Mydecine Reports Third Quarter 2021 Financial Results and



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

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

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

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

Business Highlights During and Subsequent to the Third Quarter 2021

Clinical Trials

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

IP Portfolio

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

Technology

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

Corporate

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

Financial Results for the Third Quarter 2021

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

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

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

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

For more information, please contact:

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

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

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

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

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

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

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

As at,   September 30,
2021

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

        

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

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

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