Core One Labs – Page 11 – Daily Mushroom

August 26, 2021March 9, 2022

AbbVie receives a positive reimbursement recommendation from the Canadian Agencies for Drugs and Technology in Health (CADTH) pan-Canadian Oncology Drug Review Expert Review Committee (pERC) for VENCLEXTA® in combination with azacitidine for AML patients

pERC recommends reimbursement of VENCLEXTA® (venetoclax) in combination with azacitidine for the treatment of newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive induction chemotherapy.
The VIALE-A trial demonstrated a statistically significant increase in overall survival with VENCLEXTA® in combination with azacitidine compared to placebo in combination with azacitidine alone.1
AML is one of the most difficult-to-treat blood cancers with a very low survival rate. 2,4

Montreal, QC, August 26, 2021 – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced today that the CADTH pCODR Expert Review Committee (pERC) recommends that VENCLEXTA® (venetoclax) in combination with azacitidine should be reimbursed for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy, only if the conditions listed are
met.3 AML is an aggressive and difficult-to-treat blood cancer with a low survival rate.2,4

In Canada, the five-year net survival rate is approximately 21% for people diagnosed with AML in the general population.4

“AML is one of the most common types of leukemia in adults. This cancer progresses rapidly and has a significantly lower survival rate compared to other cancers,” said Dr. Joseph Brandwein, Hematology Division Director and Professor in the Department of Medicine at the University of Alberta.

“The average age is nearly 70, and most older AML patients are not candidates for intensive chemotherapy and stem cell transplantation. For those patients, treatments to date have not been very effective. This new
regimen has demonstrated improved outcomes.”

Overall, pERC concluded that venetoclax plus azacitidine provides a treatment option for older patients and patients with comorbidities that has an impact on the disease and improves survival.3

“I was diagnosed in November 2019 with AML and my treatment plan included VENCLEXTA. I am hopeful that newly diagnosed AML patients will soon have access to this treatment,” said William Levine of Courtice, Ontario.

In the VIALE-A trial, the median overall survival of patients who received VENCLEXTA plus azacitidine was 14.7 months (95% CI, 11.9, 18.7) vs 9.6 months (95% CI, 7.4, 12.7) in patients who received azacitidine in combination with placebo. In the VENCLEXTA plus azacitidine arm, the most frequent
serious adverse reactions (≥ 5%) were febrile neutropenia (30%), pneumonia (23%), sepsis (16%) and hemorrhage (9%).1

“We have reached another important milestone. With this positive recommendation by the pCODR Expert Review Committee, we are one step closer to providing this treatment to all Canadians who need it. At AbbVie, we stand by our mission to transform the standard of care for people living with cancer,” said Tracey Ramsey, Vice President and General Manager, AbbVie Canada.

VENCLEXTA in combination with azacitidine was approved by Health Canada in December 2020. Health Canada’s approval was granted under Project Orbis, an FDA initiative which provides a framework for concurrent submission and review of oncology products among international partners.

Venetoclax is being developed by AbbVie and Roche. It 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 Facebook, Instagram, YouTube and LinkedIn.

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Media:
Muriel Haraoui
AbbVie Canada
514-717-3764
muriel.haraoui@abbvie.com
1 AbbVie Corporation Venclexta(R) (venetoclax) Product Monograph. Date of Preparation: September 27, 2016. Date of
Revision: January 21, 2021. https://www.abbvie.ca/content/dam/abbviedotcom/ca/en/documents/products/VENCLEXTA_PM_EN.pdf. Accessed August 26, 2021.
2 Leukemia & Lymphoma Society of Canada. Acute myeloid leukemia (AML). https://www.llscanada.org/leukemia/acutemyeloid-leukemia. Accessed August 26, 2021.
3 CADTH. https://www.cadth.ca/venetoclax. Accessed August 26, 2021.
4 Canadian Cancer Society. Survival statistics for acute myelogenous leukemia. https://www.cancer.ca/en/cancerinformation/cancer-type/leukemia-acute-myelogenous-aml/prognosis-and-survival/survival-statistics/?region=on.
Accessed August 26, 2021.

August 18, 2021March 9, 2022

Biomind Labs to Advance a Phase II Clinical Trial on DMT for Treatment-Resistant Depression

TORONTO — Biomind Labs Inc. (“Biomind Labs” or the “Company”) ( NEO: BMND), a leading biotech company in fast-acting psychedelics is pleased to announce that its Phase II clinical trial on N, N-dimethyltryptamine (“DMT”) for treatment-resistant depression has been approved by the Brazilian Institutional Review Board.

“A paramount step in our rapid evolution that positions us at the forefront of clinical research on the DMT molecule. DMT is an indole alkaloid found endogenously in various plant species and in humans, it is found primarily in the lungs, thyroid, adrenal gland, and in lower concentration in the brain. DMT provides the principal psychedelic in the Amazonian decoction, ayahuasca. According to a recent randomized placebo-controlled trial in patients with treatment-resistant depression conducted by our Neuroscientist Dr. Draulio Barros de Araujo, published in Psychological Medicine, ayahuasca is safe and presented a rapid antidepressant effect. This clinical trial is the first and the only completed randomized placebo-controlled trial to test a psychedelic substance in treatment-resistant depression. The results of this trial were crucial for Biomind Labs to be able to advance with an isolated form of DMT”, said Alejandro Antalich, CEO of Biomind Labs.

The Phase II clinical trial will be conducted by Dr. Draulio Barros de Araujo, will include 40 individuals and will be conducted in Brazil. Given the safety profile, the absence of overdose, tolerance and previous results with ayahuasca, Biomind Labs continues to reinforce the Molecule Clinical Development Dossier of its novel pharmaceutical BMND01, enabling a potentially successful molecule-to-market lifecycle.

“Approximately 20-30% of people with depression have inadequate responses to antidepressants and psychotherapies, even after multiple interventions. Treatment-resistant depression places great demands on healthcare resources and on patients, many of whom attempt and die by suicide. This scenario makes the search for new treatments a necessity. Clinical trials carried out in recent years have shown rapid antidepressant responses to psychedelic substances. Our scientific team is a pioneer in conducting clinical trials, using open and randomized designs with psychedelic substances in patients with treatment-resistant depression”, commented Dr. Draulio Barros de Araujo.

“We believe that DMT possesses a number of benefits in comparison to other tryptamine compounds such as psilocybin. This includes a short psychedelic experience with a duration of less than 30 minutes compared to other psychedelic compounds, including psilocybin, whose duration of experience typically lasts six hours, LSD typically lasts ten hours and ayahuasca four hours. The significant reduction in experience duration provides greater practical applicability to potentially deliver the psychedelic treatment in a supervised real-world clinical setting. This is also highly relevant to affordability, one of our core objectives. While establishing a close relationship with the psychiatry community, government authorities and health agencies, we are working towards a potentially massive and affordable solution for millions of patients suffering from depression, anxiety and eating disorders, among others”, concluded Antalich.

About Biomind Labs Inc.

Biomind Labs is a biotech research and development company aimed at transforming biomedical sciences knowledge from natural psychotropic plants into novel pharmaceutical drugs and innovative nanotech delivery systems for a variety of psychiatric and neurological conditions. Through its acceleration platform, Biomind Labs is developing novel pharmaceutical formulations of the main natural psychedelic molecules, DMT, 5-MeO-DMT and mescaline for treating a wide range of therapeutic indications. Biomind Labs’ focus is to guarantee patients access to affordable and modern-day treatments and use cases. Biomind Labs understands that long-lasting psychedelic effects make it difficult to create adequate clinical protocols to serve a larger number of patients, and this is the reason why Biomind Labs specializes in fast-acting psychedelics.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that constitute “forward-looking information” (“forward-looking information”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information.

Forward-looking statements in this document include, among others, statements relating to expectations regarding the results and timelines of the Company’s Phase II clinical trial, the molecule-to-market lifecycle of BMND01, the potential health benefits of DMT, building strong relationships with the psychiatric community, government authorities and health agencies, the business plans and growth plans of the Company and other statements that are not historical facts. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors and risks include, among others: (a) the Company may require additional financing from time to time in order to continue its operations which may not be available when needed or on acceptable terms and conditions acceptable; (b) compliance with extensive government regulation; (c) domestic and foreign laws and regulations could adversely affect the Company’s business and results of operations; (d) the stock markets have experienced volatility that often has been unrelated to the performance of companies and these fluctuations may adversely affect the price of the Company’s securities, regardless of its operating peers; (e) adverse changes in the public perception of tryptamine-based treatments and psychedelic-based therapies; (f) the impact of COVID-19; and (g) general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release.

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

The forward-looking information contained in this news release represents the expectations of the Company as of the date of this news release and, accordingly, is subject to change after such date. Readers should not place undue importance on forward-looking information and should not rely upon this information as of any other date. The Company undertakes no obligation to update these forward-looking statements in the event that management’s beliefs, estimates or opinions, or other factors, should change.

The Neo Exchange Inc. has neither approved nor disapproved the contents of this news release and is not responsible for the adequacy and accuracy of the contents herein.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210818005361/en/

August 17, 2021March 9, 2022

Core One Labs Acquires Frontier Mycology

Vancouver, British Columbia, Canada – August 17, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD6, WKN: A3CSSU) (the “Company” or “Core One”) is a research and development company focused on bringing psychedelic medicines to market through the development and production of API grade psychedelic compounds, the advancement of psychedelic assisted treatments, and the integration of novel delivery system technology. The Company is pleased to announce it has completed the acquisition (the “Transaction”) of all of the outstanding share capital of Frontier Mycology Corp. (“Frontier”).

Frontier, through its website MushroomNews.Org, is a compilation of the globe’s top mushroom news, providing compelling content, such as news and media coverage, financial analysis and relevant research on both functional and psychedelic mushrooms. Frontier’s objective is to reduce the stigma towards psychedelic medicines by providing information and transparency on all aspects of the psychedelic industry, and to drive the psychedelics industry into the forefront of modern medicine. In addition to being a trusted information source in the psychedelics’ space, Frontier also embodies a an e-commerce platform, with a growing selection of legal functional mushroom products.

Joel Shacker, CEO of the Company stated, “This acquisition further expands our presence in the psychedelic space, by allowing us access to potential investors who utilize this website as a tool for keeping up to date on this growing industry. The direct-to-consumer ecommerce platform for functional mushrooms, also allows the company to generate sales to consumers, who can then be converted to different products as the legalization of psychedelics progresses.”

Transaction Structure

The Transaction was completed pursuant to a share purchase agreement among the Company, Frontier and the shareholders of Frontier (the “Definitive Agreement”) dated effective August 16, 2021. Pursuant to the Definitive Agreement, and in consideration for the acquisition of Frontier, the Company has issued 666,666 common shares and 634,920 share purchase warrants entitling the holders to acquire a further 634,920 common shares of the Company at a price of $6.50 per share until August 17, 2023.

The Company is at arms-length from Frontier and its shareholders. The Transaction neither constitutes a fundamental change nor a change of business for the Company, nor has it resulted in a change of control of the Company within the meaning applicable securities laws and the policies of the Canadian Securities Exchange. In connection with completion of the Transaction, the Company has issued 17,964 common shares to certain third-parties who provided administrative services necessary to complete the Transaction.

ABOUT CORE ONE LABS INC.

Core One is a biotechnology research and technology life sciences enterprise focused on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy. Core One has developed a patent pending thin film oral strip (the “technology”) which dissolves instantly when placed in the mouth and delivers organic molecules in precise quantities to the bloodstream, maintaining excellent bioavailability. The Company intends to further develop and apply the technology to psychedelic compounds, such as psilocybin. Core One also holds an interest in medical clinics which maintain a combined database of over 275,000 patients. Through these clinics, the integration of its intellectual property, R&D related to psychedelic treatments and novel drug therapies, the Company intends to obtain regulatory research approval for the advancement of psychedelic-derived treatments for mental health disorders.

CORE ONE LABS INC.

Joel Shacker

Chief Executive Officer

FOR FURTHER INFORMATION:

Email: info@core1labs.com

Telephone: 1-866-347-5058

FOLLOW US:

Website: https://core1labs.com/

Twitter: https://twitter.com/Coreonelabs

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Instagram: https://www.instagram.com/coreonelabsinc/

CAUTIONARY DISCLAIMER STATEMENT

The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management’s current estimates, beliefs, intentions, and expectations. They are not guarantees of future performance. The Company cautions that all forward-looking statements are inherently uncertain, and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Such factors include, among other things: risks and uncertainties relating to the Company’s limited operating history and the need to comply with strict regulatory regulations. Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information.

In addition, psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (Canada) and it is a criminal offence to possess substances under the Controlled Drugs and Substances Act (Canada) without a prescription or authorization. Health Canada has not approved psilocybin as a drug for any indication. Core One does not have any direct or indirect involvement with illegal selling, production, or distribution of psychedelic substances in jurisdictions in which it operates. While Core One believes psychedelic substances can be used to treat certain medical conditions, it does not advocate for the legalization of psychedelics substances for recreational use. Core One does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within approved regulatory frameworks.

August 17, 2021March 9, 2022

Core One Labs (COOL) Acquires Frontier Mycology

Core One Labs Acquires Frontier Mycology

August 16, 2021March 9, 2022

atai Life Sciences Reports Second Quarter 2021 Financial Results and Business Update

-Successfully completed Initial Public Offering on Nasdaq raising $258.8 million in gross proceeds, including the underwriters’ over-allotment-

-Received $20 million upfront payment from Otsuka as part of the first major collaboration between a biopharmaceutical company developing psychedelics and large pharma-

-Advancement of 11 therapeutic programs, including initiation of Recognify’s Phase 2 and GABA’s Phase 1 trials-

-18 significant catalysts across atai’s platform anticipated over next 18 months including two clinical trials to be completed and four clinical trials to be initiated in 2021-

-Solidified leadership position with strong cash position of $453.6 million to advance our current programs and incubate, acquire and invest in new programs-

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

BERLIN and NEW YORK, Aug. 16, 2021 (GLOBE NEWSWIRE) — atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today reported its financial results for the second quarter ended June 30, 2021 and provided a corporate update.

“In the second quarter of 2021, we made significant advancements to build our business and successfully completed an initial public offering on Nasdaq, raising approximately US$258.8 million in gross proceeds,” said Florian Brand, CEO and co-founder of atai. “We have the financial resources to maximize the value of our decentralized drug development platform for improved probability of clinical success and leverage the value of our transformative pipeline. 2021 continues to be a pivotal year for atai with multiple upcoming catalysts across our expanding pipeline.”

Q2 Corporate Updates

Received $20 million as part of Perception’s collaboration with Otsuka for the development of R-ketamine, the first major collaboration between a biopharmaceutical company developing psychedelics and large pharma.
Entered a strategic partnership with IntelGenx, a leader in pharmaceutical films. As part of the strategic partnership, IntelGenx will exclusively partner with atai to develop compounds for the prevention or treatment of mental health diseases or disorders.
Announced InnarisBio in partnership with UniQuest, Australia’s leading university technology transfer company commercializing the research of The University of Queensland (UQ), to develop a novel sol-gel-based intranasal drug delivery technology to improve treatments for mental health disorders.

Recent Advancements and Upcoming Milestones for atai’s Core Value Drivers

Perception Neuroscience:
Program Details: PCN-101 is a parenteral formulation of R-ketamine, a glutamatergic modulator being developed as a rapid-acting antidepressant, with the potential to be an at-home non-dissociative alternative to S-ketamine (marketed as SPRAVATO).

Upcoming Milestones

Phase 2 randomized, double blind, placebo-controlled trial in patients with treatment-resistant depression (TRD) to be initiated in the third quarter and expected to run through late 2022.
The trial will assess efficacy and safety, dose response and duration of action in patients with TRD.

Recognify Life Sciences:
Program Details:

RL-007, a cholinergic, glutamatergic and GABA-B receptor modulator, is an orally available compound that is thought to alter the excitatory/inhibitory balance in the brain to produce pro-cognitive effects.
atai is developing this compound for the treatment of cognitive impairments associated with schizophrenia.

Q2 Advancements

In April 2021, Recognify initiated a Phase 2a study for RL-007, after receiving IND clearance from the U.S. Food and Drug Administration to commence clinical trials for the treatment of Cognitive Impairment Associated with Schizophrenia (CIAS).
The study is designed to evaluate the effects of RL-007 on safety, tolerability, electroencephalogram-based biomarkers, and cognition.

Upcoming Milestones: Topline results from the Phase 2a single-arm, multiple dose trial in patients with CIAS expected in late 2021.

GABA:
Program Details

GRX-917 is an oral formulation of a deuterated version of etifoxine, a compound that has a long history of prescription use in France for treating anxiety disorders.
GRX-917 is designed to provide rapid anxiolytic activity with improved tolerability compared to current treatments for anxiety in the United States.

Q2 Advancements

In June 2021, GABA initiated a randomized, double blind, placebo-controlled Phase 1 trial.
The study will evaluate safety, tolerability, pharmacokinetics, as well as pharmacodynamics using qEEG.

Upcoming Milestones: Topline results from the Phase 1 single ascending dose/multiple ascending dose program expected early in 2022.

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

Q2 Advancements: DemeRx received approval from the UK Medicines and Healthcare products Regulatory Agency to commence subject enrollment in our proposed Phase 1/2 clinical trial.

Upcoming Milestones

Phase 1 component of Phase 1/2 trial of DMX-1002 in recreational drug users and healthy volunteers to be initiated in Q3 2021 and is expected to read out safety data in early 2022.
The trial is designed to assess safety, tolerability, pharmacokinetics, and efficacy, and the results will inform future studies in patients with opioid use disorder.

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

Q2 Advancements

In June 2021, COMPASS completed dosing in the Phase 2b clinical trial of COMP360 psilocybin therapy for treatment-resistant depression.
The randomized, double-blind, dose-ranging study investigated the safety and efficacy of psilocybin therapy in 233 patients, making it the largest clinical trial with psilocybin to date.

Upcoming Milestones: Phase 2b trial results are expected in late 2021.

Second Quarter 2021 Financial Results

Cash and Cash Equivalents
Cash and cash equivalents totaled $453.6 million as of June 30, 2021, compared to $97.2 million as of December 31, 2020. The six month increase of $356.4 million is attributed to net proceeds of $231.6 million from our Initial Public Offering, net proceeds of $168.6 million from Series C and Series D common stock issuances, $20.0 million of license revenue proceeds, and $4.0 million proceeds from the sale of investments and conversion of convertible notes. Offsetting were cash payments of $32.0 million for investments in platform companies, and $35.8 million in net operating expenses.

Revenues
License revenue in the first half 2021 of $19.9 million was related to proceeds received from Perception’s License and Collaboration Agreement with Otsuka.

Operating Costs and Expenses
Research and development expenses were $16.0 million and $21.6 million for the three and six months ended June 30, 2021, as compared to $2.9 million and $5.0 million for the same prior year periods. The increase of $13.1 million and $16.6 million, respectively, were attributable to personnel costs, including stock-based compensation expense, and increased CRO expenses related to advancements in our R&D programs.

We recorded acquisition of in-process research and development expense of $8.0 million and $9.0 million for the three and six months ended June 30, 2021, relating to our investments in Neuronasal and InnarisBio.

General and administrative expenses for the three and six months ended June 30, 2021 were $37.3 million and $46.6 million, as compared to $2.9 million and $4.4 million in the same prior year periods. The increases of $34.4 million and $42.2 million, respectively, were attributable to personnel costs, including stock-based compensation expense, professional fees, and other costs related to support of our platform growth and public company requirements.

Total stock-based compensation expense for the three and six months ended June 30, 2021 was $37.5 million and $37.7 million, respectively, as compared to $41,000 and $82,000 for the comparable prior year periods, reflecting the recognition of expense related to the achievement of IPO performance-based partial vesting conditions.

Net loss attributable to atai stockholders for the three and six months ended June 30, 2021 was $48.5 million and $47.8 million, respectively, as compared to $16.4 million and $0.1 million for the comparable prior year periods.

Conference Call Information

atai will host a conference call and live audio webcast today at 08:30am ET to discuss its financial results and provide a corporate update. To access the live conference call, please dial 877-407-3982 from the United States, or +1 (201) 493-6780 internationally, using the conference ID: 13721888. The live and archived webcast of this call will be available in the “Events” section of the atai Life Sciences website at ir.atai.life. An archived copy of the webcast will be available on the atai website for at least 30 days after the conference call.

About atai Life Sciences

atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to acquiring, incubating and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders. atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders. atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai is headquartered in Berlin, with offices in New York and London. For more information, please visit www.atai.life.

Forward-Looking Statements

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

We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including without limitation: we are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception, and we anticipate that we will continue to incur significant losses for the foreseeable future; we will require substantial additional funding to achieve our business goals, and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our product development efforts; our limited operating history may make it difficult to evaluate the success of our business and to assess our future viability; we have never generated revenue and may never be profitable; our product candidates contain controlled substances, the use of which may generate public controversy; clinical and preclinical development is uncertain, and our preclinical programs may experience delays or may never advance to clinical trials; we 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, filed with the Securities and Exchange Commission (“SEC”) on June 21, 2021 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.

Investor Contact:
Greg Weaver
atai – Chief Financial Officer
Email: greg.weaver@atai.life

Media Contact:
Anne Donohoe
KCSA Strategic Communications
Phone: +1 (212) 896-1265
Email: atai@kcsa.com

ATAI LIFE SCIENCES N.V.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share amounts)
(unaudited)

	Three Months Ended						Six Months Ended
	June 30,						June 30,
		2021			2020			2021			2020
License revenue	$	–		$	–		$	19,880		$	–
Operating expenses:
Research and development		16,026			2,854			21,611			4,998
Acquisition of in-process research and development		7,962			120			8,934			120
General and administrative		37,331			2,851			46,604			4,421
Total operating expenses		61,319			5,825			77,149			9,539
Loss from operations		(61,319	)		(5,825	)		(57,269	)		(9,539	)
Other income (expense), net		(5,982	)		(1,321	)		(4,279	)		20,294
Net loss before income taxes		(67,301	)		(7,146	)		(61,548	)		10,755
Provision for income taxes		(58	)		–			(64	)		–
Gain on investment dilution		16,923			–			16,923			–
Losses from investments in equity method investees, net of tax		(2,937	)		(9,811	)		(4,640	)		(11,831	)
Net loss		(53,373	)		(16,957	)		(49,329	)		(1,076	)
Net loss attributable to redeemable noncontrolling
interests and noncontrolling interests		(4,912	)		(600	)		(1,556	)		(1,022	)
Net loss attributable to ATAI Life Sciences N.V. stockholders	$	(48,461	)	$	(16,357	)	$	(47,773	)	$	(54	)
Net loss per share attributable to ATAI Life Sciences N.V. stockholders– basic and diluted	$	(0.37	)	$	(0.18	)	$	(0.38	)	$	(0.00	)
Weighted average common shares outstanding attributable to ATAI Life Sciences N.V. stockholders — basic and diluted
		132,265,075			90,709,312			125,797,732			90,709,312

ATAI LIFE SCIENCES N.V.
CONDENSED CONSOLIDATED BALANCE SHEET
(Amounts in thousands)

	June 30,		December 31,
		2021		2020
	(unaudited)			(1)
Assets
Cash and cash equivalents	$	453,622	$	97,246
Prepaid expenses and other current assets		3,964		2,076
Short term notes receivable – related party		–		226
Property and equipment, net		331		71
Deferred offering costs		–		1,575
Equity method investments		19,780		–
Other investments held at fair value		6,886		–
Other investments		16,107		8,044
Long term notes receivable		1,388		911
Long term notes receivable – related parties		3,194		1,060
Other assets		689		339
Total assets	$	505,961	$	111,548
Liabilities and Stockholders’ Equity
Accounts payable	$	6,202	$	3,083
Accrued liabilities		7,824		9,215
Deferred revenue		120		–
Short-term notes payable		39		–
Contingent consideration liability – related parties		2,466		1,705
Convertible promissory notes – related parties, net of discounts and deferred issuance costs		1,176		1,199
Convertible promissory notes and derivative liability		–		978
Other liabilities		3,239		–
Total stockholders’ equity attributable to ATAI Life Sciences N.V. stockholders		474,850		90,822
Noncontrolling interests		10,045		4,546
Total liabilities and stockholders’ equity	$	505,961	$	111,548

(1)The condensed consolidated financial statements as of and for the year ended December 31, 2020 are derived from the audited consolidated financial statements as of that date.

August 16, 2021March 10, 2022

Wuhan General Group Launches M2Bio Labs in Hout Bay, South Africa

CAPE TOWN, SA / ACCESSWIRE / August 16, 2021 / WUHAN GENERAL GROUP, INC. (OTC PINK:WUHN) (“Wuhan” or the “Company”), a bioceutical company focused on alternative plant-based cannabinoids and psilocybin medical research, is pleased to announce the following corporate update:

M2Bio Sciences launches M2Bio Labs alongside the distinguished Bay Harbour Market in Hout Bay. This picturesque setting encompasses 7500 square feet which will house the following departments:

Food Sciences – Test kitchen for the Food Technology Team to develop and refine its proprietary medicinal food and beverage lines, and for the creation of alternative proteins for sustainable agriculture and consumption. The space will be decked out with offices, a lab and a fully functioning industrial kitchen.
Aromachology – Research and development lab focused on aromatherapy and cosmetics lines, for retail distribution under the Dr. AnnaRx brand.
Sustainable Materials and Packaging – 3D Printing lab dedicated to the development of hemp and mycelium composites as alternatives to single-use plastics.
Sensory Stimulation Hub – A space to study the influence of sensory stimuli on human behavior, and to examine the relationship between these stimuli and the individual’s feelings and emotions.

“We take great pride and are very excited about the cutting-edge research being conducted at M2Bio Labs. Our findings will enable us to provide effective and innovative solutions for individuals on their wellness journey. This is a first of its kind development in Africa, advancing mental health treatments in a nonclinical environment using the arts and senses – sight (vision), hearing (auditory), smell (olfactory), taste (gustatory) and touch (tactile).” said M2Bio Sciences CEO Jeff Robinson

The newly appointed Johara Hartley, Managing Director, M2Bio Labs added: “I am a firm believer that everything you need is within you, and if you still cannot find it inside, it probably grows from the ground you’re standing on. The space we are creating integrates technology, science and the arts in order to reboot neural pathways and ultimately improve the healthcare process, using holistic, alternative and progressive medicine. We plunge into the core human senses and bring the individual back to their roots, evolving their experience. As much as we work physically, we must do the internal work and that starts with the realignment of our fundamentals. The very definition of being alive is to be able to respond to stimuli, among factors like consumption, movement and growth. The world around us cannot stop, but we can choose to pause and dedicate time for our physical health and mental well-being. We are more than capable of responding fruitfully to physical, biological and environmental stressors, as the most up-to-date versions of ourselves.”

The M2Bio Labs space complements the corporate offices located in Woodstock, Cape Town.

About Wuhan General Group, Inc./ M₂Bio Sciences, Inc

Wuhan General Group, Inc. (DBA M₂Bio Sciences), through its wholly-owned subsidiary MJ MedTech is a nutraceutical biotechnology company focused on alternative plant-based cannabinoids and psilocybin medical research that develops and commercializes a range of CBD and mushrooms-based products under Dr. AnnaRx™, Medspresso™ and Liviana™ brands. In addition, our research and clinical trials with psilocybin are aimed at new therapies that will help patients who suffer from alcohol addiction, mental illness and cardiovascular diseases. Our mission is to advance botanical-based medicine to the forefront by deploying best-practice science and medicine, clinical research and emerging technologies. The Company is traded on the Over-the-Counter Bulletin Board of NASDAQ under the trading symbol “WUHN”.

For further information:

Publicly traded company (OTC Pink: WUHN)
Website: www.m2bio.co
E-mail:info@m2bio.co

Forward-Looking Statements:

Safe Harbour Statement – In addition to historical information, this press release may contain statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release include the intent, belief, or expectations of the Company and members of its management team with respect to the Company’s future business operations and the assumptions upon which such statements are based. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance, and involve risks and uncertainties and that actual results may differ materially from those contemplated by such forward-looking statements. Factors that could cause these differences include, but are not limited to, failure to complete anticipated sales under negotiations, lack of revenue growth, client discontinuances, failure to realize improvements in performance, efficiency and profitability, and adverse developments with respect to litigation or increased litigation costs, the operation or performance of the Company’s business units or the market price of its common stock. Additional factors that could cause actual results to differ materially from those contemplated within this press release can also be found on the Company’s website. The Company disclaims any responsibility to update any forward-looking statements.

SOURCE: Wuhan General Group, Inc./M₂Bio Sciences, Inc.

View source version on accesswire.com:
https://www.accesswire.com/659909/Wuhan-General-Group-Launches-M2Bio-Labs-in-Hout-Bay-South-Africa

August 13, 2021March 9, 2022

CORE ONE LABS’ CLINICS SUBMIT APPLICATION TO TREAT PATIENT WITH PSILOCYBIN PSYCHEDELIC- ASSISTED THERAPY

Vancouver, British Columbia, Canada – August 13, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABD), (Frankfurt: LD6, WKN: A3CSSU) (the “Company”) a research and technology company focused in life sciences and on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy is pleased to announce that its wholly owned subsidiaries, Rejuva Mental Health Clinic (“Rejuva”) and Bluejay Mental Health Group Inc. (“Bluejay”), have partnered to assist their patient with completing an application for exemption under section 56(1) of the Controlled Drugs and Substances Act (the “CDSA” or “Act”) of Canada for the purpose of legally accessing psilocybin for psychedelic-assisted therapy.

In Canada, psychedelics are classified as controlled substances under the CDSA, and are prohibited for all use, unless a successful application for exemption under section 56 of the Act is made to the Federal Minister of Health. Section 56 allows the Federal Minister of Health to exempt persons or controlled substances if “the exemption is necessary for a medical or scientific purpose or is otherwise in the public interest” (Health Canada).

In recent years Health Canada has endeavored to increase access to psychedelic medicine for patients facing mental health challenges, including providing select approvals for exemption under Section 56 of the CDSA. On August 4, 2020, Patty Hadju, Canada’s Federal Minister of Health granted the first legal exemptions from the CDSA under section 56(1), on compassionate grounds, to four Canadians with incurable cancer to receive psilocybin therapy to treat their anxiety.

Bluejay’s wholly owned subsidiary, GreenLeaf Medical Clinic (EST 2011), was one of the first specialized medical cannabis clinics in Canada and continues to assess patients for the appropriateness of medical cannabis into Health Canada’s Access to Cannabis for Medical Purposes Regulations (ACMPR). The management team has worked closely with Health Canada, developing a strong understanding for compliance. They have also led educators in cannabinoid therapy and have worked with thousands of patients, doctors and cultivators. Bluejay intends to be one of the first clinics to have its patients granted the section 56(1) exemption as it has been at the forefront of the progressive health movement for years.

Core One is focused on advancing the use of psychedelics as alternative modalities to treating mental health afflictions, and part of this advancement is supporting and assisting patients in gaining access to such alternatives through the Company’s various Canadian-based medical and research clinics.

“With a growing roster of clinics under our umbrella, Core One continues to execute on its long-term goal of developing an internal patient base for its biosythensized psilocybin and psychedelic treatments. Submitting the application for a section 56(1) exemption is the next step in allowing our patients access to these varieties of treatments, and as one of the first companies to do so, we will be positioned as a leader in the adoption of exemptions for patients. This scalable business model has untapped potential as patients begin to receive exemptions for mental health issues ranging from depression to addiction.” stated Joel Shacker CEO of the Company.

About Core One Labs Inc.

ON BEHALF OF THE BOARD OF DIRECTORS OF CORE ONE LABS INC.

Joel Shacker

Chief Executive Officer

FOR FURTHER INFORMATION:

Email: info@core1labs.com

Telephone: 1-866-347-5058

FOLLOW US:

Website: https://core1labs.com/

Twitter: https://twitter.com/Coreonelabs

Facebook: https://www.facebook.com/Core-One-Labs-Inc-100969251278277/

LinkedIn: https://www.linkedin.com/company/core-one-labs

Instagram: https://www.instagram.com/coreonelabsinc/

CAUTIONARY DISCLAIMER STATEMENT:

The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

August 13, 2021March 10, 2022

Goodness Growth Holdings Announces Second Quarter 2021 Financial Results

– Q2 GAAP revenue of $14.2 million increased 16% compared to Q2 2020 –
– Excluding former PA and OH subsidiaries, Q2 revenue increased 45% YoY and 8% sequentially –
– Record GAAP gross profit margin of 49% reflects greater scale and improving efficiency of operations –

MINNEAPOLIS, Aug. 13, 2021 /PRNewswire/ — Goodness Growth Holdings, Inc. (“Goodness Growth” or the “Company”) (CSE: GDNS; OTCQX: GDNSF), a physician-led, science-focused cannabis company and IP incubator, today reported financial results for its second quarter ended June 30, 2021. All currency figures referenced in this press release reflect U.S. dollar amounts.

“Our second quarter performance was in line with our expectations, and we were pleased to see increased scale and efficiency of operations contribute to record gross margin performance during the quarter,” said Chairman and Chief Executive Officer, Kyle Kingsley, M.D. “As we discussed on last quarter’s call, our wholesale performance in Maryland was temporarily impacted by the move to our recently completed state-of-the-art manufacturing facility, and we expect to see that facility reach normalized production levels during the third quarter of this year. Additionally, our expansion projects in New Mexico and Arizona will help strengthen revenue and profitability in the second half of this year, especially in the fourth quarter when the expansion projects are operating at full capacity.”

Dr. Kingsley continued, “Our operating teams are focused on flower production, strain variety and quality in all of our markets, and we’re continuing to make progress on our expansion plans in New York and we will share updates on these plans throughout the year. As a reminder, the recent passage of adult-use legislation in New York and New Mexico and the inclusion of flower to Minnesota’s medical program have substantially improved our long-term outlook in each of these markets.”

Summary of Key Financial Metrics
	Three Months Ended			Six Months Ended
US $ in millions	June 30,			June 30,
	2021	2020	Variance	2021	2020	Variance

GAAP Revenue	$14.2	$12.2	16.5%	$27.4	$24.3	12.7%
Revenue (excl. former PA and OH subsidiaries)	$14.2	$9.8	44.5%	$27.4	$19.8	38.0%
GAAP Gross Profit	$6.9	$3.6	92.5%	$12.5	$6.9	82.4%
Gross Profit Margin	48.6%	29.4%	1,920 bps	45.7%	28.2%	1,750 bps
SG&A Expenses	$8.3	$6.3	32.1%	$16.3	$13.2	24.1%
SG&A Expenses (% of Sales)	58.3%	51.4%	690 bps	59.6%	54.1%	550 bps
Adjusted EBITDA (non-GAAP)	($1.0)	($1.8)	NM	($2.7)	($4.9)	NM
Adjusted EBITDA Margin (non-GAAP)	(6.8%)	(14.5%)	770 bps	(10.0%)	(20.1%)	1,010 bps

Second Quarter Business Highlights

Total revenue of $14.2 million increased 16.5 percent year-over-year. Excluding results from the Company’s former subsidiaries in Pennsylvania, revenue increased 44.5 percent compared to Q2 2020.
Gross profit increased by $3.3 million to $6.9 million, or 48.6 percent of sales as compared to $3.6 million, or 29.4 percent of sales in Q2 2020.
During the quarter, the Company completed the planned expansion of its cultivation and processing facility in New Mexico, which is now fully operational. The Company now has four operating dispensaries and 13,000 sq. ft. of cultivation capacity in the New Mexico market, which is expected to transition to adult-use sales in the spring of calendar year 2022, pending development of operating regulations.
During the quarter, the Company announced the launch of its ground medical cannabis flower products in the state of New York. The ground flower line is being sold in 3.5-gram and 7-gram jars and will be expanded to feature indica, sativa, and hybrid strains such as Killer Kush, Wedding Cake, and a Kosher-approved Tangie Kush. These products will be available at all four of the Company’s dispensaries in New York and via home delivery.
On June 8-9, 2021, the Company hosted its inaugural Investor Day events, during which the Company discussed the long-term outlook for its various state markets and also announced that its subsidiary, Resurgent Biosciences, plans to expand its research into psychedelics. Resurgent is a non-plant/fungus touching-entity and does not intend to engage directly in the cultivation, manufacture, or distribution of any psychedelics. For more information regarding the Company’s Investor Day events and disclosures, please visit https://goodnessgrowth2021.q4ir.com.

Second Quarter Financial Summary

Total revenue was $14.2 million in the first quarter, an increase of 16.5 percent as compared to Q2 2020, including the Company’s former subsidiaries in Pennsylvania and Ohio. Excluding contributions from Pennsylvania and Ohio, revenue increased 44.5 percent. Retail revenue excluding Pennsylvania increased 35.7 percent to $11.3 million in Q2 2021 and reflected growth in each of the Company’s retail markets. Wholesale revenue, excluding Pennsylvania and Ohio increased by 92.1 percent to $2.9 million, driven by strong growth in Arizona and New York.

Gross profit was $6.9 million, or 48.6 percent of revenue, as compared to gross profit of $3.6 million or 29.4 percent of revenue in Q2 last year. The improvement in gross profit was driven by higher throughput across all markets resulting in decreased fixed cost per unit.

Total operating expenses in the second quarter were $10.2 million, a reduction of $5.5 million as compared to $15.6 million in the second quarter of 2020. The decrease in total expenses was attributable to a decrease in stock- based compensation expenses, partially offset by increased general and administrative expenses which was driven by operational buildouts in Arizona and Maryland, where the Company is in the process of completing large cultivation and manufacturing expansion projects.

Total other expenses were $1.3 million during Q2 2021, a reduction of $2.4 million compared to $3.7 million in Q2 2020. The decrease was primarily attributable to a gain on derivative liability of $1.5 million during the quarter.

EBITDA, as described in accompanying disclosures and footnotes, was a loss of $0.9 million during Q2 2021, compared to a loss of $13.2 million in Q2 2020. Adjusted EBITDA was a loss of $1.0 million in Q2 2021, as compared to a loss of $1.8 million in Q2 2020. Please refer to the Supplemental Information and Reconciliation of Non-GAAP Financial Measures at the end of this press release for additional information.

Net loss in Q2 2021 was $5.5 million, as compared to a net loss of $16.1 million in Q2 2020. The improvement in net loss was driven by the increase in gross profit margin and lower operating and other expenses, partially offset by increased income tax expense.

Other Events

On July 9, 2021, the Company announced that its subsidiary has signed a definitive agreement to purchase a medical cannabis dispensary located in Baltimore. Upon closing of the transaction, which is expected to occur later this year pending regulatory approval and subject to customary closing conditions, the Company will have two dispensaries operating in the state of Maryland.

On August 13, 2021, the Company announced in a separate news release that it had appointed Josh Rosen to its Board of Directors, expanding its number of board seats to seven. Josh Rosen is Managing Partner at Bengal Capital, and former Chief Executive Officer and Chairman of 4Front Ventures, a multi-state U.S. cannabis operator.

Balance Sheet and Liquidity

As of June 30, 2021, the Company had 126,021,801 equity shares issued and outstanding on an as-converted basis, and 154,346,560 shares outstanding on an as-converted, fully diluted basis.

As of June 30, 2021, total current assets were $42.0 million, including cash on hand of $20.8 million. Total current liabilities were $16.1 million, with $1.1 million in debt due within 12 months.

Horizon Strategy & Outlook

The Company’s Horizon strategy was unveiled during its recent Investor Day events, and is a plan for growth through fiscal year 2022. Over this timeframe, the Company expects to open an additional 6-10 Green Goods® retail dispensaries, and a majority of the Company’s markets are expected to begin to generate more substantial revenue growth as pending changes to regulatory regimes take effect.

Management has provided various outlook ranges for performance in fiscal year 2022, the achievement of which depend upon the Company’s ability to achieve expected biomass production yields, the timing of completion of various development projects, the timing of commencement of adult-use sales in New Mexico and New York, and the timing of commencement of flower sales in the Minnesota medical market.

Dr. Kingsley commented, “We believe the expansion projects we have underway, combined with growth catalysts driven by changing regulatory frameworks in our markets, will result in substantial improvements in revenue growth and profitability over the next 18 months. Variability in our performance will depend on the timing of completion of projects and regulatory approvals in our markets, but we believe we’re positioned for significant growth next year as we continue executing our Horizon strategy.”

Conference Call and Webcast Information

Goodness Growth management will host a conference call with research analysts today, Friday, August 13, 2021 at 8:00 a.m. ET (7:00 a.m. CT) to discuss its financial results for its second quarter ended June 30, 2021. Interested parties may register to attend the conference call via the following link: http://www.directeventreg.com/registration/event/9694714.

Upon registration, each participant will be provided with call details and a registrant ID for Goodness Growth’s conference ID number 9694714. A live audio webcast of this event will also be available in the Events & Presentations section of the Company’s Investor Relations website and will be archived for one year.

About Goodness Growth Holdings, Inc.

Goodness Growth Holdings, Inc., is a physician-led, science-focused holding company whose mission is to bring the power of plants to the world. The Company’s operations consist primarily of its multi-state cannabis company subsidiary, Vireo Health, and its science and intellectual property incubator, Resurgent Biosciences. The Company manufactures proprietary, branded cannabis products in environmentally friendly facilities and state-of-the-art cultivation sites, and distributes its products through its growing network of Green Goods® and other retail locations and third-party dispensaries. Its team of more than 500 employees are focused on the development of differentiated products, driving scientific innovation of plant-based medicines and developing meaningful intellectual property. Today, the Company is licensed to grow, process, and/or distribute cannabis in eight markets and operates 18 dispensaries across the United States. For more information about Goodness Growth Holdings, please visit www.goodnessgrowth.com.

Additional Information

Additional information relating to the Company’s second quarter 2021 results will be available on EDGAR and SEDAR later today. Goodness Growth refers to certain non-GAAP financial measures such as Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA) and adjusted EBITDA (defined as earnings before interest, taxes, depreciation, amortization, less certain non-cash equity compensation expense, one-time transactions, and other non-recurring non-cash items. These measures do not have any standardized meaning and may not be comparable to similar measures presented by other issuers. Please see the Supplemental Information and Reconciliation of Non-GAAP Financial Measures at the end of this news release for more detailed information regarding non-GAAP financial measures.

Contact Information

Investor Inquiries:	Media Inquiries:
Sam Gibbons	Albe Zakes
Vice President, Investor Relations	Vice President, Corporate Communications
samgibbons@goodnessgrowth.com	albezakes@goodnessgrowth.com
(612) 314-8995	(267) 221-4800

Forward-Looking Statement Disclosure

This press release contains “forward-looking information” within the meaning of applicable United States and Canadian securities legislation. To the extent any forward-looking information in this press release constitutes “financial outlooks” within the meaning of applicable United States or Canadian securities laws, such information is being provided as preliminary financial results and the reader is cautioned that this information may not be appropriate for any other purpose and the reader should not place undue reliance on such financial outlooks. Forward-looking information contained in this press release may be identified by the use of words such as “expect,” “plans,” “strategy,” “outlook,” “will,” “believe,” “continue,” “range,” “subject to,” and “pending,” or variations of such words and phrases. These statements should not be read as guarantees of future performance or results. Forward-looking information includes both known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company or its subsidiaries to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements or information contained in this press release. Financial outlooks, as with forward-looking information generally, are, without limitation, based on the assumptions and subject to various risks as set out herein. Our actual financial position and results of operations may differ materially from management’s current expectations and, as a result, our revenue and cash on hand may differ materially from the revenue and cash values provided in this press release. Forward-looking information is based upon a number of estimates and assumptions of management, believed but not certain to be reasonable, in light of management’s experience and perception of trends, current conditions, and expected developments, as well as other factors relevant in the circumstances, including assumptions in respect of current and future market conditions, the current and future regulatory environment; and the availability of licenses, approvals and permits.

Although the Company believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because the Company can give no assurance that they will prove to be correct. Actual results and developments may differ materially from those contemplated by these statements. Forward-looking information is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those projected in the forward-looking information. Such risks and uncertainties include, but are not limited to, risks related to the timing of adult-use legislation in markets where the Company currently operates; current and future market conditions, including the market price of the subordinate voting shares of the Company; risks related to the COVID-19 pandemic; federal, state, local, and foreign government laws, rules, and regulations, including federal and state laws in the United States relating to cannabis operations in the United States and any changes to such laws; operational, regulatory and other risks; execution of business strategy; management of growth; difficulty to forecast; conflicts of interest; risks inherent in an agricultural business; liquidity and additional financing; and risk factors set out in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, which is available on EDGAR with the U.S. Securities and Exchange Commission and filed with the Canadian securities regulators and available under the Company’s profile on SEDAR at www.sedar.com.

The statements in this press release are made as of the date of this release. The Company disclaims any intent or obligation to update any forward-looking information, whether as a result of new information, future events or results, or otherwise, other than as required by applicable securities laws.

Supplemental Information

The financial information reported in this news release is based on audited financial statements for the fiscal year ended December 31, 2020 and unaudited condensed interim consolidated financial statements for the fiscal quarter ended June 30, 2021. All financial information contained in this news release is qualified in its entirety with reference to such financial statements. To the extent that the financial information contained in this news release is inconsistent with the information contained in the Company’s audited financial statements, the financial information contained in this news release shall be deemed to be modified or superseded by the Company’s audited financial statements. The making of a modifying or superseding statement shall not be deemed an admission for any purposes that the modified or superseded statement, when made, constituted a misrepresentation for purposes of applicable securities laws.

GOODNESS GROWTH HOLDINGS, INC.
CONSOLIDATED BALANCE SHEETS AS OF JUNE 30, 2021 AND DECEMBER 31, 2020
(Amounts Expressed in United States Dollars, Except for Share Amounts, unaudited and condensed)

	June 30,		December 31,
	2021		2020
Assets
Current assets:
Cash	$	20,826,356	$	25,513,180
Restricted cash		–		1,592,500
Accounts receivable, net of allowance for doubtful accounts of $257,729 and $132,490, respectively		2,444,967		696,994
Inventory		16,727,640		12,644,895
Prepayments and other current assets		1,863,841		1,552,278
Notes receivable		100,561		293,700
Deferred acquisition costs		–		28,136
Assets Held for Sale		–		4,596,445
Deferred financing costs		–		120,266
Total current assets		41,963,365		47,038,394
Property and equipment, net		42,104,121		30,566,259
Operating lease, right-of-use asset		8,762,777		8,163,844
Notes receivable, long-term		3,750,000		3,750,000
Intangible assets, net		11,181,670		8,409,419
Goodwill		3,132,491		3,132,491
Deposits		1,413,719		1,412,124
Deferred tax assets		367,000		157,000
Total assets	$	112,675,143	$	102,629,531
Liabilities
Current liabilities
Accounts Payable and Accrued liabilities		10,012,597		13,477,303
Right of use liability		1,284,248		857,294
Convertible notes, net of issuance costs		–		900,000
Long-Term debt, current portion		1,110,000		1,110,000
Liabilities held for sale		–		3,595,301
Warrant Liability		3,705,859		–
Total current liabilities		16,112,704		19,939,898
Right-of-use liability		21,787,039		20,343,063
Long-Term debt		18,533,128		–
Total liabilities	$	56,432,871	$	40,282,961

Stockholders’ equity
Subordinate Voting Shares ($- par value, unlimited shares authorized; 72,660,602 shares issued and outstanding)		–		–
Multiple Voting Shares ($- par value, unlimited shares authorized; 459,950 shares issued and outstanding)		–		–
Super Voting Shares ($- par value; unlimited shares authorized; 65,411 shares issued and outstanding, respectively)		–		–
Additional Paid in Capital		170,442,492		164,079,614
Accumulated deficit		(114,200,220)		(101,733,044)
Total stockholders’ equity	$	56,242,272	$	62,346,570
Total liabilities and stockholders’ equity	$	112,675,143	$	102,629,531

GOODNESS GROWTH HOLDINGS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
THREE AND SIX MONTHS ENDED JUNE 30, 2021 AND 2020
(Amounts Expressed in United States Dollars, Except for Share Amounts, unaudited and condensed)

	Three Months Ended June 30,				Six Months Ended June 30,
	2021		2020		2021		2020
Revenue	$	14,230,900	$	12,215,365	$	27,420,789	$	24,333,932
Cost of sales		–		–		–		–
Product costs		7,273,011		8,430,507		14,779,059		17,132,160
Inventory valuation adjustments		45,000		194,234		113,000		333,242
Gross profit		6,912,889		3,590,624		12,528,730		6,868,530
Operating expenses:		–		–		–		–
Selling, general and administrative		8,299,682		6,283,343		16,335,673		13,160,468
Stock-based compensation expenses		1,408,080		8,985,422		3,722,655		11,721,360
Depreciation		246,247		219,662		417,809		222,628
Amortization		206,442		154,191		412,885		308,381
Total operating expenses		10,160,451		15,642,618		20,889,022		25,412,837

Loss from operations		(3,247,562)		(12,051,994)		(8,360,292)		(18,544,307)

Other income (expense):
Gain on disposal of assets held for sale		–		–		437,107		–
Derivative gain (loss)		1,531,371		(2,292,130)		1,689,900		(966,202)
Interest expenses, net		(2,756,358)		(1,543,169)		(3,782,504)		(2,993,433)
Other income (expenses)		(98,055)		141,859		(41,387)		(327,413)
Other expenses, net		(1,323,042)		(3,693,440)		(1,696,884)		(4,287,048)
Loss before income taxes		(4,570,604)		(15,745,434)		(10,057,176)		(22,831,355)
Current income tax expenses		(885,000)		(346,900)		(2,620,000)		(852,000)
Deferred income tax recoveries	$	(25,000)	$	(23,000)	$	210,000	$	55,000
Net loss and comprehensive loss		(5,480,604)		(16,115,334)		(12,467,176)		(23,628,355)
Net loss per share – basic and diluted		($0.04)		($0.16)		($0.10)		($0.25)
Weighted average shares used in computation of net loss per share – basic and diluted		125,557,734		98,871,038		120,856,801		93,695,441

GOODNESS GROWTH HOLDINGS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
SIX MONTHS ENDED JUNE 30, 2021 AND 2020
	Six Months Ended June 30,
(Amounts expressed in USD, except for share amounts, unaudited and condensed)	2021		2020
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$	(12,467,176)	$	(23,628,355)
Adjustments to reconcile net loss to net cash used in operating activities:
Inventory valuation adjustments		113,000		333,242
Depreciation		417,809		222,628
Depreciation capitalized into inventory		986,896		1,057,849
Non-cash operating lease expense		519,176		624,625
Amortization of intangible assets		412,885		308,381
Stock-based payments		3,722,655		11,721,360
Interest Expense		886,628		—
Gain/loss		–		53,077
Deferred income tax		(210,000)		(1,103,100)
Accretion		195,197		348,382
Derivative (Gain) Loss		(1,689,900)		966,202
Gain on disposal of OMS		(437,107)		—
Change in operating assets and liabilities:
Accounts Receivable		(1,531,985)		128,106
Prepaid expenses		(292,260)		525,028
Inventory		(4,059,044)		(516,787)
Accounts payable and accrued liabilities		(4,182,954)		1,838,680
Change in assets and liabilities held for sale		124,843		(369,485)
Net cash used in operating activities	$	(17,491,337)	$	(7,490,167)

CASH FLOWS FROM INVESTING ACTIVITIES:
PP&E Additions	$	(11,028,976)	$	(1,402,085)
Proceeds from sale of OMS net of cash		1,150,000		—
Deposits		(1,595)		16,265
Net cash provided by (used in) investing activities	$	(9,880,571)	$	(1,385,820)

CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from issuance of shares	$	–	$	7,613,490
Deferred financing costs		(865,769)		—
Proceeds from long-term debt		24,028,295		—
Convertible debt payment		(900,000)		—
Proceeds from option exercises		1,075,723		—
Lease payments		(653,165)		(652,477)
Net cash provided by financing activities	$	22,685,084	$	6,961,013

Net change in cash and restricted cash	$	(4,686,824)	$	(1,914,974)

Cash and restricted cash, beginning of period	$	25,513,180	$	9,234,173

Cash and restricted cash, end of period	$	20,826,356	$	7,319,199

Reconciliation of Non-GAAP Financial Measures

EBITDA and Adjusted EBITDA are non-GAAP measures and do not have standardized definitions under GAAP. The following information provides reconciliations of the supplemental non-GAAP financial measures, presented herein to the most directly comparable financial measures calculated and presented in accordance with GAAP. The Company has provided the non-GAAP financial measures, which are not calculated or presented in accordance with GAAP, as supplemental information and in addition to the financial measures that are calculated and presented in accordance with GAAP. These supplemental non- GAAP financial measures are presented because management has evaluated the financial results both including and excluding the adjusted items and believe that the supplemental non-GAAP financial measures presented provide additional perspective and insights when analyzing the core operating performance of the business. These supplemental non-GAAP financial measures should not be considered superior to, as a substitute for or as an alternative to, and should be considered in conjunction with, the GAAP financial measures presented.

Reconciliation of Net Loss to EBITDA and Adjusted EBITDA

	Three Months Ended				Six Months Ended
	June 30,				June 30,
	2021		2020		2021		2020
Net income (loss)	$	(5,480,604)	$	(16,115,334)	$	(12,467,176)	$	(23,628,355)
Interest expense, net		2,756,358		1,543,169		3,782,504		2,993,433
Income taxes		910,000		369,900		2,410,000		797,000
Depreciation & Amortization		452,689		373,853		830,694		531,009
Depreciation included in cost of goods sold		478,537		582,946		986,896		1,057,849

EBITDA (non-GAAP)	$	(883,020)	$	(13,245,466)	$	(4,457,082)	$	(18,249,064)

Derivative Gain		(1,531,371)		2,292,130		(1,689,900)		966,202
Inventory adjustment		45,000		194,234		113,000		333,242
Share-based compensation		1,408,080		8,985,422		3,722,655		11,721,360
Severance Expense		–		–		–		339,997
Gain on sale of discontinued operations		–		–		(437,107)		–

Adjusted EBITDA (non-GAAP)	$	(961,311)	$	(1,773,680)	$	(2,748,434)	$	(4,888,263)

View original content to download multimedia:https://www.prnewswire.com/news-releases/goodness-growth-holdings-announces-second-quarter-2021-financial-results-301354867.html

SOURCE Goodness Growth Holdings, Inc.

August 13, 2021March 9, 2022

Core One Labs’ Clinics Submit Application To Treat Patient With Psilocybin Psychedelic- Assisted Therapy

August 11, 2021March 10, 2022

Novamind Divests Non-Core Retreat Investment

Company to focus on its growing network of clinics and clinical research sites in the U.S.

TORONTO, ON / August 11, 2021 / Novamind Inc. (CSE: NM | OTC: NVMDF | FSE: HN2) (“Novamind” or the “Company”), a leading mental health company specialized in psychedelic medicine, today announced that it has completed the sale of the Company’s investment in the Synthesis Institute, a leader in psychedelic retreats and practitioner training programs located in the Netherlands (“Synthesis”).

Novamind led Synthesis’ seed financing in 2019 with a strategic investment of €750,000 (the “Strategic Investment”). Pursuant to the terms of an agreement between Synthesis and Novamind, Synthesis purchased Novamind’s Strategic Investment for €1,200,000 yielding a 60 per cent return on investment.

“Novamind was a strategic investor in Synthesis at an early stage, helping to influence the company’s direction and expansion,” said Rachel Aidan, Chief Executive Officer of Synthesis. “We remain aligned in our common mission to increase access to safe, regulated psychedelic-assisted healing.”

Novamind realized gross proceeds of approximately CAN$1,760,000 from the sale of its Strategic Investment in Synthesis (“Sale Proceeds”). Including the Sale Proceeds, Novamind’s balance sheet is strengthened with a total of CAN$9,207,945 in cash and short-term investments, and no debt (unaudited figures as at August 10, 2021).

Novamind further announced that it has elected not to proceed with a proposed investment in the Circadia Center, a retreat company operating in Costa Rica. Exiting the Company’s investments in Synthesis and Circadia is a strategic decision that enables Novamind to focus on the expansion of its network of clinics and clinical research sites located in the United States.

“Novamind has experienced rapid growth in its two core businesses,” said Yaron Conforti, Chief Executive Officer and Director. “We’ve established a unique and scalable business model that serves clients at our clinics and drug developers at our research sites. We are now exclusively focused on the continued growth of our clinic and contract research organization businesses, with near-term expansion into other U.S. states and an exciting pipeline of clinical trials.”

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

About the Synthesis Institute
Founded in 2018, Synthesis is a legal, scientist-backed psychedelic wellness, research and education platform outside of Amsterdam. Synthesis is pioneering models for transformative wellness through professional, clinically-inspired psychedelic experiences and training, providing unprecedented access for people seeking alternative therapies, as well as new modes of study for researchers investigating the effects of psychedelics in a professional setting. For more information, or to set up an exploration call, visit www.synthesisinstitute.com and www.synthesisretreat.com.

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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Category: Core One Labs

AbbVie receives a positive reimbursement recommendation from the Canadian Agencies for Drugs and Technology in Health (CADTH) pan-Canadian Oncology Drug Review Expert Review Committee (pERC) for VENCLEXTA® in combination with azacitidine for AML patients

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CORE ONE LABS’ CLINICS SUBMIT APPLICATION TO TREAT PATIENT WITH PSILOCYBIN PSYCHEDELIC- ASSISTED THERAPY

Goodness Growth Holdings Announces Second Quarter 2021 Financial Results

Core One Labs’ Clinics Submit Application To Treat Patient With Psilocybin Psychedelic- Assisted Therapy

Novamind Divests Non-Core Retreat Investment

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