Tag: financial results & corporate updates

PharmaTher Reports Financial Results for the Third Quarter of Fiscal 2022 and Provides Recent Business Highlights and Update

PharmaTher (PHRM) announced Q3 financial results including C$10.1M in cash. The company is focused on treating rare disorders with ketamine and creating novel methods of administering psychedelics.

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Cannabis Global Announces Financial and Operational Performance Highlights for the Three Months Ended Feb 28, 2022

Revenues jump more than 2,000%, Cash up over 1,800%, Expanded product offerings gaining significant traction

LOS ANGELES, CA / ACCESSWIRE / April 21, 2022 / Cannabis Global, Inc. (OTC PINK:CBGL), a licensed Los Angeles-based manufacturer and distributor in the cannabis sector, is pleased to announce financial and operational performance data for the three months ended February 28, 2022.

“The past six months represents a breakthrough period for Cannabis Global on a relative basis,” noted Arman Tabatabaei, CEO of Cannabis Global. “We are beginning to see lift-off on our commercial-stage operational model, with extremely rapid topline growth, expanded product offerings, better funding terms, and more strategic opportunities. And all of it comes from the foundation we have put in place over recent years with our R&D focus and our strong IP orientation.”

Financial Performance Highlights for the Period Ended Feb 28, 2022

• Total Revenues for the three months ended Feb 28 were $627k, up 2,330% on a year-over-year basis
• Total Revenues for the six months ended Feb 28 were $1.2M, up 3,860% on a year-over-year basis
• Cash increased 1,860% year over year to $604k
• Total Assets increased 34% year over year to $15 million

Operational Highlights for the Period Ended Feb 28, 2022

• Signed definitive agreement with Caliwanna brands for comprehensive marketing and sales integration as well as to acquire Caliwanna cannabis brands
• Summarily restructured short-term convertible debt to reduce dilution risk and position company on more favorable capital terms
• Announced intention to apply for additional patent protection for its unique inventions for the creation of nanoparticles and nanofibers made for cannabinoids
• Laid foundation for the launch of an expanded suite of edibles products

Management notes that the Company has witnessed very strong topline revenue growth over the past two quarters as it ramps up commercial stage operations. That growth has been driven by a range of new products recently introduced into the marketplace as well as a widening of the Company’s distribution footprint. Revenue growth is also being driven by the Company’s acquisition of new customers in the retail dispensary space in California.

The Company has also benefited from revamping the Cannabis Global product mix to better reflect emerging trends in major California metro areas as these cannabis markets have matured. Management notes that its recent increased focus on the “solventless” trend has been an important factor, and the Company expects that trend to continue to be a key factor this year.

Tabatabaei added, “We have made some key acquisitions that will shape our performance ahead, which we believe will feature accelerating growth. However, we are also focused on establishing a more vertically integrated model so more of that growth goes straight to the bottom line as we scale up further over the year ahead.”

About Cannabis Global, Inc.
Cannabis Global, Inc. is a Los Angeles-based, fully audited and reporting Company with the U.S. Securities & Exchange Commission, trading under the stock symbol CBGL. We are an emerging force in the cannabis marketplace with a growing product and proprietary intellectual property portfolio. We are marketing and producing Comply Bag™, an innovative solution for cannabis storage, transport and tracking. Our subsidiary, Natural Plant Extract (NPE), is a Southern California licensed cannabis manufacturer and distributor which licenses our technologies to produce edibles for the cannabis marketplace. Cannabis Global has filed three non-provisional and multiple provisional patents for cannabis infusion and nanoparticle technologies and continues an active research & development program.

Forward-Looking Statements
This news release contains “forward-looking statements” which are not purely historical and may include any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements include, among other things, the development, costs and results of new business opportunities and words such as “anticipate”, “seek”, intend”, “believe”, “estimate”, “expect”, “project”, “plan”, or similar phrases may be deemed “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with new projects, the future U.S. and global economies, the impact of competition, and the Company’s reliance on existing regulations regarding the use and development of cannabis-based products. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations and intentions contained in this press release are reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in our annual report on Form 10-K, our quarterly reports on Form 10-Q and other periodic reports filed from time-to-time with the Securities and Exchange Commission. For more information, please visit www.sec.gov.

Corporate contact:
Arman Tabatabaei
IR@cannabisglobalinc.com
+1 (310)-986-4929

IR Contact:
Stuart Smith
https://www.smallcapvoice.com/
ssmith@smallcapvoice.com

SOURCE: Cannabis Global, Inc.

View source version on accesswire.com:
https://www.accesswire.com/698272/Cannabis-Global-Announces-Financial-and-Operational-Performance-Highlights-for-the-Three-Months-Ended-Feb-28-2022

FSD Pharma Issues Corporate Updates

Toronto, April 6, 2022 – FSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE) (FRA: 0K9A) (“FSD Pharma” or the “Company”), a life sciences holding company dedicated to building a portfolio of assets and biotech solutions, announced today the following corporate updates;

1. FSD Pharma adds industry leaders Jason Sawyer and Dr. Ravinder Kumar to its Advisory Board. Jason Sawyer brings 29 years of alternative investment and business experience to FSD’s drug development efforts. He currently serves as the General Manager of Access Alternative Group S.A. (“AAG”), a Bahamas-based boutique venture investment and advisory firm. Prior to his role at AAG, Sawyer was a Principal at Crane Capital Associates and Head of its Absolute Return Strategies Group where he successfully raised more than $3.5 billion for some of the world’s leading private equity and hedge funds. In 2016, he founded Pacific West Stone and led the capital formation, investing $4.5MM in its first-year start-up phase and securing private equity financing backed by one of Canada’s largest pension funds.

Rav Kumar, PhD is an award-winning pharmaceutical industry leader, with over 30 years of global experience developing and commercializing novel drug solutions. Through his advisory role, Dr. Kumar will contribute his expertise in discovery, regulatory, preclinical and clinical, product development, manufacturing, compliance and commercialization. Dr. Kumar is currently the Director of the Centre for Medicinal Chemistry at the University of Toronto, and Chief Strategy Officer at Dalriada Drug Discovery. Prior to his current roles, Dr. Kumar served as Chief Science Officer and Advisor to The Green Organic Dutchman, Managing Director of Apotex India, and Vice President of R&D Operations, Business Development & Classic Brands at GlaxoSmithKline Canada.

2. FSD Pharma has been expanding its team aggressively at all levels to synergize its operations. The company adds the following employees to the team: Dr. Andrzej Chruscinski (Associate Vice[1]President, Clinical Affairs), Mr. Kevin Cassidy (Vice-President, Quality Systems), and Dr. Oksana Akhova (Director, Licensing, Partnership and IP). Dr. Andrzej Chruscinski trained as a physician-scientist at Stanford University earning an MD/PhD. While at Stanford, he also completed training Internal Medicine and Cardiology. After moving to Toronto, he completed a fellowship in Advanced Heart Failure/Transplantation at University Health Network. As a scientist at University Health Network, he ran a research group investigating mechanisms of transplantation tolerance. He developed antigen microarray technology to profile autoantibodies to monitor allograft function. More recently, he completed two clinical trials of tolerance induction in solid organ transplantation (LITMUS and ASCOTT). Dr. Chruscinski currently holds a medical license in Michigan, USA. Mr. Kevin Cassidy brings over 39 years of biotechnology experience to FSD Pharma. He has established and run operations, validated facilities for GMP manufacturing, biotherapeutic development, and quality testing in Canada, Chile and China. He was lead on process and business development, resulting in the first approved adenovirus-vectored vaccine. The rabies vaccine is the predecessor to several vaccines deployed in the COVID-19 pandemic. Mr. Cassidy was trained in Business Management at George Brown College and received a Bachelor of Science degree from University of Toronto.

Dr. Oksana Akhova has over two decades of experience both in industry and academia in business development, IP management and commercialization of innovative technologies. She worked across in a range of roles in academia and industry and she has strong track record in commercial licensing, management of private-public partnerships, technology marketing and business development. She has solid expertise in evaluation of companies and technologies in oncology, ophthalmology, inflammation and neurology, building financial models and IP management. She holds a PhD in oncology and an MBA with specialization in biotechnology management.

3. FSD Pharma returns to treasury 1,524,700 shares as of 31 March through its buyback program.

4. FSD Pharma adopts the RSU program and issues RSUs in Lieu of options held by Directors and Senior Management.

About FSD Pharma

FSD Pharma Inc. is a biotechnology company with three drug candidates in different stages of development. FSD BioSciences, Inc. (“FSD BioSciences”), a wholly owned subsidiary, is focused on pharmaceutical research and development of its lead compound, ultra-micronized palmitoyl ethylamine (“PEA”) or FSD-PEA (formerly called FSD-201). Lucid Psycheceuticals Inc. (“Lucid”), a wholly owned subsidiary, is focused on the research and development of its lead compounds, Lucid-PSYCH (formerly Lucid-201) and Lucid-MS (formerly Lucid-21-302). Lucid PSYCH is a molecular compound identified for the potential treatment of mental health disorders. Lucid-MS is a molecular compound identified for the potential treatment of neurodegenerative disorders.

For further information:

Company Contact:

Zeeshan Saeed, Founder, President and Executive Co-Chairman of the Board, FSD Pharma Inc.

Email: Zsaeed@fsdpharma.com

Telephone: (416) 854-8884

Investor Relations: Email: ir@fsdpharma.com, info@fsdpharma.com

Website: www.fsdpharma.com

Media Relations:

KCSA Strategic Communications

Email: FSDPharma@KCSA.com

Greenbrook TMS Reports Record Fiscal 2021 Operational and Financial Results

TORONTO–(BUSINESS WIRE)–Greenbrook TMS Inc. (TSX: GTMS, NASDAQ: GBNH) (“Greenbrook” or the “Company”), today announced its fourth quarter 2021 (“Q4 2021”) and year-end 2021 (“Fiscal 2021”) operational and financial results. All values in this news release are in United States dollars, unless otherwise stated.

FISCAL 2021 OPERATIONAL AND FINANCIAL HIGHLIGHTS

• Fiscal 2021 revenue increased by 21% to a record $52.2 million, up $9.1 million as compared to 2020 fiscal year-end (“Fiscal 2020”).
• Record high patient starts and TMS treatment volumes in Fiscal 2021. Patient starts increased by 18% to 6,429 as compared to Fiscal 2020 and TMS treatment volumes increased by 15% to 226,286 as compared to Fiscal 2020.
• Average revenue per treatment increased by 5% to $231 in Fiscal 2021 as compared to Fiscal 2020.
• Fiscal 2021 resulted in an entity-wide regional operating loss of $0.3 million, down 51% as compared to Fiscal 2020. The loss for the period and comprehensive loss decreased by 18% to $24.9 million in Fiscal 2021 as compared to Fiscal 2020.
• The Company began offering Spravato® (esketamine nasal spray) therapy at select TMS treatment centers (“TMS Centers”) in January 2021. The Company now offers Spravato® at 23 TMS Centers across the United States, building on the long-term business plan of utilizing our TMS Centers as platforms for the delivery of innovative treatments to patients suffering from Major Depressive Disorder and other mental health disorders.
• The Company completed the acquisition of Achieve TMS East, LLC and Achieve TMS Central, LLC (the “Achieve TMS East/Central Acquisition”), which included the acquisition of 17 active TMS Centers in the United States.
• The Company added 31 active TMS Centers during Fiscal 2021, including 17 active TMS Centers acquired in connection with the Achieve TMS East/Central Acquisition, with an additional two TMS Centers in development, bringing the total Company network to 149 TMS Centers as at December 31, 2021, representing an increase of 19% as compared to Fiscal 2020.
• The Company completed the listing of its common shares on the NASDAQ Stock Market LLC (“NASDAQ”). Trading on the NASDAQ commenced on March 16, 2021 under the symbol “GBNH”.

FOURTH QUARTER 2021 OPERATIONAL AND FINANCIAL HIGHLIGHTS

• Q4 2021 revenue increased by 42% to a record $14.0 million, up $4.1 million as compared to the fourth quarter of Fiscal 2020 (“Q4 2020”).
• New patient starts increased by 17% to 1,667 as compared to Q4 2020 and TMS treatment volumes increased by 13% to 61,416 as compared to Q4 2020.
• Q4 2021 resulted in an entity-wide operating income of $0.04 million, up $2.09 million as compared to an entity-wide operating loss of $2.05 million in Q4 2020.

Bill Leonard, President and Chief Executive Officer of Greenbrook commented:

“Despite the challenges we faced over the past two years, we saw continued growth in both revenue and patient treatments. We believe that the demand for treatment of mental health disorders is at an all-time high and we have the right platform to serve this unmet need. Our Spravato® program adds to our repertoire of innovative treatments, building on the Company’s long-term business plan of utilizing its center network as a platform to serve patients suffering from Major Depressive Disorder and other mental health disorders.” Bill continued: “We are extremely proud of our dedicated team that continued to deliver the highest level of patient care in a very challenging operating environment. We are excited to continue our growth plans through 2022, with specific focus on enhanced utilization of our established TMS Center platform.”

SELECTED ANNUAL AND QUARTERLY FINANCIAL AND OPERATING RESULTS ⁽¹⁾

Selected Financial Results

(US$)		Q4 2021(unaudited)		Q4 2020(unaudited)		Fiscal 2021(audited)		Fiscal 2020(audited)
Total revenue		14,047,452		9,913,552		52,198,084		43,129,179
Regional operating income (loss)		43,741		(2,050,168)		(277,981)		(567,986)
Loss before income taxes		(6,833,240)		(8,759,528)		(24,859,918)		(30,402,721)
Loss for the year and comprehensive loss		(6,833,240)		(8,759,528)		(24,859,918)		(30,402,721)
Loss attributable to the common shareholders of Greenbrook		(6,831,859)		(8,391,630)		(24,751,488)		(29,663,540)
Net loss per share (basic and diluted)(2)		(0.34)		(0.60)		(1.60)		(2.32)

__________
Notes:
(1)	Please note that additional selected consolidated financial information can be found at the end of this press release.
(2)	On January 12, 2021, the shareholders of the Company approved a special resolution for an amendment to the Company’s articles and authorized a consolidation (the “Share Consolidation”) of the Company’s outstanding Common Shares on the basis of one (1) post-consolidation Common Share for every five (5) pre-consolidation Common Shares. The Share Consolidation was completed on February 1, 2021. The Company has retrospectively presented net loss per share calculations reflecting the number of Common Shares outstanding after giving effect to the Share Consolidation

Selected Operating Results

		As at December 31,		As at December 31,
(unaudited)		2021		2020
Number of active TMS Centers(1)		147		116
Number of TMS Centers-in-development(2)		2		9
Total TMS Centers		149		125
Number of management regions		15		13
Number of TMS Devices installed		234		198
Number of regional personnel		386		305
Number of shared-services / corporate personnel(3)		44		49
Number of TMS providers(4)		135		117
Number of consultations performed(5)		14,108		11,305
Number of patient starts(5)		6,429		5,445
Number of treatments performed(5)		226,286		195,992
Average revenue per treatment(5)		$231		$220

__________
Notes:
(1)	Active TMS Centers represent TMS Centers that have performed billable TMS services during the applicable period.
(2)	TMS Centers-in-development represents TMS Centers that have committed to a space lease agreement and the development process is substantially complete.
(3)	Shared-services / corporate personnel is disclosed on a full-time equivalent basis. The Company utilizes part-time staff and consultants as a means of managing costs.
(4)	Represents clinician partners that are involved in the provision of TMS therapy services from our TMS Centers.
(5)	Figure calculated for the applicable period ended.

For more information, please refer to the Management’s Discussion & Analysis of Financial Condition and Results of Operations (“MD&A”) and the consolidated financial statements of the Company for the fiscal years ended December 31, 2021, 2020 and 2019. These documents, and the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2021 (the “Annual Report”), will be available on the Company’s website at www.greenbrooktms.com, under the Company’s SEDAR profile at www.sedar.com and under the Company’s EDGAR profile at www.sec.gov. Shareholders may receive a hard copy of the Annual Report free of charge upon request.

CONFERENCE CALL AND WEBCAST

Fourth Quarter and Year End 2021 Conference Call Details:

Bill Leonard, President and Chief Executive Officer, and Erns Loubser, the Chief Financial Officer, will host a conference call at 10:00 a.m. (Eastern Time) on April 1, 2022 to discuss the financial results for the fourth quarter and year end.

Toll Free North America: 1-866-521-4909
Toronto: 647-427-2311

Webcast:

For more information or to listen to the call via webcast, please visit: www.greenbrooktms.com/investors/events

For those that plan on accessing the conference call or webcast, please allow ample time prior to the call time.

Conference Call Replay:

Toll Free (North America): 1-800-585-8367
Toronto: 416-621-4642
Passcode: 6080804

The conference call replay will be available beginning at 1:00 p.m. ET on March 31, 2022 until 11:59 p.m. on April 30, 2022.

About Greenbrook TMS Inc.

Operating through 149 Company-operated treatment centers, Greenbrook is a leading provider of Transcranial Magnetic Stimulation (“TMS”) therapy, an FDA-cleared, non-invasive therapy for the treatment of Major Depressive Disorder and other mental health disorders, in the United States. TMS therapy provides local electromagnetic stimulation to specific brain regions known to be directly associated with mood regulation. Greenbrook has provided more than 790,000 TMS treatments to over 22,000 patients struggling with depression.

Cautionary Note Regarding Forward-Looking Information

Certain information in this press release, including with respect to the Company’s future financial and/or operating performance, the Company’s expectations regarding the impact of the Achieve TMS East/Central Acquisition on our business, the continued roll-out of the Spravato® offering at additional TMS Centers and its future growth prospects, constitute forward-looking information within the meaning of applicable securities laws in Canada and the United States, including the United States Private Securities Litigation Reform Act of 1995. In some cases, but not necessarily in all cases, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “targets”, “expects” or “does not expect”, “is expected”, “an opportunity exists”, “is positioned”, “estimates”, “intends”, “assumes”, “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”, “will” or “will be taken”, “occur” or “be achieved”. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Statements containing forward-looking information are not historical facts but instead represent management’s expectations, estimates and projections regarding future events.

Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by the Company as of the date of this press release, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including, but not limited to, the factors described in greater detail in the “Risk Factors” section of the Company’s Annual Report, in the “Risks and Uncertainties” section of the Company’s MD&A (included in the Annual Report) and in the Company’s other materials filed with the Canadian securities regulatory authorities and the United States Securities and Exchange Commission from time to time, available at www.sedar.com and www.sec.gov, respectively. These factors are not intended to represent a complete list of the factors that could affect the Company; however, these factors should be considered carefully. There can be no assurance that such estimates and assumptions will prove to be correct. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.

SELECTED CONSOLIDATED FINANCIAL INFORMATION

(audited) (US$)		Fiscal 2021		Fiscal 2020		Fiscal 2019
Total revenue		52,198,084			43,129,179			35,685,531
Direct center and patient care costs		27,592,735			21,743,256			17,368,894
Regional employee compensation		12,278,518			9,798,901			7,122,556
Regional marketing expenses		6,765,806			6,446,798			2,705,891
Depreciation		5,839,006			5,708,210			4,031,375
Total direct center and regional costs		52,476,065			43,697,165			31,228,716
Regional operating income (loss)		(277,981	)		(567,986	)		4,456,815
Center development costs		862,386			529,933			1,466,119
Corporate employee compensation		13,145,385			10,195,949			7,063,682
Corporate marketing expenses		623,560			1,030,196			1,934,227
Transaction costs		426,006			–			385,674
Other corporate, general and administrative expenses		6,472,003			3,919,216			6,987,763
Share-based compensation		879,439			591,384			690,230
Amortization		555,000			463,332			122,269
Interest expense		4,761,443			2,806,286			1,822,442
Interest income		(14,689	)		(20,990	)		(163,302	)
Earn-out consideration		–			10,319,429			–
Forgiveness of loan payable		(3,128,596	)		–			–
Loss before income taxes		(24,859,918	)		(30,402,721	)		(15,852,289	)
Income tax expense		–			–			–
Loss for the year and comprehensive loss		(24,859,918	)		(30,402,721	)		(15,852,289	)
Income (loss) attributable to non-controlling interest		(108,430	)		(739,181	)		57,590
Loss attributable to the common shareholders of Greenbrook		(24,751,488	)		(29,663,540	)		(15,909,879	)
Net loss per share (basic and diluted) (1)		(1.60	)		(2.32	)		(1.48	)

__________
Note:
(1)	The Company has retrospectively presented net loss per share calculations reflecting the number of Common Shares outstanding after giving effect to the Share Consolidation.

		Q4 2021		Q3 2021		Q2 2021		Q1 2021		Q4 2020		Q3 2020		Q2 2020		Q1 2020
(unaudited)(US$)
Revenue		14,047,452		13,130,245		13,707,212		11,313,175		9,913,552		12,006,570		9,788,555		11,420,502
Regional operating income (loss)		43,741		249,057		921,339		(1,492,118)		(2,050,168)		967,584		(225,198)		739,796
Net loss attributable to common shareholders of Greenbrook		(6,831,859)		(3,517,250)		(6,775,825)		(7,626,554)		(8,391,630)		(7,636,132)		(9,477,505)		(4,158,274)
Net loss per share – Basic(1)		(0.34)		(0.22)		(0.48)		(0.56)		(0.60)		(0.57)		(0.76)		(0.39)
Net loss per share – Diluted(1)		(0.34)		(0.22)		(0.48)		(0.56)		(0.60)		(0.57)		(0.76)		(0.39)

__________
Note:
(1)	The Company has retrospectively presented net loss per share calculations reflecting the number of Common Shares outstanding after giving effect to the Share Consolidation.

Contacts

Glen Akselrod
Investor Relations
Greenbrook TMS Inc.

Contact Information:
investorrelations@greenbrooktms.com
1-855-797-4867

Mydecine Reports Financial Results for the Fiscal Year 2021 and Provides a Business Update

MYCO-001 Smoking Cessation Clinical Trial Moves Forward Following Conditional IRB Approval

Company Advances IP Portfolio With New Patent Applications Covering Novel Molecule Families

DENVER, March 31, 2022 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology company aiming to transform the treatment of mental health and addiction disorders, today reported financial results and provided a business update for the fiscal year ended December 31, 2021.

“Last year, Mydecine made significant strides toward creating and commercializing new treatments for mental health and addiction disorders,” said CEO Josh Bartch. “The conditional IRB approval we received is yet another positive signal that we will continue to advance our Phase 2b smoking cessation study, and we will hopefully receive full FDA IND approval in the second quarter of this year. We have been working hard to reduce our expenses and increase our efficiencies to continue progressing our clinical trials and expand our IP portfolio. I’d like to personally thank our shareholders, board members and highly dedicated team for enabling Mydecine to reach these significant milestones, and we look forward to another successful year.”

“In addition to our clinical trials, our research and development team has been making significant progress in our drug development program,” said Chief Scientific Officer Rob Roscow. “Over the last year, our new chemical entity (NCE) program has produced multiple patents covering several second-generation novel molecules that we believe will offer significant improvements over classic psilocybin and MDMA. We’re using a modular development approach to our patent strategy, which gives us the flexibility to license, partner or develop our lead drug candidates from our multiple families of NCEs, all wholly owned by Mydecine.”

Highlights of the Business for the Full Year 2021

Clinical Research

• Progressed Phase 2b smoking cessation study following a positive meeting with the Food and Drug Administration (FDA) to review Mydecine’s Investigational New Drug (IND) application. In Q2 2022, the company plans to file an IND and breakthrough status application and will begin patient recruitment upon receipt of FDA approval. The multi-site study’s lead investigator will be Johns Hopkins University.
• Agreed to supply MYCO-001 for Dr. Matthew Johnson’s multi-site NIDA grant-funded smoking cessation study. Johns Hopkins University, New York University, and the University of Alabama in Birmingham are the investigative sites conducting the research. The results from this study will support the safety profile of MYCO-001.
• Signed a five-year Master Collaboration Research Agreement with Johns Hopkins University School of Medicine, demonstrating the Company’s commitment to advancing psychedelic medicine by exploring multiple molecules and drugs for various indications.

Drug Development

• Filed several provisional and full patent applications for novel molecules that outperform first-generation compounds in safety, efficacy, stability, dosing and side effects. This year, the Company intends to file a number of new composition of matter patents supporting its NCE program.
  • Patent applications include: novel MDMA analogs, improved psilocybin and other tryptamines (including a shorter duration with patch delivery), potentially heart-safe microdosing drugs, nanoemulsion technology, and technology patents covering the digital healthcare platform Mindleap.
• Unveiled an Artificial Intelligence (AI) drug discovery program that enables rapid screening of billions of compounds and will encourage near-term patent filings for novel molecules. Completed a 5-HT2A serotonin receptor model for Mydecine’s AI program with the intention to build the entire family of serotonin receptors to test its novel molecules against.
• Screened over 25 mushroom species, including various varieties of p. cubensis, and discovered and analyzed more than 40 unique compounds, with the majority appearing to be previously unreported.

Corporate

• Welcomed several new independent board members, including Gordon Neal, Josephine Wu, Dr. Saeid Babaei and Dr. Victoria Hale, who bring a wealth of experience in drug development, clinical trials and technology. The additions assist Mydecine in meeting anticipated capital markets initiatives for 2022.
• Listed on the NEO exchange and submitted an application to list on the NASDAQ.
• Completed the first international export of psilocybin mushrooms.
• Announced that Mydecine’s exclusive dealer was identified as a licensed psilocybin and MDMA supplier in Canada, allowing them to supply active pharmaceutical ingredients through Health Canada’s Special Access Program, which enables healthcare providers to request specific drugs for patients who have not responded well to other treatments.
• Successfully spun out the Company’s legacy cannabis assets to help satisfy certain requirements for a potential future uplisting.
  

Financial Results for the Fiscal Year 2021

Net Loss: The net loss attributable to common stockholders was $28.9 million, which consisted of $5.3 million loss from discontinued operations, for the fiscal year ended December 31, 2021, or a basic and diluted loss per share attributable to common stockholders of ($0.12). This is compared to a net loss attributable to common stockholders of $26.9 million, which consisted of $0.1 million loss from discontinued operations, for the fiscal year ended December 31, 2020, or a basic and diluted loss per share attributable to common stockholders of ($0.24).

Cash Position: The Company had $1.5 million in cash and cash equivalents as of December 31, 2021. Subsequent to the year end, the Company secured additional funding and is moving forward with clinical trials and projects to expand its IP portfolio.

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

As at,		December 31, 2021 $		December 31, 2020 $
Current assets
Cash		1,495,311		2,190,702
Accounts receivable		3,856		27,746
Inventory		–		47,262
Sales tax receivable		201,060		13,734
Prepaids and deposits		3,521,125		216,003
Total current assets		5,221,352		2,495,447
Non-current assets
Prepaids and deposits		1,793,894		–
Investment in joint venture		–		303,982
Loan receivable, net		–		316,110
Investment in associate		–		4,481,988
Right-of-use asset		130,546		223,645
Investment properties		–		1,418,345
Property and equipment		434,910		291,614
Total assets		7,580,702		9,531,131
Current liabilities
Accounts payable and accrued liabilities		1,587,238		1,187,486
Convertible debentures, net		–		2,959,755
Derivative liabilities		1,280,294		1,586,744
Lease liability – current portion		79,728		69,329
Total current liabilities		2,369,383		5,803,314
Non-current liabilities
Convertible debentures, net		4,354,302		–
Lease liability		67,821		167,118
Total liabilities		7,369,383		5,970,432
Shareholders’ equity
Share capital		107,349,388		85,298,435
Contributed surplus		17,536,315		12,734,636
Equity portion of convertible debentures		240,756		254,690
Accumulated other comprehensive loss		–		(444,803	)
Deficit		(124,915,140	)	(94,282,259	)
Total shareholders’ equity		211,319		3,560,699
Total liabilities and shareholders’ equity		7,580,702		9,531,131

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

		For the years ended,
		December 31, 2021		December 31, 2020
Sales		7,493		2,617
Cost of goods sold		–		–
Gross margin		7,493		2,617
Expenses
Finance cost		205,267		182,866
Corporate development		3,401,645		2,259,956
Depreciation		235,177		57,080
Consulting fees		5,220,556		3,381,726
Director and management fees		1,346,468		539,347
Foreign exchange loss		355,671		111,251
Insurance		511,501		–
Office and miscellaneous		925,568		292,070
Professional fees		2,216,950		934,135
Regulatory and filing fees		349,777		201,818
Research and development		3,960,232		1,290,548
Salaries		1,424,012		17,584
Share-based payments		3,099,743		2,487,509
Total expenses		23,252,567		11,755,890
Other income (expenses)
Change in fair value of derivative liabilities		43,688		545,194
Consideration paid in excess of net assets acquired from acquisition		–		(10,645,239	)
Impairment of goodwill and intangible assets		–		(5,031,967	)
Impairment of loan receivable		(382,902	)	–
Other expenses		–		(24,025	)
Gain on settlement of debt		1,377		33,304
Total other income (expenses)		(337,837	)	(15,122,733	)
Loss from continuing operations		(23,582,911	)	(26,876,006	)
Loss from discontinued operations		(5,314,488	)	(72,939	)
Net loss for the year		(28,897,399	)	(26,948,945	)
Foreign currency translation adjustment		–		(382	)
Net loss and comprehensive loss for the year		(28,897,399	)	(26,949,327	)
Net loss per share – Basic and diluted from continuing operations		(0.12	)	(0.24	)
Weighted average number of shares outstanding – Basic and diluted		234,086,043		113,714,260

About Mydecine Innovations Group

Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a biotechnology company developing innovative first- and-second-generation novel therapeutics for the treatment of mental health and addiction using world-class technology and drug development infrastructure. Mydecine was founded in 2020 to address a significant unmet need and lack of innovation in the mental health and therapeutic treatment environments. Our global team is dedicated to efficiently developing new therapeutics to treat PTSD, depression, anxiety, addiction and other mental health disorders. The Mydecine business model combines clinical trials and data outcome, technology, and scientific and regulatory expertise with a focus on psychedelic therapy, as well as other novel, non-psychedelic molecules with therapeutic potential. By collaborating with some of the world’s foremost authorities, Mydecine aims to responsibly fast-track the development of new medicines to provide patients suffering from mental health disorders with safe and more effective treatment options. 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, LinkedIn, YouTube and Instagram. 

For more information, please contact:
Media Contact
Morgan Kervitsky, Director of Marketing
pr@mydecineinc.com

Investor Relations
Morgan Kervitsky, Director of Marketing
contact@mydecineinc.com

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.

atai Life Sciences Announces Fourth Quarter and Full Year 2021 Financial Results, Reports on R&D Progress and Highlights Strategic Focus Areas of its Innovative Mental Health Platform

–   Highlights included positive Phase 2b data with COMP360 from a ground-breaking treatment resistant depression (TRD) trial, highly encouraging Phase 2a proof-of-mechanism data with RL-007 in cognitive impairment associated with schizophrenia (CIAS), clinical trial initiations with PCN-101, GRX-917 and DMX-1002, and successful completion of 2 cohorts in the Introspect Digital Therapeutics ketamine trials

–   Eight new programs added to platform since January 2021 bringing total, as of today, to 13 discovery and drug development programs and four enabling technologies

–   Ended 2021 very well capitalized with $362 million to execute our strategy to achieve clinically meaningful and sustained behavioral change in mental health patients through the combination of rapid acting interventions, ongoing digital support and biomarker-driven precision mental health

–   At least 14 drug development and enabling technology catalysts anticipated over the next two years, including Phase 2a proof-of-concept topline data from PCN-101 in TRD

Conference call to be held today at 8:30 a.m. EST

NEW YORK and BERLIN, March 30, 2022 (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 financial results for the fourth quarter and full year ended December 31, 2021 and provided business updates.

“2021 was a transformative year for atai. We expanded our pipeline with the launch of seven new programs, bringing our total number of development programs to 12 by end of 2021. Meanwhile, our approach to value creation and capture was validated through a significant licensing deal with Otsuka Pharmaceuticals for PCN-101. We raised over $410 million in our June 2021 IPO, Series D and other financings, and closed out 2021 well-capitalized with a cash position of $362 million,” said Greg Weaver, Chief Financial Officer of atai Life Sciences.

“From an R&D perspective, in addition to hitting many discovery and pre-clinical milestones, we initiated Phase 1 studies with GRX-917 and DMX-1002 and a Phase 2a proof-of-concept study with PCN-101 in TRD. Additionally, we announced pro-cognitive effects of RL-007 in our Phase 2a proof-of-mechanism study in CIAS, an indication where patients have currently no approved treatment options. We also increased our strategic investment in COMPASS Pathways following their positive Phase 2b data with COMP360 in TRD,” said Srinivas Rao, Chief Scientific Officer & Co-founder of atai Life Sciences.

“This exciting momentum continues in 2022 and our cash runway of approximately 2 years enables us to work towards our goal of achieving clinically meaningful and sustained behavioral change in mental health patients. We will focus on three strategic pillars: namely, rapid acting intervention, ongoing digital support and a biomarker-driven precision mental health,” said Florian Brand, Chief Executive Officer & Co-founder of atai Life Sciences.

The Company anticipates at least 14 drug development and enabling technology catalysts over the next two years, including the Phase 2a proof-of-concept topline data readout with PCN-101 for TRD and results from the Phase 1 relative bioavailability study with PCN-101 designed to bridge between the current intravenous formulation to a subcutaneous formulation to support at-home use.

atai also expects data from the Phase 1 element of a combined Phase 1/2 trial of DMX-1002 by the end of 2022 as well as topline data from a Phase 1 trial with GRX-917 by mid of this year. Just this month, the first subject in a Phase 1 with KUR-101 was dosed, and atai anticipates topline results for this study later this year. The initiation of Phase 2a proof-of-concept trials with RL-007 and GRX-917 and Phase 1 trials with EMP-01 and RLS-01 are anticipated in the second half of this year. The initiation of a Phase 1 trial with VLS-01 is expected by mid of this year.

atai also expects further advancement in its ongoing patient support technologies and precision mental health approaches. With this ongoing positive traction across the Company’s platform, atai will continue delivering on its vision to heal mental health disorders and tackle the escalating global mental health crisis head on.

In parallel to its R&D activities, in October 2021, atai launched its philanthropic arm, atai Impact. atai Impact’s first initiative, in December 2021, was the establishment of the atai Fellowship Fund in Psychedelic Neuroscience at Massachusetts General Hospital’s Center for the Neuroscience of Psychedelics. This year, atai Impact has already made sizeable donations to the Multidisciplinary Association for Psychedelics Studies (MAPS) and to leading non-profit organizations supporting humanitarian efforts in the Ukraine, with a special focus on mental health.

Conference Call and Webcast

A live webcast for today’s corporate update and fourth quarter 2021 financial results will take place today at 8:30 a.m. EST. To access the webcast, please log in at https://wsw.com/webcast/cc/atai/1358298.

The conference call will also be accessible live and for replay in the “Events” section of the Company’s website www.atai.life. The archived copy of the webcast will be available on the Company’s website for at least 30 days following the conclusion of the conference call.

Pipeline Highlights

Leveraging atai’s platform for innovation and accelerating mental healthcare solutions, the Company continues to execute on its pipeline of pharmacologically diverse candidates with the potential for rapid-acting interventions that address the unmet needs of mental health patients.

Treatment Resistant Depression (TRD)

COMPASS Pathways – COMP360: In November, atai’s strategic investment COMPASS Pathways announced Phase 2b data for COMP360 in TRD. The 233-patient trial met its primary endpoint, showing a 6.6-point reduction on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to 3 weeks when comparing the 25mg dose to the 1mg dose. COMP360 also showed both rapid response and durability of efficacy and was generally well tolerated. In Q4-2021, atai increased its holdings in COMPASS Pathways to 22.8%. COMPASS plans to hold an end-of-Phase 2 meeting with the FDA in April 2022 to discuss their Phase 3 program, which is anticipated to commence in the second half of this year.

Perception Neuroscience – PCN-101: In December 2021, the FDA gave Investigational New Drug (IND) clearance for the development of PCN-101 for the treatment of TRD. In September 2021, the Phase 2a proof-of-concept trial of PCN-101 for TRD was initiated. This randomized, double-blind, placebo-controlled Phase 2a proof-of-concept trial is designed to assess the efficacy, safety, dose response, and duration of response in patients with TRD. A topline data readout of this trial is expected by the end of 2022. The initiation of a Phase 1 relative bioavailability study, which is designed to bridge the intravenous formulation to a subcutaneous formulation of PCN-101, is anticipated for late 2022.

Viridia Life Sciences – VLS-01: VLS-01 is in preclinical development for TRD with a Phase 1 trial expected to be initiated in the middle of 2022.

Revixia Life Sciences – RLS-01: RLS-01 is in preclinical development for TRD with a Phase 1 trial expected to be initiated in the second half of 2022.

Cognitive Impairment Associated with Schizophrenia (CIAS)

Recognify Life Sciences – RL-007: In December of last year, atai announced positive biomarker data from the Phase 2a proof-of-mechanism study of RL-007 in CIAS patients. RL-007 was well tolerated and demonstrated a clinically meaningful behavioral pro-cognitive profile consistent with previous Phase 1 and 2 trials of this compound. Changes in quantitative electroencephalogram (qEEG) consistent with a previous Phase 1 trial involving a scopolamine challenge were noted. These results support the progression of RL-007 to a double-blind, placebo-controlled Phase 2a proof-of-concept trial in CIAS, which is anticipated to be initiated in the second half of 2022.

Generalized Anxiety Disorder (GAD)

GABA Therapeutics – GRX-917: In June 2021, GABA initiated a Phase 1 single and multiple ascending dose trial of GRX-917. Topline data for this trial is expected by mid of this year and the initiation of a Phase 2a proof-of-concept trial is anticipated to follow in the second half of this year.

Opioid Use Disorder (OUD)

DemeRx IB – DMX-1002: DMX-1002 is being tested in an ongoing Phase 1/2 trial to evaluate its safety, tolerability, pharmacokinetics, and efficacy. Safety data from the phase 1 element of this trial are expected in the second half of 2022.

Kures – KUR-101: A Phase 1 single ascending dose trial to evaluate the maximum tolerable dosage was initiated, with first patient dosed in March and topline results expected in the second half of 2022.

Post-Traumatic Stress Disorder (PTSD)

EmpathBio – EMP-01: EMP-01 is in preclinical development for PTSD with a Phase 1 trial expected to be initiated in the second half of 2022

Drug Discovery

atai is conducting robust drug discovery through four subsidiary companies, including two newly added companies – TryptageniX (December 2021) and Invyxis (January 2022). TryptageniX will develop new chemical entities through a unique bioprospecting and synthetic biology approach, while Invyxis brings proven medicinal chemistry and comprehensive biological evaluation capabilities to our discovery efforts. These new approaches complement atai’s existing drug discovery efforts at EntheogeniX, which uses an AI-based computational chemistry platform to create structurally differentiated molecules. Finally, PsyProtix is a discovery stage company that is developing compounds to treat specific subsets of TRD patients that are characterized by mitochondrial dysfunction, thus representing an important first step towards our goal of delivering biomarker-driven precision mental health.

Ongoing digital patient support and precision mental health

atai’s digital efforts include digital therapeutics that are focused on improving the safety, efficacy and scalability of our compounds by providing continuous digital care to patients before, during and after treatment. In addition, our efforts include a multimodal data analytics platform designed to better characterize mental health indications and that may facilitate more personalized treatments. Psyber is developing interventions that use brain computer interface-based technology to induce rapid behavioral change through biofeedback. Introspect Digital Therapeutics is focused on providing personalized, digitally delivered, evidence-based psychotherapy to patients receiving our compounds. As announced in September 2021, Introspect launched a user acceptability trial in TRD patients undergoing ketamine therapy to validate the combination of a digital app and drug in improving treatment outcomes.

Consolidated Financial Results

atai ended the year with a strong cash position of $362 million which it anticipates will be sufficient to provide a cash runway of approximately two years, including funding of additional anticipated business development activity.

Cash and Cash Equivalents

Cash and cash equivalents totaled $362.3 million as of December 31, 2021, compared to $97.2 million as of December 31, 2020. The twelve-month increase of $265.1 million is attributed to net proceeds of $409.9 million from the June IPO, Series C and Series D equity raises and other financing activities, and $20.0 million of license revenue proceeds. Offsetting were cash payments of $52.5 million of additional investment in Compass Pathways, $14.9 million investment in and loan to IntelGenx, $10.6 million additional investment in GABA, $3.5 million for investments in other platform companies and assets, and $83.3 million in net operating expenses and effect of foreign exchange rate changes.

Operating Costs and Expenses

Research and development (R&D) expenses were $13.0 million and $48.0 million for the three and twelve months ended December 31, 2021, respectively, as compared to $3.4 million and $11.4 million for the same prior year periods. The year-over-year full-year increase of $36.6 million was attributable to an increase of $23.4 million in R&D personnel costs, including a $19.1 million increase in stock-based compensation expense, and $13.2 million of increased contract research organization expenses related to advancements of R&D programs.

Acquisition of in-process R&D expense was $6.5 million and $15.5 million for the three and twelve months ended December 31, 2021, respectively, relating to investments in TryptageniX, InnarisBio, and Neuronasal. Acquisition of in-process R&D expense was $11.9 million and $12.0 million for the three and twelve months ended December 31, 2020, respectively, relating to its investments in Recognify and Kures.

General and administrative (G&A) expenses for the three and twelve months ended December 31, 2021 were $25.9 million and $92.7 million, respectively, as compared to $72.0 million and $80.7 million in the same prior year periods. The year-over-year full year increase of $12.0 million was attributable to an increase of $25.3 million in G&A personnel cost and professional consulting fees, and $9.7 million of other G&A costs related to supporting platform growth and public company requirements. These increases were partially offset by a decrease of $22.9 million in stock-based compensation expense.

Total stock-based compensation expense for the three and twelve months ended December 31, 2021 was $13.4 million and $63.4 million, respectively, as compared to $67.2 million for the fourth quarter and prior year periods, reflecting the recognition of expense in 2021 related to the achievement of IPO performance-based partial vesting conditions and the issuance of convertible notes in 2020.

Net loss attributable to shareholders for the three and twelve months ended December 31, 2021 was $88.9 million and $167.8 million, respectively, as compared to $86.6 million and $169.8 million for the comparable prior year periods.

About atai Life Sciences

atai Life Sciences is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. 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 innovative compounds, including 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 to achieve clinically meaningful and sustained behavioral change in mental health patients.

atai’s vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. atai has offices in New York, San Diego, Boston, 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. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). 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. All statements contained in this press release other than statements of historical fact, including statements regarding our future operating results and financial position, the success, cost and timing of development of our product candidates, including the progress of preclinical studies and clinical trials and related milestones, the commercialization of our current product candidates and any other product candidates we may identify and pursue, if approved, including our ability to successfully build a specialty sales force and commercial infrastructure to market our current product candidates and any other product candidates we may identify and pursue, the timing of and our ability to obtain and maintain regulatory approvals, our business strategy and plans, potential acquisitions, and the plans and objectives of management for future operations and capital expenditures, are forward-looking statements. 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: statements regarding our future operating results and financial position, the success, cost and timing of development of our product candidates, including the progress of preclinical studies and clinical trials and related milestones, the commercialization of our current product candidates and any other product candidates we may identify and pursue, if approved, including our ability to successfully build a specialty sales force and commercial infrastructure to market our current product candidates and any other product candidates we may identify and pursue, the timing of and our ability to obtain and maintain regulatory approvals, our business strategy and plans, potential acquisitions, and the plans and objectives of management for future operations and capital expenditures. Other risk factors include the important factors described in the section titled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”), as updated by our subsequent filings with the SEC, that may cause our actual results, performance or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements.

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

Contact Information

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

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

ATAI LIFE SCIENCES N.V.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share amounts)
		Year Ended
		December 31,
			2021				2020
License revenue		$	20,376			$	–
Operating expenses:
Research and development			47,956				11,408
Acquisition of in-process research and development			15,480				12,020
General and administrative			92,745				80,734
Total operating expenses			156,181				104,162
Loss from operations			(135,805	)			(104,162	)
Other income (expense), net			(796	)			2,349
Net loss before income taxes			(136,601	)			(101,813	)
Benefit from (provision for) income taxes			3,989				(305	)
Gain on investment dilution			16,923				–
Losses from investments in equity method investees, net of tax			(58,555	)			(76,507	)
Net loss			(174,244	)			(178,625	)
Net income loss) attributable to redeemable noncontrolling interests and noncontrolling interests			(6,436	)			(8,782	)
Net loss attributable to ATAI Life Sciences N.V. stockholders		$	(167,808	)		$	(169,843	)
Net loss per share attributable to ATAI Life Sciences N.V. stockholders– basic and diluted		$	(1.21	)		$	(1.83	)
Weighted average common shares outstanding attributable to ATAI Life Sciences N.V. stockholders — basic and diluted			138,265,859				93,019,072

ATAI LIFE SCIENCES N.V.
CONDENSED CONSOLIDATED BALANCE SHEET
(Amounts in thousands)
		December 31,		December 31,
		2021		2020
Assets
Cash and cash equivalents		$	362,266		$	97,246
Prepaid expenses and other current assets			11,903			2,076
Short term notes receivable			913			–
Short term notes receivable – related party			–			226
Property and equipment, net			149			71
Deferred offering costs			–			1,575
Equity method investments			16,131			–
Other investments			11,628			8,044
Long term notes receivable			–			911
Long term notes receivable – related parties			3,835			1,060
Other assets			7,341			339
Total assets		$	414,166		$	111,548
Liabilities and Stockholders’ Equity
Accounts payable		$	6,004		$	3,083
Accrued liabilities			14,829			9,215
Current portion of contingent consideration liability – related parties			51			–
Other current liabilities			51			–
Non-current portion of Contingent consideration liability – related parties			2,432			1,705
Convertible promissory notes – related parties, net of discounts and deferred issuance costs			743			1,199
Convertible promissory notes and derivative liability			–			978
Other liabilities			4,097			–
Total stockholders’ equity attributable to ATAI Life Sciences N.V. stockholders			376,908			90,822
Noncontrolling interests			9,051			4,546
Total liabilities and stockholders’ equity		$	414,166		$	111,548

MindMed Reports Full Year 2021 Financial Results and Business Highlights

– FDA cleared MindMed’s Investigational New Drug (IND) application for Phase 2b dose optimization trial of MM-120 –

– Progressed development programs for all three lead product candidates –

– Cash balance of $133.5 million at year end 2021 –

– Company to host earnings conference call today at 8:30 AM EDT –

NEW YORK, March 28, 2022 — Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED) (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel products to treat brain health disorders, today reported its financial results for the full-year ended December 31, 2021.

“2021 was a year of major advancements across all aspects of MindMed, with significant growth in our organization, development programs and research collaborations. We established a regulatory pathway for MM-120 in the treatment of GAD and, with MM-402, launched a program to develop a novel treatment for core symptoms of autism spectrum disorder – both of which represent meaningful leaps forward in the field of psychiatry,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “We expect 2022 to be a transformational year in which we continue to drive substantial growth across our pharmaceutical and digital medicine pipelines. I am incredibly proud of our team’s achievements and I am more confident than ever in our ability to continue advancing our organization and development programs. We are keenly focused on our mission to deliver novel therapies to treat brain health disorders, leading to meaningful improvements in patient outcomes in these major areas of unmet medical need.”

Recent Highlights and Anticipated Upcoming Milestones

MM-120 (LSD D-tartrate): a proprietary, pharmaceutically optimized form of lysergic acid diethylamide (LSD) that is being developed for the treatment of generalized anxiety disorder (GAD). MM-120 is also being studied under various dosing regimens for the treatment of adult attention deficit hyperactivity disorder (ADHD) and for the treatment of chronic pain. 

• In January 2022, the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug (IND) application for the Phase 2b dose-optimization trial of MM-120 for the treatment of GAD.
  • Study MMED008, a Phase 2b dose-optimization study of MM-120 for the treatment of GAD, is expected to begin in Q2 2022.
• In December 2021, Study MMED007, a Phase 2a proof-of-concept study, was initiated for the treatment of ADHD. The study is designed to assess the safety and efficacy of repeated low-dose MM-120 administration. 
• A clinical study of MM-120 in a chronic pain condition is expected to be initiated in Q4 2022.

MM-110 (zolunicant HCl or 18-MC): a derivative of ibogaine that the Company is developing for the treatment of opioid withdrawal. MM-110 is an α3β4 nicotinic cholinergic receptor antagonist that has been extensively tested in preclinical models of substance use disorders.

• In January 2022, the USAN Council assigned the non-proprietary name “zolunicant” (pronounced: zoe lun’ i kant), to MM-110 or 18-MC.  
• In December 2021, the Company completed a Phase 1 study of MM-110 with topline data expected in Q2 2022. These results will inform the design of the planned Phase 2a study in individuals undergoing standardized supervised opioid withdrawal, which is expected to commence in Q2 2022. The Phase 2a study will evaluate the safety, tolerability and efficacy of MM-110 in mitigating symptoms of opioid withdrawal and facilitating completion of detoxification.

MM-402 (R(-)-MDMA): a synthetic enantiomer of MDMA that exhibits prosocial and empathogenic activity that the Company is developing for the treatment of core symptoms of autism spectrum disorder. Preclinical studies of R(-)-MDMA demonstrate its acute prosocial effects, while its diminished dopaminergic activity suggests that it may exhibit a favorable safety, tolerability and abuse liability profile when compared to racemic MDMA or the S(+)-enantiomer of MDMA. 

• IND-enabling studies are currently ongoing and, through the Company’s collaboration with University Hospital Basel, a comparative Phase 1 pharmacokinetic/pharmacodynamic study of R(-), S(+) and + MDMA is expected to commence in mid 2022.

Digital Medicine Initiatives

• In February 2021, the Company completed the acquisition of HealthMode and fully integrated its team to enable rapid progression of digital medicine and business operations functions.
• Having engaged in a productive Pre-Submission meeting with FDA in late 2021, in January 2022, the first subjects were enrolled into the Session Monitoring System (SMS-01) study evaluating the passive collection of sensory data during a consciousness-altering therapeutic session using the MindMed Session Monitoring System (MSMS).
• Anxiety Digital Diagnoses for Precision Psychiatry (ADDAPT, MMED-D001): A Natural History Study and our newly developed mobile application to support the study is expected to launch in private beta in Q2 2022.
• In September 2021, the first participants were enrolled by invitation in the Quantifying the Processes and Events of Psychotherapy at Scale (MM061302) study.

Collaborations and Partnerships 

• University Hospital Basel (UHB): The Company continued to support the ongoing collaboration with the Liechti Lab at UHB in Switzerland. MindMed has exclusive worldwide rights to data, compounds and patent rights associated with the Liechti laboratory’s research with LSD and other psychedelic compounds, including data from preclinical studies and over 15 completed and 9 ongoing clinical trials.
  • In March 2022, the peer-reviewed publication of a double-blind placebo-controlled comparative study of LSD and psilocybin was published in Neuropsychopharmacology. The study demonstrated that the key differences between LSD and psilocybin are dose-dependent rather than substance-dependent. These findings have the potential to assist with dose-finding, trial design and inform future studies evaluating the therapeutic utility of psychedelics.
  • In November 2021, the peer-reviewed publication of a randomized, double-blind, placebo-controlled study evaluating the interacting effects of an SSRI and psilocybin in healthy volunteers was published in Clinical Pharmacology and Therapeutics. The study suggests psilocybin is safe to take in combination with an SSRI.
• Nextage Therapeutics Ltd: The Company entered into a collaboration with Nextage Therapeutics in April 2021 to explore the therapeutic potential of noribogine in a proprietary brain targeted liposome drug delivery technology system to mitigate risks of peripheral adverse effects. 
• MindShift Compounds AG: The Company continued to progress its collaborative research and development activities with MindShift Compounds AG in Basel, Switzerland, focusing on the discovery and optimization of next generation compounds, including those with and without acute perceptual effects.
• The Chopra Foundation: The company ultimately did not reach a definitive agreement for a potential collaboration and discontinued the engagement. 

Director & Officer Appointments 

• In December 2021, Robert Barrow was appointed as Chief Executive Officer and as a member of the Board of Directors. Mr. Barrow previously served as interim Chief Executive Officer and Chief Development Officer of MindMed and brings strategic expertise and deep industry insight to his role.
• In December 2021, Cynthia Hu, JD was appointed as Chief Legal Officer and Corporate Secretary.  
• In November 2021, Carrie Liao, CPA was appointed as VP, Corporate Controller and Principal Accounting Officer. 
• In September 2021, Carol Vallone and Andreas Krebs were appointed to the Board of Directors and were subsequently appointed as chair and vice chair, respectively.
• In May 2021, Sarah Vinson, MD was appointed to the Board of Directors.
• In February 2021, Daniel Karlin, MD, MA was appointed as Chief Medical Officer. 

Scientific Advisory Board Appointments

• Over the course of 2021, we made significant additions to our Scientific Advisory Board (SAB), including:
  • Robert C. Malenka, MD, PhD (Professor, Stanford University) – SAB chair
  • Maurizio Fava, MD (Psychiatrist-In-Chief, Mass General Hospital; Associate Dean and Professor of Psychiatry, Harvard Medical School)
  • Peter Bergethon, MD (President, Symmetry Research; formerly Vice President, Biogen) 
  • Robert Dworkin, PhD (Professor, Rochester University; Director, ACTTION public-private partnership)
  • Bryan Roth, MD, PhD (Professor, University of North Carolina; Director, NIMH Psychoactive Drug Screening Program) 
  • Maria Oquendo, MD, PhD (Chair and Professor of Psychiatry, University of Pennsylvania; Past President, American Psychiatric Association)

2021 Financial Results

Cash Balance. As of December 31, 2021, MindMed had cash totaling $133.5 million compared to $80.1 million as of December 31, 2020. MindMed believes its available cash and cash equivalents will be sufficient to meet its operating requirements beyond its key development milestones in 2023 and into 2024.

Net Cash in Operating Activities. The net cash used in operating activities was $45.8 million for the year ended December 31, 2021, compared to $23.6 million for the same period in 2020. 

Research and Development (R&D). R&D expenses were $34.8 million for the year ended December 31, 2021, compared to $18.6 million for the year ended 2020. The increase was primarily due to an increase of $2.7 million in expenses related to our MM-120 clinical research, $2.3 million in expenses related to our MM-110 clinical research, $3.5 million in expenses related to preclinical and other research programs, offset by a $3.5 million decrease of expense in connection with various external R&D collaborations. Internal costs increased $11.1 million primarily related to an increase in non-cash expenses of $6.6 million of stock-based compensation expenses and $2.6 million of amortization of our developed technology. 

General and Administrative (G&A). G&A expenses were $59.1 million for the year ended December 31, 2021, compared to $14.4 million for the year ended 2020. The increase was primarily due to an increase of $28.9 million in non-cash stock-based compensation expenses of which $21.9 million related to the modification of stock options and RSUs. Other contributors to the increase included higher professional services including accounting, audit, legal, compliance, director and officer insurance, and investor and public relations and personnel costs to support the growth of the company.

Net Loss. The net and comprehensive loss for the year ended December 31, 2021 was $92.3 million, compared to $33.7 million for the year ended 2020. 

Conference Call and Webcast Reminder

MindMed management will host a conference call at 8:30 AM EDT today to provide a corporate update and review the Company’s fiscal year 2021 financial results. Individuals may participate in the call via telephone by dialing (877) 407-0789 (domestic) or (201) 689-8562 (international) and using conference ID 13728028. The webcast can be accessed live here or on MindMed’s Investor Resources webpage. The webcast will be archived on the Company’s website for at least 30 days after the conference call.

About MindMed

MindMed is a clinical-stage biopharmaceutical company developing novel products to treat brain health disorders, with a particular focus on psychiatry, addiction, pain and neurology. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative drug candidates, with and without acute perceptual effects, targeting the serotonin, dopamine and acetylcholine systems.

MindMed trades on NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED. 

Forward-Looking Statements

Certain statements in this news release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “will”, “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe”, “potential” or “continue”, or the negative thereof or similar variations. Forward-looking information in this news release include, but are not limited to, statements regarding anticipated upcoming milestones and studies, results and timing of clinical studies, expected growth and developments of drugs and technologies, continuing collaborations and partnerships, and the availability of cash and cash equivalents. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; lack of product revenue; compliance with laws and regulations; difficulty associated with research and development; risks associated with clinical trials or studies; heightened regulatory scrutiny; early stage product development; clinical trial risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; as well as those risk factors discussed or referred to herein and the risks described under the headings “Risk Factors” in the Company’s filings with the securities regulatory authorities in all provinces and territories of Canada which are available under the Company’s profile on SEDAR at www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov.

For Media: media@mindmed.co

For Investors: ir@mindmed.co

GH Research Reports Full Year 2021 Financial Results and Provides Business Updates

DUBLIN, Ireland., March 28, 2022 (GLOBE NEWSWIRE) — GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today reported financial results for the full year ended December 31, 2021 and gave updates on its business.

Fourth Quarter 2021 Business Highlights

In December 2021, we reported the successful outcome of the Phase 2 part of our Phase 1/2 clinical trial of GH001, our proprietary inhalable 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) product candidate, in patients with treatment-resistant depression (TRD) (GH001-TRD-102). The primary endpoint of the Phase 2 part of the trial was met with 7 of 8 patients (87.5%) in remission (Montgomery–Asberg Depression Rating Scale (MADRS) ≤10) at day 7 after dosing (p<0.0001). Patients followed a proprietary individualized dosing regimen (IDR) with up to three increasing GH001 doses (6 mg, 12 mg and 18 mg) on a single day. No serious and no severe adverse events, no clinically significant changes in any of the safety laboratory analyses, vital signs, psychiatric safety assessments or measures of cognitive function and no signal for suicidal ideation or behavior were observed.

Furthermore, we reported positive preliminary safety results from a Phase 1 clinical pharmacology trial in healthy volunteers (GH001-HV-103), which supported the safety profile of GH001 single doses (6 mg, 12 mg and 18 mg) and the proprietary GH001 IDR with up to three increasing GH001 doses (6 mg, 12 mg and 18 mg) on a single day, given in two dose intervals (1 hour, 2 hours).

Full Year 2021 Financial Highlights

Cash position

Cash was $276.8 million as of December 31, 2021, compared to $5.9 million as of December 31, 2020.

Research and development expenses

R&D expenses were $8.6 million for the year ended December 31, 2021, compared to $338 thousand for the full year 2020. The increase was primarily due to increased activities relating to our technical developments and clinical trials and increases in employee expenses to support these activities.

General and administrative expenses

G&A expenses were $6.5 million for the year ended December 31, 2021, compared to $108 thousand for the full year 2020. The increase was primarily due to higher professional and compliance fees associated with being a public company, as well as increased employee expenses.

Net loss

Net loss was $9.2 million, or $0.211 loss per share, for the year ended December 31, 2021, compared to $446 thousand, or $0.016 loss per share, for the full year 2020.

Business Updates

GH001 for the treatment of TRD

We plan to submit clinical trial applications in several European countries for a multi-center, randomized, controlled Phase 2b trial of GH001 in TRD (GH001-TRD-201) in the third quarter of 2022.

GH001 for the treatment of additional disorders

We have recently submitted clinical trial applications in a European country for a Phase 2a proof-of-concept clinical trial of GH001 for the treatment of patients with bipolar II disorder and a current depressive episode (GH001-BD-202) and for a Phase 2a proof-of-concept clinical trial of GH001 for the treatment of patients with postpartum depression (GH001-PPD-203). We expect to submit further clinical trial applications for these trials in additional European countries. Pending regulatory clearance, we expect to initiate these trials in the third quarter of 2022.

GH001 in healthy volunteers

We now have the final safety results of our Phase 1 clinical pharmacology trial in healthy volunteers (GH001-HV-103) and the data continue to support the safety profile of GH001 single doses and the proprietary GH001 IDR. Results from pharmacokinetic analyses were aligned with the ultra-rapid onset and short duration of observed psychoactive effects. Results of cognitive function tests as well as psychoactive effect assessments were aligned with results of previous trials. The full results of the trial support that an interval down to 1 hour between individual doses of the IDR is feasible for use in future clinical trials.

Other GH001 regulatory interactions

We have recently submitted a request for a pre-IND meeting with the FDA to discuss our planned filing of a U.S. IND for GH001 in TRD. The meeting has been granted by the FDA for the second quarter of 2022. The proposed IND-opening study is a Phase 1 imaging study in patients with TRD designed to further elucidate the mechanism of action of GH001 (GH001-TRD-104). There are no current plans for additional regulatory meetings with other agencies.

Intellectual property

We have recently filed a number of new patent applications, which have not yet been published, that relate to further aspects of 5-MeO-DMT use in a therapeutic context, including novel manufacturing methods of 5-MeO-DMT, novel salt forms of 5-MeO-DMT and novel uses of 5-MeO-DMT.

Financial

Cash was approximately $273.8 million as of February 28, 2022, and we believe that our existing cash will be sufficient for us to fund our operating expenses and capital expenditure requirements into 2025.

Filing of Annual Report on Form 20-F

In connection with the announcement of our full year 2021 financial highlights, we have filed our annual report on Form 20-F with the U.S. Securities and Exchange Commission. The annual report is available on our website at www.ghres.com and shareholders may receive a hard copy free of charge upon request.

About GH Research PLC

GH Research PLC is a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders. GH Research PLC’s initial focus is on developing its novel and proprietary 5-MeO-DMT therapies for the treatment of patients with treatment-resistant depression (TRD).

About GH001

Our lead product candidate, GH001, is formulated for 5-MeO-DMT administration via a proprietary inhalation approach. With GH001, we have completed two Phase 1 healthy volunteer clinical trials and a Phase 1/2 clinical trial in patients with treatment-resistant depression (TRD). Based on the observed clinical activity, where 87.5% of patients with TRD were brought into an ultra-rapid remission with our GH001 individualized single-day dosing regimen in the Phase 2 part of the trial, we believe that GH001 has potential to change the way TRD is treated today. Across the GH001 program, no serious adverse events have been reported and GH001 was well tolerated at the investigated single dose levels and in the individualized dosing regimen.

About GH002 and GH003

GH002 is our 5-MeO-DMT product candidate formulated for administration via a proprietary injectable approach. GH003 is our 5-MeO-DMT product candidate formulated for administration via a proprietary intranasal administration approach. GH002 and GH003 are currently in preclinical development, and we anticipate developing them in subpopulations and confined use scenarios within our focus area of psychiatric and neurological disorders.

Forward-Looking Statements

This press release contains statements that are, or may deemed to be, forward-looking statements. All statements other than statements of historical fact included in this press release, including statements regarding our future results of operations and financial position, our cash runway, business strategy, product candidates, research pipeline, ongoing and currently planned preclinical studies and clinical trials, regulatory submissions and approvals, research and development costs, timing and likelihood of success, as well as plans and objectives of management for future operations are forward-looking statements. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this document speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Investor Relations:
Julie Ryan
GH Research PLC
investors@ghres.com

GH RESEARCH PLC

Consolidated Statement of Comprehensive Income

(in thousands, except share and per share amounts)

		Year ended December 31,
		2021	2020	2019
		$’000	$’000	$’000
Operating expenses
Research and development		(8,553)	(338)	(296)
General and administration		(6,547)	(108)	(14)
Loss from operations		(15,100)	(446)	(310)
Finance expense		(9)	—	—
Foreign currency translation differences		5,907	—	—
Loss before tax		(9,202)	(446)	(310)
Tax charge/(credit)		—	—	—
Loss for the year		(9,202)	(446)	(310)
Other comprehensive income/(expense)
Items that may be reclassified to profit or loss
Currency translation adjustment		(6,103)	212	(12)
Total comprehensive loss for the year		(15,305)	(234)	(322)
Attributable to owners:
Loss for the year		(9,202)	(446)	(310)
Comprehensive loss for the year		(15,305)	(234)	(322)
Loss per share
Basic and diluted loss per share (in USD)		(0.211)	(0.016)	(0.011)

GH RESEARCH PLC

Consolidated Balance Sheet

(in thousands)

		At December 31,
		2021	2020
		$’000	$’000
ASSETS
Current assets
Cash and cash equivalents		276,776	5,895
Other current assets		3,066	17
Total current assets		279,842	5,912
Non-current assets
Property, plant and equipment		82	—
Total non-current assets		82	—
Total assets		279,924	5,912
LIABILITIES AND EQUITY
Current liabilities
Trade payables		883	1
Other current liabilities		1,866	245
Total current liabilities		2,749	246
Total liabilities		2,749	246
Equity attributable to owners
Share capital		1,301	871
Additional paid-in capital		291,448	5,430
Other reserves		366	—
Foreign currency translation reserve		(5,903)	200
Accumulated deficit		(10,037)	(835)
Total equity		277,175	5,666
Total liabilities and equity		279,924	5,912