitalopram in the treatment of major depressive disorder compared with conventional selective serotonin reuptake inhibitors and venlafaxine XR: a meta-analysis [published correction appears in J Psychiatry Neurosci. 2006 Jul;31(4):228]. J Psychiatry Neurosci. 2006;31(2):122-131.
4. Mayo Clinic. Selective serotonin reuptake inhibitors (SSRIs). September 17, 2019. Accessed November 24, 2021. https://www.mayoclinic.org/diseases-conditions/depression/in-depth/ssris/art-20044825.
5. SPRAVATO (esketamine) nasal spray [Prescribing Information]. Titusville, NJ. Janssen Pharmaceuticals, Inc.
6. Abbott A. COVID’s mental-health toll: how scientists are tracking a surge in depression. Nature. 2021;590(7845):194-195.
7. EvaluatePharma (as of March 19, 2021). New drugs include new molecular entities or new active ingredients.
8. COMPASS Pathways receives FDA Breakthrough Therapy designation for psilocybin therapy for treatment-resistant depression. [Press Release] https://ir.compasspathways.com/news-events/news-releases. Published October 23, 2018. Accessed November 24, 2021.
9. COMPASS Pathways to launch phase II trial of COMP360 psilocybin therapy for post-traumatic stress disorder. [Press release] https://ir.compasspathways.com/news-releases/news-release-details/compass-pathways-launch-phase-ii-trial-comp360-psilocybin. Published November 3, 2021. Accessed November 24, 2021.
10. Open-label study of COMP360 psilocybin therapy for depression in cancer patients demonstrates feasibility of simultaneous psilocybin administration in small groups. [Press Release] https://ir.compasspathways.com/news-releases/news-release-details/open-label-study-comp360-psilocybin-therapy-depression-cancer. Published October 20, 2021. Accessed November 24, 2021.

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 has offices in New York, London, and Berlin. 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,” “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: the success, cost and timing of development of our product candidates and COMPASS Pathways’ COMP360, including the progress of preclinical and clinical trials and related milestones; 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

For atai:

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 

Posted on

Seelos Therapeutics Announces Acquisition of an Exclusive License of iX Biopharma’s Proprietary Wafer-Based Delivery Platform for Sublingual Ketamine

Seelos Therapeutics Announces Acquisition of an Exclusive License of iX Biopharma’s Proprietary Wafer-Based Delivery Platform for Sublingual Ketamine

– New SLS-003 Program Extends Seelos’ Ketamine Franchise into Additional Indications Including Chronic Neuropathic Pain and Additional Psychiatric Disorders

– Program has been Granted Orphan Drug Designation in the US for the Treatment of Complex Regional Pain Syndrome

NEW YORK, Nov. 24, 2021 /PRNewswire/ — Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced it has entered into an exclusive license agreement (License Agreement), whereby it acquired a worldwide license (excluding China, Taiwan, Macau and Hong Kong) from iX Biopharma Ltd (iX Biopharma) for Wafermine™, a sublingual racemic ketamine wafer, and a worldwide license for other sublingual ketamine wafers, delivered using a proprietary fast-dissolving wafer-based drug delivery platform technology known as WaferiX™.

Seelos plans to evaluate sublingual ketamine, now named SLS-003, in pain indications such as chronic neuropathic pain and Complex Regional Pain Syndrome (CRPS) and in additional psychiatric disorders, including post-traumatic stress disorder (PTSD).

The US Food and Drug Administration (FDA) has granted Wafermine™ Orphan Drug designation for the treatment of CRPS.

“Our licensing of this new program broadens Seelos’ ketamine franchise with a formulation that we believe will be more suitable for chronic dosing in indications like CRPS and PTSD, which are both very difficult indications to treat effectively,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos. “The pharmacokinetic, pharmacodynamic and safety profiles of SLS-003 that have been demonstrated to date suggest a formulation with the potential of being prescribed with less restrictions than current formulations. Our team is very excited to be developing both acute, in SLS-002, and a potentially chronic, in SLS-003, ketamine-based therapy programs. We look forward to initiating studies with SLS-003 in 2022 and our recent capital raises have accounted for the expected development costs for initiating studies.”

“We are delighted to collaborate with Seelos Therapeutics, whose deep insights in ketamine drug development make them an ideal partner to further the development of Wafermine™ and the other sublingual ketamine products,” said Eddy Lee, Chairman and CEO of iX Biopharma. “Licensing our WaferiX™-based pharmaceutical drugs to suitable third parties for development and commercialization is a core strategy to unlock the value of our assets. We are therefore excited that this commercially significant agreement with Seelos is a validation of our ability to deliver on this strategy.”

Pursuant to the License Agreement, Seelos will pay iX Biopharma  a one-time, upfront fee of $9,000,000, comprised of $3,500,000 in cash and $5,500,000 in restricted shares of Seelos’ common stock for the worldwide license for Wafermine™ (excluding China, Taiwan, Macau and Hong Kong), the worldwide license for WaferiX™ in other ketamine formulations, and clinical supplies. Seelos will also pay iX Biopharma certain milestone payments contingent on achievement by Seelos of certain development, regulatory and commercial milestones and a low double-digit royalty on future net sales of certain licensed products.

About iX Biopharma LTD

iX Biopharma is a specialty pharmaceutical and nutraceutical company listed on the Catalist board of the Singapore Exchange Securities Trading Limited (SGX-ST), operating a fully integrated business model from drug development to manufacturing and supply, with facilities in Australia. The Group is focused on the development and commercialization of therapies for diseases of the central nervous system using novel, patent-protected formulations for sublingual delivery.

For more information about iX Biopharma LTD, please visit their website: https://www.ixbiopharma.com/.

About WaferiX™

The licensed products utilize iX Biopharma’s patented sublingual wafer technology, known as WaferiX™, to disintegrate under the tongue rapidly for faster therapeutic action and predictable dosing. In pharmacokinetic studies, sublingual delivery using WaferiX™ increased bioavailability of active compounds when compared to oral administration, while avoiding excessively high peak plasma concentrations typical of IV bolus dosing.

About Seelos Therapeutics

Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare disorders. The Company’s robust portfolio includes several late-stage clinical assets targeting psychiatric and movement disorders, including orphan diseases. Seelos is based in New York, New York.

For more information, please visit our website: http://seelostherapeutics.com, the content of which is not incorporated herein by reference.

Forward Looking Statements

Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those related to the efficacy and potential applications for the Licensed Products and associated Wafermine technology; the satisfaction of the conditions related to any contingent milestone or royalty payments; and the funding of all future development, manufacturing and commercialization of the Licensed Products. These statements are based on Seelos’ current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos’ business and plans described herein include, but are not limited to, the risks that Seelos will not realize the expected benefits from the license with iX Biopharma, risks associated with the implementation of Seelos’ business strategy, the risks related to raising capital to fund its development plans and ongoing operations, risks related to Seelos’ current stock price, risks related to the global impact of COVID-19, as well as other factors expressed in Seelos’ periodic filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact Information: 
Anthony Marciano 
Chief Communications Officer  
Seelos Therapeutics, Inc. (Nasdaq: SEEL) 
300 Park Avenue, 2nd Floor 
New York, NY 10022 
(646) 293-2136 
anthony.marciano@seelostx.com 
https://seelostherapeutics.com/   
https://twitter.com/seelostx   
https://www.linkedin.com/company/seelos

SOURCE Seelos Therapeutics, Inc.

Related Links

https://seelostherapeutics.com/

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Novamind Unveils New Logo and Invests in Unified Brand

Novamind Unveils New Logo and Invests in Unified Brand

TORONTO, ON / November 24, 2021 / Novamind Inc. (CSE: NM | OTCQB: NVMDF | FSE: HN2) (“Novamind” or the “Company”), a leading mental health company specialized in psychedelic medicine, today launched a new logo and announced that the Company will unite its subsidiaries and brands under a single Novamind brand.

Novamind is investing in a revitalized and unified brand following a year of significant growth including expansion into new states, launching new clinics and research sites and bringing to market several innovative mental health care offerings.

Novamind Logo

Novamind’s new logo is now live on its corporate website and social media platforms. The logo integrates and flows across all digital and physical properties, and represents Novamind’s core beliefs in hope, healing and transformation. The open doorway at the centre of the logo, working in conjunction with the radiating lines, is an invitation towards an improved way of life—one where taking care of mental health is a priority.

The logo reveal kicks off the multi-phase rebrand of the Company’s network of clinics and research sites, expected to be complete in 2022. The Company is also improving its website to scale alongside its growth strategy and better serve diverse audiences with enhanced content and tools. Taking inspiration from the revitalized logo, the website will provide an accessible digital entry point to Novamind’s world-class care and clinical research offerings.

Yaron Conforti, CEO and Director, commented: “The new logo, rebrand and website reflects our rapid evolution over the last year. It’s an exciting opportunity to unify our current and future assets under one unique identity that will become a trusted and recognized name for innovative mental healthcare in communities across the U.S.”

About Novamind
Novamind is a leading mental health company enabling safe access to psychedelic medicine through a network of clinics and clinical research sites. Novamind provides ketamine-assisted psychotherapy and other novel treatments through its network of integrative mental health clinics and operates a full-service contract research organization specialized in clinical trials and evidence-based research for psychedelic medicine. For more information on how Novamind is enhancing mental wellness and guiding people through their entire healing journey, visit novamind.ca.

Contact Information
Novamind
Yaron Conforti, CEO and Director
Telephone: +1 (647) 953 9512

Samantha DeLenardo, VP, Communications
Email: media@novamind.ca

Bill Mitoulas, Investor Relations
Email: bill@novamind.ca

Forward-Looking Statements
This news release contains forward-looking statements. All statements other than statements of historical fact included in this release are forward-looking statements that involve risks and uncertainties. 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. Important factors that could cause actual results to differ materially from the Company’s expectations including the risks detailed from time to time in the Company’s public disclosure. The reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable laws.

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Kids try ketamine in the metaverse: issue 24

Here’s what’s in store for you in today’s issue:

🍄 Psychedelic therapy enters the Metaverse?!

🍄 Kids try ketamine

🍄 How psychedelics help you manage stress

🍄 Microdosing for a better sleep

🍄 And more.

Be sure to check out this week’s Daily Mushroom podcast:

Functional Mushrooms for Health & Nutrition with FreshCap CEO Tony Shields

In the episode of the Daily Mushroom Podcast, we have Tony Shields, CEO of FreshCap. Tony’s knowledge on mushrooms is deep and expansive and stems from a childhood fascination with these magnificent fungi. If you want to learn more about the benefits of functional mushrooms, this podcast is for you.

Therapeutic banner

How psychedelics help you manage stress

Psychedelic drug users had less psychological distress and more social support during pandemic lockdowns, according to a recent Tilburg University survey. 

Users were more likely to spend time outdoors, maintain healthy diets, meditate, play music, and do yoga. Non-users spent more time watching TV and following COVID news.

Ditch your opioid addiction

A new study found that people who used psychedelics within the past six months were 55% less likely to use opioids daily. 

Can microdosing before bed help you sleep better? 

MindMed (MNMD) launched a study to investigate the effects of microdosing LSD in the morning versus the evening.

Researchers will use digital devices and software to track:

  • Various sleep measures
  • Neuroplasticity
  • Mood
  • Cognitive function
  • Regulation of emotions
  • Quality of life &
  • Immune function

Too much screen time, shopping, or sex? 

Clearmind Medicine’s (CMND) proprietary compound could treat alcohol addiction, but that’s not all. It is now being evaluated to treat other addictive behaviours such as compulsive consumption of food, television, technology, shopping, gambling, and even sex.

Reducing alcohol cravings

A study discovered that psilocybin can reduce the odds of alcohol relapse! 

How does it work? Alcohol reduces a protein in the brain called mGluR2. In a rat model, researchers found that the more protein lost, the more alcohol the rats craved, creating an addictive cycle.

Psilocybin was able to restore protein levels, thus decreasing relapses.

inspirational banner

Psychedelic therapy enters the Metaverse?!

Tennessee-based ketamine company Revitalist (CALM) announced that it’s developing a mental health clinic in the Metaverse 🤯

Patients will be able to attend VR therapy sessions, pay with cryptocurrency, and earn NFTs as part of a rewards program.

Should kids try ketamine?

Most parents think they should! 

A survey shows that parents, especially those who have experienced mental illness, are very open to ketamine therapy for children. The average acceptance score was 7/10 and over 60% said they would allow their child to try ketamine therapy to treat depression. 

business banner

Allied Corp. (ALID) sourced the active ingredients to produce Psilonex™, its formulation of psilocybin, functional mushrooms, and vitamins. It will be used in conjunction with a daily dose of CBD in an upcoming clinical trial on depression, anxiety, and PTSD.

Way2Grow Biopharma, a private BC company, received a license from Health Canada to create a psychedelic production campus. The company can produce up to $30 worth of compounds to sell to pharmacies and clinics.

Delic (DELC) launched a free, virtual education program to teach the families of ketamine therapy patients how they can best support their loved ones through the healing journey.

These companies announced their quarterly highlights:

legal banner

Suing for access to MDMA

A psychiatrist is suing the Australian state of Victoria for denying a patient access to MDMA-assisted therapy. The case has been adjourned until early next year, as the government may decide to reschedule MDMA from a Schedule 9 to a Schedule 8 substance.

Tackling one of the biggest litter problems in the world!

Researchers in Australia are training oyster mushrooms to digest cigarette butts, including their microplastics. The goal is to turn some of the 4.5 trillion cigarette butts that are littered annually into a reusable material!

Need a brain-boost?

Try FreshCap’s Mushroom Coffee to have the most productive day ever!

Made with organic Lion’s Mane mushrooms to support cognition, immune-boosting Chaga, and stress-relieving Ashwagandha, it’s everything you love about coffee – made even better.

Use promo code DAILY for 10% off your order at FreshCaps.com! 

You’re welcome in advance 😉

Industry Quick Hits

Nov 15 – Lobe Sciences Announces Common Stock to Trade Under the Symbol “LOBEF” in US Markets Read more…

Nov 16 – Michael J. Fox Foundation Donates $2M to Fund Ketamine Trial to Treat Depression in Patients with Parkinson’s Disease Read more…

Nov 16 – Ketamine One (MEDI) Subsidiary IRP Health Opens Two New Veteran-Focused Clinics in Comox Valley and Ottawa Read more…

Nov 17 – Pasithea Therapeutics (KTTA) Expands At-Home Ketamine Therapy to New York City, Los Angeles, San Diego, and San Francisco Read more…

Nov 19 – Numinus to Begin Trading on the OTC Under Symbol “NUMIF” Read more…

Nov 19 – PsyBio Therapeutics Furthers Intellectual Property Portfolio with Six New Manufacturing Patent Applications Read more…

Video of the Week

Jada and Jaden Smith Discuss Psychedelics

Playlist of the Week

60s - 70s stoner rock
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AbbVie Announces First Provincial Reimbursement for VENCLEXTA® (venetoclax) with Obinutuzumab for Patients with Previously Untreated Chronic Lymphocytic Leukemia in Quebec

AbbVie Announces First Provincial Reimbursement for VENCLEXTA® (venetoclax) with Obinutuzumab for Patients with Previously Untreated Chronic Lymphocytic Leukemia in Quebec

  • Following the signing of an agreement between AbbVie and the pan-Canadian Pharmaceutical Alliance (pCPA), Quebec is the first province to reimburse the combination treatment.
  • VENCLEXTA® (venetoclax) plus obinutuzumab is the first chemotherapy-free, fixed-duration combination regimen approved by Health Canada for patients with previously untreated chronic lymphocytic leukemia (CLL).

MONTREAL, Nov. 18, 2021 /CNW/ – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced today that an agreement has been reached with the pan-Canadian Pharmaceutical Alliance (pCPA) for VENCLEXTA® (venetoclax) in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL). The regimen combines six 28-day cycles of obinutuzumab with 12 cycles of VENCLEXTA.1

Chronic Lymphocytic Leukemia in Canada (CNW Group/AbbVie Canada)
Chronic Lymphocytic Leukemia in Canada (CNW Group/AbbVie Canada)

Effective November 10, on Québec’s Listes des médicaments, VENCLEXTA is listed in combination with obinutuzumab, for the treatment of adult patients with previously untreated chronic lymphocytic leukemia. For full criteria, consult the list of medications in effect.2

“Being able to prescribe a therapy, such as venetoclax in combination with obinutuzumab, that has a finite treatment duration and manageable side effects is a welcomed option for my patients. After completing the prescribed treatment regimen, I can tell them that they can stop their medication because this effective combination helps to delay disease progression,” explains Dr. Sarit Assouline, Physician, Division of Hematology, Sir Mortimer B. Davis-Jewish General Hospital, Senior Investigator, Lady Davis Institute for Medical Research, Associate Professor, Department of Oncology, McGill University.

In October 2020, the Institut national d’excellence en santé et en services sociaux (INESSS) recommended that the Minister include VENCLEXTA, in combination with obinutuzumab, on the Listes des médicaments for the treatment of CLL. INESSS concluded that “the results of the intermediate analysis show that the venetoclax/obinutuzumab combination as first-line therapy in patients with CLL prolongs progression-free survival in a statistically and clinically meaningful way compared to the chlorambucil/obinutuzumab combination.”3

“Lymphoma Canada is pleased that this combination is available on the Listes des médicaments in Québec for the treatment of chronic lymphocytic leukemia. Due to the nature of the disease and its high relapse rate, it is important to offer patients effective treatment options so that they can face their cancer journey with the comfort of knowing that there are always alternatives,” says Antonella Rizza, Chief Executive Officer, Lymphoma Canada.

VENCLEXTA, in combination with obinutuzumab, is the third indication for VENCLEXTA for the treatment of CLL, a first-in-class B-cell lymphoma-2 (BCL-2) inhibitor. BCL-2 is a protein that prevents cancer cells from undergoing apoptosis, the process that leads to the natural death or self-destruction of cancer cells. VENCLEXTA is also approved in combination with rituximab for the treatment of adult patients with CLL who have received at least one prior therapy, and as a monotherapy for the treatment of patients with CLL with 17p deletion who have received at least one prior therapy, or patients with CLL without 17p deletion who have received at least one prior therapy and for whom there are no other available treatment options.1

“We are very proud of this tremendous milestone bringing VENCLEXTA plus obinutuzumab to people living with CLL in Quebec. This combination is a much-needed treatment option and reinforces our commitment to people living with blood cancer,” says Tracey Ramsay, Vice President and General Manager, AbbVie Canada.

CLL, which is typically a slow-progressing cancer of the bone marrow and blood[4], is one of the most common types of leukemia in adults. In Canada, CLL accounts for approximately 1,745 newly diagnosed cases of leukemia each year and is responsible for more than 600 deaths a year.5

VENCLEXTA is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

About AbbVie in Oncology
At AbbVie, we strive to discover and develop medicines that deliver transformational improvements in cancer treatment by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and by working together with our partners – scientists, clinical experts, industry peers, advocates, and patients. We remain focused on delivering these transformative advances in treatment across some of the most debilitating and widespread cancers. We are also committed to exploring solutions to help patients obtain access to our cancer medicines. AbbVie’s oncology portfolio consists of marketed medicines and a robust pipeline containing multiple new molecules being evaluated worldwide in more than 300 clinical trials and more than 20 different tumor types.

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca. Follow @abbviecanada on Twitter or find us on LinkedIn.

_____________________________________

1

Venclexta Product Monograph. AbbVie Corporation, Canada. https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/VENCLEXTA_PM_EN.pdf. Accessed November 9, 2021

2

Régie de l’assurance maladie du Québec’s Listes des médicaments. https://www.ramq.gouv.qc.ca/fr/a-propos/liste-medicaments-fournis-etablissement. Accessed November 9, 2021

3

Institut national d’excellence en santé et en services sociaux. https://www.inesss.qc.ca/fileadmin/doc/INESSS/Inscription_medicaments/Avis_au_ministre/Novembre_2020/Venclexta_2020_10.pdf. Accessed November 9, 2021

4

Lymphoma Canada. Chronic lymphocytic leukemia.www.lymphoma.ca/lymphoma/lymphoma-101/types-lymphoma/cll. Accessed November 9, 2021.

5

Canadian Cancer Statistics. Chronic lymphocytic leukemia statistics.www.cancer.ca/en/cancer-information/cancer-type/leukemia-chronic-lymphocytic-cll/statistics/?region=on. Accessed November 9, 2021.

SOURCE AbbVie Canada

For further information: Muriel Haraoui, AbbVie Canada, 514-717-3764, muriel.haraoui@abbvie.com

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Mydecine Reports Third Quarter 2021 Financial Results and Provides Business Update

Mydecine Reports Third Quarter 2021 Financial Results and Provides Business Update

To Launch Phase 2/3 Smoking Cessation Clinical Trial with Johns Hopkins University (JHU)

Signed 5-Year Research Agreement with JHU to Further Mydecine’s Research of Multiple Molecules for a Variety of Indications
—

DENVER, Nov. 16, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company’), a biotechnology and digital technology company aiming to transform the treatment of mental health and addiction disorders, today reported its financial results for the third quarter ended September 30, 2021 and provided a business update.

“During the third quarter of 2021, we entered into a 5-year research agreement with Johns Hopkins University School of Medicine, one of the most experienced university departments in conducting clinical research related to the therapeutic use of psychedelics. In collaboration with JHU, we are rapidly progressing one of our lead candidates, MYCO-001, through clinical trials with the upcoming seamless Phase 2/3 smoking cessation clinical trial, and their NIDA grant-funded smoking cessation study which will use MYCO-001. This marks the first time in over 50 years that the U.S government has funded a study of a psychedelic compound for therapeutics,” stated Joshua Bartch, CEO of Mydecine. “As we prepare for the launch of these trials, we expect to meet with the FDA for Pre-Investigational New Drug Application (Pre-IND) meetings in early 2022, another step closer to bringing to market more effective treatments for today’s unmet needs in mental health and addiction.”

Business Highlights During and Subsequent to the Third Quarter 2021

Clinical Trials

  • Prepared to supply its lead drug candidate, MYCO-001, for a JHU multi-site NIDA grant-funded smoking cessation study led by Dr. Matthew Johnson.
  • Announced upcoming launch of seamless Phase 2/3 smoking cessation clinical trial studying the science and efficacy of MYCO-001.
  • Signed a five-year research agreement with JHU School of Medicine to advance clinical trials and explore multiple molecules and medicines for a variety of indications.

IP Portfolio

  • Filed final patent application for MYCO-003 with the United States Patent and Trademark Office and the World Intellectual Property Organization, which is being developed to offer enhanced treatment of anxiety and PTSD.
  • Filed new patent for MDMA-like compounds further expanding its robust portfolio of novel compounds after MDMA-assisted psychotherapy received Breakthrough Therapy Designation from the Food and Drug Administration (FDA).
  • Filed a technology patent that allows for the creation of formulations that utilize nanoemulsion technology to enhance, stabilize and make repeatable properties of ingredients from traditional medicine. The patent will cover formulations that are generally recognized as safe by FDA (GRAS-certified).
  • Successfully synthesized a novel psilocin analogue with improved pharmaceutical properties to further expand its library of patent-pending tryptamines.

Technology

  • Launched Mindleap 2.0, an updated version of its virtual health platform, providing improved infrastructure, better user experience, and expanded content. The 2.0 version also adds focus on the conscious and trustworthy adoption of psychedelics into the broader categories of mental health.
  • Continued development of AI-driven drug discovery program, screening billions of new drug candidates and filtering them for their ability to modulate the activity of the psychedelic-related targets.

Corporate

  • Completed its spin-out transaction of ALT House Cannabis Inc., which now holds the Company’s U.S. cannabis assets in order for the Mydecine Innovations Group’s team to focus on the company’s core drug development business.

Financial Results for the Third Quarter 2021

Net Loss: Net loss attributable to common stockholders was $4.5 million for the third quarter 2021, or a basic and diluted loss per share attributable to common stockholders of $0.02, as compared to a net loss attributable to common stockholders of $17.4 million for the third quarter 2020, or a basic and diluted loss per share attributable to common stockholders of $0.11.

Cash Position: As of September 30, 2021, the Company had cash and cash equivalents of $1.6 million.

About Mydecine Innovations Group
Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a biotechnology and digital technology company developing innovative first-and-second-generation novel therapeutics for the treatment of mental health and addiction through world-class technology and drug development infrastructure. Mydecine Innovations Group was founded in 2020 on the guiding principle that there is a significant unmet need and lack of Innovations in the mental health and therapeutic treatment environments. Mydecine Innovations Group is dedicated to efficiently developing innovative therapeutics to treat PTSD, depression, anxiety, addiction, and other mental health disorders. Mydecine Innovations Group’s business model combines clinical trials and data outcome, technology, scientific and regulatory expertise with a focus on psychedelic therapy underpinned by other novel molecules with differentiated therapeutic potential. By collaborating with some of the world’s foremost authorities connected by best practices, Mydecine Innovations Group aims to responsibly fast-track the development of new medicines across its platforms, seeking to effectively treat and ultimately change the way we view mental health disorders. Mydecine Innovations Group’s vision is to bridge the current gap between what the mental healthcare system currently provides with the needs of the patients. Mydecine Innovations Group is headquartered in Denver, Colorado, USA with international offices in Leiden, Netherlands.

Learn more at: https://www.mydecine.com and follow us on Twitter, and LinkedIn.

For more information, please contact:

Media Contacts
Anne Donohoe / Nick Opich
KCSA Strategic Communications
myco@kcsa.com
1-212-896-1265 / 1-212-896-1206

Investor Contacts
Charles Lee, Investor Relations
corp@mydecineinc.com
1-720-277-9879

Allison Soss / Erika Kay
KCSA Strategic Communications
myco@kcsa.com
1-212-896-1267

On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
contact@mydecineinc.com

For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.

This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. 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 forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.

MYDECINE INNOVATIONS GROUP INC.
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
UNAUDITED
(EXPRESSED IN CANADIAN DOLLARS)

As at, September 30,
2021
$		 December 31,
2020 (audited)
$
Current assets
Cash 1,593,516 2,190,702
Rent and other receivable 135,674 27,746
Inventory 41,268 47,262
Sales tax receivable 73,632 13,734
Prepaids and deposits 3,782,180 216,003
Total current assets 5,626,270 2,495,447
Non-current assets
Prepaids and deposits 1,922,559 –
Investment in joint venture 158,432 303,982
Note receivable 327,536 316,110
Investment in associate 233,579 4,481,988
Right-of-use asset 154,347 223,645
Investment properties 1,419,347 1,418,345
Property and equipment 521,867 291,614
Total assets 10,363,937 9,531,131
Current liabilities
Accounts payable and accrued liabilities 1,315,927 1,187,486
Convertible debentures 272,740 2,959,755
Derivative liabilities 837,207 1,586,744
Lease liability – current portion 76,969 69,329
Total current liabilities 2,502,843 5,803,314
Non-current liabilities
Long-term portion of lease liability 94,515 167,118
Total liabilities 2,597,358 5,970,432
Shareholders’ equity
Share capital 105,648,795 85,298,435
Contributed surplus 14,848,383 12,734,636
Equity portion of convertible debentures 17,190 254,690
Accumulated other comprehensive loss (449,317 ) (444,803 )
Deficit (112,298,472 ) (94,282,259 )
Total shareholders’ equity 7,766,579 3,560,699
Total liabilities and shareholders’ equity 10,363,937 9,531,131

 

MYDECINE INNOVATIONS GROUP INC.
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
UNAUDITED
(EXPRESSED IN CANADIAN DOLLARS)

For the three-month
period ended,		 For the nine-month
period ended,
September
30, 2021		 September
30, 2020		 September
30, 2021		 September
30, 2020
Sales 73 17,158 21,278 43,391
Cost of goods sold (35 ) (21,153 ) (10,032 ) (31,829 )
Gross margin 38 (3,995 ) 11,246 11,562
Expenses
Finance cost 22,995 19,151 146,692 19,151
Corporate development 410,424 325,038 2,838,317 1,099,728
Amortization 47,572 61,886 126,767 128,926
Consulting fees 1,617,184 461,623 3,835,207 1,744,009
Director and management fees 454,215 186,520 1,286,723 367,622
Foreign exchange loss (gain) (65,862 ) (21,233 ) 249,746 (158,014 )
Insurance 171,704 – 324,927 –
Office and miscellaneous 427,486 113,441 648,961 170,235
Share of losses (income) from investment in Joint Venture 28,503 – 136,604 –
Share of (income) from investment in Associate 45,056 (7,470 ) 86,808 (15,411 )
Professional fees 179,130 43,255 1,529,599 143,088
Regulatory and filing fees 7,879 12,644 185,791 27,091
Research and development 1,265,610 433,408 2,587,740 434,791
Salaries 311,355 – 545,686 –
Share-based payments – 3,715,421 – 4,725,174
Total expenses (4,923,251 ) (5,343,684 ) (14,529,568 ) (8,686,360 )
Other income (expenses)
Change in fair value of derivative liabilities 353,612 (740,434 ) 575,505 (740,434 )
Impairment of investment in associate – – (4,169,616 ) –
Consideration paid in excess of net assets acquired from acquisition – (10,645,239 ) – (10,645,239 )
Write-off of inventory – (458,921 ) – (458,921 )
Other income – 35 – 35
Rental income 33,073 45,293 98,539 141,715
Gain (loss) on settlement of debt – 21,879 (2,319 ) 33,304
Total other income (expenses) 386,685 (11,777,387 ) (3,497,891 ) (11,669,540 )
Net loss for the period (4,536,528 ) (17,125,066 ) (18,016,213 ) (20,344,338 )
Foreign currency translation adjustment 44,114 (279,811 ) (4,514 ) (152,659 )
Net loss and comprehensive loss for the period (4,492,414 ) (17,404,877 ) (18,020,727 ) (20,496,997 )
Net loss per share – Basic and diluted (0.02 ) (0.11 ) (0.08 ) (0.22 )
Weighted average number of shares outstanding – Basic and diluted 240,222,065 152,596,239 228,662,632 95,039,381